Tag: Health

Novavax Stock Surges Over 20% on Positive Gavi Settlement

Posted on by slightbourne@noblecapitalmarkets.com

Shares of vaccine maker Novavax jumped over 20% on Thursday after the company announced it had reached a settlement agreement with Gavi, the Vaccine Alliance. The settlement resolves a dispute between the two organizations over a canceled COVID-19 vaccine order and provides a boost to the small cap pharmaceutical company.

In May 2021, Novavax signed an advance purchase agreement with Gavi for 350 million doses of its COVID vaccine. Gavi is a public-private global health partnership focused on increasing access to immunization in lower-income countries. It was planning to distribute Novavax’s shots globally through the COVAX initiative.

However, in 2022, Novavax terminated the agreement due to Gavi’s failure to procure any of the planned vaccine doses. Gavi sought a refund on $700 million in advance payments it had made to Novavax, but the company claimed these payments were non-refundable.

The dispute went to arbitration, with Gavi demanding full repayment of the $700 million in 2023. This presented a major financial risk for the small cap Novavax, which has a market capitalization under $5 billion.

Under the new settlement, Novavax will pay Gavi a total of up to $475 million, but in installments over 5 years. An initial $75 million payment has already been made. The remaining payments of $80 million annually through 2028 can potentially be reduced based on any future Novavax vaccine orders Gavi makes.

Gavi also has the option to order discounted Novavax vaccines over the next 5 years using “vaccine credits” provided under the settlement terms. This means that if demand arises, Novavax has the opportunity to supply more of its shots to Gavi for use in lower-income countries.

The flexible settlement terms are highly positive for Novavax’s business outlook. Instead of facing a risky $700 million payment in 2023, the company can spread payments over time while potentially recouping some of the amounts through future vaccine orders.

Many analysts viewed the Gavi arbitration as one of the largest overhangs on the beaten-down stock. Resolving this dispute eliminates a major uncertainty just as Novavax is struggling with low demand for its COVID vaccine. It also ensures Novavax can still participate in serving lower-income markets through partnerships like COVAX.

As a small cap player in the competitive vaccine space, Novavax relies heavily on such partnerships. The Gavi settlement provides the company with much-needed cash flow relief and keeps the door open to future deals. Novavax can now focus its resources on boosting sales and advancing other vaccines in its pipeline.

All told, the settlement comes as a major win for Novavax and its investors. While risks remain for the small vaccine developer, removing the Gavi arbitration cloud and securing continued market access is the optimistic boost Novavax needed right now. The company still faces challenges but has bought itself more time to strategically get back on track.

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

AstraZeneca Completes $1.1 Billion Buyout of Seattle Biotech Icosavax

Posted on by slightbourne@noblecapitalmarkets.com

UK pharmaceutical giant AstraZeneca has finalized its $1.1 billion acquisition of Icosavax, a Seattle-based biotechnology company specializing in virus-like particle (VLP) vaccines. This buyout provides key insights into AstraZeneca’s pipeline strategy and the ongoing consolidation in the biopharma sector.

Icosavax was founded in 2017 as a spinout from the University of Washington’s Institute for Protein Design. The company leverages computationally designed VLPs to induce robust and durable immune responses against respiratory viruses, including COVID-19, respiratory syncytial virus (RSV), and human metapneumovirus (hMPV).

Since its founding, Icosavax has raised over $150 million in private funding and completed a successful IPO in 2021. However, the company caught the eye of pharma giant AstraZeneca, who sees Icosavax’s VLP platform and talented research team as a strategic fit.

For AstraZeneca, this acquisition provides access to a versatile new vaccine modality with broad applicability beyond Icosavax’s current clinical programs. It also bolsters AstraZeneca’s pipeline with a Phase 1/2 COVID-19 vaccine candidate, IVX-411, which produced robust neutralizing antibody titers in early clinical testing.

Broader Implications for Investors and the Biopharma Industry

The buyout has several key implications for biotech investors and industry dynamics. Firstly, it highlights that platform technologies with versatile applications across disease areas remain highly valued, even in the ongoing biotech market downturn. Vaccines also continue to see strong corporate interest after the pandemic spotlight.

