Health Archives - Page 18 of 31

Eledon Pharmaceuticals (ELDN) – Initiating Coverage With An Outperform Rating and $10 Price Target

Posted on September 27, 2023September 27, 2023 by cpereira@noblefcm.com

Wednesday, September 27, 2023

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.

We Are Initiating Coverage Of EledonPharmaceuticals. Eledon is developing tegoprubart, an anti-CD40L antibody to modulate the immune response. Phase 1b and Phase 2 clinical trials in progress for prevention of kidney transplant rejection. The clinical trial program is designed to show superiority to the immunosuppressive drugs that are currently the standard of care after organ transplants.

Tegoprubart Blocks CD40/CD40L. Tegoprubart blocks the step in the immune response where the CD40 ligand (CD40L, also known as CD154) on T cells interacts with the CD40 receptor on either B cells or antigen-presenting cells. This binding connects the innate and adaptive immune systems and leads to a full immune response. Tegoprubart binds to the CD40L to block this step, inhibiting both B cell maturation and T-cell proliferation that leads to cellular immune responses.

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Alfasigma Makes Big Bet on Liver Disease With $1.25 Billion Intercept Buyout

Posted on September 27, 2023September 27, 2023 by slightbourne@noblecapitalmarkets.com

Italian pharma Alfasigma is expanding its gastroenterology portfolio in a major way with the proposed $1.25 billion acquisition of Intercept Pharmaceuticals. The all-cash deal provides Alfasigma with Intercept’s leading drug Ocaliva and a strengthened pipeline in progressive liver diseases.

Alfasigma will pay $19 per share to acquire Intercept, representing an 82% premium over Intercept’s share price before the deal announcement. The purchase price reflects a big bet on Ocaliva’s growth prospects and Intercept’s broader capabilities in rare liver conditions.

Ocaliva is the key asset Alfasigma gains from the deal. It’s the only FDA approved second-line treatment for primary biliary cholangitis (PBC), a progressive autoimmune disorder that damages the bile ducts in the liver. Ocaliva hit $152 million in sales over the first half of 2023 alone, underscoring its rapid growth trajectory.

Beyond Ocaliva, Alfasigma also adds Intercept’s emerging pipeline of novel therapies for PBC and other liver diseases. The crown jewel is a promising fixed-dose combination regimen that could transform the PBC treatment paradigm.

Take a look at Noble Capital Markets Senior Life Sciences Analyst Robert LeBoyer’s coverage universe.

The deal dramatically expands Alfasigma’s presence in the high-value U.S. pharma market. Previously focused primarily on the Italian market, the Intercept acquisition gives Alfasigma an anchor asset and commercial team in the U.S.

Strategically, the move aligns with Alfasigma’s vision to build up its gastroenterology and hepatology business. CEO Francesco Balestrieri highlighted Intercept’s compelling strategic fit with Alfasigma’s focus in these therapeutic areas.

Expect Alfasigma to invest heavily to maximize Ocaliva’s potential. The company sees major commercial expansion opportunities to extend Ocaliva’s reach across PBC patient populations. Alfasigma also gains Intercept’s seasoned specialty sales force to drive prescription growth.

With Intercept operating as a wholly-owned subsidiary once the buyout closes, Alfasigma is well-positioned to become a global force in progressive liver diseases. The deal enhances Alfasigma’s standing as an emerging player in the U.S. pharma market.

Look for Alfasigma to continue seeking acquisition targets to accelerate its growth. The company has the financial firepower to pursue additional deals that build up its portfolio. If the Intercept acquisition is any indication, Alfasigma has appetite for bold, transformative M&A.

The proposed buyout still requires regulatory and shareholder approval. But with a massive 82% premium offered, Intercept shareholders are likely to approve the $19 per share deal price. Expect Alfasigma to move rapidly to complete the acquisition by the end of 2023.

