Month: June 2024

Cadrenal Therapeutics (CVKD) – Data Presentation From LVAD Study Points Out The Need For Tecarfarin

Posted on by cpereira@noblefcm.com


Wednesday, June 05, 2024

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

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

Patients With LVADs Need A New Anticoagulant. A new analysis of anticoagulant regimens from a study in cardiovascular devices patients was presented at the International Society of Heart and Lung Transplantation Annual Meeting. The presentation included data from the ARIES-HM3 study testing anticoagulation with warfarin and aspirin against warfarin alone. We believe the data highlights the need for tecarfarin in left ventricular assist device (LVAD) patients.

Abbott Has An Interest In LVAD Patient Outcomes. The ARIES-HM3 study was sponsored by Abbott (ABT, Not Rated), maker of the HeartMate3 LVAD. Patients with these devices cannot take DOAC anticoagulant drugs, leaving them with only warfarin. The study tested warfarin (a vitamin K antagonist, VKA) with and without aspirin. The findings showed lower time in the therapeutic range (TTR) is a predictor of excessive bleeding events, and warfarin patients are typically below target values.


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Eskay Mining and P2 Gold Merge to Become New Golden Triangle Force

Posted on by slightbourne@noblecapitalmarkets.com

In a move to create a new exploration player focused on British Columbia’s mineral-rich Golden Triangle, Eskay Mining Corp. and P2 Gold Inc. have agreed to join forces through an all-share merger. The combined company will also gain a foothold in Nevada’s Walker Lane Trend through P2’s Gabbs gold-copper project.

Under the terms of the deal announced Monday, P2 Gold shareholders will receive 0.2778 Eskay shares for each P2 share they hold. When the transaction closes, expected by October 31st, existing Eskay shareholders will own approximately 80% of the combined company, with P2 investors holding the remaining 20%.

The merger brings together two mineral exploration companies with complementary assets and expertise in prolific mining jurisdictions. Eskay’s flagship asset is its Eskay-Corey property, a large 52,600 hectare land package located in the heart of the Golden Triangle of northwestern British Columbia. This region has gained prominence in recent years due to successful mine developments by companies like Pretivm, Seabridge Gold, and others operating in the area.

P2 Gold, meanwhile, holds the Gabbs project in Nevada’s Walker Lane mineral belt. A 2022 preliminary economic assessment outlined a potentially robust mid-sized open pit mine at Gabbs producing over 100,000 ounces of gold and 13,500 tonnes of copper annually over a 14-year mine life. The deal provides the combined company with a more advanced, development-stage asset to complement Eskay’s exploration upside in the Golden Triangle.

The current Eskay CEO, who will transition to the role of Chair for the merged entity, touted it as a significant step toward finding the next major discovery in the Golden Triangle region. He praised the P2 team’s track record of strong exploration results in the area.

The current P2 President and CEO, who previously helped discover and develop Pretivm’s high-grade Brucejack gold mine in the Golden Triangle, will take the helm as CEO of the as-yet unnamed combined company. P2 has already been contracted to plan and execute the 2024 exploration program at Eskay-Corey under an exploration services agreement.

In addition to exploration upside, the merger is expected to provide improved access to capital markets for funding the advancement of the companies’ project portfolio. As single assets, Eskay and P2’s respective market caps were around C$40 million each, limiting their ability to raise funds for major programs.

One investment manager sees the deal unlocking value, stating the combined company will have much more relevance and reduce single asset risk, putting it on the radar for more institutional investors and funds.

Prior to closing, P2 Gold will settle approximately $1.7 million in outstanding convertible debentures and $1.2 million in shareholder loans through share issuances. The transaction remains subject to shareholder approvals from both companies as well as regulatory and court approvals.

The merger continues the wave of consolidation across the mining sector, as companies seek economies of scale and diversified asset bases. If successful, the combined Eskay-P2 entity will aim to leverage its exploration and development expertise to establish new mines in mining-friendly North American jurisdictions.

Private Hiring Slows More Than Expected as Labor Market Cools

Posted on by slightbourne@noblecapitalmarkets.com

The red-hot U.S. labor market showed further signs of cooling in May as private hiring slowed more than anticipated, according to the latest employment report from payroll processor ADP.

