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.
Patients With LVADs Need A New Anticoagulant. A new analysis of anticoagulant regimens from a study in cardiovascular devices patients was presented at the International Society of Heart and Lung Transplantation Annual Meeting. The presentation included data from the ARIES-HM3 study testing anticoagulation with warfarin and aspirin against warfarin alone. We believe the data highlights the need for tecarfarin in left ventricular assist device (LVAD) patients.
Abbott Has An Interest In LVAD Patient Outcomes. The ARIES-HM3 study was sponsored by Abbott (ABT, Not Rated), maker of the HeartMate3 LVAD. Patients with these devices cannot take DOAC anticoagulant drugs, leaving them with only warfarin. The study tested warfarin (a vitamin K antagonist, VKA) with and without aspirin. The findings showed lower time in the therapeutic range (TTR) is a predictor of excessive bleeding events, and warfarin patients are typically below target values.
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.
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.
Data From Phase 1b Trial Updated. Eledon presented data from the Phase 1b trial testing tegoprubart, its drug for prevention of kidney transplant rejection, at the American Transplant Congress. We found the data to continue to show improved kidney function during the first year after transplantation, a strong indicator of organ survival, with continued safety and tolerability.
Kidney Function Measures Continue To Show Improvements Over Tacrolimus. The Phase 1b data included 13 patients who had reached 30-day post-transplant evaluation. Their mean eGFR was above 60 mL/min/1.73m² at each reported time point. The overall mean eGFR after day 30 reached 70.5 mL/min/1.73m². This is an improvement over standard-of-care immunosuppressive regimens that have eGFR rates around the 50ml/min/1.73m² level during the first year after the transplant.
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.
One of the pioneering players in applying video game technology to treating mental health conditions is going all-in on its digital therapeutic ambitions. Virtual Therapeutics announced Monday it has struck a deal to acquire Akili, Inc. in an all-cash transaction valuing the digital therapeutics firm at $276 million.
The acquisition marks a bold consolidation move as Virtual Therapeutics aims to establish itself as a diversified leader in the rapidly evolving digital health landscape. Akili shareholders will receive $0.4340 per share under the terms of the agreement, representing an 85% premium to the stock’s closing price in late April before a strategic review was announced.
Virtual Therapeutics has built a portfolio of virtual reality and immersive game experiences explicitly designed to provide mental health and cognitive fitness solutions. By adding Akili’s clinically-validated mobile software products to its platform, the combined company can offer a multi-modal suite of digital therapeutic offerings across multiple therapeutic areas.
For Akili investors, the all-cash bid comes as a welcome event after a turbulent stretch for the newly-public company. Shares had plunged over 80% from their 2022 IPO price amid slower-than-expected uptake for its flagship ADHD treatment. The $276 million deal price provides Akili shareholders with a rare exit opportunity in the cash-burning digital health space.
Founded in 2011, Boston-based Akili pioneered a new category of medicine it calls “digital therapeutics” – video game-like software programs prescribed by doctors that are clinically validated to treat medical conditions directly through cognitive engagement and video inputs. Its lead product, EndeavorRx, was cleared by the FDA in 2020 as a treatment for children with ADHD.
Virtual Therapeutics has been taking a different tack, creating visually-rich, immersive game worlds as mental health interventions for conditions like depression, anxiety, PTSD and cognitive decline. The two approaches could prove complementary, with Akili’s mobile experiences providing one delivery mechanism and Virtual Therapeutics’ VR worlds offering an alternative modality.
Combining platforms may allow the merged company to deliver a truly multi-channel digital therapeutic offering spanning mobile, console and virtual reality environments. Cost synergies from eliminating redundancies in technology, R&D and sales infrastructure could also drive improved profitability over time.
For Virtual Therapeutics CEO and co-founder Dan Elenbaas, the Akili merger represents a major milestone in his mission to “bring behavioral health services to as many patients as possible” through engaging, accessible digital experiences. With clinical validation and regulatory clearance already in hand for Akili’s products, the road to scaling distribution and driving adoption may become clearer.
Weighing the deal’s benefits, BTIG analyst Mark Westbrook called the transaction “highly complementary” and stated it positions Virtual Therapeutics as a “clear leader” in delivering validated digital mental health solutions through novel experiential mediums like gaming.
While the digital therapeutics space is still in its infancy, the Virtual Therapeutics-Akili merger creates a formidable platform anchored by real-world clinical data and evidence. Akili gets taken private at a meaningful premium, while Virtual Therapeutics absorbs validated products to accelerate growth in its core mission of delivering modern, scalable solutions to the mental health crisis.
