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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.


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Lilly Makes $1.4 Billion Bet on Radioactive Cancer Drugs with POINT Biopharma Acquisition

Posted on by slightbourne@noblecapitalmarkets.com

Pharmaceutical giant Eli Lilly is expanding its cancer treatment portfolio into a promising new area by acquiring POINT Biopharma, a company developing radioactive drugs that precisely target tumors, for $1.4 billion.

POINT specializes in radioligand therapies, an emerging approach to cancer treatment that uses radioactive particles linked to molecules that bind to receptors on cancer cells. This enables the radiation to selectively kill tumors while limiting damage to healthy tissue.

Lilly is paying $12.50 per share in cash for POINT, an 87% premium over the stock’s latest closing price. The deal will give Lilly control of POINT’s pipeline of radioligand therapy candidates, which includes two late-stage experimental drugs.

One drug, PNT20021, targets prostate cancer tumors by binding to a protein called PSMA. Study data expected later this year will show whether it extends the lives of men with metastatic castration-resistant prostate cancer.

The other late-stage drug, PNT20031, homes in on neuroendocrine tumor cells via their somatostatin receptors. It may provide a new option for patients with advanced gastroenteropancreatic neuroendocrine tumors.

Take a look at PDS Biotechnology, a clinical stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies.

Beyond these lead programs, POINT has several earlier stage radioligands in development for cancers of the breast, lung, and brain. Lilly gains full access to progress these toward human testing.

The deal also gives Lilly two specialized facilities Point has built to produce and research radioligands. Manufacturing the drugs involves linking medical radioisotopes like actinium-225 to the targeting molecules, which requires nuclear expertise.

Jacob Van Naarden, head of Lilly’s oncology division, touted the promise of radioligands to safely destroy cancer while avoiding the side effects of traditional chemo. “We are excited by the potential of this emerging modality,” he said.

Lilly has been growing its cancer treatment business in recent years through deals for other firms’ drug candidates and technologies. The POINT acquisition similarly expands Lilly’s footprint into an area well-suited for precision medicine.

The U.S. Food and Drug Administration has already approved over a half dozen radioligand therapies from Lilly competitors like Novartis. Their success is driving a surge of investment and deal-making in the radiopharmaceutical field.

But analyst Geoffrey Porges of SVB Securities thinks Lilly overpaid for POINT. “We believe the valuation fails to reflect the very high risks inherent in drug development,” he wrote in a note to investors.

Porges added that Lilly may need to invest over $2 billion more to fully develop POINT’s pipeline over the next 5-7 years, with no certainty the drugs will pan out.

Lilly expects the acquisition to close by the end of 2023 after gaining required antitrust and regulatory approvals. The majority of POINT shareholders also must tender their shares as part of the agreement.

The deal marks Lilly’s second major oncology purchase in 2022. It paid $1.1 billion earlier in the year access to cancer drug candidates from China’s Zymeworks. With POINT, Lilly is now positioned as a leader across multiple next-wave approaches in the high-stakes race to develop better cancer treatments.

Bruker Pays $108 Million to Acquire Single-Cell Biology Firm PhenomeX

Posted on by slightbourne@noblecapitalmarkets.com

Life science tools provider Bruker Corporation is expanding into the hot field of single-cell analysis through the acquisition of PhenomeX in an all-cash deal valued at around $108 million. Bruker aims to complement its existing microscopy and proteomics businesses by adding PhenomeX’s platforms for studying gene and protein expression in individual cells.

PhenomeX itself was formed just this year through the merger of two prior companies, Berkeley Lights and IsoPlexis. The combined entity offers instruments, software, and reagents to examine the genotype and phenotype of single cells in high throughput.

This enables researchers to link specific cellular traits to underlying genetics and molecular characteristics. It provides a valuable window into cell function relevant to disease as well as development of new therapies.

Bruker cited antibody discovery, cell line engineering, and cell and gene therapy as prime application areas that are fueling rapid growth in the single-cell analysis market. The company pointed to the over 400 systems PhenomeX already has installed at customers as evidence of strong demand.

PhenomeX’s key technology is its Beacon Optofluidic System, which can assess the behavior of tens of thousands of individual cells in parallel while keeping them alive for further genomic analysis. The IsoLight and IsoSpark systems complement this by measuring protein expression in each cell.

