Tag: Health

Novo Nordisk’s $4.1 Billion Bet on Weight Loss

Posted on by slightbourne@noblecapitalmarkets.com

In a bold move that underscores the burgeoning demand for weight loss and diabetes treatments, Danish pharmaceutical giant Novo Nordisk has announced a monumental $4.1 billion investment to construct a state-of-the-art manufacturing facility in Clayton, North Carolina. This strategic decision marks a significant escalation in the company’s commitment to increasing the supply of its blockbuster drugs, Wegovy and Ozempic, which have taken the medical world by storm.

The new 1.4 million-square-foot plant, slated for completion between 2027 and 2029, will be dedicated to the crucial tasks of filling and packaging syringes and injection pens for these game-changing medications. This expansion is not just about bricks and mortar; it represents a transformative step in Novo Nordisk’s production capabilities and its position in the competitive pharmaceutical landscape.

The timing of this investment is critical. Wegovy and Ozempic, both part of a class of drugs known as GLP-1s, have seen demand skyrocket, outpacing the company’s current production capacity. The resulting shortages have left many patients struggling to access these treatments, which have shown remarkable efficacy in managing weight and diabetes. The new facility aims to bridge this gap, potentially revolutionizing access to these sought-after therapies.

The scale of Novo Nordisk’s commitment is evident in the numbers. The company plans to invest a staggering $6.8 billion in production this year alone, a significant increase from the $4 billion invested last year. This ramping up of investment reflects not just the current demand but also the company’s bullish outlook on the future of these treatments.

The impact of this expansion extends beyond the realm of healthcare. The new facility is set to create 1,000 new jobs, adding to the 2,500 employees already working at Novo Nordisk’s existing North Carolina plants. This influx of high-quality jobs represents a significant economic boon for the region, further cementing North Carolina’s status as a hub for pharmaceutical manufacturing.

The demand for Wegovy, in particular, underscores the potential market for effective weight loss treatments. With an average of 35,000 U.S. patients starting Wegovy each week – up from 27,000 in May – the drug has clearly struck a chord in a nation grappling with an obesity epidemic. However, the current shortage of lower doses has hampered the drug’s rollout, a problem this new facility aims to address.

Novo Nordisk’s expansion is not happening in isolation. The weight loss and diabetes treatment market has become a battleground for pharmaceutical giants, with companies like Eli Lilly also investing heavily in manufacturing capacity for similar drugs. This competition is likely to drive further innovation and potentially lead to more accessible treatments for patients in the future.

The Clayton facility will join Novo Nordisk’s existing manufacturing network, which includes plants in Denmark, France, China, Japan, and several other countries. However, this significant investment in U.S. manufacturing capacity signals the company’s recognition of the importance of the American market and its commitment to serving patients in the region.

As construction begins on this new facility, the pharmaceutical industry watches with keen interest. The success of this venture could set a new standard for production capacity in the industry and potentially reshape how companies approach the manufacturing of high-demand drugs.

In the grand scheme of things, Novo Nordisk’s $4.1 billion investment is more than just an expansion of manufacturing capacity. It represents a vote of confidence in the future of weight loss and diabetes treatments, a commitment to addressing critical healthcare needs, and a strategic move to solidify the company’s position as a leader in this rapidly evolving field. As the facility takes shape over the coming years, it may well become a symbol of the transformative power of targeted pharmaceutical investment in addressing global health challenges.

$381M Alimera Acquisition Propels ANI Pharmaceuticals into New Markets

Posted on by slightbourne@noblecapitalmarkets.com

In a strategic move to bolster its position in the rare disease and ophthalmology markets, ANI Pharmaceuticals has announced its acquisition of Alimera Sciences for approximately $381 million. This transformative deal, expected to close in the third quarter of 2024, marks a significant step in ANI’s growth strategy and expansion into the global pharmaceutical landscape.

The acquisition terms include an upfront payment of $5.50 per share in cash, representing a substantial 75% premium over Alimera’s recent closing price. Additionally, Alimera shareholders will receive a contingent value right (CVR) of up to $0.50 per share, tied to the achievement of specific revenue targets in 2026 and 2027. This structure aligns the interests of both companies and incentivizes future growth.

