Tag: Health

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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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. 

Harmony Biosciences Bets on Cannabinoid Therapy for Rare Disorders with $200 Million Zynerba Buyout

Posted on by slightbourne@noblecapitalmarkets.com

Harmony Biosciences aims to expand its pipeline into rare neuropsychiatric disorders through the acquisition of Zynerba Pharmaceuticals and its innovative cannabinoid gel technology.

Harmony, known for its narcolepsy drug Wakix, announced Monday that it will acquire Zynerba in a deal worth up to $200 million. The buyout provides Harmony with Zynerba’s lead asset, Zygel, a synthetic cannabidiol gel in mid-stage trials for Fragile X syndrome and 22q11.2 deletion syndrome.

Zygel could become the first FDA-approved drug for managing Fragile X if it succeeds in pivotal trials. Harmony sees the drug as a way to expand beyond sleep disorders while tackling high unmet needs in orphan neuropsychiatric conditions.

Fragile X affects 80,000 in the U.S., causing intellectual disability and behavioral challenges. Zynerba’s focus aligns with Harmony’s mission in rare neurological diseases, said Harmony CEO Jeffrey Dayno, M.D. in Monday’s announcement.

“With Harmony’s scale, resources and proven commercial excellence, they are well positioned to potentially bring to market the first pharmaceutical product indicated for the treatment of behavioral symptoms of Fragile X syndrome and to maximize the value of Zygel,” added Zynerba Chairman and CEO Armando Anido.

No FDA-Approved Options Today

Fragile X syndrome stems from mutations in the FMR1 gene which codes for FMRP, a protein vital for synaptic function and neural connections. The lack of FMRP causes cognitive impairments. Around 60% of Fragile X patients don’t produce any FMRP due to methylation.

While Fragile X affects tens of thousands in the U.S. alone, there are no FDA-approved treatments. Patients rely on behavioral interventions and off-label drug use.

Zynerba’s Zygel aims to modulate the endocannabinoid system impacted by the loss of FMRP. The gel contains synthetic cannabidiol, absorbing through the skin to avoid first-pass metabolism.

Zygel already secured FDA orphan drug status for both Fragile X and 22q deletion syndrome. It also won Fast Track designation for Fragile X.

Now in pivotal Phase 3 trials, Zygel showed positive Phase 2 data in both indications. Harmony believes the drug can help patients manage behavioral symptoms if approved.

Betting Up to $200M on Approval

Under the acquisition terms, Harmony will pay $60 million upfront for Zynerba’s shares, or $1.1059 per share in cash. Zynerba shareholders will also receive one contingent value right (CVR) worth up to $2.5444 per share more.

The CVR payments depend on Zygel hitting clinical, regulatory and sales milestones:

  • $15M for completing Phase 3 Fragile X trial
  • Up to $30M for Phase 3 data (timing-based)
  • $35M for FDA approval in Fragile X
  • $15M for approval in a second indication
  • Up to $45M for reaching sales milestones

Altogether, the deal is valued at up to $200 million if Zygel secures FDA approval and reaches peak sales targets. Harmony expects the buyout to close in Q4 2023.

“Innovative potential new therapeutic option for rare/orphan neuropsychiatric disorders with high unmet medical needs,” said Harmony CEO Dayno.

Doubling Down on Rare Diseases

The acquisition aligns with Harmony’s focus on innovative treatments for overlooked neurological diseases. Zynerba’s work in underserved neuropsychiatric disorders complements Harmony’s leading drug in narcolepsy.

Harmony markets Wakix, a first-in-class H3 receptor antagonist that hit $230 million in net sales over the twelve months ending June 30, 2022. But the company sees untapped growth opportunities in adjacent rare diseases.

The Zynerba deal provides pipeline diversification into high-value orphan drug development. Harmony now has new opportunities in gene mutation disorders like Fragile X and 22q deletion syndrome.

With a profitable commercial engine already built, Harmony is betting its expertise and $430 million cash position can maximize Zygel’s impact if approved. The company sees Zynerba’s cannabinoid therapy as both a strategic fit and a long-term growth driver if milestones are met.

For shareholders, the buyout provides Harmony an approved orphan drug asset with potential peak sales upside. And for patients, it brings hope for the first therapy to address Fragile X symptoms.

