Month: October 2024

Release – ZyVersa Therapeutics CEO, Stephen C. Glover, Was a Featured Guest on The Big Biz Show to Discuss Current Trends in the Obesity Drug Market and the Potential Role of Inflammasome Inhibitors

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Oct 15, 2024

PDF Version

Lead indication for ZyVersa’s Inflammasome ASC Inhibitor IC 100 is obesity with metabolic complications.

WESTON, Fla., Oct. 15, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces that Stephen C. Glover, Co-Founder, Chairman, Chief Executive Officer, and President, was interviewed on the Big Biz Show to address current trends in the obesity drug market and the potential role of inflammasome inhibitors.

Key Points

  • Obesity is an international health crisis, with over 50% of the world’s population predicted to be overweight or obese within the next ten years.
  • Launch of incretin therapy (GLP-1 agonists) for obesity has resulted in substantial and unsurpassed weight loss, stimulating a drug revolution that has led to a 10-fold increase in venture dollars flowing into the category.
  • High levels of investment in the obesity category are expected to continue due to the trend toward development of add-on therapies to GLP-1 agonists to preserve muscle during weight loss and to attenuate obesity-related inflammation that leads to chronic complications such as cardiovascular disease, type 2 diabetes, and even neurodegenerative diseases like Parkinson’s and Alzheimer’s disease. This is reflected in the billion-dollar acquisitions recently made by Novo and Lilly, and Sanofi’s $27 Million strategic investment in Ventyx’s NLRP3 inhibitor to address the complications of obesity.
  • ZyVersa’s Inflammasome ASC Inhibitor IC 100 is being developed for use in combination with GLP-1 agonists to control obesity-associated inflammation, attenuate the associated complications, and enhance weight loss. The company is working with renowned experts in the field who are providing guidance to the development program.

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, and Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response. The lead indication for IC 100 is obesity and its associated metabolic complications. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced proprietary technologies to develop first-in-class drugs for patients with inflammatory or kidney diseases with high unmet medical needs. We are well positioned in the rapidly emerging inflammasome space with a highly differentiated monoclonal antibody, Inflammasome ASC Inhibitor IC 100, and in kidney disease with phase 2 Cholesterol Efflux MediatorTM VAR 200. The lead indication for IC 100 is obesity and its associated metabolic complications, and for VAR 200, focal segmental glomerulosclerosis (FSGS). Each therapeutic area offers a “pipeline within a product,” with potential for numerous indications. The total accessible market is over $100 billion. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate, Media, and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641        

Release – MAIA Biotechnology Announces Poster Presentation of Novel THIO Prodrugs at ENA 2024 Symposium on Molecular Targets and Cancer Therapeutics

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

October 15, 2024 8:15am EDT

  • MAIA seeks to advance two new THIO-derived telomere-targeting molecules to clinical trials

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that an abstract related to the company’s second generation of proprietary telomere-targeting THIO prodrugs has been accepted for poster presentation during the upcoming 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, taking place October 23-25, 2024, in Barcelona, Spain. The Symposium is hosted by the European Organisation for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI) and the American Association for Cancer Research (AACR).

MAIA will present the results of preclinical studies for its new THIO-based prodrugs, designated as MAIA-2021-20 and MAIA-2022-12, which are lipid-conjugated compounds derived from THIO. These second-generation compounds belong to a new chemical class of molecules called telomere targeting divalent dinucleotides. These preclinical studies were designed to evaluate the efficacy of the new molecules alone and in combination with or without immune checkpoint-blocking antibodies (anti-PD-L1).

MAIA’s Chief Scientific Officer Sergei Gryaznov, Ph.D. commented, “Our presentation will demonstrate that treatment with each of the prodrugs studied was highly efficacious and was shown to overcome immunotherapy resistance. Our results have shown marked activity in advanced tumors and resulted in tumor growth inhibition in preclinical models of lung cancer, colorectal carcinoma, melanoma and hepatocellular carcinoma. We are actively working to advance these candidates toward clinical development.”

Presentation details:

Title:New Dual-Pharmacophore Dinucleotide Prodrugs as Potent Telomere Targeting Anticancer Molecules
Abstract number:ENA24-0044
Session title:New Drugs
Date and time:Wednesday, October 23, 2024, at noon CEST
Presenting author:Ilgen Mender, Ph.D., Director of Biology Research, MAIA Biotechnology
Poster access:MAIA’s poster will be available at maiabiotech.com/publications on October 23, 2024

MAIA has designed and evaluated more than 80 THIO-like compounds to date and has submitted three U.S. patent applications for its second-generation telomere targeting agents.

