Category: Uncategorized

Release – Unicycive Therapeutics Presents Bioequivalence Data On Oxylanthanum Carbonate (OLC) At The National Kidney Foundation Spring Clinical Meeting

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

Unicycive Therapeutics Presents Bioequivalence Data On Oxylanthanum Carbonate (OLC) At The National Kidney Foundation Spring Clinical Meeting

May 15, 2024 7:03am EDT Download as PDF

– OLC Demonstrates Bioequivalence to Lanthanum Carbonate –

– Additional Poster Highlights Key Features of OLC as Perceived by Renal Dieticians –

LOS ALTOS, Calif., May 15, 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 two posters related to the Company’s lead product candidate, oxylanthanum carbonate (OLC), were presented at the National Kidney Foundation (NKF) Spring Clinical Meeting. OLC 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).

“The NKF Spring Clinical Meeting was an important meeting for Unicycive as we were able to present data from the OLC bioequivalence study and our second poster was featured as a top-rated submission,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “Phosphate binders are integral to the management of hyperphosphatemia in patients with CKD and their effectiveness is adversely affected by non-adherence and limitations of phosphate binding capacity relative to dietary intake. Our data confirms that OLC is bioequivalent to lanthanum carbonate (LC) by showing similar outcomes in both groups with respect to mean change in urinary phosphate excretion. Importantly, OLC demonstrated a well-tolerated safety profile with no serious adverse events. This data is important as it serves as one of the key components for our New Drug Application filing with the FDA under the 505(b)(2) regulatory pathway.”

Dr. Gupta, concluded, “We are grateful to Dr. Hill Gallant who delivered a poster presentation on a survey of renal dieticians who play a critical role in helping patients manage serum phosphate and are close witnesses to patients’ experiences and challenges with phosphate management. The findings of the survey concluded that strategies that reduce pill burden and increase ease of use for patients are needed, reinforcing our belief that, if approved, the characteristics of OLC including the reduction of pill volume may increase compliance and improve the quality of life for patients living with this condition.”

Presentation Details:

Title: Two-Way Crossover Study to Establish Pharmacodynamic Bioequivalence Between Oxylanthanum Carbonate and Lanthanum Carbonate
Lead Author: Vandana Mathur, MD
Results: The poster presentation described the results of the randomized, crossover bioequivalence study comparing OLC with lanthanum carbonate (LC). The study was a Phase 1, single-center, randomized 1:1, open-label, controlled, 2-way crossover study designed to demonstrate the pharmacodynamic (PD) equivalence between two phosphate binders: orally administered OLC as compared to LC. Both treatments were administered at doses of one 1000 mcg tablet three-times-a-day (TID) in healthy volunteers who received the same standardized meals to control for daily phosphate intake. OLC tablets are swallowed whole as opposed to the LC tablets that must be chewed completely. The study consisted of a screening period, two dosing periods separated by a 14-day washout period, and a follow-up period 7 days after last study drug dose. The primary PD variable was Least Squares (LS) mean change in urinary phosphate excretion from baseline (48hrs prior to dosing) to Evaluation Period (Days 1-3). The baseline characteristics were balanced between OLC/LC and LC/OLC sequences. LS mean change from baseline for OLC (-320.4mg/day) was similar to the LS mean change from BL for LC (-324.0mg/day). The 90% confidence interval for the LS mean change in urinary phosphate excretion from baseline (test-reference) was (-37.83, 45.12), which was entirely contained within the predefined ±20% acceptance range of (-64.80, 64,80). There were no serious adverse events (SAEs) and no treatment discontinuations. The incidence of treatment-emergent adverse events (TEAEs) and related AEs were also the same in both groups at 35% and 25%, respectively.

Title: Renal Dietitians Perceive Phosphate Binder and Low-Phosphate Diet Non-Compliance as Top Reasons for Above Target Serum Phosphorous Concentrations
Lead Author: Kathleen Hill Gallant, PhD, RD
Results: The poster presentation delivers results of a recent dietitian survey evaluating perceived reasons for noncompliance to phosphate binder (PB) therapy and identifies the most appealing potential aspects of OLC. The poster concluded that strategies that reduce pill burden and increase ease of use for patients may promote PB treatment compliance, which may improve patient outcomes. OLC, which is a smaller tablet that can be swallowed whole without chewing, may address compliance issues seen with current PBs. In fact, 47% of dieticians noted the high perceived potency of OLC and 34% noted its perceived lower number of pills required as the most appealing aspects of OLC.

Recent studies reported PB non-adherence rates of up to 78% in patients with end-stage kidney disease on dialysis. For the analysis, 100 renal dietitians were surveyed and there were several key findings. The most common reasons for phosphate levels above the target range were non-compliance to PB prescription (36%) or low phosphate diet (34%). The two leading reasons for PB discontinuation were too many pills and formulation issues. One-third of dietitians attributed non-compliance with patients forgetting to take their PBs with meals or snacks and 16% attributed it to high pill burden.

