Month: November 2024

Release – Cocrystal Pharma Reports Third Quarter 2024 Financial Results and Provides Updates on its Antiviral Drug-Development Programs

Posted on by aweinsoff@channelchek.com

Research News and Market Data on COCP

November 13, 2024

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BOTHELL, Wash., Nov. 13, 2024 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the three and nine months ended September 30, 2024, and provides updates on its antiviral product pipeline, upcoming milestones and business activities.

“The coming months are critically important to Cocrystal as we expect to report topline results from two ongoing clinical studies with our best-in-class antiviral candidates in major medical indications,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal. “In the Phase 2a influenza A challenge study with our oral PB2 inhibitor CC-42344, we expect to report topline results before year end. Earlier this year, we received feedback from the U.S. Food and Drug Administration (FDA) on a Pre-IND package that improves our clarity on the regulatory path and requirements for the late-stage influenza A clinical study we plan to conduct in the U.S.

“The multiple-ascending dose portion in our Phase 1 pan-norovirus/pan-coronavirus study with oral protease inhibitor CDI-988 is underway and we are on track to report topline results in late 2024 or early 2025,” he added. “We view the development of an effective antiviral for norovirus as a significant opportunity for Cocrystal. There is no approved vaccine or antiviral for norovirus, which is highly contagious and the most common cause of acute gastroenteritis. In in vitro studies, CDI-988 exhibited pan-viral activity against multiple norovirus strains, including the strain that is responsible for major outbreaks.”

“Our significant clinical progress so far this year puts us on track for an active 2025,” said James Martin, CFO and co-CEO of Cocrystal. “I’m pleased to report that based on our currently projected expenditures and our cost-efficient business model, we expect our cash will be sufficient to fund the advancement of our planned development programs through the coming 12 months.”

Antiviral Product Pipeline Overview

We apply our proprietary structure-based drug discovery platform technology for developing broad-spectrum antivirals that inhibit viral replication. By designing and selecting antiviral drug candidates that target the highly conserved regions of the viral enzymes, we seek to develop drugs that are effective against the virus and mutations of the virus, and also reduce off-target interactions that may cause undesirable side effects. Our drug discovery process differs from traditional, empirical medicinal chemistry approaches that often require iterative high-throughput compound screening and lengthy hit-to-lead processes.

Influenza Programs

Influenza is a major global health threat that may become more challenging to treat due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. Each year there are approximately 1 billion cases of seasonal influenza worldwide, 3-5 million severe illnesses and up to 650,000 deaths. On average, about 8% of the U.S. population contracts influenza each season. In addition to the health risk, influenza is responsible for an estimated $11.2 billion in direct and indirect costs in the U.S. annually.

  • Oral CC-42344 for the treatment of pandemic and seasonal Influenza A infections
    • Our novel PB2 inhibitor CC-42344 showed excellent in vitro antiviral activity against pandemic and seasonal influenza A strains, as well as strains that are resistant to Tamiflu® and Xofluza®.
    • In December 2022 we reported favorable safety and tolerability results from the oral CC-42344 Phase 1 study.
    • In December 2023 we began a randomized, double-blind, placebo-controlled Phase 2a human challenge study to evaluate the safety, tolerability, viral and clinical measurements of CC-42344 in influenza A-infected subjects in the United Kingdom, following authorization from the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
    • In May 2024 we completed enrollment in the Phase 2a human challenge study.
    • In June 2024 we reported that in vitro studies demonstrated CC-42344 inhibits the activity of the new highly pathogenic avian influenza A (H5N1) PB2 protein recently identified in humans exposed to infected dairy cows.
    • We expect to report topline results from the Phase 2a human challenge study by yearend and plan to file an IND application in 2025 to conduct a late-stage study in the U.S.
  • Inhaled CC-42344 for the therapeutic and prophylactic treatment of pandemic and seasonal Influenza A infections
    • Our preclinical testing showed superior pulmonary pharmacology with CC-42344 including high exposure to drug and a long half-life.
    • We completed CC-42344 inhalation formulation development.
    • We initiated GLP toxicology studies.
  • Influenza A/B Program
    • Our work to develop a preclinical lead of novel influenza replication inhibitors is underway.