Release – Eledon Pharmaceuticals Announces Use of Tegoprubart anti-CD40L Antibody in Second-ever Transplant of Genetically Modified Heart from a Pig to a Human

Posted on September 25, 2023September 26, 2023 by aweinsoff@channelchek.com

Research News and Market Data on ELDN

Landmark cardiac xenotransplantation procedure conducted at University of Maryland Medical Center

Tegoprubart, administered investigationally to prevent organ rejection post-transplant, targets the CD40L pathway known to play an essential role in both innate and adaptive immune cell activation and function.

IRVINE, Calif., Sept. 25, 2023 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that tegoprubart, the company’s investigational anti-CD40 antibody, was used as a cornerstone component of the chronic immunosuppressive regimen administered following the second-ever transplant of a genetically modified heart from a pig to a human. The procedure was completed on September 20th at University of Maryland Medical Center on a 58-year-old male suffering from heart failure.

“This is a momentous milestone for the transplant community and serves as a testament to the continued progress being made towards advancing novel treatment options for patients requiring an organ transplant,” said David-Alexandre C. Gros, M.D., Eledon Chief Executive Officer. “As the field of organ transplantation continues to make important scientific advances, Eledon is dedicated to delivering a novel immunosuppressive regimen with the potential to protect and prevent rejection of transplanted organs, and we are honored to play a role in this historic development.”

Following the successful transplantation, tegoprubart was administered to the patient as a novel, key component of a chronic immunosuppressive regimen designed to suppress the immune system and prevent the body from rejecting the implanted organ. In prior clinical research, tegoprubart has demonstrated a favorable safety and tolerability profile across multiple indications, including kidney transplantation, as well as clinical benefit in the prevention of rejection and the protection of organs after transplantation.

“The historic procedure we conducted on our courageous patient brings us to a pivotal moment in the history of organ transplantation. It is also a critical step in our ongoing mission to address the growing shortage of available organs,” said Muhammad M. Mohiuddin, MD, professor of surgery at University of Maryland School of Medicine (UMSOM) and scientific/program director of its Cardiac Xenotransplantation Program. “The ability to expand options in all areas including access to available organs and strategies to reduce the risk of rejection means that we are getting closer to realizing the full potential of transplantation for patients. I look forward to continued advancements so that we can hopefully make xenotransplantation an available organ source for patients in the years ahead.”

Eledon is advancing multiple research efforts related to the use of tegoprubart to reduce the risk of rejection in organ transplant. In collaboration with eGenesis, the company is currently advancing preclinical studies in which tegoprubart will be administered as part of an immunosuppression regimen to reduce the risk of rejection in nonhuman primate recipients in xenotransplant procedures. The company recently announced initiation of patient dosing in the phase 2 BESTOW clinical trial to further assess the use of tegoprubart in kidney transplantation and expects to present an updated readout from its ongoing phase 1b kidney transplantation study in November 2023. BESTOW is a head-to-head superiority study evaluating tegoprubart vs. standard of care in kidney transplantation, with a primary endpoint assessment of kidney graft function (eGFR) at 52 weeks.

The Risk of Organ Failure in Transplantation

In transplantation procedures, organ rejection is a major cause of graft failure which can be a life-threatening condition. To reduce the risk of organ damage and rejection, patients are typically treated with immunosuppressive therapies including calcineurin inhibitors (CNIs) such as tacrolimus. Strategies to better and more safely protect transplanted organs and thus increase how long they function represent a significant area of unmet need in organ transplantation.

About Eledon Pharmaceuticals and Tegoprubart (formerly AT-1501)

Eledon Pharmaceuticals is a clinical stage biotechnology company with immunology expertise that is developing therapies to protect and prevent rejection of transplanted organs, as well as to treat amyotrophic lateral sclerosis (ALS). The Company’s lead compound in development is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand (also called “CD154”), a well-validated biological target with broad therapeutic potential. Eledon is headquartered in Irvine, California. For more information, please visit the company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about planned clinical trials and the Company’s other future expectations, plans and prospects, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

GeoVax Labs, Inc. (GOVX) – Positive Data From CM04S1 Phase 2 and Preclinical Trials

Posted on September 25, 2023September 25, 2023 by cpereira@noblefcm.com

Monday, September 25, 2023

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.

