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<a href="http://www.channelchek.com/company/hhs">Research News and Market Data on HHS</a>



Monday, 16 September 2024 08:05 AM



CHELMSFORD, MA / ACCESSWIRE / September 16, 2024 /&nbsp;Harte Hanks, Inc. (NASDAQ:HHS), a global leader in customer experience for over 100 years, today announced a leadership transition within its sales organization.



Jason Chapman, a seasoned executive known for driving business transformation and leading global go-to-market teams, has been appointed as Interim Global Head of Sales and Marketing. Chapman takes over for Kelly Waller, who has stepped down as part of a planned departure due to personal reasons.



Kirk Davis, Chief Executive Officer, remarked: "The entire Harte Hanks team fully supports Kelly in her decision and wishes her the best as she moves forward. Kelly's leadership has been instrumental in reshaping and expanding our sales organization. She fostered a customer-centric approach, enhanced accountability, and implemented a modern framework for success measurement. Thanks to her efforts, our sales pipeline has grown significantly, and we enter this transition and the final stretch of 2024 from a position of strength. We are well positioned for an executive of Jason's caliber."



Jason Chapman brings a wealth of experience from renowned organizations such as Bain &amp; Company, SAP SE, Skillsoft, and most recently, Infor. In his previous roles, he successfully led large global go-to-market teams, introduced advanced productivity tools, developed partnership programs, restructured teams, and launched new go-to-market strategies. His efforts have consistently resulted in successful turnarounds, measurable transformations, and sustainable growth. Chapman holds an MBA from MIT Sloan School of Management and a bachelor's degree from Williams College.



Chapman commented on his new role: "Kelly's initiatives have refocused Harte Hanks' sales organization around the customer, creating a unified reporting structure to drive cross-selling and growth. I am eager to build on her accomplishments and leverage these improvements to accelerate sustainable growth. Harte Hanks has an exciting array of near-term opportunities, with solutions tailored to address the persistent challenges our customers face."



In her parting remarks, Kelly Waller stated: "This past year at Harte Hanks has been incredibly rewarding. I am confident that we have built a formidable team, with the right structure to drive long-term growth. While a personal matter requires me to step aside, I believe in the strength of our executive team under Kirk's leadership and the company's ability to carry forward the progress we've made. I will do everything I can to ensure a smooth and successful transition."



About Harte Hanks:



Harte Hanks (NASDAQ:HHS) is a leading global customer experience company whose mission is to partner with clients to provide them with CX strategy, data-driven analytics and actionable insights combined with seamless program execution to better understand, attract and engage their customers.



Using its unparalleled resources and award-winning talent in the areas of Customer Care, Fulfillment and Logistics, and Marketing Services, Harte Hanks has a proven track record of driving results for some of the world's premier brands, including GlaxoSmithKline, Unilever, Pfizer, Warner Bros Discovery, Volvo, Ford, FedEx, Midea, and IBM, among others. Headquartered in Chelmsford, Massachusetts, Harte Hanks has over 2,000 employees in offices across the Americas, Europe, and Asia Pacific.



For more information, visit&nbsp;<a href="https://pr.report/2le9">hartehanks.com</a>.



As used herein, "Harte Hanks" or "the Company" refers to Harte Hanks, Inc. and/or its applicable operating subsidiaries, as the context may require. Harte Hanks' logo and name are trademarks of Harte Hanks, Inc.



Cautionary Note Regarding Forward-Looking Statements:



Our press release and related earnings conference call contain "forward-looking statements" within the meaning of U.S. federal securities laws. All such statements are qualified by this cautionary note, provided pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements other than historical facts are forward-looking and may be identified by words such as "may," "will," "expects," "believes," "anticipates," "plans," "estimates," "seeks," "could," "intends," or words of similar meaning. These forward-looking statements are based on current information, expectations and estimates and involve risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to vary materially from what is expressed in or indicated by the forward-looking statements. In that event, our business, financial condition, results of operations or liquidity could be materially adversely affected and investors in our securities could lose part or all of their investments. These risks, uncertainties, assumptions and other factors include: (a) local, national and international economic and business conditions, including (i) the outbreak of diseases, such as the COVID-19 coronavirus, which has curtailed travel to and from certain countries and geographic regions, created supply chain disruption and shortages, disrupted business operations and reduced consumer spending, (ii) market conditions that may adversely impact marketing expenditures, (iii) the impact of the Russia/Ukraine conflict on the global economy and our business, including impacts from related sanctions and export controls and (iv) the impact of economic environments and competitive pressures on the financial condition, marketing expenditures and activities of our clients and prospects; (b) the demand for our products and services by clients and prospective clients, including (i) the willingness of existing clients to maintain or increase their spending on products and services that are or remain profitable for us, and (ii) our ability to predict changes in client needs and preferences; (c) economic and other business factors that impact the industry verticals we serve, including competition and consolidation of current and prospective clients, vendors and partners in these verticals; (d) our ability to manage and timely adjust our facilities, capacity, workforce and cost structure to effectively serve our clients; (e) our ability to improve our processes and to provide new products and services in a timely and cost-effective manner though development, license, partnership or acquisition; (f) our ability to protect our facilities against security breaches and other interruptions and to protect sensitive personal information of our clients and their customers; (g) our ability to respond to increasing concern, regulation and legal action over consumer privacy issues, including changing requirements for collection, processing and use of information; (h) the impact of privacy and other regulations, including restrictions on unsolicited marketing communications and other consumer protection laws; (i) fluctuations in fuel prices, paper prices, postal rates and postal delivery schedules; (j) the number of shares, if any, that we may repurchase in connection with our repurchase program; (k) unanticipated developments regarding litigation or other contingent liabilities; (l) our ability to complete anticipated divestitures and reorganizations, including cost-saving initiatives; (m) our ability to realize the expected tax refunds; and (n) other factors discussed from time to time in our filings with the Securities and Exchange Commission, including under "Item 1A. Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2022 which was filed on March 31, 2023. The forward-looking statements in this press release and our related earnings conference call are made only as of the date hereof, and we undertake no obligation to update publicly any forward-looking statement, even if new information becomes available or other events occur in the future.



Investor Relations Contact:



Rob Fink or Tom Baumann 646.809.4048/646.349.6641 FNK IR <a href="mailto:HHS@fnkir.com">HHS@fnkir.com</a>



SOURCE:&nbsp;Harte Hanks, Inc.

Research News and Market Data on HHS



Monday, 16 September 2024 08:05 AM



CHELMSFORD, MA / ACCESSWIRE / September 16, 2024 /&nbsp;Harte Hanks, Inc. (NASDAQ:HHS), a global leader in customer experience for over 100 years, today announced a leadership transition within its sales organization.



Jason Chapman, a seasoned executive known for driving business transformation and leading global go-to-market teams, has been appointed as Interim Global Head of Sales and Marketing. Chapman takes over for Kelly Waller, who has stepped down as part of a planned departure due to personal reasons.