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 topline results of the bioequivalence study, pharmacodynamic (PD) bioequivalence of OLC to Fosrenol was established.

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 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 late preclinical development for the treatment of acute kidney injury. 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:

ir@unicycive.com
(650) 543-5470

SOURCE: Unicycive Therapeutics, Inc.

Released May 15, 2024

Release – Graham Corporation Announces Filing of Universal Shelf Registration Statement

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on GHM

BATAVIA, N.Y.–(BUSINESS WIRE)– Graham Corporation (NYSE: GHM) (“GHM” or “the Company”), a global leader in the design and manufacture of mission critical fluid, power, heat transfer and vacuum technologies for the defense, space, energy, and process industries, announced today that it has filed a universal shelf registration statement on Form S-3 with the Securities and Exchange Commission (SEC). If and when the shelf registration is declared effective, it will permit the Company to offer and sell, from time to time in one or more offerings, up to $150 million of common stock, preferred stock, warrants, purchase contracts, units, or any combination of these securities.

Christopher J. Thome, Chief Financial Officer, commented, “We believe a shelf registration is a demonstration of good corporate governance as it provides GHM with enhanced financial flexibility to meet our long-term strategic goals. It enables us to access the capital markets quickly and efficiently, if and when favorable conditions align for the Company and our shareholders.”

Should the Company decide to raise capital in a future offering using the shelf registration statement, GHM will describe the specific details of that future offering in a prospectus supplement that is filed with the SEC.

The registration statement on Form S-3 has been filed with the SEC but is not yet effective. These securities may not be sold nor may offers to buy be accepted under the Form S-3 registration statement prior to the time the Form S-3 registration statement becomes effective. This News release shall not constitute an offer to sell nor the solicitation of an offer to buy the securities that are proposed to be registered on the Form S-3, nor shall there be any sale of such securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of any such state.

About Graham Corporation

GHM is a global leader in the design and manufacture of mission critical fluid, power, heat transfer and vacuum technologies for the defense, space, energy, and process industries. The Graham Manufacturing and Barber-Nichols’ global brands are built upon world-renowned engineering expertise in vacuum and heat transfer, cryogenic pumps, and turbomachinery technologies, as well as its responsive and flexible service and the unsurpassed quality customers have come to expect from the Company’s products and systems. Graham Corporation routinely posts news and other important information on its website, grahamcorp.com, where additional information on Graham Corporation and its businesses can be found.

Safe Harbor Regarding Forward Looking Statements

This news release contains 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.

Forward-looking statements are subject to risks, uncertainties and assumptions and are identified by words such as “believe,” “if,” “when,” “intended,” “should,” ”may”, “will,” and other similar words and include all statements with respect to the Company’s plans and expectations regarding its registration statement on Form S-3 and any potential future offering or capital raises and the use of proceeds therefrom. Because they are forward-looking, they should be evaluated in light of important risk factors and uncertainties. These risk factors and uncertainties are more fully described in Graham Corporation’s most recent Annual Report filed with the Securities and Exchange Commission (the “SEC”), included under the heading entitled “Risk Factors”, and in other reports filed with the SEC.

Should one or more of these risks or uncertainties materialize or should any of Graham Corporation’s underlying assumptions prove incorrect, actual results may vary materially from those currently anticipated. In addition, undue reliance should not be placed on Graham Corporation’s forward-looking statements. Except as required by law, Graham Corporation disclaims any obligation to update or publicly announce any revisions to any of the forward-looking statements contained in this news release.

For more information, contact:
Christopher J. Thome
Vice President – Finance and CFO
Phone: (585) 343-2216

Deborah K. Pawlowski
Kei Advisors LLC
Phone: (716) 843-3908
dpawlowski@keiadvisors.com

Source: Graham Corporation

Released May 13, 2024

Release – Orion Group Holdings Announces Significant Contract Award for Port Everglades Bulkhead Replacement Project

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on ORN

HOUSTON, May 09, 2024 (GLOBE NEWSWIRE) — Orion Group Holdings, Inc. (NYSE: ORN) (the “Company”), a leading specialty construction company, today announced a significant contract award valued at nearly $80 million for its Marine construction business. The contract was awarded by Port Everglades Seaport Engineering & Construction Division through Moss Construction as Managing General Contractor for the Port Everglades Bulkhead Replacement Project – Group 1, a pivotal infrastructure upgrade at one of the nation’s busiest ports. Orion has supported Port Everglades and worked with Moss successfully on previous projects.

Orion Group Holdings won the Port Everglades Bulkhead Replacement Project award through a competitive bid process. The scope of work includes the replacement of approximately 2,240 linear feet of aging steel sheet pile bulkheads, including large diameter combi-wall systems, soil anchors and encapsulated concrete caps. In addition, the project will address the aging North Bulkhead at the Entrance Channel (NBEC), which spans 1,200 feet and is vital for the safe and smooth flow of maritime traffic. The project is set to commence June 1 and will conclude in late 2026.

