Tag: Cancer

Gilead Deepens Arcus Ties With $320M Investment to Accelerate Cancer Immunotherapy Pipeline

Posted on by slightbourne@noblecapitalmarkets.com

Gilead Sciences and biotech partner Arcus Biosciences announced Tuesday an amended collaboration to accelerate development of their cancer immunotherapy programs, along with a $320 million equity investment by Gilead.

The deal builds on the companies’ 2020 partnership and boosts Gilead’s ownership in Arcus to 33% through an additional stake purchase at $21 per share. Gilead also gains a third seat on Arcus’ board, having their Chief Commercial Officer Johanna Mercier join as a director.

Strategic Focus on TIGIT

A key change is prioritizing late-stage studies for the anti-TIGIT antibody domvanalimab, the lead candidate from the collaboration. Arcus CEO Terry Rosen stated the partners want to “leverage their strengths and focus on efficiently advancing novel combinations.”

Domvanalimab is progressing in Phase 3 for non-small cell lung cancer and gastric/GEJ cancer. By accelerating these pivotal studies, expected to fully enroll by year-end, the drug could reach approval sooner if successful.

However, they are discontinuing the ARC-10 Phase 3 lung cancer trial to devote resources to the other domvanalimab studies targeting greater unmet need.

This streamlining highlights the companies’ faith in TIGIT’s potential but the necessity to optimize their most promising assets. TIGIT is an emerging immunotherapy target and domvanalimab a next-gen asset, so focusing late-stage research is prudent.

Quemliclustat Now Solo Arcus Program

Meanwhile, the planned Phase 3 study of Arcus’ CD73 inhibitor quemliclustat in pancreatic cancer will become an Arcus-only program, no longer jointly developed.

Again the theme is concentrating human capital and financial resources where they can make the biggest difference. For smaller Arcus, independence for some programs provides flexibility.

Arcus can also now fully control projects beyond domvanalimab and their PD-1 drug zimberelimab, which Gilead has options to license. This benefits Arcus’ broader pipeline and product vision.

Extends Arcus Cash Runway

Importantly, the $320 million cash infusion lengthens Arcus’ funding horizon until 2027 by their estimates. This enables advancing Phase 3 quemliclustat and AB154 studies plus potential commercial launch activities without financing concerns.

Any biotech developing novel drugs without revenue benefits immensely from having ample cash reserves. This partly protects Arcus from market volatility and general biotech funding challenges.

Gilead Building a Powerhouse

For Gilead, the enhanced Arcus alliance adds another pillar to their ambitions cancer franchise. The pharma giant has been aggressively wheeling and dealing to expand in oncology, now a key growth area.

Recent moves include the $21 billion Immunomedics acquisition and purchases of companies like Tango Therapeutics, Dragonfly Therapeutics, and Epizyme. The Arcus pact leverages access to next-generation immunotherapy science and pipeline.

Gilead is constructing a vertically integrated oncology player combining in-house and external innovation. Scale and synergies across R&D, manufacturing, and commercialization can accelerate targeted therapies to patients.

With collaborators like Arcus doing the early lifting, Gilead can then optimize late-stage studies and apply their regulatory expertise to reach approvals more quickly.

Overall the amended Arcus agreement highlights Gilead’s commitment to cancer and immunology while bolstering their presence in cutting-edge research like TIGIT inhibition. With the investment and restructuring, Gilead strengthens ties to Arcus’ science while keeping the biotech funded and focused. For both, it’s a win-win accelerating cancer drugs to market.

noble capital markets emerging growth virtual healthcare equity conference

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

GC Oncology’s $380M IPO Kickstarts 2024 Biotech Market

Posted on by slightbourne@noblecapitalmarkets.com

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.

Biotech Innovation: Emerging Cancer Vaccines and Investment Potential

Posted on by slightbourne@noblecapitalmarkets.com

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.

This innovation exemplifies the vast potential of emerging biotech companies to disrupt the cancer treatment landscape. Smaller firms like Evaxion can leverage cutting-edge technology like AI to uncover completely new therapeutic targets and strategies.