Companies added just 152,000 jobs last month, coming in well below economist projections of a 175,000 increase. It marked the lowest level of monthly job gains since January and a notable deceleration from April’s downwardly revised 188,000 figure.

The ADP report, which captures private payroll changes but not government hiring, suggests the robust labor market demand that has characterized the pandemic recovery is moderating amid higher interest rates, still-elevated inflation, and growing economic uncertainty.

“Job gains and pay growth are slowing going into the second half of the year,” said Nela Richardson, ADP’s chief economist. “The labor market is solid, but we’re monitoring notable pockets of weakness tied to both producers and consumers.”

A Shift Toward Services
While goods-producing sectors like manufacturing, mining, and construction have driven solid hiring for much of the recovery, last month they contributed only 3,000 net new jobs.

Job creation was instead carried by services industries, led by trade/transportation/utilities with 55,000 new positions. Other strong areas included education/health services (+46,000), construction (+32,000), and other services (+21,000).

However, even within services there were weak spots, including the previously booming leisure/hospitality sector which saw just a 12,000 job gain in May. Professional/business services also posted a decline.

Manufacturers Slashing Payrolls
The report highlighted particular softness in the manufacturing sector, which shed 20,000 jobs last month amid a broader industrial slowdown.

Factories have been cutting payrolls for most of the past 18 months as higher material and energy costs, supply chain disruptions, and softening demand weighed on production. The sector has contracted in seven of the last eight months, according to survey data.

Regional manufacturing indexes have also pointed to slowing activity and employment levels, including the latest readings from the Dallas and Richmond Federal Reserve districts.

Small Businesses Feeling the Pinch
Companies with fewer than 50 employees were disproportionately impacted in May, seeing a net decrease in headcounts. Those with 20-49 workers reduced staffing levels by 36,000.

The pullback at smaller firms underscores how rapidly tightening financial conditions and ebbing consumer demand have started to squeeze profits and required some businesses to adjust their workforce levels.

Annual Pay Growth Steady at 5%
Despite some loss of momentum in overall hiring, the ADP report showed private wage growth stayed on a 5% annual trajectory last month, holding steady at that level for a third consecutive period.

The elevated but moderating pace of pay increases suggests employers are still working to attract and retain staff even as overall job creation starts to wane from its torrid pandemic-era pace.

While a single data point, the ADP release could preview what’s to come from the more comprehensive government nonfarm payrolls report due out Friday. Economists expect that report to show a 190,000 increase in total U.S. payrolls for May, slowing from April’s 253,000 gain.

As borrowing costs continue climbing and spending softens, further hiring deceleration across both goods and services sectors seems likely in the months ahead, though an outright decline remains unlikely based on most economic projections.

Nvidia’s AI-Driven Stock Split Could Unlock New Investor Appeal and Dow Jones Potential

Posted on by slightbourne@noblecapitalmarkets.com

As the semiconductor industry’s unrivaled leader in artificial intelligence, Nvidia (NASDAQ: NVDA) has become a Wall Street sensation in recent years. The company’s latest strategic move – a 10-for-1 stock split – could further amplify its appeal to both individual investors and the prestigious Dow Jones Industrial Average.

The announcement of Nvidia’s stock split, effective June 7th, comes on the heels of the company’s blockbuster Q1 2024 earnings report. With revenue and forecasts exceeding analyst expectations, Nvidia’s shares have more than doubled so far this year, solidifying the chipmaker’s status as a bona fide tech titan.

Lowering the Barrier to Entry for Retail Investors
Nvidia’s decision to split its stock could open the doors wider for individual, or “retail,” investors to participate in the company’s AI-driven growth story. By reducing the per-share price from around $1,040 to approximately $104, the split makes Nvidia’s stock more accessible to investors with smaller trading accounts.

Analysts believe the lower price point could spark greater interest from retail investors, who typically trade in smaller lots compared to institutional investors. Currently, Nvidia is the most heavily weighted stock in the average retail trading portfolio, accounting for 9.3% of holdings – a figure that has more than doubled from a year ago.

