In a strategic move to bolster its commercial-stage portfolio, Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) announced on July 8, 2024, its agreement to acquire APEIRON Biologics AG for $100 million in cash. This acquisition marks a significant expansion of Ligand’s oncology footprint, particularly in the realm of rare pediatric cancers.
The crown jewel of this acquisition is QARZIBA® (dinutuximab beta), a highly differentiated oncology drug used in the treatment of high-risk neuroblastoma in patients aged 12 months and above. QARZIBA, which received European Medicines Agency approval in 2017, is currently marketed in over 35 countries by global pharmaceutical company Recordati S.p.A.
Todd Davis, CEO of Ligand, emphasized the strategic importance of this acquisition, stating, “The addition of QARZIBA to our commercial royalty portfolio further supports our growth strategy to invest in high-value medicines that deliver significant clinical value and generate predictable and long-term revenue streams for our investors.”
The deal structure includes the initial $100 million cash payment, with the potential for up to an additional $28 million based on future commercial and regulatory milestones. Specifically, these additional payments are tied to QARZIBA royalties exceeding certain predetermined thresholds by either 2030 or 2034.
From a financial perspective, this acquisition is expected to make an immediate positive impact on Ligand’s bottom line. The company projects that the deal will be accretive to its earnings per share (EPS) by approximately $1.00 on an annualized basis, with a $0.50 impact expected for 2024 alone. In light of this, Ligand has increased its 2024 adjusted EPS guidance by 17% to a range of $5.00-$5.50.
The acquisition of APEIRON represents the sixth key asset added to Ligand’s commercial stage portfolio since the beginning of 2023, underscoring the company’s aggressive growth strategy. This diversification is expected to provide Ligand with a more stable and predictable revenue stream, a key consideration for investors in the volatile biotech sector.
QARZIBA’s unique position as the only immunotherapy for high-risk neuroblastoma marketed across Europe and other parts of the world makes it a particularly valuable addition to Ligand’s portfolio. Neuroblastoma, a rare cancer that primarily affects children, has limited treatment options, highlighting the potential impact of QARZIBA on patient outcomes.
In a parallel move, Ligand has also committed to investing up to $4 million in invIOs Holding AG, a privately held spin-off of APEIRON. This investment is aimed at financing the research and development of three innovative early-stage immuno-oncology assets, further expanding Ligand’s development stage portfolio.
Peter Llewellyn-Davies, CEO of APEIRON, expressed satisfaction with the deal, noting, “This transaction is an important milestone for our company and shareholders. We have spent more than 20 years translating academic research into therapeutic products for diseases with high unmet needs.”
The acquisition is expected to close in July 2024, subject to a 30-day shareholder objection period and other customary closing conditions. Upon completion, it will significantly reshape Ligand’s commercial portfolio and financial outlook.
As the biopharmaceutical industry continues to consolidate and seek ways to mitigate risk while maximizing potential returns, Ligand’s acquisition of APEIRON represents a strategic move to strengthen its position in the oncology market. By focusing on high-value, commercially available assets like QARZIBA, Ligand is positioning itself for sustained growth in the competitive and rapidly evolving pharmaceutical landscape.
In a bold strategic move, small-cap biotech Cullinan Oncology is transforming into an autoimmune disease company and rebranding as Cullinan Therapeutics. The Massachusetts company announced the major pivot alongside a $280 million private placement financing that extends its cash runway into 2028.
Cullinan is staking its future on the emerging potential of CAR-T cell therapies to treat autoimmune conditions like systemic lupus erythematosus (SLE). The company plans to advance its lead candidate CLN-978, a bispecific T cell engager originally developed for lymphoma, into SLE. An Investigational New Drug (IND) filing is targeted for the third quarter of 2024, with additional autoimmune indications likely to follow.
The strategic refocusing comes as preliminary data from small academic studies hint that CAR-T cells could induce durable remissions in autoimmune patients by depleting pathogenic B cells and modulating the immune system. In February, researchers reported that 8 out of 15 SLE patients achieved remission for over 1 year after CAR-T treatment, allowing them to discontinue all other medications.
“The unmet need in autoimmune diseases is vast, with most patients cycling through treatment after treatment without achieving remission,” said Cullinan CEO Alejandra Carvajal. “CAR-T cell therapy represents a potential paradigm shift, with an entirely novel mechanism to re-educate the immune system.”
Cullinan is one of the first movers in the autoimmune CAR-T space, but it won’t be alone for long. Peers like Kyverna, Cabaletta, Allogene and Arbor have all initiated programs or partnerships in the last year to develop similar cell therapies.
Cullinan has stopped enrolling patients in CLN-978’s lymphoma study to fully transition to autoimmune disorders. But the company is retaining its existing oncology pipeline, including lead asset zipalertinib in non-small cell lung cancer.
To fund the new autoimmune endeavors, Cullinan raised $280 million through the sale of shares and convertible securities to institutional investors. The private placement was led by venBio Partners and included Cullinan’s existing investors.
“This successful financing provides Cullinan with the resources to rapidly advance our CLN-978 program in SLE and beyond,” stated Carvajal. “We’re excited to lead the way into this new frontier at the intersection of cell therapy and autoimmune disease.”
Cullinan is making a high-risk, high-reward bet on still-unproven science. CAR-T’s efficacy in autoimmune conditions has only been explored in small patient numbers so far. But if the approach proves transformative, Cullinan could be at the vanguard of disrupting the large autoimmune drug market.
The hefty $280 million raise buys Cullinan plenty of runway to generate data from larger trials evaluating CLN-978 and shaping its future autoimmune portfolio. For autoimmune disease patients in need of new options, all eyes will be on Cullinan’s pioneering role in the promising CAR-T space.
