Tag: Health

MustGrow Biologics Corp. (MGROF) – Reaching Another State

Posted on by cpereira@noblefcm.com


Wednesday, February 07, 2024

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

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

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

Another Approval. Oregon is the newest state to approve TerraSante for product sales, as management announced receipt of The State of Oregon Agriculture Fertilizer Registration Certificate for its product. The Company’s organic compliance certification from the USDA National Organic Program will apply to the product sales.

Expansion of Revenue. The Oregon approval provides MustGrow with another agriculture-rich state, with the state recording $5.0 billion in agriculture production on 16 million acres of farmland in 2021, which generated 13% of the states’ GDP. With the sales & marketing commercialization strategy in conjunction with BioAg Product Strategies in place for the 2024 planting season, we believe adding Oregon provides another positive to top-line revenue growth for the Company.


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) – Initial Phase 2 Data Shows Immune Responses In COVID-19 Booster Trial

Posted on by cpereira@noblefcm.com


Wednesday, February 07, 2024

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

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

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

Initial Phase 2 Data Announced. GeoVax announced positive initial findings from its Phase 2 clinical trial testing GM04S1 as a booster vaccine in patients who had previously been vaccinated with an mRNA vaccine from Pfizer or Moderna. This includes the initial safety and immune response measured 30 days after patients received the vaccine.

GM-04S1 Is Designed As A Successor To Current Vaccines. GM04S1 is an MVA-based SARS-CoV-2 vaccine designed to stimulate immunity against two viral proteins, the spike (S) and nucleocapsid (N). Prior testing showed both antibody and T-cell responses against conserved regions of the virus that are less likely to mutate and protect against future variant strains. Stimulation of both the antibody and cellular arms of the immune systems could provide long-term immunity and durability of the response.


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. 

Novartis Scoops Up MorphoSys in $2.9B Bid to Expand in Oncology

Posted on by slightbourne@noblecapitalmarkets.com

Novartis made a big move this week to expand its oncology portfolio, announcing plans to acquire German biotech MorphoSys in an all-cash deal valued at approximately $2.9 billion. The proposed acquisition continues Novartis’ strategy of striking deals and partnerships to enhance its drug development capabilities, especially in cancer.

Under the terms of the agreement, Novartis will pay $73 per share to purchase all outstanding ordinary shares of MorphoSys, representing a premium of 37% over the biotech’s closing price on February 3rd. The deal has been unanimously approved by MorphoSys’ board and is expected to close in the first half of 2024, pending regulatory and shareholder approval.

Driving Novartis’ interest is MorphoSys’ lead pipeline candidate pelabresib, an investigational BET inhibitor being studied for myelofibrosis. Myelofibrosis is a type of bone marrow cancer that disrupts the body’s normal production of blood cells.

Pelabresib is currently in the Phase 3 MANIFEST-2 trial in combination with Incyte’s Jakafi for first-line myelofibrosis patients. While the trial posted mixed results in November, Novartis believes the data support a regulatory submission in the second half of 2024. The pharma giant sees pelabresib as having potential to be a “practice changing” myelofibrosis treatment.

Beyond pelabresib, MorphoSys brings other early-stage oncology assets that could strengthen Novartis’ position in blood cancers. However, the crown jewel of MorphoSys’ portfolio – its approved non-Hodgkin’s lymphoma drug Monjuvi – is not included in the acquisition. Just before the Novartis deal was announced, MorphoSys sold the global rights to Monjuvi to Incyte for $1.5 billion.

Novartis has been actively hunting for new drug programs and technology platforms to replenish its pipeline as patents expire over the next decade on blockbuster brands like Cosentyx and Entresto. The patent cliff threatens over 50% of Novartis’ current sales.

In 2022, the pharma giant established a $1 billion fund to invest in startups focused on potentially transformational medicines. It has also been open to large M&A, as seen last year with the $20.7 billion purchase of gene therapy biotech The Medicines Company.

The MorphoSys deal reinforces Novartis’ commitment to growing its oncology division, which accounted for over 30% of total sales in 2023. Earlier this year, Novartis acquired the oncology biotech Calypso for $335 million upfront.

From an investor perspective, the MorphoSys acquisition provides Novartis with multiple shots on goal in blood cancers. If pelabresib hits, it could generate peak sales above $1 billion annually according to analysts. And with MorphoSys trading at multi-year lows, Novartis appears to have struck at an opportune time.

However, the mixed clinical data keeps pelabresib’s commercial prospects uncertain. And with most of MorphoSys’ value residing in the newly divested Monjuvi, it remains to be seen if Novartis overpaid. Investors reacted with caution on Tuesday, with Novartis shares falling 1% on news of the acquisition.

