February 2025 - Page 12 of 15

Release – Graham Corporation Reports Third Quarter Fiscal 2025 Results

Posted on February 7, 2025February 7, 2025 by aweinsoff@channelchek.com

Revenue increased 7.3% to $47.0 million driven by continued strength in key end-markets
Gross profit margin improved 260 basis points to 24.8% of sales, net margin increased 300 basis points to 3.4% of sales, and adjusted EBITDA margin¹ expanded 180 basis points to 8.6% of sales
Net income per diluted share increased 600% to $0.14 in the third quarter; adjusted net income per diluted share¹ increased 38% to $0.18
Orders of $24.8 million, driven by demand from defense, space, and aftermarket; YTD Book-to-Bill ratio of 1.0x and a backlog of $385 million²
Strong balance sheet with no debt, $30.0 million in cash, and access to $43 million under its revolving credit facility at quarter end to support growth initiatives
Reiterated full year guidance for Sales and adjusted EBITDA¹

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, today reported financial results for its third quarter for the fiscal year ending March 31, 2025 (“fiscal 2025”).

“Our strong performance through the first three quarters of our fiscal year reflects continually improving execution across our business. Customer demand for our diversified product portfolio is robust, driving margin expansion through improved product mix and operational efficiency. The progress we have shown to date, coupled with advancing discussions on both new programs and expansions with existing customers, reinforces our confidence in achieving our long-term growth targets,” said Daniel J. Thoren, Chief Executive Officer.

____________________
¹ Adjusted EBITDA margin, Adjusted Net Income per Diluted Share and Adjusted EBITDA are non-GAAP measures. See attached tables and other information for important disclosures regarding Graham’s use of these non-GAAP measures.
² Orders, backlog and book-to-bill ratio are key performance metrics. See “Key Performance Indicators” below for important disclosures regarding Graham’s use of these metrics.

Quarterly net sales of $47.0 million increased 7.3%, or $3.2 million. Sales to the defense market grew by $2.7 million, or 11.1% from the prior year period, driven by the addition of new defense programs, the ramp-up of existing programs, better execution, and the timing of key project milestones. Additionally, higher chemical/petrochemical sales contributed $2.7 million to growth, driven by increased sales of capital equipment. Aftermarket sales to the refining, chemical/petrochemical, and defense markets of $9.7 million remained strong and were 2.4% higher than the prior year. See supplemental data for a further breakdown of sales by market and region.

Gross profit for the quarter increased $2.0 million to $11.7 million compared to the prior-year period of $9.7 million. As a percentage of sales, gross profit margin increased 260 basis points to 24.8%, compared to the fiscal third quarter of 2024. This increase was driven by leverage on higher volume, better execution, and improved pricing, partially offset by higher incentive compensation compared to the prior year period.

Additionally, the third quarter of fiscal 2025 gross profit benefited $0.3 million from a $2.1 million grant received from the BlueForge Alliance earlier this fiscal year to reimburse Graham for the cost of the Company’s defense welder training programs in Batavia and related equipment. To date, the Company has received $1.5 million of funding under this grant.

Selling, general and administrative expense (“SG&A”), including amortization, totaled $9.7 million, or 20.6% of sales, up $0.9 million compared with the prior year. This increase reflects the Company’s continued investments in its people, processes, and technology to drive long-term sustainable growth.

Included in other operating income for the third quarter of fiscal 2025 was a $0.2 million reversal of a previously accrued contingent earnout liability for P3. The reversal was due to delayed orders/projects that extended beyond the earnout period.

Cash Management and Balance Sheet
Cash provided by operating activities totaled $27.9 million for the nine-month period ending December 31, 2024, an increase of $8.4 million from the comparable period in fiscal 2024. As of December 31, 2024, cash and cash equivalents were $30.0 million, up from $16.9 million at the end of fiscal 2024.

Capital expenditures of $13.8 million for the first nine months of fiscal 2025 were focused on capacity expansion, increasing capabilities, and productivity improvements. The Company increased its expected fiscal 2025 capital expenditures to be in the range of $15.0 million to $19.0 million from its previous expectations of $13.0 million to $18.0 million due to a faster pace of execution on the capital projects in process. All major capital projects are on time and on budget.

The Company had no debt outstanding at December 31, 2024 with $43 million available on its revolving credit facility after taking into account outstanding letters of credit.

Orders, Backlog, and Book-to-Bill Ratio
See supplemental data filed with the Securities and Exchange Commission on Form 8-K and provided on the Company’s website for a further breakdown of orders and backlog by market. See “Key Performance Indicators” below for important disclosures regarding Graham’s use of these metrics.

As expected, orders for the third quarter of fiscal 2025 declined to $24.8 million given the higher level of orders earlier in the fiscal year. Orders tend to be lumpy given the nature of our business (i.e. large capital projects) and in particular, orders to the defense industry, which span multiple years and are larger in size. Orders for the nine-month period ended December 31, 2024, were $144.2 million, resulting in a year-to-date book-to-bill ratio of 1.0x. After-market orders for the refining, petrochemical, and defense markets remained strong and totaled $13.0 million for the third quarter of fiscal 2025, an increase of 51% over the prior year.

Backlog at quarter end was $384.7 million, down 3.6% over the prior-year period and down 5.5% sequentially. Approximately 45% to 50% of orders currently in backlog are expected to be converted to sales in the next twelve months and another 35% to 40% are expected to convert to sales within one to two years. The majority of orders expected to convert beyond twelve months are for the defense industry, specifically the U.S. Navy.

Fiscal 2025 Outlook
The Company’s outlook for 2025 was updated as follows:

Webcast and Conference Call
GHM’s management will host a conference call and live webcast on February 7, 2025 at 11:00 a.m. Eastern Time (“ET”) to review its financial results as well as its strategy and outlook. The review will be accompanied by a slide presentation, which will be made available immediately prior to the conference call on GHM’s investor relations website.

A question-and-answer session will follow the formal presentation. GHM’s conference call can be accessed by calling (201) 689-8560. Alternatively, the webcast can be monitored from the events section of GHM’s investor relations website.

A telephonic replay will be available from 3:00 p.m. ET today through Friday, February 14, 2025. To listen to the archived call, dial (412) 317-6671 and enter conference ID number 13750971 or access the webcast replay via the Company’s website at ir.grahamcorp.com, where a transcript will also be posted once available.