While many retail investors can already buy fractional shares, the lower price could still make Nvidia more appealing to those without access to such features. The reduced share price could make Nvidia’s stock “less of an obstacle” for these investors, according to one expert.

Paving the Way for Dow Jones Inclusion
In addition to attracting more retail interest, Nvidia’s stock split could also improve the company’s prospects for inclusion in the prestigious Dow Jones Industrial Average. As a price-weighted index, the Dow favors lower-priced stocks, and Nvidia’s current share price of around $1,040 would make it the second-largest component, behind only UnitedHealth Group.

However, after the split, Nvidia’s share price would fall to approximately $104, making it the 21st-largest stock in the Dow, just behind Merck and ahead of Walt Disney. This more manageable price point could pave the way for Nvidia’s eventual inclusion in the blue-chip index.

Analysts believe Nvidia “checks all the boxes” for Dow Jones inclusion, citing the company’s strong reputation, history of sustained growth, investor appeal, and sector representation.

A Potential Boost for Shareholder Returns
Historically, companies that announce stock splits have tended to outperform the market. According to an analysis from Bank of America Global Research, stocks announcing splits have seen their shares rise an average of 25.4% over the following 12 months, compared to an 11.9% increase for the S&P 500.

However, it’s important to note that a stock split alone is unlikely to overcome broader market forces that can sway a company’s share price. As evidenced by the selloffs experienced by Amazon and Alphabet in 2022, even after their own stock splits, external factors such as rising interest rates can still weigh heavily on stock performance.

Nonetheless, Nvidia’s stock split announcement comes at a time when the company’s AI dominance has made it a must-have investment for both institutional and individual investors. By making its shares more accessible and potentially paving the way for Dow Jones inclusion, this move could further cement Nvidia’s position as a leading player in the rapidly evolving semiconductor and AI landscapes.

Release – Hemisphere Energy Declares Special Dividend

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on HMENF

Vancouver, British Columbia–(Newsfile Corp. – June 4, 2024) – Hemisphere Energy Corporation (TSXV: HME) (OTCQX: HMENF) (“Hemisphere” or the “Company”) is pleased to announce that its board of directors has approved the declaration of a special dividend to shareholders.

Given the strong financial position and performance outlook of the Company, Hemisphere is pleased to announce that its board of directors has approved the declaration of a special dividend of C$0.03 per common share. The special dividend is part of Hemisphere’s comprehensive shareholder return model, and will be paid on July 26, 2024 to shareholders of record on July 12, 2024. This special dividend is designated as an eligible dividend for Canadian income tax purposes. It is in addition to the Company’s quarterly base dividend of C$0.025 per common share announced on May 29, 2024, and is in accordance with the Company’s dividend policy.

Hemisphere has committed to shareholder returns of $10.7 million thus far in 2024, including shares repurchased and cancelled under the Company’s normal course issuer bid, two quarterly dividend payments in February and June, and the special dividend payment in July. This return of capital is funded entirely by the Company’s free cash flow and is made possible by its high-margin enhanced oil recovery (“EOR”) assets, ultra-low production decline, and healthy balance sheet.

Subsequent to Hemisphere’s last news release, the Company has now brought online all three producers in its new Marsden, Saskatchewan development play. The purpose of primary production at these wells prior to polymer flood start-up is to gather fluid samples, pressure data, and other relevant reservoir data that will assist in EOR project planning. Construction of Hemisphere’s multi-well battery is currently underway, with anticipated polymer skid delivery and EOR project start-up in the third quarter.

About Hemisphere Energy Corporation

Hemisphere is a dividend-paying Canadian oil company focused on maximizing value per share growth with the sustainable development of its high netback, low decline conventional heavy oil assets through polymer flood EOR methods. Hemisphere trades on the TSX Venture Exchange as a Tier 1 issuer under the symbol “HME” and on the OTCQX Venture Marketplace under the symbol “HMENF”.