Boundless Bio, a biotech company pioneering a new approach to treating cancer, made its public debut on the Nasdaq stock exchange today in a $100 million initial public offering. The Cambridge, Massachusetts company is the latest biotech firm to go public in 2024 after last year’s IPO drought, pricing its shares at $16 each under the ticker symbol “BOLD.”
The $100 million capital raise will provide a major boost to Boundless Bio’s pipeline of experimental cancer therapies that target extrachromosomal DNA (ecDNA), double-stranded DNA molecules that exist outside of chromosomes and can contain amplified oncogenes driving tumor growth.
“EcDNA represents an exciting new frontier in cancer biology and a promising opportunity for therapeutic intervention,” said Zachary Hartman, CEO of Boundless Bio. “With this successful IPO, we are now well-capitalized to advance our novel ecDNA-targeted candidates through clinical trials and hopefully translate this cutting-edge science into meaningful treatments for patients.”
Leading the way for Boundless is BBI-355, the company’s most advanced program that inhibits checkpoint kinase 1, an enzyme involved in ecDNA replication and transcription. BBI-355 is currently being evaluated in the Phase 1/2 POTENTIATE study, with initial data from up to 90 patients expected in the second half of this year.
Not far behind is BBI-825, an oral ribonucleotide reductase inhibitor that targets a different mechanism related to ecDNA biology. This second clinical candidate entered Phase 1/2 testing just last month in the STARMAP trial, with early results anticipated in late 2025.
In addition to developing therapeutics, a portion of the $100 million IPO proceeds will fund Boundless Bio’s efforts to create a diagnostic test called ECHO to detect ecDNA levels in cancer patients’ tumors. The company believes this could enable more precise treatment by identifying patients most likely to respond to ecDNA-targeted therapies.
The successful Nasdaq listing bucks the trend of a biotech IPO market that was essentially frozen in 2023 amid volatile market conditions. But investor sentiment appears to have rebounded in 2024, with Boundless Bio becoming the seventh biotech to go public so far this year.
“This is an incredibly promising time for Boundless Bio and for companies working on novel modalities that could reshape cancer treatment,” said Tricia Lorida, a biotech analyst at SVB Securities. “While ecDNA therapies are still at an early stage, there is certainly excitement around targeting these unique DNA drivers of tumor growth and genomic instability.”
Boundless Bio’s IPO was led by Goldman Sachs, Guggenheim Securities, Piper Sandler, and Leerink Partners as joint book-running managers. The company granted underwriters a 30-day option to purchase up to an additional 937,500 shares at the IPO price, which could raise the total deal proceeds to $115 million if exercised in full.
With the $100 million-plus capital infusion, Boundless Bio is well-positioned to advance its pioneering work in the emerging field of ecDNA biology as the company aims to unlock new therapeutic options for cancer patients. The successful IPO marks an ambitious first step, but much will ride on the clinical data readouts expected over the next couple of years.
The successful $100 million IPO by Boundless Bio could pave the way for more biotech companies to tap the public markets in 2024 as investor appetite appears to be returning. After a dismal 2023 that saw very few biotechs go public, the new year has brought a flurry of IPO activity, with Boundless Bio becoming the seventh biotech to debut on the Nasdaq. Other drug developers waiting in the wings may seize the opportunity to join the IPO queue if market conditions remain favorable. An opening of the IPO window would provide a crucial capital infusion for biotech firms to continue advancing their R&D programs amid a challenging funding environment. While clinical data will ultimately determine the fates of these newly public companies, a reinvigorated IPO market bodes well for biotech innovation lingering in the pipeline.
In a strategic move to strengthen its oncology pipeline, Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company focused on developing novel cancer therapies, has announced its acquisition of AnHeart Therapeutics Ltd. in an all-stock transaction. This acquisition promises to transform Nuvation Bio into a late-stage global oncology company, positioning it as a potential commercial organization by the end of 2025.
The deal, which is subject to approval by AnHeart’s shareholders and other customary closing conditions, is expected to close in the second quarter of 2024. Upon completion, the former shareholders of AnHeart will own approximately 33% of Nuvation Bio on a fully diluted basis, while the current stockholders of Nuvation Bio will retain a 67% stake.
The primary asset driving this acquisition is taletrectinib, AnHeart’s lead investigational therapy and a next-generation ROS1 inhibitor for the treatment of ROS1-positive non-small cell lung cancer (NSCLC). Taletrectinib has already received Breakthrough Therapy Designations from both the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA).
Notably, taletrectinib is currently completing two pivotal Phase 2 studies, TRUST-I in China and TRUST-II, a global pivotal study, potentially positioning it as a best-in-class treatment option for patients with ROS1-positive NSCLC. The NMPA has also granted Priority Review Designation to New Drug Applications for taletrectinib, further underscoring its potential.
In addition to taletrectinib, the acquisition also brings safusidenib, a potentially best-in-class mutant IDH1 inhibitor, into Nuvation Bio’s pipeline. Safusidenib is currently being evaluated in a global Phase 2 study for the treatment of patients with grades 2 and 3 IDH1-mutant glioma.
“This transaction represents a significant milestone for our company and reflects Nuvation Bio’s continued commitment to developing therapies for patients with the most difficult-to-treat cancers,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “AnHeart’s lead asset, taletrectinib, which will become our lead asset as it completes two pivotal studies, is a differentiated, next-generation ROS1 inhibitor with a potentially best-in-class profile that may overcome the significant limitations of existing therapies.”
For Nuvation Bio, this all-stock acquisition preserves the company’s robust cash balance, enabling the development of both the newly acquired assets and its existing pipeline without the immediate need to raise additional capital. This financial strength positions Nuvation Bio to execute its development strategy effectively and advance its combined portfolio of differentiated oncology therapeutic candidates.