GEO-CM04S1Phase 2 Clinical and Preclinical Data Show Efficacy. GeoVax announced publication of initial Phase 2 data from the CM04S1 trial in immunocompromised patients that showed significant immune responses. A poster presentation at a medical meeting showed preclinical data on CM04S1 efficacy against multiple variant strains. We believe both publications support our expectations that CM04S1 can effectively stimulate both humoral and cellular immunity.

Initial Responses Seen In Immunocompromised Patients. GeoVax announced the publication of initial data from its Phase 2 trial for GEO-CM04S1 in immunocompromised patients with hematological malignancies in the journal Vaccines. The data showed both humoral and cellular immune responses in patients with reduced immune function that have difficulty responding to vaccination. The immune markers were superior or comparable to historical cohorts from healthy patients receiving the Pfizer mRNA vaccine.

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Biotech Company Abpro Poised for Growth Through Merger with SPAC

Posted on September 25, 2023September 25, 2023 by slightbourne@noblecapitalmarkets.com

Abpro, an emerging biotechnology company developing novel antibody therapies, has entered into a definitive agreement to go public via a merger with Atlantic Coastal Acquisition Corp. II, a special purpose acquisition company (SPAC). The deal values Abpro at $725 million and will provide capital to advance its drug pipeline.

Abpro specializes in leveraging its proprietary technology platform to create next-generation antibody treatments for cancer, eye diseases, and viral infections. The company aims to develop breakthrough immunotherapies to help patients facing life-threatening conditions.

Though Abpro is still in the preclinical phase, it has made significant progress with its pipeline of antibody therapies. Its lead candidates target HER2+ cancers, which include aggressive forms of breast, gastric, and colorectal cancer. Abpro is also pursuing antibodies for COVID-19 treatment and ophthalmic conditions like wet AMD and DME.

Last year, Abpro announced a partnership with South Korea’s Celltrion to further develop ABP 102, an antibody-based treatment for HER2+ cancers. Under the deal, Abpro received a direct equity investment from Celltrion along with eligibility for up to $1.75 billion in milestone payments.

Abpro leverages its DiversImmune platform to design diverse antibody libraries and identify optimal drug candidates. The technology enables more precise targeting compared to conventional antibodies.

Take a look at Noble Capital Markets Senior Biotechnology Research Analyst Robert LeBoyer’s coverage list.

The merger with Atlantic Coastal will provide capital for Abpro to advance its most promising therapies into clinical studies. Abpro also plans to use the funds for business development activities and expanding its pipeline.

Atlantic Coastal is a SPAC focused on finding and merging with high-potential healthcare companies. The transaction is expected to close in Q2 2024, at which point the combined company will trade publicly.

Commenting on the merger, Abpro CEO Ian Chan stated: “This milestone will accelerate getting our therapies to patients needing life-changing treatments.”

Abpro represents an attractive investment opportunity within biotech. Analysts project the global antibody technology market to reach $272 billion by 2030, driven by rising demand for targeted immunotherapies. With its next-generation platform and infusion of growth capital, Abpro is well-positioned to compete in this thriving sector.

The transaction comes amidst a wave of biotech SPAC deals, as pre-revenue companies aim to access public growth financing. With its proprietary technology and strategic partnership in place, Abpro seems poised to leverage this deal to evolve from an R&D startup into a fully integrated biopharma company.