Norovirus Program

Norovirus is a highly contagious infection and is the most common cause of acute gastroenteritis. Worldwide, norovirus causes about one out of five cases of acute gastroenteritis that leads to diarrhea and vomiting. An estimated 685 million cases and an estimated 50,000 child deaths are attributed to norovirus each year worldwide, with an estimated societal cost of $60 billion. By targeting viral replication, we believe it is possible to develop an effective treatment and/or short-term prophylactic for closed environments for all genogroups of norovirus.

  • Oral pan-viral protease inhibitor CDI-988 for the treatment of norovirus and coronavirus infections
    • Our novel broad-spectrum protease inhibitor CDI-988 is being evaluated as a potential oral treatment for noroviruses and coronaviruses.
    • CDI-988 has shown in vitro pan-viral activity against multiple norovirus strains, including the genogroup II, genotype 4 (GII.4) norovirus strain that is responsible for major norovirus outbreaks.
    • In May 2023 we announced approval of our application to the Australian regulatory agency for a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability and pharmacokinetics (PK) of oral CDI-988 in healthy volunteers.
    • In August 2023 we announced our selection of CDI-988 as our lead for the oral treatment for norovirus, in addition to coronavirus.
    • In September 2023 we began dosing subjects in a first-in-human study in healthy volunteers with oral CDI-988.
    • In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohort in the Phase 1 study.
    • In September 2024 we advanced CDI-988 into the multiple-ascending dose cohort of the Phase 1 study.
    • We expect to report topline results from the CDI-988 Phase 1 study in late 2024 or early 2025.

COVID-19 and Other Coronavirus Programs

By targeting viral replication enzymes and proteases, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses including COVID-19 and its variants, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). CDI-988 showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses, as well as against noroviruses. The global COVID-19 therapeutics market is estimated to exceed $16 billion by the end of 2031.

  • Oral pan-viral protease inhibitor CDI-988 for the treatment of coronaviruses and noroviruses
    • CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and demonstrated a favorable safety profile and PK properties.
    • In September 2023 we dosed the first subject in our dual pan-norovirus/pan-coronavirus oral CDI-988 study, which is expected to serve as a Phase 1 study for both indications.
    • In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohort in the Phase 1 study.
    • In September 2024 we advanced CDI-988 into the multiple-ascending dose cohort of the Phase 1 study.
    • We expect to report topline results from the CDI-988 Phase 1 study in late 2024 or early 2025.

Third Quarter Financial Results

Research and development (R&D) expenses for the third quarter of 2024 were $3.2 million, compared with $4.2 million for the third quarter of 2023, with the decrease primarily due to lower clinical study expenses. General and administrative (G&A) expenses for the third quarters of 2024 and 2023 remained relatively stable at $1.8 million.

The net loss for the third quarter of 2024 was $4.9 million, or $0.49 per share, compared with a net loss for the third quarter of 2023 of $4.2 million, or $0.41 per share, that included a $1.6 million payment to the Company in 2023 for a legal settlement.

Nine Month Financial Results

R&D expenses for the first nine months of 2024 were $10.5 million, compared with $10.9 million for the first nine months of 2023. G&A expenses for the first nine months of 2024 were $4.1 million, compared with $4.6 million for the first nine months of 2023.

The net loss for the first nine months of 2024 was $14.2 million, or $1.40 per share, compared with a net loss for the first nine months of 2023 of $13.5 million, or $1.43 per share.

Cocrystal reported unrestricted cash as of September 30, 2024 of $13.0 million, compared with $26.4 million as of December 31, 2023. Net cash used in operating activities for the first nine months of 2024 was $13.3 million, compared with $11.3 million for the first nine months of 2023. The Company had working capital of $12.3 million and 10.2 million common shares outstanding as of September 30, 2024.

About Cocrystal Pharma, Inc.