But with MorphoSys providing additional expertise in hematology R&D and a foothold in the German biotech scene, Novartis can justify the deal as a strategic move to reinforce oncology leadership. The pharma giant has the resources to continue its shopping spree, with around $9 billion in annual free cash flow.

If Novartis can successfully integrate MorphoSys’ personnel and drug candidates into its pipeline, while achieving cost synergies, the acquisition could pay dividends over time as new oncology drugs emerge. But executing large M&A successfully is always challenging, and investors will watch closely how Novartis leverages its new MorphoSys assets.

Mark your calendars! Don’t miss Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference on April 17-18. This exclusive virtual event connects investors with 50 leading public biotech, healthcare services, and medical device companies. Presenting company slots are available…Read More

Cigna Unloads Medicare Assets for $3.7B, Ups Investments in Core Segments

Posted on by slightbourne@noblecapitalmarkets.com

Health insurer Cigna announced Wednesday it is divesting its Medicare Advantage, Medicare Part D, and other Medicare operations to Health Care Service Corporation (HCSC) in a $3.7 billion cash deal.

Cigna said the sale will streamline its business to focus on growing its health services and benefits platforms. Proceeds will also fund share repurchases, with the transaction expected to be accretive to adjusted earnings per share in 2025.

Refocusing the Portfolio

The sale includes Cigna’s Medicare Advantage plans, Medicare Part D prescription drug plans, Cigna Supplemental Benefits, and the CareAllies health support services unit.

With HCSC taking over these businesses, Cigna can direct more investment and resources toward expanding its Evernorth health services division and Cigna Healthcare commercial health benefits segment.

Evernorth provides pharmacy benefits management, specialty pharmacy, and health technology solutions. Cigna Healthcare offers employer-sponsored group health plans as well as individual plans.

While Cigna sees Medicare as an attractive market, the segment required outsized focus and capital relative to its size within Cigna’s broader portfolio. The sale unlocks value and simplifies operations.

Gaining Scale and Capabilities

For HCSC, the transaction accelerates growth in Medicare, where the company has over 1 million members currently across 7 states. Adding Cigna’s Medicare customers and capabilities will expand HCSC’s geographic reach and enhance its product portfolio.

The businesses being acquired generated around $5.5 billion in 2022 revenues for Cigna. So the deal provides HCSC with meaningful membership and revenue growth in Medicare and immediate scale.

Cigna built a significant presence in Medicare through organic growth and acquisitions like HealthSpring in 2011. HCSC gains these customer relationships and infrastructure with the purchase.

Focusing on What Cigna Does Best

Cigna has been optimizing its portfolio under CEO David Cordani to concentrate on its core competencies. Last year, Cigna sold its international life, accident, and supplemental benefits businesses.

The Medicare sale continues this strategic focus on areas where Cigna has differentiated capabilities and growth opportunities. Evernorth provides unique pharmacy solutions and analytics. Cigna Healthcare leverages the company’s strong employer and health plan expertise.

The transaction value of $3.7 billion represents about 10 times Medicare Advantage customer revenue and 16 times Medicare Part D customer revenue. This appears a solid price for Cigna to unlock capital from non-core assets.

Financial Benefits

Cigna expects the deal will be 5-10% accretive to adjusted EPS in 2025 once completed. The company reaffirmed its 2024 outlook and long-term 10-13% annual EPS growth target.

Proceeds from the divestiture will primarily fund share buybacks, representing an attractive return of capital for investors. Cigna previously had around $7.5 billion remaining on its buyback authorization.

The deal is expected to close in the first quarter of 2025 after securing necessary regulatory clearances. There is no financing condition, providing transaction certainty.

Overall, the sale highlights Cigna’s disciplined portfolio approach to drive shareholder value. Consolidating its focus while monetizing Medicare strengthens Cigna’s growth trajectory in targeted segments. For HCSC, the deal accelerates its diversification into a key government market.

Cadrenal Therapeutics (CVKD) – Peer-Reviewed Journal Reviews Uses of DOAC Drugs, Pointing To The Need For Tecarfarin

Posted on by cpereira@noblefcm.com


Thursday, February 01, 2024

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

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

New Article Discusses Uses and Contraindicated Patient Groups. An article in the Journal of the American College of Cardiology titled “When Direct Oral Anticoagulants Should Not Be Standard Treatment: JACC State-of-the-Art Review” summarized indications where DOAC drugs are commonly used, indications where they should not be used, and indications where efficacy is uncertain. The paper identifies conditions that tecarfarin is being developed to treat and supports the need we see for the drug.

DOAC Drugs Are Not For All Patients. The Direct Oral Anticoagulants (DOAC) drugs are anticoagulants that act on one specific protein in the clotting cascade. The class includes Eliquis (apixaban), Xarelto (rivaroxaban), Savaysa (edoxaban), and Pradaxa (dabigatran). Although these are effective in many conditions, some clinical trials have shown adverse findings and conditions where they should not be used.