Kirk Davis, Chief Executive Officer, remarked: &#8220;The entire Harte Hanks team fully supports Kelly in her decision and wishes her the best as she moves forward. Kelly&#8217;s leadership has been instrumental in reshaping and expanding our sales organization. She fostered a customer-centric approach, enhanced accountability, and implemented a modern framework for success measurement. Thanks to her efforts, our sales pipeline has grown significantly, and we enter this transition and the final stretch of 2024 from a position of strength. We are well positioned for an executive of Jason&#8217;s caliber.&#8221;



Jason Chapman brings a wealth of experience from renowned organizations such as Bain &amp; Company, SAP SE, Skillsoft, and most recently, Infor. In his previous roles, he successfully led large global go-to-market teams, introduced advanced productivity tools, developed partnership programs, restructured teams, and launched new go-to-market strategies. His efforts have consistently resulted in successful turnarounds, measurable transformations, and sustainable growth. Chapman holds an MBA from MIT Sloan School of Management and a bachelor&#8217;s degree from Williams College.



Chapman commented on his new role: &#8220;Kelly&#8217;s initiatives have refocused Harte Hanks&#8217; sales organization around the customer, creating a unified reporting structure to drive cross-selling and growth. I am eager to build on her accomplishments and leverage these improvements to accelerate sustainable growth. Harte Hanks has an exciting array of near-term opportunities, with solutions tailored to address the persistent challenges our customers face.&#8221;



In her parting remarks, Kelly Waller stated: &#8220;This past year at Harte Hanks has been incredibly rewarding. I am confident that we have built a formidable team, with the right structure to drive long-term growth. While a personal matter requires me to step aside, I believe in the strength of our executive team under Kirk&#8217;s leadership and the company&#8217;s ability to carry forward the progress we&#8217;ve made. I will do everything I can to ensure a smooth and successful transition.&#8221;



About Harte Hanks:



Harte Hanks (NASDAQ:HHS) is a leading global customer experience company whose mission is to partner with clients to provide them with CX strategy, data-driven analytics and actionable insights combined with seamless program execution to better understand, attract and engage their customers.



Using its unparalleled resources and award-winning talent in the areas of Customer Care, Fulfillment and Logistics, and Marketing Services, Harte Hanks has a proven track record of driving results for some of the world&#8217;s premier brands, including GlaxoSmithKline, Unilever, Pfizer, Warner Bros Discovery, Volvo, Ford, FedEx, Midea, and IBM, among others. Headquartered in Chelmsford, Massachusetts, Harte Hanks has over 2,000 employees in offices across the Americas, Europe, and Asia Pacific.



For more information, visit&nbsp;hartehanks.com.



As used herein, &#8220;Harte Hanks&#8221; or &#8220;the Company&#8221; refers to Harte Hanks, Inc. and/or its applicable operating subsidiaries, as the context may require. Harte Hanks&#8217; logo and name are trademarks of Harte Hanks, Inc.



Cautionary Note Regarding Forward-Looking Statements:



Our press release and related earnings conference call contain &#8220;forward-looking statements&#8221; within the meaning of U.S. federal securities laws. All such statements are qualified by this cautionary note, provided pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements other than historical facts are forward-looking and may be identified by words such as &#8220;may,&#8221; &#8220;will,&#8221; &#8220;expects,&#8221; &#8220;believes,&#8221; &#8220;anticipates,&#8221; &#8220;plans,&#8221; &#8220;estimates,&#8221; &#8220;seeks,&#8221; &#8220;could,&#8221; &#8220;intends,&#8221; or words of similar meaning. These forward-looking statements are based on current information, expectations and estimates and involve risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to vary materially from what is expressed in or indicated by the forward-looking statements. In that event, our business, financial condition, results of operations or liquidity could be materially adversely affected and investors in our securities could lose part or all of their investments. These risks, uncertainties, assumptions and other factors include: (a) local, national and international economic and business conditions, including (i) the outbreak of diseases, such as the COVID-19 coronavirus, which has curtailed travel to and from certain countries and geographic regions, created supply chain disruption and shortages, disrupted business operations and reduced consumer spending, (ii) market conditions that may adversely impact marketing expenditures, (iii) the impact of the Russia/Ukraine conflict on the global economy and our business, including impacts from related sanctions and export controls and (iv) the impact of economic environments and competitive pressures on the financial condition, marketing expenditures and activities of our clients and prospects; (b) the demand for our products and services by clients and prospective clients, including (i) the willingness of existing clients to maintain or increase their spending on products and services that are or remain profitable for us, and (ii) our ability to predict changes in client needs and preferences; (c) economic and other business factors that impact the industry verticals we serve, including competition and consolidation of current and prospective clients, vendors and partners in these verticals; (d) our ability to manage and timely adjust our facilities, capacity, workforce and cost structure to effectively serve our clients; (e) our ability to improve our processes and to provide new products and services in a timely and cost-effective manner though development, license, partnership or acquisition; (f) our ability to protect our facilities against security breaches and other interruptions and to protect sensitive personal information of our clients and their customers; (g) our ability to respond to increasing concern, regulation and legal action over consumer privacy issues, including changing requirements for collection, processing and use of information; (h) the impact of privacy and other regulations, including restrictions on unsolicited marketing communications and other consumer protection laws; (i) fluctuations in fuel prices, paper prices, postal rates and postal delivery schedules; (j) the number of shares, if any, that we may repurchase in connection with our repurchase program; (k) unanticipated developments regarding litigation or other contingent liabilities; (l) our ability to complete anticipated divestitures and reorganizations, including cost-saving initiatives; (m) our ability to realize the expected tax refunds; and (n) other factors discussed from time to time in our filings with the Securities and Exchange Commission, including under &#8220;Item 1A. Risk Factors&#8221; in our Annual Report on Form 10-K for the year ended December 31, 2022 which was filed on March 31, 2023. The forward-looking statements in this press release and our related earnings conference call are made only as of the date hereof, and we undertake no obligation to update publicly any forward-looking statement, even if new information becomes available or other events occur in the future.



Investor Relations Contact:



Rob Fink or Tom Baumann646.809.4048/646.349.6641FNK IRHHS@fnkir.com



SOURCE:&nbsp;Harte Hanks, Inc.

Release - Harte Hanks Announces New Leadership in Sales Transition

Harte Hanks

Media and Marketing

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<a href="http://www.channelchek.com/company/pdsb">Research News and Market Data on PDSB</a>



Median Overall Survival remains at 30 months; Objective Response Rate of 36% and Disease Control Rate of 77%



11/53 (21%) of patients experienced 90-100% tumor shrinkage



VERSATILE-003 Phase 3 clinical trial planned to begin this year



PRINCETON, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced updated data from the VERSATILE-002 trial evaluating Versamune®&nbsp;HPV (formerly PDS0101) in combination with KEYTRUDA®&nbsp;(pembrolizumab) as a first-line (1L) treatment for patients with HPV16-positive recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). The data were presented during a poster session on September 14 at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain.