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

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans for the future development of preclinical and clinical drug candidates, our expectations regarding future characteristics of the product candidates we develop, the expected time of achieving certain value-driving milestones in our programs, including preparation, commencement and advancement of clinical studies for certain product candidates in 2024 and 2025, the viability and efficacy of potential treatments for diseases our product candidates are designed to treat, expectations for the markets for certain therapeutics, our ability to execute our clinical and regulatory goals and deploy regulatory guidance towards future studies, and the expected sufficiency of our cash balance to advance our programs and fund our planned operations. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from future inflation, potential future increases in interest rates uncertainty in the financial markets, the possibility of a recession, and geopolitical conflict including in Ukraine and Israel on our Company, our collaboration partners, and on the U.S., UK, Australia and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions on our ability to proceed with studies as well as similar problems with our vendors and our current and any future clinical research organization (CROs) and contract manufacturing organizations (CMOs), the ability of our CROs to recruit volunteers for, and to proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical studies, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes including potential downward pressure on government spending on healthcare in the wake of the recent presidential election in the U.S., the impact of the recent U.S. presidential election on regulation affecting the FDA and other healthcare agencies and potential staffing issues, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2023. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com

Media Contact:
JQA Partners
Jules Abraham
917-885-7378
Jabraham@jqapartners.com

Financial Tables

Source: Cocrystal Pharma, Inc.

Released November 13, 2024

Release – Kratos Awarded $116.7 Million Prime Contract from the U.S. Space Development Agency for Ground System to Support Advanced Fire Control Missions

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on KTOS

Kratos Led Team Will Design, Implement and Operate Ground Infrastructure Supporting Interoperability Across Multi-Vendor LEO Constellations Using its Kratos OpenSpace® Platform

SAN DIEGO, Nov. 13, 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 been awarded a contract valued at a maximum of $116.7 million over five years to create and operate an Advanced Fire Control Ground Infrastructure (AFCGI) for the U.S. Space Development Agency’s (SDA) Advanced Fire Control (AFC) program. The AFC will deliver integrated space and ground elements to demonstrate advanced fire control missions for missile defense.

Advanced fire control brings highly sophisticated systems for space-based sensing. These systems enable precise, real-time coordination for tracking operations in space for effective responses to threats. Among its applications, the AFCGI will support SDA’s Fire-control On Orbit-support-to-the-war Fighter program, also known as FOO Fighter or F2, which is tasked with detecting and tracking advanced missile threats, including hypersonic missiles.

As the AFCGI prime contractor, Kratos will lead a team of partner companies to:

  • Deliver and manage ground segment resources, including ground entry points and terrestrial network connections;
  • Fit-out and manage a government-owned, contractor-operated (GOCO) facility called the Demonstration Operations Center;
  • Manage a government-procured, contractor-operated cloud environment to provide cloud services, including hosting space vehicle mission operations center software and interfacing with mission partner systems; and,
  • Provide program management, systems engineering, integration, verification, and operations and maintenance of the AFC ground infrastructure.

Members of the Kratos-led team include ASRC Federal Systems Solutions, LLC, Peraton, Inc., Sphinx Defense, Inc. and Stellar Solutions, Inc.

Core to the AFCGI, Kratos will provide a Ground Resource Manager (GRM) which will be built for the FOO Fighter program and designed to support any future fire control demonstrations. Built upon Kratos’s OpenSpace Ground Platform, the GRM will ensure interoperability to support new space vehicles built by multiple manufacturers from multiple AFC constellations. OpenSpace is an orchestrated, software-defined and cloud-native platform based on accepted industry standards. With it, these satellite manufacturers will be able to synchronize their Command and Control (C2) missions into the AFCGI infrastructure, and new network elements and software applications will integrate seamlessly into the AFCGI. The GRM will act as the hub for the AFC constellations, serving to demonstrate modern capabilities as they evolve to support increasingly sophisticated operational programs.

Phil Carrai, President of Kratos’ Space Division stated, “Advancements in missile technology and hypersonics that can travel at more than 3000 mph present new adversarial threats and will require new defensive capabilities to identify, track and respond to them rapidly. The AFCGI will serve as a standing sandbox for exploring and validating new technologies, solutions and techniques to address these threats with commensurate speed and agility. The GRM will enable the Space Force to capitalize on best of breed technologies from across the most advanced developers, and seamlessly integrate and orchestrate their operations.”