Explore other SPAC Mergers via Spactrac reports from Noble Capital Markets

FG Merger Corp. (FGMC) – Asymmetric Return Profile Acquisition To Unlock iCoreConnect Saas Potential

Heritage Distilling Co.: Liquor With A Kicker

Boston Scientific to Acquire Relievant Medsystems for $850 Million

Posted on September 20, 2023September 20, 2023 by slightbourne@noblecapitalmarkets.com

Medical device maker Boston Scientific announced Monday it will acquire Relievant Medsystems for $850 million upfront and additional contingent payments. Relievant has developed a minimally invasive technology to treat chronic low back pain.

The deal aims to expand Boston Scientific’s portfolio in neuromodulation, the use of devices to modulate nerve activity. Relievant’s Intracept system uses targeted radiofrequency energy to ablate the basivertebral nerve, stopping pain signals from reaching the brain. It is the only FDA-cleared device specifically for vertebrogenic pain, a type of chronic back pain originating in the vertebrae.

Relievant’s system is designed to provide long-term pain relief and improve function through an outpatient procedure. It targets an estimated 5.3 million patients in the U.S. with vertebrogenic pain from degenerative disc disease or vertebral compression fractures. Boston Scientific cited Relievant’s novel technology and strong clinical data from multiple randomized controlled trials in deciding to acquire the company.

The Intracept procedure is implant-free, sparing patients from potential complications associated with implants. It also avoids destroying the intervertebral disc. The system has been used to treat over 2,000 patients since receiving FDA clearance in 2018 based on Level 1 clinical evidence.

The deal expected to close in the first half of 2024 pending approvals. Boston Scientific said Relievant is projected to generate over $70 million in sales this year with 50%+ growth in 2024. The acquisition is forecasted to be neutral or slightly accretive to Boston Scientific’s adjusted earnings per share.

“We look forward to working with the Relievant team to expand access to care for those with chronic back pain,” said Jim Cassidy, president of Neuromodulation at Boston Scientific. Both companies aim to transform the diagnosis and treatment of vertebrogenic pain through a minimally invasive approach.

Take a moment to take a look at Noble Capital Markets Senior Research Analyst Gregory Aurand’s coverage list.

Ocugen (OCGN) – OCU400 Update Shows Improvement In Three Vision Measures

Posted on September 14, 2023September 14, 2023 by cpereira@noblefcm.com

Thursday, September 14, 2023

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.

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Data Shows Clinically Meaningful Improvements. Ocugen provided an update to the Phase 1/2 clinical trial data for OCU400 in retinitis pigmentosa (RP) and Leber congenital amaurosis (LCA), two rare diseases in which genetic mutations cause loss of vision and progress to blindness. We see these data as clinically meaningful for these indications as well as providing proof-of-concept for Ocugen’s method of targeting a “master control gene” that has downstream effects on other genes.

We See Proof-of-Concept For The “Master Control Gene” Approach. RP is a group of genetic disorders with over 100 possible genetic mutations that may be present and contributing to loss of vision. This makes the course of disease highly variable and difficult to target with a single therapy. Ocugen has been developing OCU400 to target the RHO and NR2E3 genes that control pathways and regulate other genes that act later in those pathways. The data show that OCU400 can affect several genetic pathways in eye, with improvements in three measures of vision.

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Rocket Shares Soar as FDA Aligns on Danon Disease Gene Therapy Trial

Posted on September 14, 2023September 14, 2023 by slightbourne@noblecapitalmarkets.com

Rocket Pharmaceuticals (NASDAQ: RCKT) announced it has reached alignment with the U.S. Food and Drug Administration (FDA) on the design of a global pivotal Phase 2 trial for its gene therapy RP-A501 in Danon Disease. This marks an important milestone on the path to delivering a potentially transformative treatment for this devastating inherited cardiomyopathy.

Danon Disease is caused by genetic mutations in the LAMP2 gene leading to fatal heart failure. There are currently no approved therapies. The disease affects an estimated 15,000 to 30,000 patients in the U.S. and Europe, taking the lives of most males by age 20 and females by 40. RP-A501 aims to be the first-ever therapy to change the course of Danon Disease.

