Tag: Health

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.

YS Biopharma Co., Ltd. (YS) – Supply Disruptions Still Hit the Quarter, But Outlook Remains Strong

Posted on by cpereira@noblefcm.com


Wednesday, January 24, 2024

https://www.ysbiopharm.comSector(s): Healthcare Industry: Biotechnology Full Time Employees: 865 Key Executives Name Title Pay Exercised Year Born Dr. Hui Shao Pres, CEO & Exec. Director N/A N/A 1969 Ms. Chunyuan Wu Chief Financial Officer

Gregory Aurand, Senior Vice President, Equity Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

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

Reported fiscal Q2 2024 and 1H 2024.  In the fiscal Q2 ended September 30, 2023, YS Biopharma reported revenues of RMB96.82 million, and RMB273.1 million for the first six months of fiscal 2024.  We expected RMB121.8 million and RMB298.1 million, respectively. In the fiscal Q2, the Company reported a net loss of RMB103.7 million, or a loss of RMB1.13 per share, vs. our expected loss of RMB78.7 million, or a loss of RMB0.82 per share.

Revenues were still impacted by Covid-related issues. The Company has been working to improve raw material supply, inventory management and production output. Vaccine production returned to normal levels during the quarter, with the FQ2 expected to be the last quarter impacted by the Covid-related production delays. Management now expects third quarter YSJA vaccine revenues to be more normalized, increasing approximately 50% sequentially.


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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. 

Inhibrx Sells Lead Asset INBRX-101 to Sanofi for Up to $2.2 Billion

Posted on by slightbourne@noblecapitalmarkets.com

Biotechnology company Inhibrx announced today that it has entered into a definitive agreement to sell its lead therapeutic candidate, INBRX-101, to French pharmaceutical giant Sanofi in a deal valued at up to $2.2 billion.

INBRX-101 is a recombinant alpha-1 antitrypsin (AAT) therapy being developed for the treatment of alpha-1 antitrypsin deficiency (AATD), a rare genetic disorder that can cause severe lung and liver disease. Under the terms of the agreement, Sanofi will acquire Inhibrx through a merger in which Inhibrx shareholders will receive $30 per share in cash, a contingent value right (CVR) worth up to $5 per share, and one share in a new publicly traded company called Inhibrx Biosciences for every four shares of Inhibrx held.

Inhibrx Biosciences will retain all of Inhibrx’s pipeline assets and infrastructure outside of INBRX-101. This includes several early-stage therapeutic candidates such as INBRX-105 for solid tumors, INBRX-106 for hematologic malignancies, and INBRX-109 for conventional chondrosarcoma. The new company will receive $200 million in cash funding from Sanofi and begin trading publicly after the completion of the merger.

The total potential value of the upfront cash payment, CVR, and Inhibrx’s debt assumption implies an aggregate transaction value of approximately $2.2 billion. Inhibrx shareholders will also own 92% of the equity in the newly formed Inhibrx Biosciences, which will provide opportunities for future value creation.

The acquisition provides Sanofi with full rights to develop and commercialize INBRX-101 globally. The drug candidate is currently in a registrational Phase 2/3 trial evaluating its safety and efficacy in patients with AATD. Inhibrx believes INBRX-101 has multi-billion dollar peak sales potential if approved, which likely drove Sanofi’s interest in the asset.

Inhibrx’s innovative AAT therapy utilizes the company’s novel therapeutic protein engineering capabilities. INBRX-101 is designed to maintain the stability and activity of AAT, potentially enabling less frequent dosing than current AAT therapies. This next-generation approach could position INBRX-101 as a best-in-class treatment option for AATD.

The proposed transaction has been unanimously approved by the boards of directors of both companies and is expected to close in Q2 2024, subject to Inhibrx shareholder approval, regulatory clearances, and other customary closing conditions. Until then, it will be business as usual for Inhibrx as it continues developing its pipeline assets.

For Sanofi, the acquisition expands its portfolio in rare diseases while strengthening its capabilities in protein sciences and engineering. Adding INBRX-101 provides Sanofi with a promising late-stage candidate that can leverage its expertise and infrastructure in pulmonary diseases. Sanofi has been active on the deals front lately, including a recent $3.2 billion deal for Amunix Pharmaceuticals, as it refreshes its pipeline.