About Kratos OpenSpace
Kratos’ OpenSpace family of solutions enables the digital transformation of satellite ground systems to become a more dynamic and powerful part of the space network. The family consists of three product lines: OpenSpace SpectralNet for converting satellite RF signals to be used in digital environments; OpenSpace quantum products, which are virtual versions of traditional hardware components; and the OpenSpace Platform, the first commercially available, fully orchestrated, software-defined ground system. These three OpenSpace lines enable government agencies, commercial satellite operators and other service providers to implement digital operations at their own pace and in ways that meet their unique mission goals and business models. For more information about the OpenSpace family visit www.KratosDefense.com/OpenSpace.

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

Primary Logo

Source: Kratos Defense & Security Solutions, Inc.

Release – Commercial Vehicle Group Announces Departure of Carlos Jimenez

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on CVGI

NEW ALBANY, Ohio, Nov. 12, 2024 (GLOBE NEWSWIRE) — Commercial Vehicle Group (the “Company” or “CVG”) (NASDAQ: CVGI), a diversified industrial products and services company, announced that Carlos Jimenez, who briefly held the role of Executive Vice President, Global Operations and Supply Chain, is resigning from the Company effective immediately for personal reasons that would prevent him from fulfilling his responsibilities at CVG. Mr. Jimenez’s resignation is not due to any concerns with the Company.

The Company is in the process of conducting a comprehensive search for a permanent replacement to lead Global Operations and Supply Chain. In the interim period, James Ray, President and Chief Executive Officer, will assume oversight responsibilities for Global Operations and Supply Chain.

About CVG

At CVG, we deliver real solutions to complex design, engineering and manufacturing problems while creating positive change for our customers, industries, and communities we serve. Information about CVG and its products is available at www.cvgrp.com.

Investor Relations Contact:Media Contact:
Ross Collins or Stephen PoePatrick Woolford
Alpha IR GroupDirector, Communications
CVGI@alpha-ir.comPatrick.woolford@cvgrp.com

Source: Commercial Vehicle Group, Inc.

Release – Unicycive Announces Third Quarter 2024 Financial Results and Provides Business Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

November 13, 2024 7:15am EST  Download as PDF

– OLC New Drug Application (NDA) Accepted by the FDA with a PDUFA Target Action Date of June 28, 2025–

– Commercial Planning in Progress for 2025 Launch –

– Late Breaker Poster Presentation on OLC at ASN Kidney Week –

– Successful Completion of UNI-494 Phase 1 Trial –

LOS ALTOS, Calif., Nov. 13, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended September 30, 2024, and provided a business update.

“We are pleased with the tremendous progress we have made over the last several months highlighted by the acceptance of our New Drug Application for oxylanthanum carbonate (OLC) which may result in the potential approval of our first drug in 2025,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “If approved, we believe OLC’s high potency and low pill burden would provide a best-in-class option for patients with chronic kidney disease (CKD) on dialysis who have hyperphosphatemia and face adherence challenges with current treatment regimens. With the NDA acceptance now behind us, we are actively preparing to commercialize OLC with the goal of bringing this innovative new treatment to market in the second half of 2025.”

“We have also made progress on our second asset, UNI-494, as we announced the successful completion of our Phase 1 clinical trial providing the necessary data to potentially advance to Phase 2 clinical development. UNI-494 is targeting acute kidney injury (AKI), a challenging and often under-treated disease. We plan to request a meeting with the FDA by the end of this year to continue advancing our clinical development program for UNI-494,” concluded Dr. Gupta.