About Graham Corporation
Graham 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. Graham Corporation and its family of 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 “expects,” “future,” “outlook,” “anticipates,” “believes,” “could,” “guidance,” ”may”, “will,” “plan” and other similar words. All statements addressing operating performance, events, or developments that Graham Corporation expects or anticipates will occur in the future, including but not limited to, profitability of future projects and the business, its ability to deliver to plan, its ability to continue to strengthen relationships with customers in the defense industry, its ability to secure future projects and applications, expected expansion and growth opportunities, anticipated sales, revenues, adjusted EBITDA, adjusted EBITDA margins, capital expenditures and SG&A expenses, the timing of conversion of backlog to sales, orders, market presence, profit margins, tax rates, foreign sales operations, customer preferences, changes in market conditions in the industries in which it operates, changes in general economic conditions and customer behavior, forecasts regarding the timing and scope of the economic recovery in its markets, and its acquisition and growth strategy, are forward-looking statements. 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.

Non-GAAP Financial Measures
Adjusted EBITDA is defined as consolidated net income (loss) before net interest expense, income taxes, depreciation, amortization, other acquisition related expenses, and other unusual/nonrecurring expenses. Adjusted EBITDA margin is defined as Adjusted EBITDA as a percentage of sales. Adjusted EBITDA and Adjusted EBITDA margin are not measures determined in accordance with generally accepted accounting principles in the United States, commonly known as GAAP. Nevertheless, Graham believes that providing non-GAAP information, such as Adjusted EBITDA and Adjusted EBITDA margin, is important for investors and other readers of Graham’s financial statements, as it is used as an analytical indicator by Graham’s management to better understand operating performance. Moreover, Graham’s credit facility also contains ratios based on Adjusted EBITDA. Because Adjusted EBITDA and Adjusted EBITDA margin are non-GAAP measures and are thus susceptible to varying calculations, Adjusted EBITDA, and Adjusted EBITDA margin, as presented, may not be directly comparable to other similarly titled measures used by other companies.

Adjusted net income and adjusted net income per diluted share are defined as net income and net income per diluted share as reported, adjusted for certain items and at a normalized tax rate. Adjusted net income and adjusted net income per diluted share are not measures determined in accordance with GAAP, and may not be comparable to the measures as used by other companies. Nevertheless, Graham believes that providing non-GAAP information, such as adjusted net income and adjusted net income per diluted share, is important for investors and other readers of the Company’s financial statements and assists in understanding the comparison of the current quarter’s and current fiscal year’s net income and net income per diluted share to the historical periods’ net income and net income per diluted share. Graham also believes that adjusted net income per share, which adds back intangible amortization expense related to acquisitions, provides a better representation of the cash earnings of the Company.

Forward-Looking Non-GAAP Measures
Forward-looking adjusted EBITDA and adjusted EBITDA margin are non-GAAP measures. The Company is unable to present a quantitative reconciliation of these forward-looking non-GAAP financial measures to their most directly comparable forward-looking GAAP financial measures because such information is not available, and management cannot reliably predict the necessary components of such GAAP measures without unreasonable effort largely because forecasting or predicting our future operating results is subject to many factors out of our control or not readily predictable. In addition, the Company believes that such reconciliations would imply a degree of precision that would be confusing or misleading to investors. The unavailable information could have a significant impact on the Company’s fiscal 2025 financial results. These non-GAAP financial measures are preliminary estimates and are subject to risks and uncertainties, including, among others, changes in connection with purchase accounting, quarter-end, and year-end adjustments. Any variation between the Company’s actual results and preliminary financial estimates set forth above may be material.

Key Performance Indicators
In addition to the foregoing non-GAAP measures, management uses the following key performance metrics to analyze and measure the Company’s financial performance and results of operations: orders, backlog, and book-to-bill ratio. Management uses orders and backlog as measures of current and future business and financial performance, and these may not be comparable with measures provided by other companies. Orders represent written communications received from customers requesting the Company to provide products and/or services. Backlog is defined as the total dollar value of net orders received for which revenue has not yet been recognized. Management believes tracking orders and backlog are useful as they often times are leading indicators of future performance. In accordance with industry practice, contracts may include provisions for cancellation, termination, or suspension at the discretion of the customer.

The book-to-bill ratio is an operational measure that management uses to track the growth prospects of the Company. The Company calculates the book-to-bill ratio for a given period as net orders divided by net sales.

Given that each of orders, backlog, and book-to-bill ratio are operational measures and that the Company’s methodology for calculating orders, backlog and book-to-bill ratio does not meet the definition of a non-GAAP measure, as that term is defined by the U.S. Securities and Exchange Commission, a quantitative reconciliation for each is not required or provided.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250206161483/en/

Christopher J. Thome
Vice President – Finance and CFO
Phone: (585) 343-2216

Tom Cook
Investor Relations
(203) 682-8250
Tom.Cook@icrinc.com

Source: Graham Corporation

Released February 7, 2025

Zomedica Corp. (ZOM) – New TRUFORMA Assay Improves Diagnostic Offering

Posted on February 7, 2025February 7, 2025 by cpereira@noblefcm.com

Friday, February 07, 2025

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.

Zomedica Launches New ACTH Assay For Equine PPID. Zomedica has launched an updated TRUFORMA assay for diagnosis of Equine PPID, Pituitary Pars Intermedia Dysfunction, an endocrine disorder in horses also known as Equine Cushing’s Disease. The new assay measures ACTH and one of its breakdown products, CLIP, then calculates a value that can be compared with established standard levels. The measures in this assay allow for better, faster diagnosis at the point-of-care.

PPID Is A Common Condition In Older Horses. An estimated 20% of the horses over 15 years of age are affected by PPID. Benign tumors or enlargement of the pituitary gland leads to overproduction of endocrine hormones and dysregulation of metabolism. ACTH is one of the hormones affected, causing a variety of symptoms that may lead to muscle wasting, thirst, urination, behavior, immune suppression, and metabolic changes. This affects the horse’s overall health, quality of life, and value to the owner.