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 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.

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

Source: MAIA Biotechnology, Inc.

Released October 15, 2024

Oil Prices Tumble Over 5% as Israel Unlikely to Target Iran’s Oil Industry

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Oil futures dropped over 5% as fears of Israeli attacks on Iran’s oil facilities eased.
– Weak demand in China and OPEC’s downward revision of oil forecasts are adding pressure on crude prices.
– The International Energy Agency (IEA) signals a surplus in global oil supply, further dampening the market.

Oil prices fell sharply on Tuesday, dropping more than 5%, as geopolitical concerns surrounding Israel and Iran’s oil industry began to ease. Initially, fears of potential supply disruptions spiked oil prices after Iran launched a missile attack on Israel earlier this month, but the market has now calmed as Israel is not expected to strike Iran’s oil infrastructure.

At the same time, the International Energy Agency (IEA) has weighed in, signaling that its member nations are prepared to take action if any supply disruption occurs in the Middle East. For now, however, global oil supply remains steady, and with the absence of major disruptions, the market faces a likely surplus in the new year.

As of Tuesday morning, energy prices were reacting to both the geopolitical environment and broader market dynamics:

  • West Texas Intermediate (WTI) November futures fell by $3.74, or 5.07%, to $70.08 per barrel. Year to date, U.S. crude oil has seen a 2% decline.
  • Brent crude, the global benchmark, fell by $3.67, or 4.7%, to $73.79 per barrel, continuing its year-to-date drop of about 4%.
  • Gasoline prices also dipped, with the November contract down 4.47% to $2.014 per gallon, bringing year-to-date losses to nearly 4%.
  • Natural gas was the exception, seeing a slight rise of 1.36% to $2.528 per thousand cubic feet.

The significant drop in crude prices reflects more than just geopolitics. The oil market has been facing weakening demand, particularly from China, and ongoing concerns about a global economic slowdown. OPEC’s recent decision to cut its 2024 oil demand forecast for the third consecutive month has further contributed to the pressure on oil prices.

China’s oil consumption has been particularly weak in recent months, with the IEA reporting that Chinese demand dropped by 500,000 barrels per day (bpd) in August. This marked the fourth consecutive monthly decline, adding to the overall bearish sentiment surrounding global oil demand.

The broader outlook for 2024 and 2025 also suggests slower demand growth compared to the post-pandemic recovery. The IEA projects global oil demand to increase by just under 900,000 bpd in 2024 and 1 million bpd in 2025, which is a noticeable drop from the 2 million bpd growth seen in the previous years.

At the same time, crude production in the Americas, particularly the U.S., is on track to grow. According to the IEA, American-led production will increase by 1.5 million bpd this year and next, further contributing to the global supply glut.

For the third consecutive month, OPEC has revised its oil demand forecast downward, reflecting concerns about slower economic growth and subdued consumption in major markets like China. The cuts come as the cartel faces pressure to balance supply with softer global demand.

As a result of these factors, analysts now expect the oil market to shift its focus away from geopolitical fears and towards demand weakness, which could define the market’s trajectory in the months ahead. While geopolitical events may continue to inject short-term volatility, the more significant concern remains the fundamental imbalance between supply and demand.

Seanergy Maritime (SHIP) – Outlook for Capesize Vessel Market Remains Favorable, Increasing Our 2024 and 2025 Estimates

Posted on by cpereira@noblefcm.com


Tuesday, October 15, 2024

Seanergy Maritime Holdings Corp. is a prominent pure-play Capesize shipping company listed in the U.S. capital markets. Seanergy provides marine dry bulk transportation services through a modern fleet of Capesize vessels. The Company’s operating fleet consists of 18 vessels (1 Newcastlemax and 17 Capesize) with an average age of approximately 13.4 years and an aggregate cargo carrying capacity of approximately 3,236,212 dwt. Upon completion of the delivery of the previously announced Capesize vessel acquisition, the Company’s operating fleet will consist of 19 vessels (1 Newcastlemax and 18 Capesize) with an aggregate cargo carrying capacity of approximately 3,417,608 dwt. The Company is incorporated in the Marshall Islands and has executive offices in Glyfada, Greece. The Company’s common shares trade on the Nasdaq Capital Market under the symbol “SHIP”.