Haemonetics Expands Hospital Portfolio Through $253 Million Acquisition of OpSens

Posted on by slightbourne@noblecapitalmarkets.com

Medical technology firm Haemonetics Corporation recently announced a definitive agreement to acquire OpSens, Inc. in an all-cash deal valued at approximately $253 million. OpSens is a medical device company specializing in innovative fiber optic sensor technology for interventional cardiology applications. This strategic acquisition allows Haemonetics to expand its hospital business into the high-growth interventional cardiology market estimated at $1 billion.

Haemonetics, based in Boston, offers a suite of products for blood and plasma collection, the surgical suite, and hospital transfusion services. With the addition of OpSens’ sensor-guided guidewire and pressure guidewire products for transcatheter aortic valve replacement (TAVR) and percutaneous coronary intervention (PCI), Haemonetics bolsters its portfolio with clinically validated technology to improve patient outcomes.

OpSens’ core offerings include the SavvyWire, the first sensor-guided guidewire for TAVR procedures which enables shorter hospital stays, and the OptoWire, a pressure guidewire used to aid coronary artery disease diagnosis by measuring key parameters like fractional flow reserve (FFR). OpSens leverages proprietary optical technology across its sensor solutions for medical devices and critical industrial applications.

According to Stewart Strong, President of Global Hospital at Haemonetics, this acquisition expands Haemonetics’ leadership in interventional cardiology while providing a foundation for additional growth. By combining OpSens’ innovative technology with Haemonetics’ commercial infrastructure and hospital relationships, there is tremendous potential to increase adoption and improve patient care globally.

Strategically, Haemonetics gains several advantages from the purchase:

  • Access to a $1 billion total addressable market in interventional cardiology, a specialty area witnessing increasing procedure volume. OpSens’ competitive, clinically validated offerings are well-positioned for long-term growth.
  • The ability to accelerate OpSens product adoption leveraging Haemonetics’ existing commercial footprint and depth of penetration in U.S. hospitals for its VASCADE vascular closure portfolio.
  • Expanded product breadth and enhanced diversification into adjacent applications like industrial sensors. OpSens technology can be leveraged across Haemonetics’ hospital business and new markets.
  • Opportunities for continued R&D, clinical study efforts, and other business development activities to augment internal product development. Haemonetics aims to expand its hospital division via organic and inorganic investments.

Financially, Haemonetics expects the deal will be immediately accretive to revenue growth. On an adjusted basis, earnings per share is also expected to be accretive right away. Due to one-time integration costs, GAAP earnings per share may be slightly dilutive in the first full fiscal year before turning accretive.

Haemonetics will finance the transaction through existing cash balances and its revolving credit facility. This will result in a manageable rise in the company’s net debt to EBITDA ratio to around 2.1x. The purchase is anticipated to close by January 2024, subject to customary approvals.

In summary, the acquisition of OpSens for $253 million in cash strengthens Haemonetics’ position in the attractive interventional cardiology space while providing new technologies, commercial synergies, and earnings accretion over the long-term. It signals a bold move to supplement organic growth with value-enhancing strategic M&A, as Haemonetics looks to deliver innovation and drive better patient outcomes through continued expansion.

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

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.

MAIA Biotechnology (MAIA) – THIO-101 To Add US Clinical Sites and Present Data At ESMO

Posted on by cpereira@noblefcm.com


Friday, October 06, 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.

FDA Clearance For THIO-101 Has Been Received. MAIA announced that it has received clearance of its IND application, allowing the THIO-101 trial to open clinical sites in the US. While the Phase 2 THIO-101 trial has been underway in Australia and Europe since July 2022, the IND clearance was needed for starting clinical treatment sites in the US. We see this as a strong positive, since US clinical data is considered the most reliable standard for data. Since THIO-101 is a multi-national trial, this should provide support for the potential application for FDA approval.

Preliminary Results From THIO-101 Have Been Scheduled For Presentation At ESMO. The THIO-101 trial tests THIO in patients with progressive or relapsing non-small cell lung cancer (NSCLC) after being treated with a checkpoint inhibitor. Patients receive treatment with a combination of THIO and Libtayo (cemiplimab), giving two mechanisms of action against the cancer cell. The poster presentation will be presented at the European Society for Medical Oncology on October 23, 2023.


