Health Archives - Page 5 of 30

Traws Pharma (TRAW) – Traws Reports 2Q24 and Gives Post-Acquisition Update

Posted on August 16, 2024August 16, 2024 by cpereira@noblefcm.com

Friday, August 16, 2024

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 a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications. Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma.

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.

Operations Were Integrated During The Second Quarter. Traws Reported a 2Q24 loss of $123.1 million or $(4.87) per share, including a $117.5 million charge for in-process research and development related to the acquisition of Transfynydd. Excluding the charge, net loss would have been around $5.7 million or about $(0.22) per share. The company ended the quarter with $16.4 million in cash, which we expect to fund operations and clinical milestone announcements through the end of 2024.

Influenza Program Is In Phase 1.TRX100 (tivoxavir marboxil) is a cap-dependent endonuclease inhibitor for influenza. Inhibition of this enzyme in the influenza virus inhibits viral replication of both influenza A and B strains. Early dosing studies have shown safety and tolerability, with data to support a single oral dose for therapeutic or prophylactic use. A Phase 1 dose single-dose escalation study is currently in progress.

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Unicycive Therapeutics (UNCY) – 2Q24 Reported With Guidance For NDA Submission By End Of August

Posted on August 15, 2024August 15, 2024 by cpereira@noblefcm.com

Thursday, August 15, 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.

OLC Data and NDA Dominated 2Q24. Unicycive reported 2Q24 income of $3.0 million or $0.08 per share and a loss of $(0.15) on a fully diluted basis. Loss from operations for 2Q24 was $7.4 million, with a gain of $16.8 million from the change in fair value of warrant conversion. This offsets a charge of $11.8 million in 1Q24, bringing the six-month total for fair value of warrant conversion to $5.0 million. Cash on June 30 was $41.8 million, which we expect to fund operations into 2H25.

Pivotal Study Met Its Endpoints and Showed Patients Reaching Target Levels. As discussed in our Research Note on June 26, Unicycive reported results from its OLC pivotal study met its tolerability and safety endpoints with data that compares favorably with Fosrenol (lanthanum carbonate). Over 90% of the patients were able to lower their serum phosphate to target levels, with 70% reaching target at the lowest dose tested. We believe these results could make OLC highly competitive in the marketplace.

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Schwazze (SHWZ) – Post Call Notes and Updated Model

Posted on August 15, 2024August 15, 2024 by cpereira@noblefcm.com

Thursday, August 15, 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.

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Audit. Schwazze and its auditor are working diligently to complete the necessary re-audit of the 2023 financials. While management did not provide a timetable, we believe the process will be completed in the near-term. No material misstatements have been uncovered to date. Once audited financials are filed, we expect the Company to apply for re-listing of its shares.

Re-Scheduling. We continue to expect re-scheduling to occur in the near-term, which will have a positive impact on the entire industry. Schwazze continues to believe the elimination of 280e taxes will have a significant impact on cash flows for the Company. The Company also will seek to refile past tax returns to capture prior excess taxes paid under 280e.

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Cocrystal Pharma (COCP) – 2Q24 Reported With Focus On Influenza

Posted on August 15, 2024August 15, 2024 by cpereira@noblefcm.com

Thursday, August 15, 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 Programs Reported Strong Progress. Cocrystal reported a 2Q24 loss of $5.3 million or $(0.54) per share, with $18.1 million in cash on June 20, 2024. The Phase 2a human challenge study testing the influenza vaccine CC-42344 is on schedule to report results later in 2025. During the quarter, preclinical testing for CC-42344 showed efficacy against the avian influenza A (H5N1), a new strain that has infected dairy cattle and has jumped to humans. Separately, CDI-988 reached a Phase 1 clinical milestone and is expected to report full top-line results for coronavirus and norovirus in late 2024/early 2025.