The news sent Rocket’s stock price soaring 34% to $20.46 in after-hours trading on Tuesday, as investors welcomed the positive regulatory update.

The planned Phase 2 pivotal trial will be a global, single-arm, open label study enrolling 12 Danon Disease patients. This includes a pediatric safety lead-in of 2 patients. All participants will receive a dose of 6.7 x 1013 GC/kg of RP-A501 delivered through intravenous infusion.

To support potential accelerated approval by the FDA, the co-primary efficacy endpoints at 12 months are LAMP2 protein expression and reduction in left ventricular mass, a key measure of heart damage. Expression of LAMP2, which is deficient in Danon patients, and decreased cardiac hypertrophy would signal RP-A501 is restoring cardiac function at its root genetic cause.

Take a moment to look at Ocugen Inc., a biotechnology company focused on discovering, developing and commercializing novel gene and cell therapies and vaccines.

Secondary trial endpoints consist of the biomarker troponin, heart failure questionnaires, functional classification, event-free survival, and safety. These could support eventual full approval. A concurrent global natural history study will provide an external control arm for comparison.

According to Rocket CEO Dr. Gaurav Shah, “RP-A501 has the potential to restore normal cardiac function and provide a lifetime of benefit to patients with Danon Disease who have no other viable treatment options.” The company believes this pivotal trial design sets the most rapid path to deliver RP-A501 to patients in dire need.

Rocket’s gene therapy approach involves using an engineered virus called AAV9 to deliver a functional LAMP2 gene into patients’ heart cells. The gene insert encodes LAMP2B, a key protein involved in the cellular recycling process called autophagy. Restoring LAMP2B in the heart could potentially halt the accumulation of cellular debris and improve cardiac structure and function.

The company has already manufactured sufficient high-quality RP-A501 drug product at its in-house cGMP facility to supply the full pivotal Phase 2 trial. Qualified potency assays are also in place to support quality control and regulatory compliance.

Looking ahead, Rocket plans to file a Clinical Trial Application in the EU in Q3 2023 to initiate study activities abroad. The company also recently secured an ICD-10 code from the Centers for Medicare and Medicaid Services for LAMP2 deficiency, which will support diagnostic efforts.

This alignment with the FDA represents a major achievement for both Rocket and the Danon Disease community. RP-A501 would be the first-ever approved treatment for this deadly cardiovascular condition. The gene therapy aims to be a one-time curative infusion that could provide transformative and lifelong benefits to affected patients.

Beyond Danon Disease, Rocket believes this program paves the way for developing genetic medicines against other inherited heart diseases. Cardiac gene therapy has long faced hurdles, but the company is forging a new path for treating genetic cardiovascular conditions at their root.

With the pivotal Phase 2 trial design now locked in, Rocket can move full speed ahead on enrolling patients and gathering data to support potential approval. The company expects to release initial results from the trial evaluating RP-A501 in 2024. This could lead to a approved treatment for Danon Disease in the not too distant future—bringing tremendous hope to patients and families affected by this devastating illness.

Tonix Pharmaceuticals announces poster presentation involving TNX-1700 in preclinical colorectal cancer models at the 7th International Cancer Immunotherapy Conference 2023.

Mainz Biomed Reports Strong ColoAlert Data, Identifies Biomarkers for FDA Trial

Posted on September 13, 2023September 13, 2023 by slightbourne@noblecapitalmarkets.com

Mainz Biomed (NASDAQ:MYNZ) announced highly positive results this week from its ColoFuture clinical trial evaluating the integration of novel mRNA biomarkers into its ColoAlert screening test for colorectal cancer. The results demonstrated ColoAlert’s strong performance for detecting colorectal cancer and advanced adenomas, while also identifying promising biomarkers to further improve early detection capabilities.