Meanwhile, the new Inhibrx Biosciences will emerge as an up-and-coming biotech with strong financial backing, a seasoned management team, and innovative technology platforms. The company will continue operating under the Inhibrx name and leadership. This strategic deal allows Inhibrx to unlock significant value from its lead program while retaining its other assets and resources to drive future growth.

The transaction is a win for both parties, providing Sanofi with a potential blockbuster drug and Inhibrx shareholders with an attractive return and ongoing upside through Inhibrx Biosciences. It demonstrates the broader trend of big pharma leveraging M&A to access innovative therapies from smaller biotech players. As Inhibrx’s programs advance, it will be interesting to see if Inhibrx Biosciences attracts buyout interest down the road. But for now, the company seems well-positioned to create value by advancing its earlier-stage pipeline.

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

ZyVersa Therapeutics, Inc. (ZVSA) – Research Study Details Role Of Inflammasomes In TNBC Brain Metastases

Posted on by cpereira@noblefcm.com


Thursday, January 18, 2024

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

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

Publication Shows Inflammasome Activity In Triple Negative Breast Cancer. A new study has been published in a peer-reviewed journal, Acta Neuropathologica Communications, showing the role of inflammasomes in the growth of brain metastases in triple-negative breast cancer (TNBC). The study found the components that form inflammasomes were upregulated and activated, starting the pathway for metastatic TNBC tumor cells to proliferate. We see this as an important potential indication for ZyVersa IC 100, a drug that blocks inflammasomes.

ZyVersa Is Developing IC 100 As An Inflammasome Inhibitor. Inflammasomes are protein complexes that assemble from three component proteins. Upon activation by pathogens or cell damage, inflammasomes form and provide signals for inflammation. Inflammasomes also form aggregates that stimulate cytokine release and maintain the inflammation process.


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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. 

Johnson & Johnson Spends $2 Billion to Buy Ambrx and Expand in Oncology

Posted on by slightbourne@noblecapitalmarkets.com

Johnson & Johnson announced Monday that it will acquire clinical-stage biotech Ambrx Biopharma for $2 billion, making a big bet on Ambrx’s proprietary platform for developing next-generation antibody drug conjugates (ADCs) to treat cancer.

The acquisition provides Johnson & Johnson access to Ambrx’s promising pipeline of ADC candidates, while also allowing the healthcare giant to leverage Ambrx’s novel conjugate technology that improves the efficacy and safety of ADCs. Ambrx’s proprietary platform incorporates synthetic amino acids to allow site-specific conjugation of antibodies to toxic payloads, creating more stable ADCs with less off-target effects.

Johnson & Johnson is particularly interested in Ambrx’s lead asset ARX517, an anti-PSMA ADC currently in Phase 1/2 development for metastatic castration-resistant prostate cancer (mCRPC). Prostate cancer has long been a focus for J&J and its Janssen pharmaceuticals unit, with blockbuster prostate cancer drug Zytiga bringing in over $2 billion in annual sales prior to losing patent protection in 2019.

The pressing need for improved mCRPC treatments provided additional impetus for the deal. Over 185,000 men in the U.S. currently have mCRPC, with a poor median overall survival of less than two years. The early data for ARX517 demonstrates promising anti-tumor activity, and Johnson & Johnson believes the drug could become a first-in-class targeted ADC therapy for mCRPC if approved.

“We see a unique opportunity to harness the potential of this innovative ADC platform, and with our deep understanding of prostate cancer, deliver a targeted PSMA therapeutic for addressing the growing needs of the more than 185,000 patients living with metastatic castration-resistant disease today,” said Dr. Yusri Elsayed, Global Therapeutic Area Head for Oncology at Johnson & Johnson.

Beyond ARX517, Ambrx has several other ADC candidates in its pipeline targeting cancer antigens like HER2 and CD70, providing Johnson & Johnson with a robust suite of new ADC therapies that can be optimized using Ambrx’s conjugate technology.

