Tag: Biotech

AbbVie Expands Alzheimer’s Pipeline with $1.4B Acquisition of Aliada Therapeutics

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– AbbVie acquires Aliada Therapeutics, adding ALIA-1758 and its unique drug-delivery platform.
– Expands AbbVie’s neuroscience pipeline with advanced Alzheimer’s treatments.
– Aliada’s MODEL platform enhances drug delivery across the blood-brain barrier.

AbbVie has strategically bolstered its Alzheimer’s portfolio by acquiring Boston-based Aliada Therapeutics in a deal valued at $1.4 billion. The acquisition brings AbbVie ALIA-1758, a Phase I anti-amyloid antibody targeting Alzheimer’s disease, along with Aliada’s novel Modular Delivery (MODEL) platform. This technology aims to improve the delivery of therapeutics across the blood-brain barrier (BBB), a significant challenge in developing drugs for the central nervous system.

With Alzheimer’s becoming a critical area for biotech and pharma innovation, AbbVie’s acquisition comes amid heightened interest in anti-amyloid therapies. The recent successes of Biogen and Eisai’s Leqembi and Eli Lilly’s Kisunla, the first FDA-approved disease-modifying treatments for Alzheimer’s, have demonstrated the potential of anti-amyloid treatments, though they come with risks. ALIA-1758 is designed to target pyroglutamate amyloid beta, an epitope similar to that in Kisunla, and leverages Aliada’s MODEL platform to improve therapeutic delivery.

The MODEL platform is engineered to transport therapeutic agents across the BBB by targeting transferrin and CD98 receptors, both of which are abundantly expressed in brain endothelial cells. The technology effectively carries antibodies across the BBB, allowing higher therapeutic concentrations in the brain to address amyloid plaques associated with Alzheimer’s. This targeted approach has the potential to provide superior treatment efficacy compared to previous approaches.

This acquisition aligns with AbbVie’s strategy of expanding its presence in neuroscience. The company already has a robust portfolio that includes experimental therapies like ABBV-916, another anti-amyloid antibody; ABBV-552, which targets nerve terminals to enhance synaptic function; and AL002, an antibody developed in partnership with Alector Therapeutics. With the addition of ALIA-1758, AbbVie strengthens its position in the field and continues to invest in innovation that could transform the treatment landscape for neurodegenerative diseases.

While the Alzheimer’s market is promising, AbbVie’s expansion comes with some caution. Analysts have noted that investor sentiment in anti-amyloid drugs is mixed, given the high cost and developmental challenges. However, AbbVie’s investment signals confidence in the MODEL platform’s potential to enhance drug delivery, particularly in addressing diseases with significant unmet needs like Alzheimer’s. AbbVie is optimistic that Aliada’s technology will complement its existing assets and support long-term growth in the neuroscience sector.

Expected to close by the end of 2024, the acquisition of Aliada Therapeutics is subject to regulatory approvals and standard closing conditions. The deal underscores AbbVie’s ongoing commitment to innovation and its mission to bring novel treatments to patients suffering from Alzheimer’s and other neurological disorders.

Three Biotech Companies Price Their IPOs, Raising Significant Capital for Future Growth

Posted on by cpatches
Key Points:
– Upstream Bio raised $255 million to fund advanced trials for its respiratory disease drug verekitug, achieving a valuation of $830 million.
– Ceribell raised $180 million to further develop its AI-powered EEG platform, focusing on diagnosing serious neurological conditions.
– CAMP4 Therapeutics raised $75 million to continue its work in gene expression therapies, pricing its IPO below expectations at $11 per share.

Three biotech companies priced their initial public offerings (IPOs) on Thursday, securing substantial funding to advance their innovative therapies and technologies. The companies—Upstream Bio, Ceribell, and CAMP4 Therapeutics—collectively raised millions, with plans to use the proceeds for various clinical trials and product developments.

Upstream Bio: Raising $255 Million for Respiratory Therapies Upstream Bio led the day by raising $255 million, with its shares priced at the higher end of the expected range. Initially planning to sell 12.5 million shares between $15 and $17 each, the company increased the offering to 15 million shares due to high demand, pricing them near $17. This could further rise if underwriters exercise their option to purchase an additional 2.25 million shares. The company, which now has a valuation of around $830 million, will trade on the NASDAQ under the ticker symbol UPB.

Upstream Bio is using the capital to advance clinical trials for its lead drug, verekitug, which is being tested for severe asthma and chronic rhinosinusitis with nasal polyps. The drug targets a receptor for thymic stromal lymphopoietin, a key player in inflammatory diseases. Proceeds will also help initiate a phase 3 trial for severe asthma.

Ceribell: Secures $180 Million for AI-Powered Neurological Diagnostics Ceribell, a commercial-stage medical technology company, raised $180 million through its IPO, with 10.6 million shares priced at $17 each, giving the company a valuation of $578 million. Like Upstream, Ceribell also granted underwriters the option to purchase additional shares—up to 1.6 million more. The company will trade on the NASDAQ under the symbol CBLL.

Ceribell specializes in AI-powered neurological diagnostic tools, notably its point-of-care electroencephalography (EEG) platform, designed to help in the diagnosis and management of critical neurological conditions. The technology is expected to revolutionize the way healthcare providers address neurological emergencies.

CAMP4 Therapeutics: Raises $75 Million Despite Pricing Below Expectations CAMP4 Therapeutics saw its IPO priced below expectations, at $11 per share, compared to an initial range of $14 to $16. Despite this, the company managed to sell 6.8 million shares, surpassing its original goal of 5 million, for total gross proceeds of $75 million. CAMP4 will begin trading on the NASDAQ under the ticker symbol CAMP.

CAMP4 focuses on regulatory RNA-targeting therapeutics, aiming to upregulate gene expression in genetic diseases. The proceeds will be used to further develop its drug pipeline, including its recent collaboration with BioMarin to target RNA sequences for therapeutic applications.

