March 2024 - Page 12 of 15

Release – QuantaSing Announces Unaudited Financial Results for the Second Quarter of Fiscal Year 2024

Posted on March 7, 2024March 7, 2024 by aweinsoff@channelchek.com

March 7, 2024

BEIJING, March 07, 2024 (GLOBE NEWSWIRE) — QuantaSing Group Limited (NASDAQ: QSG) (“QuantaSing” or the “Company”), a leading online learning service provider in China, today announced its unaudited financial results for the second quarter of the fiscal year ending June 30, 2024 (the “second quarter of FY 2024”, which refers to the quarter from October 1, 2023 to December 31, 2023).

Highlights for the Second Quarter of FY 2024

Revenues for the second quarter of FY 2024 were RMB980.5 million (US$138.1 million), representing an increase of 12.8% from the first quarter of the fiscal year ending June 30, 2024 (the “first quarter of FY 2024”) and an increase of 24.7% from the second quarter of the fiscal year ended June 30, 2023 (the “second quarter of FY 2023”).
Gross billings of individual online learning services¹ for the second quarter of FY 2024 were RMB944.6 million (US$133.0 million), representing an increase of 24.0% from the first quarter of FY 2024 and an increase of 15.4% from the second quarter of FY 2023.
Net income for the second quarter of FY 2024 was RMB107.6 million (US$15.2 million), compared with RMB66.7 million in the first quarter of FY 2024, and a net loss of RMB41.4 million in the second quarter of FY 2023.
Adjusted net income² for the second quarter of FY 2024 was RMB103.9 million (US$14.6 million), compared with RMB94.0 million in the first quarter of FY 2024, and RMB21.8 million in the second quarter of FY 2023.
Total registered users increased by 44.6% to approximately 112.4 million as of December 31, 2023, from 77.8 million as of December 31, 2022.
Paying learners increased by 24.2% year over year to approximately 0.4 million in the second quarter of FY 2024.

Mr. Peng Li, Chairman and Chief Executive Officer of QuantaSing, commented, “We are pleased to report solid topline growth for the quarter, underscoring the success of our strategic initiatives to expand and diversify our course offerings. Our focus on catering to the growing demand for senior learner courses has been particularly rewarding, and we remain committed to addressing the spiritual and cultural needs of the middle-aged and elderly population, with the goal of empowering everyone to lead fulfilling lives in their golden years. In addition to our ongoing efforts to drive revenue growth and optimize cost efficiencies, we are actively pursuing new initiatives that hold significant potential for expanding and diversifying our business. We remain steadfast in our commitment to sustaining our growth trajectory and delivering sustainable value to our shareholders.”

Mr. Dong Xie, Chief Financial Officer of QuantaSing, added, “We continued to build on our growth trajectory in the second quarter of fiscal year 2024, with total revenues increasing by 24.7% year over year and 12.8% sequentially, primarily driven by our skills upgrading courses. During the quarter, we remained committed to optimizing efficiencies and cost structures. Looking ahead, we will strengthen our core business and prudently develop new business initiatives to drive sustainable growth and deliver value to our shareholders.”

Financial Results for the Second Quarter of FY 2024

Revenues

Revenues increased by 24.7% year over year to RMB980.5 million (US$138.1 million) in the second quarter of FY 2024, primarily driven by the growth in revenues from skills upgrading courses, which primarily consist of courses aiming to improve the soft skills of individuals, such as short-video production course targets freelancers or amateurs who create video content and intend to improve their skillsets³.

Revenues from individual online learning services increased by 24.1% year over year to RMB873.6 million (US$123.0 million) in the second quarter of FY 2024, up from RMB704.0 million in the second quarter of FY 2023. This growth was primarily due to 1) skills upgrading courses³ increased to RMB456.4 million (US$64.3 million) in the second quarter of FY 2024 from RMB192.9 million in the second quarter of FY 2023, and 2) recreation and leisure courses³ increased to RMB96.1 million (US$13.5 million) in the second quarter of FY 2024 from RMB12.2 million in the second quarter of FY 2023, partially offset by the decrease of RMB177.9 million (US$25.1 million) in revenues from financial literacy courses.
Revenues from enterprise services were RMB57.6 million (US$8.1 million) in the second quarter of FY 2024, compared to RMB82.3 million in the second quarter of FY 2023, representing a year-over-year change of 30.0%, primarily due to a change in revenues from related party transactions.
Revenues from others increased to RMB49.3 million (US$7.0 million) in the second quarter of FY 2024 from RMB0.1 million in the second quarter of FY 2023, mainly driven by the increase in revenues from the Company’s newest business endeavor, live e-commerce, which is aligned with its commitment to diversified revenue streams.

Cost of revenues

Cost of revenues was RMB145.0 million (US$20.4 million) in the second quarter of FY 2024, compared to RMB99.3 million in the second quarter of FY 2023, representing a change of 46.1%. The increase was primarily due to increased labor outsourcing costs of RMB26.1 million (US$3.7 million) and higher procurement costs of RMB23.7 million (US$3.3 million), and was partially offset by a RMB16.5 million (US$2.3 million) decrease in staff costs.