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

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

Graham Corp. (GHM) – A Transition At The Top

Posted on February 7, 2025February 7, 2025 by cpereira@noblefcm.com

Friday, February 07, 2025

Graham Corporation designs, manufactures and sells critical equipment for the energy, defense and chemical/petrochemical industries. The Company designs and manufactures custom-engineered ejectors, vacuum pumping systems, surface condensers and vacuum systems. It is a nuclear code accredited fabrication and specialty machining company. It supplies components used inside reactor vessels and outside containment vessels of nuclear power facilities. Its equipment is found in applications, such as metal refining, pulp and paper processing, water heating, refrigeration, desalination, food processing, pharmaceutical, heating, ventilating and air conditioning. For the defense industry, its equipment is used in nuclear propulsion power systems for the United States Navy. The Company’s products are used in a range of industrial process applications in energy markets, including petroleum refining, defense, chemical and petrochemical processing, power generation/alternative energy and other.

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.

A Transition. Yesterday, Graham Corporation announced its current President and CEO, Daniel Thoren, will transition to the role of Executive Chairman, effective June 10, 2025. Matthew J. Malone, current Vice President and General Manager for Graham subsidiary Barber-Nichols, will be appointed to President & COO effective February 2025 and is expected to assume the CEO role of Graham Corporation in June 2025. The transition is part of an established succession plan.

Malone Background. Mr. Malone brings over 15 years of engineering and executive experience to his new role as President and Chief Operating Officer. Mr. Malone joined Barber-Nichols in 2015 as a Project Engineer focused on rocket engine turbopump design and development. He was promoted to Navy Program Manager in 2018, overseeing key U.S. Navy programs, and was appointed Vice President of Operations at Barber-Nichols in 2020 and then General Manager in 2021.

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

EuroDry (EDRY) – Rating Lowered to Market Perform, Awaiting an Improvement in Time Charter Rates

Posted on February 7, 2025February 7, 2025 by cpereira@noblefcm.com

Friday, February 07, 2025

EuroDry Ltd. was formed on January 8, 2018 under the laws of the Republic of the Marshall Islands to consolidate the drybulk fleet of Euroseas Ltd. into a separate listed public company. EuroDry was spun-off from Euroseas Ltd. on May 30, 2018; it trades on the NASDAQ Capital Market under the ticker EDRY. EuroDry operates in the dry cargo, drybulk shipping market. EuroDry’s operations are managed by Eurobulk Ltd., an ISO 9001:2008 and ISO 14001:2004 certified affiliated ship management company and Eurobulk (Far East) Ltd. Inc., which are responsible for the day- to-day commercial and technical management and operations of the vessels. EuroDry employs its vessels on spot and period charters and under pool agreements.

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

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

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

Sale of M/V Tasos. EuroDry Ltd. recently agreed to sell the M/V Tasos, a vessel built in 2000, for ~$5 million. The vessel is expected to be scrapped and recycled and will be delivered to its buyer between mid-February and mid-March 2025. Eurodry expects to book a gain of approximately $2.1 million. Following the sale of the M/V Tasos, Eurodry will have a fleet of 12 vessels with total cargo capacity of 843,402 dwt. Upon delivery of two Ultramax vessels in 2027, the fleet will consist of 14 vessels with total cargo capacity of 970,402 dwt.

Market environment. Charter rates have continued to decline due, in part, to a weak outlook for the economy in China, which accounts for a large portion of dry bulk trade, and previous route disruptions that have largely abated. The Panama Canal has returned to full capacity, further undermining dry bulk rates. Recent U.S. tariffs imposed on imports from China could also weigh on its economy. While higher scrapping rates and more stringent environmental regulations could constrain the available bulker fleet, we are not optimistic that rates will make a significant recovery in 2025 despite a historically low industry order book.

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

DLH Holdings (DLHC) – Transition Ongoing

Posted on February 7, 2025February 7, 2025 by cpereira@noblefcm.com

Friday, February 07, 2025

DLH delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.

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.

Revenue Decline. 1Q25 y-o-y lower revenue was driven by the unbundling of contracts to small business set-asides, which negatively impacted revenue by $3.5 million, $1.5 million from the winding down of acquired small business contracts, another $1.5 million from winding down of international business, and roughly $2 million of HHS revenue that was pushed out into the second quarter of 2025.

Strong Pipeline. DLH’s pipeline remains strong with over $4.0 billion of new business opportunities. For fiscal year 2025, management identified 13 opportunities worth a total of $700 million. The Company is focused on opportunities that leverage DLH’s digital transformation, cyber security, research and development, and systems engineering capabilities.

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

Alumis and ACELYRIN Announce Definitive Merger Agreement in All-Stock Transaction

Posted on February 7, 2025February 7, 2025 by cpatches

Key Points:
– Alumis and ACELYRIN have agreed to an all-stock merger, creating a well-capitalized biopharmaceutical company focused on advancing immunology treatments.
– The combined company will have approximately $737 million in cash and securities, supporting multiple clinical trial readouts and operations into 2027.
– Alumis will retain its name and leadership team, with an expanded board including two ACELYRIN members, and the merger is expected to close in Q2 2025.

Alumis Inc. (NASDAQ: ALMS) and ACELYRIN (NASDAQ: SLRN) have announced a definitive merger agreement, combining the two clinical-stage biopharmaceutical companies in an all-stock transaction aimed at advancing immunology treatments and optimizing clinical outcomes.

Strategic Rationale and Financial Position

The merger will create a strongly capitalized company with a combined cash, cash equivalents, and marketable securities position of approximately $737 million as of year-end 2024. This financial strength is expected to support the advancement of the companies’ combined pipeline through multiple key clinical data readouts and fund operating expenses and capital expenditures into 2027.

The combined company will leverage its track record in research and development and a proprietary data and analytics platform to drive innovation in immune-mediated diseases.

Martin Babler, President, CEO, and Chairman of Alumis, stated: “Through this combination with ACELYRIN, Alumis will have the financial flexibility and runway to advance an expanded late-stage pipeline, now including lonigutamab, and build commercial capabilities. Since completing our IPO, Alumis has operated with speed and rigor, and the multiple development milestones expected in 2025 and 2026, coupled with potential additional indications for ESK-001, represent exciting breakthroughs for our patients and value-driving opportunities for the combined company’s stockholders. As we move forward together, we will maintain financial discipline and a flexible capital allocation strategy with the goal of maximizing the value of our highly differentiated portfolio.”