For further information, please visit the Company’s website at www.hemisphereenergy.ca to view its corporate presentation or contact:

Don Simmons, President & Chief Executive Officer
Telephone: (604) 685-9255
Email: info@hemisphereenergy.ca

Website: www.hemisphereenergy.ca

Forward-looking Statements

Certain statements included in this news release constitute forward-looking statements or forward-looking information (collectively, “forward-looking statements”) within the meaning of applicable securities legislation. Forward-looking statements are typically identified by words such as “anticipate”, “continue”, “estimate”, “expect”, “forecast”, “may”, “will”, “project”, “could”, “plan”, “intend”, “should”, “believe”, “outlook”, “potential”, “target” and similar words suggesting future events or future performance. In particular, but without limiting the generality of the foregoing, this news release includes forward-looking statements including that a quarterly dividend will be paid in June 2024; that a special dividend will be paid to shareholders on July 26, 2024 to shareholders of record on July 12, 2024; and the timing of Hemisphere’s anticipated polymer skid delivery and EOR project start-up in the third quarter.

Forward‐looking statements are based on a number of material factors, expectations or assumptions of Hemisphere which have been used to develop such statements and information, but which may prove to be incorrect. Although Hemisphere believes that the expectations reflected in such forward‐looking statements or information are reasonable, undue reliance should not be placed on forward‐looking statements because Hemisphere can give no assurance that such expectations will prove to be correct. In addition to other factors and assumptions which may be identified herein, assumptions have been made regarding, among other things: the timing for payment of the special dividend; no delays in the anticipated timing for delivery of the polymer skid and EOR project; the general continuance of current industry conditions; the timely receipt of any required regulatory approvals; the ability of Hemisphere to obtain qualified staff, equipment and services in a timely and cost efficient manner; drilling results; the ability of the operator of the projects in which Hemisphere has an interest in to operate the field in a safe, efficient and effective manner; the ability of Hemisphere to obtain financing on acceptable terms; field production rates and decline rates; the ability to replace and expand oil and natural gas reserves through acquisition, development and exploration; the timing and cost of pipeline, storage and facility construction and expansion and the ability of Hemisphere to secure adequate product transportation; future commodity prices; currency, exchange and interest rates; regulatory framework regarding royalties, taxes and environmental matters in the jurisdictions in which Hemisphere operates; and the ability of Hemisphere to successfully market its oil and natural gas products.

The forward‐looking statements included in this news release are not guarantees of future performance and should not be unduly relied upon. Such information and statements, including the assumptions made in respect thereof, involve known and unknown risks, uncertainties and other factors that may cause actual results or events to defer materially from those anticipated in such forward‐looking statements including, without limitation: changes in project timelines and workstreams; changes in commodity prices; changes in the demand for or supply of Hemisphere’s products, the early stage of development of some of the evaluated areas and zones; unanticipated operating results or production declines; changes in tax or environmental laws, royalty rates or other regulatory matters; changes in development plans of Hemisphere or by third party operators of Hemisphere’s properties, increased debt levels or debt service requirements; inaccurate estimation of Hemisphere’s oil and gas reserve volumes; limited, unfavourable or a lack of access to capital markets; increased costs; a lack of adequate insurance coverage; the impact of competitors; and certain other risks detailed from time‐to‐time in Hemisphere’s public disclosure documents, (including, without limitation, those risks identified in this news release and in Hemisphere’s Annual Information Form).

The forward‐looking statements contained in this news release speak only as of the date of this news release, and Hemisphere does not assume any obligation to publicly update or revise any of the included forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by applicable securities laws.

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.

info

SOURCE: Hemisphere Energy Corporation

Core Scientific Enters AI Compute Market with $3.5B Deal

Posted on by slightbourne@noblecapitalmarkets.com

In a significant development in the high-performance computing (HPC) space, Core Scientific, a leading digital infrastructure provider for bitcoin mining and hosting services, has announced a landmark deal with CoreWeave, an AI hyperscaler. The 12-year agreement will see Core Scientific deliver approximately 200 megawatts of infrastructure to host CoreWeave’s high-performance compute operations, positioning the company as a major player in the AI data center space.

This strategic move marks a significant expansion of Core Scientific’s hosting business and earnings power, while maintaining its strong bitcoin mining franchise. The deal is expected to generate over $3.5 billion in cumulative revenue for Core Scientific during the initial contract terms, with estimated average annual revenue of $290 million. This development highlights the growing importance of HPC in the tech industry and the opportunities it presents for emerging growth companies.