Bio-Path Surges on Expansion into Obesity Market

Posted on by cpatches
Key Points:
– Stock Surge: Bio-Path Holdings’ stock rose 30% after announcing BP1001-A, its new obesity treatment program, with trading volume significantly higher than average.
– New Focus: The company plans preclinical studies for BP1001-A by Q4 2024, marking its first use of DNAbilize technology for non-cancer applications.
– Market Opportunity: A September report projects the obesity treatment market could reach $200 billion by 2031, with up to 16 new drugs expected by 2029, presenting a lucrative opportunity for Bio-Path.

Shares of Bio-Path Holdings (NASDAQ: BPTH) surged by 30% as of 11 a.m. Tuesday, driven by significantly increased trading volume of 57 million shares, far exceeding its average volume of 329,000. The rally follows the company’s announcement of a new therapeutic program aimed at addressing obesity and related metabolic diseases using its DNAbilize® technology. This marks the company’s first foray into non-cancer applications, potentially opening the door to a new growth avenue for the biotech firm.

Bio-Path initiated the development of BP1001-A, targeting insulin sensitivity to treat obesity and type 2 diabetes, with plans to begin preclinical studies as soon as the fourth quarter of 2024. In a statement, Bio-Path’s President and CEO, Peter Nielsen, expressed enthusiasm about the expansion into obesity treatments, citing the growing epidemic as a critical health issue. “Developing BP1001-A for the treatment of obesity should have a high probability of success as its mechanism of action has the potential to treat insulin resistance, which is the underpinning of obesity, Type 2 diabetes, and other related diseases,” Nielsen said.

The company’s announcement also coincided with the completion of patient enrollment in the third dosing cohort of its ongoing Phase 1 clinical trial for BP1002, a treatment for acute myeloid leukemia (AML).

In a September report from analysts at Morningstar and Pitchbook, the obesity treatment market was forecast to see as many as 16 new drugs by 2029, vying for a slice of this lucrative and rapidly expanding market, currently dominated by industry giants Novo Nordisk and Eli Lilly. The same report projected that the global market for obesity treatments could balloon to $200 billion by 2031, highlighting the significant commercial potential in addressing obesity and related metabolic diseases.

Bio-Path Holdings is primarily known for its DNAbilize® technology, which uses RNAi nanoparticle drugs that can be administered via simple intravenous infusion. The company’s lead product candidate, prexigebersen (BP1001), is currently in a Phase 2 trial for blood cancers, while BP1001-A is being studied for solid tumors in a Phase 1 trial.

As Bio-Path explores the obesity space, this expansion could represent a major opportunity for growth, particularly as the market for obesity treatments continues to evolve at a rapid pace.

Viking’s Surprise Move in the $150 Billion Weight Loss Race

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Viking Therapeutics stock surges 20% after announcing early advancement to late-stage trials for weight loss drug
– Company’s experimental injection VK2735 shows promising results, potentially rivaling industry giants
– Decision to skip additional mid-stage trial could accelerate drug’s market entry by a year
– Viking also developing a convenient monthly injection and oral version of the drug

In a stunning turn of events, the relatively unknown biotech company Viking Therapeutics has suddenly become the talk of Wall Street. The San Diego-based firm saw its stock price soar by over 20% on Thursday, following a game-changing announcement that has investors and health enthusiasts alike sitting up and taking notice.

The catalyst for this dramatic surge? Viking Therapeutics revealed its plans to fast-track its experimental weight loss injection, VK2735, directly into late-stage trials. This bold move, which comes earlier than expected, has positioned the company as a potential dark horse in the fiercely competitive GLP-1 market, currently dominated by pharmaceutical giants Novo Nordisk and Eli Lilly.

The GLP-1 market, projected to balloon to a staggering $150 billion by the end of the decade, has been a battlefield for drug companies seeking to capitalize on the growing demand for effective weight loss solutions. Viking’s unexpected leap forward has not only caught the attention of investors but also sent ripples through the industry, with shares of both Novo Nordisk and Eli Lilly dipping more than 1% in response.

What makes Viking’s VK2735 so promising? In a phase two trial, patients receiving weekly doses of the injection lost up to 14.7% of their body weight over just 13 weeks – an impressive figure that puts it in the same league as its more established competitors. But Viking isn’t stopping there. The company is also developing a monthly injection version of VK2735, which could offer a more convenient option for patients compared to the weekly regimens of current market leaders.

Adding another layer of intrigue, Viking is simultaneously working on an oral version of VK2735. In early-stage trials, this pill form demonstrated a 3.3% weight loss compared to placebo, opening up the possibility of a non-injectable alternative in the future.

The decision to skip an additional mid-stage trial and move directly to phase three could shave off a significant amount of time from Viking’s development timeline. Analysts now estimate that this strategic move could accelerate the drug’s market entry by as much as a year, potentially launching in 2028 instead of the previously projected 2029.

Viking’s CEO, Brian Lian, expressed confidence in the company’s direction during a recent earnings call, citing positive feedback from the Food and Drug Administration as a key factor in their decision to expedite the development process. The company is now preparing for a crucial meeting with the FDA in the fourth quarter to discuss the design and timing of the phase three trial.

As Viking Therapeutics gears up for this next critical phase, the biotech world watches with bated breath. Could this underdog company be on the verge of disrupting the weight loss drug market? With its promising results and aggressive development strategy, Viking is certainly positioning itself as a formidable contender in the race to capture a slice of the lucrative GLP-1 pie.

For investors and health-conscious individuals alike, the message is clear: keep a close eye on Viking Therapeutics. This small biotech firm might just be holding the key to the next big breakthrough in weight loss treatment.