Secondly, it reflects Big Pharma’s pursuit of emerging biotech innovation to replenish pipelines and access cutting-edge modalities like VLPs. With the Icosavax deal, AstraZeneca gains talented scientists and potential new products without costly in-house R&D.

Thirdly, from a structure standpoint, the deal provides an upfront cash payout to Icosavax investors but leaves upside through future contingent payments on pipeline advancement. This highlights a flexible model to balance the high valuations sought by biotechs with the risk management needs of acquirers.

Finally, the buyout continues the wave of consolidation between large and small biopharma players. With the market downturn squeezing biotech funding, more mergers and acquisitions are likely on the horizon. Investors should watch for other innovative biotechs with promising science that become acquisition targets.

What Drove AstraZeneca’s Interest in Icosavax

AstraZeneca has been one of the more active Big Pharmas on the M&A front, and the Icosavax deal provides strategic rationale. The VLP technology adds a promising new platform to AstraZeneca’s vaccine capabilities, already bolstered by its previous acquisitions of drug delivery player MedImmune and biotech Sobi.

Icosavax’s potential COVID-19 and RSV vaccine candidates can be added to AstraZeneca’s pipeline as it looks to expand beyond its core oncology portfolio. Additionally, Icosavax’s team and VLP engineering expertise will be valuable assets for the company.

By acquiring Icosavax while still early-stage compared to more established biopharmas, AstraZeneca secures access to the technology at a reasonable price. The $1.1 billion price tag is well below the multi-billion deals that some commercial-stage biotechs have commanded.

Overall, Icosavax represented an opportunity for AstraZeneca to obtain cutting-edge vaccine technology and talent to boost its R&D capabilities in new directions. It highlights that Big Pharmas are willing to buy innovation at early stages rather than develop it internally.

Take a moment to take a look at emerging growth healthcare and biotech companies by taking a look at Noble Capital Markets’ Senior Research Analyst Robert LeBoyers’s coverage universe

The Future for Icosavax’s Programs

While the buyout places Icosavax’s pipeline under AstraZeneca’s control, active development of the VLP programs is expected to continue. Lead COVID-19 vaccine candidate IVX-411 recently began Phase 1/2 trials, and its RSV and hMPV programs are progressing towards clinical stages as well.

AstraZeneca has expressed interest in advancing Icosavax’s full portfolio of vaccines leveraging the versatility of the VLP platform. Its resources and late-stage development expertise can help progress these experimental vaccines through clinical trials and regulatory approval pathways.

Meanwhile, Icosavax will continue operations as an AstraZeneca subsidiary based in Seattle. Keeping its operations separate allows Icosavax to retain its innovative biotech culture while benefiting from AstraZeneca’s financial backing and synergies.

In summary, AstraZeneca’s acquisition of Icosavax underscores its strategy of looking to smaller biotechs to supplement its pipeline with cutting-edge science. The deal rewards Icosavax investors for their early backing while retaining upside potential through milestone payments. For the biopharma industry, it exemplifies the ongoing consolidation between pharmas and biotechs amidst market pressures. Investors should watch for other emerging biotechs that may become tomorrow’s M&A targets.

XOMA to Acquire Kinnate Biopharma in All-Cash Buyout Deal

Posted on by slightbourne@noblecapitalmarkets.com

Biotech royalty company XOMA Corporation (NASDAQ: XOMA) has entered an agreement to fully acquire clinical-stage oncology firm Kinnate Biopharma Inc. (NASDAQ: KNTE) in an all-cash deal valued up to $150 million.

This bold acquisition provides XOMA an opportunity to expand its cancer drug royalty portfolio while handing Kinnate shareholders an immediate payday.

For XOMA, the deal delivers two key benefits:

First, it stands to add approximately $9.5 million in cash to the balance sheet, providing extra fuel for future investments and deal-making.

But more importantly, it grants XOMA rights to Kinnate’s pipeline of early-stage oncology candidates. These experimental drugs, if eventually approved, could generate lucrative milestone and royalty payments for XOMA down the road.

Kinnate’s leading assets are two precision medicines in Phase 1 testing – an FGFR inhibitor for cancers driven by FGFR mutations and a pan-RAF inhibitor targeting BRAF and NRAS mutant tumors. Both therapies show promise in initial trials, with additional data expected later this year.