Bruker views the acquisition as a launching point into the single-cell biology space, which it called a natural adjacency to its existing fluorescence microscopy offerings. The company has begun expanding beyond its core analytical instrumentation business into faster-growth life science markets.

But some analysts questioned the hefty valuation Bruker paid, amounting to a 90% premium over PhenomeX’s stock price prior to the merger announcement of its predecessor companies. While the technology is cutting-edge, PhenomeX remains an early-stage business posting minimal revenue.

Bruker may need to invest significantly more over years to fully commercialize PhenomeX’s products and turn it into a growth contributor. But the opportunity to lead a new market niche ultimately justified the price.

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

Single-cell analysis has become one of the hottest areas within the life sciences amid the precision medicine revolution. Researchers are realizing individual cells often differ genetically and behave differently even within the same tissue sample. Analyzing them as a group obscures key insights.

By examining each cell’s genotype and phenotypic traits individually, links can be drawn to implicate specific genes in cellular functions relevant to diseases like cancer. This enables more targeted drug discovery.

The market is still in its early days but is on a steep growth trajectory as biopharma companies incorporate single-cell capabilities into their R&D. Bruker already enjoys strong relationships through its existing product lines and now gains a foothold to capitalize.

Meanwhile, gaining Bruker’s global commercial infrastructure and resources provides a major boost to PhenomeX, which was formed through the merger of two startups. Having an established industry leader backing its technology and lowering R&D risks strengthens its prospects.

For Bruker investors, the purchase expands the company’s total addressable market by billions in the coming years. While not yet profitable, PhenomeX offers a bridge into a complementary fast-growing segment aligned with Bruker’s strengths.

The deal is the largest in Bruker’s recent spate of acquisitions to reshape itself beyond analytical tools into a more diversified life sciences player. It mirrors consolidation in the broader market as major instrumentation firms seek more exposure to biopharma and cell-based research markets.

If Bruker can successfully integrate and scale up PhenomeX’s platform, the $108 million price tag may prove to be a bargain entry point into the booming single-cell analysis space.

Release – Comtech to Report Fourth Quarter Fiscal 2023 Results on October 12, 2023

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CMTL

BY THE COMTECH EDITORIAL TEAM – OCT 3, 2023 | 2 MIN READ

MELVILLE, N.Y. –
October 3, 2023– Comtech (NASDAQ: CMTL) today announced that it plans to release its fourth quarter fiscal 2023 and full year results after the market closes on Thursday, October 12, 2023.

At 5:00 p.m. ET that day, Ken Peterman, Comtech’s Chief Executive Officer and President, will hold a conference call to discuss the Company’s fourth quarter fiscal 2023 and full year results, operations, and business trends. A real-time webcast of the call will be available to the public at the investor relations section of the Comtech web site at www.comtech.com. Alternatively, investors can access the conference call by dialing (800) 579-2543 (domestic) or (785) 424-1789 (international) and using the conference I.D. of “Comtech.” A replay of the call will also be available by dialing (800) 839-3020 or (402) 220-7234 through Thursday, October 26, 2023.

About Comtech

Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, satellite and space communications technologies, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.

Forward-Looking Statements

Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.

PCMTL

View source version on businesswire.com: https://www.businesswire.com/news/home/20231003217522/en/

Comtech Investor Relations

Robert Samuels

631-962-7102

robert.samuels@comtech.com

Release – U.S. Army Awards Comtech $48.6 Million for Next Generation EDIM SATCOM Solutions

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CMTL

BY THE COMTECH EDITORIAL TEAM – OCT 3, 2023 | 2 MIN READ

Comtech EDIM to Become One of the Primary Solutions Used for U.S. Military SATCOM

MELVILLE, N.Y. –
October 3, 2023– Comtech (NASDAQ: CMTL) announced today the company was recently awarded a $48.6 million contract to deliver Enterprise Digital Intermediate Frequency Multi-Carrier (EDIM) modems in support of U.S. Army satellite communications (SATCOM) digitization and modernization programs.