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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. 

The Emerging Biotech Sector: A Bright Spot for Investors

Posted on by slightbourne@noblecapitalmarkets.com

The biotechnology sector has seen a flurry of activity recently, with major drugmakers looking to acquire smaller biotech firms to boost their pipelines. According to a recent Bloomberg News report, French pharmaceutical giant Sanofi is in talks to acquire Mirati Therapeutics, a clinical-stage biotech focused on developing novel cancer treatments.

While negotiations are still ongoing, this potential deal highlights the enormous value being seen in emerging biotech firms like Mirati that are pioneering cutting-edge medicines. Mirati’s lead drug candidate is a treatment for non-small cell lung cancer, one of the most common and deadly forms of cancer.

Other pharma giants have also inked deals to tap into biotech innovation. Earlier this month, cancer drug developer Immunome merged with Morphimmune. And Eli Lilly recently completed its acquisition of POINT Biopharma for $1.4 billion.

These mergers and acquisitions underscore the biotech sector’s immense growth prospects. With novel approaches to treating cancer, genetic diseases, and other unmet medical needs, biotechs have become hotbeds for innovation. And major drugmakers are increasingly looking to tap into these scientific advancements through strategic deals.

For investors, the busy M&A environment highlights the potential windfalls in identifying and investing in promising biotech firms early on. While risky, buying shares in companies with disruptive technologies before they are on Big Pharma’s radar can result in exponential returns.

With science rapidly advancing, the coming decades are likely to see huge leaps in biomedical innovations. The recent wave of pharma-biotech mergers shows large drugmakers recognize the future potential of biotech. Savvy investors who spot these opportunities stand to profit as more biotech firms are snatched up or grow into full-fledged pharmaceutical leaders themselves.

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

The Promise of Biotech

Biotechnology represents an exciting new frontier in drug development. Unlike traditional pharmaceuticals derived from chemical compounds, biotech drugs utilize living organisms and biological molecules to treat disease.

Some key innovations driving growth in biotech include:

  • Gene therapy – Altering genes to treat genetic conditions. Gene editing tools like CRISPR have made gene therapy more precise and scalable.
  • Cell therapy – Using modified human cells as treatments, such as CAR T-cell therapy for blood cancers.
  • RNA interference – Silencing specific genes by blocking mRNA translation through RNAi mechanisms.
  • Monoclonal antibodies – Targeted antibodies cloned from immune cells are blockbuster therapies for cancer, autoimmunity, and more.
  • Vaccines – Novel vaccine platforms like mRNA vaccines are enabling rapid development of new vaccines.

These advanced technologies promise to revolutionize medicine and usher in an era of personalized, precision medicine. The possibilities span from regenerative medicine to reversing aging. For investors, biotech represents enormous growth potential.

Biotech Deal Frenzy

Given the vast promise of biotech, it is no surprise that pharmaceutical giants have been scooping up biotech firms at a fierce clip. Small promising biotechs are prime targets for acquisition.

Big Pharma companies like Sanofi, Merck, and Bristol-Myers need to refill drying pipelines. Revenue-generating biotech drugs can also help offset losses from older medications losing patent protection.

For the acquiring company, buying a biotech with an innovative drug candidate eliminates the risks and costs of developing a new medicine from scratch. And the more established resources and expertise of a pharma giant can help push novel therapies through late-stage trials and regulatory approvals.

Meanwhile, being acquired provides biotech startups with an influx of funds and resources to continue advancing their pipeline. It also offers a lucrative exit for early investors.

As the healthcare needs of the global population increase, larger pharmaceutical companies will likely continue acquiring emerging biotechs to remain competitive. This M&A frenzy shows no signs of slowing down.

Investment Opportunities

For investors, the busy biotech M&A environment provides exciting opportunities to profit. Here are some tips:

  • Seek out early-stage biotechs with promising technologies before they become acquisition targets. The ideal scenario is investing pre-IPO.
  • Focus on firms with advanced clinical pipelines addressing urgent unmet needs like cancer, rare diseases, neurodegeneration, etc.
  • Evaluate the strength of a biotech’s intellectual property and licensing agreements for its core technology.
  • Assess the management team’s experience in drug development and commercialization.
  • Consider biotechs focused on next-gen platforms like gene editing, cell therapy, RNAi, etc which are garnering lots of interest.
  • Be prepared to hold for longer time horizons and have a higher risk tolerance. Clinical trials have high failure rates.