The acquisition also brings together the talented teams from both companies, with Nuvation Bio’s current management team, including Dr. Hung, remaining at the helm. Additionally, Min Cui, Ph.D., Founder and Managing Director of Decheng Capital, an investor in AnHeart, and Junyuan Jerry Wang, Ph.D., Co-Founder and Chief Executive Officer of AnHeart, will join Nuvation Bio’s board of directors.
As the demand for innovative cancer therapies continues to grow, Nuvation Bio’s acquisition of AnHeart Therapeutics represents a strategic move to bolster its oncology pipeline and position itself as a potential commercial organization in the near future. With taletrectinib and safusidenib as promising additions to its portfolio, Nuvation Bio is poised to make significant strides in addressing the unmet needs of patients with challenging forms of cancer.
In a bold move to fortify its oncology pipeline, pharmaceutical giant AstraZeneca (NASDAQ: AZN) has agreed to acquire clinical-stage biotech Fusion Pharmaceuticals (NASDAQ: FUSN) for up to $2.4 billion. The deal gives AstraZeneca full access to Fusion’s pioneering radioconjugate (RC) therapies and expertise as it aims to transform cancer treatment and unseat traditional chemotherapy and radiation regimens.
Fusion specializes in developing a promising new class of precision oncology drugs called RCs, which dispense powerful, targeted radiation directly to cancer cells via targeting molecules like antibodies. By delivering potent radioisotope payloads to tumors in this manner, RCs may improve upon external beam radiation’s limitations and indiscriminately toxic effects.
Under the agreed terms, AstraZeneca will pay $21 per share in cash upfront to acquire all outstanding Fusion shares, valuing the biotech at approximately $2 billion. This headline price represents a staggering 97% premium over Fusion’s closing price prior to deal announcement. AstraZeneca has also committed up to $3 per share in additional contingent value rights tied to a future regulatory milestone, which could push the total deal value to $2.4 billion if achieved.
For AstraZeneca, the acquisition paves the way for a major expansion into promising RC therapeutics, which could revolutionize how cancers are treated in the future. The crown jewel of the deal is FPI-2265, Fusion’s lead RC candidate that uses the alpha particle-emitting isotope actinium-225 to target PSMA proteins in metastatic castration-resistant prostate cancer. FPI-2265 is already in Phase 2 clinical trials with early data expected in 2024.
Beyond this advanced asset, AstraZeneca gains control of Fusion’s broader pipeline of RC programs and candidates across multiple solid tumor types. Just as importantly, the transaction provides AstraZeneca with Fusion’s specialized R&D capabilities, manufacturing infrastructure, and actinium-225 supply chain specifically tailored for developing these next-wave radiotherapeutics.
This strategic acquisition doubles down on AstraZeneca’s burgeoning radio-isotope therapy initiatives. The pharma giant already has a collaboration with Fusion exploring lung cancer applications using one of its RC molecules. By bringing Fusion’s RC therapy capabilities fully in-house, AstraZeneca can now swiftly integrate and scale up this cutting-edge treatment modality across its industry-leading oncology portfolio.
For Fusion investors, the buyout represents a lucrative exit at a substantial premium, especially compared to the company’s $300 million market cap prior to deal reports. While always bittersweet to see a promising biotech get absorbed, Fusion’s technology and team are now set to be fueled by abundant AstraZeneca resources in pursuing RC breakthroughs.
The transaction, expected to close in Q2 2024 pending customary approvals, foreshadows a future where RCs could potentially supplant chemotherapy and radiotherapy as more precise, less toxic foundational cancer regimens. While still an emerging field, AstraZeneca’s bold multi-billion dollar investment signals its confidence in harnessing RCs’ unique advantages over traditional oncology treatments.
As AstraZeneca executes an ambitious pivot toward next-generation RC therapies, biotech and pharma investors would be wise to monitor this rapidly evolving space. The acquisition of Fusion continues to position the pharma titan at the vanguard of replacing archaic cancer protocols with targeted radioconjugate precision medicines.
Novartis made a big move this week to expand its oncology portfolio, announcing plans to acquire German biotech MorphoSys in an all-cash deal valued at approximately $2.9 billion. The proposed acquisition continues Novartis’ strategy of striking deals and partnerships to enhance its drug development capabilities, especially in cancer.
Under the terms of the agreement, Novartis will pay $73 per share to purchase all outstanding ordinary shares of MorphoSys, representing a premium of 37% over the biotech’s closing price on February 3rd. The deal has been unanimously approved by MorphoSys’ board and is expected to close in the first half of 2024, pending regulatory and shareholder approval.
Driving Novartis’ interest is MorphoSys’ lead pipeline candidate pelabresib, an investigational BET inhibitor being studied for myelofibrosis. Myelofibrosis is a type of bone marrow cancer that disrupts the body’s normal production of blood cells.
Pelabresib is currently in the Phase 3 MANIFEST-2 trial in combination with Incyte’s Jakafi for first-line myelofibrosis patients. While the trial posted mixed results in November, Novartis believes the data support a regulatory submission in the second half of 2024. The pharma giant sees pelabresib as having potential to be a “practice changing” myelofibrosis treatment.
Beyond pelabresib, MorphoSys brings other early-stage oncology assets that could strengthen Novartis’ position in blood cancers. However, the crown jewel of MorphoSys’ portfolio – its approved non-Hodgkin’s lymphoma drug Monjuvi – is not included in the acquisition. Just before the Novartis deal was announced, MorphoSys sold the global rights to Monjuvi to Incyte for $1.5 billion.
