Tag: Health

Ocugen (OCGN) – Ocugen Completes Phase 1 Dosing For OCU410 In Dry AMD

Posted on by cpereira@noblefcm.com


Friday, July 26, 2024

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

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

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

Escalating Dose Stage Has Completed Dosing. Ocugen reported completion of the escalating dose stage of its Phase 1/2 ArMaDa trial testing OCU410 in Geographic Atrophy (GA), a late-stage complication of dry age-related macular degeneration (dry AMD). OCU410 uses Ocugen’s “master regulatory gene” approach, with a single injection to deliver the nuclear receptor gene RAR-related orphan receptor A (RORA). This gene regulates pathways that lead to dry age-related macular degeneration.

Next Stage In Phase 1/2 Trial Expected In 3Q24. The Phase 1/2 ArMaDa trial is testing OCU410 in geographic atrophy (GA), a lesion secondary to dry AMD at 14 retina surgical centers in the US. The first stage of the trial administered three escalating doses of OCU410. The second stage will randomize patients into three arms at a ratio of 1:1:1 to compare the medium and high dosage levels to a control group. Endpoints will be efficacy and safety.


Get the Full Report

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

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Dexcom’s Stock Plummets: A Wake-Up Call for the Diabetes Management Giant

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Dexcom shares dropped over 40% in a single day, the worst in company history.
– Disappointing Q2 revenue and lowered full-year guidance shocked investors.
– Internal issues, not market changes, appear to be the primary cause of the downturn.

Dexcom, a leader in diabetes management technology, experienced a seismic shock on Friday, July 26, 2024, as its stock plunged more than 40% following a disappointing second-quarter earnings report. This dramatic fall, erasing approximately $18 billion in market capitalization, marks the company’s worst single-day performance since its 2005 IPO.

The catalyst for this financial tremor was Dexcom’s Q2 revenue report, which fell short of analyst expectations. Despite a 15% year-over-year increase to $1 billion, it missed the projected $1.04 billion target. More alarmingly, the company significantly lowered its full-year revenue guidance from $4.20-$4.35 billion to $4.00-$4.05 billion, a reduction that caught many investors off guard.

During the earnings call, CEO Kevin Sayer attributed the shortfall to several internal factors. A major restructuring of the sales team led to disruptions in customer relationships, particularly affecting the crucial durable medical equipment (DME) channel. The company also faced challenges with lower-than-expected new customer acquisition and reduced revenue per user, partly due to rebates offered for their new G7 continuous glucose monitor.

The magnitude of the guidance cut raised eyebrows among analysts. JPMorgan downgraded Dexcom’s stock, expressing shock at the level of disruption caused by internal reorganization. However, they and other analysts, including those from William Blair and Leerink, maintained that these issues are likely transient and should not significantly impact Dexcom’s long-term trajectory.

Interestingly, Dexcom’s woes do not appear to be linked to broader market trends, such as the rising popularity of GLP-1 weight loss treatments. Instead, the company’s stumbles seem largely self-inflicted, a fact that has both frustrated and perplexed market watchers.

Looking ahead, Dexcom is pinning hopes on its new over-the-counter continuous glucose monitor, Stelo, cleared by the FDA in March 2024 and set for an August launch. Designed for Type 2 diabetes patients who don’t use insulin, Stelo represents a significant expansion of Dexcom’s addressable market.

Despite the current turmoil, some analysts believe the market’s reaction may be overblown. Leerink analysts, in particular, argue that the magnitude of the sell-off is excessive given the likely temporary nature of Dexcom’s challenges.

Nevertheless, the incident serves as a stark reminder of the volatility inherent in the healthcare technology sector. It underscores the importance of effective execution, particularly in sales and customer relationship management, even for established market leaders.

As Dexcom works to right the ship, investors and industry observers will be watching closely. The company’s ability to overcome these short-term hurdles and leverage opportunities like the Stelo launch will be crucial in regaining market confidence.