The acquisition reflects Johnson & Johnson’s strategy of using deals to access innovation, especially in high-potential areas like oncology. With in-house R&D productivity under scrutiny, major players like J&J and its pharma peers have turned to M&A to supplement pipeline development. Cancer has been the top therapy area target for M&A over the past 5 years, according to EY data, demonstrating the demand for innovative oncology drugs.

Ambrx was founded in 2003 as a spin-out from The Scripps Research Institute. The company raised over $200 million in venture capital and held its IPO in 2021, listing on the NASDAQ exchange. The $2 billion buyout price represents a nice return for Ambrx’s backers and shareholders.

The deal is expected to close in the first half of 2024, pending approval from Ambrx stockholders as well as regulatory clearance. Upon completion of the acquisition, Ambrx’s stock will be delisted and it will no longer be an independent public company.

Johnson & Johnson’s acquisition of Ambrx highlights the pharma industry’s race to find new modalities like ADCs that can precisely target cancer cells while minimizing side effects. With cancer poised to become the leading cause of death globally, the need for better tolerated treatments has never been more pressing. J&J is making a big bet that Ambrx’s next-gen ADC platform can yield breakthroughs in achieving that goal.

Take a moment to take a look at Noble Capital Markets’ Senior Research Analyst Robert LeBoyer’s coverage universe.

Merck Acquires Harpoon Therapeutics for $680 Million To Diversify Cancer Immunotherapies

Posted on by slightbourne@noblecapitalmarkets.com

Merck has announced a definitive agreement to acquire clinical-stage biotech Harpoon Therapeutics for $23 per share in an all-cash deal valued at approximately $680 million. The acquisition provides Merck with Harpoon’s promising pipeline of novel T-cell engager immunotherapies that harness the body’s immune system to treat cancer.

Harpoon’s lead asset is HPN328, an investigational T-cell engager targeting delta-like ligand 3 (DLL3) for the treatment of small cell lung cancer (SCLC) and other neuroendocrine tumors expressing DLL3. HPN328 directs a patient’s T-cells to kill tumor cells displaying DLL3. In October 2022, Harpoon reported positive interim data from the ongoing Phase 1/2 trial showing encouraging tolerability and early signs of efficacy for HPN328.

The acquisition expands Merck’s burgeoning oncology portfolio, adding a new modality to its toolkit. “This agreement reflects the creativity and commitment of scientists and clinical development teams at Harpoon. We look forward to further evaluating HPN328 in innovative combinations with other pipeline candidates,” stated Dr. Dean Y. Li, President of Merck Research Laboratories.

Harpoon’s TriTAC and ProTriTAC Platforms

Beyond HPN328, Merck also gains Harpoon’s proprietary TriTAC and ProTriTAC platforms for developing novel T-cell engagers. TriTACs (tri-specific T-cell activating constructs) are engineered protein therapies designed to recruit a patient’s immune cells to attack tumor cells. The ProTriTAC platform applies a prodrug concept to remain inactive until reaching the tumor site.

Harpoon has an extensive pipeline of TriTAC candidates against various cancer targets, including:

  • HPN217: Targets B-cell maturation antigen (BCMA) for relapsed/refractory multiple myeloma, currently in Phase 1.
  • HPN601: Targets epithelial cell adhesion molecule (EpCAM) for solid tumors expressing EpCAM.
  • HPN424: Targets delta-like ligand 4 (DLL4) for solid tumors.
  • Other preclinical TriTACs targeting tumor antigens like NaPi2b, FLT3, and DLL3.

The platforms offer modular designs to quickly generate and test new immunotherapies directed to disease-specific targets. Merck can leverage these platforms to strengthen its immunotherapy pipeline in cancer and possibly other disease areas.

Merck Building an Oncology Powerhouse

Cancer immunotherapies represent the next wave of innovation in oncology drug development. The Harpoon acquisition aligns with Merck’s strategy to establish leadership in immuno-oncology.