Release – MustGrow Joins Industry Consortium “Global Alliance Against TR4” to defeat Banana Fungal Disease Fusarium wilt TR4

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MGROF

Jul 9, 2024 

  • MustGrow joins alliance of international banana leaders, including Bayer, Chiquita, Del Monte, Dole, and Fyffes.
  • MustGrow is collaborating to bring its uniquely effective technologies to help address this global issue.
  • MustGrow’s mustard-derived biofungicide has shown efficacy versus TR4.

SASKATOON, Saskatchewan, Canada, July 9, 2024 – MustGrow Biologics Corp. (TSXV:MGRO) (OTC:MGROF) (FRA:0C0) (the “Company” or “MustGrow”) is pleased to accept membership into the Global Alliance Against TR4 (https://iica.int/en/global-alliance), an international consortium of world-leading banana players committed to defeat Fusarium wilt TR4 (“TR4”), a fungal disease jeopardizing the future of bananas.  MustGrow is collaborating to bring its uniquely effective technologies to help address this global issue, joining international banana leaders, including Bayer, Chiquita, Del Monte, Dole, and Fyffes.

“I celebrate the willingness of MustGrow to join forces in this endeavor to put an end to this hazard, and contribute in this manner to the food security and the economy of several families involved in the banana value chain,” Gabriel Rodríguez Marqués, IICA Representative in Paraguay Executive Secretariat of the Global Alliance Against TR4. “I extend my gratitude and underscore the assurances of my highest consideration.”

The deadly disease pathogen TR4 has been wreaking havoc and ravaging the $25 billion global banana industry – with infected plantations experiencing 100% loss and being quarantined for decades.  A flurry of apocalyptic media accounts are revealing a race to save bananas from extinction after the disease has left a trail of scorched banana plantations in its wake.

MustGrow vs. TR4

Under commercial partnership with Bayer, Bayer has the option to continue to build on MustGrow’s work in treating TR4.  MustGrow’s approach harnesses the natural defense mechanism of the mustard plant to develop organic, safe, and effective biofungicides and biopesticides to treat a variety of pests, fungus, and disease, including TR4.

MustGrow’s previously-disclosed work has demonstrated 100% control of TR4 in a laboratory setting of five different plate samples at five different application rates.  All 25 plates showed 100% disease control utilizing MustGrow’s biofungicide technology after a five-day period. In field trial settings, application of MustGrow’s biofungicide demonstrated positive dose response with reduced incidence and severity of TR4 symptoms in banana plants after 21 days. Importantly, even at higher application rates there was no damage or phytotoxic effects to the banana plants, allowing MustGrow to explore treating the banana plants directly, in addition to soil applications.

Sustainable innovations and green technologies are necessary to ensure agricultural production continues to address food safety and security as well as soil health. MustGrow’s rapidly developing solutions are focused on sustainable, safe, and effective, organic plant-based crop protection solutions that harness the mustard seed’s natural defense mechanism to treat diseases, pests and weeds.  MustGrow’s technology has shown consistent efficacy in multiple global regions, in multiple crops, in multiple applications, over multiple years.  The commercial development collaboration between Bayer and MustGrow demonstrates the importance of innovation in sustainable technologies in agricultural regions around the world.

Additional Sources

Bananas As We Know Them Are Doomed VICE News
Disease Is Ravaging the $25 Billion Banana Industry Bloomberg
Why The World’s Most Popular Banana May Go Extinct  Business Insider
The world’s bananas are in trouble BBC World Service
Why The Banana Business Of Chiquita And Dole Is At Risk CNBC

About Global Alliance Against TR4

At the Global Alliance Against TR4, our purpose is bringing together the world’s efforts to defeat TR4, a fungal disease jeopardizing bananas’ future. We’re a worldwide, multi-stakeholder community, uniting food brands, value chain companies, researchers, trade associations, financial services, the public sector and civil society. We recognize that TR4 is an urgent threat, and that we can fight it more effectively together than we ever could alone. As the Global Alliance, we’re co-ordinating research and training efforts at every stage, from the lab to the plantation. And we’re raising funds and awareness through our business and public engagement campaign, The Banana Action Group.

About MustGrow

MustGrow is an agriculture biotech company developing organic biocontrol and biofertility products by harnessing the natural defense mechanism and organic materials of the mustard plant to sustainably protect the global food supply and help farmers feed the world.  MustGrow and its leading global partners — Bayer, Janssen PMP (pharmaceutical division of Johnson & Johnson), Sumitomo Corporation, and Univar Solutions’ NexusBioAg — are developing mustard-based organic solutions for applications in biocontrol to potentially replace harmful synthetic chemicals in preplant soil treatment and weed control, to postharvest disease control and food preservation.  Bayer has a commercial agreement to develop and commercialize MustGrow’s biocontrol soil applications in Europe, Africa, and the Middle East.  Concurrently, with new formulations derived from food-grade mustard, the Company is pursuing the adoption and use of its Organic Materials Review Institute (OMRI Listed®) and California’s Organic Input Material (OIM) Program registered biofertility product, TerraSanteTM, in key U.S. states including California.  Over 150 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection and yield enhancements.  Pending regulatory approval, MustGrow’s patented liquid technologies could be applied through injection, standard drip or spray equipment, improving functionality and performance features.  MustGrow has approximately 51.6 million basic common shares issued and outstanding and 54.1 million shares fully diluted.  For further details, please visit www.mustgrow.ca.

Contact Information

Corey Giasson
Director & CEO
Phone: +1-306-668-2652
info@mustgrow.ca

MustGrow Forward-Looking Statements

Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.

Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”.  Examples of forward-looking statements in this news release include, among others, statements MustGrow makes regarding: the commencement of its membership into the Global Alliance Against TR4; the outcome or the ability of its technologies to combat TR4;; whether MustGrow’s organic biofertility product will complement the Company’s existing biocontrol programs in preplant soil fumigation, postharvest food preservation, and bioherbicide; the application of MustGrow’s biofungicide, and the efficacy of MustGrow’s technology. Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow.  Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include market receptivity to investor relations activities as well as those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2023 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available at www.sedar.com.  Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.

This release does not constitute an offer for sale of, nor a solicitation for offers to buy, any securities in the United States.

Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.

© 2024 MustGrow Biologics Corp. All rights reserved.

AI Revolution in Healthcare: Simplify Healthcare Acquires Virtical.ai

Posted on by slightbourne@noblecapitalmarkets.com

In a groundbreaking move, Simplify Healthcare has announced its acquisition of Virtical.ai, setting the stage for a dramatic transformation in health insurance technology. This strategic merger, revealed on June 24, 2024, combines Simplify Healthcare’s established SaaS platform with Virtical.ai’s advanced artificial intelligence capabilities, promising to revolutionize how health insurance providers operate in an increasingly complex market.

The timing of this acquisition is particularly significant as the healthcare industry grapples with mounting pressures to personalize services, streamline operations, and navigate intricate regulatory landscapes. By integrating Virtical.ai’s AI prowess into its Simplify Health Cloud™ platform, Simplify Healthcare aims to empower health insurance companies (Payers) with sophisticated tools to address these challenges effectively.

At the core of this acquisition lies the transformative potential of AI-driven solutions. Virtical.ai’s technology, which has been trained on an extensive database of health plan-specific documents, excels in data extraction and comparison. This capability enables Payers to offer highly personalized plans and benefits to both employer and individual segments, potentially revolutionizing the way health insurance is customized to meet individual needs.

Simplify Healthcare’s leadership team has expressed enthusiasm about the merger’s potential to reshape the industry. They emphasize the ability of AI models to process complex documents such as Statements of Benefits and Coverage (SBCs) and Machine Readable Files (MRFs), highlighting the potential for significant advancements in plan comparison, selection, and price transparency.

The acquisition also addresses critical challenges in network management. Virtical.ai’s platform can identify gaps in Payer networks by analyzing provider and member locations. This feature allows Payers to strategically promote their network coverage strengths and address deficiencies, ensuring members have access to suitable providers within their area. Moreover, the ability to benchmark negotiated provider rates against competitors offers Payers valuable insights for rate-setting and targeted marketing initiatives.

Virtical.ai’s leadership shares the excitement about the merger’s potential impact. They highlight how their AI models, built on decades of industry experience, are positioned to drive membership growth and revenue when integrated with Simplify Healthcare’s enterprise SaaS platform.

The integration of Virtical.ai’s technology is expected to enhance several of Simplify Healthcare’s existing solutions, including Benefits1™, Provider1™, Service1™, Claims1™, and Experience1™. These enhancements promise to provide Payers with more precise solutions to complex challenges in delivering products, benefits, and provider data.

Simplify Healthcare’s strategic team underscores the acquisition’s importance in the face of market disruptions. They believe that combining their industry-leading platform with Virtical.ai’s innovative AI solutions in Health Plan Sales and Network Management will empower Payers to achieve growth despite facing disruptive market and regulatory forces.

This merger also reflects a broader industry trend towards leveraging AI and machine learning to improve efficiency and personalization. By utilizing both generative AI and machine learning algorithms on unstructured document content and structured data, the combined entity aims to deliver cutting-edge solutions to Payers navigating the complexities of AI integration.

As the healthcare landscape continues to evolve, this acquisition positions Simplify Healthcare at the forefront of the AI revolution in health insurance technology. The promise of more personalized health plans, optimized network coverage, and data-driven decision-making tools could significantly impact not only Payers but also brokers and, ultimately, healthcare consumers.

With this bold move, Simplify Healthcare and Virtical.ai are poised to play a pivotal role in shaping the future of health insurance in an increasingly digital and personalized world. Their combined expertise and technological capabilities have the potential to drive innovation, enhance efficiency, and improve the overall experience for all stakeholders in the health insurance ecosystem.

Take a moment to take a look at GoHealth Inc. (GOCO), a health insurance marketplace that leverages modern machine-learning algorithms and helps individuals find the best health insurance plan for their specific needs.

Boston Scientific Acquires Silk Road’s TCAR Platform for $1.16B

Posted on by slightbourne@noblecapitalmarkets.com

Boston Scientific Corporation has taken a major strategic step to strengthen its position in the vascular medical technology space by announcing a definitive agreement to acquire Silk Road Medical, Inc. for approximately $1.16 billion. This acquisition adds an innovative and clinically differentiated technology for stroke prevention to Boston Scientific’s already impressive portfolio of vascular solutions.

The target company, Silk Road Medical, is a pioneering medical device firm that has developed a revolutionary platform called TCAR (transcarotid artery revascularization) to treat carotid artery disease, a major cause of strokes. Carotid artery disease is responsible for one-third of all strokes and occurs when the carotid arteries in the neck become narrowed or blocked due to plaque buildup. Traditional treatment options include medical therapy management, stenting, or open surgery, all of which carry risks.

Silk Road’s TCAR procedure takes a minimally invasive approach by accessing the carotid artery through a small incision in the neck and temporarily reversing blood flow away from the brain during stenting. This prevents plaque from dislodging and causing a stroke, while a stent is placed to stabilize the blockage and prevent future strokes. Cat Jennings, President of Vascular Peripheral Interventions at Boston Scientific, praised the TCAR platform as “a notable advancement in the field of vascular medicine” that has “revolutionized stroke prevention and the treatment of carotid artery disease.”

The TCAR system gained U.S. Food and Drug Administration approval in 2015 and is supported by several clinical studies demonstrating a reduced risk of stroke and other complications associated with traditional open surgery. Notably, Silk Road Medical’s products are the only devices commercially available for use during the TCAR procedure, positioning the company as a leader in this fast-growing market segment.

