Tag: Health

Integra Bets on Ear, Nose, and Throat Growth With $280 Million Acclarent Purchase

Posted on by slightbourne@noblecapitalmarkets.com

Medical device maker Integra LifeSciences announced today it will purchase Acclarent, a leader in ear, nose and throat (ENT) technologies, from Johnson & Johnson’s Ethicon division for $275 million upfront plus future regulatory milestones. The deal values Acclarent at approximately 2.5 times sales, with the company generating $110 million in revenues during 2022.

For Integra, the acquisition provides an opportunity to significantly expand its footprint beyond neurosurgery and establish the company as a major player in the attractive ENT specialty devices segment. The global ENT market is projected to grow at a 5-6% clip annually, adding an estimated $1 billion in addressable market opportunity for Integra.

Acclarent brings to Integra pioneered balloon dilation platforms for treating chronic sinusitis as well as novel treatments for Eustachian tube dilations. Its flagship products are the only FDA-approved stents for maintaining sinus openings after surgery. Acclarent also provides image guidance systems to assist surgeons with minimally invasive procedures.

The company maintains strong brand awareness and deep clinical relationships after rebuilding its commercial presence following a period of declining sales between 2017-2020.

Integra management sees substantial room for additional share gains in ENT given Acclarent’s leadership in balloon dilation and the generally fragmented supplier landscape in ENT today. The global sinus dilation devices market alone is projected to reach $3.5 billion by 2030, providing a sizable growth pipeline for Acclarent’s portfolio.

Strategic and Financial Benefits

The acquisition furthers Integra’s strategy to complement its legacy strength in neurosurgery with scaled positions across faster-growth clinical applications adjacent to its core.

Integra aims to replicate its #1 share in dural repair for neuro procedures by becoming one of few dominant players in ENT. The company believes the combination of its commercial infrastructure and Acclarent’s innovative portfolio can support above-market growth for the foreseeable future.

Financially, Acclarent is being acquired at an attractive upfront valuation of 2.5 times sales. Integra management expects the deal will be immediately accretive to earnings per share after closing.

Acclarent generated gross margins in line with Integra’s overall company average in 2022, providing opportunities for further margin expansion from operating leverage as the business scales.

The transaction also comes at a time when medtech valuations have declined from their pandemic peaks, enabling Integra to obtain Acclarent at what it believes to be an opportunistic price.

Cultural and Portfolio Fit

Integra CEO Jan De Witte highlighted the cultural alignment between both organizations and focus on restoring patient lives as key rationales behind the deal.

De Witte said, “Acclarent’s culture of pioneering technologies aligns with Integra’s legacy of innovation to transform care and restore patients’ lives. We are looking forward to welcoming the Acclarent employees to the Integra team. Together, we can make a profound impact on the future of ENT and neurosurgery.”

Acclarent will operate as part of Integra’s $1.3 billion Codman Specialty Surgical division focused on neurosurgery. Integra sees substantial opportunities for its neurosurgery and ENT sales teams to collaborate on treating certain brain tumors by leveraging skull base surgical approaches.

Integra also gains access to a robust ENT product development pipeline, including next-generation surgical staplers, powered sinus surgery technologies, and potential new indications for Acclarent’s balloon dilation platforms.

Acclarent’s R&D and regulatory expertise will help accelerate Integra’s internal efforts to bring new generations of minimally invasive surgery products to market.

Smooth Post-Close Integration

Integra expects to retain Acclarent’s entire workforce as part of ensuring a smooth organizational transition after the deal closes. The company aims to operate Acclarent as an independent business unit during the near-term while integrating back-office functions.

Manufacturing operations will continue to be outsourced to third parties and Integra anticipates no supply chain disruptions to Acclarent’s product availability.

The transaction is projected to close by the second quarter of 2024, subject to customary antitrust and regulatory clearances globally. Transition services agreements will provide additional support for up to four years following deal closure.

By maintaining continuity of strategy, personnel and manufacturing, Integra hopes to achieve targeted revenue and cost synergies from the integration of Acclarent, while continuing its above-market growth trajectory in the ENT segment. The addition of Acclarent’s portfolio and innovative roadmap makes this transaction an important step forward in Integra’s strategy to complement leadership in neurosurgery with scaled positions in some of medtech’s most attractive and fastest-growing markets.