Merck already markets the blockbuster PD-1 checkpoint inhibitor Keytruda, approved for 30 different cancer indications. Keytruda generated $17.2 billion in sales in 2021. Now with Harpoon, Merck adds T-cell engagers to its arsenal. These therapies provide another way to leverage the immune system against hard-to-treat tumors like SCLC.

Merck is also developing numerous other novel agents across various modalities:

  • Cancer vaccines targeting specific tumor mutations (Personalized Cancer Vaccine, V590, V591)
  • Antibody-drug conjugates (belantamab mafodotin, ladiratuzumab vedotin)
  • Bispecific fusion proteins targeting both PD-1 and LAG-3
  • First-in-class inhibitors (MK-6482, KL-A)

Combined with its extensive capabilities in discovery research and clinical development, Merck is positioning itself as an oncology powerhouse able to take on cancers from all angles.

The Harpoon acquisition provides another building block in this strategy. In Harpoon’s pipeline and platforms, Merck gains cutting-edge T-cell engager capabilities to complement internal immuno-oncology programs. Merck can advance Harpoon’s therapies into new combination regimens and indications to maximize their potential.

Deal Details

Under the terms of the agreement, Merck will acquire Harpoon through a subsidiary, purchasing all outstanding Harpoon shares for $23 each in cash. This represents a premium of 118% over Harpoon’s previous closing share price.

The deal has been approved by Harpoon’s Board of Directors and is expected to close in the first half of 2024, pending shareholder approval and regulatory clearances. It will be accounted for as an asset acquisition by Merck.

Harpoon shareholders will vote on the acquisition at a future shareholder meeting. The waiting period under the Hart-Scott-Rodino Antitrust Improvements Act will also need to expire.

Advisors on the deal include Evercore Group for Merck and Centerview Partners for Harpoon.

With promising new immunotherapies and platforms adding to its robust oncology pipeline, Merck strengthens its leadership in the high-growth cancer drug market. The Harpoon acquisition provides Merck with new T-cell engager capabilities to help develop life-changing medicines for patients with cancer worldwide.

Annual JPMorgan Conference Attracts Investors Seeking Insights Into Biotech’s Promising Pipeline

Posted on by slightbourne@noblecapitalmarkets.com

The buzz in biotech circles is building as the industry prepares to descend on San Francisco for the annual JPMorgan Healthcare Conference running January 8th through 11th. The high-profile event represents a prime opportunity for investors to gain valuable insights into the sector’s most promising up-and-comers.

Now in its 42nd year, the JPMorgan conference attracts leading biotech and pharmaceutical companies along with institutional investors, analysts, and dealmakers. Presenting firms range from massive big pharma players to small emerging growth biotechs.

Nearly 500 companies are slated to present this year, most running 30-minute Q&A sessions. These tightly packed presentations offer a wealth of intel for those looking to separate promising science from speculative hype.

The event also facilitates crucial networking and dealmaking. With so many industry leaders gathered in one place, the conference often catalyzes partnerships, financing deals, and even M&A activity.

For investors, the information bonanza can heavily influence trading decisions in the year ahead. The majority of presenting firms see significant stock volatility around their presentations as analysts and investors digest new details.

This is especially true for micro-cap biotechs developing novel platforms. The conference represents their best shot at introducing promising science to a captive audience.

Noble Capital Markets analyst Robert LeBoyer will be at the JPMorgan conference seeking hidden gems among early-stage drug developers to add to his coverage universe. His focus areas include oncology, rare diseases, and molecular diagnostics.

The four-day gathering kicks off Monday evening with keynote presentations from industry luminaries like Eli Lilly CEO Dave Ricks and CVS Health Executive Vice President Karen Lynch.

But the real action gets going Tuesday morning when company presentations start at 7:30am local time. With non-stop panels running through Thursday afternoon, the schedule stays jam-packed.

Much of the focus tends to fall on clinical trial data reveals and pipeline updates for major drug development programs. However, digging into the schedules of micro-cap presenters can pay off big for enterprising analysts and investors.

These small companies are often where the next generation of groundbreaking therapies get their start. Wall Street has seen many cases where a small or microcap biotech makes waves at JPMorgan only to become a mammoth player years later.