Sales and marketing expenses

Sales and marketing expenses were RMB657.1 million (US$92.6 million) in the second quarter of FY 2024, compared to RMB622.9 million in the second quarter of FY 2023, representing a change of 5.5%. The change was mainly due to an increase in labor outsourcing costs of RMB85.3 million (US$12.0 million) and marketing and promotion expenses of RMB64.5 million (US$9.1 million), partially offset by a decrease in staff costs of RMB120.5 million (US$17.0 million), which includes a decrease in share-based compensation expenses of RMB31.0 million (US$4.4 million). The decrease in share-based compensation was primarily driven by 1) the reversal of share-based compensation expenses resulting from employee turnover during the second quarter of FY 2024, and 2) less share-based compensation expenses recognized for the second quarter of FY 2024 in accordance with the corresponding accounting treatment.

Research and development expenses

Research and development expenses were RMB41.0 million (US$5.8 million) in the second quarter of FY 2024, compared to RMB64.3 million in the second quarter of FY 2023, representing a decrease of 36.2%. The decrease was primarily due to lower share-based compensation expenses of RMB19.0 million (US$2.7 million).

General and administrative expenses

General and administrative expenses were RMB35.1 million (US$4.9 million) in the second quarter of FY 2024, compared to RMB44.5 million in the second quarter of FY 2023, representing a decrease of 21.3%. The decrease was primarily due to lower share-based compensation expenses and office expenses, partially offset by an increase in professional service fees.

Net income and adjusted net income

Net income was RMB107.6 million (US$15.2 million) in the second quarter of FY 2024, compared with a net loss of RMB41.4 million in the second quarter of FY 2023. Adjusted net income was RMB103.9 million (US$14.6 million) in the second quarter of FY 2024, compared with RMB21.8 million in the second quarter of FY 2023.

Earnings per share and adjusted earnings per share⁴

Basic and diluted net income per share were RMB0.65 (US$0.09) and RMB0.64 (US$0.09), respectively, in the second quarter of FY 2024, compared with basic and diluted net loss per share of RMB0.89 in the second quarter of FY 2023. Basic and diluted adjusted net income per share were RMB0.63 (US$0.09) and RMB0.62 (US$0.09), respectively, in the second quarter of FY 2024, compared with basic and diluted adjusted net income per share of RMB0.07 in the second quarter of FY 2023.

Balance Sheet

As of December 31, 2023, the Company had cash and cash equivalents and short-term investments of RMB1,050.8 million (US$148.0 million), compared with RMB930.6 million as of June 30, 2023.

Financial Outlook

Based on currently available information, for the third quarter of FY 2024 (which refers to the quarter from January 1, 2024 to March 31, 2024), the Company expects its revenues to be in the range of RMB900 million to RMB930 million, representing a year-over-year increase of 11.5% to 15.2%. The forecasts reflect the Company’s current and preliminary views on the market and its operating conditions, which are subject to change.

Recent Developments

On June 9, 2023, the Company announced that its board of directors had approved a share repurchase program of up to US$20.0 million of the Company’s Class A ordinary shares in the form of American Depositary Shares (“ADSs”) for a 12-month period beginning on June 9, 2023 (the “Share Repurchase Program”). As of December 31, 2023, the Company had accumulatively repurchased an aggregate of approximately 1.6 million ADSs for approximately US$7.8 million under the Share Repurchase Program.

On January 18, 2024, the Company announced the introduction of its first private label Chinese Baijiu brand, YUNTING. YUNTING is crafted in a core production facility located in the town of Maotai in China, a world-renowned Baijiu production site protected by Geographical Indication.

On January 22, 2024, the Company announced that Mr. Chenyang Wei was appointed as an independent director of QuantaSing and as a member of the Audit Committee.

Starting in early 2023, leveraging its cumulative insights into the adult learning sector and profound understanding of individual needs, the Company has started to explore the new e-commerce business (the “E-commerce Business”), primarily focusing on the livestreaming sales of Baijiu. Since the first quarter of FY 2024, the Company has further expanded its E-commerce Business to cover a wide range of merchandise and services catering to the demands of its users.

Since the first quarter of FY 2024, the Company has also started to explore AI and technology related business (the “AI and Technology Business”), leveraging its track record of empowering its online learning business with robust technological capabilities. The AI and Technology Business will primarily focus on the application of AI technology and other AI related area with potential business opportunities and synergies with the Company’s existing technology infrastructure and business. The Company has undertaken and will continue to undertake steps to align its corporate structure and management with the development needs of each business line and achieve management efficiency.