Powered by AI-Driven Discovery

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.

Other emerging biotech firms are also investing in AI-driven drug development, including companies like Recursion Pharmaceuticals, Exscientia, Insitro, and Valo Health. The massive potential of AI is transforming biopharmaceutical R&D.

Accelerating Innovation

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.

For investors interested in growth opportunities in small-cap biotech companies, the upcoming Noble Capital Markets Virtual Conference on April 17-18th features presentations from emerging healthcare and biotech companies.

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.

The industry is positioned for continued expansion as emerging firms translate discoveries into new medicines. For investors, the high-growth biotech sector warrants attention despite its inherent risks.

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.

Bristol Myers Squibb $4.1B RayzeBio Buyout

Posted on by slightbourne@noblecapitalmarkets.com

Pharma giant Bristol Myers Squibb (BMY) announced Tuesday that it will acquire clinical-stage biotech RayzeBio for $4.1 billion, continuing Bristol’s strategy of deals to refresh its drug pipeline amid upcoming patent expirations.

RayzeBio is developing a novel targeted radiotherapy called RYZ101 to treat multiple types of cancer. The company’s technology combines tumor-targeting antibodies with radioactive isotope payloads that selectively damage cancer cells’ DNA when delivered.

RYZ101 is currently in Phase 3 testing for treating metastatic castration-resistant prostate cancer. Early clinical data showed promising results with the drug demonstrating tumor response rates of 44-55%.

Bristol gains full rights to RYZ101 and RayzeBio’s broader platform for linking radioisotopes to cancer-fighting proteins. The deal gives Bristol a potential new blockbuster cancer treatment as competition intensifies in the immuno-oncology space.

Shoring Up the Cancer Business

Bristol already markets leading cancer immunotherapies Opdivo and Yervoy. However, Opdivo faces patent expiration in 2028/2031, forcing Bristol to find new long-term growth drivers.

The RayzeBio deal comes right after Bristol announced the $13.1 billion acquisition of schizophrenia drug developer Karuna Therapeutics last Friday. Karuna’s lead drug KarXT could generate peak annual sales of over $3 billion, analysts project.

These acquisitions help future-proof Bristol’s business as its top-selling drugs face new competition. Blood thinner Eliquis, which makes up over 30% of Bristol’s revenue, will see biosimilar rivals by 2026. Cancer drug Revlimid, acquired in Bristol’s 2019 buyout of Celgene, faces generics soon too.

“We are focused on strengthening our portfolio through a combination of internal programs and targeted business development,” said Bristol Myers CEO Giovanni Caforio. The RayzeBio and Karuna deals “complement our existing pillars of growth,” he added.

Betting Big on Radio-Pharmaceuticals

In addition to RYZ101’s potential, Bristol gains RayzeBio’s expertise with radio-pharmaceuticals. Attaching radioactive particles to antibodies allows them to precisely pinpoint tumor cells and kill them via DNA damage.

RayzeBio’s technology overcomes past challenges with radio-drugs such as lack of tumor specificity and rapid decay of radioisotopes. Linking radioisotopes to robust antibodies circumvents these issues and improves the drugs’ efficacy.

Analysts see radio-pharmaceuticals as an emerging trend in oncology. Radio-immunotherapies like RayzeBio’s could complement immuno-oncology drugs that activate the immune system against cancer.

By acquiring RayzeBio’s platform, Bristol can expand development of new radio-drug conjugates across its oncology pipeline. Bristol may also look to license out the technology to other companies given the heightened industry interest.

An Expensive Acquisition

Bristol is paying a huge premium to acquire RayzeBio before the biotech can prove RYZ101’s efficacy in late-stage testing. The $4.1 billion price tag works out to $62.50 per share, more than double RayzeBio’s prior closing price.

But Bristol likely wanted to preempt competition for the promising biotech asset. Amgen and Novartis are also developing radio-pharmaceutical drugs for cancer. And RayzeBio would have commanded an even higher valuation had RYZ101 succeeded in Phase 3.