Novartis has been actively hunting for new drug programs and technology platforms to replenish its pipeline as patents expire over the next decade on blockbuster brands like Cosentyx and Entresto. The patent cliff threatens over 50% of Novartis’ current sales.
In 2022, the pharma giant established a $1 billion fund to invest in startups focused on potentially transformational medicines. It has also been open to large M&A, as seen last year with the $20.7 billion purchase of gene therapy biotech The Medicines Company.
The MorphoSys deal reinforces Novartis’ commitment to growing its oncology division, which accounted for over 30% of total sales in 2023. Earlier this year, Novartis acquired the oncology biotech Calypso for $335 million upfront.
From an investor perspective, the MorphoSys acquisition provides Novartis with multiple shots on goal in blood cancers. If pelabresib hits, it could generate peak sales above $1 billion annually according to analysts. And with MorphoSys trading at multi-year lows, Novartis appears to have struck at an opportune time.
However, the mixed clinical data keeps pelabresib’s commercial prospects uncertain. And with most of MorphoSys’ value residing in the newly divested Monjuvi, it remains to be seen if Novartis overpaid. Investors reacted with caution on Tuesday, with Novartis shares falling 1% on news of the acquisition.
But with MorphoSys providing additional expertise in hematology R&D and a foothold in the German biotech scene, Novartis can justify the deal as a strategic move to reinforce oncology leadership. The pharma giant has the resources to continue its shopping spree, with around $9 billion in annual free cash flow.
If Novartis can successfully integrate MorphoSys’ personnel and drug candidates into its pipeline, while achieving cost synergies, the acquisition could pay dividends over time as new oncology drugs emerge. But executing large M&A successfully is always challenging, and investors will watch closely how Novartis leverages its new MorphoSys assets.
Mark your calendars! Don’t miss Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference on April 17-18. This exclusive virtual event connects investors with 50 leading public biotech, healthcare services, and medical device companies. Presenting company slots are available…Read More
The New Year has kicked off with a bang in biotech, as CG Oncology has completed the first initial public offering in the space for 2024. The cancer-focused biotech raised a whopping $380 million in its IPO on the Nasdaq, sailing past its initial target range of $181 million.
CG Oncology priced its shares at $19 apiece, above the $16-18 range it had set ahead of the IPO. The impressive deal is being viewed by many analysts and investors as a positive indicator that the biotech IPO market is rebounding in 2024 after a relatively slow 2023.
The robust demand for CG Oncology stock reflects renewed optimism and openness to investing in early-stage biotech companies, especially those with innovative science and strong leadership teams.
CG Oncology is developing a novel oncolytic virus therapy known as cretostimogene grenadenorepvec for the treatment of non-muscle invasive bladder cancer. Oncolytic viruses represent an exciting new approach in cancer treatment, wherein specially engineered viruses are able to infect and destroy cancer cells directly while also stimulating anti-tumor immune responses.
Cretostimogene grenadenorepvec is an adenovirus that has been engineered to replicate selectively in bladder cancer cells and stimulate the immune system by expressing granulocyte-macrophage colony-stimulating factor (GM-CSF). Early stage clinical data have shown promising signs of efficacy.
The company plans to use the IPO proceeds to fund a Phase 3 clinical trial of its lead candidate as well as earlier stage pipeline programs. Success in the Phase 3 study could support regulatory approval and commercialization.
CG Oncology was founded in 2018 by a veteran team of biotech entrepreneurs and scientists. The company pursued a pre-IPO crossover financing round in 2022, enabling it to build momentum heading into its public debut.
The IPO success places CG Oncology in a strong position to advance its pipeline. With the influx of capital, the company will be able to aggressively pursue its clinical development plans without relying heavily on external partners.
Moreover, the validation and visibility provided by being a public company can potentially help CG Oncology forge productive collaborations and access additional funding in the future.
Looking ahead, the positive investor response to CG Oncology seems likely to pave the way for more biotech IPOs in 2024. A robust IPO market provides fuel for innovation and discoveries that can transform patient lives.
The biotech sector sputtered in 2022, with only around 20 IPOs completed versus more than 50 in 2021. However, sentiment appears to be shifting, perhaps signaling sunnier days ahead.
In addition to favorable market conditions, biotech companies pursuing IPOs seem to be taking valuable lessons from 2022 by tightening focus on fundamentals like drug efficacy and visibility on clinical milestones.
Other than CG Oncology, a host of biotechs have already filed with SEC intentions to go public in 2024, spanning exciting areas like gene therapy, neurology, and synthetic biology.
With fresh capital and investor enthusiasm, the next generation of biotech companies can pursue ambitious goals to develop innovative medicines. More early-stage companies may also gain the funding needed to initiate or advance clinical trials.
CG Oncology’s big IPO pop reflects the right combination of cutting-edge science, unmet medical need, and strong leadership. This formula will likely be replicated by other emerging biotech stars in the making.
In all, the successful CG Oncology IPO kicks off 2024 as a promising year for biotech funding, innovation, and progress against once intractable diseases. Investors and industry observers will be tracking the IPO market closely through the year for signs of sustained momentum. If the appetite for compelling biotech stories persists, it could drive a much-needed renaissance helping to unlock new medical frontiers.
Mark your calendars! Don’t miss Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference April 17-18. This exclusive virtual event connects investors with 50 leading public biotech, healthcare services, and medical device companies. Presenting company slots are available.
Cancer research is rapidly evolving thanks to innovative biotech companies utilizing cutting-edge technology like artificial intelligence. One company at the forefront of this biotech revolution is Evaxion Biotech, which is developing novel personalized cancer vaccines powered by its proprietary AI platform.