Conference Call Information

The Company’s management team will hold a conference call at 07:00 A.M. Eastern Time on Thursday, March 7, 2024 (08:00 P.M. Beijing Time on the same day) to discuss the financial results. Listeners may access the call by dialing the following numbers:

International:	1-412-902-4272
United States Toll Free:	1-888-346-8982
Mainland China Toll Free:	4001-201203
Hong Kong Toll Free:	800-905945
Conference ID:	QuantaSing Group Limited

The replay will be accessible through March 14, 2024 by dialing the following numbers:

International:	1-412-317-0088
United States Toll Free:	1-877-344-7529
Access Code:	8029802

A live and archived webcast of the conference call will be available at the Company’s investor relations website at https://ir.quantasing.com.

Non-GAAP Financial Measures

To supplement the Company’s consolidated financial statements, which are prepared and presented in accordance with U.S. GAAP, the Company uses gross billings of individual online learning services, adjusted net income/(loss) and basic and diluted adjusted net income/(loss) per share as its non-GAAP financial measures. Gross billings of individual online learning services for a specific period represents revenues of the Company’s individual online learning services net of the changes in deferred revenues in such period, further adjusted by value-added tax and certain cost deduction in such period. Adjusted net income/(loss) represents net (loss)/income excluding share-based compensation expense. Basic and diluted adjusted net income/(loss) per share represents adjusted net income/(loss) attributable to ordinary shareholders of QuantaSing Group Limited divided by weighted average number of ordinary shares outstanding during the periods used in computing adjusted net income/(loss) per share, basic and diluted. The Company believes that the non-GAAP financial measures provide useful information about the Company’s results of operations, enhance the overall understanding of the Company’s past performance and future prospects and allow for greater visibility with respect to key metrics used by the Company’s management in its financial and operational decision-making.

The non-GAAP financial measures are not defined under U.S. GAAP and are not presented in accordance with U.S. GAAP. The non-GAAP financial measures have limitations as analytical tools, and when assessing the Company’s operating performance, investors should not consider them in isolation, or as a substitute for revenue, net (loss)/income, net (loss)/income per share, basic and diluted or other consolidated statements of operations data prepared in accordance with U.S. GAAP. The Company’s definition of non-GAAP financial measures may differ from those of industry peers and may not be comparable with their non-GAAP financial measures.

The Company mitigates these limitations by reconciling the non-GAAP financial measures to the most comparable U.S. GAAP performance measures, all of which should be considered when evaluating the Company’s performance. For more information on these non-GAAP financial measures, please see the table captioned “QuantaSing Group Limited Unaudited Reconciliation of GAAP and Non-GAAP Results” near the end of this release.

Exchange Rate Information

This announcement contains translations of certain Renminbi (“RMB”) amounts into U.S. dollars (“US$”) at specified rates solely for the convenience of the reader. Unless otherwise stated, all translations from Renminbi to U.S. dollars were made at the rate of RMB7.0999 to US$1.00, the exchange rate on December 29, 2023, set forth in the H.10 statistical release of the Federal Reserve Board. The Company makes no representation that the Renminbi or U.S. dollars amounts referred to could be converted into U.S. dollars or Renminbi, as the case may be, at any particular rate or at all.

Safe Harbor Statements

This announcement contains forward-looking statements within the meaning of Section 27A of Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended and the Private Securities Litigation Reform Act of 1955. All statements other than statements of historical or current fact included in this press release are forward-looking statements, including but not limited to statements regarding QuantaSing’s financial outlook, beliefs and expectations. These statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “potential,” “continue,” “ongoing,” “targets,” “guidance” and similar statements. Among other things, the Financial Outlook in this announcement contains forward-looking statements. The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”), in its annual report to shareholders, in press releases, and other written materials and in oral statements made by its officers, directors or employees to third parties. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: the Company’s growth strategies; its future business development, results of operations and financial condition; its ability to attract and retain new users and learners and to increase the spending and revenues generated from users and learners; its ability to maintain and enhance the recognition and reputation of its brand; its expectations regarding demand for and market acceptance of its services and products; trends and competition in China’s adult learning market; changes in its revenues and certain cost or expense items; the expected growth of China’s adult learning market; PRC governmental policies and regulations relating to the Company’s business and industry, general economic and political conditions in China and globally, and assumptions underlying or related to any of the foregoing. Further information regarding these and other risks, uncertainties, or factors is included in the Company’s filings with the SEC, including, without limitation, the final prospectus related to the IPO filed with the SEC dated January 24, 2023. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

About QuantaSing Group Limited

QuantaSing is a leading online service provider in China dedicated to improving people’s quality of life and well-being by providing lifelong personal learning and development opportunities. The Company is the largest service provider in China’s online adult learning market and China’s adult personal interest learning market in terms of revenue, according to a report by Frost & Sullivan based on data from 2022. By leveraging its proprietary tools and technology, QuantaSing offers easy-to-understand, affordable, and accessible online courses to adult learners, empowering users to pursue personal development. Leveraging its extensive experience in individual online learning services and its robust technology infrastructure, the Company has expanded its services to corporate clients, and diversified its operations into its e-commerce business and its AI and technology business.