Under the contract, Comtech will design, develop, test, and deliver EDIM units and provide hardware, software, and sustainment services to support performance enhancements for EDIM solutions. Comtech’s EDIM modems are designed to support multiple satellite providers and will become one of the primary modems used for U.S. military SATCOM.Comtech’s EDIM modems will also replace the aging Enhanced Bandwidth Efficient Modem (EBEM) currently supporting Army, Navy, and Air Force SATCOM users with an advanced digital and software-defined platform.

“Our EDIM SATCOM modems are designed to enable the Department of Defense (DoD) to move to digitized, hybrid satellite network architectures-enabling warfighters to easily roam across orbital regimes and blend capabilities from traditionally disparate networks to maintain an information advantage in the world’s most challenging geographies,” said Ken Peterman, President and CEO, Comtech. “This strategic contract award further illustrates the trust of our DoD customers and Comtech’s ability to deliver innovative software-defined solutions that meet the mission demands of today and can easily adapt to meet the operational needs of the future. Our EDIM modems are designed to continuously evolve over time with the ability to introduce performance enhancements and new blended services that can reduce operator burden and significantly enhance all-domain mission effectiveness.”

Built on open architecture standards, Comtech’s EDIM solutions are designed to be easily integrated with other terrestrial and non-terrestrial communications systems to enabled unified hybrid network infrastructures that will bring forward a new era of blended, smart-enabled connectivity.

Comtech’s portfolio of defense technologies and services, including those provided under this contract, are uniquely designed to align with Space Force Enterprise SATCOM vision and deliver capabilities that will enhance Combined Joint All Domain Command and Control operations. Comtech’s expansive portfolio of defense and security technologies is designed to continuously evolve over time to enable digitalized SATCOM ground network infrastructures; introduce 5G, 5G advanced and 6G capabilities; and integrate Comtech’s proven Dynamic Cloud Platform services across blended terrestrial, non-terrestrial, military and commercial networks to significantly enhance mission effectiveness in future all-domain operations.

About Comtech

Comtech Telecommunications Corp. is a leading global technology company providing terrestrial and wireless network solutions, next-generation 9-1-1 emergency services, satellite and space communications technologies, and cloud native capabilities to commercial and government customers around the world. Our unique culture of innovation and employee empowerment unleashes a relentless passion for customer success. With multiple facilities located in technology corridors throughout the United States and around the world, Comtech leverages our global presence, technology leadership, and decades of experience to create the world’s most innovative communications solutions.For more information, please visit www.comtech.com.

Forward-Looking Statements

Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results and performance could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.

PCMTL

Investor Relations

Robert Samuels

631-962-7102

robert.samuels@comtech.com

Media Contact

Jamie Clegg

480-532-2523

jamie.clegg@comtech.com

Release – Defense Metals Commences Phase 2 Infrastructure Sonic, Open Pit Geotechnical, and Exploration Target Core Drilling at Wicheeda Rare Earth Element Project

Posted on by aweinsoff@channelchek.com

Research News and Market Data on DFMTF

VANCOUVER, BC, Oct. 3, 2023 /CNW/ – Defense Metals Corp. (“Defense Metals” or the “Company“; (TSXV: DEFN) (OTCQB: DFMTF) (FSE: 35D) is pleased to announce it has commenced Phase 2 of its planned infrastructure and open pit geotechnical drilling. Sonic overburden characterization (site infrastructure geotechnical) and diamond core drilling (open pit geotechnical and near resource exploration) is expected to be complete within 4 to 6 weeks, with results to follow. The work, with the support of the Defense Metals’ technical team and APEX Geoscience Ltd., is being completed by SRK Consulting (Canada) Inc. (“SRK“) one of the principal consultants for the preliminary feasibility study (“PFS“) regarding the Company’s Wicheeda Rare Earth Element (REE) Project located near Prince George, Canada.

Image 1: Sonic Infrastructure Geotechnical Drilling Underway Within WSF Area (CNW Group/Defense Metals Corp.)
Image 2: Geotechnical Drill Core from Hole WI23-80 Wicheeda REE Deposit Open Pit Highwall (CNW Group/Defense Metals Corp.)

Craig Taylor, CEO of Defense Metals, commented:

“We are pleased to commence Phase 2 geotechnical investigations. This work will provide critical inputs for the ongoing PFS study, and in the case of exploration targets have the potential to expand resources. The Company’s technical teams and principal Engineering contractors continue to push forward keeping us on track for a planned PFS completion by the end of Q2 2024.” 