For investors comfortable with risk, the payoffs for spotting the next potential biotech star could be immense as entire new markets for cutting-edge medicines continue to emerge.

Kyowa Kirin Bets on Gene Therapy With $477M Orchard Therapeutics Acquisition

Posted on by slightbourne@noblecapitalmarkets.com

Japan-based pharma Kyowa Kirin has agreed to acquire gene therapy specialist Orchard Therapeutics in a deal worth up to $477.6 million. The buyout aims to strengthen Kyowa Kirin’s emerging presence in the high-potential genetic medicine field.

Under the terms, Kyowa Kirin will pay $16 per Orchard ADS in cash upfront, representing a 144% premium to Orchard’s recent share price. Orchard shareholders will also receive a contingent value right worth an additional $1 per ADS if certain regulatory milestones are met.

The total potential payout values the deal at $477.6 million. Kyowa Kirin expects the acquisition to close in Q1 2024 pending approvals.

Orchard focuses on developing therapies using genetically modified hematopoietic stem cells (HSCs) taken from patients themselves. Its treatments aim to correct the underlying genetic cause of diseases in a single administration.

The company’s lead asset is Libmeldy, approved in Europe for treating a rare metabolic disorder called MLD. It also has two other programs for pediatric neurological conditions in late-stage testing.

Beyond the commercial and near-term pipeline assets, Kyowa Kirin gains Orchard’s HSC gene therapy platform. This technology can be leveraged to develop new treatments for diseases in Kyowa Kirin’s wheelhouse like oncology, autoimmune disorders, and others.

Kyowa Kirin has made gene and cell therapy a priority as part of its vision to deliver transformative new medicines. Orchard’s proven development capabilities and leadership position in HSC gene therapy make it an ideal fit for this strategy.

The high premium paid reflects Orchard’s status as a pioneer in the burgeoning field of genetic medicine. The deal provides Kyowa Kirin immediate scale and expertise in leveraging gene therapy.

Kyowa Kirin also gains commercial infrastructure to support the global launch of Libmeldy. The FDA is currently reviewing Libmeldy for approval in the U.S. with a decision date in March 2024.

Orchard’s two other clinical programs in development also address rare pediatric neurological disorders with immense unmet need. Additional earlier stage preclinical assets add further upside to the pipeline.

The deal continues biotech industry consolidation as large players acquire innovators to reinforce their drug development pipelines. The competition among pharmas for gene therapy assets has intensified as the field matures.

For Orchard investors, the buyout represents a significant premium after a long stretch of the stock languishing. But with cash running low, the company faced challenges transitioning its pipeline programs to commercial status alone.

The deal provides ample resources to continue advancing Orchard’s mission of tackling rare genetic diseases. Kyowa Kirin expects to hit $1 billion in sales from the MLD treatment alone if approved in the U.S.

Gene therapy has disrupted drug development over the past decade with its potential to deliver curative, lifelong treatment through a single administration. As technology improves, dealmaking and R&D in the space continues gaining steam.

Kyowa Kirin is the latest pharma to bet big on gene therapy’s possibilities. If it can successfully harness Orchard’s specialized platform and assets, the deal may pave the way to developing life-changing genetic medicines while delivering solid returns to shareholders.

Standard BioTools and SomaLogic to Merge, Creating $1B Life Sciences Tools Leader

Posted on by slightbourne@noblecapitalmarkets.com

Standard BioTools and SomaLogic have announced plans to unite through an all-stock merger aimed at creating a diversified life sciences tools platform with over $1 billion in equity value. The deal brings together technologies, expertise and customer bases across genomics, proteomics and other omics fields.

Standard BioTools provides genomic analysis tools catering to academic and clinical research settings. SomaLogic specializes in proteomics technology that profiles proteins for biopharmaceutical drug discovery. Their complementary offerings provide scale, synergies, and cross-selling opportunities.

Under the merger agreement, SomaLogic shareholders will receive 1.11 shares of Standard BioTools stock for each SomaLogic share they own. This values SomaLogic at over $370 million based on recent Standard BioTools share prices.