For more information, please visit: https://ir.quantasing.com.

Contact

Investor Relations
Leah Guo
QuantaSing Group Limited
Email: ir@quantasing.com
Tel: +86 (10) 6493-7857

Robin Yang, Partner
ICR, LLC
Email: QuantaSing.IR@icrinc.com
Phone: +1 (212) 537-0429

_________________________________

¹ Gross billings of individual online learning services is a non-GAAP financial measure. For a reconciliation of revenues of individual online learning services to gross billings of individual online learning services, see the “Non-GAAP Financial Measures” section and the table captioned “QuantaSing Group Limited Unaudited Reconciliation of GAAP and Non-GAAP Results” below.
² Adjusted net income/(loss) is a non-GAAP financial measure. For a reconciliation of net (loss)/income to adjusted net income/(loss), see the “Non-GAAP Financial Measures” section and the table captioned “QuantaSing Group Limited Unaudited Reconciliation of GAAP and Non-GAAP Results” below.
³ The Company has introduced a new presentation of its revenues, which split other personal interest courses into skills upgrading courses and recreation and leisure courses, to better align with its business strategies and provide useful and updated information to investors. Skills upgrading courses mainly include short-video production courses and memory training courses. Recreation and leisure courses mainly include personal well-being courses, electronic keyboard courses and standing meditation courses. The historical revenues presentation has been conformed to the current presentation.
⁴ Basic and diluted adjusted net income/(loss) per share are non-GAAP financial measures. For a reconciliation of basic and diluted net (loss)/income per share to basic and diluted adjusted net income/(loss) per share, see the “Non-GAAP Financial Measures” section and the table captioned “QuantaSing Group Limited Unaudited Reconciliation of GAAP and Non-GAAP Results” below.

View full release here.

Orion Group Holdings (ORN) – Some Insider Buying

Posted on March 7, 2024March 7, 2024 by cpereira@noblefcm.com

Thursday, March 07, 2024

Joe Gomes, 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.

Insider Buying. Two Orion executives-CEO Travis Boone and General Counsel Chip Earle-added to their Orion holdings following the February 28th release of full year results. We would note Orion shares fell on the earnings news, dropping as low as $5.81 after closing the prior day at $6.92. While the purchases were modest, the acquisition of shares on the heels of the price drop is informative, in our view.

Travis Boone. On March 4th, CEO Travis Boone reported the purchase of 12,000 ORN shares at an average cost of $7.01 per share. The shares were acquired at prices ranging from $6.91-$7.08. The recent purchase increased Mr. Boone’s overall Orion stake to 402,557 shares. Notably, this appears to be the first open market purchases made by Mr. Boone.

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*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.

MAIA Biotechnology (MAIA) – New THIO-101 Update Shows Consistent Overall Response Rate

Posted on March 7, 2024March 7, 2024 by cpereira@noblefcm.com

Thursday, March 07, 2024

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

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.

Third Line Patients’ Preliminary Overall Response Rate (ORR) Shows Improvement. MAIA announced updated data from its THIO-101 trial. The trial enrolled patients with Stage 3 or 4 NSCLC who have progressive disease after treatment with checkpoint inhibitor therapy with or without standard of care chemotherapy. These advanced disease patients were treated with the combination of THIO and Libtayo (cemiplimab, an anti-PD-1 checkpoint inhibitor from Regeneron). The data was from the first patients receiving treatment as third-line therapy that reached an evaluation timepoint by January 8, 2024.

ORR Greatly Exceeded Published Studies. New data was from patients who had received the THIO combination as third-line treatment. The overall response rate was 38%, with 3 out of 8 patients showing a complete response (CR) or partial response (PR). This compares with response rates of about 6% in published studies.

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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).

GeoVax Labs (GOVX) – Vaccine Production Technology Reaches Milestone With Manufacturing Facility Validation

Posted on March 7, 2024March 7, 2024 by cpereira@noblefcm.com

Thursday, March 07, 2024

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

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

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

Commercial Scale Production Facility Achieves Validation. GeoVax has announced that its manufacturing technology for producing commercial-scale MVA-based vaccines has been validated for production. This signifies the successful transfer of the technology from the research facility to the commercial cGMP manufacturing plant, with production runs that meet specifications for use in clinical trials and commercial sales. This was a milestone we had anticipated that allows higher quantities, faster production, and greater yields of its proprietary MVA-based vaccines.

The New Manufacturing Facility Cam Produce The Pipeline Vaccines. Products that can be made in the system include CM04S1, its vaccine currently in two different Phase 2 trials to stimulate protective responses against COVID for immunocompromised patients with hematological cancers and in Phase 2 as a universal booster for COVID. The facility can also produce the vaccines in development for infectious diseases including smallpox, Ebola, zika, and malaria.

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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).

Commercial Vehicle Group (CVGI) – Fourth Quarter Post Call Commentary

Posted on March 7, 2024March 7, 2024 by cpereira@noblefcm.com

Thursday, March 07, 2024

Joe Gomes, 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.