At the heart of this acquisition are Alimera’s two key commercial products, ILUVIEN® and YUTIQ®, both targeting eye conditions such as diabetic macular edema and chronic non-infectious uveitis. These assets are expected to contribute significantly to ANI’s revenue stream, adding approximately $105 million in highly durable branded revenue. The integration of these products aligns with ANI’s recent strategic focus on ophthalmology, complementing its existing rare disease portfolio.

The deal is projected to have a substantial positive impact on ANI’s financial performance. The company anticipates high single-digit to low double-digit accretion in adjusted non-GAAP earnings per share (EPS) in 2025, with even more substantial accretion expected in subsequent years. Furthermore, ANI projects an additional $35-$38 million in adjusted non-GAAP EBITDA for 2025, including approximately $10 million in identified cost synergies.

Beyond the immediate financial benefits, this acquisition significantly expands ANI’s geographic footprint. Alimera’s established presence in European markets, including direct operations in Germany, the United Kingdom, Portugal, and Ireland, provides ANI with a springboard for international growth. The deal also brings valuable partnerships in Asia and the Middle East, further diversifying ANI’s global reach.

Strategically, this move strengthens ANI’s position in the rare disease sector, which is expected to become the company’s primary growth driver. Post-acquisition, the rare disease segment is projected to account for approximately 45% of ANI’s pro forma 2024 revenues, with robust growth potential. The transaction also leverages ANI’s existing rare disease infrastructure, creating operational efficiencies and expanding its reach to over 3,600 physicians in the ophthalmology field.

To finance the acquisition, ANI will utilize a combination of cash on hand and $280 million in committed debt financing from J.P. Morgan and Blackstone Credit & Insurance. The company anticipates a pro-forma leverage of 3.2x upon closing, with significant organic de-levering expected in 2025.

The boards of directors of both companies have approved the transaction, which now awaits customary closing conditions, including regulatory approvals and Alimera shareholder approval. Both companies have enlisted top-tier financial and legal advisors to navigate the complexities of the deal, underscoring its strategic importance.

This acquisition represents a pivotal moment for ANI Pharmaceuticals, positioning it as a stronger player in the rare disease and ophthalmology markets. By integrating Alimera’s products and expertise, ANI is set to enhance its market presence, diversify its revenue streams, and potentially accelerate the growth of its existing products, including Purified Cortrophin® Gel, in the ophthalmology sector.

As the pharmaceutical industry continues to evolve, with an increasing focus on specialized treatments for rare diseases, this strategic move by ANI Pharmaceuticals demonstrates its commitment to growth and innovation. The successful integration of Alimera Sciences could serve as a catalyst for ANI’s long-term success, benefiting patients, physicians, and shareholders alike in the rapidly advancing field of ophthalmology and rare disease treatment.

Tonix Pharmaceuticals (TNXP) – Tonix Announces Positive Pre-NDA Meeting – NDA Submission On Schedule

Posted on by cpereira@noblefcm.com


Friday, June 21, 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.

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

NDA For Tonmya Expected In 2H24. Tonix announced that it has received written feedback from the FDA from its pre-NDA meetings. The meetings covered the CMC (chemistry, manufacturing, and controls) section of the Tonmya new drug application (NDA). Based on the written feedback, Tonix believes it is in alignment with the FDA on important issues. This keeps the NDA filing on schedule for submission in 2H24.

Tonix Reaches CMC Agreement and Alignment. Topics of the meetings included the proposed drug substance and commercial specifications, shelf-life assignment, manufacturing, and commercial drug packaging. We see this as a significant milestone toward the NDA submission and approval, as many NDA applications have been delayed or received Complete Response Letters (CRLs) due to issues with manufacturing and the CMC section.


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

Cocrystal Pharma (COCP) – Cocrystal Updates Studies On Influenza and Bird Flu

Posted on by cpereira@noblefcm.com


Friday, June 21, 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.

Potential Efficacy Against A New Strain Of Avian Influenza. Cocrystal has announced that studies of its influenza drug, CC-42344, have shown efficacy against the new avian influenza strain H5N1. Cocrystal has used its proprietary technology to determine the strain’s mutations and structure, then conduct preliminary tests. The binding site for CC-42344 was not changed and can block reproduction of the new strain, making it an effective vaccine against the virus. 