While the road ahead may be bumpy, Dexcom’s strong market position and innovative product pipeline suggest that this may be a temporary setback rather than a long-term decline. However, the company will need to demonstrate improved execution and a clear path to recovery in the coming quarters to fully reassure investors and regain its market momentum.

Viking’s Surprise Move in the $150 Billion Weight Loss Race

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Viking Therapeutics stock surges 20% after announcing early advancement to late-stage trials for weight loss drug
– Company’s experimental injection VK2735 shows promising results, potentially rivaling industry giants
– Decision to skip additional mid-stage trial could accelerate drug’s market entry by a year
– Viking also developing a convenient monthly injection and oral version of the drug

In a stunning turn of events, the relatively unknown biotech company Viking Therapeutics has suddenly become the talk of Wall Street. The San Diego-based firm saw its stock price soar by over 20% on Thursday, following a game-changing announcement that has investors and health enthusiasts alike sitting up and taking notice.

The catalyst for this dramatic surge? Viking Therapeutics revealed its plans to fast-track its experimental weight loss injection, VK2735, directly into late-stage trials. This bold move, which comes earlier than expected, has positioned the company as a potential dark horse in the fiercely competitive GLP-1 market, currently dominated by pharmaceutical giants Novo Nordisk and Eli Lilly.

The GLP-1 market, projected to balloon to a staggering $150 billion by the end of the decade, has been a battlefield for drug companies seeking to capitalize on the growing demand for effective weight loss solutions. Viking’s unexpected leap forward has not only caught the attention of investors but also sent ripples through the industry, with shares of both Novo Nordisk and Eli Lilly dipping more than 1% in response.

What makes Viking’s VK2735 so promising? In a phase two trial, patients receiving weekly doses of the injection lost up to 14.7% of their body weight over just 13 weeks – an impressive figure that puts it in the same league as its more established competitors. But Viking isn’t stopping there. The company is also developing a monthly injection version of VK2735, which could offer a more convenient option for patients compared to the weekly regimens of current market leaders.

Adding another layer of intrigue, Viking is simultaneously working on an oral version of VK2735. In early-stage trials, this pill form demonstrated a 3.3% weight loss compared to placebo, opening up the possibility of a non-injectable alternative in the future.

The decision to skip an additional mid-stage trial and move directly to phase three could shave off a significant amount of time from Viking’s development timeline. Analysts now estimate that this strategic move could accelerate the drug’s market entry by as much as a year, potentially launching in 2028 instead of the previously projected 2029.

Viking’s CEO, Brian Lian, expressed confidence in the company’s direction during a recent earnings call, citing positive feedback from the Food and Drug Administration as a key factor in their decision to expedite the development process. The company is now preparing for a crucial meeting with the FDA in the fourth quarter to discuss the design and timing of the phase three trial.

As Viking Therapeutics gears up for this next critical phase, the biotech world watches with bated breath. Could this underdog company be on the verge of disrupting the weight loss drug market? With its promising results and aggressive development strategy, Viking is certainly positioning itself as a formidable contender in the race to capture a slice of the lucrative GLP-1 pie.

For investors and health-conscious individuals alike, the message is clear: keep a close eye on Viking Therapeutics. This small biotech firm might just be holding the key to the next big breakthrough in weight loss treatment.

Augmedix and Commure Join Forces in $139 Million Healthcare AI Deal

Posted on by slightbourne@noblecapitalmarkets.com

In a significant move that could reshape the landscape of healthcare technology, Augmedix, Inc. (Nasdaq: AUGX) has announced its acquisition by Commure, Inc. The all-cash transaction, valued at approximately $139 million, marks a pivotal moment in the evolution of ambient AI and medical documentation solutions.

Announced on July 19, 2024, the deal will see Augmedix stockholders receive $2.35 per share, representing a substantial premium of 169% over the company’s recent trading history. This acquisition not only provides a windfall for Augmedix investors but also signals a strong vote of confidence in the company’s innovative approach to reducing administrative burdens in healthcare.