For instance, cancer therapy innovator Mirati Therapeutics has skyrocketed from a $200 million micro-cap at the 2012 conference to now boast a $10 billion valuation. The company’s promising clinical data updates year after year built significant investor enthusiasm.

Success stories like Mirati help explain why the JPMorgan conference receives such massive interest despite its insider feel. Registering to attend requires an invitation, and getting meetings with management teams can prove challenging given packed schedules.

But resourceful attendees find ways to build productive agendas even without formal presentations. The four-day stretch offers countless sidebar conversations and impromptu meetups.

The healthcare sector faces no shortage of complex challenges, from surging costs to ageing populations across the developed world. But the constant flow of biopharmaceutical innovation provides reason for long-term optimism.

Conferences like JPMorgan offer a window into the relentless progress companies of all sizes are making against the world’s most pressing health needs. For investors, finding the next breakthrough drug before it makes headlines could lead to substantial upside. That’s why analysts like LeBoyer eagerly make the trek each year.

The scope of the JPMorgan Healthcare Conference mirrors the diverse breadth of the wider industry. Oncology, rare diseases, neurology, infectious diseases – no area with unmet needs goes overlooked.

Both science and business play equal roles at a conference ultimately aimed at facilitating capital flows into the most promising research. The progress showcased reflects the entwinement of noble medical advancement and shrewd financial investment.

In that sense, JPMorgan offers the ideal backdrop for launching promising biotech companies into the public markets. The conference’s elevated stage has introduced scores of now-large firms over the years, and 2024 will undoubtedly add to that list.

For a list of emerging growth biotech companies, take a look at Noble Capital Markets’ Senior Research Analyst Robert LeBoyer’s coverage universe.

Goldman Sachs Throws Weight Behind Life Sciences’ Hottest Startups with $650M Fund

Posted on by slightbourne@noblecapitalmarkets.com

Goldman Sachs Asset Management (GSAM) has raised $650 million for its inaugural life sciences private equity fund, West Street Life Sciences I, reflecting the firm’s bullish outlook on the high-growth potential in the sector.

The fund exceeded its original fundraising target and ranks as one of the largest-ever first-time private life sciences growth funds. GSAM secured commitments from a diverse group of institutional, strategic, and high net worth investors, including meaningful capital from Goldman’s own employees.

“We are in a golden-era of innovation in the life sciences, where technological breakthroughs are creating new approaches to diagnosing and treating disease,” said Amit Sinha, head of GSAM’s Life Sciences Investing Group. “We believe the current environment provides an attractive opportunity for investing in the next generation of leading life sciences companies.”

GSAM’s entrance into life sciences PE highlights the wave of investor interest into the sector, as rapid scientific and technological advancements transform healthcare. The strategy will focus on high-growth investment opportunities in early to mid-stage therapeutic companies developing innovative drugs and treatments, as well as life sciences tools and diagnostics companies.

Specifically, the fund will target several key themes that GSAM believes will drive significant growth, including precision medicine, genetic medicine, cell therapy, immunotherapy, synthetic biology, and artificial intelligence. By leveraging GSAM’s global platform and Advisory Board of seasoned life sciences experts, the fund aims to identify the most promising companies in these emerging areas.

The Life Sciences Investing Group at the helm of managing the fund was established in 2021 and is led by Amit Sinha. The team brings decades of combined experience investing in life sciences and will tap into GSAM’s broader resources and expertise to source deals and create value.

According to Marc Nachmann, global head of Asset & Wealth Management at Goldman Sachs, “Life sciences represents one of the most exciting areas in the private investing landscape, with advances in technology transforming healthcare at an unprecedented pace. We have a long history of partnering with companies in this space and look forward to bringing the full resources of Goldman Sachs to world-class management teams who are driving progress in the industry.”

The new fund has already made 5 investments totaling approximately $90 million into high-potential life sciences startups. The deals include companies using precision medicine, immunotherapy, and artificial intelligence to develop new therapies in oncology, neurology, rare diseases, and other areas.

One portfolio company, MOMA Therapeutics, is pioneering novel therapeutics targeting mitochondrial diseases, which lack effective treatments. Another investment, Nested Therapeutics, is developing a new modality of antibody therapeutics focused on hard-to-drug intracellular protein targets.