As of the latest data cut of the VERSATILE-002 single-arm, Phase 2 trial on May 17, 2024, Versamune®&nbsp;HPV plus pembrolizumab continued to be well tolerated in this 1L R/M HPV16-positive HNSCC population. Enrollment in the trial (n=53) is complete, 10 patients remain on study treatment and 27 patients (including the 10 on treatment) continue to be followed for survival. Median patient follow-up is 16 months. The data demonstrated the following:



<ul class="wp-block-list">
<li>Median Overall Survival (mOS) was 30 months with a lower 95% confidence interval of 19.7 months; Published mOS for pembrolizumab is 12-18 months1,2</li>



<li>Objective Response Rate (ORR) of 36% (19/53); Published ORR for pembrolizumab is 19-25%1,2</li>



<li>Disease Control Rate (DCR) is 77% (41/53)</li>



<li>21% (11/53) of patients had deep tumor responses and shrinkage of 90-100%</li>



<li>9% (5/53) of patients had a complete response</li>



<li>Treatment-related adverse events of Grade ≥3 were seen in 9 patients (Grade 3, n=8 and Grade 4, n=1)</li>
</ul>



“The updated response data we presented at ESMO show the strong clinical activity and durability of Versamune®&nbsp;HPV plus pembrolizumab,” said Jared Weiss, M.D., Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine at the University of North Carolina, and principal investigator of the VERSATILE-002 clinical trial. “Continued evaluation shows the promise of this combination in improving survival for patients with HPV16-positive HNSCC.”



A global, randomized, controlled Phase 3 clinical trial, VERSATILE-003, that will evaluate Versamune®&nbsp;HPV plus pembrolizumab vs. pembrolizumab monotherapy as 1L treatment in patients with HPV16-positive R/M HNSCC with CPS ≥1 is planned to start this year.



“We’re encouraged to see that as the data from our VERSATILE-002 clinical trial have matured, responses continue to improve, suggesting durability of the Versamune®&nbsp;HPV induced anti-tumor immune response,” said Dr. Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech. “The encouraging patient survival and clinical responses coupled with promising tolerability as seen in the VERSATILE-002 trial underscore our belief in the potential of the combination to be the first HPV-targeted immunotherapy for HNSCC, and a significant advancement in the treatment of the growing population of patients with HPV16-positive HNSCC. We are working toward initiating the VERSATILE-003 Phase 3 study this year.”



Versamune®&nbsp;HPV has been granted Fast Track designation by the FDA.



<ol class="wp-block-list">
<li>Harrington K. et al. J Clin Oncol. 2022 ascopubs.org/journal/jco on October 11, 2022: DOI <a href="https://www.globenewswire.com/Tracker?data=a1GowC9NHhkV2xWO313ZoLafJmwMspt-J6FF7Dj2AA1jh0d5bNxlf0Q2l2CI0WExoFEmEC5Wx6dtpfMWx6ZOC9UuHeS7rqNwC0cCmyi9_QNSmDxSPjFF0HdOS7fdGNNp" target="_blank" rel="noreferrer noopener">https://doi.org/10.1200/JCO.21.02508</a></li>



<li>Licitra L. et al. 2024, International Journal of Radiation Oncology <a href="https://www.globenewswire.com/Tracker?data=hjgNiFkfrqgPG1SYqQcEMxA4l_RXdSM-hEZKuX76d0yOuomHB5NnikOld5aKgshCgNNvXkAyOl0jaz4bsIW8_rN14gQT2c3CQFQLlEZvfPJxq9e4r3lHvVss7birONxP" target="_blank" rel="noreferrer noopener">Volume 118, Issue 5</a>e2-e3April 01</li>
</ol>



No head-to-head studies have been performed comparing Versamune®&nbsp;HPV with other treatments



About PDS Biotechnology PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune®&nbsp;HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.



For more information, please visit&nbsp;<a href="https://www.globenewswire.com/Tracker?data=DBLBY9uDBbYsrp60lFzFukDF4NtbrYax3m9vuJ4d_62RjErB7fcpSDMkaFXzszdbOAS7va-Cg3sRq_jBVUoLVHEzm6PLm7Pcc7rRkupN2qk=" rel="noreferrer noopener" target="_blank">www.pdsbiotech.com</a>.



Forward Looking Statements This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS01ADC, Versamune®&nbsp;HPV (formerly PDS0101), PDS0203 and other Versamune®&nbsp;and Infectimune®&nbsp;based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS01ADC, Versamune®&nbsp;HPV, PDS0203 and other Versamune®&nbsp;and Infectimune®&nbsp;based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.  



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



Keytruda®&nbsp;is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck &amp; Co., Inc., Rahway, N.J., USA.



Investor Contact: Mike Moyer LifeSci Advisors Phone +1 (617) 308-4306 Email:&nbsp;<a href="https://www.globenewswire.com/Tracker?data=PTbSJc9Y0WvTU1eT0vCaBayOA3wsfRLgRcl3SqhkMT_AfD4mWu8BK-jaYfCRENrupc_0VZ_zeQxqpUwFCS9nMga74tYuRT230QCS8t7JJBK1gk3QrOuEnixudgC--V8u" rel="noreferrer noopener" target="_blank"></a><a href="mailto:mmoyer@lifesciadvisors.com">mmoyer@lifesciadvisors.com</a>



Media Contact: Gina Mangiaracina 6 Degrees Phone +1 (917) 797-7904 Email:&nbsp;<a href="https://www.globenewswire.com/Tracker?data=UCygcr2bIgO6JYREZcPTCJKoC3czkWv0Rmg8sU4PTVjgPakrzc7WP8QBULIJQplqiR2LOOAQflCRDLtdqX1LaiUlbKhgsWpJoyZqBf2ori5bC7EveUpfFH2v-SUgd7rK" rel="noreferrer noopener" target="_blank"></a><a href="mailto:gmangiaracina@6degreespr.com">gmangiaracina@6degreespr.com</a> <img src="https://ml.globenewswire.com/media/ZDdlMzYyNDgtZTk2Yy00MTk1LWI1ZDUtZmJhZGJlNjMzNjFlLTEwMjg3NjE=/tiny/PDS-Biotechnology-Corporation.png">



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Research News and Market Data on PDSB



Median Overall Survival remains at 30 months; Objective Response Rate of 36% and Disease Control Rate of 77%



11/53 (21%) of patients experienced 90-100% tumor shrinkage



VERSATILE-003 Phase 3 clinical trial planned to begin this year



PRINCETON, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) &#8212; PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced updated data from the VERSATILE-002 trial evaluating Versamune®&nbsp;HPV (formerly PDS0101) in combination with KEYTRUDA®&nbsp;(pembrolizumab) as a first-line (1L) treatment for patients with HPV16-positive recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). The data were presented during a poster session on September 14 at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain.