Augmedix, a pioneer in ambient AI medical documentation, has made significant strides in liberating clinicians from time-consuming paperwork. By leveraging artificial intelligence to transform natural conversations into organized medical notes and structured data, Augmedix has been at the forefront of enhancing clinical efficiency and decision support.

Commure, the acquiring company, is no stranger to healthcare innovation. As a leading provider of technology solutions to healthcare systems, Commure has been working to streamline operations and improve patient care across hundreds of care sites. The merger with Augmedix aligns perfectly with Commure’s mission to make health the focus of healthcare by eliminating distractions and keeping providers connected to their patients.

Manny Krakaris, CEO of Augmedix, expressed enthusiasm about the deal, stating, “This proposed transaction with Commure provides certainty and a premium value for our stockholders, representing a transformative next step in Augmedix’s mission.” He emphasized the potential for scaling ambient documentation solutions and accelerating the development of innovative features and AI capabilities.

Tanay Tandon, CEO of Commure, shared a similar sentiment, highlighting the strategic importance of the acquisition. “We’re taking a huge step forward in building the health AI operating system of the future,” Tandon remarked, underlining the goal of consolidating various point solutions into a single, integrated platform for healthcare providers and operations teams.

The transaction is expected to close in late Q3 or early Q4 of 2024, subject to approval by Augmedix stockholders and other customary closing conditions. Upon completion, Augmedix will transition from a publicly-traded company to a wholly-owned subsidiary of Commure, operating as a private entity.

This merger comes at a critical time in healthcare, as the industry grapples with burnout among medical professionals and the need for more efficient, patient-focused care. By combining Augmedix’s expertise in ambient AI documentation with Commure’s broad reach and resources, the newly formed entity aims to address these challenges head-on.

The deal also reflects the growing importance of AI in healthcare. As language models and AI technologies continue to advance, their potential to transform medical practice becomes increasingly clear. This acquisition positions the combined company at the forefront of this transformation, with the potential to set new standards in healthcare IT and clinical workflow optimization.

For the healthcare community, this merger promises a future where technology works seamlessly in the background, allowing medical professionals to focus more on patient care and less on administrative tasks. It also signals a trend towards consolidation in the healthcare tech sector, as companies seek to create more comprehensive, integrated solutions.

As the healthcare industry watches this deal unfold, many will be eager to see how the combined strengths of Augmedix and Commure will translate into practical improvements for clinicians, patients, and health systems alike. With the backing of Commure’s resources and the innovative spirit of Augmedix, the future of AI-driven healthcare solutions looks brighter than ever.

Cocrystal Pharma (COCP) – CDI-988 Reaches Milestone In Phase 1 Trial For Norovirus and Coronavirus

Posted on by cpereira@noblefcm.com


Friday, July 19, 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.

CDI-988 Completes Phase 1 SAD Trial. Cocrystal announced that CDI-988 has completed the single ascending dose stage of the Phase 1 trial for CDI-988, its oral protease inhibitor in development for norovirus and coronavirus. The trial was designed to test the safety and tolerability of CDI-988, as well as its pharmacokinetics. The results justify moving forward to the multiple ascending dose (MAD) stage, expected later in FY2024.

SAD Study Was Designed To Test Basic Safety. The SAD trial was a double-blind trial to test a single oral administration of escalating doses ranging from 100 mg to 600 mg of CDI-988. The objectives were to determine basic safety, tolerability, and pharmacokinetics including food effects. There were no serious adverse events or treatment-emergent adverse events, with no laboratory or exam abnormalities. Safety and tolerability were considered sufficient to continue to the next stage of the trial.