The combined company expects to generate $80 million in cost synergies by 2026 through optimization of its integrated operations. It will also hold over $500 million in cash to fund growth initiatives and new product development.

Standard BioTools CEO Michael Egholm touted SomaLogic’s proteomics capabilities as an ideal fit to accelerate his company’s strategy in the over $100 billion life science tools industry. The deal diversifies Standard BioTools’ portfolio beyond genomics while leveraging its global commercial infrastructure.

SomaLogic provides proteomic analysis that reveals functional expressions of genes, filling a key gap left by genomics. Its SOMAscan platform uses aptamer-based technology to measure thousands of proteins in biological samples.

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

The technology has become an industry leader in enabling biopharma researchers to identify and validate new drug targets. SomaLogic has relationships with nine of the ten largest pharma companies along with partnerships like its recently launched proteogenomics offering with Illumina.

Standard BioTools plans to tap into these biopharma relationships to cross-sell its genomic analysis tools. Meanwhile, SomaLogic can leverage Standard BioTools’ strong presence selling to academic labs. The combined customer base spans nearly all major end markets.

SomaLogic interim CEO Adam Taich called the merger an opportunity to better serve translational and clinical research customers while creating shareholder value. The healthy $500 million cash position provides ample capital to fund the commercial ramp.

Standard BioTools increased its 2023 revenue outlook to $100-105 million following the merger news. SomaLogic maintained its full-year guidance of $80-84 million. Together, the combined entity expects to generate over $180 million this year.

The boards of both companies have unanimously approved the transaction. Major shareholders holding around 16% of Standard BioTools stock and 1% of SomaLogic have also committed support through voting agreements.

The deal is expected to close in the first quarter of 2024 after securing shareholder and antitrust regulatory approvals. The combined company will operate under the Standard BioTools name and stock ticker, with dual headquarters in South San Francisco and Boulder, Colorado.

Standard BioTools has undergone major changes after a period of underperformance, divesting its sequencing business earlier this year. The merger with SomaLogic continues its strategic shift toward life science research tools.

Together, the companies aim to accelerate development of new diagnostics and precision medicines through their multi-omics technology. Providing genomics, proteomics and other readouts on disease samples provides deeper insights to researchers.

With scale, synergies, ample resources, and multi-pronged revenue opportunities, the combined Standard BioTools and SomaLogic expects to occupy a strengthened position in the competitive life science tools space. Their integration marks the continued consolidation in the industry amid rising demand for omics-based research capabilities.

PDS Biotechnology Corp. (PDSB) – Strong Phase 2 Survival Data, But Stock Sells Off Anyway

Posted on by cpereira@noblefcm.com


Wednesday, October 04, 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.

PDS Biotech Updated Phase 2 Survival Data. PDS Biotech updated its Phase 2 VERSATILE-002 data presented at the ACSO conference in May 2023. This trial is testing the combination of PDS0101 and pembrolizumab (Keytruda, from Merck) in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). The data presented at ASCO in May included patients followed up to 12 months, while the update followed patients up to 24 months. 

Survival Of 74% Is A Significant Improvement. Patients that were followed for two years had an overall survival rate of 74% compared with published studies showing less than 30% survival. Overall survival at 12 months at 80% compares with published results of 30% to 50%. Tumor shrinkage was seen in 60% (31/52) and confirmed by second MRI scan (overall response rate, ORR) in 27% (14/52 patients). Treatment related adverse events (TRAEs) were limited to Grade 3 in 13% (8/55) patients, and none had Grade 4 or Grade 5. We see these data as significantly improved over pembrolizumab alone or with chemotherapy.


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. 

Investors Take Interest in MAIA Biotechnology as FDA Clears Path for Cancer Drug Trial

Posted on by slightbourne@noblecapitalmarkets.com

Shares of MAIA Biotechnology were trading higher Tuesday after the company announced that the FDA has cleared its application to test its experimental cancer therapy THIO in patients in the United States.

MAIA Biotech is developing THIO as a novel immunotherapy approach for advanced non-small cell lung cancer (NSCLC). With FDA clearance of its Investigational New Drug (IND) application, the company can now include U.S. cancer patients in its ongoing mid-stage trial evaluating THIO’s safety and efficacy.

This regulatory win is driving investor enthusiasm and higher trading volume for MAIA stock today.