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. 

Cardinal Health Bolsters Specialty Offering With $1.2 Billion Acquisition

Posted on by slightbourne@noblecapitalmarkets.com

Cardinal Health announced Wednesday that it will acquire Specialty Networks for $1.2 billion in cash, strengthening the healthcare giant’s services for specialty physician practices. Specialty Networks provides technology-enabled group purchasing, practice management solutions, and data analytics to over 11,500 specialty providers across key areas like urology, rheumatology, and gastroenterology.

The deal enhances Cardinal Health’s capabilities in strategically important specialty areas while expanding its platform serving independent physicians. Here are some key details on the acquisition:

Expanding Service Offerings

Specialty Networks gives Cardinal Health new clinical and economic services to offer specialty physicians and practices. Its analytics platform, PPS Analytics, taps into electronic medical records, imaging systems, and other data sources to generate insights improving patient care and outcomes.

Cardinal gains Specialty Networks’ expertise optimizing specialty practice operations and finance. And through group purchasing relationships Specialty Networks facilitates, Cardinal Health can provide access to discounted products and services.

The combined specialty offerings will aim to boost efficiency, revenues, and coordination of care for specialty providers. This strengthens Cardinal’s value proposition as a distribution and services partner.

Supporting Independent Physicians

A key aspect is Specialty Networks’ focus on independent and community-based specialty practices. With over 1,200 physician practice customers, it expands Cardinal’s reach and understanding of this critical healthcare segment.

The medical landscape is increasingly consolidated, making it more vital for Cardinal Health to support independent practices’ success. Specialty Networks’ experience and technology assets aid in this aim.

Cardinal Health can also leverage Specialty Networks’ physician expertise and relationships to accelerate development of its Navista Network. This network assists independent community oncologists with practice solutions and clinical trials access.

Mark your calendars! Don’t miss Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference on April 17-18. This exclusive virtual event connects investors with 50 leading public biotech, healthcare services, and medical device companies. Presenting company slots are available…Read More

Enhanced Analytics and Insights

Specialty Networks’ rich specialty patient data and analytics capabilities will enhance Cardinal’s offerings. Its PPS Analytics platform mines electronic records and images using artificial intelligence to generate diagnostic and treatment insights.

Cardinal gains access to millions of longitudinal specialty patient data points. This strengthens its real-world evidence and insights for biopharma partners on the safety, efficacy and use of therapies.

The specialty data and analytics also aid population health management and value-based care initiatives. And they support Cardinal’s direct provider services like improved medication adherence programs.

Driving Growth in Key Areas

Specialty Networks expands Cardinal’s presence and cross-selling opportunities in strategic specialty therapeutic areas:

  • Urology – large patient population with ongoing and acute care needs
  • Rheumatology – fast growing with new advanced treatments
  • Gastroenterology – increasing prevalence of GI diseases

These are growth priorities where Specialty Networks strengthens Cardinal’s advantages. The deal accelerates Cardinal’s specialty growth plans through enhanced resources and newly integrated offerings.

Strong Cultural and Strategic Fit

Cardinal Health and Specialty Networks share a mission to bring value to physician practices while improving patient outcomes. Keeping Specialty Networks’ management team intact ensures continuity of its culture and physician focus.

The companies also have experience collaborating, as Specialty Networks is already a Cardinal Health specialty GPO partner. This makes integration of the businesses more seamless.

The acquisition is expected to be accretive to Cardinal’s non-GAAP earnings per share within 12 months post closing. Specialty Networks gives Cardinal Health a stronger specialty platform and differentiated assets to better serve practices and patients. Combining specialized expertise and technologies, the deal creates benefits for physicians and Cardinal Health alike.

Gilead Deepens Arcus Ties With $320M Investment to Accelerate Cancer Immunotherapy Pipeline

Posted on by slightbourne@noblecapitalmarkets.com

Gilead Sciences and biotech partner Arcus Biosciences announced Tuesday an amended collaboration to accelerate development of their cancer immunotherapy programs, along with a $320 million equity investment by Gilead.

The deal builds on the companies’ 2020 partnership and boosts Gilead’s ownership in Arcus to 33% through an additional stake purchase at $21 per share. Gilead also gains a third seat on Arcus’ board, having their Chief Commercial Officer Johanna Mercier join as a director.

Strategic Focus on TIGIT

A key change is prioritizing late-stage studies for the anti-TIGIT antibody domvanalimab, the lead candidate from the collaboration. Arcus CEO Terry Rosen stated the partners want to “leverage their strengths and focus on efficiently advancing novel combinations.”