“We are excited to continue our relationship with Moss and the Port Everglades Seaport Engineering & Construction Division by delivering this critical marine project that will modernize and strengthen the Port’s capabilities. With our deep marine construction expertise, we look forward to supporting port business into the future,” said Travis Boone, Chief Executive Officer of Orion Group Holdings, Inc. “This project not only reinforces our commitment to maintaining the highest standards of maritime infrastructure but also ensures Port Everglades continues to serve as a critical hub for the world-class cruise industry and the growing international cargo and petroleum business.”

Orion Group Holdings, Inc. is a renowned name in specialty construction, known for its dedication to safety, quality, innovation, and timely project execution. With these new contract awards, Orion continues to strengthen its position as an industry leader capable of tackling complex projects with unmatched expertise.

About Orion Group Holdings

Orion Group Holdings, Inc., a leading specialty construction company serving the infrastructure, industrial and building sectors, provides services both on and off the water in the continental United States, Alaska, Hawaii, Canada and the Caribbean Basin through its marine segment and its concrete segment. The Company’s marine segment provides construction and dredging services relating to marine transportation facility construction, marine pipeline construction, marine environmental structures, dredging of waterways, channels and ports, environmental dredging, design and specialty services. Its concrete segment provides turnkey concrete construction services including place and finish, site prep, layout, forming, and rebar placement for large commercial, structural and other associated business areas. The Company is headquartered in Houston, Texas with regional offices throughout its operating areas. The Company’s website is located at: https://www.oriongroupholdingsinc.com.

Forward-Looking Statements

The matters discussed in this press release may constitute or include projections or other forward-looking statements within the meaning of the “safe harbor” provisions of Section 27A of the Securities Exchange Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, of which provisions the Company is availing itself. Certain forward-looking statements can be identified by the use of forward-looking terminology, such as ‘believes’, ‘expects’, ‘may’, ‘will’, ‘could’, ‘should’, ‘seeks’, ‘approximately’, ‘intends’, ‘plans’, ‘estimates’, or ‘anticipates’, or the negative thereof or other comparable terminology, or by discussions of strategy, plans, objectives, intentions, estimates, forecasts, outlook, assumptions, or goals. In particular, statements regarding future operations or results, including those set forth in this press release, and any other statement, express or implied, concerning future operating results or the future generation of or ability to generate revenues, income, net income, gross profit, EBITDA, Adjusted EBITDA, Adjusted EBITDA margin, or cash flow, including to service debt or maintain compliance with debt covenants, and including any estimates, forecasts or assumptions regarding future revenues or revenue growth, are forward-looking statements. Forward-looking statements also include project award announcements, estimated project start dates, anticipated revenues, and contract options which may or may not be awarded in the future. Forward-looking statements involve risks, including those associated with the Company’s fixed price contracts that impacts profits, unforeseen productivity delays that may alter the final profitability of the contract, cancellation of the contract by the customer for unforeseen reasons, delays or decreases in funding by the customer, levels and predictability of government funding or other governmental budgetary constraints, and any potential contract options which may or may not be awarded in the future, and are at the sole discretion of award by the customer. Past performance is not necessarily an indicator of future results. Considering these and other uncertainties, the inclusion of forward-looking statements in this press release should not be regarded as a representation by the Company that the Company’s plans, estimates, forecasts, goals, intentions, or objectives will be achieved or realized. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update information contained in this press release whether as a result of new developments or otherwise, except as required by law.

Please refer to the Company’s 2023 Annual Report on Form 10-K, filed on March 1, 2024 which is available on its website at www.oriongroupholdingsinc.com or at the SEC’s website at www.sec.gov, for additional and more detailed discussion of risk factors that could cause actual results to differ materially from our current expectations, estimates or forecasts.

Contacts:

Financial Profiles, Inc.
Margaret Boyce 310-622-8247
orn@finprofiles.com 

The Rise of PIPEs in the Biotech World

Posted on by slightbourne@noblecapitalmarkets.com

For biotech companies operating in the small and micro-cap arena, access to capital can often be the difference between make or break. Developing cutting-edge therapies is an expensive endeavor, with clinical trials alone costing millions. When equity markets turn volatile, these small players can find themselves in a funding crunch that stalls or derails their most promising innovations.

This dilemma has led to a surge in an alternative financing technique known as the PIPE – a private investment in public equity. PIPEs allow select investors to directly purchase shares or convertible securities from a public biotech company at a discounted price in a private placement. In exchange, these investors gain access to highly coveted non-public information like interim clinical trial data or study results before they hit the mainstream.

The allure is obvious – getting an early peek under the hood allows “PIPE investors” to make educated bets on a company’s prospects ahead of any market-moving news releases. If the confidential data looks promising, they can stock up on discounted shares before the positive study results send the share price shooting upwards.

For the issuing biotech, a PIPE deal solves a dire cash crunch while attracting buy-in from reputable healthcare funds who often have existing holdings. It’s a win-win that has fueled a PIPE boom, with U.S. biotechs raising a record $5.7 billion through these private placements in Q1 2024 alone according to Jefferies data.