Key Highlights

  • Announced the acceptance of the New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) for OLC for the treatment of hyperphosphatemia in patients with CKD on dialysis. The FDA set a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025.
  • Announced initial results from the patient reported outcome survey conducted during the UNI-OLC-201 pivotal clinical trial. In the survey, OLC consistently outperformed the other phosphate binders in all categories: 79% of patients preferred OLC compared to 18% of patients who preferred their prior therapy; 98% of patients said that OLC was easy to take compared to 55% for their prior therapy; and 89% of patients said they were satisfied with OLC while only 49% were satisfied with their prior therapy.
  • Announced the successful completion of the UNI-494 Phase 1 study in healthy volunteers. The Phase 1 study was a single center, double-blind, placebo-controlled, randomized single ascending dose (Part 1) and multiple ascending dose (Part 2) study in healthy volunteers conducted in the United Kingdom. UNI-494 was well-tolerated as a single dose up to 160 mg and in multiple doses at 40 mg twice-a-day. The absorption of UNI-494 was fast, and UNI-494 was rapidly metabolized to release nicorandil. Collectively, the results will help determine the dose and schedule of UNI-494 in a potential Phase 2 clinical trial in patients with acute kidney injury.
  • Granted a patent on UNI-494 to treat AKI by the United States Patent and Trademark Office (USPTO). The patent, valid until 2040, secures protection of a method of treating a disease or a condition (“method of use”) related to AKI or contrast-induced-nephropathy by administering the UNI-494 compound.
  • Delivered four presentations on OLC and UNI-494 at the American Society of Nephrology (ASN) Kidney Week 2024 including a late-breaker poster presentation highlighting favorable safety and tolerability data of OLC. The presentation highlighted the positive pivotal clinical trial data demonstrating that OLC was able to achieve serum phosphate control in more than 90% of patients with CKD on dialysis who entered the maintenance phase of the trial. A poster presentation also described the results from the UNI-494 Phase 1 study results, and two preclinical posters were presented.
  • Two preclinical studies for both OLC and UNI-494 were featured in two publications: “Systemic Absorption of Oxylanthanum Carbonate is Minimal in Preclinical Models” was published in the Pharmaceutical Chemistry Journal; “Evaluation of UNI-494 in Acute Kidney Injury Treatment Efficacy When Administered After Ischemia-Reperfusion in a Rat Model” was published in EC Pharmacology and Toxicology.
  • UNCY was added to the Russell Microcap® Index effective July 1, 2024. Membership in the Russell Microcap® Index, which remains in place for one year is accompanied by automatic inclusion in the appropriate growth and value style indexes.

Financial Results for the Quarter Ended September 30, 2024

Research and Development (R&D) expenses were $3.0 million for the three months ended September 30, 2024, compared to $3.4 million for the three months ended September 30, 2023. The decrease in research and development expenses was primarily due to decreased drug development costs.

General and Administrative (G&A) expenses were $3.2 million for the three months ended September 30, 2024, compared to $2.6 million for the three months ended September 30, 2023. The increase was primarily due to increased non-cash stock compensation expense.

Other Income was $2.2 million for the three months ended September 30, 2024 compared to $1.6 million in the three months ended September 30, 2023, due primarily to a decrease in the fair value of our warrant liability.

Net loss attributable to common stockholders for the three months ended September 30, 2024 was $4.1 million, compared to a net loss attributable to common stockholders of $4.4 million, for the three months ended September 30, 2023. The decreased net loss for the three-month period ended September 30, 2024 was attributable to a decrease in the fair value of our warrant liability.

As of September 30, 2024, cash and cash equivalents totaled $32.3 million. The Company believes that it has sufficient resources to fund planned operations into 2026.

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. Positive pivotal trial results were reported in June 2024 for OLC, and a New Drug Application (NDA) is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025. OLC is protected by a strong global patent portfolio including an issued patent on composition of matter with exclusivity until 2031, and with the potential patent term extension until 2035 after OLC approval. Unicycive’s second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. UNI-494 has successfully completed a Phase 1 trial. For more information, please visit Unicycive.com and follow us on LinkedIn 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:

Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

Chris Calabrese
LifeSci Advisors
ccalabrese@lifesciadvisors.com

SOURCE: Unicycive Therapeutics, Inc.

V2X (VVX) – AIP Selling More Shares

Posted on by cpereira@noblefcm.com


Wednesday, November 13, 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.

Round 2. American Industrial Partners (AIP) is selling another trance of VVX shares, this time 2.5 million shares with up to an additional 375,000 shares to be sold. As we noted in AIP September’s stock sale, we had expected AIP eventually to begin to sell off its stake, so we are not surprised with this additional sale. V2X will not receive any proceeds from the sale. The additional float is a positive for investors, in our view.

Ownership. Upon the completion of this offering, investment funds affiliated with AIP will beneficially own approximately 44.9% of V2X’s outstanding common stock, or 14,167,286 shares (or approximately 43.7% if the underwriters exercise their option to purchase additional shares in full).