Impact of UAW Strike on 4Q. Fourth quarter results were negatively impacted by a work stoppage at a customer facility due to the UAW strike. Management estimated the strike reduced revenue by about $12 million and had a $0.05/sh negative impact on EPS. We expect that eventually the revenue will come back, it is just a question of timing.

New Wins. CVG recorded in excess of $150 million of new wins in 2023 on a fully ramped basis, continuing the Company’s strong track record of success. The wins continue to be focused within the Electrical Systems segment and support the product ramp-up at the new plants in Mexico and Morocco, which are focused on meeting the demand growth in electrical systems. CVG is currently expanding its Morocco footprint with an additional new plant under construction.

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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).

AI in Healthcare: The Next Frontier for Investors?

Posted on March 7, 2024March 7, 2024 by slightbourne@noblecapitalmarkets.com

In the ever-evolving world of technology, few terms have captured the imagination of investors quite like artificial intelligence (AI). From autonomous vehicles to virtual assistants, AI has permeated nearly every facet of modern life, disrupting traditional business models and creating new opportunities for growth and innovation.

One sector that is increasingly feeling the transformative impact of AI is healthcare. As the industry grapples with challenges such as rising costs, workforce shortages, and the need for more personalized and efficient care, AI is emerging as a powerful tool to address these issues and unlock new frontiers in medicine.

The applications of AI in healthcare are vast and varied, ranging from drug discovery and disease diagnosis to patient monitoring and virtual nursing assistants. At the forefront of this revolution are companies that are harnessing the power of AI to develop cutting-edge solutions and drive technological advancements in the field.

One area where AI is making significant strides is medical imaging and diagnostics. Companies like Enlitic, a pioneer in deep learning for radiology, are developing AI systems that can analyze medical images with unprecedented accuracy, aiding in the early detection of diseases and reducing the risk of misdiagnosis. By automating and enhancing the analysis of X-rays, CT scans, and MRI images, these AI solutions have the potential to improve patient outcomes while reducing the workload on healthcare professionals.

Another promising application of AI in healthcare is drug discovery and development. Traditionally, the process of bringing a new drug to market has been time-consuming and costly, often taking years and billions of dollars in research and clinical trials. However, AI is revolutionizing this process by analyzing vast amounts of data, identifying promising drug candidates, and accelerating the drug discovery pipeline.

Companies are leveraging machine learning algorithms to search through millions of potential drug compounds, predicting their efficacy and safety profiles with remarkable accuracy. This not only speeds up the drug development process but also increases the likelihood of successful clinical trials and faster time-to-market for new therapies.

Beyond drug discovery and medical imaging, AI is also playing a crucial role in personalized medicine and patient care. Companies are developing AI-powered virtual healthcare assistants that can provide personalized medical advice, triage patients, and even monitor chronic conditions remotely. By leveraging natural language processing and machine learning, these AI solutions can offer accessible and affordable healthcare services, particularly in underserved or remote areas.

For investors, the proliferation of AI in healthcare presents both opportunities and challenges. On the one hand, the potential for groundbreaking innovations and disruptive technologies in this sector could translate into significant returns for those who identify and invest in the right companies early on. However, the healthcare industry is also heavily regulated, and navigating the complex web of regulatory approvals and clinical trials can be a significant hurdle for AI-driven healthcare solutions.

Furthermore, as with any emerging technology, there are ethical considerations and potential risks associated with the use of AI in healthcare. Concerns around data privacy, algorithmic bias, and the potential for AI to perpetuate or exacerbate existing healthcare disparities must be carefully addressed to ensure the responsible and equitable deployment of these technologies.

Despite these challenges, the investment community is eagerly watching the AI healthcare space, recognizing the immense potential for transformative innovations and lucrative returns. As the adoption of AI in healthcare continues to accelerate, companies that can successfully navigate the regulatory landscape, mitigate risks, and deliver tangible solutions that improve patient outcomes and healthcare efficiency are likely to emerge as leaders in this burgeoning field.

For savvy investors, the key to capitalizing on the AI healthcare revolution lies in conducting thorough due diligence, understanding the competitive landscape, and identifying companies with robust AI capabilities, strong intellectual property portfolios, and a clear path to commercialization and scalability.

While AI may be a buzzword that often moves markets, in the healthcare sector, it represents a genuine paradigm shift with the potential to save lives, reduce costs, and transform the way we approach healthcare delivery. As such, investors who can separate the hype from the reality and identify the true pioneers in this space may be well-positioned to reap the rewards of this technological revolution.

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Mortgage Rates and Stocks Find Relief as Powell Reinforces Rate Cut Prospects

Posted on March 7, 2024March 7, 2024 by slightbourne@noblecapitalmarkets.com

The housing and stock markets received a welcome boost this week as Federal Reserve Chair Jerome Powell reinforced expectations for interest rate cuts later this year. In his semi-annual monetary policy testimony to Congress, Powell acknowledged that recent data shows inflation is moderating, paving the way for potential rate reductions in 2024.