As highlighted in a recent company press release, Evaxion is expanding its cancer vaccine pipeline to target a new class of AI-discovered tumor antigens called endogenous retroviruses (ERVs). ERVs are remnants of ancient viruses in our DNA that are often abnormally activated in cancer cells, making them visible targets for cancer vaccines.
Evaxion’s focus on ERV-based vaccines represents a breakthrough, transformative concept in cancer treatment. The company’s AI technology allows for identification of the most relevant ERV targets from patient genomic data, enabling truly personalized cancer vaccines.
Such precision vaccines could provide solutions for cancer patients unresponsive to current immunotherapies like checkpoint inhibitors. Evaxion aims to expedite development of this personalized vaccine approach, with initial proof-of-concept studies beginning mid-2024.
Evaxion’s pivot to ERV-based vaccines is powered by its proprietary AI platform, AI-Immunology. This technology integrates advanced computational models that can decode the complexity of the human immune system’s interaction with cancer.
AI-Immunology allows rapid prediction and design of novel immunotherapy candidates. This is lightyears beyond traditional vaccine discovery dependent on lengthy trial-and-error experiments.
Evaxion’s AI technology provides a holistic, personalized approach to identify the most relevant targets and optimal vaccine strategies for each patient. This is key for developing effective cancer immunotherapies against the incredible heterogeneity seen across tumors and patients.
AI-Immunology represents a scalable, adaptable platform that can be applied to infectious diseases as well. Evaxion is also pursuing viral and bacterial vaccines powered by its AI discovery engine.
Evaxion aims to accelerate innovation of its AI-discovered cancer vaccines. As indicated in its recent press release, the company has already initiated preclinical ERV vaccine studies, with plans for early proof-of-concept data by mid-2024.
This represents a rapid timeline from discovery to initial validation, enabled by AI-Immunology’s predictive modeling capabilities. Evaxion notes there is already significant interest around its ERV vaccine concept, which may help attract partners and investment to further accelerate development.
The company’s expedited progress exemplifies the ability of emerging biotech firms to move quickly from ideas to validation. Unencumbered by legacy infrastructure, these agile startups can transition discoveries into the clinic at unprecedented speed.
Investment Commentary
Evaxion’s pioneering AI platform and progress on its cancer vaccine pipeline highlights the compelling investment opportunities in emerging biotech companies.
These small firms offer differentiated technologies like AI-Immunology that enable transformative innovation not easily captured within larger pharmaceutical companies. First-mover advantage allows rapid value creation.
However, biotech investment carries significant risk. Clinical failures remain high across the industry. Diversification across a basket of emerging firms helps mitigate risks.
The conference provides access to executive management teams from over 50 public microcap companies in the biotech, healthcare, and medical devices sector. It represents an excellent opportunity for exposure to innovative companies shaping the future of healthcare.
Biotech Revolution
We are in the midst of a biotechnology revolution led by innovative emerging firms. New technologies like AI and genomic profiling are unlocking unprecedented insights into disease biology and enabling personalized therapeutics.
Evaxion’s focus on AI-powered cancer vaccines represents just one example of transformative innovation occurring in the biotech sector. Other areas of rapid progress include gene therapies, cell therapies, targeted oncology treatments, and more.
Driven by these technological breakthroughs, the pace of biopharmaceutical advancement today is unprecedented. Venture capital investment in U.S. biotech startups hit record levels in 2021, topping $30 billion across over 1,000 deals.
Careful selection of companies with differentiated technologies like Evaxion’s AI platform can yield exciting returns. Ongoing evaluation of clinical execution remains key, as early scientific promise must still translate to real-world efficacy.
Overall, the biotech arena offers fertile ground for investment in innovation. The upcoming Noble Capital Markets Virtual Healthcare Conference highlights the wealth of emerging firms driving the biotechnology revolution.
Pharmaceutical giant Eli Lilly is expanding its cancer treatment portfolio into a promising new area by acquiring POINT Biopharma, a company developing radioactive drugs that precisely target tumors, for $1.4 billion.
POINT specializes in radioligand therapies, an emerging approach to cancer treatment that uses radioactive particles linked to molecules that bind to receptors on cancer cells. This enables the radiation to selectively kill tumors while limiting damage to healthy tissue.
Lilly is paying $12.50 per share in cash for POINT, an 87% premium over the stock’s latest closing price. The deal will give Lilly control of POINT’s pipeline of radioligand therapy candidates, which includes two late-stage experimental drugs.
One drug, PNT20021, targets prostate cancer tumors by binding to a protein called PSMA. Study data expected later this year will show whether it extends the lives of men with metastatic castration-resistant prostate cancer.
The other late-stage drug, PNT20031, homes in on neuroendocrine tumor cells via their somatostatin receptors. It may provide a new option for patients with advanced gastroenteropancreatic neuroendocrine tumors.
Beyond these lead programs, POINT has several earlier stage radioligands in development for cancers of the breast, lung, and brain. Lilly gains full access to progress these toward human testing.
The deal also gives Lilly two specialized facilities Point has built to produce and research radioligands. Manufacturing the drugs involves linking medical radioisotopes like actinium-225 to the targeting molecules, which requires nuclear expertise.
Jacob Van Naarden, head of Lilly’s oncology division, touted the promise of radioligands to safely destroy cancer while avoiding the side effects of traditional chemo. “We are excited by the potential of this emerging modality,” he said.
Lilly has been growing its cancer treatment business in recent years through deals for other firms’ drug candidates and technologies. The POINT acquisition similarly expands Lilly’s footprint into an area well-suited for precision medicine.
The U.S. Food and Drug Administration has already approved over a half dozen radioligand therapies from Lilly competitors like Novartis. Their success is driving a surge of investment and deal-making in the radiopharmaceutical field.