The Rise of High-Performance Computing

HPC is a critical component in various industries, including AI, scientific research, and cryptocurrency mining. The increasing demand for powerful computing capabilities has led to a surge in the adoption of HPC solutions. Core Scientific’s agreement with CoreWeave demonstrates the company’s commitment to meeting this growing demand and diversifying its business model.

AI Computing: A Key Driver of Growth

AI computing is a significant driver of the HPC market, with applications in various sectors, including healthcare, finance, and technology. The increasing adoption of AI solutions has led to a rise in demand for high-performance computing infrastructure. CoreWeave’s partnership with Core Scientific will enable the company to expand its AI compute capabilities, further solidifying its position in the AI hyperscale space.

Bitcoin Mining and HPC: A Synergistic Relationship

Core Scientific’s roots in bitcoin mining have provided a natural segue into HPC. The company’s existing infrastructure and expertise in high-power computing have enabled it to expand into the HPC space seamlessly. This synergistic relationship between bitcoin mining and HPC presents opportunities for companies like Core Scientific to leverage their existing infrastructure and expertise to tap into the growing HPC market.

Opportunities for Emerging Growth Companies

The HPC space presents significant opportunities for emerging growth companies. As demand for high-performance computing continues to outpace supply, companies like Core Scientific are well-positioned to meet customer needs with a much shorter time to power than greenfield data center projects. This deal demonstrates how small-cap companies can leverage their existing infrastructure and expertise to tap into the growing HPC market, providing a pathway for growth and expansion.

Investment Opportunities in the HPC Space

The HPC space offers attractive investment opportunities for investors seeking exposure to emerging growth companies. As the demand for high-performance computing continues to grow, companies like Core Scientific are poised to benefit from this trend. Investors can capitalize on this growth by investing in companies that are well-positioned to meet the increasing demand for HPC solutions.

In conclusion, Core Scientific’s strategic move into the AI compute space highlights the growing importance of HPC in the tech industry. This deal demonstrates the opportunities available for emerging growth companies in the HPC space and the potential for investors to capitalize on this growth. As the demand for high-performance computing continues to rise, companies like Core Scientific are poised to benefit from this trend, making them attractive investment opportunities for investors seeking exposure to the HPC space.

Release – Eledon Presents Updated Data from Ongoing Phase 1b Trial Evaluating Tegoprubart for Prevention of Rejection in Kidney Transplantation

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ELDN

June 3, 2024

PDF Version

Data from 13 participants presented at the American Transplant Congress continue to support safety and tolerability profile of tegoprubart

Overall mean eGFR of all reported time points after day 30 post-transplant of 70.5 mL/min/1.73m²

Mean eGFR measured above 60 mL/min/1.73m² at all reported time points after day 30 post-transplant

IRVINE, Calif., June 03, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today presented updated data from the Company’s ongoing open-label Phase 1b trial and open-label extension study evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients. Results from the poster, titled “Biomarkers of Inflammation and eGFR in an Ongoing Phase 1B Study of an Anti-CD40L Antibody Tegoprubart, for the Prevention of Rejection in Kidney Transplant,” were presented at the American Transplant Congress (ATC) taking place in Philadelphia, PA from June 1-5, 2024.

“Eledon continues to build a robust set of encouraging results demonstrating the safety and efficacy of tegoprubart in kidney transplant recipients in our Phase 1b trial,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Calcineurin inhibitors, the current standard of care, do not adequately serve the transplant community due to frequent and difficult–to-manage side effects. By contrast, tegoprubart’s observed clinical profile to date gives us confidence in its potential to supplant calcineurin inhibitors as a next-generation immunosuppression agent for patients who have received a new kidney. We look forward to accruing incremental data through the ongoing Phase 1b and open-label extension studies while continuing to enroll in our Phase 2 BESTOW trial, with enrollment completion anticipated by the end of the year.”