Get the Full Report

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

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – The United States Eventing Association Names Zomedica’s PulseVet(R) as the Official Shock Wave of the USEA

Posted on by aweinsoff@channelchek.com

News Research and Market Data on ZOM

Zomedica will sponsor a variety of high-profile events within the USEA

ANN ARBOR, MI / ACCESSWIRE / July 17, 2024 / Zomedica Corp. (NYSE American:ZOM) (“Zomedica” or the “Company”), a veterinary health company offering point-of-care diagnostics and therapeutic products for equine and companion animals, is honored to announce that the United States Eventing Association, Inc. (USEA), a leading equestrian sports organization, has named PulseVet as the “Official Shock Wave of the USEA” for 2024. As part of its partnership with the USEA, PulseVet Shock Wave is also a “Gold Sponsor” of the USEA American Eventing Championships, “Bronze Sponsor” of the USEA Classic Series, and “Contributing Sponsor” of the USEA EA21 Program, the USEA Annual Meeting and Convention, and the USEA Adult Team Championships.

Zomedica’s PulseVet system is a world leader in veterinary electro-hydraulic shock wave technology for the treatment of a wide variety of conditions in equine, canine, and feline patients. The high-energy sound waves stimulate cells and release healing growth factors in the body that reduce inflammation, increase blood flow, and accelerate bone and soft tissue development. PulseVet’s technology is used in conditions including tendon and ligament healing, bone healing, osteoarthritis, chronic pain, and wound healing.

Zomedica CEO Larry Heaton commented, “We are excited to engage with USEA as the Official Shock Wave of their organization. Zomedica is committed to helping veterinarians provide the best possible care for horses at every level of training and competition, from rehabilitation to maintaining peak performance.”

“We are grateful to Zomedica for partnering with U.S. Eventing as its newest sponsor. Keeping our equine partners healthy and happy is a top priority, and we are thankful to have a brand committed to the same goals. Our event horses are a part of the family, and we are glad that the PulseVet shock wave device is focused on keeping them in top shape,” stated USEA CEO Rob Burk.

“As a long-time member, I am thrilled to partner with the USEA and help educate all those who enjoy the sport of eventing,” Zomedica’s Senior Product Manager of Therapeutics, Courtney Calnan, commented. “Eventing requires our equine teammates to be an ultimate athlete. I’m excited for the members of USEA to learn how the PulseVet system can help their partners feel their best.”

PulseVet’s electro-hydraulic shock wave technology has been clinically proven to treat tendon, ligament, and muscle injuries; osteoarthritis; degenerative joint disease; navicular syndrome; chronic back and neck pain; fractures; and wounds. Electro-hydraulic shock wave continues to be the most researched type of shock wave in the veterinary industry. The total addressable market for PulseVet devices in the US is estimated at $1 billion, with additional recurring revenue of $150 million annually for related consumables.

About the United States Eventing Association

The USEA is a non-profit 501(c)(3) educational organization committed to providing eventing enthusiasts with a competitive level suited to their individual skills. By assisting and educating competitors, event organizers, and officials; maintaining responsible safety standards; and registering qualified competitions and clinics, the USEA offers a strong and continuous training opportunity for an ever-expanding field of world-class competitors. Just as importantly, the USEA provides a means for all riders, regardless of age or ability, to experience the thrill of eventing. To learn more, visit www.useventing.com.

About Zomedica

Zomedica is a leading equine and companion animal healthcare company dedicated to improving animal health by providing veterinarians innovative therapeutic and diagnostic solutions. Our gold standard PulseVet® shock wave system, which accelerates healing in musculoskeletal conditions, has transformed veterinary therapeutics. Our suite of products also includes the Assisi® Loop line of therapeutic devices and the TRUFORMA® diagnostic platform, the TRUVIEW™ digital cytology system, and the VetGuardian® no-touch monitoring system, all designed to empower veterinarians to provide top-tier care. In the aggregate, their total addressable market in the U.S. exceeds $2 billion. Headquartered in Michigan, Zomedica employs approximately 150 people and manufactures and distributes its products from its world-class facilities in Georgia and Minnesota. An NYSE American company, Zomedica grew revenue 33% in 2023 to $25 million and maintains a strong balance sheet with approximately $91 million in liquidity as of March 31, 2024. Zomedica is advancing its product offerings, leveraging strategic acquisitions, and expanding internationally as we work to enhance the quality of care for pets, increase pet parent satisfaction, and improve the workflow, cash flow and profitability of veterinary practices. For more information visit www.zomedica.com.