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

Hans Baldau, Research Associate, Noble Capital Markets, Inc.

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

Updating Estimates. We are increasing our 2024 EBITDA and EPS estimates to $102.1 million and $2.56, respectively, from $101.1 million and $2.35. Additionally, we have increased our 2025 EPS estimates to $102.0 million and $2.39 from $101.3 million and $2.00. Our revised estimates reflect greater operating days and modestly higher time charter rates, along with lower interest expense.

Capesize Vessel Market Fundamentals. We think the outlook for the Capesize shipping market will remain favorable through 2025. Many of the same 2024 tailwinds that have benefited the Capesize market are expected to continue, including strong demand growth for dry bulk commodities, continued disruptions in the Red Sea, and a historically low orderbook for Capesize vessels. Additionally, lower interest rates could boost global economic trade and benefit industry participants. 


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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. 

Bit Digital (BTBT) – Vertically Integrating with Acquisition of Enovum

Posted on by cpereira@noblefcm.com


Tuesday, October 15, 2024

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.

HPC Business Integrated. Bit Digital announced the acquisition of Enovum Data Centers for approximately CAD $62.8 million (USD $46 million), consisting of CAD$56 million in cash and 1.62 million shares being issued to Enovum’s management. The transaction will vertically integrate the Company’s HPC business with a Tier 3 datacenter and a pipeline of expansion site opportunities. In addition to vertically integrating and potential expansion, the acquisition provides Bit Digital with potential synergies for margin expansion and operational flexibility.

Who is Enovum? Enovum is an owner, operator, and developer of HPC datacenters based in Montreal, Canada. The company has a 4MW Tier 3 datacenter in Montreal powered by renewable hydroelectricity, a benefit to Bit Digital’s carbon-free strategy. The site is leased through 2036 with two five-year extension options, and is fully leased to more than a dozen customers with it expected to generate CAD$10 million of revenue in 2025.


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. 

S&P 500 Hits Record High as Chip Stocks Surge and Corporate Earnings Take Center Stage

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– S&P 500 hits an intraday record high driven by strong performance from chip stocks, with Nvidia and Apple leading the charge.
– Investors focus on upcoming corporate earnings reports from major companies like Bank of America and Netflix, as well as key economic data.
– Boeing and Caterpillar stocks drag on the Dow due to job cuts and rating downgrades, while the broader market shows cautious optimism.

The S&P 500 and Nasdaq indices reached new highs on Monday, buoyed by a rally in chip stocks and positive market sentiment as investors prepared for a week filled with critical corporate earnings reports and important economic data. The S&P 500 achieved an intraday record high, continuing the momentum it gained from last week’s solid performance. Meanwhile, the Nasdaq also rose as tech stocks, particularly Nvidia and Apple, saw substantial gains.

Nvidia’s stock rose by 2.2%, while Apple gained 1.6%, propelling an index of semiconductor companies to its highest point in over two months. The strength of these companies underscored the resilience of the technology sector, which has continued to lead market gains throughout 2024. With the semiconductor index posting significant growth, the technology sector contributed heavily to the S&P 500’s rise, with five out of eleven sectors inching higher.

Despite the overall strength of the S&P 500 and Nasdaq, the Dow Jones Industrial Average struggled due to underperformance from major industrial stocks. Caterpillar, a bellwether for the industrial sector, fell by 3% after being downgraded by Morgan Stanley from “equal weight” to “underweight.” Boeing also faced challenges, as the company’s stock slipped 2.4% after announcing a larger-than-expected third-quarter loss, job cuts, and a delay in the delivery of its 777X jet.

As corporate earnings season kicks into full gear, investors are eagerly awaiting results from major companies including Bank of America, Citigroup, Johnson & Johnson, and Netflix. Analysts are projecting year-over-year third-quarter earnings growth of 4.9% for the S&P 500. Last week, bank earnings set a positive tone for the earnings season, with JPMorgan delivering strong results that injected optimism into the market.

However, concerns remain regarding high stock valuations. The S&P 500 is trading at nearly 22 times forward earnings, significantly higher than its long-term average of 15.7. As corporate results roll in, companies will need to deliver strong numbers to justify the elevated stock prices, making this earnings season a pivotal moment for the market.