But analyst Geoffrey Porges of SVB Securities thinks Lilly overpaid for POINT. “We believe the valuation fails to reflect the very high risks inherent in drug development,” he wrote in a note to investors.
Porges added that Lilly may need to invest over $2 billion more to fully develop POINT’s pipeline over the next 5-7 years, with no certainty the drugs will pan out.
Lilly expects the acquisition to close by the end of 2023 after gaining required antitrust and regulatory approvals. The majority of POINT shareholders also must tender their shares as part of the agreement.
The deal marks Lilly’s second major oncology purchase in 2022. It paid $1.1 billion earlier in the year access to cancer drug candidates from China’s Zymeworks. With POINT, Lilly is now positioned as a leader across multiple next-wave approaches in the high-stakes race to develop better cancer treatments.
Mainz Biomed (NASDAQ:MYNZ) announced highly positive results this week from its ColoFuture clinical trial evaluating the integration of novel mRNA biomarkers into its ColoAlert screening test for colorectal cancer. The results demonstrated ColoAlert’s strong performance for detecting colorectal cancer and advanced adenomas, while also identifying promising biomarkers to further improve early detection capabilities.
The ColoFuture study is a multi-center international trial assessing whether integrating recently acquired mRNA biomarkers from Université de Sherbrooke can enhance ColoAlert’s sensitivity and specificity profile. ColoAlert is Mainz’s flagship product, a simple yet highly accurate home-based test using stool samples to detect colorectal cancer and advanced precancerous adenomas.
The product is already commercialized across Europe and select international territories. However, ColoFuture aimed to identify ways to further extend ColoAlert’s technical capabilities in preparation for an upcoming U.S. clinical trial that could lead to FDA approval.
Interim analysis from the ColoFuture trial included 220 subjects across centers in Germany, Norway and Denmark. On the primary endpoints for colorectal cancer detection, ColoAlert achieved 94% sensitivity and 97% specificity after integrating the novel mRNA biomarkers.
For identifying advanced adenomas, a key precursor to cancer, the updated test demonstrated 81% sensitivity. According to Mainz Biomed CEO Guido Baechler, “The power to detect lesions in a pre-cancerous stage can change the entire CRC diagnostic landscape. If advanced adenomas are identified early, they are curable.”
The positive data catalyzed strong trading volume as Mainz Biomed’s stock price rose 15% on over 1.5 million shares traded. The market enthusiastically welcomed the results.
The mRNA biomarkers evaluated in ColoFuture were specifically selected from research at Université de Sherbrooke. Published analysis of the biomarkers showed ability to detect signals from patients with either colorectal cancer or advanced adenomas. Mainz Biomed acquired these biomarker rights in January 2022.
By treating patients before polyps progress to cancer, integrating these biomarkers into ColoAlert could help prevent colorectal cancer altogether. This could greatly improve patient outcomes and reduce the burden of this deadly disease.
The positive data provides validation of ColoAlert’s accuracy as a non-invasive screening tool. It also gives Mainz Biomed multiple novel mRNA biomarkers to integrate into its upcoming U.S. clinical trial, dubbed ReconAAsense, which could support FDA approval under the PMA pathway.
According to Baechler, “As we look forward to publishing and presenting the full dataset, we eagerly await the outcome from our ReconAAsense clinical trial which remains on track to report results in Q4 of this year.”
With colorectal cancer remaining a leading cause of cancer deaths, early detection is critical. ColoAlert offers a simple, at-home solution that people can easily incorporate into routine wellness screenings. The new biomarkers identified in ColoFuture could make the test accessible to even more patients.
Mainz Biomed continues to spearhead innovation in the field, leveraging the latest advances in genetics to improve detection. The impressive ColoFuture results provides further validation of ColoAlert’s accuracy, while also charting a path forward to commercialization in the U.S.
With pivotal FDA trial data on the horizon, Mainz Biomed is positioned to disrupt the market, offering an easy yet cutting-edge approach to potentially save lives through early colorectal cancer detection.
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations. AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BMCA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com.
Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Merger Combines Cash And Phase 2/3 Product. Ayala has agreed to merge with Advaxis, Inc. (ADXS, $2.37, Not Rated), with Ayala shareholders owning 62.5% and Advaxis shareholders owning 37.5% of the newly combined company. Importantly, Advaxis had $28.2 million on July 31, 2022, which we believe will allow continuation of the RINGSIDE Phase 2/3 trial in desmoid tumors.
Combined Company Will Have A Late Stage Product and An Immunotherapy Technology. The new company will have funding to move AL102 forward and to continue development of Advaxis’ proprietary Lm platform for antigen delivery. This platform is based on its proprietary technology using a modified bacteria, Listeria monocytogenes, for delivering antigens to stimulate the immune system against tumors. Advaxis ADXS-504 is in a dose-finding Phase 1 study for prostate cancer.
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.
Merger brings U.S. management and presence, cash to develop compelling late-stage asset
Lead candidate AL102 being evaluatedin ongoing Phase 2/3 RINGSIDE study, a potential registration trial in desmoid tumors
Ayala and Advaxis stockholders will respectively own approximately 62.5% and37.5%
Combined Company to Seek Uplisting to Nasdaq
Conference Call and Webcast today at 8:00am ET
REHOVOT, Israel and WILMINGTON, Del. and MONMOUTH JUNCTION, N.J., Oct. 19, 2022 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA) (Ayala), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare tumors and aggressive cancers and Advaxis, Inc. (OTCQX: ADXS) (Advaxis), a biotechnology company devoted to the discovery, development and commercialization of immunotherapies based on a technology which uses engineered Listeria monocytogenes, today announced that they have entered into a definitive merger agreement. The merger would result in a combined company that will focus predominantly on the development and commercialization of Ayala’s lead program AL102 for the treatment of desmoid tumors and Advaxis’s candidate ADXS-504 in development for prostate cancer.