As of the April 2024 cutoff date, updated data from the 13 participants in the ongoing Phase 1b trial support tegoprubart’s potential to protect organ function in patients undergoing kidney transplantation. Data from historical studies using standard of care, calcineurin inhibitor-based immunosuppression therapy typically report aggregate mean estimated glomerular filtration rates (eGFRs) of approximately 50 mL/min/1.73m2 during the first year after kidney transplant. In the ongoing Phase 1b trial, mean eGFR was above 60 mL/min/1.73m² at each reported time points after day 30, with an overall mean eGFR of 70.5 mL/min/1.73m² for all the reported time points after day 30 post-transplant. Two participants completed 12 months on therapy post-transplant, and both demonstrated mean eGFRs above 90 mL/min/1.73m² at one-year post-transplant.

Results demonstrated that tegoprubart is generally safe and well tolerated in patients undergoing de novo kidney transplantation. Three subjects have discontinued the study due to hair loss and fatigue, viral infection, and rejection, respectively. There have been no cases of hyperglycemia, new onset diabetes, or tremor, all of which are side effects often associated with standard of care immunosuppression therapy. There have been no cases of graft loss or death.

Eledon is currently conducting a Phase 1b trial (NCT05027906), a Phase 2 trial (BESTOW; NCT05983770), and a long-term safety and efficacy extension study (NCT06126380) to evaluate tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant.

A copy of the ATC poster can be found on the Investor section of the Company’s website at https://ir.eledon.com/news-and-events/publications-and-presentations.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with kidney transplantation, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; and risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

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Source: Eledon Pharmaceuticals, Inc.

Release – MAIA Biotechnology Reveals New Clinical Data Showing THIO’s Strong Efficacy In Non-Small Cell Lung Cancer

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

June 04, 2024 8:41am EDTDownload as PDF

THIO’s favorable disease control and overall response rates exceed reported standard-of-care data in third line treatment

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced new efficacy data from its Phase 2 THIO-101 clinical trial evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who failed 2 or more standard-of-care therapy regimens. Updated results show a favorable overall response rate (ORR) of 38% and a disease control rate (DCR) of 85% from THIO + CPI in third-line treatment. The new data was presented in a poster session at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting on June 3, 2024.

The primary objectives of THIO-101 Phase 2 trial are to examine the safety and tolerability of THIO as an anticancer drug and as an immune system primer, and to examine the clinical efficacy of THIO in the form of ORR. At the time of the most recent data cut-off (April 30, 2024), all evaluable patients had completed ≥1 post-baseline assessment.

Results from third-line treatment:

  • Disease control rate (DCR) was 85% for THIO vs. standard of care DCR of 25–35% for chemotherapy1
  • 65% of patients crossed the 5.8-month overall survival (OS) threshold2
  • 85% of patients crossed the 2.5-month progression-free survival (PFS) threshold3-4
  • Median survival follow-up time is currently 9.1 months (n=20)

Results from third-line treatment with THIO 180mg (optimal dose selection)

  • Median PFS of 5.5 months (24.1 weeks)
  • 78% OS rate at 6 months
  • 38% ORR vs. standard of care 6–10% for chemotherapy2
  • 75% of patients crossed the 5.8-month OS threshold2
  • 88% of patients crossed the 2.5-month PFS threshold3-4
  • Median survival follow-up time is currently 9.1 months (n=8)

1 Matsumoto H, et al. Transl Lung Cancer Res 2021;10:2278–89.
2 Girard N, et al. J Thorac Onc 2009;12:1544-1549.
3 Shepherd F, et al. N Engl J Med 2005;353:123-132.
4 Fossella F, et al. J Clin Oncol 2000;18(12):2354-62.

“All exceptional measures of efficacy in our trial to date have exceeded our own expectations and outperformed standard of care treatments,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “The data presented at ASCO advances THIO’s excellent clinical profile as a strong, safe, and highly effective alternative for patients who progressed following chemotherapy and other available treatments. We eagerly anticipate full efficacy data from THIO-101 in the second half of this year.”

To date, treatment with THIO + cemiplimab has been generally well tolerated in a heavily pre-treated patient population. Full enrollment in THIO-101 was completed on February 19, 2024, earlier than expected as per trial design. The Company expects that THIO-101 will be the first completed clinical study of a telomere targeting agent in the field of cancer drug discovery and treatment.