Domvanalimab is progressing in Phase 3 for non-small cell lung cancer and gastric/GEJ cancer. By accelerating these pivotal studies, expected to fully enroll by year-end, the drug could reach approval sooner if successful.

However, they are discontinuing the ARC-10 Phase 3 lung cancer trial to devote resources to the other domvanalimab studies targeting greater unmet need.

This streamlining highlights the companies’ faith in TIGIT’s potential but the necessity to optimize their most promising assets. TIGIT is an emerging immunotherapy target and domvanalimab a next-gen asset, so focusing late-stage research is prudent.

Quemliclustat Now Solo Arcus Program

Meanwhile, the planned Phase 3 study of Arcus’ CD73 inhibitor quemliclustat in pancreatic cancer will become an Arcus-only program, no longer jointly developed.

Again the theme is concentrating human capital and financial resources where they can make the biggest difference. For smaller Arcus, independence for some programs provides flexibility.

Arcus can also now fully control projects beyond domvanalimab and their PD-1 drug zimberelimab, which Gilead has options to license. This benefits Arcus’ broader pipeline and product vision.

Extends Arcus Cash Runway

Importantly, the $320 million cash infusion lengthens Arcus’ funding horizon until 2027 by their estimates. This enables advancing Phase 3 quemliclustat and AB154 studies plus potential commercial launch activities without financing concerns.

Any biotech developing novel drugs without revenue benefits immensely from having ample cash reserves. This partly protects Arcus from market volatility and general biotech funding challenges.

Gilead Building a Powerhouse

For Gilead, the enhanced Arcus alliance adds another pillar to their ambitions cancer franchise. The pharma giant has been aggressively wheeling and dealing to expand in oncology, now a key growth area.

Recent moves include the $21 billion Immunomedics acquisition and purchases of companies like Tango Therapeutics, Dragonfly Therapeutics, and Epizyme. The Arcus pact leverages access to next-generation immunotherapy science and pipeline.

Gilead is constructing a vertically integrated oncology player combining in-house and external innovation. Scale and synergies across R&D, manufacturing, and commercialization can accelerate targeted therapies to patients.

With collaborators like Arcus doing the early lifting, Gilead can then optimize late-stage studies and apply their regulatory expertise to reach approvals more quickly.

Overall the amended Arcus agreement highlights Gilead’s commitment to cancer and immunology while bolstering their presence in cutting-edge research like TIGIT inhibition. With the investment and restructuring, Gilead strengthens ties to Arcus’ science while keeping the biotech funded and focused. For both, it’s a win-win accelerating cancer drugs to market.

noble capital markets emerging growth virtual healthcare equity conference

Mark your calendars! Don’t miss Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference on April 17-18. This exclusive virtual event connects investors with 50 leading public biotech, healthcare services, and medical device companies. Presenting company slots are available…Read More

Science 37 to be Acquired by eMed in Deal to Expand Virtual Clinical Trials

Posted on by slightbourne@noblecapitalmarkets.com

Clinical research company Science 37 announced Monday that it has entered into a definitive agreement to be acquired by telehealth provider eMed in a deal valued at approximately $38 million. Under the agreement, eMed will commence a tender offer to purchase all outstanding shares of Science 37 stock for $5.75 per share in cash, representing a 21.3% premium over Science 37’s share price last week.

The deal will allow eMed to leverage Science 37’s remote clinical trial capabilities and proprietary Metasite technology platform to expand patient access and accelerate enrollment for clinical studies. Science 37’s decentralized clinical trial model enables patients to participate from home via telehealth, rather than having to travel to physical trial sites.

This acquisition comes at a pivotal time, as the biotech industry embraces virtual and hybrid trial designs in the wake of the COVID-19 pandemic. Science 37 was an early pioneer in decentralized trials, giving the company a first-mover advantage. According to Science 37 CEO David Coman, “eMed provides the greatest value to our stockholders, customers, patients, and employees. Stockholders will receive a premium, trial sponsors will gain greater access to patients, faster enrollment, and confidence in the Company’s capital position.”

For eMed, the deal significantly expands its digital healthcare footprint, adding Science 37’s network of telehealth investigators, coordinators, and software platform to its existing suite of at-home diagnostics and virtual care services. eMed was an early mover as well, having developed the first at-home COVID-19 test kit in 2020. Since then, the company has expanded into at-home testing and treatment for flu, UTIs, and other conditions.

The combined resources of both companies will provide end-to-end support for decentralized clinical trials, from patient recruitment to at-home sample collection to telemedicine visits. This could be a game-changer in improving patient diversity in trials and enabling studies focused on rare diseases or targeted therapies.

According to Science 37’s latest financial update, the company expects approximately $58-59 million in revenue for 2023 and over $50 million in cash reserves as of December 31, 2023. The company projected 2023 revenue of $50-60 million.