As of the latest data cut of the VERSATILE-002 single-arm, Phase 2 trial on May 17, 2024, Versamune®&nbsp;HPV plus pembrolizumab continued to be well tolerated in this 1L R/M HPV16-positive HNSCC population. Enrollment in the trial (n=53) is complete, 10 patients remain on study treatment and 27 patients (including the 10 on treatment) continue to be followed for survival. Median patient follow-up is 16 months. The data demonstrated the following:




Median Overall Survival (mOS) was 30 months with a lower 95% confidence interval of 19.7 months; Published mOS for pembrolizumab is 12-18 months1,2



Objective Response Rate (ORR) of 36% (19/53); Published ORR for pembrolizumab is 19-25%1,2



Disease Control Rate (DCR) is 77% (41/53)



21% (11/53) of patients had deep tumor responses and shrinkage of 90-100%



9% (5/53) of patients had a complete response



Treatment-related adverse events of Grade ≥3 were seen in 9 patients (Grade 3, n=8 and Grade 4, n=1)




“The updated response data we presented at ESMO show the strong clinical activity and durability of Versamune®&nbsp;HPV plus pembrolizumab,” said Jared Weiss, M.D., Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine at the University of North Carolina, and principal investigator of the VERSATILE-002 clinical trial. “Continued evaluation shows the promise of this combination in improving survival for patients with HPV16-positive HNSCC.”



A global, randomized, controlled Phase 3 clinical trial, VERSATILE-003, that will evaluate Versamune®&nbsp;HPV plus pembrolizumab vs. pembrolizumab monotherapy as 1L treatment in patients with HPV16-positive R/M HNSCC with CPS ≥1 is planned to start this year.



“We’re encouraged to see that as the data from our VERSATILE-002 clinical trial have matured, responses continue to improve, suggesting durability of the Versamune®&nbsp;HPV induced anti-tumor immune response,” said Dr. Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech. “The encouraging patient survival and clinical responses coupled with promising tolerability as seen in the VERSATILE-002 trial underscore our belief in the potential of the combination to be the first HPV-targeted immunotherapy for HNSCC, and a significant advancement in the treatment of the growing population of patients with HPV16-positive HNSCC. We are working toward initiating the VERSATILE-003 Phase 3 study this year.”



Versamune®&nbsp;HPV has been granted Fast Track designation by the FDA.




Harrington K. et al. J Clin Oncol. 2022 ascopubs.org/journal/jco on October 11, 2022: DOI https://doi.org/10.1200/JCO.21.02508



Licitra L. et al. 2024, International Journal of Radiation Oncology Volume 118, Issue 5e2-e3April 01




No head-to-head studies have been performed comparing Versamune®&nbsp;HPV with other treatments



About PDS BiotechnologyPDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune®&nbsp;HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.



For more information, please visit&nbsp;www.pdsbiotech.com.



Forward Looking StatementsThis communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS01ADC, Versamune®&nbsp;HPV (formerly PDS0101), PDS0203 and other Versamune®&nbsp;and Infectimune®&nbsp;based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS01ADC, Versamune®&nbsp;HPV, PDS0203 and other Versamune®&nbsp;and Infectimune®&nbsp;based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.  



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



Keytruda®&nbsp;is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck &amp; Co., Inc., Rahway, N.J., USA.



Investor Contact:Mike MoyerLifeSci AdvisorsPhone +1 (617) 308-4306Email:&nbsp;mmoyer@lifesciadvisors.com



Media Contact:Gina Mangiaracina6 DegreesPhone +1 (917) 797-7904Email:&nbsp;gmangiaracina@6degreespr.com



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Release - PDS Biotech Announces Updated Results from VERSATILE-002 Phase 2 Clinical Trial Presented at ESMO 2024

Biotechnology

PDS Biotechnology Corp.

PDSB

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<a href="http://www.channelchek.com/company/tnxp">Research News and Market Data on TNXP</a>



September 16, 2024 7:00am EDT



The World Health Organization (WHO) released its preferred target product profile (TPP) criteria for mpox vaccines at its Mpox Research and Innovation Scientific Conference held August 29-30



TNX-801, Tonix’s attenuated live-virus vaccine candidate, has characteristics that align closely with WHO’s TPP



On August 14, 2024, the WHO determined that the upsurge of mpox in a growing number of countries in Africa constitutes a public health emergency of international concern1-4: cases of the potentially lethal new Clade I mpox also detected in Sweden, Thailand and Singapore



CHATHAM, N.J., Sept. 16, 2024 (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, announced today that the World Health Organization’s (WHO’s) preferred target product profile (TPP), released at the WHO sponsored Mpox Research and Innovation Scientific Conference held August 29-30, 2024, aligns with the characteristics of TNX-801 (horsepox, live virus) vaccine, which is being developed for preventing mpox (formerly known as monkeypox). Key elements of the WHO draft TPP include single-dose, durable protection, administration without special equipment, and stability at ambient temperature. Other potential beneficial characteristics include the ability to limit forward transmission, use in case-contact vaccination strategies and suitability for use in immunocompromised individuals.



“The characteristics of TNX-801 align with the draft TPP released at the WHO sponsored Mpox Research and Innovation Scientific Conference,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “In animal studies TNX-801 has shown single dose protection against a lethal challenge of Clade I monkeypox virus administered by intratracheal route.5&nbsp;In addition, protected animals did not produce any infectious virus suggesting TNX-801 has the potential to block forward transmission as expected with live-virus vaccines. TNX-801 is designed for percutaneous administration using a bifurcated needle, like the products and delivery used in WHO’s accelerated smallpox eradication project. Since TNX-801 is a live-virus vaccine, we expect the stability of lyophilized TNX-801 at ambient temperature to be similar to live vaccinia virus vaccines including ACAM2000. We believe TNX-801 can be shipped and stored without the need for a costly and cumbersome ultra-cold supply chain, a particular advantage in lesser developed parts of the world. The stability of live virus vaccines eliminates the need for ultra-cold storage which complicates the widespread use of mRNA vaccines in Africa, where they are needed most right now. Finally, studies on immunocompromised animals6&nbsp;suggest that TNX-801 may be given to persons with immunocompromising conditions such as HIV, which is another property that will be essential for public health.”



Dr. Lederman continued, “The recent WHO declaration of a Public Health Emergency of International Concern (PHEIC) underscores the urgent need for new vaccines to control this outbreak and save lives. We have been motivated to develop TNX-801 because single-dose vaccines simplify logistics of administration, achieve higher coverage by reducing vaccinee dropout between doses and allow for case-contact or “ring” strategies to vaccinate the contacts of confirmed mpox patients.7,8&nbsp;Ring vaccination is deemed essential for controlling mpox but requires single-dose vaccines that interrupt forward transmission.”7,8



On August 26, 2024, Tonix announced a collaboration with Bilthoven Biologics (Bbio) to develop GMP manufacturing processes for its mpox vaccine. Bbio is part of the world’s largest vaccine manufacturer, the Cyrus Poonawalla Group, which also includes the Serum Institute of India.