Follow Zomedica

Cautionary Note Regarding Forward-Looking Statements

Except for statements of historical fact, this news release contains certain “forward-looking information” or “forward-looking statements” (collectively, “forward-looking information”) within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate” and other similar words, or statements that certain events or conditions “may” or “will” occur and include statements relating to our expectations regarding future results. Although we believe that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. We cannot guarantee future results, performance, or achievements. Consequently, there is no representation that the actual results achieved will be the same, in whole or in part, as those set out in the forward-looking information.

Forward-looking information is based on the opinions and estimates of management at the date the statements are made, including assumptions with respect to economic growth, demand for the Company’s products, the Company’s ability to produce and sell its products, sufficiency of our budgeted capital and operating expenditures, the satisfaction by our strategic partners of their obligations under our commercial agreements, our ability to realize upon our business plans and cost control efforts and the impact of COVID-19 on our business, results and financial condition.

Our forward-looking information is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking information. Some of the risks and other factors that could cause the results to differ materially from those expressed in the forward-looking information include, but are not limited to: the expected market and Zomedica’s share of such market, continued growth of sales, the outcome of clinical studies, the application of generally accepted accounting principles, which are highly complex and involve many subjective assumptions, estimates, and judgments, uncertainty as to whether our strategies and business plans will yield the expected benefits; uncertainty as to the timing and results of development work including the development of new cartridges; uncertainty as to the timing and results of verification and validation studies; uncertainty as to the timing and results of commercialization efforts, as well as the cost of commercialization efforts, including the cost to develop an internal sales force and manage our growth; uncertainty as to our ability to successfully integrate acquisitions; uncertainty as to our ability to supply products in response to customer demand; uncertainty as to the likelihood and timing of any required regulatory approvals, or other requirements for our products in the Middle East, Africa and India, and the availability and cost of capital; the ability to identify and develop and achieve commercial success for new products and technologies; veterinary acceptance of our products, particularly in the Middle East, Africa and India; competition from related products; the level of expenditures necessary to maintain and improve the quality of products and services; changes in technology and changes in laws and regulations; our ability to secure and maintain strategic relationships; performance by our strategic partners of their obligations under our commercial agreements, including product manufacturing obligations; risks pertaining to permits and licensing, intellectual property infringement risks, risks relating to any required clinical trials and regulatory approvals, risks relating to the safety and efficacy of our products, the use of our products, intellectual property protection, risks related to the COVID-19 pandemic and its impact upon our business operations generally, including our ability to develop and commercialize our products, and the other risk factors disclosed in our filings with the SEC and under our profile on SEDAR+ at www.sedarplus.com. Readers are cautioned that this list of risk factors should not be construed as exhaustive.

The forward-looking information contained in this news release is expressly qualified by this cautionary statement. We undertake no duty to update any of the forward-looking information to conform such information to actual results or to changes in our expectations except as otherwise required by applicable securities legislation. Readers are cautioned not to place undue reliance on forward-looking information.

Investor Relations Contact:
Zomedica Investor Relations
investors@zomedica.com
1-734-369-2555

SOURCE: Zomedica Corp.

Unicycive Therapeutics (UNCY) – Patient Survey Data From Pivotal Trial Shows Patients Prefer OLC

Posted on by slightbourne@noblecapitalmarkets.com


Thursday, July 11, 2024

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

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

Pivotal Trial Included A Patient Satisfaction Survey. In late June, Unicycive released safety, efficacy, and dosing data from its Pivotal trial for OCL. As discussed on our Research Note on June 26, over 90% of the patients were able to reach target serum phosphate levels. The trial included a pre-specified patient survey asking about ease of use, satisfaction, and overall preference that shows patients prefer OLC over their current phosphate binders. We see this as an important point that could make it the best treatment in a $1 billion drug category.