In addition to earnings reports, investors are keenly watching for crucial economic data, particularly the September retail sales figures due to be released on Thursday. These figures are expected to provide insight into the financial health of U.S. consumers, a key factor influencing market sentiment.

On the monetary policy front, Minneapolis Fed President Neel Kashkari made headlines by suggesting that modest interest-rate cuts could be on the horizon as inflation nears the Federal Reserve’s 2% target. Similarly, Fed Governor Christopher Waller is set to provide further insights into the Fed’s stance on interest rates. While investors have scaled back expectations for a large interest-rate cut, the CME Group’s FedWatch tool shows an 84.2% probability of a 25-basis-point reduction at the Fed’s November meeting.

While tech stocks soared, other sectors showed more caution. Boeing’s job cuts and delivery delays, alongside Caterpillar’s rating downgrade, weighed on the Dow, dragging the index down by 0.10%. Meanwhile, energy stocks took a hit as oil prices declined, with the energy sector slipping 0.4%. On the other hand, defense stocks such as Northrop Grumman and Lockheed Martin saw gains amid rising geopolitical tensions, including Iran’s missile launch against Israel.

In contrast, B. Riley Financial experienced a significant 20% jump after announcing a deal to sell its Great American Group unit to Oaktree Capital for $386 million, reflecting optimism in the financial sector.

Despite these mixed performances, the overall market remains cautiously optimistic as traders brace for a critical week that will provide further clues about the strength of corporate America and the broader U.S. economy.

Release – Unicycive Therapeutics Announces Late-Breaker Poster Presentation on Oxylanthanum Carbonate (OLC) at the American Society of Nephrology (ASN) Kidney Week 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

October 14, 2024 7:03am EDT Download as PDF

LOS ALTOS, Calif., Oct. 14, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that a poster presentation on oxylanthanum carbonate (OLC) was selected for a Late-Breaker session at the American Society of Nephrology (ASN) Kidney Week 2024. Unicycive will also deliver three additional poster presentations on OLC and UNI-494. The conference will take place October 24-27, 2024 in San Diego, CA.

Late Breaking Science Poster:

Title:Effects of Oxylanthanum Carbonate in Patients Receiving Maintenance Hemodialysis with Hyperphosphatemia
Lead Author:Geoffrey A. Block, MD, FASN, Associate Chief Medical Officer & Senior Vice President, Clinical Research & Medical Affairs, U.S. Renal Care
Session Title:Late-Breaking Science Posters [LB-PO]
Poster Board:#TH-PO1188
Date/Time:Thursday, October 24, 2024 from 10:00 a.m. – 12:00 p.m. PT
  

Three additional poster presentations:

Title:Intravenous UNI-494 Slows the Progression or Halts/Reverses Acute Kidney Injury When Administered After Ischemia/Reperfusion in Rats
Lead Author:Satya Medicherla, Ph.D., Vice President, Preclinical Pharmacology, Unicycive
Session Title:AKI: Mechanisms
Poster Board:#FR-PO155
Date/Time:Friday, October 25, 2024 from 10:00 a.m. – 12:00 p.m. PT
Title:Combination Oxylanthanum Carbonate and Tenapanor Lowers Urinary Phosphate Excretion in Rat
Lead Author:Satya Medicherla, Ph.D., Vice President, Preclinical Pharmacology, Unicycive
Session Title:CKD-MBD: Basic and Translational
Poster Board:#SA-PO243
Date/Time:Saturday, October 26, 2024 from 10:00 a.m. – 12:00 p.m. PT
Title:UNI-494 Phase I Safety, Tolerability, and Pharmacokinetics
Lead Author:Guru Reddy, PH.D., Vice President of Preclinical R&D, Unicycive
Session Title:AKI: Clinical, Outcomes, and Trials – Management
Poster Board:#SA-PO036
Date/Time:Saturday, October 26, 2024 from 10:00 a.m. – 12:00 p.m. PT
  

About Oxylanthanum Carbonate (OLC)

Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.5 billion in 2023, with the United States accounting for more than $1 billion of that total. Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.

Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. As part of the clinical development program, two clinical studies were conducted in over 100 healthy volunteers. The first study was a dose-ranging Phase I study to determine safety and tolerability. The second study was a randomized, open-label, two-way crossover bioequivalence study to establish pharmacodynamic bioequivalence between OLC and Fosrenol. Based on the results of the bioequivalence study, pharmacodynamic (PD) bioequivalence of OLC to Fosrenol was established. A pivotal clinical trial was also conducted in CKD patients on hemodialysis that achieved the study objective and established favorable tolerability of OLC at clinically effective doses.