The poster and updated Company presentations can be accessed on the company’s website.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with cemiplimab (Libtayo®) followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About MAIA Biotechnology, Inc.

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.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240604727806/en/

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

Released June 4, 2024

Release – Katherine O’Halloran Appointed as Interim GoHealth Chief Financial Officer 

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOCO

Jun 04, 2024 at 8:00 AM EDT

O’Halloran, current Chief Accounting Officer, brings 30 years of experience in Finance and Accounting at public and private companies

Former CFO Jason Schulz departs for personal reasons after building high-performing finance organization during company turnaround 

Company to conduct search process for permanent CFO

CHICAGO, June 04, 2024 (GLOBE NEWSWIRE) — GoHealth, Inc. (GoHealth) (NASDAQ: GOCO), a leading health insurance marketplace and Medicare-focused digital health company, announced that its Board of Directors has appointed Katherine O’Halloran, Chief Accounting Officer, as interim Chief Financial Officer.

Ms. O’Halloran’s appointment follows the resignation of Jason Schulz, Chief Financial Officer and Treasurer, effective immediately. Mr. Schulz’s resignation is for personal reasons and is in no way related to his performance, internal relationships, nor GoHealth’s business performance, financial reporting, or controls, where the Company has invested in and built a high performing finance function. Mr. Schulz will continue to support GoHealth with transition services through September 1, 2024 while the Company conducts a search process to identify a permanent CFO. 

“Katie brings significant finance, accounting and audit expertise. With her background and strong knowledge of our business, we are confident that she will effectively lead our finance function during this interim period as we conduct a thorough search process to identify a permanent CFO. As Katie enters her new role, she will be supported by a deep and talented finance team to help build on the momentum underway throughout our business,” said Vijay Kotte, CEO of GoHealth. “I would also like to thank Jason for his contributions as CFO over the last two years, where he has leveraged his significant operating financial expertise to drive our transformational turnaround and establish a strong foundation to drive GoHealth’s continued stability, innovation and growth.” 

Ms. O’Halloran joined GoHealth as Chief Accounting Officer in April 2023. From January 2022 until April 2023, she was the Chief Financial Officer at VanEnkevort Tug & Barge, Inc. Prior to VanEnkevort Tug & Barge, she spent the previous 16 years in various finance and accounting leadership roles at Great Lakes Dredge & Dock Corporation (Nasdaq: GLDD).

Investor Relations
John Shave
jshave@gohealth.com

V2X (VVX) – Capital Structure Enhancement

Posted on by slightbourne@noblecapitalmarkets.com


Tuesday, June 04, 2024

For more than 70 years, Vectrus has provided critical mission support for our customers’ toughest operational challenges. As a high-performing organization with exceptional talent, deep domain knowledge, a history of long-term customer relationships, and groundbreaking technical expertise, we deliver innovative, mission-matched solutions for our military and government customers worldwide. Whether it’s base operations support, supply chain and logistics, IT mission support, engineering and digital integration, security, or maintenance, repair and overhaul, our customers count on us for on-target solutions that increase efficiency, reduce costs, improve readiness, and strengthen national security. Vectrus is headquartered in Colorado Springs, Colo., and includes about 8,100 employees spanning 205 locations in 28 countries. In 2021, Vectrus generated sales of $1.8 billion. For more information, visit the company’s website at www.vectrus.com or connect with Vectrus on Facebook, Twitter, and LinkedIn.

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

Repricing and Extension. Yesterday, V2X announced a repricing and extension of its $907 million First Lien term loan. The actions are another step by management to enhance the capital structure, in our view, and should lead to lower interest costs and additional financial flexibility.

Details. Under the repricing, the annual interest margin was reduced by 50 basis points to 2.75%. Additionally, the 10-basis point credit spread adjustment was eliminated from the Company’s Secured Overnight Financing Rate, further improving the anticipated savings from the repricing. The company also extended the maturity of the loan by two years to December 2030.


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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. 