Under the terms of the agreement, Boston Scientific will acquire all outstanding shares of Silk Road Medical for $27.50 per share in cash. Silk Road Medical is expected to generate net revenue of $194-198 million in 2024, reflecting 10-12% growth over the prior fiscal year. Boston Scientific anticipates the acquisition will be immaterial to its adjusted earnings per share in 2024 and 2025, and accretive thereafter.

For Boston Scientific, this strategic acquisition aligns perfectly with its core vascular business and strengthens its stroke solutions capabilities. By acquiring Silk Road Medical, Boston Scientific gains access to the innovative TCAR technology and can leverage its global commercial footprint and extensive physician relationships to drive further adoption of the platform. The combined entity can also explore potential synergies and opportunities to expand the applications of the TCAR technology beyond carotid artery disease.

The transaction is subject to customary closing conditions, including regulatory approvals, and Boston Scientific expects to complete the acquisition in the second half of 2024. While integrating Silk Road Medical’s operations, Boston Scientific plans to reinforce its commitment to providing meaningful innovation for physicians who treat patients with peripheral vascular disease.

This acquisition represents a strategic move by Boston Scientific to bolster its vascular offerings with a clinically differentiated and commercially successful stroke prevention technology. By integrating Silk Road Medical’s cutting-edge TCAR platform, Boston Scientific further solidifies its position as a leader in the vascular medical technology space and demonstrates its dedication to advancing solutions that improve patient outcomes and reduce the cost of healthcare.

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

Quantum Leap: The Next Big Investment Opportunity in Healthcare?

Posted on by slightbourne@noblecapitalmarkets.com

Imagine a world where diseases are detected at the earliest stages, new life-saving drugs are developed in a fraction of the time, and medical resources are optimized to deliver the best possible care. This future may not be as far-fetched as it sounds, thanks to a revolutionary technology called quantum computing.

What is Quantum Computing?
Quantum computing is a mind-bending technology that harnesses the strange behavior of particles at the subatomic level. Unlike traditional computers that process information as binary bits (0s and 1s), quantum computers use quantum bits or qubits that can exist in multiple states simultaneously. This superposition phenomenon allows quantum computers to perform millions of calculations at once, making them exponentially more powerful than classical computers.

The Healthcare Revolution
While quantum computing may seem like something straight out of a science fiction movie, its potential applications in healthcare are very real and could transform the industry as we know it.

  1. Accelerating Drug Discovery
    One of the most promising applications of quantum computing is in the field of drug discovery. Finding new medicines is a painstakingly slow and expensive process, often taking decades and billions of dollars. Quantum computers can simulate complex molecular interactions at an unprecedented scale, allowing researchers to quickly identify promising drug candidates. This could dramatically shorten the drug development timeline, saving lives and billions of dollars.

Consider this: It takes an average of 10 years and $2.6 billion to develop a new drug from initial discovery to market approval. With quantum computing, pharmaceutical companies could potentially cut development times by years, significantly reducing costs and getting life-saving treatments to patients faster.

  1. Personalized Medicine
    We all have unique genetic makeups that influence our response to different treatments. Personalized medicine aims to tailor therapies to an individual’s genetic profile, but analyzing vast amounts of genomic data is a daunting task for classical computers. Quantum computers can process and identify patterns in complex genetic data, enabling truly personalized treatment plans that maximize efficacy and minimize side effects.

Imagine a future where your doctor can analyze your entire genome and prescribe a medication tailored specifically to your genetic makeup, minimizing the risk of adverse reactions or ineffective treatments. This level of precision could revolutionize healthcare, improving outcomes and reducing waste.

  1. Enhanced Medical Imaging
    Medical imaging techniques like MRI and CT scans generate massive amounts of data. Quantum computing can enhance image processing, improving clarity and resolution, enabling earlier detection of diseases like cancer. Early detection is key to successful treatment and could save countless lives.

With quantum-enhanced imaging, doctors could potentially identify tumors and other abnormalities at much earlier stages, significantly increasing the chances of successful treatment and survival.

  1. Optimized Healthcare Logistics
    Healthcare systems involve intricate logistics, from managing hospital resources to optimizing patient care. Quantum computing’s ability to solve complex optimization problems can help hospitals better manage staff, equipment, and patient flow, leading to improved efficiency and reduced costs.

By optimizing resource allocation and patient flow, quantum computing could help hospitals reduce wait times, improve patient experiences, and ultimately deliver better care at lower costs.

The Investment Opportunity
While quantum computing is still in its early stages, the potential payoffs in healthcare are staggering. Tech giants like IBM, Google, and startups like Rigetti Computing are investing heavily in quantum research. As the technology matures, we can expect to see a surge of investment opportunities in quantum computing companies and healthcare firms that leverage this technology.

Analysts estimate that quantum computing could create a $450 billion to $850 billion annual market by 2045, with healthcare being one of the prime beneficiaries. Early investors in this space could see massive returns as the technology takes off.

Of course, there are challenges to overcome, such as building stable, large-scale quantum computers and developing algorithms tailored for healthcare applications. However, the potential rewards are vast, both in terms of human lives saved and financial returns for savvy investors who recognize the transformative power of quantum computing in healthcare.

Quantum computing holds the promise to revolutionize healthcare by accelerating drug discovery, enabling personalized medicine, enhancing medical imaging, and optimizing resource management. While the technology is still in its early stages, the potential benefits for medicine are enormous. As we continue to explore and develop quantum computing, the future of healthcare looks brighter than ever, offering new hope for patients and medical professionals alike.