Bristol expects the acquisition will reduce its adjusted earnings by about 13 cents per share in 2024. But Bristol maintained its existing profit guidance for 2022 and 2023, implying confidence the long-term benefits outweigh the near-term costs.

The company plans to finance the purchase using new debt. Bristol’s strong cash flows should allow it to service the additional debt load as it waits for RYZ101 to potentially reach the market around 2025.

Conclusion: Bolstering Its Firepower

The back-to-back deals for Karuna Therapeutics and RayzeBio showcase Bristol Myers Squibb’s strategy to acquire new therapies and drug platforms that can drive growth over the next decade. While expensive, these acquisitions reduce Bristol’s reliance on aging blockbuster drugs facing patent cliffs.

Gaining Karuna’s potential multi-billion dollar schizophrenia medicine and RayzeBio’s cutting-edge radio-pharmaceutical technology gives Bristol valuable new firepower to deploy in the fiercely competitive pharma market. If successful, the deals will ensure Bristol Myers remains an industry leader as it confronts upcoming challenges from biosimilar and generic competition.

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

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

Posted on by cpereira@noblefcm.com


Wednesday, December 13, 2023

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

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

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

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

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


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

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

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

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

Posted on by cpereira@noblefcm.com


Wednesday, November 15, 2023

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

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

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

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

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


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

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

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

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

Posted on by cpereira@noblefcm.com


Wednesday, November 15, 2023

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

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

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

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

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


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

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

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

PDS Biotechnology Corp. (PDSB) – Triple Therapy Data Shows Benefits That Far Exceed Published Studies

Posted on by cpereira@noblefcm.com


Friday, November 10, 2023

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

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

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

Triple Therapy Trial Results Show Much Longer Survival In HPV-Positive Cancer. PDS announced data from the Triple Therapy Combination conducted by the NCI (National Cancer Institute of the National Institutes of Health). This trial tested the combination of PDS0101, the tumor-targeted IL-12 derivative PDS0301, and a checkpoint inhibitor to give three mechanisms of action against HPV-positive cancers. While the patient sample is small, these results far exceed survival seen in published studies.

Results Shows Significant Improvements Over Expectations. Final survival data from the patients that had no previous therapy with immune checkpoint inhibitors (ICI naïve patients) showed 6 out of 8 (75%) of the patients alive at 36 months, compared with published studies with about 30% to 50% alive at 12 months and less than 30% alive at 24 months. Median overall survival for the ICI naïve patients has not been reached. 


Get the Full Report

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

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

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

Cargo Therapeutics Positions for One of 2023’s Largest Biotech IPOs

Posted on by slightbourne@noblecapitalmarkets.com

Cargo Therapeutics is gearing up for an initial public offering (IPO) that could be one of the biggest biotech listings in 2023. The cancer-focused gene therapy startup aims to raise around $300 million through the sale of 18.75 million shares priced between $15 to $17.

If successful, it would be a rare bright spot in an otherwise dreary IPO market for life science companies this year. Cargo’s offering comes at a time when biotech IPOs have slowed to a trickle amid volatile market conditions.

The company is developing CRG-022, an experimental CD22 CAR-T therapy for certain blood cancers. Cargo’s candidate takes a patient’s own T-cells and engineers them to target and kill cancerous B-cells expressing the CD22 antigen.

Cargo hopes CRG-022 can benefit patients with large B-cell lymphoma who have failed previous CD19 CAR-T treatment. It initiated a potentially pivotal Phase 2 trial for this population in September. Data from the study could support regulatory approval in 2025.

Beyond blood cancers, Cargo intends to study CRG-022 in solid tumors expressing CD22. This includes some forms of breast, lung, colorectal and liver cancers. The company believes its therapy may demonstrate activity in a wider range of advanced cancers than existing CAR-Ts.