However, this lucrative trend is also igniting a raging controversy. The investing community is deeply divided between those with a rarefied seat at the PIPE table, and those feeling deprived of a chance at the same insight and opportunities.

On one side are specialist healthcare funds like Adage Capital, Logos Capital, and EcoR1 which have made PIPEs their bread-and-butter. They argue the confidential data access merely levels the playing field, as professional biotech investors already do rigorous public-sourced analyses that give them an edge over casual investors.

“You have companies spending years running clinical trials, taking huge risks to develop these drugs for patients. PIPEs give them a fighting chance to meet funding needs when equity markets turn hostile,” says Oleg Nodelman of EcoR1. “It’s better than watching all that work disintegrate.”

Opposing them are generalist investors and even some biotech CEOs who decry PIPEs as sanctioned insider trading that unfairly favors an elite group. Sounding the loudest alarms are those burned by buying into hyped PIPEs only to see outsized stock gains instantly materialize for PIPE investors.

“There are instances where stocks rallied over 40% the day positive PIPE data was announced,” notes Daphne Zohar, CEO of Seaport Therapeutics, who avoids PIPEs. “These lopsided deals make generalist investors feel the deck is stacked against them.”

The controversy deepened when an investor sued Taysha Gene Therapies in April, alleging company leaders strategically timed disclosures alongside a $150 million PIPE to maximize profits for an inner circle before share prices spiked.

As PIPEs proliferate from niche deals into a $5 billion-plus financing pipeline, stakes are rising for all sides. Furious retail investors have even conjectured PIPEs could enable “shadow trading” – using confidential data about one company’s study to invest in an unrelated competitor ahead of public releases.

While merely allegations now, any concrete evidence of foul play could precipitate a harsh regulatory crackdown to ensure fair markets. Already some PIPEs have seen muted stock bounces as news travels faster about these non-public data disclosures.

For now, cash-strapped biotechs seem willing to accept the criticism as a worthwhile price to pay for crucial growth capital. PIPE defenders argue if disclosure rules are followed, there’s no meaningful distinction between benefiting from non-public information as an investor versus as a biotech executive or regulator with early trial data access.

Only time will tell if the alluring but contentious PIPE well runs dry from overuse and regulatory scrutiny. But in today’s turbulent climate, it offers a vital lifeline to biotech innovators facing turbulent public capital currents. Just be prepared to defend your stake in this high-stakes game of data-driven musical chairs.

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

Blockbuster Music Rights Deal: Blackstone Outbids Concord for Hipgnosis Songs

Posted on by slightbourne@noblecapitalmarkets.com

In a major shakeup in the booming music rights acquisition space, private equity giant Blackstone has emerged victorious in a heated bidding war to acquire Hipgnosis Songs Fund, trumping an earlier offer from music company Concord.

The deal, valued at around $1.57 billion, sees Blackstone acquiring the prized music rights portfolio of Hipgnosis, which holds over 65,000 songs from iconic artists like Shakira, Red Hot Chili Peppers, Blondie, and Neil Young. Blackstone’s superior cash offer of $1.30 per share outmaneuvered Concord’s bid of $1.25 per share, which had previously received the backing of Hipgnosis’ board. However, the board has now withdrawn its recommendation in favor of Blackstone’s higher bid.

The transaction represents a significant expansion of Blackstone’s already formidable music rights holdings. The private equity titan has been aggressively building its intellectual property portfolio, with existing assets including hit songs from superstars like Justin Bieber, Justin Timberlake, and performance rights organization SESAC, which boasts affiliates like Bob Dylan and Adele.

The Hipgnosis acquisition also sets the stage for an insightful discussion at Noble Capital Markets’ upcoming Consumer, Communications, Media and Technology Virtual Conference in June. Hosted by leading industry analysts, the conference will provide a comprehensive look at the latest trends, challenges, and opportunities shaping the dynamic technology, media, and telecom landscape. With disruptive forces like streaming, 5G, and AI reshaping multiple industries, analysts are eager to examine the strategic implications and growth avenues for major players across this critical sector. The music rights boom will undoubtedly be a key topic of discussion, but the conference aims to deliver a holistic perspective on the evolving TMT ecosystem.

As the dust settles on this blockbuster deal, all eyes will be on Blackstone’s next strategic moves in the world of music IP. With its substantial resources and existing portfolio, the private equity titan is well-positioned to further consolidate its dominance in this lucrative arena. The company’s aggressive pursuit of Hipgnosis signals its belief in the long-term value and growth potential of iconic musical works as the industry continues its shift towards streaming platforms and new content consumption models emerge.

Direct Digital Holdings (DRCT) – Marcum Gives A Bad Impression

Posted on by cpereira@noblefcm.com


Wednesday, April 24, 2024

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

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

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

Non-compliance notice. On April 17 the company was not able to file its 10-K on time, and, subsequently, received a notification of non-compliance from NASDAQ. Notably, the company has 30 days to submit an actionable plan to regain compliance. Importantly, the failure to file its 10-K on time was attributed to the inability of  its auditor, Marcum, to verify impressions data. 