For homebuyers and prospective sellers who have grappled with soaring mortgage rates over the past year, Powell’s remarks offer a glimmer of hope. Mortgage rates, which are closely tied to the Fed’s benchmark rate, have retreated from their recent highs, dipping below 7% for the first time since mid-February.

According to Mortgage News Daily, the average rate for a 30-year fixed-rate mortgage settled at 6.92% on Thursday, while Freddie Mac reported a weekly average of 6.88% for the same loan term. This marks the first contraction in over a month and a significant improvement from the peak of around 7.3% reached in late 2023.

The moderation in mortgage rates has already begun to revive homebuyer demand, as evidenced by a nearly 10% week-over-week increase in mortgage applications. The Mortgage Bankers Association (MBA) noted that the indicator measuring home purchase applications rose 11%, underscoring the sensitivity of first-time and entry-level homebuyers to even modest rate changes.

“Mortgage applications were up considerably relative to the prior week, which included the President’s Day holiday. Of note, purchase volume — particularly for FHA loans — was up strongly, again showing how sensitive the first-time homebuyer segment is to relatively small changes in the direction of rates,” said Mike Fratantoni, MBA’s chief economist.

This renewed interest from buyers coincides with a much-needed increase in housing inventory. According to Realtor.com, active home listings grew 14.8% year-over-year in February, the fourth consecutive month of annual gains. Crucially, the share of affordable homes priced between $200,000 and $350,000 increased by nearly 21% compared to last year, potentially opening doors for many previously priced-out buyers.

The stock market has also responded positively to Powell’s testimony, interpreting his comments as a reassurance that the central bank remains committed to taming inflation without derailing the economy. Despite a hotter-than-expected inflation report in January, Powell reiterated that rate cuts are likely at some point in 2024, provided that price pressures continue to subside.

Investors cheered this stance, propelling the S&P 500 to new record highs on Thursday. The benchmark index gained nearly 1%, while the tech-heavy Nasdaq Composite surged 1.4%, underscoring the market’s preference for a more dovish monetary policy stance.

However, Powell cautioned that the timing and magnitude of rate cuts remain uncertain, as the Fed seeks to strike a delicate balance between containing inflation and supporting economic growth. “Pinpointing the optimal timing for such a shift has been a challenge,” said Jiayi Xu, Realtor.com’s economist. “Specifically, the risk of a dangerous inflation rebound is looming if rate cuts are made ‘too soon or too much.'”

This ambiguity has contributed to ongoing volatility in both the housing and stock markets, as market participants attempt to gauge the Fed’s next moves. While the prospect of rate cuts has provided relief, concerns remain that the central bank may need to maintain a more hawkish stance if inflationary pressures prove more stubborn than anticipated.

Nevertheless, Powell’s remarks have injected a sense of optimism into the markets, at least temporarily. For homebuyers, the potential for lower mortgage rates could translate to increased affordability and a more favorable environment for purchasing a home. Meanwhile, investors have embraced the possibility of a less aggressive monetary policy stance, driving stocks higher in anticipation of a potential economic soft landing.

As the data continues to unfold, both the housing and stock markets will closely monitor the Fed’s actions and rhetoric. While challenges persist, Powell’s testimony has offered a glimpse of light at the end of the tunnel, reigniting hopes for a more balanced and sustainable economic landscape in the months ahead.

Release – GeoVax Achieves Milestone in Transition to Commercially Validated Manufacturing System

Posted on March 6, 2024March 6, 2024 by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Manufacturing Process for Phase 3 and Commercial Production

Being Developed for GeoVax MVA-Based Vaccines

Atlanta, GA, March 6, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced a significant milestone toward implementation of a validated chicken embryonic fibroblast (CEF) based production system for the company’s MVA-based vaccines, with the release of its first lot of GEO-CM04S1 (next-generation Covid-19 vaccine) produced with a commercial manufacturing platform. This milestone marks the successful completion of the transfer and scale-up of manufacturing from the research-focused Center for Biomedicine & Genetics at City of Hope (Duarte, CA) to the experienced CDMO ABL Europe (a subsidiary of Oxford Biomedica), the Company’s cGMP (current Good Manufacturing Procedures) manufacturing partner.

David Dodd, GeoVax President and CEO, commented, “The successful establishment of cGMP production at ABL Europe represents great progress for GeoVax and the CM04S1 program. This latest manufacturing milestone also validates our choice of ABL Europe as our partner for cGMP production of our MVA-based vaccine candidates. This gives us a high degree of confidence in our manufacturing process as we move into late-stage clinical development for CM04S1, addressing a critically important unmet medical need for immunocompromised populations.”