Fosrenol® is a registered trademark of Shire International Licensing BV.
1Reason Research, LLC 2022 survey. Results here.

About Hyperphosphatemia

Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.

Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

About UNI-494

UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease. UNI-494 has a novel mechanism of action that restores mitochondrial function and may be beneficial for the treatment of several diseases including kidney disease. Unicycive has completed enrollment in the UNI-494 Phase 1 dose-ranging safety study in healthy volunteers in the United Kingdom, and expects to report results in the third quarter of 2024. UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide. UNI-494 has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the prevention of Delayed Graft Function (DGF) in kidney transplant patients.

About Acute Kidney Injury

Acute kidney injury (AKI) is defined as a sudden loss of kidney function that is determined based on increased serum creatinine levels and decreased urine output and is limited to a duration of 7 days. The primary causes of AKI include sepsis, ischemia, hypoxia, and drug-induced nephrotoxicity. Delayed Graft Function is a type of acute kidney injury that occurs in the first week after kidney transplantation. AKI is estimated to occur in 20-200 per million population in the community, 7-18% of patients in the hospital, and approximately 50% of patients admitted to the intensive care unit. Importantly AKI is associated with morbidity and mortality; an estimated 2 million people die of AKI worldwide every year whereas survivors of AKI are at increased risk of chronic kidney disease and end stage renal disease.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.

Forward-looking statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact:

ir@unicycive.com
(650) 543-5470

SOURCE: Unicycive Therapeutics, Inc.

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Source: Unicycive Therapeutics, Inc.

Released October 14, 2024

Release – Alliance Resource Partners, L.P. Announces Third Quarter 2024 Earnings Conference Call

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ARLP

October 14, 2024

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TULSA, Okla.–(BUSINESS WIRE)– Alliance Resource Partners, L.P. (NASDAQ: ARLP) will report its third quarter 2024 financial results before the market opens on Monday, October 28, 2024. Alliance management will discuss these results during a conference call beginning at 10:00 a.m. Eastern that same day.

To participate in the conference call, dial U.S. Toll Free (877) 407-0784 and request to be connected to the Alliance Resource Partners, L.P. earnings conference call. International callers should dial (201) 689-8560 and request to be connected to the same call. Investors may also listen to the call via the “Investors” section of ARLP’s website at www.arlp.com.

An audio replay of the conference call will be available for approximately one week. To access the audio replay, dial U.S. Toll Free (844) 512-2921; International Toll (412) 317-6671 and request to be connected to replay using access code 13749425.

About Alliance Resource Partners, L.P.

ARLP is a diversified energy company that is currently the largest coal producer in the eastern United States, supplying reliable, affordable energy domestically and internationally to major utilities, metallurgical and industrial users. ARLP also generates operating and royalty income from mineral interests it owns in strategic coal and oil & gas producing regions in the United States. In addition, ARLP is evolving and positioning itself as a reliable energy partner for the future by pursuing opportunities that support the advancement of energy and related infrastructure.

News, unit prices and additional information about ARLP, including filings with the Securities and Exchange Commission (“SEC”), are available at www.arlp.com. For more information, contact the investor relations department of ARLP at (918) 295-7673 or via e-mail at investorrelations@arlp.com.

Investor Relations Contact
Cary P. Marshall
Senior Vice President and Chief Financial Officer
(918) 295-7673
investorrelations@arlp.com

Source: Alliance Resource Partners, L.P.

Release – Kratos Receives $45 Million Satellite System Related Contract Award

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on KTOS

SAN DIEGO, Calif., Oct. 14, 2024 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a technology company in the defense, national security and global markets, announced today that it has recently received a new, sole source, approximate $45 million single award contract related to a new satellite system. Work under this new satellite system contract award will be performed at secure Kratos engineering, production and integration facilities. Due to customer related, competitive and other considerations, no additional information will be provided regarding the new contract award at this time.

Phil Carrai, President of Kratos Satellite Business Unit, said, “The Kratos team is laser focused on rapidly developing and delivering leading technology products, software and systems to our National Security related customers in support of Mission Critical Space and Satellite system requirements. We are excited about this new space system program opportunity.”