Proceeds from the IPO will help fund Cargo’s clinical programs and earlier R&D. According to its SEC filing, the company had $42.4 million in cash at the end of June 2022 but accumulated losses exceeding $77 million. The capital infusion will provide runway through the expected interim Phase 2 data readout.

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

Cargo’s offering will be a key test of investor appetite for preclinical biotech IPOs. These platform companies developing multiple experimental drugs based on a core technology have fallen out of favor recently.

However, Cargo could attract more interest with CRG-022 already in mid-stage testing and potential for near-term commercialization. The FDA has approved several CAR-T cell therapies over the past five years, providing a regulatory pathway for followers like Cargo.

But biotech IPOs in general face challenges in the current environment. Volatility, rising interest rates, and recession fears have rocked stock markets in 2022. Biotech has been among the hardest hit sectors, with the Nasdaq Biotech Index down over 30% year-to-date.

Companies pursuing IPOs have been forced to scale back valuations and offering sizes. Those that do list are often trading below issue price. So far in 2022, only around 15 biotechs have braved public markets compared to 60+ in recent years.

Yet some experts believe companies with innovative therapies and strong data can still obtain IPO financing. Cargo will provide a barometer of latent investor demand for biotech offerings amid the downturn.

A successful IPO could potentially reinvigorate biotech’s depressed financing environment. It may encourage other firms contemplating IPOs to move forward with planned deals.

Conversely, a lackluster response would signal biotech IPOs remain out-of-favor for now. This could lead companies to instead pursue private financing to advance programs and extend runways.

In any case, Cargo’s listing will generate insight into the health of biotech capital markets. The deal’s performance could significantly influence investment decisions and sentiment around the battered sector heading into 2023.

All eyes will be on whether one of biotech’s most promising young companies can buck the prevailing IPO trends. Cargo’s offering will help determine if the window for issuance might finally be opening back up.

Onconova Therapeutics (ONTX) – Rigosertib Data Presented In Ultra-Rare Disease

Posted on by cpereira@noblefcm.com


Friday, October 13, 2023

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

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

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

Rigosertib Data In RDEB-SCC Presented. Onconova presented data from an Investigator-initiated trial (IIT) testing rigosertib in RDEB-associated SCC (recessive dystrophic epidermolysis bullosa associated with squamous cell carcinoma), an ultra-rare but fatal disease with no effective treatment. The data was presented at the European Academy of Dermatology and Venereology (EADV) in Berlin. Results showed complete remission for 2 of the 4 patients tested for over 12 months with one patient still in treatment.

RDEB-SCC Is A Rare But Fatal Disease. RDEB-SCC is an ultra-orphan disease in which mutations in the genes for collagen VII result in structural abnormalities in the skin. This results in fragile skin with failure of the epidermal layer to anchor properly, causing severe blisters and a cycle of chronic injury. The development of squamous cell carcinoma (SCC) often causes death by age 45. Tumors in RDEB-SCC were found to be sensitive to inhibition of an enzyme involved in cell cycle regulation known as PKL-1 (polo-like kinase-1). Rigosertib is an inhibitor of  PLK-1 and was selected for the ITT trial.


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

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

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

PDS Biotechnology Corp. (PDSB) – Data For PDS0301 Phase 1/2 To Show Immune Response and Safety Data

Posted on by cpereira@noblefcm.com


Thursday, October 12, 2023

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

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

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

First PDS 0301 Prostate Cancer Data To Be Presented. PDS Biotech announced that data from a Phase 1/2 study testing PDS0301 in combination with docetaxel to treat prostate cancer will be presented by National Cancer Institute (NCI) scientists at the Cytokines 2023 meeting on October 15-18. This combination uses PDS0301 with docetaxel to stimulate an immune response and kill the cancer cells. Preliminary data from the trial shows increases in populations of immune cells, pro-inflammatory cytokines, and decreases in PSA levels.