Beyond these advanced assets, Kinnate also boasts alluring preclinical programs in areas like CDK4 inhibition and c-MET inhibition.

For a royalty collector like XOMA, acquiring rights to future royalties on these promising cancer compounds is a savvy move. XOMA’s expertise is striking licensing and royalty deals with biopharma partners. Adding Kinnate’s pipeline to its war chest provides ample new opportunities to flex this deal-making muscle.

And XOMA has a proven track record here. Its lucrative sale last year of royalty rights to the Novartis drug VABYSMO generated over half a billion in cash proceeds. Funneling the proceeds into new royalty streams helps ensure consistent future revenues.

On the flip side, the buyout delivers Kinnate shareholders a decent return amid a downtrodden biotech market. The deal’s maximum price of $2.5879 per share only carries a modest 7% premium over Kinnate’s recent average share price.

But with small-cap biotech valuations crushed across the board, it allows Kinnate investors to cash out at favorable terms compared to remaining standalone. After announcing plans to merge with an unrelated freight company, receiving a buyout provides a more attractive outcome.

Shareholders also retain some upside through CVRs granting them proceeds from any deal for Kinnate’s programs in the year post-buyout.

Importantly, insiders holding nearly half of Kinnate’s shares have signed agreements to tender their stock. This influential support should pave the way to completing the acquisition.

The proposed deal checks all the boxes. XOMA diversifies its royalty portfolio, Kinnate shareholders get paid at a premium, and the cancer drugs have a new catalyst to advance development.

Sometimes simple deals done for the right reasons benefit everyone involved. This cash buyout looks to be just such a win-win-win transaction.

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Unicycive Therapeutics (UNCY) – Initiating Coverage With An Outperform Rating

Posted on by cpereira@noblefcm.com


Wednesday, February 14, 2024

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

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

OLC Could Become The Preferred Drug For Renal Dialysis Patients. Unicycive Therapeutics is developing drugs to treat kidney diseases. The lead drug candidate, OLC (oxylanthanum carbonate), is a phosphate binding agent for the treatment of high phosphate levels in renal dialysis patients. We believe OLC will show advantages over the current phosphate binding drugs and has potential to be the best drug in a category with over $1 billion in US sales. Our price target is $6 per share.

We Believe OLC Will Show Advantages Over Other Phosphate Binders. Patients receiving renal dialysis typically have elevated phosphorus levels in their blood. There are six phosphate binding drugs available to reduce high phosphate levels, however the number of pills required leads to poor compliance. Notably, OLC was formulated to reduce the pill burden and help patients lower their phosphate levels to recommended ranges.


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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. 

Gilead Sciences Acquires CymaBay Therapeutics for $4.3 Billion in Cash

Posted on by slightbourne@noblecapitalmarkets.com

Gilead Sciences announced Monday that it will acquire clinical-stage biotech CymaBay Therapeutics for $4.3 billion, gaining seladelpar, an investigational treatment for primary biliary cholangitis (PBC) that is currently under FDA priority review.

PBC is a progressive autoimmune disease that damages the bile ducts in the liver, causing bile acid buildup that can lead to irreversible scarring and liver failure. An estimated 130,000 Americans live with PBC, which mostly affects women over 40.

CymaBay’s seladelpar is an oral selective peroxisome proliferator-activated receptor delta (PPARδ) agonist that targets metabolic and inflammatory pathways involved in PBC. Data from late-stage studies demonstrate seladelpar’s potential as a best-in-class therapy for second-line PBC patients who don’t respond adequately to first-line treatment with ursodeoxycholic acid (UDCA).

The drug received breakthrough therapy and orphan drug designations from the FDA and EMA based on positive mid-stage results. In December 2022, CymaBay submitted a new drug application to the FDA, which was granted priority review last month. An approval decision is expected by August 14, 2024.

According to the phase 3 RESPONSE trial, seladelpar achieved significant improvements in reducing alkaline phosphatase levels and relieving itch symptoms compared to placebo. Nearly 62% of patients on seladelpar attained a biochemical response versus 20% on placebo.