We Consider Patient Preference To Be A Strong Point. OLC was developed as an improved formulation of Fosrenol (lanthanum citrate) that would require fewer and smaller pills. This was intended to improve compliance and maintain phosphate levels in the proper range. The Pivotal study for the NDA application showed sufficient safety, tolerability, and effective dose levels, with a pre-specified patient survey to collect post-treatment opinions.


Get the Full Report

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

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

GeoVax Labs (GOVX) – Looking Forward To Continued Progress In 2H24

Posted on by slightbourne@noblecapitalmarkets.com


Wednesday, July 10, 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 Reached Important Milestones For Both Platforms During 1H2024. The first half of 2024 has been a transformational period for GeoVax. A Phase 2 trial testing CM04S1 as a booster vaccine for COVID-19 reported initial data in February, then received a BARDA grant to conduct a large Phase 2b in June. The Gedeptin gene therapy program in head and neck cancer reported interim Phase 1/2 data showing successful proof-of-concept. Both programs are moving forward with additional milestones in 2H24.

BARDA Grant Allocates $367 Million For A Phase 2b Trial. In June, GeoVax announced that it has received a grant from BARDA to conduct a Phase 2b trial testing CM04S1 as a booster vaccine to protect healthy patients from COVID-19. As discussed in our Research Note on June 28, the grant terms include payments to GeoVax for clinical supplies and regulatory costs of $24.3 million (which could be increased to $45 million). The balance will be payable to Allucent, the CRO that will conduct the trial.


Get the Full Report

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

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Lilly Expands Immunology Footprint with $3.2 Billion Morphic Acquisition

Posted on by slightbourne@noblecapitalmarkets.com

Pharmaceutical giant Eli Lilly and Company (NYSE: LLY) announced on July 8, 2024, its plans to acquire Morphic Holding, Inc. (NASDAQ: MORF) for $3.2 billion, marking a significant expansion of its presence in the immunology space. This strategic move aims to enhance Lilly’s pipeline in inflammatory bowel disease (IBD) treatments and broaden its portfolio of oral integrin therapies.

Under the agreement, Lilly will pay $57 per share in cash for all outstanding Morphic shares, representing a substantial 79% premium over Morphic’s closing stock price on July 5, 2024. The transaction, approved by both companies’ boards of directors, is expected to close in the third quarter of 2024, pending customary closing conditions and regulatory approvals.

At the heart of this acquisition is Morphic’s lead program, MORF-057, a selective oral small molecule inhibitor of α4β7 integrin. This promising compound is currently undergoing multiple Phase 2 studies for the treatment of ulcerative colitis and Crohn’s disease, two prevalent forms of IBD. The oral nature of MORF-057 could offer significant advantages over existing injectable therapies, potentially improving patient compliance and quality of life.

Dr. Daniel Skovronsky, Chief Scientific Officer of Lilly and President of Lilly Research Laboratories, highlighted the potential impact of oral therapies in IBD treatment. “Oral therapies could open up new possibilities for earlier intervention in diseases like ulcerative colitis, and also provide the potential for combination therapy to help patients with more severe disease,” he stated. This acquisition underscores Lilly’s commitment to developing first-in-class molecules in gastroenterology, an area where the company has been making substantial investments.

The deal also brings Morphic’s preclinical pipeline into Lilly’s fold, including molecules targeting autoimmune diseases, pulmonary hypertensive diseases, fibrotic diseases, and cancer. This addition further diversifies Lilly’s research and development efforts, potentially opening new avenues for therapeutic breakthroughs.

For Morphic, this deal represents a validation of its Integrin Technology platform and years of research. Dr. Praveen Tipirneni, CEO of Morphic Therapeutic, expressed confidence in Lilly’s ability to maximize MORF-057’s potential. “Lilly brings unparalleled resources and commitment to the inflammation and immunology field,” he noted, adding that the acquisition could “unlock new possibilities in IBD treatment.”