Onconova Therapeutics (ONTX) – Poster Presentations Show Activity Of Narazaciclib In Breast Cancer and Lymphoma

Posted on by cpereira@noblefcm.com


Wednesday, December 13, 2023

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications. Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma.

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.

Additional Presentations At Medical Meetings Show Broad Activity and Targeting. In the past week, Onconova has presented additional narazaciclib data at the American Society of Hematology (ASH) conference and the San Antonio Breast Cancer Symposium (SABCS). These presentations show broad multi-kinase activity, improved inhibition of tumor growth, and synergy with other drugs used in mantle cell lymphoma.

The Data Are Consistent With Earlier Presentations. The additional data details broad multi-kinase effects of narazaciclib. Comparisons with the three approved CDK4/6 inhibitors have shown narazaciclib stops cancer cell proliferation by inhibiting more targets and leads to potent, irreversible G1cell cycle blockade. Its side effect profile allows for daily dosing, rather than the 3-week dosing followed by a week of rest to allow recovery.


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

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

DLH Holdings (DLHC) – Fourth Quarter In-Line

Posted on by cpatches


Monday, December 11, 2023

DLH delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.

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.

4Q Results. Revenue of $101.5 million was slightly above management’s revised guidance of $100 million, and up from $67.2 million in 4Q22. While the majority of the revenue increase was due to GRSi, which contributed $33.1 million, the Company did see organic growth. Due to the expected $7.7 million non-cash impairment charge, DLH reported a net loss of $2.6 million, or $0.18/sh compared to net income of $3.4 million, or EPS of $0.24/sh in 4Q22.

Non-GAAP. On a non-GAAP basis, DLH reported adjusted operating income of $7.8 million, adjusted EBITDA of $12.1 million, and adjusted net income of $2.3 million, or $0.16/sh in 4Q23, compared to $5.1 million, $7.0 million, and $3.7 million, or EPS of $0.26/sh, respectively, last year.


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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. 

Pushing the Frontiers: Innovation and Investment in Organ Transplantation

Posted on by slightbourne@noblecapitalmarkets.com

The NobleCon19 panel discussion moderated by Nathan Cali, investment banker at Noble Capital Markets, on organ transplantation featured prominent figures in the field, including Dr. Karin Hehenberger, an organ transplant patient and founder of Lyfebulb, Dr. David Alexandre Gros, CEO of Eledon Pharmaceuticals, Dr. Muhammed Mohiuddin, director of the cardiac xenotransplantation program at the University of Maryland, and Dr. Pietr Witoski, surgery director of pancreatic and islet tranplant program at the University of Chicago. The discussion delved into their experiences, challenges in the organ transplant landscape, and revolutionary advancements, especially focusing on the concept of xenotransplantation.

Organ transplantation has come a remarkably long way since the first successful procedures in the 1950s and 60s. Yet there remain significant unmet needs and opportunities to further improve patient outcomes, quality of life, and access to these lifesaving procedures. At a presentation during NobleCon19, a panel of experts explored some of the latest breakthroughs and remaining challenges in areas ranging from immunosuppression to cross-species transplantation.

A Complex Treatment Paradigm

As patient-turned-advocate Dr. Karin Hehenberger related from personal experience, undergoing an organ transplant and living with a graft is filled with difficulties. The trauma of the surgery itself and needing immune-suppressing drugs just to avoid rejection deliver blows to physical health and mental wellbeing. This begins with a harrowing wait for a matching donor organ, continues through post-operative complications like infections, and extends for the rest of one’s life.

The panelists agreed the pressure on patients could be significantly reduced through innovation. More targeted immunosuppressants without harmful side effects would greatly improve quality of life after transplant surgery. Some emerging drug candidates like Eledon Pharmaceuticals Tegoprubart show early signs of progress on this front. There is also a global shortage of donor organs trailing far behind demand; new sources through xenotransplantation or regenerative medicine techniques could help resolve this shortage.

“We need a community where transplanted patients can come together, generate data, and advocate for change,” urged Dr. Hehenberger.