New auditor expected soon. Marcum is terminating its relationship with the company, citing its inability to verify the company’s impressions data. Importantly, we expect the company to sign a top 10 US accounting firm within the 30-day window. The audit should be able to ramp quickly, given that the company will be able to provide timely access to all the data the was requested by the previous auditor. Additionally, we expect Nasdaq will accept its plan and grant the company up to 6 months to complete the10-K filing, as well as its first quarter 10-Q filing. 


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. 

Release – Ocugen Announces Dosing Completion Of Subjects With Geographic Atrophy In Cohort 2 Of Phase 1/2 ArMaDa Clinical Trial Of OCU410—A Modifier Gene Therapy

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

April 19, 2024

MALVERN, Pa., April 19, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that dosing is complete in the second cohort of its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV-hRORA)—a modifier gene therapy candidate being developed for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD). GA affects approximately 1 million people in the United States alone.

“We are very enthusiastic about the potential of OCU410 as a one-time, gene-agnostic option for the treatment of GA,” said Dr. Huma Qamar, Chief Medical Officer of Ocugen. “OCU410 regulates multiple pathways involved with the disease, including lipid metabolism, inflammation, oxidative stress, and membrane attack complex (complement) with a single sub-retinal injection.”

Dosing in the second cohort is complete and 3 subjects received 200 mL single subretinal administration of the medium dose (5×1010 vg/mL) of OCU410. Up to 13 leading retinal surgery centers across the United States are participating in the ArMaDa clinical trial.

“Currently we have two FDA approved, anti-complement therapies for GA targeting a single pathway of the disease, which has multifactorial and complex etiology,” said Syed M. Shah, MD, Vice Chair of Research and Digital Medicine and Director of Retina Service at Gundersen Health System, La Crosse, WI, and the lead investigator for the OCU410 Phase 1/2 trial. “The limited benefit comes with the burden of continued multiple intravitreal injections spanning over several years. This novel modifier gene therapy has the potential to transform the therapeutic landscape in GA treatment.”

A Data and Safety Monitoring Board meeting will convene next month to review the 4-week safety data of the medium dose cohort before proceeding with high dose, which is the final dose in the Phase 1 dose-escalation study.

The ArMaDa Phase 1/2 clinical trial will assess the safety of unilateral subretinal administration of OCU410 in subjects with GA and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose-ranging study consisting of three dose levels [low dose (2.5×1010 vg/mL), medium dose (5×1010 vg/mL), and high dose (1.5 ×1011 vg/mL). Phase 2 is a randomized, outcome accessor-blinded, dose-expansion study in which subjects will be randomized in a 1:1:1 ratio to either one of two OCU410 treatment groups or to an untreated control group.

The Company will continue to provide clinical updates on an ongoing basis.

About dAMD and GA
dAMD affects approximately 10 million Americans and more than 266 million people worldwide. It is characterized by the thinning of the macula. The macula is the part of the retina responsible for clear vision in one’s direct line of sight. dAMD involves the slow deterioration of the retina with submacular drusen (small white or yellow dots on the retina), atrophy, loss of macular function and central vision impairment. dAMD accounts for 85-90% of the total AMD population.

About OCU410
OCU410 utilizes an AAV delivery platform for the retinal delivery of the RORA (ROR Related Orphan Receptor A) gene. The RORA protein plays an important role in lipid metabolism, reducing lipofuscin deposits and oxidative stress, and demonstrates an anti-inflammatory role as well as inhibiting the complement system in in-vitro and in-vivo (animal model) studies. These results demonstrate the ability for OCU410 to target multiple pathways linked with dAMD pathophysiology. Ocugen is developing AAV-RORA as a one-time gene therapy for the treatment of GA.

About Ocugen, Inc. 
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact: 
Tiffany Hamilton 
Head of Communications 
Tiffany.Hamilton@ocugen.com  

Tesla Slashes Workforce by Over 10% as Demand Softens

Posted on by slightbourne@noblecapitalmarkets.com

In a move that has sent shockwaves through the electric vehicle industry, Tesla Inc. announced plans to lay off more than 10% of its global workforce. The decision, confirmed by CEO Elon Musk in an internal memo, comes on the heels of a disappointing first-quarter delivery report that missed analyst estimates and left the company with an excess inventory of over 46,000 vehicles.

The layoffs, which are expected to impact at least 14,000 employees out of Tesla’s 140,000-strong workforce, are part of a broader effort to cut costs and increase productivity as the company prepares for its “next phase of growth,” according to Musk’s memo. The move underscores the challenges facing Tesla amid a slowdown in EV demand, both in the United States and globally.

“As we prepare the company for our next phase of growth, it is extremely important to look at every aspect of the company for cost reductions and increasing productivity,” Musk wrote in the memo. “As part of this effort, we have done a thorough review of the organization and made the difficult decision to reduce our headcount by more than 10% globally. There is nothing I hate more, but it must be done.”