Overall, the launch of West Street Life Sciences I demonstrates Goldman Sachs’ confidence in the booming life sciences sector and its commitment to funding innovation. With its deep expertise, global resources, and strategic focus on cutting-edge healthcare technologies, GSAM is positioning itself to capitalize on the most promising opportunities. The new fund is a bellwether for the growing intersection of finance, biotech, and next-gen medicine.

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

ZyVersa Therapeutics, Inc. (ZVSA) – Novel Therapies For Renal Diseases and Inflammation

Posted on by cpereira@noblefcm.com


Wednesday, January 03, 2024

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

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

Initiating Coverage With An Outperform Rating. ZyVersa Therapeutics is a biotechnology company focused on renal and inflammatory diseases. Its lead product, VAR 200, is in development to reduce renal cholesterol and lipid accumulation in the kidney. These accumulations damage the kidney and lead to loss of filtration in kidney diseases. Its second product in development, IC 100, is an inflammasome inhibitor to inhibit the inflammation that contributes to many chronic diseases.

Renal Diseases. Accumulation of renal cholesterol and lipids in the kidney leads to cellular damage that starts a decline in filtration function and leakage of protein into the urine. VAR 200 was developed to reduce levels of cholesterol and lipids in renal cells to reduce the damage, scarring, and disease progression. The first clinical trial in diabetic kidney disease (DKD) is planned for early 2024.


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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. 

Ocugen (OCGN) – OCU400 Receives RMAT Designation, OCU410 Treated First Patient

Posted on by cpereira@noblefcm.com


Wednesday, December 20, 2023

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

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

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

OCU400 Received RMAT Designation. The FDA has designated OCU400 as a Regenerative Medicine Advanced Therapy (RMAT) for treating retinitis pigmentosa associated with RHO mutations. RMAT designation is intended to speed development of regenerative medicines, and is awarded to therapies that have potential treat, reverse, or modify a life-threatening disease. We see this as a validation of Ocugen’s clinical trial data. Additional data submissions to expand the designation to other gene mutations in RP and Leber congenital amaurosis (LCA) are planned.

Phase 3 Trial Should Benefit From RMAT Designation. RMAT designation includes the benefits of Fast Track and Breakthrough designations, with increased guidance from the FDA. It also allows the use of surrogate markers as endpoints in clinical trials, and accelerated review after the application is filed. Ocugen is currently finalizing the design of the Phase 3 trial for OCU400. We expect the trial to begin in early 2024 with data available in 2H24.


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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. 

MAIA Biotechnology (MAIA) – MAIA Selects THIO Dose For Continued Studies In Non-Small Lung Cancer

Posted on by cpereira@noblefcm.com


Wednesday, December 20, 2023

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

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

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

MAIA Selects THIO Middle Dose Level For Future Studies. MAIA announced that it has selected the 180mg dose of THIO  to continue the Phase 2 THIO-101 trial in non-small lung cancer (NSCLC). The THIO-101 trial tested three THIO dose levels (60mg, 180mg, or 360mg) followed by cemiplimab (Libtayo), an anti-PD-1 checkpoint inhibitor from Regeneron. The 180mg dose level showed a better safety profile with better measures of efficacy. All future patients in the trial will be treated with the 180mg dose.

Trial Shows The Best THIO Disease Control Data To Date. MAIA also stated that the trial shows all dose levels exceed the disease control rate thresholds in stage 1 of the trial. Disease control rates in the first 8 out of 9 patients exceeded the goal of disease control in 8 out of 19 patients per arm. The 180mg dose had the best preliminary response rate compared with the 60mg and 360mg arms. We see strong results as consistent with prior data presentations showing large survival improvements for THIO treated patients.


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. 

Bluebird Bio Announces $150 Million Public Offering to Fund Approved Gene Therapies

Posted on by slightbourne@noblecapitalmarkets.com

Cambridge-based gene therapy developer Bluebird Bio announced a public offering of $150 million in common stock to raise capital supporting its three approved treatments and provide working capital.