Avian Influenza Strain Has Begun To Infect Humans. Avian influenza H5N1 has caused significant illness in commercial bird flocks since 2003. Its impact was limited until recent outbreaks in dairy cattle and infections in diary workers. This ability to mutate and infect other species is a significant step toward causing widespread outbreaks in humans, elevating it to a public health concern.


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

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

GeoVax Labs (GOVX) – GeoVax Receives BARDA Award For COVID Vaccine Trial

Posted on by cpereira@noblefcm.com


Tuesday, June 18, 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.

Grant Provides Up To $367 Million Funding For The Phase 2b Trial. GeoVax announced that it has been selected to receive a Project NexGen grant to test CM04S1 in a Phase 2b study for prevention of COVID-19. The study will test CM04S1 against an approved vaccine in a randomized trial enrolling 10,000 volunteers. GeoVax will receive about $24.3 million for manufacturing, materials, and trial preparations, which can be increased to $45 million. About $343 million will be awarded to a CRO to conduct the trial.

Phase 2b Trial Will Have A Large Enrollment. The trial is designed as a Phase 2b double-blind study comparing GeoVax CM-04S1 to an approved mRNA COVID-19 vaccine. Enrollment will have an estimated 10,000 healthy volunteers to determine efficacy, safety, and immunogenicity of the vaccines. Previous trials with CM04S1 have shown both humoral and cellular immunity to multiple strains of the SARS-CoV-2 virus, with rapid and durable protection.


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

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. 

Healthcare AI Trailblazer Tempus Goes Public in $410 Million Offering

Posted on by slightbourne@noblecapitalmarkets.com

The artificial intelligence revolution is rapidly expanding into new industries and sectors. While AI has already transformed fields like consumer technology and autonomous vehicles, one area holding immense potential for disruption is healthcare. A new public company, Tempus AI, is looking to capitalize on this opportunity at the intersection of artificial intelligence and precision medicine.

Tempus, based in Chicago, priced its initial public offering on Thursday, raising $410.7 million by selling 11.1 million shares at $37 each. With this successful IPO, the AI healthcare company now carries a fully diluted market valuation around $8 billion as a newly minted public enterprise. Tempus also granted underwriters a 30-day option to purchase an additional 1.665 million shares.

The sizeable offering highlights immense investor demand for companies leveraging artificial intelligence to solve major challenges across different domains. AI and machine learning firms have seen warm receptions on the public markets over the last couple of years as the powerful capabilities of these technologies have become more apparent and applicable.

However, Tempus represents one of the first opportunities for public investors to gain exposure to the rapidly evolving field of AI-driven precision medicine and healthcare applications. The company aims to use artificial intelligence models to provide decision support tools that enable doctors to offer more personalized care tailored specifically to each patient’s condition and circumstances.

Underpinning Tempus’ AI healthcare platform is its multimodal database containing a massive repository of data aggregated from healthcare providers across the country. This includes molecular data, medical images, electronic records, and treatment information across millions of patient lives for major disease areas like cancer, diabetes, neurological disorders and more.

Tempus deploys proprietary artificial intelligence models that ingest and learn patterns from this immense, constantly updating dataset. These AI models can then provide personalized analysis and therapeutic recommendations to physicians treating patients. On the life sciences side, pharmaceutical companies pay to access Tempus’ data and AI capabilities to aid in drug discovery and development of new therapies.

The core premise is that Tempus’ operating system for precision medicine becomes smarter and more powerful with every new data point added. This sets up a virtuous learning cycle where the AI models help enable better patient outcomes, leading to more data to further enhance the predictive prowess of the AI over time.

While still a relatively small company generating around $100 million in revenue for 2023, Tempus has grand ambitions to help usher in an era of AI-augmented healthcare. The company envisions its technology empowering doctors to defeat deadly diseases through intelligent, data-driven treatment strategies precisely tailored to each individual patient’s unique molecular profile.