The valuable role of patient communities mirrors the interdisciplinary cooperation needed among the surgeons, specialists, social workers, and other caregivers that make organ transplantation successful. As Dr. Hehhenberger explained, the assessment process for transplant eligibility spans physical health, mental fitness, medication compliance, accessible transportation, and financial support. It is complex care with little margin for error.

An Evolving Market Landscape

Currently, the organ transplant market racks up over $5 billion in value each year and continues expanding at a steady pace. Much of this activity centers specifically around kidney transplants, where surgical innovations and public policy initiatives keep pushing the boundaries. As Dr. DA Gros noted, there are now a quarter million Americans living with a functioning kidney graft – proof of concept for an underappreciated treatment paradigm.

And yet, the surface has barely been scratched in terms of serving potential patients. Over half a million more remain tethered to dialysis as a stand-in for natural kidney function, with 125,000 added to this group annually in the U.S. alone. Dialysis generates its own burdens: decreased workplace productivity, infection risks, lower quality of life. From both humanitarian and financial viewpoints, empowering wider transition from dialysis to transplantation promises tremendous upside.

Experts on the panel targeted improved education around organ transplant options as a key opportunity. Many patients lack full information about the benefits transplant procedures can offer, or they confront social stigmas against this route. Policy revisions to widen access and increase support for lower-income patient communities could have an outsized impact as well.

Meanwhile, the business of organ transplantation continuously evolves. Major pharma companies like Bristol Meyers Squib remain heavily invested, yet a series of smaller players also drive momentum through novel immuno-therapy products. Audience members were encouraged to track firms like Aelix and Tacus for the next wave of clinical updates that will shape standard of care.

Pioneering the Future

Homing in on the future, speakers keyed in on barriers still to be conquered in transplantation medicine. While kidney procedures serve as a beachhead, there is a pressing need to expand reliable methods across more organ types while lengthening graft duration at the same time. This is no small task.

It will require rethinking conventional assumptions for a field that has relied predominantly on broad immune suppression since its inception. Some emerging biotech pipelines target specific T and B cell pathways implicated in chronic organ rejection, attempting to avoid toxicity associated with generalized immunosuppression. Early data hints at improved longevity for liver and heart grafts, but longer studies are still needed.

An even more radical solution highlighted by multiple panelists is the concept of xenotransplantation: introducing organs from other species like pigs into human patients. Recent demonstrations of human-pig heart and skin grafts saw patients survive months post-procedure compared to an anticipated span of days or weeks. The results electrified the transplant community given implications for essentially eliminating organ supply constraints.

That said, experts admit there are hurdles left to address before clinical adoption. Ethical quandaries exist around genetically modifying donor animals and infectious disease transmission risks from one species to another. Questions also persist about which immune pathways necessitate targeting for prolonged graft survival and how to refine the anti-rejection pharmaceutical regimens employed.

Signs point to countries with more flexible regulatory regimes as the likely springboards for refining xenotransplant methods and technology in the shorter-term. Yet the longer-term promise seems resoundingly clear. “If allowed, we will solve the organ shortage problem,” declared surgeon Dr. Peter Witoski when asked about outlook for the field.

A Call to Action

In closing the panel presentation, speakers underscored a sense of guarded optimism balanced with persistent unmet needs in transplantation medicine today. Limitations around donor organ supply and chronic graft failure continue exacting a real human toll, even if raw statistics showcase a steady rise in life-saving procedures overall.

It will take coordinated effort from policy makers, researchers, clinicians, investors and patient advocates to push new discoveries over the finish line – where they can impact the maximum number of lives. Key questions around optimal business models for novel therapeutics, data transparency, and equitable access are unlikely to solve themselves.

Yet the convergence of breakthrough technologies and innovative platforms for generating evidence, educating stakeholders and disseminating insights points toward a sea change for what the future may hold in this vital area of healthcare. The experts and audience members left the discussion around organ transplantation feeling energized to play their respective parts in driving that change.

Watch the webcast from The Organ Transplant presentation at NobleCon19 here

Pfizer Weight Loss Pill Hits Snag in Mid-Stage Trial

Posted on by slightbourne@noblecapitalmarkets.com

Pharmaceutical giant Pfizer suffered a setback this week in the high-stakes race to tap into the burgeoning multi-billion dollar weight loss drug market. The company announced it is halting development of the twice-daily formulation of its experimental obesity pill danuglipron after underwhelming mid-stage trial results.