Pipeline Highlights

Alumis’ ESK-001: A next-generation, allosteric TYK2 inhibitor, currently in Phase 3 ONWARD trials for moderate-to-severe plaque psoriasis (PsO) and Phase 2b LUMUS trials for systemic lupus erythematosus (SLE). Key Phase 2 52-week updates expected in 2025, with Phase 3 topline data in H1 2026.
Alumis’ A-005: A CNS-penetrant allosteric TYK2 inhibitor, targeting neuroinflammatory and neurodegenerative diseases like multiple sclerosis (MS) and Parkinson’s Disease. A Phase 2 trial is set to begin in H2 2025.
ACELYRIN’s Lonigutamab: A subcutaneous anti-IGF-1R therapy with best-in-class potential for thyroid eye disease (TED), currently under Phase 2 evaluation.

Transaction Terms & Leadership Structure

Exchange Ratio: ACELYRIN stockholders will receive 0.4274 shares of Alumis common stock for each ACELYRIN share owned.
Ownership Breakdown: 55% Alumis stockholders, 45% ACELYRIN stockholders post-transaction.
Leadership: The combined company will operate under the Alumis name and be led by Alumis’ executive team, strengthened by key ACELYRIN professionals and medical experts.
Board Expansion: The board will grow to nine members, including two from ACELYRIN.
Closing Timeline: The transaction is expected to close in Q2 2025, subject to regulatory and shareholder approvals.

This merger brings together two companies dedicated to transforming immunology treatments, strengthening their pipeline, and delivering long-term value to patients and investors alike.

January Jobs Report Shows Slower-Than-Expected Growth

Posted on February 7, 2025February 7, 2025 by cpatches

Key Points:
– January job growth slowed to 143,000, falling below expectations and marking a sharp decline from December’s revised 307,000 gain.
– Wage growth increased by 4.1% over the past year, outpacing inflation but continuing to pose affordability challenges for consumers.
– The Federal Reserve and markets are closely monitoring labor trends, while rising trade policy uncertainty and potential economic shifts under President Trump add to financial volatility.

The U.S. labor market saw weaker-than-expected job growth in January, with nonfarm payrolls increasing by 143,000, below the Dow Jones forecast of 169,000 and down from a revised 307,000 in December. Meanwhile, the unemployment rate declined to 4.0%, showing continued resilience in the job market despite the slowdown in hiring.

Key Takeaways from the January Jobs Report

Weaker Job Growth: January’s 143,000 job gain marks a sharp decline from December and falls below expectations.
Downward Revisions: Total payroll numbers for 2024 were revised downward by 589,000 over the trailing 12-month period ending in March 2024.
Sector Performance:
- Healthcare: +44,000 jobs
- Retail: +34,000 jobs
- Government: +32,000 jobs
Labor Force Participation: Increased 0.1% from December to 62.6%.
2024 Job Growth Trend: The monthly average for job growth in 2024 stood at 166,000 per month.
Wage Growth: Average hourly earnings rose 4.1% over the past year, partly due to minimum wage hikes in parts of the country.
Affordability Challenges: Wage growth continues to outpace recent inflation rates, but many consumers still face affordability challenges.

Market and Federal Reserve Reactions

Markets showed little reaction to the report in early trading, as investors had largely anticipated a slowdown in job creation. Federal Reserve officials are closely monitoring labor market data as they consider future monetary policy moves. The Fed cut its benchmark interest rate by a full percentage point in late 2024, and today’s report may influence their next steps regarding interest rate adjustments. President Trump recently stated that the Fed’s decision last week to hold rates steady was well-advised, despite previously criticizing the move.

Broader Economic and Political Context

Some indicators, such as hiring rates, suggest slower movement in the job market. Meanwhile, business executives remain optimistic that Trump’s policies—such as tax cuts and deregulation—will boost economic growth. However, Trump’s recent tariff decisions have rattled markets, adding to economic uncertainty. Rising trade policy uncertainty could further heighten financial market volatility in the coming months.

The Historical Importance of Jobs Reports

The monthly jobs report is one of the most closely watched economic indicators, providing insights into labor market health, consumer spending power, and broader economic momentum. Historically, strong job growth has been associated with economic expansion, while sluggish reports can indicate slowdowns or even recessions. Policymakers, investors, and businesses use these reports to make critical decisions on interest rates, hiring strategies, and economic forecasts. In the current environment, sustained job growth and wage pressures suggest a resilient labor market, even as broader economic uncertainties loom.

With job growth slowing but unemployment remaining stable, policymakers will weigh the need for further economic stimulus against concerns of overheating the labor market. The upcoming months will be crucial in determining whether this slowdown is temporary or indicative of a broader labor market trend.

Release – Cadrenal Therapeutics Announces Chief Medical Officer Transition to Advance Clinical Development of Tecarfarin

Posted on February 6, 2025February 6, 2025 by aweinsoff@channelchek.com

Research News and Market Data on CVKD

James J. Ferguson, MD, FACC, FAHA, joins as Chief Medical Officer
Extensive experience provides strong support for advancing specialized cardiovascular assets, including leading the late-stage clinical development of tecarfarin and other business development opportunities

PONTE VEDRA, Fla. – Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company focused on the development of specialized cardiovascular therapies, with the late-stage asset tecarfarin, a new Vitamin K antagonist, today announced a leadership transition appointing James J. Ferguson, MD, FACC, FAHA, as its new Chief Medical Officer, effective immediately. Dr. Ferguson is a distinguished medical expert with over 25 years of leadership in the cardiovascular field and deep expertise in clinical development. Dr. Ferguson will lead the late-stage clinical development of tecarfarin to include the pivotal trial in LVAD patients and other indications in rare cardiovascular conditions requiring life-long anticoagulation therapy as well as other business development opportunities to build the Company’s pipeline.

Dr. Ferguson replaces Douglas W. Losordo, MD. Cadrenal thanks Dr. Douglas Losordo for his contributions to advancing the development of our tecarfarin program.