As previously reported (see Defense Metals news release dated August 16, 2023) the SRK geotechnical investigation includes the following scopes:

  • Geotechnical engineering (waste rock, tailings, contact water pond, and site infrastructure geotechnical investigation),
  • Tailings alternative assessment prior to advancing into PFS-level design of a preferred alternative, and
  • Geochemical characterization (to support mine planning/waste management and to develop preliminary water chemistry predictions for the main mine facilities).

Currently two rigs, sonic and core drills, are operating at the Project, with sonic operations focused on overburden and bedrock characterization within the potential waste rock storage (WSF) footprint (see Image 1), and geotechnical core drilling underway with the east highwall of the proposed open pit (see Image 2).

With WSF drilling nearing completion, sonic operations are expected to transition to the proposed contact water pond (CWP), and crusher and conveyor footprints, followed by tailing storage facility (TSF) and TSF alternative geotechnical investigations.

In pit geotechnical core drilling will progress from current drilling on the east highwall, followed by south, north, and west pit walls. Drilling into the south pit wall is expected to collar in REE mineralized dolomite carbonatite. In addition, geotechnical core drilling of the west pit wall is co-purposed with testing of a high priority ground radiometric geophysical anomaly with the potential to represent undiscovered carbonatite body (see Defense Metals’ news release dated September 5, 2023).

Qualified Person

The scientific and technical information contained in this news release as it relates to the Wicheeda REE Project has been reviewed and approved by Kristopher J. Raffle, P.Geo. (B.C.), Principal and Consultant of APEX Geoscience Ltd. of Edmonton, Alberta, who is a director of Defense Metals and a “Qualified Person” as defined in NI 43-101. 

About the Wicheeda REE Property

Defense Metals 100% owned, 6,759-hectare (~16,702-acre) Wicheeda Project is located approximately 80 km northeast of the city of Prince George, British Columbia; population 77,000. The Wicheeda REE Project is readily accessible by all-weather gravel roads and is near infrastructure, including hydro power transmission lines and gas pipelines. The nearby Canadian National Railway and major highways allow easy access to the port facilities at Prince Rupert, the closest major North American port to Asia.

About Defense Metals Corp.

Defense Metals Corp. is a mineral exploration and development company focused on the development of its 100% owned Wicheeda Rare Earth Element Deposit located near Prince George, British Columbia, Canada. Defense Metals Corp. trades on the TSX Venture Exchange under the symbol “DEFN”, in the United States, trading symbol “DFMTF” on the OTCQB and in Germany on the Frankfurt Exchange under “35D”.

Defense Metals is a proud member of Discovery Group. For more information please visit: http://www.discoverygroup.ca/

For further information, please visit www.defensemetals.com or contact:

Todd Hanas, Bluesky Corporate Communications Ltd.
Vice President, Investor Relations
Tel: (778) 994 8072
Email: todd@blueskycorp.ca

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.