The transaction comes amid rapid growth in the global IBD therapeutics market. With the increasing prevalence of IBD worldwide and the limitations of current treatments, there is a significant unmet need for novel, more effective therapies. Lilly’s acquisition of Morphic positions the company to potentially capture a larger share of this expanding market and address critical patient needs.

From a financial perspective, the $3.2 billion deal represents a significant investment for Lilly. The company will determine the accounting treatment of the transaction as either a business combination or an asset acquisition upon closing, which will impact how it’s reflected in Lilly’s financial results and guidance.

The acquisition has ignited interest across the pharmaceutical industry, with analysts speculating that it could trigger a wave of similar deals in the integrin therapy space. As large pharmaceutical companies seek to bolster their pipelines and secure promising assets in high-growth therapeutic areas, smaller biotechnology firms with innovative platforms may become increasingly attractive targets.

However, Lilly faces the challenge of successfully integrating Morphic’s team and technologies into its existing operations. The company’s ability to manage this integration smoothly will be crucial in realizing the full potential of this deal and translating it into tangible benefits for patients and shareholders alike.

Lilly’s acquisition of Morphic represents a strategic move to strengthen its position in the immunology market, particularly in IBD treatments. With the potential to bring novel oral therapies to patients and expand its research capabilities, this deal could have far-reaching implications for both Lilly and the broader landscape of IBD treatment. As the transaction progresses towards closing, industry observers and patients alike will be watching closely to see how Lilly leverages this significant investment to drive innovation and improve patient outcomes in the years to come.

Ligand Pharmaceuticals Expands Oncology Portfolio with $100 Million APEIRON Biologics Acquisition

Posted on by slightbourne@noblecapitalmarkets.com

In a strategic move to bolster its commercial-stage portfolio, Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) announced on July 8, 2024, its agreement to acquire APEIRON Biologics AG for $100 million in cash. This acquisition marks a significant expansion of Ligand’s oncology footprint, particularly in the realm of rare pediatric cancers.

The crown jewel of this acquisition is QARZIBA® (dinutuximab beta), a highly differentiated oncology drug used in the treatment of high-risk neuroblastoma in patients aged 12 months and above. QARZIBA, which received European Medicines Agency approval in 2017, is currently marketed in over 35 countries by global pharmaceutical company Recordati S.p.A.

Todd Davis, CEO of Ligand, emphasized the strategic importance of this acquisition, stating, “The addition of QARZIBA to our commercial royalty portfolio further supports our growth strategy to invest in high-value medicines that deliver significant clinical value and generate predictable and long-term revenue streams for our investors.”

The deal structure includes the initial $100 million cash payment, with the potential for up to an additional $28 million based on future commercial and regulatory milestones. Specifically, these additional payments are tied to QARZIBA royalties exceeding certain predetermined thresholds by either 2030 or 2034.

From a financial perspective, this acquisition is expected to make an immediate positive impact on Ligand’s bottom line. The company projects that the deal will be accretive to its earnings per share (EPS) by approximately $1.00 on an annualized basis, with a $0.50 impact expected for 2024 alone. In light of this, Ligand has increased its 2024 adjusted EPS guidance by 17% to a range of $5.00-$5.50.

The acquisition of APEIRON represents the sixth key asset added to Ligand’s commercial stage portfolio since the beginning of 2023, underscoring the company’s aggressive growth strategy. This diversification is expected to provide Ligand with a more stable and predictable revenue stream, a key consideration for investors in the volatile biotech sector.

QARZIBA’s unique position as the only immunotherapy for high-risk neuroblastoma marketed across Europe and other parts of the world makes it a particularly valuable addition to Ligand’s portfolio. Neuroblastoma, a rare cancer that primarily affects children, has limited treatment options, highlighting the potential impact of QARZIBA on patient outcomes.

In a parallel move, Ligand has also committed to investing up to $4 million in invIOs Holding AG, a privately held spin-off of APEIRON. This investment is aimed at financing the research and development of three innovative early-stage immuno-oncology assets, further expanding Ligand’s development stage portfolio.