The announcement has sent shockwaves through the industry, with analysts offering mixed reactions to the news. Dan Ives, a noted Tesla bull at Wedbush Securities, described the layoffs as an “ominous signal” that speaks to tough times ahead for the company. “Demand has been soft globally, and this is an unfortunately necessary move for Tesla to cut costs with a softer growth outlook,” Ives said, adding that the move signals that Musk is navigating a “Category 5 storm.”

However, not all analysts view the layoffs as a negative development. Garrett Nelson, an analyst at CFRA, sees the move as consistent with actions undertaken by other automakers – and particularly EV pure-plays such as Rivian and Lucid – amid slowing EV growth rates. “We view the announcement as a sign of the times, but the fact Tesla is taking action to reduce costs amid the slowdown should be positive for the bottom line,” Nelson said.

The layoffs come at a critical juncture for Tesla, which has long been hailed as a pioneer in the electric vehicle space. After years of breakneck growth and ambitious expansion plans, the company now finds itself grappling with a rapidly changing market landscape. Rising interest rates and higher overall prices have dampened consumer demand for electric vehicles, while increased competition from legacy automakers and upstart EV manufacturers has intensified pressure on Tesla to maintain its competitive edge.

Musk has repeatedly emphasized the importance of affordability in driving EV adoption, fueling speculation that Tesla was working on a next-generation vehicle that would start at around $25,000. However, recent reports suggesting that the company had canceled the project were met with a swift denial from Musk, who instead teased the debut of a Tesla robotaxi on August 8.

As Tesla prepares to report its first-quarter earnings on April 23, all eyes will be on the company’s ability to weather the current storm and chart a course for long-term growth. The layoffs, while painful, may be a necessary step in ensuring Tesla’s long-term competitiveness in an increasingly crowded and challenging market.

Biotechs Onconova and Trawsfynydd Merge to Create Traws Pharma

Posted on by slightbourne@noblecapitalmarkets.com

In a deal uniting two biotech companies from opposite coasts, Onconova Therapeutics and Trawsfynydd Therapeutics announced they are combining forces through an all-stock merger. The newly created entity, dubbed Traws Pharma, will have a deep pipeline spanning virology and oncology when it begins trading on the Nasdaq as “TRAW” this Wednesday.

Traws is being launched with an approximately $28 million cash balance after a $14 million private placement investment led by elite life sciences funds OrbiMed and Torrey Pines. The cash provides ample runway as Traws prepares for multiple clinical catalysts in 2024 across its three lead programs.

The combined company will be led by an executive team blending leadership from the previous organizations. Incoming CEO Werner Cautreels, Ph.D., previously headed Trawsfynydd, while Onconova’s Steven Fruchtman, M.D., will serve as President and Chief Scientific Officer of Oncology for Traws.

On the virology side, Traws inherits Trawsfynydd’s advancing pipeline of antiviral candidates for influenza and COVID-19. Viroksavir, a novel cap-dependent endonuclease inhibitor, has completed Phase 1 testing for influenza and is slated to begin Phase 2 trials in the second half of this year. Early data could read out by the first half of 2025.

Travaltrelvir is Trawsfynydd’s oral protease inhibitor targeting COVID-19. A first-in-human Phase 1 study initiated screening in the first quarter, with topline data expected in the second half of 2024. If positive, Traws plans to rapidly advance travaltrelvir into a Phase 2 trial in the second half of 2024 enrolling moderate to severe COVID-19 patients.

From Onconova, Traws gains narazaciclib, a next-generation CDK4/6 inhibitor being evaluated in a Phase 1/2 trial for low-grade endometrioid endometrial cancer (LGEEC). Preclinical data suggests narazaciclib could offer an improved therapeutic window over approved CDK4/6 drugs like palbociclib with potentially fewer bone marrow and GI toxicities.

The merger deal terms entail Trawsfynydd shareholders receiving 75.7% ownership in the combined Traws entity, with Onconova shareholders getting 13.7% and the OrbiMed/Torrey Pines investors getting 10.6%. A key piece allows current Onconova investors to retain a contingent value right (CVR) entitling them to potential future proceeds from narazaciclib.

Traws’ board will blend representation as well, co-led by Executive Chairman Iain Dukes, DPhil from OrbiMed and Nikolay Savchuk, Ph.D. of Torrey Pines, along with continuing Onconova directors.

While delivering upside potential from a fresh pipeline spanning anti-infectives and cancer, the Traws merger does come with a degree of complexity and deal risk. The share issuances require a shareholder vote, which could potentially disrupt the closing if there are any hiccups.

But if the transaction goes through as anticipated, Traws Pharma will emerge as a unique hybrid biotech play. Bolstered by crossover financing, it will seek to advance multiple clinical candidates toward key data inflections that could help unlock their full therapeutic and commercial potential across areas of significant unmet medical need.

Take a moment to take a look at more biotech companies by taking a look at Noble Capital Market’s Senior Research Analyst Robert Leboyer’s coverage list.