Science 37’s board of directors unanimously approved the acquisition deal with eMed. Major Science 37 shareholders, including Redmile Group, LLC, have also agreed to tender their shares in support of the acquisition.

The deal is expected to close in Q1 2024, pending tender of a majority of outstanding Science 37 shares and satisfaction of other customary closing conditions. Once completed, Science 37 will become a privately held subsidiary of eMed.

This Science 37 acquisition comes on the heels of eMed’s parent company, Evernow Inc., raising $100 million in Series B funding last March. The current deal highlights continued investor appetite for telehealth and digital health companies that are expanding access to care.

In fact, Noble Capital Markets will be hosting a Virtual Healthcare Conference from on April 17-18, 2024, featuring presentations from emerging growth companies in the healthcare sector. The conference will provide a platform for companies to showcase their innovations in digital health, telemedicine, medical devices and more.

The Science 37 and eMed deal also demonstrates the growing intersection between telehealth and clinical research. Other companies like Medable and Excelya are exploring how hybrid and decentralized trials can boost patient recruitment and retention. By meeting patients where they are, virtual trials enable more representative, diverse study populations.

While some industry experts say a hybrid approach will become the standard, decentralized trials are still a relatively new model. This acquisition provides eMed with a first-mover advantage, but expect other digital health companies to underscore their clinical trial offerings moving forward. In the meantime, all eyes will be on eMed and Science 37 as they pioneer the next generation of virtual clinical research.

HEALWELL Makes Big Move into AI-Powered EHR Market Through Intrahealth Acquisition

Posted on by slightbourne@noblecapitalmarkets.com

Healthcare technology firm HEALWELL AI is starting 2024 off strong with the strategic acquisition of Intrahealth Systems, a global provider of electronic health record (EHR) software. This $24 million deal provides HEALWELL with a platform to showcase and scale up its impressive AI capabilities within the massive EHR solutions market.

For investors focused on healthcare tech and AI, this is an exciting play on some of the most promising trends reshaping the industry. As digital health and telemedicine expand rapidly, there is surging demand for next-gen EHR systems equipped with cutting-edge analytics and AI.

HEALWELL is aiming to be at the forefront of this movement by uniting its physician-designed AI with Intrahealth’s established EHR solutions and multi-national customer base.

With over 15,000 clinicians and millions of patients served across Canada, Australia, and New Zealand, Intrahealth boasts an impressive footprint and high-margin recurring revenue exceeding $12 million annually.

HEALWELL plans to turbocharge Intrahealth’s offerings by embedding its own AI-powered clinical decision support software. This technology has already demonstrated major promise in preventative care by enabling earlier disease detection and personalized interventions.

Integrating these AI capabilities into a widely adopted EHR platform like Intrahealth opens up tremendous possibilities to amplify outcomes and lower costs for healthcare providers globally. This direction aligns perfectly with growing adoption of value-based care models that prioritize proactive, tech-enabled, and patient-centric treatment.

For HEALWELL specifically, the benefits of acquiring Intrahealth extend well beyond the technology integration upside. This established player provides HEALWELL with a stable source of profitable SaaS revenue to complement its R&D pipeline. And Intrahealth’s international reach significantly expands HEALWELL’s total addressable market.

The deal also furthers HEALWELL’s broader acquisition-driven strategy focused on consolidating AI, data science, and digital health assets. Intrahealth delivers an ideal platform to demonstrate the power of HEALWELL’s innovations to a large audience of potential customers and partners.

With healthcare spending continuing to spiral globally, there is tremendous appetite for tools that can optimize care and reduce waste. This thematic tailwind, combined with Intrahealth’s impressive financials and HEALWELL’s tech prowess, makes the acquisition look like a savvy move.

Investors can gain valuable insights into the healthcare technology landscape at the upcoming Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference from April 17-18, 2024. This premier small-mid cap event will feature presentations from over 50 public emerging growth companies in the space.

The opportunity in AI-enhanced software platforms like EHR looks especially strong when considering the sheer size of the healthcare IT market. According to Grand View Research, this sector is projected to reach $230 billion by 2028, expanding at nearly 12% annually.

Within this landscape, EHR systems are a central focus, with MarketsandMarkets forecasting this specific niche to be worth $48 billion globally by 2027. First movers with differentiated offerings stand to grab significant market share as adoption of next-gen EHR accelerates.

By snapping up Intrahealth, HEALWELL is positioning itself as a frontrunner in this race to redefine the EHR status quo. Investors interested healthcare technology and AI should keep a close eye on how successfully HEALWELL leverages this strategic acquisition. The company’s progress integrating its robust AI into Intrahealth’s solutions will be an important proof point.