Tempus’ successful public offering provides a major cash influx to fund investments and growth initiatives as it aims to cement itself as a pioneer in the burgeoning field of AI healthcare applications. For investors seeking exposure to AI’s transformative potential across sectors, the newly public Tempus may offer an intriguing option to capitalize on precision medicine powered by artificial intelligence.

Only time will tell if Tempus can fully deliver on its bold vision. But the company’s lucrative public debut underscores big expectations that AI could play a pivotal role in ushering healthcare into a new technologically-advanced frontier of personalized patient care and therapeutic development in the years ahead.

Take a moment to take a look at more emerging growth healthcare investment ideas on display at the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference.

Medtech Industry Heats Up as KARL STORZ Acquires Surgical Robotics Firm Asensus

Posted on by slightbourne@noblecapitalmarkets.com

The medtech deal landscape just got a major shake-up with medical technology giant KARL STORZ announcing it will acquire surgical robotics company Asensus Surgical for $0.35 per share in cash. The $775 million transaction represents a significant premium for Asensus shareholders and will create a new leader in robotic surgery systems within KARL STORZ’s vast product portfolio.

The acquisition highlights the intense interest and competition around next-generation surgical robotics platforms. KARL STORZ is doubling down on the space by bringing Asensus and its augmented intelligence technologies in-house to enhance its robotic surgery offerings, particularly the promising LUNA system Asensus had in development.

For the medtech sector and investors, this high-profile deal carries several implications:

Robotic Surgery Becomes Key Priority
KARL STORZ’s major bet on Asensus signals just how strategically important robotic-assisted surgery has become for medtech companies. The ability to market cutting-edge robotic platforms that improve precision and outcomes is now table stakes in many areas of surgery.

Medtechs involved in supporting technologies like visualization, data integration, and procedural automation should see increased interest and investment from larger players looking to beef up their surgical robotics capabilities. KARL STORZ’s acquisition also puts increased pressure on peers like Intuitive Surgical and Stryker to stay ahead of the innovation curve.

More Consolidation Could Follow
Billion-dollar acquisitions often beget more deals as competitors look to keep pace and buttress their own product portfolios. This could kick off another wave of M&A in the surgical robotics space specifically, with smaller innovative companies becoming prime targets for medtech incumbents.

But beyond just robotics, KARL STORZ’s aggressive move may spur more consolidation across the broader medtech landscape. Major strategic buyers have been a bit apprehensive on M&A recently. This deal could provide a catalyzing force for other medtechs, pharmaceuticals, and life science companies to start getting more acquisitive, especially with several cutting-edge names trading at more attractive valuations.

Public Listing Exits Will Continue
By taking Asensus private, KARL STORZ adds another data point to the growing trend of medtech companies going private or getting acquired by larger players. With the IPO markets effectively shuttered and sustaining a public listing increasingly difficult for many small-to-mid-sized medtechs, a lucrative exit via acquisition could become the preferred route.

Investors may need to adjust expectations and position accordingly. Rather than holding out for the “next big IPO,” top-performing private medtech holdings may deliver the biggest windfall by positioning to get scooped up via M&A premium valuations down the road.

Capital Allocation Will Be Key
The KARL STORZ-Asensus transaction underscores how critically important prudent capital allocation and portfolio management will be for medtech investors. The 67% premium paid by the German firm highlights the potential upside for backing innovative, promising names before they get acquired.

But it also serves as a reminder of the downside risks – making the wrong medtech bets can lead to significant impairment if firms struggle to remain viable acquisition targets or get their technologies to market successfully. Having robust processes to separate the wheat from the chaff across the medtech universe will be paramount moving forward.

KARL STORZ’s acquisition of Asensus represents both an ambitious strategic move for the medical device titan and an intriguing data point for medtech investors to digest. As the broader life science space continues rapidly evolving, this landmark M&A deal provides some insight into the developing landscape that savvy medtech investors will need to navigate adeptly.

Rare Disease Pharma Play: Cycle Bids $466M for Vanda

Posted on by slightbourne@noblecapitalmarkets.com

Cycle Pharmaceuticals Ltd., a rapidly growing pharmaceutical company laser-focused on rare diseases, has set its sights on acquiring Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) for $8.00 per share in an all-cash transaction valuing Vanda at $466 million.