Peter Llewellyn-Davies, CEO of APEIRON, expressed satisfaction with the deal, noting, “This transaction is an important milestone for our company and shareholders. We have spent more than 20 years translating academic research into therapeutic products for diseases with high unmet needs.”

The acquisition is expected to close in July 2024, subject to a 30-day shareholder objection period and other customary closing conditions. Upon completion, it will significantly reshape Ligand’s commercial portfolio and financial outlook.

As the biopharmaceutical industry continues to consolidate and seek ways to mitigate risk while maximizing potential returns, Ligand’s acquisition of APEIRON represents a strategic move to strengthen its position in the oncology market. By focusing on high-value, commercially available assets like QARZIBA, Ligand is positioning itself for sustained growth in the competitive and rapidly evolving pharmaceutical landscape.

Take a moment to take a look at emerging biotech companies by taking a look at Noble Capital Markets Research Analyst Robert LeBoyer’s coverage list.

Schwazze (SHWZ) – Noble Consumer Virtual Conference

Posted on by cpereira@noblefcm.com


Monday, July 01, 2024

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

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

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

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

Conference. We hosted Schwazze Chairman Justin Dye at the Noble Capital Emerging Growth Conference on June 27th. The entire presentation with Q&A can be found at https://www.channelchek.com/videos/schwazze-shwz-noble-capital-markets-virtual-consumer-tmt-conference-replay. The following are key highlights of the presentation.

Improving Outlook. Schwazze is seeing improvement in both Colorado and New Mexico from a competitive standpoint. In Colorado, pricing continues to stabilize, which will prove positive to both the top line and gross margin dollars. In New Mexico, enhanced enforcement of illegal operators and the illicit market is beginning to produce results, which will benefit Schwazze over the longer-term, in our view.


Get the Full Report

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

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

GeoVax Labs (GOVX) – CRO Partnership For Clinical Trial Allows Sponsored Phase 2b Trial To Move Forward

Posted on by cpereira@noblefcm.com


Friday, June 28, 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.

Partnership For BARDA-Funded Trial Announced. GeoVax announced a partnership with Allucent, a global clinical management organization (CRO), to conduct the Phase 2 clinical trial for CM04S1. The trial has been awarded approximately $357 million in funding through Project NextGen, with about $24.3 million going to GeoVax and the balance to fund the clinical trial costs. We see the partnership as an important step toward the start of the clinical trial, as well as another scientific validation for CM04S1 and the GeoVax manufacturing technologies.

The Partnership Allows The Trial To Begin As Expected. Under the grant, GeoVax is the trial sponsor with responsibility for manufacturing and providing vaccine supplies. The grant also requires a CRO to conduct the trial and manage its clinical operations. The announcement of the partnership with Allucent, a global CRO that can provide these services, allows the trial to move forward with a possible starting date during summer 2024.


Get the Full Report

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

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Unicycive Therapeutics (UNCY) – The Moment We’ve Been Waiting For: OLC Pivotal Trial Meets Endpoints For Phosphate Control

Posted on by cpereira@noblefcm.com


Wednesday, June 26, 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.

Side Effect Rates Were Low. Unicycive announced top-line results from its pivotal study to determine OLC (oxylanthanum carbonate) tolerability, safety, and dosing. The trial 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. An NDA filing is expected in 3Q24.

Low Discontinuation Rate Met The Primary Endpoint. Tolerability, the rate of discontinuations due to treatment related adverse events (TRAEs), was the primary endpoint. The Evaluable Population of 71 patients had only 1 TRAE discontinuation, a rate of 1.4%.  In the Safety Population, a total of 3 patients out of 86 discontinued due to TRAEs, a rate of 3.5%. In total, 5 patients discontinued due to AEs in the Safety Population, 3 were related to OLC and 2 were deemed unrelated to OLC.


Get the Full Report

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

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.