The U.S. Food and Drug Administration (FDA) approved vaccines for mpox are a two-dose non-replicating vaccine called Jynneos® from Bavarian Nordic9&nbsp;and a one-dose live-virus vaccine from Emergent for people at high risk for mpox infection.10&nbsp;WHO recently authorized Jynneos for use in adults.11&nbsp;Recently data in animals have been reported for a two-dose mRNA vaccine from Moderna.12



About TNX-801*



TNX-801 is a live replicating attenuated vaccine based on horsepox that is believed to provide immune protection with better tolerability than 20th&nbsp;Century vaccinia viruses. As previously disclosed, TNX-801 protected animals against lethal challenge with intratracheal Clade I monkeypox virus.5&nbsp;After a single dose vaccination, TNX-801 prevented clinical disease and lesions and also decreased shedding in the mouth and lungs of non-human primates.6&nbsp;The Findings are consistent with mucosal immunity and suggest the ability to block forward transmission, similar to Dr. Edward Jenner’s vaccinia vaccine, which eradicated smallpox and kept mpox out of the human population. TNX-801 combines immune protection with improved tolerability compared to other vaccines based on orthopoxviruses and is administered with a single dose which has advantages over two-dose regimens. The focus on single-dose vaccines confirms early recommendations by the Bipartisan Commission on Biodefense,&nbsp;7&nbsp;and the U.S. National Academies of Science.7,8&nbsp;The National Academies of Science (NAS) report highlights the difficulty of a ring vaccination strategy with even a two-dose regimen.&nbsp;7&nbsp;The U.S. National Institutes of Health (NIH) selected Tonix’s COVID-19 vaccine, TNX-1800 for Project NextGen. TNX-1800 is an engineered version of horsepox that expresses the spike protein of SARS-CoV-2.&nbsp;13,14



About Mpox* On August 14, 2024, the WHO determined that the upsurge of mpox in a growing number of countries in Africa constitutes a PHEIC the second such declaration in the past two years called in response to an mpox outbreak.1&nbsp;The current outbreak is caused by Clade I monkeypox virus, while the 2022 outbreak was Clade 2 monkeypox virus. The global mpox outbreak, which commenced in 2022 has affected over 90,000 persons in countries where mpox had previously not been endemic, including Europe and the US. The spread of Clade IIb strain mpox in 2022 underscores the pandemic potential of mpox. Unlike Clade IIb mpox, the Clade I strain of mpox appears to be spreading to countries neighboring the Democratic Republic of the Congo, including Burundi, Rwanda, Uganda and Kenya. Clade I mpox is typically associated with approximately twenty times the case fatality rates than Clade IIb mpox in Africa. According to the U.S. Centers for Disease Control and Prevention (CDC), and other experts, there is a significant risk that the deadlier Clade I strain may appear in the U.S.2,3



Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in October of 2024 for TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. The FDA has 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. Tonix recently announced the U.S. Department of Defense (DoD), Defense Threat Reduction Agency (DTRA) awarded it a contract for up to $34 million over five years in an Other Transaction Agreement (OTA) 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. The company’s Good Manufacturing Practice (GMP)-capable advanced manufacturing facility in Dartmouth, MA was purpose-built to manufacture TNX-801 and the GMP suites are ready to be reactivated in case of a national or international emergency. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has 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&nbsp;<a href="https://www.globenewswire.com/Tracker?data=3JmOcLs2xN2SBaGcrVIC68B8WaEMwhV0qinfnHEv88ah84zZf07qxpmxIDesDZAs1PUFMwHNHzAZvjCmXbaZGYjXP49dtT-tcPzRuVw7x4M=" rel="noreferrer noopener" target="_blank">www.tonixpharma.com</a>.



1WHO Press Release August 14, 2024. “WHO Director-General declares mpox outbrfeak a public health emergency of international concern”. URL:&nbsp;<a href="https://www.globenewswire.com/Tracker?data=gV3KAdAHWRPAW8ECt2-F3nlFSoSzIqlNMsstAJfEkMIZoMnGQ-VHZbH3VYcwr1ge2PdKtip96Mpe01uQZh92IlgsclFHCrKePsYHPwYs-diiMD4e4gz0onNwt1TMBlHIuTxgxluUbHfGf202B9ybgoC_bzqAnKzp-u7c2SQvuKvF2GrPIH8k-gd2G19cvy5Ov2clPDekzRDi3q0Ijx4gwnojSXwdfKVKJ09tl2lop0DfNXEjIff4vci5hMLPraj9rJ812RwGqmSOYZv_Fi0vUyS3XIZFVHnmd8UiV9zfvPg0R4E3SRpVsFnkIfiI4PcY-pK-EeQYOK6q6b7CrqD7O69Sj3MYJXVJHhPfJLGdYXvytaJJhFDlxJprBI_WieOf" rel="noreferrer noopener" target="_blank">www.who.int/news/item/14-08-2024-who-director-general-declares-mpox-outbreak-a-public-health-emergency-of-international-concern</a>&nbsp;(accessed 8-15-24) 2McQuiston JH, et al.&nbsp;U.S. Preparedness and Response to Increasing Clade I Mpox Cases in the Democratic Republic of the Congo. 2024, MMWR Morbi Mortal Wkly Rep: United States. p. 435-440 3CDC. 2022-2023 Mpox: US Map and Case Count. https://www.cdc.gov/poxvirus/mpox/response/2022/us-map.html 4World Health Organization SAGE meeting highlights on updated mpox vaccine recommendations. 2024, March 5Noyce RS, et al.&nbsp;Viruses. 2023 Jan 26;15(2):356. Doi: 10.3390/v15020356. PMID: 36851570; PMCID: PMC9965234 6Trefry,&nbsp;SV et al. bioRxiv&nbsp;2023.10.25.564033;&nbsp;doi:&nbsp;https://doi.org/10.1101/2023.10.25.564033 7Bipartisan Commission on Biodefense. Box the Pox: Reducing the risk of Smallpox and Other Ortho poxviruses, Washington:2024 8U.S. National Academies of Science. Future State of Smallpox Medical Countermeasures. Washington:2024 9Zaeck LM, et al. Low levels of monkeypox virus-neutralizing antibodies after MVA-BN vaccination in healthy individuals. Nat Med. 2023 Jan;29(1):270-278. doi: 10.1038/s41591-022-02090-w. Epub 2022 Oct 18. PMID: 36257333; PMCID: PMC9873555. 10August 30, 2024. Reuters. “US FDA approves Emergent's smallpox vaccine for people at high risk of mpox”. https://www.msn.com/en-us/health/other/us-fda-approves-emergent-s-smallpox-vaccine-for-people-at-high-risk-of-mpox/ 11Keaton, J. Sept. 13, 2024.&nbsp;Associated Press.&nbsp;“WHO grants first mpox vaccine approval to ramp up response to disease in Africa.” URL: https://bit.ly/4e4yyeb 12Mucker et al., (in press) Comparison of protection against mpox following mRNA or modified vaccinia Ankara vaccination in nonhuman primates, Cell (2024), https://doi.org/10.1016/j.cell.2024.08.043 13Awasthi M, et al.&nbsp;Viruses. 2023 Oct 21;15(10):2131. Doi: 10.3390/v15102131. PMID: 37896908; PMCID: PMC10612059. 14Awasthi M, et al.&nbsp;Vaccines&nbsp;(Basel). 2023 Nov 2;11(11):1682. Doi: 10.3390/vaccines11111682.PMID:&nbsp;38006014