About MAIA Biotech and THIO

MAIA Biotech is a clinical-stage immunotherapy company aiming to improve cancer treatment by targeting telomeres. Telomeres play an important role in cancer cell survival and resistance to standard therapies.

The company’s lead therapy THIO represents a first-in-class telomere-targeting agent for NSCLC. Early preclinical research indicates THIO can induce cancer cell death and stimulate anti-tumor immune responses.

MAIA is positioning THIO as a second or third line of treatment for NSCLC patients who have stopped responding to initial immunotherapy. The company sees THIO’s novel approach as a way to improve outcomes in this hard-to-treat population.

Phase 2 Trial Details

THIO is currently being tested in a Phase 2 clinical trial involving sites across Europe, Asia Pacific, and now with FDA clearance, the United States.

The trial is evaluating THIO in combination with the PD-1 checkpoint inhibitor Libtayo in advanced NSCLC patients. Researchers want to see if giving THIO first to “prime” the immune system, followed by Libtayo, can enhance and prolong the immune response against cancer cells.

The primary goal is assessing THIO’s safety and antitumor activity based on overall response rates. Secondary goals include evaluating biomarkers and overall survival. The trial expects to enroll approximately 90 patients total.

Next Steps for MAIA

While still early stage, the FDA clearance represents an important milestone for MAIA as it works to expand THIO’s potential reach. Being able to include U.S. sites should support faster enrollment and generate data from a larger, more diverse patient population.

Positive Phase 2 results would support advancing to a pivotal Phase 3 study, which the company hopes could lead to regulatory approval. MAIA sees a multi-billion dollar market opportunity in later-line NSCLC treatment.

The company is also exploring THIO’s potential in other cancer types like melanoma, prostate cancer, and multiple myeloma.

Why Investors are Excited

FDA clearance of THIO’s IND removes a key regulatory hurdle for MAIA. Being able to test the therapy in the major U.S. market is critical for the smaller biotech company.

Today’s stock move reflects investors’ increased confidence in THIO’s outlook and MAIA’s ability to execute on development plans. If the Phase 2 trial goes well, it would further validate THIO’s novel approach and cancer-fighting potential.

While still highly speculative given the early stage, MAIA represents an intriguing immunotherapy play for investors interested in emerging approaches for hard-to-treat cancers. The company’s focus on telomere biology and unique combination strategy with Libtayo differentiate it from other biotechs.

MAIA stock could continue to be volatile in the months ahead as Phase 2 data approaches. But the FDA clearance has put a spotlight on this previously lesser known name. For investors open to some risk, MAIA may be a cancer immunotherapy stock to have on the radar.

Take a look at more research on MAIA Biotechnology by Noble Capital Markets Senior Research Analyst Robert LeBoyer.

Biotech Poised for a Powerful Comeback

Posted on by slightbourne@noblecapitalmarkets.com

After a fallow period, signs point to the biotech sector regaining its prior momentum. Several factors indicate a pending return to rapid growth and prolific innovation for biotech companies. This prospective resurgence could replicate the boom years of the 1980s and 1990s.

The first driver is scientific advancements that open new possibilities. CRISPR gene editing has revolutionized biotech, allowing cheaper and easier manipulation of genetic code. This enables creation of novel treatments and cures previously out of reach. Other breakthroughs like mRNA vaccines have proven the ability to rapidly develop radically new therapeutic approaches.

Vast amounts of genomic data generated in recent decades have also unlocked new understandings of biologically rooted diseases. By identifying key genetic drivers, drug targets can be validated to produce higher success rates in clinical trials. Failed drug candidates have historically been a major drag on biotech.

Substantial investment capital is also lining up behind biotech again after the sector fell out of favor. While biotech IPOs dropped sharply in 2022, venture funding actually rose to its second highest level ever at $32 billion. Investor appetite remains strong, especially for companies with promising new platforms.

Large cash piles among pharmaceutical giants could further bolster biotech. Big pharma companies have routinely turned to buying biotech firms to fill product pipelines. With major players like Pfizer and Merck holding over $25 billion in deployable cash reserves, expect more dealmaking ahead.

Take a look at several emerging growth biotech companies by looking at Noble Capital Market’s Senior Research Analyst Robert LeBoyer’s coverage list.