Release – MAIA Biotechnology Announces Year-To-Date Achievements And Highlights Recent Clinical Progress For Novel Anticancer Agent

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

June 06, 2024 10:07am EDT

  • New science for cancer therapy drives powerful value proposition
  • Exceptional measures of efficacy by lead drug THIO in Phase 2 clinical trial
  • Funding of more than $12M year-to-date, including $7.4 million in Q2’24 so far
  • Secured continued insider investment through independent board members’ participation in private placement equity financings
  • Newest data shows THIO’s strong outperformance against standard-of-care treatments in non-small cell lung cancer (NSCLC)
  • 38% overall response rate (ORR) in third-line (3L) setting (THIO 180mg) vs. ~6% for currently available treatments in a similar population
  • 5.5 months median progression-free survival (PFS) (3L, THIO 180mg) more than double PFS of current chemotherapy treatments

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced Company highlights and key achievements year-to-date, including recent clinical progress for lead candidate THIO, a potential first-in-class cancer telomere targeting agent in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC).

“MAIA’s new science for cancer therapy is driving a powerful value proposition for our portfolio of novel anticancer compounds,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “Our most recent clinical data points to THIO’s promising disease control, response rates, and post-therapy patient benefits. Third-line treatment with THIO has significantly outperformed reported standard-of-care data in NSCLC.

“Our confidence in the science and clinical pathways for our immuno-oncology therapies continues to grow,” Dr. Vitoc added. “This week at ASCO 2024, our poster presentation and prospects for conducting studies in various geographies has generated a wealth of positive response and excitement from U.S. and foreign oncologists and investigators about our growing cancer treatment business.”

THIO’s dual mechanism of action is designed to induce telomeric DNA damage and boost cancer-specific immune responses. The Phase 2 THIO-101 clinical trial evaluates THIO sequenced with an immune checkpoint inhibitor (CPI), cemiplimab, in patients with advanced non-small cell lung cancer (NSCLC) who failed two or more standard-of-care therapy regimens prior to THIO dosing. MAIA successfully secured a high value clinical supply agreement for the cemiplimab used throughout the THIO-101 trial.

As of April 30, 2024, THIO-101 data from THIO 180mg + CPI in third-line treatment showed, in part:

– overall response rate (ORR) of 38%
– disease control rate (DCR) of 85%
– median progression-free survival (PFS) of 5.5 months
– median survival follow-up time of 9.1 months

“THIO works well in all doses and has an excellent safety profile, but 180mg has shown the greatest efficacy and is well tolerated compared to existing therapies. Hence, we selected 180mg per cycle as the dose going forward,” noted Dr. Vitoc. “For this heavily pre-treated population, comparative third-line data is limited. Checkpoint inhibitor resistant and platinum resistant patients are by far the largest populations with unmet medical needs in NSCLC and are also a substantial part of NSCLC cancer therapy market. We believe that our trial is providing the first real dataset in CPI-resistant patients like this. We are confident about THIO’s prospects for substantially extending patient survival and establishing a new standard of care for cancer.

“We remain steadfast in our goals for responsible access to capital. We have increased our access to cash while keeping dilution to a minimum. We plan to continue this strategy, which has shown desired outcomes so far this year while our share price has more than tripled,” added Dr. Vitoc.

MAIA reported cash and current assets of $8.7 million as of March 31, 2024. The Company’s cash position has significantly improved due to approximately $12.4 million in funds raised since February 2024 pursuant to a combination of private placements of our equity securities and sales under our at-the-market offering facility, of which approximately $7.4 million has been raised since April 1, 2024 with $6.4 million of this amount due to sales under the ATM facility to fund continuing clinical development. Our independent directors have shown continued support by investing almost $900,000 in our March and April 2024 private placements with other accredited investors.

MAIA’s Phase 2 THIO-101 clinical trial is expected to near completion in 2024. The Company is also engaged in research and development for a portfolio of second-generation THIO-like compounds.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with cemiplimab (Libtayo®) followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About MAIA Biotechnology, Inc.

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.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240606104003/en/

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

Released June 6, 2024

GTCR to Take Surmodics Private in $627 Million Medical Tech Deal

Posted on by slightbourne@noblecapitalmarkets.com

One of the medical technology industry’s leading providers of coating systems and surface modification is being taken private by private equity firm GTCR in a $627 million deal. Surmodics (SRDX) announced Monday that it has entered into a definitive agreement to be acquired by GTCR in an all-cash transaction valuing the company at $43 per share.

The acquisition price represents a premium of over 41% to Surmodics’ average trading price over the past 30 days. It comes amid a broader push by private equity to double down on investments in the healthcare technology space as medical device innovation accelerates.

Surmodics has been a pioneer in the delivery of surface modification solutions that enhance the biocompatibility of medical products. The Eden Prairie, Minnesota-based company’s technologies are used by blue-chip medical device manufacturers to enable products to interact more safely and effectively with the human body.

Its proprietary coating and treatment platforms are integrated into thousands of devices including vascular intervention technologies, minimally invasive surgical tools, in vitro diagnostics, and ophthalmic products. Surface treatments from Surmodics can improve device thromboresistance, lubricity, durability, adhesion, and biocompatibility.

Those differentiated capabilities caught the eye of GTCR, which has significant experience investing in healthcare companies. The Chicago-based private equity firm currently manages over $25 billion in equity capital across multiple investment strategies.

For Surmodics shareholders, the $43 per share cash deal represents an attractive exit price. In addition to the 41% premium to the recent trading average, the buyout price is 26% higher than where the stock closed on Friday. The company’s shares soared 25% on Monday following news of the transaction.

Surmodics’ Board of Directors unanimously approved the merger agreement and recommends shareholders vote in favor of the deal. The transaction is expected to close in the second half of 2024, subject to shareholder approval, regulatory clearances, and other customary closing conditions.

Upon completion of the acquisition, Surmodics will become a privately held company and its shares will cease trading on the Nasdaq exchange.