“We welcome Dr. Ferguson to our team and are confident that he will play a critical role in driving the late-stage clinical development of tecarfarin and the prioritization of indications. Dr. Ferguson brings expertise and strong relationships with cardiovascular clinical and scientific thought leadership, which will be instrumental as we prepare for late-stage clinical development of our tecarfarin program,” said Quang X. Pham, Chief Executive Officer, Cadrenal Therapeutics, Inc.

Dr. Ferguson joins Cadrenal after serving as Chief Medical Officer at Matinas BioPharma. Previously, Dr. Ferguson was Head of U.S. Cardiovascular Medical Affairs at Amgen and held several senior positions at AstraZeneca, including Vice President of US Cardiovascular Medical and Scientific External Relations, Therapeutic Area Vice President of Cardiovascular Global Medical Affairs, and US Development brand leader for BRILINTA.

“I’m truly honored to be joining Cadrenal at this exciting and transformative time. I look forward to advancing the late-stage clinical development of tecarfarin and bringing forward the first innovation in vitamin K-targeted anticoagulation in 70 years. This product could have a truly meaningful impact for patients in whom there continues to be major unmet medical needs with standard warfarin therapy,” said Dr. Ferguson.

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company focused on developing specialized therapeutics for rare cardiovascular conditions. The Company is developing tecarfarin, a vitamin K antagonist (VKA) designed to be a better and safer anticoagulant than warfarin for individuals with implanted cardiac devices. Cadrenal strives to improve outcomes and reduce major adverse events for these patients. Although warfarin is widely used off-label for several rare cardiovascular diseases, extensive clinical and real-world data have shown it to have significant serious side effects. With its innovation, Cadrenal aims to meet the unmet needs of this patient population by relieving them and their healthcare providers of some of warfarin’s greatest clinical challenges.

Cadrenal is pursuing a product in a pipeline approach with tecarfarin. Tecarfarin received Orphan Drug designation (ODD) for advanced heart failure patients with implanted left ventricular assist devices (LVADs). In 2025, the Company plans to initiate a pivotal Phase 3 trial evaluating tecarfarin versus warfarin for LVAD patients. The Company also received ODD and fast-track status for tecarfarin in end-stage kidney disease and atrial fibrillation (ESKD+AFib).

Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus to build a pipeline of specialized cardiovascular therapies. For more information, visit www.cadrenal.com and connect with us on LinkedIn.

Safe Harbor

Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding the contributions to be made by Dr. Ferguson including leading the late-stage clinical development of tecarfarin to include the pivotal trial in LVAD patients and other indications in rare cardiovascular conditions requiring life-long anticoagulation therapy as well as other business development opportunities to build the Company’s pipeline, as well as advancing other indications in rare cardiovascular conditions requiring chronic anticoagulation; playing a critical role in driving the late-stage clinical development of tecarfarin and the prioritization of indications; Dr. Ferguson’s expertise and strong relationships with cardiovascular clinical and scientific thought leadership being instrumental as the Company prepares for the for late-stage clinical development of our tecarfarin programs; advancing the late-stage clinical development of tecarfarin and bringing forward the first innovation in vitamin K-targeted anticoagulation in 70 years; the product having a truly meaningful impact for patients in whom there continues to be major unmet medical needs with standard warfarin therapy; the Company striving to improve outcomes and reduce major adverse events for patients; the Company aiming to meet the unmet needs of the patient population by relieving them and their healthcare providers of some of warfarin’s greatest clinical challenges; and the Company initiating in 2025 a pivotal Phase 3 trial evaluating tecarfarin versus warfarin for LVAD patients. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to derive benefits from the contributions expected to be made by Dr. Ferguson; the ability to initiate the pivotal Phase 3 clinical trial for tecarfarin in LVAD patients in 2025 and provide improved outcomes; the ability to enter into collaborations with development partners; the ability of tecarfarin to provide a safer alternative to LVAD patients and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250206066131/en/

Lisa DeScenza

LaVoieHealthScience

(978) 395-5970

ldescenza@lavoiehealthscience.com

Release – Direct Digital Holdings Launches AI Council to Bridge the AI Gap for Small and Medium-size Business Advertisers

Posted on February 6, 2025February 6, 2025 by aweinsoff@channelchek.com

Research News and Market Data on DRCT

February 06, 2025 9:00 am EST Download as PDF

The new initiative aims to ensure SMBs and mid-market brands aren’t left behind in the digital marketplace

HOUSTON, Feb. 6, 2025 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital Holdings” or the “Company”), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC (“Colossus SSP”) and Orange 142, LLC (“Orange 142”), today announced the formation of its Artificial Intelligence (AI) Council, a new initiative aimed at demystifying and operationalizing artificial intelligence for small and mid-sized business (SMB) advertisers. The cutting-edge council will tackle the widening disparity in AI utilization between large corporations and smaller enterprises by equipping these businesses with actionable AI strategies to enhance their competitiveness in the digital arena.

As digital landscapes evolve, the adoption of AI in advertising has become a critical factor for success. Yet, many SMBs and mid-market brands are disadvantaged due to resource limitations and a lack of specialized knowledge. The AI Council at Direct Digital Holdings is designed to change this narrative by providing small and mid-sized businesses with the tools and insights necessary to leverage AI effectively, leveling the playing field with larger competitors.

“Artificial intelligence is transforming digital advertising, but too often, small and mid-sized businesses are left behind,” said Anu Pillai, Chief Technology Officer at Direct Digital Holdings and Member of the AI Council. “The AI Council’s mission is to bridge this gap. By democratizing access to AI tools and strategies, we empower small and medium-sized businesses to participate and lead in their markets.”

The AI Council will focus on supporting small and mid-sized businesses in several key areas:

Education and Workshops: Offering seminars and resources that explain AI concepts in straightforward terms, making the technology accessible and understandable.
Strategy Development: Assisting small and mid-sized businesses in developing AI-driven advertising strategies that are tailored to their unique business needs and market conditions.
Technology Implementation: Providing support in the implementation of AI tools, from automated bidding systems to customer data analysis, ensuring small and mid-sized businesses can harness AI’s full potential without the need for in-house experts.
Performance Monitoring: Guiding businesses in setting up systems to monitor the effectiveness of AI applications, enabling continuous improvement and optimization
Free Ebooks: We have produced a series of eBooks to help guide SMBs through the process of navigating the complex landscape.
Practical Guides: Practical guides include a framework for employee generative AI usage policy and best practices for generative AI prompting.