Kenneth A. Berlin, President and Chief Executive Officer of Advaxis, said, “Advaxis took a thorough approach in our quest to find the right partner with the right products. This merger is expected to enhance Advaxis’s portfolio of clinical assets, with Ayala’s proprietary gamma secretase inhibitors that are being developed as targeted therapies for rare and aggressive tumors. Ayala’s lead candidate, AL102, is currently being investigated in the Phase 2/3 RINGSIDE study in desmoid tumors, which we believe will accelerate the stage of product development for the combined company dramatically. We are particularly excited about very promising interim data from RINGSIDE, which showed that AL102 monotherapy had meaningful anti-tumor activity with tumor shrinkage in the majority of patients that appeared to be deepening over time. The combined management team has extensive commercial and R&D experience, and we believe we have the cash to advance the combined portfolio through key milestones in 2023, including longer-term data from Part A of RINGSIDE, clarity on the registration path for AL101 in recurrent/metastatic adenoid cystic carcinoma (ACC) and initial clinical and PSA data from the Phase 1 trial of ADXS-504 in prostate cancer. We believe that this transaction will also help drive our efforts to return to a Nasdaq listing and enhance our ability to access capital.”
Roni Mamluk, Ph.D., President and Chief Executive Officer of Ayala commented, “We are pleased to announce the proposed merger with Advaxis, which is expected to provide our pipeline and AL102 with additional financial resources as well as additional infrastructure in the U.S. The two companies have a shared mission to develop innovative therapies to improve the lives of patients with cancer and I believe we have found a good partner to advance our pipeline and create value for our stakeholders.”
Additional Transaction Details
Subject to the terms and conditions of the merger agreement, at the closing of the merger, each outstanding share of Ayala common stock will be converted into the right to receive shares of common stock of Advaxis based on the exchange ratio set forth in the merger agreement. Upon completion of the merger, Ayala stockholders will own approximately 62.5% of the combined company’s outstanding common stock and Advaxis stockholders will own approximately 37.5%, subject to the terms of the merger agreement. Advaxis will, at the effective time of the merger, assume the outstanding restricted stock units and stock options of Ayala, subject to the terms of the merger agreement. No fractional shares will be issued in connection with the merger and Advaxis will pay cash in lieu of any such fractional shares. The merger is intended to qualify for U.S. federal income tax purposes as a tax-free reorganization under the provisions of Section 368(a) of the Internal Revenue Code of 1986, as amended.
Consummation of the merger is subject to certain closing conditions, including, among other things, approval by the stockholders of Ayala. At the closing of the merger, Ayala will be delisted from The Nasdaq Global Market. The combined company’s common stock is expected to begin trading on the OTCQX at the effective time of the merger, subject to Advaxis’ planned efforts to have the stock of the combined company listed on Nasdaq, as to which no assurances can be made.
Management and Board of Directors
At the effective time of the merger, the executive officers of the combined company will include Mr. Kenneth A. Berlin, President, Chief Executive Officer and Director; Andres Gutierrez, M.D., Ph.D., current Chief Medical Officer of Advaxis; and Igor Gitelman, Interim Chief Financial Officer of Advaxis. Roni Mamluk, Ph.D., Founder and Chief Executive Officer of Ayala, and Yossi Maimon, Chief Financial Officer of Ayala will resign their positions and will help with the transition. Gary Gordon, M.D., Chief Medical Officer of Ayala, will also resign his position but is expected to continue in an advisory role for a period of time. The board of directors of the combined company is expected to consist of seven members: two designated by Advaxis, four designated by Ayala, and Mr. Berlin.
Conference Call and Webcast
There will be a conference call and webcast at 8:00 a.m. Eastern Time today, Wednesday, October 19, 2022, with Advaxis and Ayala to discuss the merger and respond to questions.
Investors Dial: Int’l Investors Dial: Investors in Israel Dial: Conference ID:
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare tumors and aggressive cancers. Ayala’s approach is focused on predicting, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors, including adenoid cystic carcinoma (ACC) and desmoid tumors. AL102 has received Fast Track Designation from the U.S. FDA and is currently in the Phase 3 portion of a pivotal study for patients with desmoid tumors (RINGSIDE). AL101 has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations. For more information, visit www.ayalapharma.com.
About Advaxis, Inc.
Advaxis, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of proprietary Lm-based antigen delivery products. These off-the-shelf immunotherapies are a significant advancement in immunotherapy as they integrate multiple functions into a single therapy by directing antigen presenting cells to stimulate T-cells and other components of the immune system, while reducing tumor protection in the tumor microenvironment, facilitating the elimination of tumors. The company has two programs in the clinic: ADXS-503 for late-stage lung cancer and ADXS-504 for early-stage prostate cancer. To learn more about Advaxis, visit www.advaxis.com.