Dodd continued, “While we continue the use of CEF-based production for our CM04S1 clinical programs, it is important to also recognize the significant advancements made in our commercial-scale production capabilities. Our multi-product license of ProBioGen’s AGE1.CR.PIX® suspension cell line enhances our capacity to produce MVA-based vaccines (including CM04S1 and GEO-MVA) and immunotherapies at an unprecedented scale. These developments signify GeoVax’s commitment to improving vaccine accessibility through cost-effective and scalable manufacturing processes.”

About GEO-CM04S1

GEO-CM04S1 is a next-generation Covid-19 vaccine based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. CM04S1 presents both the spike and nucleocapsid antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to non-variable parts of the virus. The more broadly specific and functional engagement of the immune system is designed to protect against the continually emerging variants of Covid-19. Results released during 2023 demonstrated the safety and efficacy of CM04S1 and emphasize the role it will play in protecting immunocompromised patients from greater risk of severe disease, hospitalization and death from SARS-CoV-2 infection.

About GEO-MVA

In response to the global need to address the continued emerging threat from Mpox (monkeypox), GeoVax previously announced having secured rights from the National Institutes of Health (NIH) covering preclinical, clinical and commercial uses of the NIH-MVA as a vaccine against Mpox or smallpox. The Company is currently pursuing different regulatory pathways toward achievement of an expedited approval and intends to become the first U.S.-based supplier of the MVA vaccine to prevent Mpox and smallpox.

About GeoVax

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

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Company Contact:	Investor Relations Contact:	Media Contact:
info@geovax.com	paige.kelly@sternir.com	sr@roberts-communications.com
678-384-7220	212-698-8699	202-779-0929

Release – MAIA Biotechnology Announces Strong Efficacy of THIO As Third-Line Treatment For Non-Small Cell Lung Cancer Patients

Posted on March 6, 2024March 6, 2024 by aweinsoff@channelchek.com

Research News and Market Data on MAIA

March 06, 2024 8:48am EST

Combination THIO 180mg + cemiplimab achieved 38% overall response rate (ORR) in difficult-to-treat, third-line non-small cell lung cancer (NSCLC)
ORR of 38% significantly exceeds standard of care ORR in NSCLC third-line in patients without a targetable mutation who progressed on checkpoint inhibitors and chemotherapy

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced positive efficacy data for third-line treatment in its Phase 2 THIO-101 clinical trial evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in advanced non-small cell lung cancer (NSCLC).

As of January 8, 2024, overall response rate (ORR), characterized as partial or complete response to therapy, was 38% (3 out of 8 patients) in the efficacy evaluable population for combination THIO 180mg + cemiplimab in third-line treatment for NSCLC patients who failed treatment with immune checkpoint inhibitors in prior lines of therapy, with or without chemotherapy.

“As an impressive measure of efficacy, the strong response rate of 38% in third-line treatment supports our premise that THIO administration prior to cemiplimab can improve tumor responses to immunotherapy in advanced NSCLC patients resistant to CPIs and other standard treatments,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “Around 60-70% of NSCLC patients do not have a targetable mutation and cannot benefit from a biomarker-targeted therapy, making it the greatest unmet medical need population in lung cancer. In currently available treatments for these patients in third-line, response rates range around 6%.¹ We are encouraged by the excellent efficacy findings in THIO-101 to date, adding impressive ORR to unprecented disease control rates (DCR), and further demonstrating the potential of our first-in-class treatment to redefine the standard of care for NSCLC patients.”

The efficacy evaluable population defined in the THIO-101 protocol considers all subjects who received at least one dose of THIO treatment and have at least one postbaseline tumor assessment (scans). Two third-line patients in the 180mg dose cohort did not have recorded scans at the data cutoff. Safety remained consistent with previous reports.

The Company recently announced early completion of enrollment in the THIO-101 trial. THIO-101 is expected to be the first completed clinical study of a telomere-targeting agent in the field of cancer drug discovery and treatment.

About THIO

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

About THIO-101, a Phase 2 Clinical Trial

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

About MAIA Biotechnology, Inc.

Forward Looking Statements

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

¹ Journal of Thoracic Oncology, Volume 4, Number 12, December 2009. *Note: no updated 3rd line NSCLC data in recent years.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240306359543/en/

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

Source: MAIA Biotechnology, Inc.

Released March 6, 2024

Release – Tonix Pharmaceuticals Selects EVERSANA® to Support Launch Strategy and Commercialization Planning of Tonmya™ for the Management of Fibromyalgia

Posted on March 6, 2024March 6, 2024 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

March 06, 2024 8:00am ESTDownload as PDF

Tonmya is a potential new first-line, centrally acting non-opioid analgesic for the management of fibromyalgia, supported by statistically significant results from two Phase 3 trials

New Drug Application (NDA) submission to the FDA planned for the second half of 2024

CHATHAM, N.J., March 06, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that EVERSANA^®, a leading provider of commercialization services to the global life sciences industry, has been selected to support the launch strategy and commercial planning of Tonmya (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) in the U.S. Specifically, EVERSANA will work with Tonix to assess the fibromyalgia landscape and help plan an efficient go-to-market strategy.