Regulatory incentives additionally sweeten the proposition of getting back into biotech. The FDA is actively supporting development in areas like gene therapy, rare diseases, and certain cancers through its pilot programs and priority reviews. This guidance can derisk investments.

The maturing ecosystem around biotech also fuels its potential rebound. Experienced veteran executives can now be tapped to steer startups. Clustering in hubs like Boston and San Francisco persists to provide concentration of talent, capital, and resources.

While risks like high failure rates remain, the ingredients are aligning for biotech’s next generation. Comparisons to the internet boom of the late 1990s resonate, with biotech representing a similar pivotal platform shift. The world’s demographics also underpin demand for new therapies – aging populations in developed nations will drive need.

This fertile environment parallels periods that produced prior biotech booms. In the late 1970s and 80s, the industry arose virtually from scratch around pioneering companies like Genentech and Amgen. The advent of genetic engineering allowed creation of the first biologic drugs.

Another surge came through the 90s as enabling technologies like high throughput screening scaled up the drug discovery process. The mapping of the human genome unleashed another wave of possibilities.

Today’s scientific advances pose an even greater leap, allowing drug development and treatment paradigms hardly imaginable just decades ago. The bounds of human understanding keep expanding.

The stars are aligning for biotech 2.0, an evolution building on past successes but catalyzed by new potentials. It promises to usher in an era of curative therapies, genomic precision, and accelerated innovation. The post-pandemic landscape offers the ideal springboard for this biotech revival.

With therapeutic bottlenecks getting cleared, investor interest rekindling, and confidence restored, expect biotech to reclaim its prior growth trajectory. The lessons of past booms were well learned, leaving companies better positioned to capitalize. Weapons to fight disease grow more powerful by the month.

The public expects and demands new treatments for pressing needs, from cancer to neurological conditions. Demographics favor biotech’s prospects as populations age. An energized ecosystem stands ready to nourish exciting science from lab to market.

The pieces are in place for biotech liftoff. As science unlocks new horizons, investor insight aligns with public health demands, fueling momentum. Biotech’s foundational role in driving modern medical progress is poised to only accelerate. The cycle of innovation spins up again.

Cocrystal Pharma (COCP) – CDI-988 Begins Phase 1a/b Clinical Trial

Posted on by cpereira@noblefcm.com


Monday, October 02, 2023

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

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

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

CDI-988 Begins Clinical Studies. Cocrystal announced that CDI-988 has begun Phase 1a/b studies, meeting our expected timeframe. CDI-988 is a 3CL protease inhibitor that interferes with an enzyme early in the viral lifecycle, stopping a virus from reproducing. This early action contrasts with other approaches that seek to kill the virus after it reaches the bloodstream. The study objective is to establish safety, dosing, and pharmacokinetics for design of a Phase 2 study.

Phase 1a/b Study Will Test Ascending Dose Cohorts. The study will have a Phase 1a single ascending-dose stage (SAD) in which patients receive a single administration of CDI-988. As safety is established for each dose, subsequent groups receive higher doses. The Phase 1b stage will have multiple administrations of CDI-988 at ascending doses (MAD). Since CDI-988 is an orally administered vaccine, pharmacokinetic data will include the effect of food drug adsorption. The results of the study will be used to design Phase 2 studies in both norovirus, a frequent cause of acute gastroenteritis, and COVID-19.


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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. 

Baudax Bio (BXRX) – Orphan Drug Designation Granted By FDA for TI-168

Posted on by cpereira@noblefcm.com


Friday, September 29, 2023

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

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.

Treatment of Hemophilia A with inhibitors.  As announced yesterday, the FDA granted Orphan Drug Designation to the Company’s novel treatment. TI-168 is the IND-cleared Treg therapy to address Factor VIII (FVIII) inhibitors in Hemophilia A patients.  Baudax Bio expects to initiate Phase 1/2a trial enrollment early 2024.

Important FDA acknowledgement.  The FDA has authority to grant orphan drug status for new treatments in rare diseases affecting fewer than 200,000 patients in the United States.  The designation qualifies sponsoring companies with qualified clinical trial tax credits, exemption from user fees, potential seven years of market exclusivity after approval, and other benefits. It is estimated that 105,000-165,000 Hemophilia A patients are affected with autoantibody inhibitors in the U.S.


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.