Eric DeMarco, President and CEO of Kratos, said, “Kratos’ strategy is to invest our own internal funds and be first to market with affordable, relevant hardware and software for our National Security customers and partners. In addition to Kratos’ first to market, OpenSpace Virtualized Software for Satellite C2 and TT&C, we are first to market with our suite of tactical jet drones flying today; including Valkyrie, our Erinyes hypersonic vehicle, Kratos Zeus and Oriole SRM’s and our family of jet engines for drones, missiles and loitering munitions.”

About Kratos Defense & Security Solutions
Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low cost future manufacturing which is a value add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, hypersonic vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter. For more information, visit www.KratosDefense.com.

Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 31, 2023, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.

Press Contact:
Claire Burghoff
claire.burghoff@kratosdefense.com

Investor Information:
877-934-4687
investor@kratosdefense.com

Source: Kratos Defense & Security Solutions, Inc.

Release – Comstock Inc. to Host Q3 Earnings Call on October 22, 2024, at 4:30pm ET

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on LODE

  • Corrado De Gasperis, Executive Chairman, Director & CEO, and William McCarthy, COO, will provide business updates and the Company’s third quarter financial results followed by a live Q&A session.
  • Investors and other interested parties are invited to join and learn more about Comstock’s innovative technologies and commercializing businesses that enable systemic decarbonization.

VIRGINIA CITY, Nev., Oct. 14, 2024 (GLOBE NEWSWIRE) — Comstock Inc. (NYSE: LODE) (“Comstock” and the “Company”) is pleased to announce that the Company’s Executive Chairman, Director & CEO, Corrado De Gasperis, and COO, William McCarthy, will be providing an overview of recent financial results, along with important fuels, metals and mining business updates on Tuesday, October 22, 2024, at 4:30pm ET. We invite all investors and other interested parties to register for the webinar at the link below.

Date: Tuesday, October 22, 2024
Time: 4:30pm ET
Register: Webinar Registration

HAVE QUESTIONS? There will be an allotted time following the live presentation for a Q&A session. Unaddressed questions will be reviewed by management and responded to accordingly. You may submit your question(s) beforehand in the registration form (linked above) or by email at: ir@comstockinc.com.

About Comstock Inc.

Comstock Inc. (NYSE: LODE) commercializes innovative technologies that contribute to global decarbonization and the clean energy transition by efficiently converting under-utilized natural resources, primarily, woody biomass into low-carbon renewable fuels, end-of-life metal extraction and renewal, and generative AI-enabled advanced materials synthesis and mineral discovery for sustainable mining. To learn more, please visit www.comstock.inc.

Comstock Social Media Policy

Comstock Inc. has used, and intends to continue using, its investor relations link and main website at www.comstock.inc in addition to its Twitter, LinkedIn and YouTube accounts, as means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

Contacts

For investor inquiries:For media inquiries or questions:
RB Milestone Group LLCComstock Inc., Tracy Saville
Tel (203) 487-2759Tel (775) 847-7573
ir@comstockinc.comquestions@comstockinc.com
 