Cautionary Statement Regarding “Forward-Looking” Information

This news release contains “forward‐looking information or statements” within the meaning of applicable securities laws, which may include, without limitation, statements relating to advancing the Wicheeda REE Project, the expected completion of the PFS and the expected timeline, the completion and expected timelines for sonic and geotechnical drilling and the expected results and outcomes (including the potential for undiscovered carbonatite), the technical, financial and business prospects of the Company, its project and other matters. All statements in this news release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Such statements and information are based on numerous assumptions regarding present and future business strategies and the environment in which the Company will operate in the future, including the price of rare earth elements, the anticipated costs and expenditures, accuracy of assay results, performance of available laboratory and other related services, future operating costs, interpretation of geological and metallurgical data, the ability to achieve its goals, that general business and economic conditions will not change in a material adverse manner, that financing will be available if and when needed and on reasonable terms. Such forward-looking information reflects the Company’s views with respect to future events and is subject to risks, uncertainties and assumptions, including the risks and uncertainties relating to the interpretation of exploration and metallurgical results, risks related to the inherent uncertainty of exploration, metallurgy and development and cost estimates, the potential for unexpected costs and expenses and those other risks filed under the Company’s profile on SEDAR at www.sedarplus.ca. While such estimates and assumptions are considered reasonable by the management of the Company, they are inherently subject to significant business, economic, competitive and regulatory uncertainties and risks. Factors that could cause actual results to differ materially from those in forward looking statements include, but are not limited to, continued availability of capital and financing and general economic, market or business conditions, adverse weather and climate conditions, failure to maintain or obtain all necessary government permits, approvals and authorizations, failure to maintain community acceptance (including First Nations), risks relating to unanticipated operational difficulties (including failure of equipment or processes to operate in accordance with specifications or expectations, cost escalation, unavailability of personnel, materials and equipment, government action or delays in the receipt of government approvals, industrial disturbances or other job action, and unanticipated events related to health, safety and environmental matters), risks relating to inaccurate geological, metallurgical and engineering assumptions, decrease in the price of rare earth elements, the impact of Covid-19 or other viruses and diseases on the Company’s ability to operate, an inability to predict and counteract the effects of COVID-19 and other viruses and diseases on the business of the Company, the price of commodities, capital market conditions, restriction on labour and international travel and supply chains, loss of key employees, consultants, or directors, increase in costs, delayed results, litigation, and failure of counterparties to perform their contractual obligations. The Company does not undertake to update forward‐looking statements or forward‐looking information, except as required by law.

SOURCE Defense Metals Corp.

Release – PDS Biotech Announces Interim 24-Month Survival Rate of 74% in Immune Checkpoint Inhibitor Naïve Head and Neck Cancer Patients Treated with PDS0101 in Combination with KEYTRUDA® (pembrolizumab)

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

  • Interim VERSATILE-002 data for the first-line treatment of recurrent or metastatic head and neck cancer patients who were immune checkpoint inhibitor (ICI) naïve; published 24-month survival rate of less than 30% for approved ICI1.
  • Received feedback from US Food and Drug Administration (FDA) on the Company’s amended Investigational New Drug (IND) application allowing initiation of VERSATILE-003 Phase 3 trial in the fourth quarter of 2023.
  • 12-month overall survival (OS) rate of 56% in ICI refractory patients; published median 12-month OS rate of 17% with no salvage chemotherapy following tumor progression on ICI (ICI Refractory)2*.
  • Well tolerated with no patients having Grade 4 or 5 combination treatment-related adverse events.
  • Interim VERSATILE-002 data and VERSATILE-003 Phase 3 trial design to be discussed during Key Opinion Leader (KOL) Roundtable today at 8:00 a.m. EDT.

PRINCETON, N.J., Oct. 03, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced updated interim data based on an August 2nd cut off from the VERSATILE-002 Phase 2 clinical trial evaluating PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with unresectable, recurrent, or metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC). VERSATILE-002 is investigating two patient populations whose cancer has returned or spread – ICI naïve and ICI refractory. The ICI naïve group had not responded to standard-of-care treatments but had not yet been treated with an ICI. The ICI refractory group included patients who had not responded to multiple prior treatments, including ICI therapy. Data presented at ASCO was based on a January 13th cut off.

“The updated interim data from our VERSATILE-002 clinical trial further validates the potential of PDS0101 when combined with KEYTRUDA® to address the urgent need for more effective therapies that are well tolerated and allow advanced recurrent and metastatic HPV16-positive head and neck cancer patients to live significantly longer lives than current approaches,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “Following feedback from the FDA, we look forward to evaluating this promising combination treatment in the VERSATILE-003 Phase 3 clinical trial, which we expect to initiate in the fourth quarter of 2023. VERSATILE-003 will investigate the efficacy and safety of PDS0101 combined with KEYTRUDA® compared to KEYTRUDA® monotherapy in ICI-naïve patients with recurrent or metastatic HPV16-positive HNSCC. The primary endpoint for the study will be overall survival.”