Advaxis: Tim McCarthy LifeSci Advisors, LLC tim@lifesciadvisors.com +1 917-679-9282
Important Information about the Merger and Where to Find It
This communication relates to a proposed transaction between Ayala Pharmaceuticals, Inc. (“Ayala”) and Advaxis, Inc. (“Advaxis”). In connection with the proposed transaction, Advaxis intends to file with the Securities and Exchange Commission (“SEC”) a registration statement on Form S-4 that will include a proxy statement of Ayala and that will constitute a prospectus with respect to shares of Advaxis’s common stock to be issued in the proposed transaction (“Proxy Statement/Prospectus”). Each of Ayala and Advaxis may also file other documents with the SEC regarding the proposed transaction. This document is not a substitute for the Proxy Statement/Prospectus or any other document which Ayala or Advaxis may file with the SEC. INVESTORS, AYALA STOCKHOLDERS AND ADVAXIS STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT ARE OR WILL BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND RELATED MATTERS. Investors, Ayala stockholders and Advaxis stockholders will also be able to obtain free copies of the Proxy Statement/Prospectus (when available) and other documents containing important information about Ayala, Advaxis and the proposed transaction that are or will be filed with the SEC by Ayala or Advaxis through the website maintained by the SEC at www.sec.gov. Copies of the documents filed with the SEC by Advaxis will also be available free of charge on Advaxis’s website at https://www.advaxis.com/financial-information/sec-filings or by contacting Advaxis’s investor relations department by email at ir@advaxis.com. Copies of the documents filed with the SEC by Ayala will also be available free of charge at https://ir.ayalapharma.com/financial-information/sec-filings or by contacting Ayala’s investor relations department by email at jallaire@lifesciadvisors.com.
Participants in the Solicitation
Ayala and Advaxis and certain of their respective directors and executive officers may be deemed to be participants in the solicitation of proxies in respect of the proposed transaction. Information regarding Ayala’s directors and executive officers, including a description of their direct or indirect interests, by security holdings or otherwise, is contained in Ayala’s proxy statement for its 2022 annual meeting of stockholders which was filed with the SEC on April 27, 2022. Information regarding Advaxis’s directors and executive officers, including a description of their direct or indirect interests, by security holdings or otherwise, is contained in Advaxis’s proxy statement for its 2022 annual meeting of stockholders which was filed with the SEC on February 28, 2022. Additional information regarding the direct and indirect interests of the participants in the solicitation of proxies in connection with the proposed transaction, including the interests of Ayala and Advaxis directors and executive officers in the transaction, which may be different than those of Ayala and Advaxis stockholders generally, will be contained in the Proxy Statement/Prospectus and any other relevant documents that are or will be filed with the SEC relating to the transaction. You may obtain free copies of these documents using the sources indicated above.
No Offer or Solicitation
This communication is not intended to and shall not constitute an offer to sell or the solicitation of an offer to buy or sell any securities or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Certain statements contained in this filing may be considered forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including statements regarding the proposed transaction involving Ayala Pharmaceuticals, Inc. (“Ayala”) and Advaxis, Inc. (“Advaxis”), the ability to consummate the proposed transaction, and the ability to list the common stock of the combined company on Nasdaq. 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,” and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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: (i) the risk that the conditions to the closing of the proposed transaction are not satisfied, including the failure to timely or at all obtain stockholder approval for the proposed transaction or the failure to timely or at all obtain any required regulatory clearances; (ii) uncertainties as to the timing of the consummation of the proposed transaction, the ability of each of Ayala and Advaxis to consummate the proposed transaction, and the ability of the combined company to meet the requirements to list its common stock on Nasdaq; (iii) the ability of Ayala and Advaxis to integrate their businesses successfully and to achieve anticipated synergies; (iv) the possibility that other anticipated benefits of the proposed transaction will not be realized, including without limitation, anticipated revenues, expenses, earnings and other financial results, and growth and expansion of the combined company’s operations, and the anticipated tax treatment of the combination; (v) potential litigation relating to the proposed transaction that could be instituted against Ayala, Advaxis or their respective directors; (vi) possible disruptions from the proposed transaction that could harm Ayala’s and/or Advaxis’s respective businesses; (vii) the ability of Ayala and Advaxis to retain, attract and hire key personnel; (viii) potential adverse reactions or changes to relationships with customers, employees, suppliers or other parties resulting from the announcement or completion of the proposed transaction; (ix) potential business uncertainty, including changes to existing business relationships, during the pendency of the proposed transaction that could affect Ayala’s or Advaxis’s financial performance; (x) certain restrictions during the pendency of the proposed transaction that may impact Ayala’s or Advaxis’s ability to pursue certain business opportunities or strategic transactions; (xi) legislative, regulatory and economic developments; (xii) unpredictability and severity of catastrophic events, including, but not limited to, acts of terrorism or outbreak of war or hostilities, as well as management’s response to any of the aforementioned factors; and (xiv) such other factors as are set forth in Ayala’s periodic public filings with the SEC, including but not limited to those described under the heading “Risk Factors” in Ayala’s Form 10-K for the fiscal year ended December 31, 2021, and Advaxis’s periodic public filings with the SEC, including but not limited to those described under the heading “Risk Factors” in Advaxis’s Form 10-K for the fiscal year ended October 31, 2021. Ayala and Advaxis can give no assurance that the conditions to the proposed transaction will be satisfied. Except as required by applicable law, Ayala and Advaxis 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.
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations. AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BMCA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com.
Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
KOL Event Reviewed AL102 and Desmoid Tumors. Ayala held a KOL webcast to discus AL102, its gamma secretase inhibitor, the current treatments for desmoid tumors, and AL102 clinical development. After reviewing the RINGSIDE Phase 2/3 Part A dose-finding data, we continue to believe AL102 has potential to succeed in the placebo-controlled Part B portion. We continue to rate the stock Market Perform due to the time required for the study and capital requirements.
Clinical Review. The presentations began with a clinical review of desmoid tumors, the mechanism of action for AL102, and the AL102 clinical studies. The RINGSIDE Phase 2/3 trial was designed in two parts, with Part A testing three regimens with different doses and administration schedules. Safety and tumor volume were evaluated at 16 weeks, and data used to select one dose for Part B. The results of Part A were announced in September 2022, with patients moving to an open label extension phase.
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.