While the drug induced significant weight loss in obese patients, it came at the cost of poor tolerability. Over half of participants dropped out of the phase 2 study due to adverse gastrointestinal side effects like nausea and diarrhea.

Nonetheless, Pfizer still intends to stay in the game with a once-daily version of danuglipron. The company aims to release fresh phase 2 data on the more competitive formulation in early 2024 before determining next steps.

For a drugmaker grappling with fading Covid-19 revenues, the news deals a tough blow to its strategy to offset declines through potential new blockbusters for obesity. Just last year, CEO Albert Bourla tagged the total addressable weight loss market at a whopping $90 billion.

But competition is cutthroat, with Novo Nordisk and Eli Lilly vying to convert millions from their injectable diabetes meds to an oral option. Their rival pills have already posted mid-teens percentage weight loss results that position them to potentially leapfrog Pfizer’s attempt.

Danuglipron Quick Facts

  • Twice-daily formulation now discontinued after 6.9% to 11.7% weight loss at 32 weeks
  • Well below 14-15% loss seen as competitive threshold
  • High rates of nausea, vomiting, diarrhea
  • Over 50% dropout rate

Key Takeaways for Investors
The disappointing data for danuglipron’s twice-daily pill underscores several investor concerns around Pfizer’s efforts to expand into weight loss medicines.

Uphill Battle Against Rivals
Novo Nordisk and Eli Lilly already dominate the obesity drug landscape with their injectable products Saxenda and Ozempic. Lilly’s oral candidate tirzepatide is showing roughly 15% weight loss over 72 weeks, clearing the competitive bar Pfizer failed to hit.

While the field is large enough for multiple winners, Pfizer faces substantial share challenges from these deeply entrenched rivals. Its best-case outcome may be carving off a small slice rather than market leadership.

Tolerability Issues Limiting
Danuglipron has now faltered twice in mid-stage studies due to side effects leading over half of volunteers to quit treatment. The once-daily route shows some promise, but gastrointestinal problems may hamper uptake if they persist. By comparison, tirzepatide posted a 21% dropout rate.

Uncertainty Remains High
With phase 3 trials still a distant prospect, the program faces a long road ahead fraught with risk. While danuglipron evinced significant weight-loss efficacy, real-world commercial success depends greatly on improving its poor tolerability profile.

Until then, uncertainty around Pfizer’s weight loss aspirations stays high. Expect sales projections to remain muted absent positive late-stage outcomes down the line. But rivals like Lilly and Novo aren’t standing still either, making danuglipron’s path ahead even trickier.

Merck Bets on Neurodegenerative Disease Treatments with Caraway Buyout

Posted on by slightbourne@noblecapitalmarkets.com

Pharmaceutical giant Merck announced Tuesday that it will acquire Caraway Therapeutics, a preclinical biotech company pursuing novel approaches to treating genetically defined neurodegenerative and rare diseases. The deal reflects Merck’s ongoing commitment to developing much-needed disease-modifying therapies for progressive brain conditions.

Under the agreement, Merck will make an upfront payment to obtain Caraway, followed by additional milestone payments contingent upon the progress of certain Caraway pipeline assets. Though financial terms were not disclosed, the total potential consideration could reach up to $610 million.

“Caraway’s multidisciplinary approach has yielded important progress in evaluating novel mechanisms of modulation of lysosomal function with potential for the treatment of progressive neurodegenerative diseases,” said George Addona, Merck’s head of discovery. “We look forward to applying our expertise to build upon this work with the goal of developing much needed disease-modifying therapies for these conditions.”

Unlike symptomatic treatments, disease-modifying therapies aim to directly impact underlying disease processes and ultimately alter the course of a condition’s progression. This has remained an elusive goal for brain diseases like Alzheimer’s and Parkinson’s.

Caraway’s work targets dysfunctions in cellular “recycling” processes that clear toxic materials from the brain. Its treatments stimulate lysosomes, which act as cell disposal units, to boost their activity. Researchers believe a boost in waste clearance could counter neurodegeneration.