The medical coatings and surface technology space has seen heightened M&A activity in recent years as major medical product companies seek to enhance their product pipelines. Private equity investors like GTCR have ample dry powder to deploy into healthcare sectors positioned for durable growth driven by demographic tailwinds and innovation.

While going private will provide Surmodics with flexibility to invest for the long-term, the $627 million price tag validates the company’s tools and know-how as essential for next-generation medical device engineering. As healthcare investors compete to back enablers of cutting-edge medical products, GTCR’s bet on Surmodics’ coating capabilities could pay off handsomely.

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Novavax Soars on Major Sanofi Partnership, Opening New Doors for Biotech Investors

Posted on by slightbourne@noblecapitalmarkets.com

In a dramatic turn of events, shares of Novavax skyrocketed over 130% on Friday after the struggling vaccine maker announced a landmark deal with global pharmaceutical giant Sanofi. This multibillion-dollar agreement could prove to be a game-changer, not just for Novavax’s outlook, but for biotech investors evaluating the emerging opportunities across the vaccine technology landscape.

The centerpiece of the deal is a co-commercialization partnership for Novavax’s protein-based Covid-19 vaccine beginning in 2025. Sanofi, with its vast global reach and resources, will take the lead in marketing and distributing the shot in most major markets outside of regions where Novavax already has existing commercial agreements.

For Novavax, which has grappled with sluggish demand and manufacturing challenges for its Covid vaccine, gaining access to Sanofi’s commercial juggernaut could unlock vastly greater market penetration worldwide. As a relatively small biotech player, going it alone has proven tremendously difficult against the entrenched dominance of mRNA giants like Pfizer and Moderna.

Investors clearly perceive the blockbuster potential in marrying Novavax’s innovative vaccine technology with Sanofi’s large-scale commercial capabilities and existing healthcare footprint. Expanded patient access could drive significant upside for Novavax’s revenues and growth trajectory in the coming years, breathing new life into a company that was on the brink.

But the deal goes far beyond just commercializing Novavax’s existing Covid vaccine. In a strategic masterstroke, Sanofi also secured the rights to develop new combination vaccines using Novavax’s breakthrough Matrix-M adjuvant technology, along with its Covid shot as a foundational component.

This pipeline partnership opens up a world of lucrative new product opportunities spanning respiratory illnesses like influenza to other viral targets. With Sanofi’s vast resources and deep experience in vaccines, the French pharma leader could rapidly advance and widely commercialize groundbreaking combination shots powered by Novavax’s underlying technology platform.

From an investment perspective, the potential to create multiple new high-value assets from a proven backbone of innovative biotech is hugely compelling. Sanofi is putting over $1 billion on the table in upfront fees and milestone payments tied to development and commercial objectives. Novavax will also earn royalties on all future product sales utilizing its technology.

Crucially, this deal relieves immense financial pressure from Novavax’s shoulders. Just a few months ago, the company warned of “substantial doubt” about its ability to continue operating through a dwindling cash position. Now flush with fresh capital from Sanofi and newly monetized royalty streams, Novavax can comfortably lift its “going concern” status while funding its own vaccine pipeline initiatives.

Investors should see the partnership as transformative, clearing the dark clouds of existential risk that had been swirling over Novavax and positioning the biotech for long-term sustainability through diversified vaccine revenue channels.

But Novavax’s good fortune goes beyond just its own prospects. The validation of its unique Matrix-M adjuvant and protein-based vaccine technology by a pharma titan like Sanofi should resonate across the broader biotech landscape. Smaller innovators working on novel vaccine platforms or therapeutic approaches could see heightened investor interest and appetite for collaborations.

The deal underscores how big pharma incumbents remain hungry for cutting-edge technologies to refresh and future-proof their product pipelines. More acquisitions and mutually beneficial licensing deals could emerge as large players double down on biotech externally to fuel new innovation cycles.

For biotech venture investors scouting breakthrough opportunities and transformative technology platforms, the Novavax-Sanofi partnership should serve as an encouraging proof-of-concept. Companies advancing truly differentiated science with clear competitive advantages and value-driving datasets now have a highly visible pathway to lucrative partnerships, exits or harnessing corporate funding muscle to propel their own commercialization dreams.

In life sciences industries where innovation is the key to disruption, this high-profile deal should instill greater confidence around investing in upstart biotechs clearing novel clinical and technological hurdles. The prospects of future value realization and exit opportunities just got a welcome booster shot.

While Novavax finally resolved one existential crisis, it may have just birthed an exciting new era of opportunity across the biotech investment landscape.

Release – PDS Biotech Appoints Stephan Toutain as Chief Operating Officer

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

PRINCETON, N.J., May 02, 2024 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced the appointment of Stephan Toutain, MS, MBA, as Chief Operating Officer (COO), effective as of May 1, 2024.

“We are thrilled to welcome Stephan to the PDS Biotech team as Chief Operating Officer. His invaluable experience spans many aspects of the life sciences industry, from drug development to commercialization, providing a wealth of knowledge to our team,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “Stephan’s strategic vision, proven ability to drive operational excellence, and distinguished track record, particularly in oncology, will be instrumental as we advance our lead program into a pivotal clinical trial.”

Mr. Toutain brings more than 30 years of operational experience in the pharmaceutical industry from drug development, general management, operations, commercial development, market access and sales and marketing leadership with prior global expertise in the oncology and orphan drugs markets. Before joining PDS Biotech, he served as COO at Anavex Life Sciences from May 2018 to April 2024 and Chief Commercial Officer at Interleukin Genetics from July 2016 to August 2017. Mr. Toutain also worked with Alnylam Pharmaceuticals to build its early access program. In addition, he led Global Commercial Development for Sarepta Therapeutics and served as General Manager for Alexion Pharmaceuticals in Europe. Mr. Toutain has also held various U.S. commercial, marketing and product management positions with Celgene Corporation and Johnson & Johnson. He received a Master of Business Administration from the University of North Carolina Kenan-Flagler Business School and a Master of Engineering in Biotechnology from the University of Nancy II in France.