The ColoFuture study is a multi-center international trial assessing whether integrating recently acquired mRNA biomarkers from Université de Sherbrooke can enhance ColoAlert’s sensitivity and specificity profile. ColoAlert is Mainz’s flagship product, a simple yet highly accurate home-based test using stool samples to detect colorectal cancer and advanced precancerous adenomas.

The product is already commercialized across Europe and select international territories. However, ColoFuture aimed to identify ways to further extend ColoAlert’s technical capabilities in preparation for an upcoming U.S. clinical trial that could lead to FDA approval.

Interim analysis from the ColoFuture trial included 220 subjects across centers in Germany, Norway and Denmark. On the primary endpoints for colorectal cancer detection, ColoAlert achieved 94% sensitivity and 97% specificity after integrating the novel mRNA biomarkers.

For identifying advanced adenomas, a key precursor to cancer, the updated test demonstrated 81% sensitivity. According to Mainz Biomed CEO Guido Baechler, “The power to detect lesions in a pre-cancerous stage can change the entire CRC diagnostic landscape. If advanced adenomas are identified early, they are curable.”

The positive data catalyzed strong trading volume as Mainz Biomed’s stock price rose 15% on over 1.5 million shares traded. The market enthusiastically welcomed the results.

The mRNA biomarkers evaluated in ColoFuture were specifically selected from research at Université de Sherbrooke. Published analysis of the biomarkers showed ability to detect signals from patients with either colorectal cancer or advanced adenomas. Mainz Biomed acquired these biomarker rights in January 2022.

By treating patients before polyps progress to cancer, integrating these biomarkers into ColoAlert could help prevent colorectal cancer altogether. This could greatly improve patient outcomes and reduce the burden of this deadly disease.

The positive data provides validation of ColoAlert’s accuracy as a non-invasive screening tool. It also gives Mainz Biomed multiple novel mRNA biomarkers to integrate into its upcoming U.S. clinical trial, dubbed ReconAAsense, which could support FDA approval under the PMA pathway.

According to Baechler, “As we look forward to publishing and presenting the full dataset, we eagerly await the outcome from our ReconAAsense clinical trial which remains on track to report results in Q4 of this year.”

With colorectal cancer remaining a leading cause of cancer deaths, early detection is critical. ColoAlert offers a simple, at-home solution that people can easily incorporate into routine wellness screenings. The new biomarkers identified in ColoFuture could make the test accessible to even more patients.

Mainz Biomed continues to spearhead innovation in the field, leveraging the latest advances in genetics to improve detection. The impressive ColoFuture results provides further validation of ColoAlert’s accuracy, while also charting a path forward to commercialization in the U.S.

With pivotal FDA trial data on the horizon, Mainz Biomed is positioned to disrupt the market, offering an easy yet cutting-edge approach to potentially save lives through early colorectal cancer detection.

Take a look at more biotechnology companies by viewing Robert LeBoyer’s coverage list.

Biocept Licenses Cancer Test to Plus Therapeutics in $1.5 Million Deal

Posted on September 8, 2023September 8, 2023 by slightbourne@noblecapitalmarkets.com

Biocept, Inc. (NASDAQ: BIOC) has signed a licensing agreement with Plus Therapeutics, Inc. (NASDAQ: PSTV) for Biocept’s proprietary CNSide cancer detection test. The non-exclusive deal further expands an existing partnership between the companies.

Under the agreement, Plus Therapeutics receives the right to use CNSide testing in clinical trials and commercially if approved by regulators. In return, Plus will pay Biocept $150,000 upfront in stock along with fees for each test performed.

CNSide detects, quantifies, and monitors tumor cells in cerebrospinal fluid to diagnose leptomeningeal metastases, a type of cancer affecting the brain and spinal cord membranes.

Take a look at PDS Biotechnology Corporation, a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies.

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Plus Therapeutics is currently using CNSide in a Phase 1/2a clinical trial of its targeted radiotherapy Rhenium 186 Obisbemeda for treating leptomeningeal metastases. The company will pay Biocept $6,000 for each test conducted at Biocept’s lab during the trial.