Forward Looking Statements&nbsp; 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 Toni’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 Toni’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 <a href="https://www.globenewswire.com/Tracker?data=h-pF_zPQ2vsppov04F39rRolpUxClhCYCfgq_PquzheuLgfY-6EzqgSSCo-A8Ggzj6z27rdHOoaSBGB6SjgMN66gC7j72bYTMfsM7E23yjIQGD9TvRm9bBLZ_YoYSzSOWaCfz3LGMVydLmrCdPvD7w==" rel="noreferrer noopener" target="_blank">investor.relations@tonixpharma.com</a> (862) 904-8182



Peter Vozzo ICR Westwicke <a href="https://www.globenewswire.com/Tracker?data=jw7eBwZZcQ99GbUQuUMBKFfsAESD9jg1Ah07JXAZX1D-dm0IRJxFVuYzZMWmQzNt9zwcxu1wnSy6at3TapPDBZ53mdkNQgaF_p8E8OUN0YTIH4V_mcAdMHwR6PHfgqQd" rel="noreferrer noopener" target="_blank">peter.vozzo@westwicke.com</a> (443) 213-0505



Media Contact



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



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Source: Tonix Pharmaceuticals Holding Corp.



Released September 16, 2024







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Research News and Market Data on TNXP



September 16, 2024 7:00am EDT



The World Health Organization (WHO) released its preferred target product profile (TPP) criteria for mpox vaccines at its Mpox Research and Innovation Scientific Conference held August 29-30



TNX-801, Tonix’s attenuated live-virus vaccine candidate, has characteristics that align closely with WHO’s TPP



On August 14, 2024, the WHO determined that the upsurge of mpox in a growing number of countries in Africa constitutes a public health emergency of international concern1&#8211;4: cases of the potentially lethal new Clade I mpox also detected in Sweden, Thailand and Singapore



CHATHAM, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) &#8212; Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that the World Health Organization’s (WHO’s) preferred target product profile (TPP), released at the WHO sponsored Mpox Research and Innovation Scientific Conference held August 29-30, 2024, aligns with the characteristics of TNX-801 (horsepox, live virus) vaccine, which is being developed for preventing mpox (formerly known as monkeypox). Key elements of the WHO draft TPP include single-dose, durable protection, administration without special equipment, and stability at ambient temperature. Other potential beneficial characteristics include the ability to limit forward transmission, use in case-contact vaccination strategies and suitability for use in immunocompromised individuals.



“The characteristics of TNX-801 align with the draft TPP released at the WHO sponsored Mpox Research and Innovation Scientific Conference,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “In animal studies TNX-801 has shown single dose protection against a lethal challenge of Clade I monkeypox virus administered by intratracheal route.5&nbsp;In addition, protected animals did not produce any infectious virus suggesting TNX-801 has the potential to block forward transmission as expected with live-virus vaccines. TNX-801 is designed for percutaneous administration using a bifurcated needle, like the products and delivery used in WHO’s accelerated smallpox eradication project. Since TNX-801 is a live-virus vaccine, we expect the stability of lyophilized TNX-801 at ambient temperature to be similar to live vaccinia virus vaccines including ACAM2000. We believe TNX-801 can be shipped and stored without the need for a costly and cumbersome ultra-cold supply chain, a particular advantage in lesser developed parts of the world. The stability of live virus vaccines eliminates the need for ultra-cold storage which complicates the widespread use of mRNA vaccines in Africa, where they are needed most right now. Finally, studies on immunocompromised animals6&nbsp;suggest that TNX-801 may be given to persons with immunocompromising conditions such as HIV, which is another property that will be essential for public health.”



Dr. Lederman continued, “The recent WHO declaration of a Public Health Emergency of International Concern (PHEIC) underscores the urgent need for new vaccines to control this outbreak and save lives. We have been motivated to develop TNX-801 because single-dose vaccines simplify logistics of administration, achieve higher coverage by reducing vaccinee dropout between doses and allow for case-contact or “ring” strategies to vaccinate the contacts of confirmed mpox patients.7,8&nbsp;Ring vaccination is deemed essential for controlling mpox but requires single-dose vaccines that interrupt forward transmission.”7,8



On August 26, 2024, Tonix announced a collaboration with Bilthoven Biologics (Bbio) to develop GMP manufacturing processes for its mpox vaccine. Bbio is part of the world’s largest vaccine manufacturer, the Cyrus Poonawalla Group, which also includes the Serum Institute of India.



The U.S. Food and Drug Administration (FDA) approved vaccines for mpox are a two-dose non-replicating vaccine called Jynneos® from Bavarian Nordic9&nbsp;and a one-dose live-virus vaccine from Emergent for people at high risk for mpox infection.10&nbsp;WHO recently authorized Jynneos for use in adults.11&nbsp;Recently data in animals have been reported for a two-dose mRNA vaccine from Moderna.12



About TNX-801*



TNX-801 is a live replicating attenuated vaccine based on horsepox that is believed to provide immune protection with better tolerability than 20th&nbsp;Century vaccinia viruses. As previously disclosed, TNX-801 protected animals against lethal challenge with intratracheal Clade I monkeypox virus.5&nbsp;After a single dose vaccination, TNX-801 prevented clinical disease and lesions and also decreased shedding in the mouth and lungs of non-human primates.6&nbsp;The Findings are consistent with mucosal immunity and suggest the ability to block forward transmission, similar to Dr. Edward Jenner’s vaccinia vaccine, which eradicated smallpox and kept mpox out of the human population. TNX-801 combines immune protection with improved tolerability compared to other vaccines based on orthopoxviruses and is administered with a single dose which has advantages over two-dose regimens. The focus on single-dose vaccines confirms early recommendations by the Bipartisan Commission on Biodefense,&nbsp;7&nbsp;and the U.S. National Academies of Science.7,8&nbsp;The National Academies of Science (NAS) report highlights the difficulty of a ring vaccination strategy with even a two-dose regimen.&nbsp;7&nbsp;The U.S. National Institutes of Health (NIH) selected Tonix’s COVID-19 vaccine, TNX-1800 for Project NextGen. TNX-1800 is an engineered version of horsepox that expresses the spike protein of SARS-CoV-2.&nbsp;13,14