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SKYX Platforms (SKYX) – Seeding Future Revenue Growth

Posted on by cpereira@noblefcm.com


Wednesday, November 13, 2024

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

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

Q3 results. The company reported Q3 revenue of $22.2 million and an adj. EBITDA loss of $2.6 million. While the revenue was slightly below our estimate of $24.1 million, the adj. EBITDA loss was milder than our estimate of $3.4 million.

Gaining traction with Home Depot. Since announcing the partnership in July, the company’s presence in Home Depot locations has expanded to 100 stores. Additionally, SKYX products are available on Home Depot’s website. We anticipate more SKUs to become available both online and in stores soon, as a wide variety of SKYX products are expected to arrive from the company’s manufacturing partner, Ruee Appliances.  


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FreightCar America (RAIL) – Stock Price Decline May Offer an Attractive Entry Point for Investors

Posted on by cpereira@noblefcm.com


Wednesday, November 13, 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.

Third quarter financial results. FreightCar America generated third quarter adjusted net income to common stockholders of $2.455 million or $0.08 per share compared to $3.953 million or $0.13 per share during the prior year period. We had anticipated adjusted net income to common stockholders of $2.465 million or $0.07 per share. Average shares outstanding of 31.4 million were lower than our estimate of 34.5 million. Revenue and rail car deliveries increased to $113.3 million and 961, respectively, compared to $61.9 million and 503 during the third quarter of 2023. On a year-over-year basis, adjusted EBITDA increased to $10.9 million compared to $3.5 million during the prior year period and our estimate of $9.8 million. Free cash flow amounted to $5.7 million.

Full year 2024 corporate guidance. While guidance for revenue and rail car deliveries is unchanged, management narrowed its guidance range for EBITDA to $37.0 million to $39.0 million compared to previous expectations of $35.0 million to $39.0 million.


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Aurania Resources (AUIAF) – Black Sands Beach Project in Corsica is Taking Shape

Posted on by cpereira@noblefcm.com


Wednesday, November 13, 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.

New assay results. Aurania received preliminary results from studies conducted by SGS Laboratories on a sample of magnetic sand taken from Nonza Beach, Corsica. The nickel-bearing mineral in the black magnetic sand is indeed awaruite, a natural nickel-iron alloy. SGS was able to isolate a nearly pure awaruite concentrate from the magnetic sand using a combination of grinding and flotation. New assays of awaruite flotation concentrate yielded 71.4% nickel, 0.98% cobalt, 0.65% copper, 0.58 grams of gold per tonne, 0.09 grams of platinum per tonne, and 0.39 grams of palladium per tonne. The flotation method recovered 83.8% of the nickel contained in the magnetic sand, which had a head grade of 6% nickel. Studies of identical sands at nearby Albo Beach are underway.

Extraction and processing. Aurania hired IHC Mining Advisory Services (IMAS) to identify the best means to extract and recover the black beach sands at Albo-Nonza. IHC proposed two different scenarios focused on the extraction of heavy minerals containing nickel and iron. The preferred scenario uses a floating suction and cutter-head dredge on floating pontoons. IMAS estimated the capital cost of the cutter suction dredger scenario to be €13 million, including €7.8 million for the dredging equipment and €5.2 million for a processing plant.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Ocugen (OCGN) – Ocugen Clinical Showcase Highlights Fundamentals, Clinical Data, and Patient Stories

Posted on by cpereira@noblefcm.com


Wednesday, November 13, 2024

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

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

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

Ocugen Held A Meeting With Scientists, Doctors, and Patients. On November 12, Ocugen held a Clinical Showcase meeting to present the scientific basis of its Gene Modifier technology, interim data updates from its clinical trials, and allow patients to discuss their experiences with the treatments.

First OCU410 Data Shows Efficacy. The Phase 2 ArMaDa trial is testing OCU410 in Geographic Atrophy (GA), a lesion in patients with dry age-related macular degeneration that leads to blindness. The presentations included its four mechanisms of action and the clinical outcomes from the initial patient cohorts in the dose-escalation stage of the trial. These data at 6 months compare favorably to approved complement inhibitors for GA.