Merck has been an investor in Caraway since 2018 through its venture capital arm MRL Ventures Fund. Now, by folding Caraway’s team and portfolio into its research labs, Merck aims to leverage its considerable drug development capabilities to advance lysosomal modulation treatments for neurodegeneration.

“This is a testament to the hard work and dedication of the Caraway team and our mission to develop therapeutics with the potential to alter the progression of devastating neurodegenerative diseases and help patients,” said Caraway CEO Martin D. Williams in a statement. “This acquisition leverages Merck’s industry-leading research and development capabilities to help further advance our discovery and preclinical programs.”

Alongside Merck, Caraway has been backed by several high-profile life sciences investors including SV Health Investors, AbbVie Ventures, Amgen Ventures, and Eisai Innovation.

An Urgent Need for Better Brain Treatments

Currently available medications can only manage symptoms for a period of time for Alzheimer’s, Parkinson’s, and related neurodegenerative diseases. None treat underlying pathologies or substantially slow worsening cognition and functionality.

Alzheimer’s alone impacts more than 6 million Americans and the prevalence is expected to triple in the next 30 years if no new treatments emerge. Experts have emphasized the urgent need for innovations.

Major players in the pharmaceutical industry have confronted disappointed late-stage clinical trial results among proposed Alzheimer’s treatments over the past decade, suffering high-profile setbacks.

Yet Merck’s buy-in suggests promise still exists in Caraway’s early-stage lysosomal modulation approach, even though treatments haven’t advanced to human testing yet. Merck aims to apply its extensive expertise to push potential therapies over the finish line where others have stumbled before.

Continuing a Neuroscience Focus

Alongside this deal, Merck continues to expand its research across neurodegenerative diseases in other ways. Thus far in 2023, Merck has also entered into research collaborations to pursue non-amyloid targets for Alzheimer’s and chiral chemistry for better brain penetrance among compounds targeting neurological conditions.

“The alignment with Caraway’s innovative science and focus on elucidating disease-modifying neurotherapeutics dovetails nicely with our ongoing work,” said Addona.

Overall, Merck’s acquisition of Caraway signals both increasing momentum around emerging theories of neurodegeneration—like waste clearance’s role—and a formidable commitment by the pharma organization to translating the latest science into paradigm-shifting treatments for patients.

Q32 Bio to Combine with Homology Medicines and Advance Autoimmune Pipeline

Posted on by slightbourne@noblecapitalmarkets.com

Q32 Bio, a clinical-stage biotech developing treatments for autoimmune and inflammatory diseases, announced it has entered into a definitive agreement to merge with Homology Medicines in an all-stock deal. The combined company will operate under the Q32 Bio name and focus on progressing Q32’s pipeline of novel immunomodulators.

Q32 is developing bempikibart (ADX-914), an anti-IL-7Rα antibody, as well as ADX-097, a tissue-targeted complement inhibitor. The merger will provide Q32 with access to public markets and additional capital to support the advancement of these programs through upcoming milestones.

Under the terms of the agreement, Homology Medicines shareholders will receive 25% ownership in the combined company, with Q32 shareholders owning 75%. The Board of Directors will consist of seven members from Q32 Bio and two from Homology Medicines. The companies expect the transaction to close in Q1 2024.

Regaining Worldwide Rights to Lead Candidate Bempikibart

Concurrent with the merger announcement, Q32 revealed that it has re-acquired full worldwide rights to bempikibart from Amgen. Q32 originally licensed bempikibart from Amgen in 2021 after the pharma giant took it through Phase 1 trials.

Bempikibart blocks signaling mediated by IL-7 and TSLP to modulate T cell-driven inflammation. It is currently being evaluated in two Phase 2 studies in atopic dermatitis and alopecia areata, with topline results expected in the second half of 2024.

Regaining full rights to bempikibart provides Q32 with greater control over the program’s development and commercial potential. The merger and additional funding will support pivotal studies to bring bempikibart to market.

Advancing Complement Inhibitor ADX-097 into the Clinic

In addition to bempikibart, Q32 is developing ADX-097 as an innovative approach to inhibiting complement activation for autoimmune and inflammatory disorders. Excessive complement activation is implicated in diseases like ANCA-associated vasculitis, IgA nephropathy, and NMOSD.