Overall, the Intrahealth deal provides HEALWELL with both an immediate boost in revenue and profitability, plus a long-term growth driver if the combined EHR/AI offering gains traction. This is exactly the sort of calculated, opportunistic move investors should want to see in an emerging healthcare technology leader like HEALWELL.

NAYA Biosciences Strengthens Pipeline Through Acquisition of Gene Therapy Asset

Posted on by slightbourne@noblecapitalmarkets.com

NAYA Biosciences is expanding its clinical portfolio through the acquisition of an innovative gene therapy program from Florida Biotechnologies focused on treating rare mitochondrial diseases. This binding deal demonstrates NAYA’s strategy to rapidly build pipeline assets in high-potential areas like gene therapy.

NAYA has entered into a binding letter of intent to acquire Florida Biotechnologies for $20 million in NAYA shares, with potential milestone payments up to $5 million more. The deal specifically targets Florida Biotech’s clinical-stage gene therapy for Leber’s Hereditary Optic Neuropathy (LHON).

LHON is a rare mitochondrial genetic disease leading to progressive vision loss and blindness. There are currently no approved treatments. Florida Biotech’s AAV gene therapy aims to deliver functional copies of the mutated gene to restore cellular function.

Encouraging Safety Data

This therapeutic has already demonstrated encouraging safety data in a 28-patient Phase 1 trial conducted by Florida Biotech and the University of Miami’s Bascom Palmer Eye Institute. Building on this initial study, NAYA aims to accelerate Phase 2 development and provide early access to patients.

The therapy delivers the gene of interest inside an adeno-associated virus (AAV) vector containing a mitochondrial targeting sequence. This sequence enables delivery specifically to mitochondria, the key site of pathology in LHON and many other mitochondrial diseases.

Broad Applicability

While the lead indication is LHON, NAYA highlights this approach has potential for various mitochondrial orphan diseases. The platform’s strong intellectual property covers use of different AAV capsids and routes of administration.

This flexibility and the high unmet need enables a streamlined regulatory path, including Regenerative Medicine Advanced Therapy and priority review voucher opportunities. The technology has already received over $6 million in grant funding to date.

The asset aligns with NAYA’s focus on innovative regenerative medicine approaches with near-term clinical potential. Gene therapy represents a key component of NAYA’s strategy to build a pipeline addressing major unmet needs.

Expertise in Developing Gene Therapies

NAYA has extensive in-house expertise to advance the acquired AAV gene therapy through late-stage trials toward commercialization. For example, NAYA Chief Medical Officer Dr. Fred Grossman previously led development of the first approved gene therapy, Glybera, during his time at uniQure.

Florida Biotech co-founder Dr. Peter Kash also joins NAYA’s board, bringing over 36 years of biotech leadership experience, including developing and financing gene therapy pioneer Kite Pharma. This expertise will prove valuable for unlocking the platform’s full potential.

Execution of Broader Growth Strategy

NAYA Biosciences was formed earlier in 2023 through the merger of Clinigence Holdings and 4Front Biotech. This deal created a holding company structure to facilitate pipeline expansion through additional strategic acquisitions.

The Florida Biotechnologies program represents the next step in this growth strategy. NAYA plans to continue acquiring high-potential clinical assets to build a robust portfolio spanning gene therapy, oncology, fertility and other areas.

These efforts support NAYA’s overall mission of providing patients earlier access to transformative therapies. The company aims to take an entrepreneurial approach to aggressively advance new technologies through development.

Pending Merger to Unlock Public Markets

NAYA’s deal to acquire Florida Biotechnologies is contingent upon the completion of NAYA’s previously announced merger with fertility company INVO Bioscience, expected in Q1 2024.

The merger will create a publicly traded life sciences company under the INVO name, providing access to capital to support NAYA’s development programs and commercialization. The combined company is valued at over $100 million.

Conclusion

In summary, NAYA Bioscience’s move to acquire Florida Biotechnologies’ AAV gene therapy strengthens its pipeline and aligns with its strategy to focus on high-potential clinical assets. Leveraging its development expertise, NAYA is positioned to accelerate this innovative therapy toward commercialization and fill an important unmet need for patients with mitochondrial diseases.

Biotech Innovation: Emerging Cancer Vaccines and Investment Potential

Posted on by slightbourne@noblecapitalmarkets.com

Cancer research is rapidly evolving thanks to innovative biotech companies utilizing cutting-edge technology like artificial intelligence. One company at the forefront of this biotech revolution is Evaxion Biotech, which is developing novel personalized cancer vaccines powered by its proprietary AI platform.

As highlighted in a recent company press release, Evaxion is expanding its cancer vaccine pipeline to target a new class of AI-discovered tumor antigens called endogenous retroviruses (ERVs). ERVs are remnants of ancient viruses in our DNA that are often abnormally activated in cancer cells, making them visible targets for cancer vaccines.