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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. 

GeoVax Labs (GOVX) – 3Q24 Reported With Continued Flow Of Good News

Posted on by cpereira@noblefcm.com


Wednesday, November 13, 2024

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

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.

3Q24 Report Reviews Progress During The Quarter. GeoVax reported a loss of $5.8 million or $(0.91) per share. The quarter included first revenues from its BARDA contract for the Project NextGen Phase 2b trial testing CM04S1 as a preventive vaccine for COVID-19. The company gave updates and data timeframes for clinical trials with CM04S1, MVA, and Gedeptin. During the quarter, it raised $13.5 million and ended with a cash balance of $8.6 million on September 30, 2024.

Gedeptin Trial Design Announced. GeoVax announced that the Phase 2 trial in head and neck squamous cell carcinoma (HNSCC) will test Gedeptin in combination with an immune checkpoint inhibitor (ICI) in recurrent patients before surgery. A single-cycle of Gedeptin will be given with a standard dose of Keytruda (pembrolizumab), followed by a second cycle of Keytruda alone, then surgery. Endpoints will include standard measures of response, tumor shrinkage, and survival that would make the data comparable to other treatments. The trial is expected to begin in 1H25.


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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. 

Direct Digital Holdings (DRCT) – Building Back Better

Posted on by cpereira@noblefcm.com


Wednesday, November 13, 2024

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

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

Weak Q3 Results, likely the trough. Q3 revenues declined 85% to $9.1 million, with a decline in both its Buy-side and Sell-side businesses, down 12% and 96%, respectively. Adj. EBITDA was a negative $2.8 million. Management blamed the weak fundamentals on a business disruption caused by a “false and disproven” blog post by Adalytics, which it sued for defamation. Notably, the Q3 results puts the company back on track on its financial reporting under its new auditor BDO. 

Guidance anticipates a strong revenue rebuild. Management anticipates rebound in revenues as one of its largest clients rebuilds volume. We expect strong sequential Q4 revenue to $14.5 million, up from $9.1 million in Q3. Full year 2024 revenue is expected to be $67.7 million, with full year 2024 adj. EBITDA loss of $8.6 million. Management anticipates strong full year 2025 revenue growth to a range of $90 million to $110 million. 


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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. 

Stock Market Gains on Inflation Data as Fed Rate Cut Remains Likely

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– US stocks rise as inflation data meets forecasts, supporting a potential December Fed rate cut.
– Consumer Price Index (CPI) shows annual inflation at 2.6% with core inflation at 3.3%, aligning with expectations.
– FedWatch tool indicates 80% likelihood of a rate cut in December, reinforcing investor confidence.

US stocks gained in Wednesday afternoon trading as the latest consumer inflation report aligned with expectations, reinforcing the likelihood of a Federal Reserve interest rate cut in December. The Dow Jones Industrial Average (^DJI) rose by approximately 0.4%, recovering from previous session losses, while the S&P 500 (^GSPC) and the tech-heavy Nasdaq Composite (^IXIC) saw increases of about 0.3% and 0.2%, respectively. Bitcoin (BTC-USD) also continued its bullish trend, climbing 5% to over $92,000 per coin as investors maintained optimism in the digital asset market.

The October Consumer Price Index (CPI) reported a 2.6% year-over-year increase, with core inflation — which excludes volatile food and energy prices — rising by 3.3%. Both monthly and annual inflation rates met analyst forecasts, with core inflation edging up 0.3% month-over-month. These figures suggest that inflation may be stabilizing, a welcome development for the Fed as it considers a rate cut to support economic growth.

Minneapolis Fed President Neel Kashkari commented on the importance of inflation data for upcoming Fed policy decisions. He stated that while the numbers are in line with expectations, any unexpected rise in inflation could influence the Fed’s approach. The latest CME FedWatch tool data indicates an 80% chance of a December rate cut, as traders expect the Fed to act cautiously in light of recent economic and inflation trends.