“EVERSANA shares our commitment to delivering novel therapeutics to patients in need,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We are excited to further refine our business strategy for the anticipated launch of Tonmya in 2025. It has been over a decade since patients suffering with fibromyalgia have been provided a new therapeutic option.”

“Today’s dynamic market requires experts that can help customers navigate the complexities of launch and commercial planning,” said Jim Lang, CEO, EVERSANA. “Together, we look forward to bringing a new treatment option to market for the millions of Americans suffering from this chronic disorder.”

Tonmya is a centrally acting, non-opioid medication. As previously announced, Tonix’s second positive Phase 3 study, RESILIENT, met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results (p=0.001 or better) were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function.

Tonix plans to submit a New Drug Application to the U.S. Food and Drug Administration in the second half of 2024 for Tonmya for the management of fibromyalgia and has scheduled a Type B pre-NDA meeting with FDA for the second quarter of 2024.

About Tonmya* (also known as TNX-102 SL)

Tonmya is a centrally acting, non-opioid, non-addictive, bedtime medication. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia. In December 2023, the company announced highly statistically significant and clinically meaningful topline results in RESILIENT, a second positive Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. RELIEF, the first positive Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints.

*Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

About EVERSANA^®

EVERSANA is a leading independent provider of global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 650 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and X.

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two positive Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase) a biologic designed to treat cocaine intoxication with Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a 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 the areas of rare disease and infectious disease. 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 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, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, 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 Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
443-213-0495

Matt Braun
EVERSANA
Matt.braun@eversana.com

Source: Tonix Pharmaceuticals Holding Corp.

Released March 6, 2024

V2X (VVX) – A Solid End to 2023

Posted on March 6, 2024March 6, 2024 by cpereira@noblefcm.com

Wednesday, March 06, 2024

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

Joe Gomes, 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 Solid 2023. The transformation of V2X continued in 2023. The Company has emerged as a leader in the operational segment of the broader federal services marketplace. V2X is advancing how missions are operated by leveraging converged and engineered solutions, at the intersection of technology and operations. This includes modernization and sustainment support that elongates platform life cycles while enhancing capabilities.

4Q23 Results. Record revenue of $1.04 billion was up 6.4% y-o-y, and above our $1.01 billion forecast. Adjusted EBITDA came in at $82.1 million versus $82.3 million in 4Q22 and our $75 million estimate. Adjusted diluted EPS was $1.22 compared to $0.97 last year and our $0.97 estimate.

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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).

Entravision Communications (EVC) – Its Digital Business Does A Faceplant

Posted on March 6, 2024March 6, 2024 by cpereira@noblefcm.com

Wednesday, March 06, 2024

Entravision Communications Corporation is a diversified Spanish-language media company utilizing a combination of television and radio operations to reach Hispanic consumers across the United States, as well as the border markets of Mexico. Entravision owns and/or operates 53 primary television stations and is the largest affiliate group of both the top-ranked Univision television network and Univision’s TeleFutura network, with television stations in 20 of the nation’s top 50 Hispanic markets. The Company also operates one of the nation’s largest groups of primarily Spanish-language radio stations, consisting of 48 owned and operated radio stations.

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.

Mixed Q4 results. Total company Q4 revenue of $320.1 million, an increase of 8.0%, was better than our $309.7 million estimate, driven by 19% growth in its Digital businesses. Both TV and Radio declined in the quarter due to the absence of year earlier Political advertising. Q4 adj. EBITDA of $16.2 million was slightly below our $19.0 million estimate.

Meta takes its business in-house. The recent financial results were overshadowed by a late announcement that Meta plans to take its advertising sales in-house, ending its relationship with Entravision and all its sales partners. Meta accounted for roughly 52% of total company revenues and 40% of adj. EBITDA in 2023.

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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).

CoreCivic, Inc. (CXW) – Terming Out Some Debt

Posted on March 6, 2024March 6, 2024 by cpereira@noblefcm.com

Wednesday, March 06, 2024

CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. We provide a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. We are the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and believe we are the largest private owner of real estate used by government agencies in the United States. We have been a flexible and dependable partner for government for nearly 40 years. Our employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.

Joe Gomes, 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.

Debt Offering. Last night after market close, CoreCivic announced an offering of $500 million aggregate principal amount of 8.25% senior notes due 2029. The aggregate principal amount of the Notes to be issued in the offering was increased to $500 million from the previously announced $450 million. The aggregate net proceeds from the sale of the Notes are expected to be approximately $490.3 million.

Uses. CoreCivic intends to use the net proceeds, together with borrowings under the Company’s revolving credit facility and cash on hand, to fund the concurrent cash tender offer for any and all of the $593.1 million outstanding aggregate principal amount of 2026 Notes. Any remaining funds will be used to redeem 2026 Notes that remain outstanding thereafter. With excess cash on hand, the Company could pay most of the remaining principal with cash, modestly tapping into the revolver.

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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).