The pioneer in gene therapies will offer shares on the NASDAQ under the ticker symbol BLUE, with underwriters granted a 30-day option to purchase an additional $22.5 million in stock. Bluebird stated the final size and terms remain subject to market conditions.

Goldman Sachs and J.P. Morgan are serving as joint book runners on the deal, with Raymond James as co-manager on the offering. All shares sold will come directly from Bluebird Bio.

Proceeds from the public stock sale will specifically further commercialization, manufacturing, and launch efforts behind the company’s newly approved gene therapies – Zynteglo for beta thalassemia, Skysona for cerebral adrenoleukodystrophy, and Lyfgenia for sickle cell disease.

The capital raise also provides balance sheet support as Bluebird continues its transition into a fully-integrated commercial biotech selling proprietary therapies targeting rare diseases.

Analysts see the offering as a move to seize current investor enthusiasm and strengthen Bluebird’s financial position after a turbulent few years adjusting to regulatory setbacks.

With three potent gene therapies now approved since August 2022, Bluebird looks to ride accelerating momentum as its treatments reach more patients globally. But the specialized nature of gene therapy production and administration constrains rapid scaling despite massive market opportunities.

Hefty expenses can also accrue during the early stages of drug launches pending insurance coverage and reimbursement decisions country by country.

Tuesday’s proposed $150 million offering suggests management sees room to accelerate growth in 2024 while demand runs hot for novel gene therapies.

Gene Therapies Target Root Causes of Diseases by Manipulating Genes

The permanent gene corrections from one-time gene therapy represent potential cures promising to revolutionize treatment for blood disorders, cancers, inherited disorders and degenerative diseases.

After gene therapy showed immense promise in the 2010s, developmental and safety hurdles caused temporary setbacks for the emerging category.

But breakthrough approvals over the past 18 months from Bluebird and others have reinvigorated investor appetite to fund the next generation of radical genetic medicines now reaching patients in need.

While small in patient size, the market chances to generate multi-billion sales treating high unmet needs in rare diseases with no other solutions for the underlying condition.

Goldman Sachs and JPMorgan’s involvement arranging Bluebird’s latest stock sale reflects rising investor intrigue and renewed confidence in realizing gene therapy’s paradigm-changing potential after past stumbles.

Still Long Road Ahead as Gene Therapies Slowly Build Adoption

However, analysts caution the road remains long translating hype into real revenues as gene therapy faces entrenched barriers preventing mass adoption anytime soon.

Priced at over $2 million per treatment, gene therapies today dispense more hope than profit for developers. Reimbursement pushback from insurers and intense medical limitations temper growth projections.

Bluebird’s approved drugs currently treat tiny populations measured in the single digit thousands globally. But success establishing coverage helps pave the way for expanding into wider therapeutic indications in time.

With fresh financing now on tap, Bluebird Bio stock offers a investment into a maturing gene therapy leader well-positioned to ride coming decades of medical advancements illuminating genetics’ role beating back disease.

Yet expectations likely stay muted near-term for all gene therapy plays absent key inflection events bringing more treatments past global regulatory gates.

Cadrenal Therapeutics (CVKD) – Addressing Unmet Anticoagulation Needs In Orphan Populations

Posted on by cpereira@noblefcm.com


Monday, December 18, 2023

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.

Initiating Coverage Of CVKD.  Cadrenal Therapeutics is developing tecarfarin, an oral anticoagulant for prevention of systemic thromboembolism (blood clots) in rare medical conditions where patients cannot take the commonly prescribed oral anticoagulants. The only available therapy is warfarin, a drug with wide variations in bloodstream levels that requires frequent monitoring to prevent side effects including excessive bleeding risk.

Phase 3 Trial Is Expected In 2024. The lead orphan indication for tecarfarin is in patients with end-stage kidney disease (ESKD) with atrial fibrillation (AFib, irregular heartbeat). The ACTOR-AF Phase 3 trial has been designed as a randomized, double-blind, placebo-controlled study testing tecarfarin against placebo. The amended protocol is expected to be submitted in 1H24 to allow patient treatment to begin in 2H24.


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