CC-42344 Moves Forward. CC-42344 is a vaccine for influenza that works through inhibition of PB2, a viral enzyme needed for early steps in the reproduction cycle of the influenza virus. CC-42344 has completed enrollment in a Phase 2a study testing the vaccine in human volunteers in the UK. Data is expected later in 2024, to be followed by an IND for clinical studies in the US. An inhaled version is currently in toxicology studies, with Phase 1 studies for prophylactic and post-exposure therapeutic use planned for 2025.

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Schwazze (SHWZ) – A First Look into 2Q24 Results

Posted on August 14, 2024August 14, 2024 by cpereira@noblefcm.com

Wednesday, August 14, 2024

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.

Results. Revenue of $43.2 million increased 2% y-o-y and was in-line with our $43 million estimate. Gross profit margin fell to 44% from 54.4% a year ago, but was in-line with our 43.6% projection. The GM decline reflects ongoing pricing pressure in both Colorado and New Mexico, as well as a greater mix of 3rd-party products in New Mexico and higher medical sales in Colorado. Schwazze reported a net operating loss of $2.7 million and a net loss of $13.9 million, or $0.20/sh. We were at a net loss of $0.19/sh.

Quarter Highlights. Schwazze generated sequential quarterly growth across all key financial metrics during the quarter. The Company continued to focus on sharper pricing and promotional strategies to drive store traffic and market share in both Colorado and New Mexico. Wholesale margins continued to show improvement.

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PDS Biotechnology (PDSB) – PDS 2Q24 Financial Results Recap A Productive Quarter

Posted on August 14, 2024August 14, 2024 by cpereira@noblefcm.com

Wednesday, August 14, 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.

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FDA Alignment Allows Phase 3 To Move Forward. PDS Biotech announced a loss of $8.3 million or $(0.23) per share for 2Q24. Cash at June 30, 2024, was $57.7 million, which we estimate to be sufficient to fund operations into 2H25. The company announced FDA alignment on the design of the Phase 3 VERSATILE-003 Plus trial, with preparations underway to begin the trial by year-end.

Meeting Results Confirmed Three-Arm Design Of Phase 3. PDS held a Pre-Phase 3 meeting with the FDA to get alignment on the design and analysis of the Phase 3 VERSATILE-003 Plus trial with the additional treatment arm testing the Triplet Combination of Versamune HPV, PDS01ADC, and Keytruda. The company’s immediate focus will be to start the VERSAMUNE-003 doublet arm by YE2024 while conducting the dose optimization stage separately. The design of the trial was discussed in our Research Note on July 9.

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Cadrenal Therapeutics (CVKD) – 2Q24 Financial Report Confirms Discussions With Abbott For Tecarfarin Development

Posted on August 8, 2024August 8, 2024 by cpereira@noblefcm.com

Thursday, August 08, 2024

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

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LVAD Development Takes The Spotlight Cadrenal reported 2Q24 loss of $2.4 million or $(0.15) per share. Tecarfarin development in ESRD with AFib continues, and the FDA granted Orphan Drug Designation for tecarfarin in implanted circulatory support devices, such as LVADs. The company also confirmed that it was in discussions with Abbott (ABT, Not Rated) to develop tecarfarin as an anticoagulant for LVAD patients. We believe this disclosure could lead to a development agreement between the two companies.

Discussions With Abbott Confirmed. Abbott makes the HeartMate 3 LVAD device and has presented data from its ARES-HM3 study highlighting the need for an improved anticoagulant in LVAD patients. This presentation was discussed in our Research Note on June 5. While a collaboration has not been announced, confirmation of discussions for a pivotal trial testing tecarfarin in LVAD patients is good news.

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GeoVax Labs (GOVX) – GeoVax Highlights Trial Progress In 2Q24 Report

Posted on August 7, 2024August 7, 2024 by cpereira@noblefcm.com

Wednesday, August 07, 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.