Eledon Pharmaceuticals (ELDN) – Data Update From Phase 1b Trial Shows Continued Tegoprubart Benefits

Posted on by slightbourne@noblecapitalmarkets.com


Tuesday, June 04, 2024

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

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

Data From Phase 1b Trial Updated. Eledon presented data from the Phase 1b trial testing tegoprubart, its drug for prevention of kidney transplant rejection, at the American Transplant Congress. We found the data to continue to show improved kidney function during the first year after transplantation, a strong indicator of organ survival, with continued safety and tolerability.

Kidney Function Measures Continue To Show Improvements Over Tacrolimus. The Phase 1b data included 13 patients who had reached 30-day post-transplant evaluation. Their mean eGFR was above 60 mL/min/1.73m² at each reported time point. The overall mean eGFR after day 30 reached 70.5 mL/min/1.73m².  This is an improvement over standard-of-care immunosuppressive regimens that have eGFR rates around the 50ml/min/1.73m² level during the first year after the transplant.


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.

Kelly Services (KELYA) – Motion Recruitment Partners in the Fold

Posted on by slightbourne@noblecapitalmarkets.com

Tuesday, June 04, 2024

Kelly (Nasdaq: KELYA, KELYB) connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. We’re always thinking about what’s next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 350,000 people around the world and connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice. Revenue in 2021 was $4.9 billion. Visit kellyservices.com and let us help with what’s next for you.

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

Completed. Kelly Services has completed the acquisition of Motion Recruitment Partners, LLC (“MRP”), from Littlejohn & Co., LLC, a private investment firm. As we highlighted in past reports, this is a transformational acquisition for Kelly, the largest in its history. We believe MRP will be a key driver in Kelly posting a higher revenue growth rate as well as continued expansion of Kelly’s adjusted EBITDA margin.

MRP Refresher. MRP is the parent company to a group of leading global talent solution providers. The acquisition of MRP strengthens the scale and capabilities of Kelly’s staffing and consulting solutions across technology, telecommunications, and government specialties in North America, and recruitment process outsourcing solutions globally.


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. 

NYSE Trading Halt Highlights Need for Robust Systems Amid Market Changes

Posted on by slightbourne@noblecapitalmarkets.com

The New York Stock Exchange experienced a technical glitch this morning that triggered trading halts in dozens of stocks, including big names like Chipotle, Berkshire Hathaway, and the meme stock GameStop. The issue stemmed from problems with the price bands published by the Consolidated Tape Association, which are used to prevent excess volatility by pausing trading if prices move too far too quickly.

While the specific cause is still being investigated, the timing raised concerns given the recent move by U.S. stock exchanges to a one-day settlement cycle last week. This SEC-mandated change requires trades to be settled one day after execution instead of two, compressing timeframes for transferring securities.

Regulators and market participants have been on high alert for potential snags as systems adapt to the new settlement cycle. Today’s incident underscores the critical importance of robust trading infrastructure and risk controls as market practices evolve.

Halting Mechanism Kicks In
At around 11am ET, the NYSE listed over 60 stocks as temporarily halted due to hitting their “limit up, limit down” (LULD) bands, which are circuit breaker levels to prevent extreme price swings. While some of those may have been unrelated cases of normal volatility, many were likely impacted by the pricing data issue.

The stock seeing among the biggest volatility was GameStop, which spiked over 70% at the open before being halted. Speculation swirled that investor Keith Gill, known as “Roaring Kitty” from the 2021 meme stock frenzy, may have taken a large new position.

Trading resumed around 11:45am after the exchange confirmed the pricing data problems had been resolved. While temporary, such disruptions can impact market quality, trading execution and risk management for investors and firms.

Need for Resilient Systems
As financial markets continually evolve, today’s problems highlight the crucial need for exchanges, trading platforms, and market participants to have ultra-resilient, glitch-proof systems able to adapt flawlessly to changes. Even brief failures can undermine market confidence and integrity.

While technological errors are inevitable at times, regulators and investors alike will be scrutinizing today’s NYSE issue and responses carefully. Having rock-solid trading infrastructure and controls in place to prevent and handle disruptions seamlessly is essential for maintaining fair, orderly and efficient markets.

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