Unlike current complement drugs that cause systemic inhibition, ADX-097 is engineered to potently inhibit complement only in targeted tissues. This allows greater on-target activity with potentially improved safety.

Q32 recently completed a Phase 1 trial of ADX-097, demonstrating a favorable tolerability and immunogenicity profile. The company will now advance ADX-097 into Phase 2 testing, with initial proof-of-concept data expected by end of 2024 and topline results from two trials in 2H 2025.

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

Strengthening Financial Position to Reach Critical Milestones

To support its pipeline advancement, Q32 has secured a $42 million private placement in conjunction with the proposed merger. New and existing investors participated, including OrbiMed, Bristol Myers Squibb, Sanofi Ventures and others.

This additional capital will fund operations through several key milestones:

  • Phase 2 data for bempikibart in atopic dermatitis and alopecia areata in 2H 2024
  • Initial Phase 2 proof-of-concept data for ADX-097 by end of 2024
  • Topline Phase 2 results for ADX-097 in 2H 2025

The combined company is expected to have approximately $115 million in cash at closing, providing runway into mid-2026. This strengthened financial position will enable Q32 to reach meaningful catalysts for its lead programs.

Experienced Leadership to Drive Clinical Development

The combined immunology-focused company will be led by the Q32 Bio executive team, including:

  • Jodie Morrison, CEO
  • Shelia Violette, PhD, Founder and CSO
  • Jason Campagna, MD, PhD, CMO
  • Saul Fink, PhD, CTO
  • Maria Marzilli, MPH, EVP of Corporate Strategy & Operations
  • David Appugliese, JD, SVP, Head of People

Q32’s management has extensive experience leading R&D, corporate strategy, and operations at companies like Editas Medicine, Bioverativ, and Ironwood Pharmaceuticals.

Ms. Morrison commented, “The proposed merger with Homology Medicines and concurrent private placement is expected to provide Q32 Bio with the capital to drive development of our autoimmune and inflammatory pipeline through multiple clinical milestones. We look forward to delivering Phase 2 data for bempikibart and ADX-097 that could support the advancement of these programs toward commercialization.”

The transaction will provide Q32 Bio with the financial capacity and public listing to further advance its pipeline of novel immunology therapies for patients with autoimmune and inflammatory diseases. Shareholders of both companies will have the opportunity to realize future value if the combined pipeline progresses as planned.

MustGrow Biologics Corp. (MGROF) – Knocking Down the First Domino

Posted on by cpereira@noblefcm.com


Thursday, November 16, 2023

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.

Registration Approval. MustGrow announced that its TerraSante product received the Washington State Department of Agriculture Fertilizer Registration Certificate and will apply to TerraSante product sales in Washington State. This comes after it was awarded an organic compliance certification from the USDA National Organic Program (OMRI) at the end of last month.

Near Future Revenue. Now being able to sell TerraSante, MustGrow has formed a sales & marketing commercialization strategy in conjunction with BioAg Product Strategies for the 2024 planting season. In the state, agriculture production totaled $9.49 billion, with the state being the largest producer of apples, blueberries, hops, pears, etc. Organic acres total 105,660, representing $652 million in total farm gate sales. We believe there is opportunity for MustGrow to market TerraSante to farmers and has the organic certificates to support it.


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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. 

Schwazze (SHWZ) – Staying the Course

Posted on by cpereira@noblefcm.com


Thursday, November 16, 2023

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.

3Q23 Results. Revenue of $46.7 million was up 8.2% y-o-y and in-line with our $47 million estimate. Adjusted EBITDA totaled $14.1 million and the Company generated $6.9 million of CFFO. The bottom line was impacted by a number of one-time impacts, which resulted in a $1.9 million loss, or a loss of $0.03/sh. We had forecast a $7.1 million loss, or a loss of $0.10/sh.

Light. The overall environment remains challenged, whether due to supply, less demand or increased competition, but there are pockets of light suggesting we should see incremental improvement in the environment over time. Schwazze continues to stay the course and we expect them to come out of the current malaise a stronger, better positioned 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. 