Forward-Looking Statements

This press release and any related calls or discussions may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” “plan,” “should,” “intend,” “may,” “will,” “would,” “potential” and similar expressions identify forward-looking statements but are not the exclusive means of doing so. Forward-looking statements include statements about matters such as: future market conditions; future explorations or acquisitions; future changes in our research, development and exploration activities; future financial, natural, and social gains; future prices and sales of, and demand for, our products and services; land entitlements and uses; permits; production capacity and operations; operating and overhead costs; future capital expenditures and their impact on us; operational and management changes (including changes in the Board of Directors); changes in business strategies, planning and tactics; future employment and contributions of personnel, including consultants; future land and asset sales; investments, acquisitions, joint ventures, strategic alliances, business combinations, operational, tax, financial and restructuring initiatives, including the nature, timing and accounting for restructuring charges, derivative assets and liabilities and the impact thereof; contingencies; litigation, administrative or arbitration proceedings; environmental compliance and changes in the regulatory environment; offerings, limitations on sales or offering of equity or debt securities, including asset sales and associated costs; business opportunities, growth rates, future working capital, needs, revenues, variable costs, throughput rates, operating expenses, debt levels, cash flows, margins, taxes and earnings. These statements are based on assumptions and assessments made by our management in light of their experience and their perception of historical and current trends, current conditions, possible future developments and other factors they believe to be appropriate. Forward-looking statements are not guarantees, representations or warranties and are subject to risks and uncertainties, many of which are unforeseeable and beyond our control and could cause actual results, developments, and business decisions to differ materially from those contemplated by such forward-looking statements. Some of those risks and uncertainties include the risk factors set forth in our filings with the SEC and the following: adverse effects of climate changes or natural disasters; adverse effects of global or regional pandemic disease spread or other crises; global economic and capital market uncertainties; the speculative nature of gold or mineral exploration, and lithium, nickel and cobalt recycling, including risks of diminishing quantities or grades of qualified resources; operational or technical difficulties in connection with exploration, metal recycling, processing or mining activities; costs, hazards and uncertainties associated with precious and other metal based activities, including environmentally friendly and economically enhancing clean mining and processing technologies, precious metal exploration, resource development, economic feasibility assessment and cash generating mineral production; costs, hazards and uncertainties associated with metal recycling, processing or mining activities; contests over our title to properties; potential dilution to our stockholders from our stock issuances, recapitalization and balance sheet restructuring activities; potential inability to comply with applicable government regulations or law; adoption of or changes in legislation or regulations adversely affecting our businesses; permitting constraints or delays; challenges to, or potential inability to, achieve the benefits of business opportunities that may be presented to, or pursued by, us, including those involving battery technology and efficacy, quantum computing and generative artificial intelligence supported advanced materials development, development of cellulosic technology in bio-fuels and related material production; commercialization of cellulosic technology in bio-fuels and generative artificial intelligence development services; ability to successfully identify, finance, complete and integrate acquisitions, joint ventures, strategic alliances, business combinations, asset sales, and investments that we may be party to in the future; changes in the United States or other monetary or fiscal policies or regulations; interruptions in our production capabilities due to capital constraints; equipment failures; fluctuation of prices for gold or certain other commodities (such as silver, zinc, lithium, nickel, cobalt, cyanide, water, diesel, gasoline and alternative fuels and electricity); changes in generally accepted accounting principles; adverse effects of war, mass shooting, terrorism and geopolitical events; potential inability to implement our business strategies; potential inability to grow revenues; potential inability to attract and retain key personnel; interruptions in delivery of critical supplies, equipment and raw materials due to credit or other limitations imposed by vendors; assertion of claims, lawsuits and proceedings against us; potential inability to satisfy debt and lease obligations; potential inability to maintain an effective system of internal controls over financial reporting; potential inability or failure to timely file periodic reports with the Securities and Exchange Commission; potential inability to list our securities on any securities exchange or market or maintain the listing of our securities; and work stoppages or other labor difficulties. Occurrence of such events or circumstances could have a material adverse effect on our business, financial condition, results of operations or cash flows, or the market price of our securities. All subsequent written and oral forward-looking statements by or attributable to us or persons acting on our behalf are expressly qualified in their entirety by these factors. Except as may be required by securities or other law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Neither this press release nor any related calls or discussions constitutes an offer to sell, the solicitation of an offer to buy or a recommendation with respect to any securities of the Company, the fund, or any other issuer.

Lundbeck to Acquire Longboard Pharmaceuticals in Strategic Deal to Boost Neuroscience Pipeline

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Lundbeck acquires Longboard Pharmaceuticals for $2.6 billion to strengthen its neuro-rare disease portfolio.
– Lead asset, bexicaserin, in late-stage trials, holds potential as a breakthrough treatment for epilepsy-related conditions.
– The acquisition aligns with Lundbeck’s strategy of expanding in rare neurological disorders and advancing its development pipeline.

H. Lundbeck A/S (Lundbeck), a global leader in brain health, has announced a landmark deal to acquire Longboard Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company specializing in transformative treatments for neurological disorders. This $2.6 billion acquisition marks a pivotal moment for Lundbeck, reinforcing its commitment to building a strong portfolio in rare and complex neurological diseases.

The strategic deal will enable Lundbeck to further expand its reach in neuro-rare conditions, a field with high unmet medical needs. Longboard’s lead asset, bexicaserin, is being developed to treat Developmental and Epileptic Encephalopathies (DEEs), including Dravet syndrome, Lennox-Gastaut syndrome, and other severe epilepsy disorders. With this acquisition, Lundbeck gains access to a potential blockbuster drug that has shown encouraging results in both preclinical and clinical trials.