Preliminary Results Show Immune Stimulation With Tolerability. The presentation includes 18 patients with metastatic castrate resistant prostate cancer (mCRPC, n=11) and sensitive prostate cancer (mCRPC, n=7). Patients received one of three dose levels tested in combination with a standard dose of docetaxel every three weeks. Results showed decreases in PSA ranging from -4% to -100%, with increases in CD4 and CD8 immune cells. Cytokines INF-gamma and IL-10 were increased, with decreases in the Treg (suppressive regulatory) cells. These responses are consistent with our expectations for an effective immune response.


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

Bristol Myers Squibb to Acquire Mirati Therapeutics for $4.8 Billion

Posted on by slightbourne@noblecapitalmarkets.com

Pharma giant Bristol Myers Squibb (BMY) announced today that it will acquire clinical-stage biotech Mirati Therapeutics (MRTX) for $58 per share in an all-cash deal totaling $4.8 billion. Mirati stockholders will also receive a contingent value right worth up to $12 per share, bringing the total potential deal value to $5.8 billion.

The acquisition will expand Bristol Myers Squibb’s oncology portfolio and pipeline. Mirati’s lead asset is KRAZATI (adagrasib), the first and only FDA-approved drug targeting the KRAS G12C mutation. KRAS mutations occur in about 13% of non-small cell lung cancers (NSCLC) and are linked to poor prognosis.

KRAZATI was granted accelerated approval in October 2022 as a second-line treatment for KRAS G12C-mutated NSCLC. It is also being tested in combination with a PD-1 inhibitor as a potential first-line NSCLC therapy. Beyond lung cancer, KRAZATI has shown promise in colorectal and pancreatic cancers.

“With multiple targeted oncology assets including KRAZATI, Mirati is another important step forward in our efforts to grow our diversified oncology portfolio,” said Bristol Myers CEO Giovanni Caforio. The company aims to leverage its global commercial infrastructure to maximize KRAZATI’s reach.

Mirati’s earlier-stage pipeline includes MRTX1719, an innovative PRMT5 inhibitor, as well as several KRAS-targeted agents. MRTX1719 could be the first targeted therapy for MTAP-deleted tumors, which represent about 10% of cancers.

“Bristol Myers Squibb’s global scale, resources and commitment to innovation will enable Mirati’s therapeutics to benefit more patients, faster,” said Mirati CEO Charles Baum.

Strategic Fit

Lung cancer is the most common cancer and leading cause of cancer death globally. The addition of KRAZATI establishes Bristol Myers as a leader in developing targeted lung cancer therapies. Mirati also expands Bristol Myers’ presence in colorectal and pancreatic cancers.

The acquisition builds on Bristol Myers’ recent deals for Turning Point Therapeutics and Eisai’s oncology business. As patents expire for the pharma giant’s top-selling cancer immunotherapy Opdivo, it aims to refill its oncology pipeline.

“With a strong strategic fit, great science and clear value creation opportunities for our shareholders, the Mirati transaction is aligned with our business development goals,” said Caforio.

Broader Biopharma Implications

The blockbuster Mirati acquisition also has significant implications for the broader biotech and biopharma sector. As large pharmas look to replenish pipelines, M&A activity has intensified. The deal shows that promising clinical-stage biotechs with innovative oncology pipelines continue to be attractive buyout targets.

Analysts note the 52% buyout premium Bristol Myers paid as a sign of their urgency to tap into Mirati’s next-gen oncology science. For startup biotechs pursuing novel approaches in high-value areas like oncology, it underscores the possibility of commanding large premium buyouts from “big pharma” acquirers.

However, smaller players also face the risk of being squeezed out as consolidation accelerates. The Mirati deal exemplifies the scaling up required to compete in cutting-edge areas like targeted cancer therapies. Smaller biotechs could find it increasingly difficult to independently develop and commercialize new drugs in the future.

That said, smaller biotechs may also benefit from big pharma’s growing appetite for M&A. The premiums being offered for innovative science and pipelines create lucrative exit opportunities for startups. And the influx of capital from buyouts can fund the next generation of biotech innovation.