GeoVax Made Significant Advances In 2Q24. GeoVax reported a 2Q24 loss of $5.1 million or $(1.99) per share. The company reviewed the progress made during the quarter, including the DARPA grant for the Phase 2 CM04S1 trial, two CM04S1 trials in immunocompromised cancer patients, and announcement of the Phase 2 Gedeptin trial design.

Financial Results Reflect First Grant Revenues. During 2Q, GeoVax recognized $0.3 million in revenues from work related to the Phase 2 CM04S1 trial. Revenue is recognized as the work is completed on a cost-reimbursement basis, with billings recorded as receivables. The company had $1.6 million in cash on June 30 and plans to raise capital in the near future.

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New Hope for Rare Disease Patients: FDA Panel Backs Zevra’s Drug

Posted on August 5, 2024August 5, 2024 by slightbourne@noblecapitalmarkets.com

Key Points:
– FDA advisory panel recommends approval of arimoclomol for Niemann-Pick disease type C (NPC).
– If approved, arimoclomol would be the first FDA-approved treatment for NPC in the US.
– Final FDA decision expected by September 21, 2024.

In a significant development for patients with a rare and devastating brain disease, an FDA advisory panel has recommended approving arimoclomol, a drug developed by Zevra Therapeutics. This decision marks a potential turning point in the treatment of Niemann-Pick disease type C (NPC), a condition that currently lacks FDA-approved therapies in the United States.

NPC is a serious genetic disorder that impairs the body’s ability to process and transport fats, leading to their accumulation in various organs, including the brain. This buildup causes progressive neurological damage, severely impacting patients’ quality of life. The disease is caused by mutations in either the NPC1 or NPC2 genes, which are responsible for producing proteins involved in cellular cholesterol transport.

Arimoclomol’s journey to potential approval has been marked by setbacks and perseverance. In 2021, the FDA initially rejected the drug, requesting additional evidence of its efficacy. However, under the new ownership of Zevra Therapeutics (formerly KemPharma), arimoclomol has found new life. The company submitted a reinforced New Drug Application (NDA) with additional long-term data, which seems to have addressed the FDA’s previous concerns.

The FDA’s Genetic Metabolic Diseases Advisory Committee (GeMDAC) voted 11 to 5 in favor of approving arimoclomol. This recommendation is based on a comprehensive review of clinical data, including results from a pivotal trial and a four-year open-label extension study. These studies demonstrated a decrease in the NPC Clinical Severity Scale (NPCCSS) score compared to placebo, indicating a meaningful clinical benefit for patients.

Arimoclomol works by inducing the heat shock response in cells, which helps to correct the protein misfolding that contributes to NPC. This novel approach has earned the drug several FDA designations, including orphan drug, fast track, breakthrough therapy, and rare pediatric disease status, underscoring its potential significance in treating this devastating condition.

If approved, arimoclomol would become the first FDA-approved treatment for NPC in the United States. Currently, US patients rely on off-label use of miglustat (Zavesca), which is approved for NPC in some European countries. The FDA’s final decision on arimoclomol is expected by September 21, 2024, the Prescription Drug User Fee Act (PDUFA) action date for the NDA.

The market implications of arimoclomol’s potential approval are substantial. GlobalData forecasts that the NPC drug market could reach $220 million by 2031 across the US, Germany, and the UK. This represents a significant opportunity for Zevra Therapeutics and, more importantly, a beacon of hope for NPC patients and their families.

Zevra’s CEO, Neil McFarlane, expressed confidence in arimoclomol’s clinical benefit and optimism about its path to approval. The company’s persistence in addressing the FDA’s initial concerns and providing robust long-term data has seemingly paid off, potentially bringing a much-needed treatment option to a patient population with limited choices.

This story underscores the complex and often challenging path of drug development for rare diseases. It highlights the importance of persistence and comprehensive clinical data in addressing regulatory concerns and ultimately bringing innovative treatments to patients in need. If approved, arimoclomol could significantly improve the lives of people with NPC, offering hope to a community that has long awaited an effective treatment option.