In addition to internal experts, the AI Council will collaborate with technologists, academic leaders, and industry innovators to stay on the cutting edge of AI developments. This collaborative approach ensures that the Council’s initiatives are based on the latest research and best practices, making state-of-the-art AI solutions accessible to small and mid-sized business advertisers. “By leveraging both advertising and AI partners, our company will develop innovative products tailored to the unique needs of small businesses. This includes AI-driven marketing tools that help small and mid-sized businesses optimize their dollars as well as strategic initiatives such as AI training programs and workshops to empower small businesses with the knowledge and skills needed to thrive in a competitive market,” said Christy Nolan, VP of Delivery Solutions at Direct Digital Holdings and Member of the AI Council.

The AI Council will be an ongoing effort to ensure that all Direct Digital Holdings customers, regardless of size, have the tools and knowledge to succeed in an increasingly AI-driven world.

Please visit the DDH AI Council Resource Center to download the eBooks and practical guides.

About Direct Digital Holdings

Direct Digital Holdings (Nasdaq: DRCT) brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within the general market and multicultural media properties. The Company’s buy-side platform, Orange 142, delivers significant ROI for middle-market advertisers by providing data-optimized programmatic solutions for businesses in sectors ranging from energy to healthcare to travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions generate billions of impressions per month across display, CTV, in-app, and other media channels.

View original content to download multimedia:https://www.prnewswire.com/news-releases/direct-digital-holdings-launches-ai-council-to-bridge-the-ai-gap-for-small-and-medium-size-business-advertisers-302370022.html

SOURCE Direct Digital Holdings

Released February 6, 2025

Release – Bit Digital, Inc. Announces Strategic Rebranding of its HPC Business to WhiteFiber

Posted on February 6, 2025February 6, 2025 by aweinsoff@channelchek.com

Research News and Market Data on BTBT

NEW YORK, February 6, 2025 /PRNewswire/ — Bit Digital, Inc. (Nasdaq: BTBT) (“Bit Digital” or the “Company”) announced today that it has officially rebranded its HPC business as WhiteFiber, Inc. (“WhiteFiber”). WhiteFiber encompasses the Company’s GPU Cloud business and its HPC data center business, Enovum Data Centers (“Enovum”). The new WhiteFiber website can be found at www.whitefiber.com.

Sam Tabar, CEO of Bit Digital, commented: “Rebranding our HPC business to WhiteFiber is an important step in establishing a distinct identity for this transformative venture. WhiteFiber represents the convergence of cutting-edge technology and seamless connectivity, underscoring our commitment to delivering vertically integrated HPC solutions. By combining data center colocation with GPU cloud services, we provide the high-performance infrastructure required for the most demanding AI workloads. With this rebrand, we signal to our customers, partners, and investors that we are focused on building a platform of unmatched reliability, efficiency, and innovation. Our WhiteFiber business is currently servicing more than 20 customers compared to just 1 at the start of 2024. We look forward to expanding both our customer base and existing partnerships through industry-leading performance and reliability.”

This rebranding underscores Bit Digital’s commitment to addressing the surging demand for data centers and sustainable, cutting-edge HPC and AI cloud infrastructure. WhiteFiber’s platform is engineered to support the most demanding workloads with unparalleled performance, reliability, and efficiency, empowering industries to meet the challenges of tomorrow. The Company’s bitcoin mining and ETH staking businesses will continue to operate under the Bit Digital brand.

About Bit Digital

Bit Digital, Inc. is a global platform for high-performance computing (“HPC”) infrastructure and digital asset production headquartered in New York City. Our operations are located in the US, Canada, and Iceland. For additional information, please contact ir@bit-digital.com or visit our website at www.bit-digital.com.

Investor Notice

Investing in our securities involves a high degree of risk. Before making an investment decision, you should carefully consider the risks, uncertainties and forward-looking statements described under “Risk Factors” in Item 3.D of our Annual Report on Form 20-F for the fiscal year ended December 31, 2023 (“Annual Report”). Notwithstanding the fact that Bit Digital Inc. has not conducted operations in the PRC since September 30, 2021 we have previously disclosed under Risk Factors in our Annual Report: “We may be subject to fines and penalties for any noncompliance with or any liabilities in our former business in China in a certain period from now on.” Although the statute of limitations for non-compliance by our former business in the PRC is generally two years and the Company has been out of the PRC, for more than two years, the Authority may still find its prior bitcoin mining operations involved a threat to financial security. In such event, the two-year period would be extended to five years. If any material risk was to occur, our business, financial condition or results of operations would likely suffer. In that event, the value of our securities could decline and you could lose part or all of your investment. The risks and uncertainties we describe are not the only ones facing us. Additional risks not presently known to us or that we currently deem immaterial may also impair our business operations. In addition, our past financial performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results in the future. Future changes in the network-wide mining difficulty rate or bitcoin hash rate may also materially affect the future performance of Bit Digital’s production of bitcoin. Actual operating results will vary depending on many factors including network difficulty rate, total hash rate of the network, the operations of our facilities, the status of our miners, and other factors. See “Safe Harbor Statement” below.

Safe Harbor Statement

This press release may contain certain “forward-looking statements” relating to the business of Bit Digital, Inc., and its subsidiary companies. All statements, other than statements of historical fact included herein are “forward-looking statements.” These forward-looking statements are often identified by the use of forward-looking terminology such as “believes,” “expects,” or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website at http://www.sec.gov. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.

Release – Graham Corporation Announces Transition to Strengthen Core Leadership Team and Support Continued Growth

Posted on February 6, 2025February 6, 2025 by aweinsoff@channelchek.com

Research News and Market Data on GHM

February 06, 2025 7:30am EST Download as PDF

As part of its established succession plan, President & CEO, Daniel J. Thoren to transition to Executive Chairman and Strategic Advisor effective June 2025

Matthew J. Malone, current Vice President and General Manager for Graham subsidiary Barber-Nichols, appointed to President & COO effective February 2025; expected to assume CEO role of Graham Corporation in June 2025

Executing according to succession plan previously approved by the Board of Directors; deepens bench strength of the Executive Leadership Team, ensures a smooth leadership transition, positions the business for continued growth and success

The Company reiterates its sales and Adjusted EBITDA guidance as provided on November 8, 2024

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, today announced key leadership changes as part of its established succession plan.