Evaxion’s focus on ERV-based vaccines represents a breakthrough, transformative concept in cancer treatment. The company’s AI technology allows for identification of the most relevant ERV targets from patient genomic data, enabling truly personalized cancer vaccines.

Such precision vaccines could provide solutions for cancer patients unresponsive to current immunotherapies like checkpoint inhibitors. Evaxion aims to expedite development of this personalized vaccine approach, with initial proof-of-concept studies beginning mid-2024.

This innovation exemplifies the vast potential of emerging biotech companies to disrupt the cancer treatment landscape. Smaller firms like Evaxion can leverage cutting-edge technology like AI to uncover completely new therapeutic targets and strategies.

Powered by AI-Driven Discovery

Evaxion’s pivot to ERV-based vaccines is powered by its proprietary AI platform, AI-Immunology. This technology integrates advanced computational models that can decode the complexity of the human immune system’s interaction with cancer.

AI-Immunology allows rapid prediction and design of novel immunotherapy candidates. This is lightyears beyond traditional vaccine discovery dependent on lengthy trial-and-error experiments.

Evaxion’s AI technology provides a holistic, personalized approach to identify the most relevant targets and optimal vaccine strategies for each patient. This is key for developing effective cancer immunotherapies against the incredible heterogeneity seen across tumors and patients.

AI-Immunology represents a scalable, adaptable platform that can be applied to infectious diseases as well. Evaxion is also pursuing viral and bacterial vaccines powered by its AI discovery engine.

Other emerging biotech firms are also investing in AI-driven drug development, including companies like Recursion Pharmaceuticals, Exscientia, Insitro, and Valo Health. The massive potential of AI is transforming biopharmaceutical R&D.

Accelerating Innovation

Evaxion aims to accelerate innovation of its AI-discovered cancer vaccines. As indicated in its recent press release, the company has already initiated preclinical ERV vaccine studies, with plans for early proof-of-concept data by mid-2024.

This represents a rapid timeline from discovery to initial validation, enabled by AI-Immunology’s predictive modeling capabilities. Evaxion notes there is already significant interest around its ERV vaccine concept, which may help attract partners and investment to further accelerate development.

The company’s expedited progress exemplifies the ability of emerging biotech firms to move quickly from ideas to validation. Unencumbered by legacy infrastructure, these agile startups can transition discoveries into the clinic at unprecedented speed.

Investment Commentary

Evaxion’s pioneering AI platform and progress on its cancer vaccine pipeline highlights the compelling investment opportunities in emerging biotech companies.

These small firms offer differentiated technologies like AI-Immunology that enable transformative innovation not easily captured within larger pharmaceutical companies. First-mover advantage allows rapid value creation.

However, biotech investment carries significant risk. Clinical failures remain high across the industry. Diversification across a basket of emerging firms helps mitigate risks.

For investors interested in growth opportunities in small-cap biotech companies, the upcoming Noble Capital Markets Virtual Conference on April 17-18th features presentations from emerging healthcare and biotech companies.

The conference provides access to executive management teams from over 50 public microcap companies in the biotech, healthcare, and medical devices sector. It represents an excellent opportunity for exposure to innovative companies shaping the future of healthcare.

Biotech Revolution

We are in the midst of a biotechnology revolution led by innovative emerging firms. New technologies like AI and genomic profiling are unlocking unprecedented insights into disease biology and enabling personalized therapeutics.

Evaxion’s focus on AI-powered cancer vaccines represents just one example of transformative innovation occurring in the biotech sector. Other areas of rapid progress include gene therapies, cell therapies, targeted oncology treatments, and more.

Driven by these technological breakthroughs, the pace of biopharmaceutical advancement today is unprecedented. Venture capital investment in U.S. biotech startups hit record levels in 2021, topping $30 billion across over 1,000 deals.

The industry is positioned for continued expansion as emerging firms translate discoveries into new medicines. For investors, the high-growth biotech sector warrants attention despite its inherent risks.

Careful selection of companies with differentiated technologies like Evaxion’s AI platform can yield exciting returns. Ongoing evaluation of clinical execution remains key, as early scientific promise must still translate to real-world efficacy.

Overall, the biotech arena offers fertile ground for investment in innovation. The upcoming Noble Capital Markets Virtual Healthcare Conference highlights the wealth of emerging firms driving the biotechnology revolution.