About Mpox*On August 14, 2024, the WHO determined that the upsurge of mpox in a growing number of countries in Africa constitutes a PHEIC the second such declaration in the past two years called in response to an mpox outbreak.1&nbsp;The current outbreak is caused by Clade I monkeypox virus, while the 2022 outbreak was Clade 2 monkeypox virus. The global mpox outbreak, which commenced in 2022 has affected over 90,000 persons in countries where mpox had previously not been endemic, including Europe and the US. The spread of Clade IIb strain mpox in 2022 underscores the pandemic potential of mpox. Unlike Clade IIb mpox, the Clade I strain of mpox appears to be spreading to countries neighboring the Democratic Republic of the Congo, including Burundi, Rwanda, Uganda and Kenya. Clade I mpox is typically associated with approximately twenty times the case fatality rates than Clade IIb mpox in Africa. According to the U.S. Centers for Disease Control and Prevention (CDC), and other experts, there is a significant risk that the deadlier Clade I strain may appear in the U.S.2,3



Tonix Pharmaceuticals Holding Corp.*Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in October of 2024 for TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. The FDA has 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. Tonix recently announced the U.S. Department of Defense (DoD), Defense Threat Reduction Agency (DTRA) awarded it a contract for up to $34 million over five years in an Other Transaction Agreement (OTA) 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. The company’s Good Manufacturing Practice (GMP)-capable advanced manufacturing facility in Dartmouth, MA was purpose-built to manufacture TNX-801 and the GMP suites are ready to be reactivated in case of a national or international emergency. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has 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&nbsp;www.tonixpharma.com.



1WHO Press Release August 14, 2024. “WHO Director-General declares mpox outbrfeak a public health emergency of international concern”. URL:&nbsp;www.who.int/news/item/14-08-2024-who-director-general-declares-mpox-outbreak-a-public-health-emergency-of-international-concern&nbsp;(accessed 8-15-24)2McQuiston JH, et al.&nbsp;U.S. Preparedness and Response to Increasing Clade I Mpox Cases in the Democratic Republic of the Congo. 2024, MMWR Morbi Mortal Wkly Rep: United States. p. 435-4403CDC. 2022-2023 Mpox: US Map and Case Count. https://www.cdc.gov/poxvirus/mpox/response/2022/us-map.html4World Health Organization SAGE meeting highlights on updated mpox vaccine recommendations. 2024, March5Noyce RS, et al.&nbsp;Viruses. 2023 Jan 26;15(2):356. Doi: 10.3390/v15020356. PMID: 36851570; PMCID: PMC99652346Trefry,&nbsp;SV et al. bioRxiv&nbsp;2023.10.25.564033;&nbsp;doi:&nbsp;https://doi.org/10.1101/2023.10.25.5640337Bipartisan Commission on Biodefense. Box the Pox: Reducing the risk of Smallpox and Other Ortho poxviruses, Washington:20248U.S. National Academies of Science. Future State of Smallpox Medical Countermeasures. Washington:20249Zaeck LM, et al. Low levels of monkeypox virus-neutralizing antibodies after MVA-BN vaccination in healthy individuals. Nat Med. 2023 Jan;29(1):270-278. doi: 10.1038/s41591-022-02090-w. Epub 2022 Oct 18. PMID: 36257333; PMCID: PMC9873555.10August 30, 2024. Reuters. “US FDA approves Emergent&#8217;s smallpox vaccine for people at high risk of mpox”. https://www.msn.com/en-us/health/other/us-fda-approves-emergent-s-smallpox-vaccine-for-people-at-high-risk-of-mpox/11Keaton, J. Sept. 13, 2024.&nbsp;Associated Press.&nbsp;“WHO grants first mpox vaccine approval to ramp up response to disease in Africa.” URL: https://bit.ly/4e4yyeb12Mucker et al., (in press) Comparison of protection against mpox following mRNA or modified vaccinia Ankara vaccination in nonhuman primates, Cell (2024), https://doi.org/10.1016/j.cell.2024.08.04313Awasthi M, et al.&nbsp;Viruses. 2023 Oct 21;15(10):2131. Doi: 10.3390/v15102131. PMID: 37896908; PMCID: PMC10612059.14Awasthi M, et al.&nbsp;Vaccines&nbsp;(Basel). 2023 Nov 2;11(11):1682. Doi: 10.3390/vaccines11111682.PMID:&nbsp;38006014



Forward Looking Statements&nbsp;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 Toni’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 Toni’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 MorrisTonix Pharmaceuticalsinvestor.relations@tonixpharma.com(862) 904-8182



Peter VozzoICR Westwickepeter.vozzo@westwicke.com(443) 213-0505



Media Contact



Ray JordanPutnam Insightsray@putnaminsights.com(949) 245-5432







Source: Tonix Pharmaceuticals Holding Corp.



Released September 16, 2024

Release - Tonix Pharmaceuticals Announces That its Single Dose Mpox Vaccine Candidate TNX-801 Aligns with WHO’s Newly Issued Preferred Target Product Profile for Mpox Vaccines in Global Health Emergency

Biopharmaceuticals

TNXP

Tonix Pharmaceuticals Holding Corp.

<figure class="wp-block-table"><table class="has-fixed-layout"><tbody><tr><td>Key Points: - An assassination attempt on former President Donald Trump adds to the volatility surrounding the 2024 U.S. presidential election. - Investors fear increased political instability, which could impact market sentiment, particularly in small and micro-cap stocks. - Market movements highlight the fragile balance between politics and economic confidence as election tensions rise.</td></tr></tbody></table></figure>



The recent assassination attempt on Donald Trump, the Republican presidential nominee, underscores a key theme in this year’s U.S. election cycle: rising political tensions and their impact on financial markets. On Sunday, Secret Service officers thwarted an apparent assassination attempt at Trump’s West Palm Beach golf course, shaking both political and economic spheres. The event further exacerbates an already turbulent election year, where unpredictable developments have consistently affected investor sentiment.



Political uncertainty is a well-known driver of market volatility, and this incident amplifies the existing concerns. With both parties engaged in heated battles, any threat to a high-profile candidate like Trump has a significant ripple effect on investor confidence. The attempted assassination, while fortunately thwarted, introduces fears of escalating political violence, which could weigh heavily on market behavior, particularly as the election draws near.



In fact, political instability tends to trigger risk aversion among investors, who seek safer assets in uncertain times. The U.S. stock market’s reaction to political events often involves a flight to quality, with investors moving toward bonds, precious metals, or large-cap stocks, while small and micro-cap companies tend to bear the brunt of the volatility. These companies, which rely more heavily on investor confidence and market stability, can see exaggerated price swings during periods of uncertainty.