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

Deal Terms

Under the definitive agreement, Bristol Myers will pay $58 per share for Mirati’s outstanding common stock. This represents a 52% premium over Mirati’s 30-day volume-weighted average price. Including Mirati’s $1.1 billion cash balance, the total equity value comes to $4.8 billion.

Each Mirati shareholder will also receive a CVR worth up to $12 per share. This contingent value right payment is triggered if Mirati’s MRTX1719 is approved within 7 years as a NSCLC therapy after two or fewer systemic treatments. The CVR adds up to $1 billion in potential additional value.

The transaction is expected to close in the first half of 2024, pending approval from regulators and Mirati shareholders. Bristol Myers anticipates the deal will be dilutive to its non-GAAP earnings through 2025 as it integrates Mirati. It plans to finance the acquisition through cash and debt offerings.

Caforio stated: “With a strong strategic fit, great science and clear value creation opportunities for our shareholders, the Mirati transaction is aligned with our business development goals.” The deal furthers Bristol Myers Squibb’s transformation into a leading oncology-focused biopharma.

Cancer Drug Developer Immunome To Merge With Morphimmune in Quest For Targeted Therapies

Posted on by slightbourne@noblecapitalmarkets.com

Immunome, a clinical-stage biotech developing novel antibody drugs for cancer, plans to merge with private peer Morphimmune in an all-stock deal. The combined company will unite complementary technology platforms with the goal of creating best-in-class targeted oncology therapies.

Morphimmune brings its proprietary Targeted Effector platform designed to selectively deliver anti-cancer payloads directly to tumor cells. Immunome contributes its human memory B cell interrogation platform that can identify novel antibodies against disease-associated antigens.

The merged entity, which will operate under the Immunome name, intends to submit 3 IND applications within 18 months after the transaction closes. The deal is expected to be completed by the end of 2023.

Leading the charge as new Immunome CEO will be current Morphimmune chief Clay Siegall, an industry veteran who previously founded and led Seattle Genetics for over two decades. Siegall built Seagen into a multi-billion cancer drug company on the back of its antibody-drug conjugate (ADC) technology.

His experience commercializing ADCs, which similarly target treatments directly to tumors, is highly relevant. Siegall called the merger “the first step in establishing a preeminent oncology company.”

The transaction will also bring in $125 million via a concurrent private placement from healthcare institutional investors. Participants include Enavate Sciences, EcoR1 Capital, Redmile Group, and Janus Henderson.

The fresh funding will support advancement of Immunome’s lead asset, a novel IL-38 targeting antibody. It originates from the company’s memory B cell interrogation platform, which sorts through patient blood samples to uncover new therapeutic candidates.

From Morphimmune, a potent TLR7 agonist and radioligand therapy are currently in preclinical testing. The TLR7 program stimulates the immune system against cancer cells when targeted via Morphimmune’s effector platform. The radioligand directly delivers cell-killing radiation.

Siegall highlighted the productive synergy between Morphimmune’s delivery technology and Immunome’s antibody generation engine. The combined company will be able to pursue a wider array of novel targets across multiple therapeutic modalities.

For investors, the merger and additional capital provide Immunome with a deeper pipeline and strengthened financial footing. The $125 million infusion should fund operations well into 2024 even with increased R&D activity.

The more diversified targeted therapy portfolio also helps mitigate risk, with programs based on different mechanisms of action. This provides more shots on goal for achieving clinical success and advancing partnership opportunities.

However, Immunome stock initially fell on news of the deal, indicating some investors were unimpressed by the initial progress made since its August 2020 IPO. The cash position was also becoming strained, likely necessitating the additional financing.

But the opportunity to start fresh under industry ace Siegall may give the story new appeal. His track record of building shareholder value and delivering oncology drugs could reinvigorate Immunome.

The merger puts all the pieces in place to become a fully integrated cancer therapy player. Immunome now has platform technology, industry expertise, development capabilities and a strengthened balance sheet.

Execution will be key, but Siegall’s involvement is about as good as it gets in terms of leadership. For long-term investors, Immunome may offer an intriguing backdoor into the vision of one of biotech’s most accomplished CEOs.