Health Archives - Page 10 of 30

MAIA Biotechnology (MAIA) – New THIO-101 Update Shows Consistent Overall Response Rate

Posted on March 7, 2024March 7, 2024 by cpereira@noblefcm.com

Thursday, March 07, 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.

Third Line Patients’ Preliminary Overall Response Rate (ORR) Shows Improvement. MAIA announced updated data from its THIO-101 trial. The trial enrolled patients with Stage 3 or 4 NSCLC who have progressive disease after treatment with checkpoint inhibitor therapy with or without standard of care chemotherapy. These advanced disease patients were treated with the combination of THIO and Libtayo (cemiplimab, an anti-PD-1 checkpoint inhibitor from Regeneron). The data was from the first patients receiving treatment as third-line therapy that reached an evaluation timepoint by January 8, 2024.

ORR Greatly Exceeded Published Studies. New data was from patients who had received the THIO combination as third-line treatment. The overall response rate was 38%, with 3 out of 8 patients showing a complete response (CR) or partial response (PR). This compares with response rates of about 6% in published 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.

GeoVax Labs (GOVX) – Vaccine Production Technology Reaches Milestone With Manufacturing Facility Validation

Posted on March 7, 2024March 7, 2024 by cpereira@noblefcm.com

Thursday, March 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.

Commercial Scale Production Facility Achieves Validation. GeoVax has announced that its manufacturing technology for producing commercial-scale MVA-based vaccines has been validated for production. This signifies the successful transfer of the technology from the research facility to the commercial cGMP manufacturing plant, with production runs that meet specifications for use in clinical trials and commercial sales. This was a milestone we had anticipated that allows higher quantities, faster production, and greater yields of its proprietary MVA-based vaccines.

The New Manufacturing Facility Cam Produce The Pipeline Vaccines. Products that can be made in the system include CM04S1, its vaccine currently in two different Phase 2 trials to stimulate protective responses against COVID for immunocompromised patients with hematological cancers and in Phase 2 as a universal booster for COVID. The facility can also produce the vaccines in development for infectious diseases including smallpox, Ebola, zika, and malaria.

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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).

Schwazze (SHWZ) – A Management Change

Posted on February 26, 2024February 26, 2024 by cpereira@noblefcm.com

Monday, February 26, 2024

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

Joe Gomes, 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.

CEO Steps Away. Friday, Schwazze announced Nirup Krishnamurthy’s resignation as Schwazze Chief Executive Officer and as a member of the Board of Directors, effective February 20, 2024, due to personal reasons. In his place, Forrest Hoffmaster, the Company’s Chief Financial Officer, has been appointed to the additional role of interim CEO.

Forrest Hoffmaster. Mr. Hoffmaster joined the Company in January 2023, bringing over 30 years of executive experience in finance and operations for both public and private companies. Prior to Schwazze, Mr. Hoffmaster served as CEO of New Seasons Market, a specialty gourmet food retailer, where he navigated the company through one of the most disruptive periods in the retail grocery industry. Under his leadership, Mr. Hoffmaster implemented a focused growth and cost optimization program, enabling the company to grow EBITDA by over 30% in two years. Prior to New Seasons Market, Forrest held leadership positions with other leading grocers, including Whole Foods Market and H-E-B.

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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).

MAIA Biotechnology (MAIA) – THIO-101 Patient Enrollment Completed Ahead Of Schedule

Posted on February 23, 2024February 23, 2024 by cpereira@noblefcm.com

Friday, February 23, 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.

Enrollment In THIO-101 Has Been Completed. MAIA announced that it has completed enrollment of the Part B of the Phase 2 THIO-101 clinical trial. Allowing time for patient follow-up and analysis, the preliminary data announcement is expected in 2H24. This is ahead of schedule, shortening our expected development timeframe.

Optimal Dose Selection Allowed Earlier Completion. The THIO-101 trial was designed with several stages. Part A was a lead-in to verify the safety seen in earlier trials. Part B was designed to find the optimal dose, with patients receiving doses of 60mg, 180mg, or 360mg. In December 2023, the 180mg dose was selected and new patients were only enrolled at 180mg. This allowed Part B to reach the target enrollment ahead of schedule.

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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).

Ocugen (OCGN) – Ocugen Clinical Showcase Meeting Details OCU400 and Potential Gene Therapy Breakthroughs

Posted on February 22, 2024February 22, 2024 by cpereira@noblefcm.com

Thursday, February 22, 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.

Presentations Focused On OCU400. Ocugen held an investor meeting to present details of its gene therapy programs and clinical progress. The presentations included a review of the “Master Regulatory Gene” technology, OCU400 clinical results, and plans for the Phase 3 clinical trial. Next, a panel including the inventor of the technology, two doctors who have treated patients, and a patient discussed their experiences with OCU400.

Important Milestones Are Ahead. The presentations started with a review of the product pipeline progress during 2023 and the milestones ahead in 2024. These included milestones in the clinical trials for OCU400, OCU410, OCU410ST, and NeoCart. The company reiterated its goal of forming a partnership for OCU400 during the coming year. We have not included any up-front payments, milestones, or sales royalties in our models at this time.

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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).

Novavax Stock Surges Over 20% on Positive Gavi Settlement

Posted on February 22, 2024February 22, 2024 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 February 21, 2024February 21, 2024 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 February 20, 2024February 20, 2024 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.

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

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

Posted on February 14, 2024February 14, 2024 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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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

Gilead Sciences Acquires CymaBay Therapeutics for $4.3 Billion in Cash

Posted on February 13, 2024February 13, 2024 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.

“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 February 12, 2024February 12, 2024 by cpereira@noblefcm.com

Monday, February 12, 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 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).

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

Posted on February 8, 2024February 8, 2024 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

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SOURCE Cadrenal Therapeutics, Inc.

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

Posted on February 8, 2024February 8, 2024 by cpereira@noblefcm.com

Thursday, February 08, 2024

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

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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).