Bexicaserin is a next-generation superagonist specifically targeting 5-HT2C receptors. This innovative approach differentiates the drug from existing treatments for epilepsy, positioning it as a potential best-in-class therapy for patients suffering from these debilitating conditions. The drug is currently being evaluated in a global phase III trial under the DEEp SEA Study, involving approximately 480 patients with DEEs. If successful, bexicaserin could be a cornerstone in Lundbeck’s portfolio, with an estimated global peak sales potential of between $1.5 and $2 billion following its anticipated launch in 2028.

The acquisition aligns with Lundbeck’s Focused Innovator strategy, which seeks to invest in high-potential, cutting-edge treatments that address the most pressing needs in brain health. The transaction will not only enhance Lundbeck’s ability to provide innovative solutions for patients with neuro-rare disorders, but it will also bolster the company’s capabilities in treating complex neurological conditions.

Lundbeck’s CEO, Charl van Zyl, has emphasized that this acquisition represents a significant step in advancing the company’s mission of improving the lives of patients with severe brain disorders. “Bexicaserin addresses a critical unmet need for patients suffering from rare and severe epilepsies, for which there are very few treatment options. This acquisition will become a cornerstone in Lundbeck’s neuro-rare franchise and drive growth into the next decade,” van Zyl noted.

Longboard’s expertise and its leading asset, bexicaserin, will complement Lundbeck’s existing neuroscience portfolio, creating new opportunities for research and development in rare neurological disorders. This acquisition also adds valuable intellectual property and a broader reach into under-served markets, providing the potential for substantial growth in revenue and market share.

In terms of financial impact, the acquisition is expected to be funded through existing cash resources and bank financing, with integration costs projected at around $80 million in 2024. Lundbeck aims to leverage its financial strength to ensure that the acquisition delivers long-term value for shareholders.

With bexicaserin having already received Breakthrough Therapy Designation (BTD) from the U.S. FDA, the future looks promising for this cutting-edge treatment. Lundbeck’s integration of Longboard Pharmaceuticals and its innovative technologies is poised to reshape the landscape for rare epilepsy treatment and boost the company’s leadership in neurological disorders.

Take a moment to take a look at more emerging growth biotechnology companies by taking a look at Noble Capital Markets’ Research Analyst Robert LeBoyer’s coverage list.

Tonix Pharmaceuticals (TNXP) – A New Era For Tonix Begins With The Tonmya NDA Filing

Posted on by cpereira@noblefcm.com


Friday, October 11, 2024

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.

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.

We Expect The NDA Filing For Tonmya Approval To Be Submitted Shortly. We anticipate the NDA submission for Tonmya to be announced around the end of October 2024. This would start the FDA review process, which we expect to lead to marketing approval in mid-2025. In July, Tonmya received Fast Track Review, a designation that gives advantages in the regulatory pathway. With a pending NDA submission for a drug that could be used by millions of patients, we believe the company’s progress has not been reflected in the stock price.

Fast Track Review Is A Significant Distinction. The Fast Track Review designation from the FDA is awarded to drugs that can make significant impact on serious medical conditions. The designation provides important benefits including increased communications with the FDA, as well as eligibility for Accelerated Approval and Priority Review. We expect the application for Accelerated Approval to be filed shortly after the NDA is completed. This could shorten the FDA’s review period by up to 4 months.


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. 

AZZ Inc. (AZZ) – Tempering Our Expectations; Rating Remains an Outperform

Posted on by cpereira@noblefcm.com


Friday, October 11, 2024

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.

Second quarter financial results. For the fiscal year (FY) 2025, AZZ reported second quarter adjusted net income of $41.3 million or $1.37 per share compared to $37.2 million or $1.27 per share during the prior year period and our estimate of $40.8 million or $1.35 per share. AZZ maintained its FY 2025 sales guidance range of $1.525 billion to $1.625 billion, lifted the lower end of adjusted EBITDA to a range of $320 million (from $310 million) to $360 million, and increased adjusted diluted EPS expectations to a range of $4.70 to $5.10 from $4.50 to $5.00.

Updating estimates. We have lowered our 2025 EBITDA and EPS estimates to $343.0 million and $4.95, respectively, from $350.3 million and $5.00. Our estimates reflect seasonality in the second half of the year. Our 2026 EBITDA and EPS estimates have been reduced to $361.2 million and $5.45, respectively, from $366.8 million and $5.70. Our 2026 estimates reflect a slower ramp in revenue from the new facility under construction in Washington, Missouri.


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.