MustGrow Biologics Corp. (MGROF) – Tack On Another Approval

Posted on August 1, 2024August 1, 2024 by cpereira@noblefcm.com

Thursday, August 01, 2024

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

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

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Another State. MustGrow announced the Company has received the Idaho State Department of Agriculture approval for TerraSante, allowing the product to commence sales in the state. The state follows the existing Organic OMRI Listed certifications in Oregon and Washington. Idaho now joins the list of states to authorize product sales, including the aforementioned Oregon and Washington and California.

Market Size. Idaho provided approximately $1.3 billion in crop production from potatoes in 2023, an increase from $1.2 billion in 2022, as potatoes are the state’s top crop. Other commodities the state provides includes barley, alfalfa hay, peppermint oil, and food trout. Overall, the state’s crop production was $3.3 billion in 2021.

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GeoVax Labs (GOVX) – Gedeptin Phase 2 Head and Neck Trial Design Announced

Posted on August 1, 2024August 1, 2024 by cpereira@noblefcm.com

Thursday, August 01, 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.

Gedeptin Will Be Tested As A Neoadjuvent. GeoVax announced the design of the Phase 2 trial testing Gedeptin in head and neck cancer. As planned, a Clinical Advisory Panel completed its data review from the clinical trials and made its design recommendation. The trial will test Gedeptin in combination with an immune checkpoint inhibitor (ICI) before surgery in head and neck squamous cell carcinoma (HNSCC) patients after first recurrence. The trial is expected to start in 1H25.

Trial Will Use A Single Cycle Of Gedeptin Before Surgery. The trial will enroll patients with HNSCC after first relapse. Patients will be treated with a single cycle of Gedeptin/fludarabine and a checkpoint inhibitor, followed by surgery. This adds Gedeptin’s intracellular activation of a chemotherapy agent to kill cancer cells with the immune response of the checkpoint inhibitor. The planned enrollment is 36 patients with a primary endpoint of pathological response rate.

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Eledon Pharmaceuticals (ELDN) – Eledon Announces Patient Enrollment Milestone and Confirms Timeframe For Completion

Posted on July 30, 2024July 30, 2024 by cpereira@noblefcm.com

Tuesday, July 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.

Eledon Announced It Has Reached Two-Thirds Patient Enrollment Milestone. Eledon has enrolled its 80thpatient in the Phase 2 BESTOW trial testing tegoprubart against tacrolimus for prevention of kidney transplant rejection. The trial is expected to reach its full enrollment of 120 patients by YE2024 as expected.

The BESTOW Trial Is Designed To Compare Tegoprubart To Tacrolimus. The Phase 2 BESTOW trial is an open-label active-comparator trial comparing tegoprubart directly against tacrolimus, the standard of care in kidney transplantation. The primary endpoint is superior mean eGFR (a measure of kidney graft function) at 12 months post-transplant, with additional endpoints to provide clinically meaningful measures for comparison with tacrolimus.

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Tonix Pharmaceuticals (TNXP) – A Mid-Summer Month’s Progress: Tonmya Gets Fast Track Review and Antiviral Gets $34 Million Grant

Posted on July 29, 2024July 29, 2024 by cpereira@noblefcm.com

Monday, July 29, 2024

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.

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Tonix Announced Two Significant Developments In Late July. Tonmya (TNX-102 SL) has received Fast Track Review designation from the FDA. This designation is awarded to products that can make significant impact on serious medical conditions. The designation provides important benefits for Tonmya including eligibility for Accelerated Approval and Priority Review Fast Track Review. The NDA application for approval is expected to be filed in 2H24.

Fast Track Review Is A Significant Distinction. The FDA awards Fast Track Review to drugs that treat serious conditions with unmet needs. It is given when the FDA believes the drug is either providing a therapy where none exists and/or has meaningful advantages over existing therapies. We have long believed the Tonmya Phase 3 data meets both requirements.

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