Gilead aims to leverage its extensive experience in developing treatments for liver diseases like hepatitis C and nonalcoholic steatohepatitis (NASH) to advance seladelpar. The deal expands Gilead’s presence in the PBC space, complementing its existing medicine Ocaliva, which is approved as a second-line option.

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“We are looking forward to advancing seladelpar by leveraging Gilead’s long-standing expertise in treating and curing liver diseases,” commented Gilead CEO Daniel O’Day. “Building on the strong R&D work by the CymaBay team, we have the potential to address a significant unmet need for people with PBC.”

Under the terms of the agreement, Gilead will commence a tender offer to acquire all outstanding CymaBay shares at $32.50 per share in cash, representing a 27% premium over the stock’s closing price on February 9. Following the tender offer, Gilead will mop up any untendered shares via a second-step merger at the same price.

The deal is anticipated to close in the first quarter of 2024, subject to customary closing conditions and regulatory clearances. Once the transaction is completed, CymaBay will become a wholly owned subsidiary of Gilead.

Gilead expects the buyout will boost its top-line revenue growth, while being neutral to earnings per share in 2025 before turning significantly accretive thereafter.

For CymaBay, the takeover marks the culmination of years of effort advancing seladelpar into late-stage testing and regulatory review. “Now that seladelpar has achieved priority review with the FDA, we are excited that Gilead can apply its expertise to bring seladelpar as quickly as possible to people with PBC,” noted CymaBay CEO Sujal Shah.

The profitable exit provides a major return for CymaBay investors, as the purchase price represents a substantial premium over the stock’s pre-announcement valuation. CymaBay shares have languished below $4 for much of the past two years.

Gilead has actively pursued M&A to augment its pipeline and product portfolio across therapeutic areas like oncology, inflammation, and antivirals. The company faces looming patent expiries on flagship HIV medicines. New growth drivers like seladelpar could help offset that impact.

PBC currently affects a relatively small patient population, but analysts project seladelpar could generate peak annual sales above $1 billion. Gilead likely sees potential to expand seladelpar’s utility to other cholestatic liver diseases.

Nonetheless, the deal does carry risks for Gilead. Seladelpar’s broad mechanism regulating gene expression raises safety concerns about potential side effects. Patients in late-stage testing experienced elevations in low-density lipoprotein cholesterol.

By acquiring CymaBay outright, Gilead shoulders all future R&D costs rather than opting for a partnership deal to share expenses. If seladelpar encounters any regulatory or commercial setbacks, Gilead lacks an immediate fallback option for its PBC program.

But with priority review underway and approval expected within six months, Gilead moved aggressively to lock up rights to a promising PBC candidate. Adding seladelpar provides another growth avenue beyond HIV and bolsters Gilead’s mission of delivering transformative medicines for underserved diseases.

Ocugen (OCGN) – Raising Price Target to $8 Based On Clinical Progress

Posted on by cpereira@noblefcm.com


Monday, February 12, 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.

New Price Target Reflects Clinical Progress In Several Programs. We are raising our price target on OCGN to $8 from $5 to reflect the company’s recent progress. Its clinical programs now include retinitis pigmentosa (RP), dry age-related macular degeneration (dAMD), and Stargardt disease. Since OCU410 has recently begun clinical trials in dAMD, we have adjusted our probability of market entry to arrive at a new price target.

OCU400 Has Produced Meaningful Data In RP and Advanced Toward Phase 3. Ocugen is finalizing the design of the Phase 3 for OCU400 and expects to begin the trial in Q24. The Phase 1/2 trial has completed dosing of the RP patients and three LCA patients. Final LCA patient data could allow FDA approval for expansion to LCA patients in 2H24. Data reported during 2023 showed meaningful improvements in vision for patients with RP, leading to its RMAT designation from the FDA and an expanded access program.


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

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

Release – Cadrenal Therapeutics Appoints Jeff Cole as Chief Operating Officer In Advance Of Tecarfarin Phase 3 Pivotal Trial

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVKD

PONTE VEDRA, Fla., Feb. 8, 2024 — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a novel Vitamin K Antagonist (VKA) for unmet needs in anticoagulation (blood thinning) therapy, today announced the appointment of Jeff Cole to the newly created position of Chief Operating Officer. In this role, Mr. Cole will be responsible for the Company’s manufacturing and supply chain operations, intellectual property, commercialization strategies, and supporting partnering activities for tecarfarin.