“I am excited to join the PDS Biotech team during this pivotal time as the company hones its late-stage clinical strategy on the novel triple combination,” said Mr. Toutain. “I am eager to contribute my experience and insights to drive forward our mission of transforming how the immune system targets and fights cancer.”

The Company also announced today that on May 1, 2024, PDS Biotech granted a nonstatutory stock option to Mr. Toutain to purchase 200,000 shares of PDS Biotech common stock as a material inducement to Mr. Toutain’s employment with PDS Biotech and in accordance with Nasdaq Listing Rule 5635(c)(4) and PDS Biotech’s 2019 Inducement Plan, as amended, which was adopted on June 17, 2019 and provides for the granting of equity awards to new employees of PDS Biotech.

The stock option has an exercise price of $3.61, the closing price of PDS Biotech’s common stock on May 1, 2024. The stock option vests over a four-year period, with one-quarter of the shares vesting on the first anniversary of the grant date and the remaining shares vesting monthly over the 36-month period thereafter, subject to continued employment with the Company through the applicable vesting dates.

About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced head and neck squamous cell cancers (HNSCC). PDS Biotech’s lead program is a proprietary dual-acting combination of IL-12 fused antibody drug conjugate (ADC) PDS01ADC and T-cell activator Versamune® HPV in regimen with a standard-of-care immune checkpoint inhibitor. We believe that proof-of-concept long-term data have shown positive survival results and tumor shrinkage with this combination and indicate favorable tolerability.

We believe that with a novel investigational “inside-outside” mechanism, the PDS01ADC and Versamune® HPV immunotherapy has shown compelling results with potential to successfully disrupt a tumor’s inside defenses, while also generating potent, targeted killer T-cells to attack the tumor from the outside. We believe that data from more than 350 patients, as well as ongoing clinical trials across multiple tumor types and standard treatment regimens, have validated the potential for both platforms and point to potential broad utility.

Our Infectimune® based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses, including long-lasting memory T-cell responses in pre-clinical studies to date. For more information, please visit www.pdsbiotech.com.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS01ADC, PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS01ADC, PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. 

Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation.

Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com

Media Contact:
Gina Mangiaracina
6 Degrees
Phone +1 (917) 797-7904
Email: gmangiaracina@6degreespr.com

X4 Pharmaceuticals Hits Jackpot With Xolremdi Approval, Unlocking M&A Potential

Posted on by slightbourne@noblecapitalmarkets.com

In a significant value-creating event, X4 Pharmaceuticals has secured FDA approval for its lead drug Xolremdi, ushering the biotech into the commercial realm and positioning it as an attractive M&A target in the hot rare disease space.

Xolremdi (mavorixafor) nabbed approval to treat WHIM (warts, hypogammaglobulinemia, infections and myelokathexis) syndrome, an ultra-rare primary immunodeficiency disorder. As the first approved therapy tackling WHIM’s genetic root cause, the CXCR4 inhibitor fills a massive unmet need where treatment options were previously limited to symptom management.

With its novel mechanism mobilizing infection-fighting white blood cells out of the bone marrow, Xolremdi demonstrated impressive clinical benefits in Phase 3. These included slashing rates of severe infections and boosting critical white blood cell levels like neutrophils and lymphocytes in WHIM patients.

While WHIM’s prevalence is difficult to pinpoint given its rarity, X4 estimates around 1,000 cases in the U.S. However, the commercial opportunity could be larger if the company successfully identifies underdiagnosed patients through its genetic screening initiatives and physician education efforts.

Xolremdi isn’t a curevbut holds potential to bolster long-term immune defenses for WHIM patients who chronically suffer from infections, warts, and abnormally low antibody levels. This positions the drug as a high-value therapy that can command premium pricing despite the tiny patient population.

Indeed, X4 has set an eyebrow-raising $496,400 annual list price for Xolremdi in patients over 50 kg, and $372,300 for smaller individuals. While pricey, these kinds of ultra-orphan drug costs are typical and highlight the blockbuster revenue potential if X4 can rapidly build out its U.S. presence and strike reimbursement wins with payers.

With its first FDA approval in hand, X4 is kicking its commercial launch into high gear. The company has deployed and trained a 24-person field force blanketing the country, established distribution channels, and stockpiled launch supplies ahead of the Xolremdi decision. Smooth execution out of the gate will be crucial.

This pivotal milestone transforms X4 from a clinical-stage biotech into a fully integrated rare disease player with an approved therapy, commercial infrastructure, and revenue stream. That fresh commercial status boosts X4’s profile considerably, increasing the odds it could become an enticing buyout target.

Big Pharma has been extremely hungry to expand rare disease franchises through M&A, driven by high unmet needs, accelerated regulatory pathways, and lucrative pricing opportunities in niche markets. Potential suitors could view X4’s new orphan disease platform as complementary.

Further underlining X4’s M&A appeal, the Xolremdi approval came with a priority review voucher as a bonus. These valuable vouchers can be redeemed to fast-track another regulatory filing or sold to other drugmakers for hundreds of millions.

Additionally, X4 believes mavorixafor has therapeutic potential beyond WHIM. The biotech aims to rapidly initiate a Phase 3 program testing the drug in chronic neutropenia, expanding its pipeline.

While the ultra-rare WHIM population limits how much a solo acquirer could value Xolremdi’s revenue stream, the drug’s approval derisks X4’s pipeline and corporate strategy. With its first FDA win and voucher under its belt, X4 stands as an intriguing M&A target that could fetch a premium from buyers seeking a rare disease foothold.