VERSATILE-002: ICI Naïve

Highlights of the interim data from the ICI naïve cohort include:

  • 24-month overall survival (OS) rate is 74%; published 24-month survival rate of less than 30% for approved ICI1.
  • 12-month OS rate is 80%; published results of 30-50% with approved ICIs1.
  • Tumor shrinkage seen in 60% (31/52) of patients.
  • Confirmed overall response rate (ORR) is 27% (14/52) to date.
  • Median progression-free survival (PFS) is 8.1 months to date; published results of 2-3 months PFS with approved ICIs1.
  • 13% (8/62) of patients experienced Grade 3 treatment-related adverse events (TRAE) and 0% (0/62) experienced Grade 4 or 5 TRAE; published results report 13-17% Grade 3-5 TRAE with approved ICI monotherapy1.
  • 60% (33/55) of patients have CPS score of 1-19 (who generally have a weaker response to KEYTRUDA®), and 40% (22/55) have CPS score >20 (who generally have a higher response to KEYTRUDA®).

VERSATILE-002: ICI Refractory

The goal of this ICI refractory cohort was to confirm and to better understand the role of PDS0101 in prolonging the survival of advanced HPV16-positive head and neck cancer patients who received PDS0101 in combination with KEYTRUDA®. This analysis is also intended to provide insight to the contribution of PDS0101 to overall survival in the National Cancer Institute-led study evaluating the combination of PDS0101, PDS0301 (antibody conjugated IL12), and an ICI.

Highlights of the interim data from the ICI refractory cohort include:

  • The 12-month OS rate is 56%. The published median 12-month OS rate is 17% with no salvage chemotherapy following tumor progression on ICI (ICI Refractory)2*.
  • 0% (0/21) confirmed ORR suggests that PDS0101’s impact on survival does not appear to be dependent on tumor shrinkage.
  • 4% (1/25) of patients experienced Grade 3 TRAE and 0% (0/21) patients experienced Grade 4 and 5 TRAE.

“We are pleased with the OS results and knowledge gained from the ICI refractory cohort of VERSATILE-002. In agreement with our Data Monitoring Committee (DMC), we will not progress to stage 2 of this cohort in VERSATILE-002. As previously announced, we have no plans to further develop this combination for ICI refractory patients,” said Lauren V. Wood, MD, Chief Medical Officer of PDS Biotech. “PDS0101 appears to immunologically alter the patient’s tumor microenvironment to promote survival. This important data will help inform our development plans for PDS0101.”

Key Opinion Leader Roundtable
Today, Tuesday, October 3, 2023, from 8:00 – 9:00 AM EDT, the Company will host a Key Opinion Leader (KOL) Roundtable on Addressing Current and Future Treatments for Recurrent/Metastatic Human Papillomavirus (HPV)-Positive Head and Neck Squamous Cell Carcinoma (HNSCC) and the Potential Application of PDS0101, including a discussion of the interim data from the VERSATILE-002 trial.

A live webcast of the event will be available online in the Investor Relations section of the Company’s website at https://www.pdsbiotech.com/index.php/investors. A replay will be available for 90 days following the webcast.

1*Ferris R.L., Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck; N Engl J Med 2016; 375:1856-1867; Burtness B et al., Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE- 048): a randomized, open-label phase 3 study; Lancet 2019; 394(10212):1915-1928. *No control or comparative studies have been conducted between immune checkpoint inhibitors and PDS0101.
https://www.opdivo.com/head-and-neck-cancer
https://www.keytruda.com/head-and-neck-cancer/keytruda-clinical-trials/
2Bila M, Van Dessel J, Smeets M, Vander Poorten V, Nuyts S, Meulemans J, Clement PM. A Retrospective Analysis of a Cohort of Patients Treated With Immune Checkpoint Blockade in Recurrent/Metastatic Head and Neck Cancer. Front Oncol. 2022 Jan 27;12:761428. doi: 10.3389/fonc.2022.761428. PMID: 35155226; PMCID: PMC8828639. *No controlled or comparative studies have been conducted between PDS0101 and no salvage chemotherapy.

About PDS0101
PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically active immune responses, and the combination of PDS0101 with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

About VERSATILE-002
VERSATILE-002 is a single-arm Phase 2 trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech’s proprietary Versamune® technology, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab).The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve and ICI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.