Daniel J. Thoren, President and Chief Executive Officer, will transition to the role of Executive Chairman, effective June 10, 2025 and will remain active in the operations of the Company for the foreseeable future. As part of the transition, Mr. Thoren will serve as a strategic advisor, focusing on guiding strategy and helping the Company grow through business development. With this change, Jonathan W. Painter, Chairman of the Board of Directors, will transition to Lead Independent Director.

In alignment with this plan, the Board of Directors has approved the appointment of Matthew J. Malone as President and Chief Operating Officer, reporting to Mr. Thoren, effective February 5, 2025. In this role, Mr. Malone will oversee, guide and lead each of the Company’s business units. Prior to this appointment, Mr. Malone has served as Vice President and General Manager of Barber-Nichols since 2021. Concurrently, Michael E. Dixon, Director of Sales and Marketing of Barber-Nichols, will be promoted to General Manager of Barber-Nichols reporting to Mr. Malone, effective February 5, 2025.

The Company further announced its intention for Mr. Malone to assume the role of Chief Executive Officer on June 10, 2025, and the expectation of his appointment to the Board of Directors. At that time, Mr. Dixon is expected to assume the role of Vice President of Graham Corporation and General Manager of Barber-Nichols.

Jonathan W. Painter, Chairman of the Board of Directors said, “I am pleased to announce these leadership appointments in accordance with our planned succession strategy, which demonstrates the bench strength of our executive team and reflects Graham’s commitment to developing exceptional talent. I would like to personally thank Dan for his leadership and tremendous accomplishments while serving as CEO since August of 2021 and we look forward to continuing to work with him in this next chapter, while he steps back from the day-to-day demands of public company leadership.”

Mr. Thoren said, “I am grateful to have led Graham as CEO and am proud of the great work we have completed during my tenure. Today’s appointments further highlight the strong talent we have attracted and developed across the entire organization, and I am pleased with the opportunity this transition has created within the Company. Matt Malone has demonstrated outstanding leadership capabilities throughout his time with Barber-Nichols and Graham, and his deep understanding of our business makes him the ideal choice to lead the Company into its next chapter of growth. Similarly, Mike Dixon’s promotion to lead Barber-Nichols reflects his deep industry knowledge, product expertise and institutional knowledge of Barber-Nichols. I look forward to working alongside Matt, Mike, and the rest of the executive team to ensure we achieve our long-term strategic objectives and have complete confidence that under this new leadership structure, our company will continue to thrive and create value for our stakeholders.”

Matt Malone brings over 15 years of engineering and executive experience to his new role as President and Chief Operating Officer. Mr. Malone joined Barber-Nichols in 2015 as a Project Engineer focused on rocket engine turbopump design and development. He was promoted to Navy Program Manager in 2018, overseeing key U.S. Navy programs and was appointed Vice President of Operations at Barber-Nichols in 2020 and then General Manager in 2021. Earlier in his career, he held a variety of engineering and management positions at GE Transportation. Mr. Malone earned his B.S. in Mechanical Engineering with honors in design optimization from Pennsylvania State University and his M.S. in Mechanical Engineering from Georgia Institute of Technology.

Mike Dixon has been an integral part of Barber-Nichols for the past six years, most recently serving as Director of Sales and Marketing. During his tenure, he has played a pivotal role in expanding the Company’s technical capabilities and securing major contracts in the space and aerospace, and defense sectors. Prior to joining the Company, he held roles of increasing responsibility at Sundyne and began his career at ESS Metron. Mr. Dixon holds a B.S. in Mechanical Engineering from Northern Illinois University.

Financial Update and Fiscal Third Quarter 2025 Earnings Call

The Company today reiterated its sales and Adjusted EBITDA guidance as provided on November 8, 2024. The Company will provide additional details on its fiscal third quarter 2025 results during its earnings conference call scheduled for February 7, 2025.

About Graham Corporation

Graham 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. Graham Corporation and its family of 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 “expects,” “future,” “guidance,” “will,” “plan” and other similar words. All statements addressing operating performance, events, or developments that Graham Corporation expects or anticipates will occur in the future, including but not limited to, expected future management personnel changes and the timing of such changes, expected expansion and growth opportunities, anticipated adjusted EBITDA, and its growth strategy, are forward-looking statements. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250205168400/en/

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

Tom Cook
Investor Relations
Phone: (203)-682-8250
Tom.Cook@icrinc.com

Source: Graham Corporation

Released February 6, 2025

Release – Tonix Pharmaceuticals Announces Positive Topline Results from Phase 1 Trial for TNX-1500, a Next Generation anti-CD40L mAb Candidate for Prevention of Kidney Transplant Rejection and Treatment of Autoimmune Diseases

Posted on February 6, 2025February 6, 2025 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

February 06, 2025 8:00am EST Download as PDF

Results from the Phase 1 single ascending dose study support proceeding to develop a Phase 2 trial for the prevention of kidney transplant rejection

TNX-1500 blocked the primary and secondary antibody responses to a test antigen at the 10 mg/kg and 30 mg/kg i.v. doses

TNX-1500 showed mean half-life of 34-38 days for the 10 mg/kg and 30 mg/kg doses supporting monthly dosing for future efficacy trials

TNX-1500 was generally well-tolerated with a favorable safety profile

Anti-CD40L has multiple potential indications in addition to solid organ and bone marrow transplantation including autoimmune diseases: potential pipeline in a product

CHATHAM, N.J., Feb. 06, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced positive topline results from its Phase 1, single ascending dose trial of TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody, or mAb)* in healthy participants. The objectives of the Phase 1 trial were to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous TNX-1500, as well as to support dosing in a planned Phase 2 trial in kidney transplant recipients.

“There remains a significant need for new agents with improved activity and safety to prevent transplant rejection and treat autoimmune diseases,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “First generation anti-CD40L mAb therapy, particularly ruplizumab (a.k.a., humanized 5c8 or BG9588) showed activity in modulating autoimmunity and rejection in allo- and xeno-transplantation but was limited by an increased risk of thrombosis.¹^-3 Tonix created TNX-1500, a next generation anti-CD40L mAb, by reengineering the Fc region of ruplizumab, to preserve activity with improved safety. The results of the Phase 1 study indicate that TNX-1500 has met these design objectives. We believe the results of this study and our prior animal studies^4,5 indicate that TNX-1500 is potentially best-in-class among next-generation anti-CD40L mAbs in development.”

Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals said, “Topline results from the TNX-1500 Phase 1 study showed TNX-1500 at the 10 mg/kg and 30 mg/kg doses blocked both the primary and secondary antibody responses to a test antigen. The pharmacokinetic data support monthly dosing at doses of 10 mg/kg or above. Based on these findings, we are eager to advance this promising candidate into a Phase 2 efficacy study. We believe TNX-1500 has the potential to prevent organ transplant rejection and improve graft survival with reduced long-term toxicity burden relative to current immunosuppressive regimens.”

Methods and Topline Results

Dosing: TNX-1500 solution was infused i.v. over a period of one hour to achieve doses of 3 mg/kg, 10 mg/kg, and 30 mg/kg. Participants were observed in the clinic for one day and followed with periodic clinic visits to Day 120.
Keyhole Limpet Hemocyanin (KLH) Challenge: To evaluate the immune modulation potency of TNX-1500, participants received an antigen challenge with KLH (Immucothel^®) administered subcutaneously (SC) on Day 2 and Day 29 of the study.
Disposition: A total of 26 participants were enrolled in three Cohorts (3 mg/kg, 10 mg/kg, and 30 mg/kg). A total of 24 participants completed the study and two discontinued early (one placebo participant was lost to follow-up and one on TNX-1500 withdrew consent).
Tolerability: TNX-1500 was generally well-tolerated with a favorable safety and tolerability profile. The only treatment-emergent adverse event (TEAE) occurring in ≥ 3 participants among all TNX-1500 groups was aphthous ulcer, occurring in one participant each in the 3 mg/kg, 10 mg/kg, and 30 mg/kg groups; all were rated as mild, possibly related, and resolved in 2-10 days. There were no TEAEs assessed as related to KLH administration. No TEAEs led to study discontinuation and there were no serious adverse events. There were no thromboembolic events, which were prespecified as TEAEs of special interest.
Pharmacodynamics: TNX-1500 at 10 mg/kg and 30 mg/kg blocked both the primary and secondary anti-KLH Ab responses, evidenced by the mean Ab level at all sampled timepoints (through Day 120) being below the lower limit of quantitation (400 µg/L). TNX-1500 at 3 mg/kg blocked the primary response to KLH Day 2 challenge and reduced the peak secondary response to KLH Day 29 challenge by approximately two thirds (69%) relative to the peak response to placebo.
Pharmacokinetics: The mean (SD) half-life of TNX-1500 was: 3 mg/kg, 19.6 (9.29) days; 10 mg/kg, 37.8 (5.46) days; and 30 mg/kg, 33.7 (4.83) days.

Tonix plans to discuss these results with the U.S. Food and Drug Administration (FDA) in an End-of-Phase 1 meeting. Pending alignment with the FDA, a Phase 2 study of TNX-1500 in kidney transplant recipients will be pursued.

About TNX-1500

TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a humanized monoclonal antibody that binds and functionally inhibits the CD40-ligand (CD40L), also known as CD154. TNX-1500 is being developed for the prevention of allograft and xenograft rejection, for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT) and for the treatment of autoimmune diseases. Two published articles in the American Journal of Transplantation demonstrate TNX-1500 prevents rejection, prolongs survival and preserves graft function as a single agent or in combination with other drugs in non-human primate renal and heart allografts. ^4,5

*TNX-1500 is an investigational new biologic and is not approved for any indication

Citations

Lederman S, et al, J Exp Med. 1992;175(4):1091-101. doi: 10.1084/jem.175.4.1091. PMID: 1348081; PMCID: PMC2119166.
Boumpas DT, et. al. Arthritis Rheum. 2003;48(3):719-27. doi: 10.1002/art.10856. PMID: 12632425.
Pierson RN 3rd, et al. Transplantation. 1999;68(11):1800-5. doi: 10.1097/00007890-199912150-00026. PMID: 10609959.
Lassiter G, et al. Am J Transplant. 2023;23(8):1171-1181. doi: 10.1016/j.ajt.2023.03.022.
Miura S, et al. Am J Transplant. 2023;23(8):1182-1193. doi: 10.1016/j.ajt.2023.03.025.

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the U.S. National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.

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 by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of 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, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Healthcare
peter.vozzo@icrhealthcare.com
(443) 213-0505

Media Contact

Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432

Indication and Usage

Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.

Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.

Important Safety Information

Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded

Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.

Do not use Zembrace or Tosymra if you have:

history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace and Tosymra may cause serious side effects including:

changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before

The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrance only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.

This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Source: Tonix Pharmaceuticals Holding Corp.

Released February 6, 2025

Lucky Strike Entertainment (LUCK) – Expecting a Stronger Finish

Posted on February 6, 2025February 6, 2025 by cpereira@noblefcm.com

Thursday, February 06, 2025

Lucky Strike Entertainment is one of the world’s premier location-based entertainment platforms. With over 360 locations across North America, Lucky Strike Entertainment provides experiential offerings in bowling, amusements, water parks, and family entertainment centers. The company also owns the Professional Bowlers Association, the major league of bowling and a growing media property that boasts millions of fans around the globe. For more information on Lucky Strike Entertainment, please visit ir.luckystrikeent.com.

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.

Q2 Results. The company reported Q2 revenue and adj. EBITDA of $300.7 million and $98.8 million, both of which were modestly lower than our estimates of $321.0 million and $104.5 million, respectively. Notably, operating results were impacted by reduced corporate events that were attributed to election outcome concerns, a shortened holiday event window, and New Year’s Eve falling in Q3 this year. Importantly, we anticipate the company will offset the softness in the second half.

Strategic initiatives. With consumers cautious over the macroeconomic environment and some uncertainty around revenue, management is focused on optimizing labor costs, and offering more promotional items to attract value conscious consumers. Furthermore, the company is focused on rebranding locations to Lucky Strike from Bowlero, and pursuing acquisitions in the bowling and broader entertainment space.

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