For healthcare investors seeking new frontiers, the combined digital mental health company resulting from this deal could be an enticing way to capitalize on gaming technology being repurposed for medical applications. Virtual reality video games may be just what the doctor ordered.
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.
Presentations On Long COVID Trial, Upcoming PTSD Trial. Tonix presented data from its Phase 2 PREVAIL trial testing Tonmya, previously TNX 102 SL, at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting. The data showed improvement in symptoms that we believe support findings from Phase 3 trials in fibromyalgia. A poster presentation detailed design of an upcoming study in Acute Stress disorders after automobile accidents, expected to begin in 2Q24.
PREVIAL Data Showing Improvement In Symptoms. The study was designed as a proof-of-concept in Long COVID. Although the primary endpoint of multi-site pain reduction after 14 weeks was not met, the treatment group showed measures of effect size that met prespecified criteria for further evaluation. The study showed improvements in fatigue, sleep quality, cognition function, disability, and Patient Global Impression of Change. We believe these measures are consistent with effects seen in the Phase 3 RELIEF and RESILIENT trials.
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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).
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.
First Quarter Results. MustGrow reported zero revenue in the quarter and a net loss of CAD$1.0 million or a loss of $0.02 per share. We estimated revenue of CAD$1,000 and a net loss of CAD$1.2 million or a loss of $0.02 per share. We expect similar revenue performance until the fourth quarter of the 2024 fiscal year when TerraSante sales are expected to begin.
Cash Flow/Capital Use. MustGrow had cash used in operating activities of CAD$931,372, similar to last year at CAD$912,387. The Company had cash and cash equivalents of CAD$5.9 million as of March 31, 2024. Barring any revenue generation, we estimate an approximate 18-month runway before needing new capital.
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.
One of the medical technology industry’s leading providers of coating systems and surface modification is being taken private by private equity firm GTCR in a $627 million deal. Surmodics (SRDX) announced Monday that it has entered into a definitive agreement to be acquired by GTCR in an all-cash transaction valuing the company at $43 per share.
The acquisition price represents a premium of over 41% to Surmodics’ average trading price over the past 30 days. It comes amid a broader push by private equity to double down on investments in the healthcare technology space as medical device innovation accelerates.
Surmodics has been a pioneer in the delivery of surface modification solutions that enhance the biocompatibility of medical products. The Eden Prairie, Minnesota-based company’s technologies are used by blue-chip medical device manufacturers to enable products to interact more safely and effectively with the human body.
Its proprietary coating and treatment platforms are integrated into thousands of devices including vascular intervention technologies, minimally invasive surgical tools, in vitro diagnostics, and ophthalmic products. Surface treatments from Surmodics can improve device thromboresistance, lubricity, durability, adhesion, and biocompatibility.
Those differentiated capabilities caught the eye of GTCR, which has significant experience investing in healthcare companies. The Chicago-based private equity firm currently manages over $25 billion in equity capital across multiple investment strategies.
For Surmodics shareholders, the $43 per share cash deal represents an attractive exit price. In addition to the 41% premium to the recent trading average, the buyout price is 26% higher than where the stock closed on Friday. The company’s shares soared 25% on Monday following news of the transaction.
Surmodics’ Board of Directors unanimously approved the merger agreement and recommends shareholders vote in favor of the deal. The transaction is expected to close in the second half of 2024, subject to shareholder approval, regulatory clearances, and other customary closing conditions.
The medical coatings and surface technology space has seen heightened M&A activity in recent years as major medical product companies seek to enhance their product pipelines. Private equity investors like GTCR have ample dry powder to deploy into healthcare sectors positioned for durable growth driven by demographic tailwinds and innovation.
While going private will provide Surmodics with flexibility to invest for the long-term, the $627 million price tag validates the company’s tools and know-how as essential for next-generation medical device engineering. As healthcare investors compete to back enablers of cutting-edge medical products, GTCR’s bet on Surmodics’ coating capabilities could pay off handsomely.
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GAITHERSBURG, Md., May 24, 2024 /PRNewswire/ — YS Biopharma Co., Ltd. (Nasdaq: YS) (“YS Biopharma” or the “Company”), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced it is changing its legal name from “YS Biopharma Co., Ltd.” to “LakeShore Biopharma Co., Ltd”.