About VERSATILE-003
The VERSATILE-003 Phase 3 clinical trial is a randomized, active comparator-controlled study designed to investigate the safety and efficacy of PDS0101 combined with KEYTRUDA® compared to KEYTRUDA® monotherapy in ICI-naïve patients with recurrent or metastatic HPV16-positive HNSCC. The primary efficacy endpoint for VERSATILE-003 is overall survival. The Phase 3 study is expected to involve approximately 90-100 clinical sites globally.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

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

Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

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

Release – InPlay Oil Corp. Confirms Monthly Dividend for October 2023

Posted on by aweinsoff@channelchek.com

Research News and Market Data on IPOOF

CALGARY, AB, Oct. 2, 2023 /CNW/ – InPlay Oil Corp. (TSX: IPO) (OTCQX: IPOOF) (“InPlay” or the “Company”) is pleased to confirm that its Board of Directors has declared a monthly cash dividend of $0.015 per common share payable on October 31, 2023, to shareholders of record at the close of business on October 16, 2023. The monthly cash dividend is expected to be designated as an “eligible dividend” for Canadian federal and provincial income tax purposes.

About InPlay Oil Corp.

InPlay is a junior oil and gas exploration and production company with operations in Alberta focused on light oil production. The company operates long-lived, low-decline properties with drilling development and enhanced oil recovery potential as well as undeveloped lands with exploration possibilities. The common shares of InPlay trade on the Toronto Stock Exchange under the symbol IPO and the OTCQX Exchange under the symbol IPOOF.

www.inplayoil.com

SOURCE InPlay Oil Corp.

For further information: Doug Bartole, President and Chief Executive Officer, InPlay Oil Corp., Telephone: (587) 955-0632; Darren Dittmer, Chief Financial Officer, InPlay Oil Corp., Telephone: (587) 955-0634

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.

Labrador Gold Corp. (NKOSF) – Drilling to Resume Next Week

Posted on by cpereira@noblefcm.com


Tuesday, October 03, 2023

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

The final stretch. Drilling at Labrador Gold’s 100%-owned Kingsway gold project is targeting the Appleton Fault over a 12-kilometer strike length. The drilling is part of the company’s ongoing 100,000-meter diamond drilling program of which 83,000 meters of drilling has been completed. The company is beginning to receive assays back from the laboratory for samples from approximately 8,877 meters of core which will be released in batches once they have been interpreted. With ~C$11.5 million in cash, Labrador Gold is well-funded to complete the remaining 17,000 meters of planned drilling.

Drilling resumes next week. Labrador Gold expects to resume drilling next week with three rigs. Drilling will target the Gap Zone between the Big Vein and Pristine targets, the Knobby Occurrence, and the Golden Glove target. Permits have been received to drill in the Gap Zone and in the area south of the Big Vein target to the southern boundary of the property which encompasses the Knobby Occurrence and Golden Glove. 


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The $8 Billion Trial of Fallen Crypto Titan Sam Bankman-Fried Begins

Posted on by slightbourne@noblecapitalmarkets.com

The criminal trial of Sam Bankman-Fried, the disgraced founder of bankrupt crypto exchange FTX, kicks off on Tuesday in New York. Bankman-Fried faces seven charges related to allegedly misusing billions in customer funds to cover losses at his hedge fund, Alameda Research. If convicted on all counts, he could face over 100 years in prison.

The charges include wire fraud, conspiracy to commit wire fraud, securities fraud, conspiracy to commit money laundering, and conspiracy to commit bank fraud. Prosecutors claim Bankman-Fried orchestrated “one of the biggest financial frauds in American history” by funneling customer deposits from FTX to Alameda to cover bad bets.

Up to $8 billion in customer money has allegedly gone missing. The government’s star witnesses will likely be former Alameda CEO Caroline Ellison and FTX co-founder Gary Wang, both of whom have pleaded guilty to charges and are cooperating.

The trial is anticipated to last 6 weeks. Jury selection begins Tuesday morning. Bankman-Fried has pleaded not guilty, and his defense may argue he was following lawyer guidance and unaware his actions were illegal. A second trial on additional charges is set for March 2024.

The Rise and Fall of Sam Bankman-Fried

Bankman-Fried first made his name in 2017 exploiting arbitrage opportunities in bitcoin prices across exchanges. He launched trading firm Alameda Research to capitalize on these trades. Alameda’s success led to the 2019 founding of FTX, which offered innovative crypto trading products.