Looking at broader market factors, post-election economic optimism has slowed somewhat as investors consider the potential impact of President-elect Donald Trump’s policy promises on inflation and growth. Concerns over rising borrowing costs due to increased Treasury yields have tempered market enthusiasm, adding some caution to the economic outlook. However, the inflation data provides a clearer backdrop for the Fed, likely keeping it on a path toward reducing rates next month, which could help offset higher yields and bolster economic activity.

Investors continue to keep a close eye on inflation as well as any signals from the Fed. With the markets increasingly expecting rate cuts, the stability of inflation numbers may provide confidence for both consumers and businesses as they plan for 2024. Meanwhile, the growing strength of assets like bitcoin reflects a broader trend of investor confidence across diverse sectors.

As the year winds down, the stock market will closely monitor any changes in inflation, economic data, and Fed commentary, which will likely guide trading activity into 2024.

Honeywell’s Future in Question as Elliott Management Urges Corporate Breakup

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Elliott Management holds a major stake in Honeywell, urging a split into Aerospace and Automation segments.
– Elliott projects a 75% stock price boost within two years if Honeywell proceeds with the split.
– Reflecting a broader trend, Elliott argues for simplification to enhance focus and unlock value.

Activist investor Elliott Management has acquired a $5 billion stake in Honeywell International and is calling for the industrial conglomerate to split into two separate companies. Elliott’s proposal would see Honeywell divide along its two main business lines: Aerospace, which supplies critical technology to military and commercial clients, and Automation, a major supplier of sensors and control systems for industrial applications. Elliott’s managing partner, Jesse Cohn, and partner Marc Steinberg believe that a breakup would unlock significant shareholder value, projecting a 75% increase in Honeywell’s stock price within two years if their recommendations are followed.

In a letter addressed to Honeywell’s board, Cohn and Steinberg argue that the company’s current conglomerate structure has become a drag on its growth. They point to underperformance since 2019, attributing it to an unwieldy corporate structure and ineffective investor communication. Elliott, however, did not direct criticism at Honeywell’s CEO, Vimal Kapur, who took the reins in 2023 and has pursued an aggressive M&A strategy to enhance Honeywell’s portfolio. Nevertheless, Elliott contends that Honeywell would achieve better performance by focusing on core areas, which could be achieved more effectively through a separation.

Honeywell’s Aerospace division, which Elliott calls the company’s “crown jewel,” has been a consistent source of revenue, yet has received only 10% of the M&A investment allocated by Honeywell in the past 20 years. Elliott suggests that by reallocating resources and focusing exclusively on high-performing units, both Aerospace and Automation could realize their full potential independently. Additionally, Elliott argues that Honeywell’s back-office operations—such as legal, IT, and HR—are largely divided between the two units, making a split more feasible than in typical conglomerates.

Honeywell responded to Elliott’s recommendations by stating its openness to shareholder perspectives and welcoming further engagement with the activist investor. Despite this, Honeywell’s board was reportedly unaware of Elliott’s involvement prior to the public release of the letter. In keeping with its careful approach to activism, Elliott consulted extensively with industry experts and former employees to understand the company’s operational and strategic options, even enlisting investment bankers and consultants to aid in its analysis.

Elliott’s push for a breakup reflects a growing trend across industrial conglomerates, many of which have embraced separations in recent years. General Electric, for example, completed a long-awaited division into distinct units, which has driven significant stock gains in 2024. Similarly, 3M and Johnson Controls have shed divisions in favor of streamlined operations. Elliott argues that such moves allow companies to focus on core competencies, attract dedicated investor interest, and ultimately improve shareholder value—a transformation it believes Honeywell would benefit from.

Elliott’s recommendation proposes that the split would yield two businesses each valued at over $100 billion if taken public independently. They also suggest that Honeywell divest some additional non-core segments, such as its personal protective equipment and Advanced Materials units, a step Kapur has already considered. Cohn and Steinberg emphasized that their proposed path for Honeywell is not unprecedented, pointing out that investor sentiment has moved away from conglomerates in favor of more focused companies.

As Honeywell’s board weighs Elliott’s recommendations, the company’s future remains uncertain, but Elliott’s pressure may catalyze significant changes to its longstanding structure. With this move, Elliott hopes to add Honeywell to its track record of successful activist campaigns, having previously advocated for similar strategic breakups in companies like Marathon Petroleum and Alcoa.