The unsolicited proposal, disclosed publicly on June 6th, represents an attractive 98% premium to Vanda’s share price prior to an earlier $4.05 per share acquisition offer from Future Pak LLC announced in April. Cycle’s $8.00 bid also represents a 58% premium to Vanda’s closing price on June 5th.

Vanda, which has been publicly traded since 2006, currently markets therapies for sleep disorders, jet lag, and schizophrenia, with additional pipeline candidates in development. The company’s shares have struggled over the past year, trading as low as $3.30 before the Future Pak offer surfaced.

Cycle was founded in 2012 with the sole mission of developing and commercializing treatments for underserved rare disease patients. The company has quickly built an arsenal of six approved drugs, including recent U.S. launches of TASCENSO ODT for multiple sclerosis in 2023 and TIOPRONIN for a rare metabolic disorder in 2024.

In disclosing its proposal publicly, Cycle cited its “extensive U.S. operational footprint and distribution,” stating this makes it “a strong strategic fit” to maximize the value of Vanda’s commercial products and pipeline. Cycle reported $109 million in 2023 net sales and $40 million in operating profits.

The proposal represents “immediate, compelling and certain cash value” for Vanda shareholders according to Cycle. Its $8.00 per share cash bid exceeds the cash component of Future Pak’s most recent $23 per share revised offer on May 7th, which included stock and contingent value rights.

Cycle stated it has substantial cash reserves on hand and is highly confident it can secure committed debt financing for the transaction after limited due diligence. The firm is aiming to complete diligence within 2-3 weeks and finalize a definitive merger agreement shortly thereafter.

While Cycle stated a preference to reach an agreement privately with Vanda’s board, it has gone public with its proposal “for the benefit of Vanda shareholders” to encourage them to voice support for the premium cash bid.

The rare disease focus of both companies could make this an intriguing strategic fit, while Cycle’s bold premium cash offer puts the onus on Vanda’s board to either embrace this higher-valued bid or make a compelling case that greater long-term value could be unlocked by rejecting it. Regardless, this acquisition play instantly ratchets up the stakes in Vanda’s strategic review process.

MAIA Biotechnology (MAIA) – THIO-101 Data Update Shows Continued Efficacy

Posted on by cpereira@noblefcm.com


Wednesday, June 05, 2024

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.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.

Presentation At ASCO Updates Phase 2 THIO-101 Trial. MAIA presented data from its Phase 2 THIO-101 trial at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting. The new data includes additional patients followed for longer time periods, giving more observation points. We believe the data continues to show that THIO shows meaningful improvements over published data in several important measures of efficacy. 

Third Line Treatment Shows Disease Control and Tumor Response. Patients had advanced non-small cell lung cancer (NSCLC) and were treated with the combination of THIO and cemiplimab (Libtayo, an anti-PD-1 checkpoint inhibitor from Regeneron) after failing 2 or more standard-of-care therapy regimens. The data included 20 patients who had failed two previous lines of therapy including platinum chemotherapy and checkpoint inhibitors, with a group dosed at 60 mg (n=12) and a group dosed at 180 mg (n=8). The 180 mg dose was selected as the optimal dose for further studies.


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

Cadrenal Therapeutics (CVKD) – Data Presentation From LVAD Study Points Out The Need For Tecarfarin

Posted on by cpereira@noblefcm.com


Wednesday, June 05, 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.

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.


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

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. 

Eledon Pharmaceuticals (ELDN) – Data Update From Phase 1b Trial Shows Continued Tegoprubart Benefits

Posted on by slightbourne@noblecapitalmarkets.com


Tuesday, June 04, 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.

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.


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

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.

Virtual Therapeutics Levels Up in Digital Mental Health With $276M Akili Deal

Posted on by slightbourne@noblecapitalmarkets.com

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.

Take a moment to discover more emerging growth biotechnology companies by taking a look at Noble Capital Markets’ Research Analyst Robert LeBoyer’s coverage list.

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 Pharmaceuticals (TNXP) – Tonmya Presentations From Previous and Upcoming Trials

Posted on by cpereira@noblefcm.com


Friday, May 31, 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.

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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