Job Market Stays Resilient as Openings Hold Steady

Posted on by slightbourne@noblecapitalmarkets.com

The latest employment data shows the resilience of the US labor market, even as the Federal Reserve remains locked in an inflation battle. The number of job openings across the country was essentially unchanged in February at 8.76 million, according to the Job Openings and Labor Turnover Survey (JOLTS) released by the Labor Department.

While just a slight 0.1% uptick from January’s revised 8.75 million openings, the figure highlights how robust hiring demand remains from employers over a year into the Fed’s interest rate hiking campaign. Job vacancies have been sticky at extremely elevated levels, leaving Fed officials frustrated in their efforts to ease wage growth and inflationary pressures.

“The labor market continues to defy expectations of a meaningful cooling,” said Samantha Gunther, economist at Credence Economics. “With openings still so high, wage growth is likely to remain too strong for the Fed’s liking in the months ahead.”

The JOLTS data precedes this week’s highly anticipated March jobs report, which is forecast to show nonfarm payrolls increased by 230,000 positions. That would mark a fourth straight month of job gains over 200,000, underscoring the employment market’s enduring tightness.

There were some modest signs of a gradual loosening in labor conditions buried within February’s openings figures. Job vacancies fell in sectors like information, healthcare and retail trade. More notably, the overall level of layoffs jumped to 1.8 million, the highest since last April, led by a spike in the leisure and hospitality industry.

“While the bar remains high for calling a turn in the labor cycle, we’re seeing some initial hints of cracks starting to form,” said Ryan Bingham, lead labor economist at ADP. “Higher borrowing costs are clearly starting to bite for certain service-sector businesses.”

The report also showed rates of workers quitting their jobs to pursue other opportunities held steady at 2.2% in February, the lowest since the summer of 2020. The diminished quits rate could indicate employees are feeling less confident about switching roles in a more uncertain economic climate.

Another indicator pointing to some easing was the ratio of available workers to job openings, which slipped to 1.36 from 1.43 in January. While still a very tight ratio favoring employers over job seekers, it marked progress toward better balance after peaking above 2-to-1 last year.

For the Fed, the upshot is likely more patience in leaving interest rates elevated. Chair Jerome Powell reiterated last week that stronger labor market “gives” would be needed to bring down unacceptably high inflation back toward the 2% goal.

With payroll growth expected to remain solid and job openings still extremely elevated, it will take more time before productivity-enhancing labor slack emerges. The latest JOLTS figures suggest that process is underway, however gradual it may prove to be.

Big Pharma Goes Bio-Prospecting: Why Major Drug Makers Are Buying Innovative Biotech Startups

Posted on by slightbourne@noblecapitalmarkets.com

The biotech sector has seen a flurry of acquisition activity in recent months, with large pharmaceutical companies opening their checkbooks to snap up promising small and micro-cap players. This deal-making frenzy underscores the value that nimble startups can bring to big pharma through their cutting-edge research and drug development pipelines.

For the pharmaceutical giants, acquiring innovative biotechs provides a vital influx of new drug candidates and therapies to revitalize stagnant pipelines and drive future revenue growth. Many large drug makers have struggled to internally develop enough new blockbuster treatments to replace aging cash cows going off-patent. Rather than go it alone in risky early-stage R&D, they are turning to biotech upstarts working at the frontiers of medicine.

These small biotech firms are proving to be fertile ground for novel drug discoveries. Despite their tiny team and budget, biotech startups can move nimbly to translate university research into therapeutic candidates. Their laser focus on narrow areas like orphan diseases, gene therapies, or targeted oncology treatments allows them to rapidly innovate in ways that large pharma bureaucracies cannot.

By acquiring these startups, big pharma gains a fast-track to promising new drugs and therapies that would take years and billions to develop internally. They can get first-mover advantage on groundbreaking new treatment modalities. Just as importantly, they acquire the entrepreneurial scientific talent behind the discoveries.

This acquisition appetite from pharma giants shows no signs of slowing. Just this month, AbbieVie acquired small biotech Landos Biopharma for $212 million to gain its promising autoimmune pipeline. AstraZeneca paid $2.4 billion for Fusion Pharmaceuticals and its next-gen oncology radioconjugates. The list goes on.

The drivers behind this deal surge were presciently spotted by Channelchek back in December 2023. Channelchek’s biotech research analysis predicted that the beaten-down biotech sector was poised for a major rebound, writing:

“The fresh upswing in biotech M&A follows a wave of dip buying from some the world’s largest asset managers in shares of industry leaders like Vertex Pharmaceuticals and Regeneron Pharmaceuticals. Warren Buffett’s Berkshire Hathaway has been particularly aggressive stepping in to purchase stakes in key biopharma bluechips.”

Channelchek’s forecast proved accurate, as biotech stocks have rallied and M&A activity has heated up in recent months. Big pharma’s shopping spree for innovative biotechs continues to gain momentum.