Bankman-Fried amassed a $26 billion personal fortune at one point. He became a major political donor and crypto’s poster child. But in 2022, as crypto prices crashed, his empire crumbled. Regulators allege Bankman-Fried secretly used FTX customer deposits to cover Alameda’s losses from the start.

Though FTX claimed to have robust risk management, it had little record-keeping. Alameda lost $3.7 billion despite claims it was profitable. It used FTX customer funds and overvalued FTT tokens as collateral for billions in loans. Lenders issued margin calls in 2022, but Alameda lacked assets to cover debts.

The Collapse and Charges

When FTX’s reliance on customer funds was exposed, customers raced to withdraw. But FTX didn’t have their money. Bankman-Fried tried unsuccessfully to find investors for a bailout. He claimed publicly that assets were fine, but privately admitted billions were missing. FTX paused withdrawals, and Bankman-Fried turned to rival Binance for a takeover.

But the deal fell through as the extent of missing funds and mismanagement was revealed. Bankman-Fried resigned, and FTX filed bankruptcy on November 11, 2022. The DOJ arrested Bankman-Fried in the Bahamas in December on fraud and money laundering charges. Prosecutors allege he knowingly misled investors and misused billions in customer deposits from the very start.

Billions Remain Missing

While FTX’s bankruptcy team has recovered over $7 billion so far, billions more in customer funds remain unaccounted for. Bankman-Fried was previously hailed as an effective altruist who touted crypto’s potential for good. But regulators say greed and deception drove FTX from the beginning. The human toll of lost life savings won’t be fully known for some time.

Bankman-Fried now faces the prospect of spending most of his life in prison. The outcome of the trial could shape crypto regulation going forward. But the damage to retail investors and confidence in the industry has already been done. Crypto may never fully shed the stain of FTX’s epic collapse.

Bond Market Signals Recession Warning As Yields Invert

Posted on by slightbourne@noblecapitalmarkets.com

The bond market is sounding alarm bells about the economic outlook. The yield on the 2-year Treasury briefly exceeded the 10-year yield this week for the first time since 2019. Known as a yield curve inversion, this phenomenon historically signals a recession could be on the horizon.

While not a guarantee, yield curve inversions have preceded every recession over the past 50 years. Here is what is happening in the bond market and what it could mean for investors.

Why Did Yields Invert?

Yields on short-term bonds like 2-year Treasuries tend to track the Federal Reserve’s policy rate. With the Fed aggressively hiking rates to combat inflation, short-term yields have been rising quickly.

Meanwhile, long-term yields like the 10-year are influenced by investors’ growth and inflation expectations. As optimism over the economy’s trajectory wanes, investors have been driving down long-term yields.

This dynamic inversion, where short-term rates exceed longer-duration ones, reflects mounting concerns that the Fed’s rate hikes will severely slow economic activity. Markets increasingly fear rates may cause a hard landing into recession.

Image credit: Cnbc.com

Growth and Inflation Concerns Intensify

The yield curve has flashed the most negative signal since the lead up to the pandemic recession. This suggests investors see a lack of catalysts for growth on the horizon even as inflation remains stubbornly high.

Ongoing supply chain problems, the war in Ukraine putting pressure on food and energy prices, and fears of a housing market slowdown are all weighing on outlooks. There is a sense the Fed lacks effective tools to bring down inflation without crushing the economy.

Meanwhile, key economic indicators like manufacturing surveys have weakened significantly. This points to activity already slowing ahead of when rate hikes would take full effect.

Implications for Investors

The risks of a recession are rising. Yield curve inversions have foreshadowed every recession since the 1950s. However, they have also sometimes occurred 1-2 years before downturns start.

This suggests investors should prepare for choppiness, but not panic. Rotating toward more defensive stocks like healthcare and consumer staples can help portfolios better weather volatility. At the same time, cyclical sectors like tech and industrials could face more pressure.

In fixed income, short-term bonds may offer opportunities as the Fed potentially cuts rates during a downturn. But credit-sensitive sectors like high-yield bonds and leveraged loans could struggle if defaults rise.

While uncertainty abounds, the inverted yield curve highlights the delicate balancing act ahead for the Fed and concerns over still-high inflation. Investors will be closely watching upcoming data for signs of how quickly the economy is slowing. For now, caution and safe-haven assets look to be in favor as recession worries cast a long shadow.

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.