Mr. Cole brings over 25 years of experience in global pharmaceutical manufacturing and commercial operations, finance, and corporate development to the Company. This includes senior executive roles at both private and publicly-traded companies such as Espero BioPharma, Valeant Pharmaceuticals International (now Bausch Health Companies), and Legacy Pharmaceuticals. Mr. Cole co-founded Espero, a biopharmaceutical company focusing on the late-stage development and commercialization of medicines to treat cardiovascular diseases, and served as Board Director, President, and Chief Financial Officer where he was responsible for the company’s supply chain, commercialization, and multiple licensing and M&A transactions.

“Jeff is an extremely accomplished pharmaceutical operations executive with a deep understanding of product development, manufacturing, and commercialization. His experience will serve Cadrenal well as we advance our tecarfarin clinical program and evaluate partnering opportunities,” commented Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics.

While at Valeant, Mr. Cole held roles of increasing responsibility, including as General Manager, Vice President of Corporate Development, and Chief Financial Officer of North America, where revenue more than tripled during his tenure. As General Manager at Valeant, Mr. Cole managed a division of U.S. prescription and OTC products across multiple therapeutic areas with responsibility for product development, supply, and commercial operations. Prior to the pharmaceutical industry, Mr. Cole served as Principal in the Financial Management Consulting practice at PricewaterhouseCoopers.

“I am excited to be joining the team at Cadrenal at a pivotal time when demand is increasing for a new anticoagulation therapy to address the unmet needs for patients with left ventricular assist devices (LVADs), antiphospholipid syndrome (APS), and those with end-stage kidney disease (ESKD) and atrial fibrillation (AFib),” added Jeff Cole. “I look forward to leveraging my experience to advance tecarfarin to the market and help those underserved patient groups.”

Mr. Cole holds an MBA with honors from the University of Michigan and a BS in accounting from the University of Southern California.

ABOUT CADRENAL THERAPEUTICS, INC.

Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with certain medical conditions. Tecarfarin has orphan drug and fast track designations from the FDA for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib). Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients with left ventricular assist devices (LVADs) and those with thrombotic antiphospholipid syndrome (APS). Tecarfarin is specifically designed to leverage a different metabolism pathway than the oldest and most commonly prescribed Vitamin K Antagonist (warfarin). Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit: www.cadrenal.com.

Safe Harbor Statement

Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding the Mr. Cole’s experience serving the Company well as it advances its tecarfarin clinical program and evaluates partnering opportunities and leveraging Mr. Cole’s experience to advance tecarfarin to the market and help underserved patient groups. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the expected contribution from Mr. Cole and the ability to advance tecarfarin with patients with left ventricular assist devices (LVADs), thrombotic APS, and those with AFib and ESKD and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
858-337-0766
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/cadrenal-therapeutics-appoints-jeff-cole-as-chief-operating-officer-in-advance-of-tecarfarin-phase-3-pivotal-trial-302057004.html

SOURCE Cadrenal Therapeutics, Inc.

MAIA Biotechnology (MAIA) – Journal Article Confirms MOA In An Additional Tumor Type

Posted on by cpereira@noblefcm.com


Thursday, February 08, 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.

New Publication Shows Multiple Activities of THIO In SCLC. MAIA announced the publication of an article in the peer-reviewed journal Nature Communications that discusses the dual mechanism of action and effects of THIO in small cell lung cancer (SCLC). This is another tumor type in which THIO has been shown to have direct killing effects on cancer cells and activation the cGAS-STING signaling pathway that leads to an immune response. We see this as consistent with previous data confirming THIO benefits.

MAIA Is Developing THIO For Both Major Lung Cancers. Out of all lung cancer cases, non-small cell lung cancer (NSCLC) comprises about 87% while small cell (SCLC) comprises about 13%. Although less common than NSCLC, SCLC is highly aggressive and highly metastatic. SCLC cells have high telomerase activity that enables their high proliferation rate and  immortality. MAIA has received Orphan drug designation from the FDA for SCLC, while the Phase 2 THIO-101 trial is testing THIO in NSCLC.


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

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

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.


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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. 

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.


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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. 

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.


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