PDS Biotechnology Corp. (PDSB) – Clinical Milestones For 2024 Announced With 3Q23 Financial Results

Posted on by cpereira@noblefcm.com


Wednesday, November 15, 2023

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

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.

Several Data Presentations With New Trials Expected In 2024. PDS Biotech reported a 3Q loss of $10.8 million or $(0.35) per share, ending the quarter with $54.3 million in cash. The company reviewed several clinical data presentations made during the quarter and gave updates on the expected milestones for its clinical trials and pipeline products.

VERSATILE-003 Is On Schedule To Begin In 1Q24. The Phase 3 VERSATILE-003 trial has received FDA comments on the amended IND and final study design. Clinical supplies have been made for the trial to start in 1Q23. The trial will test the combination of PDS0101 with Keytruda (pembrolizumab, from Merck) against Keytruda alone in patients with HPV16+ recurrent or metastatic head and neck cancer. 


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. 

Onconova Therapeutics (ONTX) – 3Q23 Reported With Several 2024 Milestones Announced

Posted on by cpereira@noblefcm.com


Wednesday, November 15, 2023

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications. Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma.

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.

Clinical Milestones For Narazaciclib and Rigosertib Expected In 2024. Onconova reported a 3Q23 loss of $4.7 million or $(0.23) per share. Cash on hand at the end of the quarter was $25.2 million, which we believe is sufficient to fund operations through 3Q24. The company reviewed several recent data presentations and the clinical milestones ahead for 2024.

An Additional Dose Level Has Been Added To The Narazaciclib Phase 1/2 Study.  As expected, Onconova announced that an additional dosing cohort has been added to the Phase 1/2 dose-escalation trial in solid tumors. The maximum tolerated dose  (MTD) was not reached in the first 6 cohorts, and did not show neutropenia and diarrhea commonly seen in other CDK4/6 inhibitors. This allows a higher dose level to be tested. The Phase 1/2 trial is expected to continue into 1Q23, followed by Phase 2 dose selection.


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

Cocrystal Pharma (COCP) – 3Q23 Reported As Three Trials Make Progress

Posted on by cpereira@noblefcm.com


Tuesday, November 14, 2023

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

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

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

3Q23 Reported. Cocrystal reported a 3Q23 loss of $4.2 million or $(0.41) per share. The loss included a reversal of a 2Q22 legal charge of $1.6 million after a verdict was overturned by an Appeals Court and money returned to the company. During 3Q23, clinical progress included the start of the Phase 1 trial testing CDI-988 in pan-coronavirus and pan-norovirus trials, and authorization to begin a Phase 2a human challenge study in influenza A. 

CC-42344 To Start Clinical Trials Shortly. Cocrystal has received authorization from the UK’s MHRA (Medicines and Healthcare Regulatory Agency) to begin Phase 2a testing CC-42344, its orally administered protease inhibitor for influenza A. This placebo-controlled trial will administer a pharmaceutically prepared dose of influenza virus to infect healthy volunteers with, then test the safety and immunologic measurements of CC-42344 against the virus. Separately, Dr. Sam Lee, President and Co-CEO is scheduled to make a presentation at the World Vaccine Congress West Coast on the development of CC-42344 on November 28.


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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. 

YS Biopharma Co., Ltd. (YS) – Tapping Into The Power Of The Immune System

Posted on by cpereira@noblefcm.com


Monday, November 13, 2023

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.

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PIKA Immunomodulating Platform.  The novel PIKA technology has the capability to target and accelerate the immune response in a wide variety of vaccines and immuno-oncology therapeutics. PIKA activates and enhances the body’s immune response, increasing the effectiveness of vaccines. In immuno-oncology, with its multiple modes of action able to induce the production of multiple tumor-inhibitory cytokines and tumor cell apoptosis, PIKA could be applied to broad-spectrum anti-tumor activity in cancers.  

Significant Opportunities in Anti-Viral and Immuno-Oncology Markets. There are large unmet needs in Africa, Southeast Asia and China, among other parts of the world, in rabies, hepatitis B and cancers. The Asia-Pacific region is expected to have the highest growth rate in the world with higher levels of utilization of immunotherapies, driven by low vaccine penetration, increasing cancer prevalence, and improving patient awareness and disposable income.


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.