As Nico Pronk, Chief Executive Officer at Noble Capital Markets, stated: “Our platform aims to help amplify the stories of these cutting-edge biotech innovators to the investors and strategic partners seeking out emerging growth opportunities.” There is a funding gulf that still exists for startups looking to take their discoveries to the next level.

For investors and emerging biotechs seeking to capitalize on this next wave of consolidation, Noble Capital Markets is hosting its Emerging Growth Virtual Healthcare Equity Conference on April 17-18, 2024. This online investor forum will allow public healthcare, biotech and medical devices firms to present their company stories directly to institutional funds, family offices, and retail investor audiences. To register for this event showcasing the future disruptors of healthcare, visit the conference registration page here.

The big pharma acquisition binge shines a light on the value that small, innovative biotech players can bring to the healthcare ecosystem through their scientific discoveries. With deep-pocketed buyers on the prowl, the stage is set for the next generation of medical breakthroughs to be commercialized at scale.

Release – PDS Biotechnology Announces Conference Call and Webcast for Business Update and Full Year 2023 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

PRINCETON, N.J., March 20, 2024 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell-activating platforms, today announced that the Company will provide a business update and release financial results for the year ended December 31, 2023, on Wednesday, March 27, 2024. Following the release, management will host a conference call to review the financial results and provide a business update.

Wednesday, March 27, 2024, 8:00 AM ET
Domestic: 877-704-4390
International: 201-389-0920
Conference ID: 13745320
Webcast: PDS Biotech Earnings Webcast

After the live webcast, the event will be archived on PDS Biotech’s website for six months.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS01ADC and Infectimune® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches. Our Versamune® platform activates the right type, quantity and potency of tumor attacking T cells. Our IL-12 fused antibody drug conjugate (PDS01ADC) is designed to target the tumor to promote suppression of the tumor’s defenses while promoting T-cell activity in the tumor. To date, Versamune® HPV (PDS0101), PDS01ADC and PDS0101 co-administered with PDS01ADC, our lead clinical candidates, have demonstrated the ability to shrink tumors and/or stabilize disease when used as single agents or in combination with approved therapies in patients with a broad range of solid tumors in multiple Phase 2 clinical trials. We plan to advance our lead program into a pivotal trial for the treatment of recurrent/metastatic HPV16-positive head and neck cancer. Our Infectimune® based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses, including long-lasting memory T-cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on X at @PDSBiotech.

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

Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation.

Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com

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

Drivers Brace for Higher Gas Prices as Oil Costs Spike

Posted on by slightbourne@noblecapitalmarkets.com

Motorists across the nation are once again feeling the pinch at the gas pump as oil prices have climbed sharply in recent months. After a brief reprieve earlier this year, the national average price for a gallon of regular gasoline has risen over 18 cents in just the last month to around $3.40 according to AAA data. Experts warn that prices could jump another 10-15 cents over the next couple of weeks alone.

The primary culprit behind the surge is the rising cost of crude oil. Both the U.S. benchmark West Texas Intermediate and the global Brent crude have seen prices spike, with WTI crude now hovering around $79 per barrel and Brent north of $83 per barrel. Just a few months ago, WTI started 2024 just over $70 a barrel.

As crude gets more expensive for refiners to purchase, the costs get passed along to consumers in the form of higher gasoline prices. Tighter supplies and seasonal factors are also contributing to price increases at the pump.

“This week, Gulf Coast refiners began transitioning to more expensive summer blend gasoline, which accounts for nearly 50% of the nation’s refining capacity,” said Andy Lipow of Lipow Oil Associates. “That switch means higher prices are ahead.”

California drivers are being hit particularly hard, with the statewide average price per gallon already at a lofty $4.88 as of Wednesday. Refinery maintenance, lower inventory levels, and the changeover to summer blends have caused California gas prices to jump around 25 cents in recent weeks according to Lipow.

The overall lower supply situation is being exacerbated by disruptions at some key refineries. For example, BP’s massive Whiting refinery in Indiana, the largest in the Midwest, is still recovering from a recent power outage caused by cold weather that impacted production.

Historically, spring represents the start of the annual rise in gas prices as refiners transition to summer blends and demand picks up with more drivers hitting the road after the winter months. Consumer demand typically peaks during summer’s peak driving season.

While higher energy costs were one of the main factors driving an unexpected increase in inflation in February, rising gas prices take an oversized toll on household budgets. The latest Consumer Price Index data showed the gasoline index spiked 3.8% last month alone after declining in January.

Analysts caution there is likely more pain at the pump on the horizon with the summer driving season still ahead. Unless crude oil prices reverse course or refining capacity increases, American drivers can expect gasoline to remain unusually expensive compared to this time last year.

“With the industry having less refining capacity and the economy remaining relatively strong, I expect retail gasoline prices to set new records across the nation in the coming months,” Lipow stated.

Whether taking a road trip for spring break or commuting to and from work and activities, consumers have little choice but to absorb the impact of elevated gas prices cutting into other spending. Budgets will be further squeezed if crude oil costs remain stubbornly high and gasoline supply remains tight.