YS Biopharma Co., Ltd. (YS) – Supply Disruptions Still Hit the Quarter, But Outlook Remains Strong

Posted on by cpereira@noblefcm.com


Wednesday, January 24, 2024

https://www.ysbiopharm.comSector(s): Healthcare Industry: Biotechnology Full Time Employees: 865 Key Executives Name Title Pay Exercised Year Born Dr. Hui Shao Pres, CEO & Exec. Director N/A N/A 1969 Ms. Chunyuan Wu Chief Financial Officer

Gregory Aurand, Senior Vice President, Equity Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

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

Reported fiscal Q2 2024 and 1H 2024.  In the fiscal Q2 ended September 30, 2023, YS Biopharma reported revenues of RMB96.82 million, and RMB273.1 million for the first six months of fiscal 2024.  We expected RMB121.8 million and RMB298.1 million, respectively. In the fiscal Q2, the Company reported a net loss of RMB103.7 million, or a loss of RMB1.13 per share, vs. our expected loss of RMB78.7 million, or a loss of RMB0.82 per share.

Revenues were still impacted by Covid-related issues. The Company has been working to improve raw material supply, inventory management and production output. Vaccine production returned to normal levels during the quarter, with the FQ2 expected to be the last quarter impacted by the Covid-related production delays. Management now expects third quarter YSJA vaccine revenues to be more normalized, increasing approximately 50% sequentially.


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. 

Inhibrx Sells Lead Asset INBRX-101 to Sanofi for Up to $2.2 Billion

Posted on by slightbourne@noblecapitalmarkets.com

Biotechnology company Inhibrx announced today that it has entered into a definitive agreement to sell its lead therapeutic candidate, INBRX-101, to French pharmaceutical giant Sanofi in a deal valued at up to $2.2 billion.

INBRX-101 is a recombinant alpha-1 antitrypsin (AAT) therapy being developed for the treatment of alpha-1 antitrypsin deficiency (AATD), a rare genetic disorder that can cause severe lung and liver disease. Under the terms of the agreement, Sanofi will acquire Inhibrx through a merger in which Inhibrx shareholders will receive $30 per share in cash, a contingent value right (CVR) worth up to $5 per share, and one share in a new publicly traded company called Inhibrx Biosciences for every four shares of Inhibrx held.

Inhibrx Biosciences will retain all of Inhibrx’s pipeline assets and infrastructure outside of INBRX-101. This includes several early-stage therapeutic candidates such as INBRX-105 for solid tumors, INBRX-106 for hematologic malignancies, and INBRX-109 for conventional chondrosarcoma. The new company will receive $200 million in cash funding from Sanofi and begin trading publicly after the completion of the merger.

The total potential value of the upfront cash payment, CVR, and Inhibrx’s debt assumption implies an aggregate transaction value of approximately $2.2 billion. Inhibrx shareholders will also own 92% of the equity in the newly formed Inhibrx Biosciences, which will provide opportunities for future value creation.

The acquisition provides Sanofi with full rights to develop and commercialize INBRX-101 globally. The drug candidate is currently in a registrational Phase 2/3 trial evaluating its safety and efficacy in patients with AATD. Inhibrx believes INBRX-101 has multi-billion dollar peak sales potential if approved, which likely drove Sanofi’s interest in the asset.

Inhibrx’s innovative AAT therapy utilizes the company’s novel therapeutic protein engineering capabilities. INBRX-101 is designed to maintain the stability and activity of AAT, potentially enabling less frequent dosing than current AAT therapies. This next-generation approach could position INBRX-101 as a best-in-class treatment option for AATD.

The proposed transaction has been unanimously approved by the boards of directors of both companies and is expected to close in Q2 2024, subject to Inhibrx shareholder approval, regulatory clearances, and other customary closing conditions. Until then, it will be business as usual for Inhibrx as it continues developing its pipeline assets.

For Sanofi, the acquisition expands its portfolio in rare diseases while strengthening its capabilities in protein sciences and engineering. Adding INBRX-101 provides Sanofi with a promising late-stage candidate that can leverage its expertise and infrastructure in pulmonary diseases. Sanofi has been active on the deals front lately, including a recent $3.2 billion deal for Amunix Pharmaceuticals, as it refreshes its pipeline.

Meanwhile, the new Inhibrx Biosciences will emerge as an up-and-coming biotech with strong financial backing, a seasoned management team, and innovative technology platforms. The company will continue operating under the Inhibrx name and leadership. This strategic deal allows Inhibrx to unlock significant value from its lead program while retaining its other assets and resources to drive future growth.

The transaction is a win for both parties, providing Sanofi with a potential blockbuster drug and Inhibrx shareholders with an attractive return and ongoing upside through Inhibrx Biosciences. It demonstrates the broader trend of big pharma leveraging M&A to access innovative therapies from smaller biotech players. As Inhibrx’s programs advance, it will be interesting to see if Inhibrx Biosciences attracts buyout interest down the road. But for now, the company seems well-positioned to create value by advancing its earlier-stage pipeline.

Take a look at more emerging growth biotech companies by taking a look at Noble Capital Markets’ Senior Research Analyst Robert LeBoyer’s coverage universe.