Once Biocept completes the technology transfer to enable Plus to run CNSide in-house, Plus will pay $300,000 plus $2,800 per test performed. Plus also has an option to negotiate for third-party exclusivity rights to CNSide for a $1 million payment.

The deal provides non-dilutive funding for Biocept as it seeks to establish CNSide as a standard of care. Biocept’s stock jumped 63% in pre-market trading on the news, while Plus Therapeutics rose 10%.

“We are gratified that Plus continues to recognize the value of CNSide in leptomeningeal metastases disease management,” said Biocept President and CEO Antonino Morales. “This agreement further validates the clinical utility of CNSide.”

Plus Therapeutics CEO Marc Hedrick stated CNSide is the “emerging gold standard” for diagnosing patients with leptomeningeal metastases. The licensing deal allows Plus to pair CNSide with its novel radiotherapeutic drug candidate.

The agreement highlights growing industry interest in leveraging Biocept’s proprietary technology to improve cancer detection and monitoring. As CNSide gains further validation, Biocept aims to secure additional partnerships and drive adoption of the test.

Take a moment to look at Onconova Therapeutics Inc., a clinical-stage biopharmaceutical company focused on discovering and developing novel products for cancer patients.

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MustGrow Biologics Corp. (MGROF) – Expansion of Janssen Agreement

Posted on September 7, 2023September 7, 2023 by cpereira@noblefcm.com

Thursday, September 07, 2023

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.

Expansion. MustGrow and Janssen PMP have announced an expansion of their Exclusive Evaluation and Option Agreement to now include postharvest potatoes and bananas globally. We view the announcement as further evidence of the efficacy of MustGrow’s biological mustard plant-based technologies and another step in the path to commercialization.

Janssen. Over the past 15 months of postharvest evaluation work, Janssen PMP and MustGrow have produced very encouraging and efficacious results, supporting the decision to add postharvest potatoes and bananas to Janssen PMP’s exclusive evaluation work. According to Janssen, “The postharvest banana market is one of our historical markets where the need for natural fungicides is growing. Also, developing a natural technology acting as an anti-sprouting and as a fungicide for stored potatoes is a major opportunity for Janssen PMP…”

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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).

Tonix Pharmaceuticals (TNXP) – Long COVID Study Did Not Meet Primary Endpoint But Provides Important Data

Posted on September 6, 2023September 6, 2023 by cpereira@noblefcm.com

Wednesday, September 06, 2023

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

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

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

Phase 2 PREVAIL Study Announces Mixed Results. Tonix announced that the Phase 2 PREVAIL study testing TNX-102 SL in Long COVID did not meet its primary endpoint of multi-site pain reduction at week 14. The study was able to improve several important symptoms of Long COVID that could become acceptable endpoints in a Phase 3 trial.

Several Measures Showed Benefits In The Trial. PREVAIL was a blinded placebo-controlled study with an enrollment of 63 patients. Several secondary endpoints showed consistent benefits over the course of the study. These include fatigue, sleep quality, cognitive function, disability, and the Patient Global Impression of Change (PGIC). We believe these data show the drug can reduce several important symptoms of Long COVID.

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

Posted on August 31, 2023August 31, 2023 by cpereira@noblefcm.com

Thursday, August 31, 2023

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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2Q2023 Results. MustGrow reported zero revenue and a net loss of CAD$1.2 million, or a loss of $0.02 per share, during the quarter. We estimated revenue of CAD$1,000 and a net loss of $1.0 million. Similar to last quarter, we anticipate comparable quarterly results going forward until MustGrow receives regulatory approval in at least one market.

Capital and Cash Flows. MustGrow had cash of CAD$5.0 million at the end of the second quarter, down from CAD$6.1 million in the previous quarter, with the Company using cash of CAD$1.1 million of CFFO. We estimate that the Company currently has an approximate 14 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).