Dr. David Shao, Director, President, Co-Chief Executive Officer, and Chief Business Officer of the Company, commented, “We have decided to change our company name to LakeShore Biopharma to align with our global market positioning and international brand image. This change marks one of the first steps for us to expand our market reach, and we are eager to move forward and drive success under our new company name.”
The name change and trading symbol change will not affect any rights of shareholders or the Company’s operations and financial position. The Company’s ordinary shares and warrants will continue to be listed on the Nasdaq. Effective with the opening of the trading day on May 28, 2024, the ticker symbol of the Company’s ordinary shares and warrants will change from “YS” to “LSB” and from “YSBPW” to “LSBPW”, respectively. There is no action required by the Company’s current shareholders with respect to the company name or ticker symbol changes. The Company’s CUSIP will not change in connection with the name change.
About LakeShore Biopharma (formerly known as YS Biopharma)
LakeShore Biopharma, previously known as YS Biopharma, is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulating technology platform and a new generation of preventive and therapeutic biologics targeting Rabies, Coronavirus, Hepatitis B, Influenza, Shingles, and other virus infections. The Company operates in China, the United States, Singapore, and the Philippines, and is led by a management team that combines rich local expertise and global experience in the biopharmaceutical industry. For more information, please visit investor.ysbiopharma.com.
For biotech investors scouring for the next big opportunity, the massive manufacturing expansions underway at pharma giant Eli Lilly (LLY) are worth a close look. The company just announced another staggering $5.3 billion investment into a key production facility in Indiana to crank up supply of its blockbuster obesity and diabetes drugs.
This commitment brings Lilly’s total investment at the Lebanon, Indiana site to an incredible $9 billion – representing the firm’s largest-ever manufacturing bet in its nearly 150-year history. It highlights the huge demand that Lilly’s game-changing medications like Mounjaro and Zepbound are facing from physicians and patients alike.
For small biotech firms developing the next generation of weight loss, diabetes and metabolism therapies, Lilly’s supply chain moves send an important signal – this market is headed for explosive growth in the coming years. Companies sitting on promising pipeline candidates could emerge as attractive buyout targets.
At the heart of Lilly’s expansion plans are its incretin drugs, which mimic gut hormones to suppress appetite and regulate blood sugar. Mounjaro, approved for diabetes, and Zepbound, greenlit for chronic weight management, both contain the active ingredient tirzepatide.
Since their launches, demand for these effective and convenient once-weekly injectable treatments has far outstripped supply. Shortages have been widespread in the U.S. as Lilly raced to build out its production infrastructure.
The new $9 billion Indiana campus will be instrumental in increasing Lilly’s capacity to manufacture tirzepatide at scale. When fully operational in 2028, it will employ around 900 skilled workers including scientists, engineers and technicians.
But this plant is just one piece of Lilly’s supply chain mobilization for incretin drugs. Since 2020, the company has plowed over $18 billion into building, acquiring and expanding manufacturing sites in the U.S. and Europe. New facilities are also coming online in North Carolina, Ireland and Germany through 2026.
These investments are already paying dividends. On its latest earnings call, Lilly hiked its 2023 revenue guidance by $2 billion, citing greater visibility into ramping up production of Mounjaro, Zepbound and its incretin pipeline over the remainder of the year.
For small biotechs, the supply chain frenzy at Lilly underscores the commercial opportunity in obesity, diabetes and metabolism. With over 40% of U.S. adults classified as obese, safe and effective chronic weight management regimens like Lilly’s incretin franchise could disrupt a massive global market worth billions annually.
The manufacturing expansions suggest appetite for these therapies will continue to surge, fueling demand for the next generation of medications offering better efficacy, tolerability and dosing schedules. Smaller drug developers operating in this space could become prime M&A candidates as deep-pocketed pharmas look to build out their obesity and diabetes portfolios.
Case in point: Lilly itself acquired Zepbound through its $8 billion buyout of Protunor Biopharma in 2022. Several major deals have already reshaped the incretin drug landscape in recent years, including Pfizer’s $6.7 billion purchase of Akero Therapeutics for its NASH/diabetes pipeline.
With its bold investments, Lilly is putting its money where its mouth is when it comes to obesity and metabolic disease. For lean biotechs advancing the next wave of therapies in this booming treatment category, that could spell opportunity knocking in the form of lucrative buyout offers or partnerships down the line.
Keep an eye on this space as Lilly’s supply chain moves underscore that the fight against fat is only just beginning for the pharmaceutical industry.
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.
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.
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, 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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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.
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.
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.
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.
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.
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