Small and micro-cap stocks are especially vulnerable in uncertain political environments. These companies often have more limited access to capital and are more sensitive to market fluctuations. Historically, political risks, particularly those involving threats to major candidates, have led to a pullback in smaller stocks as investors pivot toward safer, more liquid assets.



If market anxiety continues to rise over the course of the election season, small-cap stocks could see increased volatility. Investors may start to question how the election’s outcome, influenced by these dramatic events, will impact regulatory frameworks, tax policies, and economic growth. This is especially true for sectors tied closely to government policies, such as healthcare, energy, and technology.



The 2024 election cycle has been unusual, marked by extraordinary levels of polarization, political violence, and uncertainty. The July assassination attempt on Trump in Pennsylvania, coupled with Sunday’s incident, only serves to escalate concerns. Political violence, if it continues, may raise questions about the security and stability of the election process itself, further unsettling markets.



While the S&amp;P 500 and other major indices have shown resilience so far, the small and micro-cap sectors remain more fragile. Any further threats to political figures or destabilizing events could drive more dramatic responses from these stocks. The next few weeks are likely to be crucial as investors digest the implications of these incidents alongside expected changes in monetary policy and global economic developments.



As the FBI continues its investigation into the latest assassination attempt, the political climate will likely remain in focus for investors. While larger companies with diversified portfolios may weather the storm, smaller and more speculative investments will require greater scrutiny. In an unpredictable election cycle like this, market participants may look for safer opportunities and hedge against the risks of political violence or upheaval.



Ultimately, the intersection of political drama and market dynamics this year serves as a reminder that investors should stay agile and informed. Whether these assassination attempts will influence the broader market remains to be seen, but in this highly charged environment, investors will be watching closely for any signs of escalation as the election unfolds.

Key Points:&#8211; An assassination attempt on former President Donald Trump adds to the volatility surrounding the 2024 U.S. presidential election.&#8211; Investors fear increased political instability, which could impact market sentiment, particularly in small and micro-cap stocks.&#8211; Market movements highlight the fragile balance between politics and economic confidence as election tensions rise.



The recent assassination attempt on Donald Trump, the Republican presidential nominee, underscores a key theme in this year’s U.S. election cycle: rising political tensions and their impact on financial markets. On Sunday, Secret Service officers thwarted an apparent assassination attempt at Trump’s West Palm Beach golf course, shaking both political and economic spheres. The event further exacerbates an already turbulent election year, where unpredictable developments have consistently affected investor sentiment.



Political uncertainty is a well-known driver of market volatility, and this incident amplifies the existing concerns. With both parties engaged in heated battles, any threat to a high-profile candidate like Trump has a significant ripple effect on investor confidence. The attempted assassination, while fortunately thwarted, introduces fears of escalating political violence, which could weigh heavily on market behavior, particularly as the election draws near.



In fact, political instability tends to trigger risk aversion among investors, who seek safer assets in uncertain times. The U.S. stock market’s reaction to political events often involves a flight to quality, with investors moving toward bonds, precious metals, or large-cap stocks, while small and micro-cap companies tend to bear the brunt of the volatility. These companies, which rely more heavily on investor confidence and market stability, can see exaggerated price swings during periods of uncertainty.



Small and micro-cap stocks are especially vulnerable in uncertain political environments. These companies often have more limited access to capital and are more sensitive to market fluctuations. Historically, political risks, particularly those involving threats to major candidates, have led to a pullback in smaller stocks as investors pivot toward safer, more liquid assets.



If market anxiety continues to rise over the course of the election season, small-cap stocks could see increased volatility. Investors may start to question how the election’s outcome, influenced by these dramatic events, will impact regulatory frameworks, tax policies, and economic growth. This is especially true for sectors tied closely to government policies, such as healthcare, energy, and technology.



The 2024 election cycle has been unusual, marked by extraordinary levels of polarization, political violence, and uncertainty. The July assassination attempt on Trump in Pennsylvania, coupled with Sunday’s incident, only serves to escalate concerns. Political violence, if it continues, may raise questions about the security and stability of the election process itself, further unsettling markets.



While the S&amp;P 500 and other major indices have shown resilience so far, the small and micro-cap sectors remain more fragile. Any further threats to political figures or destabilizing events could drive more dramatic responses from these stocks. The next few weeks are likely to be crucial as investors digest the implications of these incidents alongside expected changes in monetary policy and global economic developments.



As the FBI continues its investigation into the latest assassination attempt, the political climate will likely remain in focus for investors. While larger companies with diversified portfolios may weather the storm, smaller and more speculative investments will require greater scrutiny. In an unpredictable election cycle like this, market participants may look for safer opportunities and hedge against the risks of political violence or upheaval.



Ultimately, the intersection of political drama and market dynamics this year serves as a reminder that investors should stay agile and informed. Whether these assassination attempts will influence the broader market remains to be seen, but in this highly charged environment, investors will be watching closely for any signs of escalation as the election unfolds.

Assassination Attempt on Trump Sparks Uncertainty in Markets Amid Unusual Election Cycle

Assassination Attempt

Donald Trump

Election

Political tensions

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 Monday, September 16, 2024



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



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



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



Strong fiscal Q4. SelectQuote's fiscal Q4 revenue of $307.2 million and adj. EBITDA of $14.4 million exceeded our&nbsp;estimates of $271.3 million and a loss of $2.2 million, respectively.&nbsp; In our view, the strong performance demonstrated the power of the company’s synergistic business model, which serves consumers' needs both for insurance policies and pharmacy services.&nbsp;



Pharmacy momentum. Total revenue grew an impressive 38% over the prior year period, driven largely by the company’s Healthcare Services segment, which is comprised primarily of SelectRx (home-direct pharmacy business). Healthcare Services revenue was up roughly 75%, year-over-year with SelectRx membership growing to approximately 82,000, up from roughly 75,000 at the end of fiscal Q3. 



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

Monday, September 16, 2024



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



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



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



Strong fiscal Q4. SelectQuote&#8217;s fiscal Q4 revenue of $307.2 million and adj. EBITDA of $14.4 million exceeded our&nbsp;estimates of $271.3 million and a loss of $2.2 million, respectively.&nbsp; In our view, the strong performance demonstrated the power of the company’s synergistic business model, which serves consumers&#8217; needs both for insurance policies and pharmacy services.&nbsp;



Pharmacy momentum. Total revenue grew an impressive 38% over the prior year period, driven largely by the company’s Healthcare Services segment, which is comprised primarily of SelectRx (home-direct pharmacy business). Healthcare Services revenue was up roughly 75%, year-over-year with SelectRx membership growing to approximately 82,000, up from roughly 75,000 at the end of fiscal Q3. 



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

SelectQuote (SLQT) - Taking Steps for the Long Term

Financial Services

Insurance Broker

SelectQuote

SLQT

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 Monday, September 16, 2024



Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media &amp; 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.&nbsp;The company reported Q2 revenue of&nbsp;$105.8 million, which was in line with our $105.0 million estimate. Due to lower than expected Selling &amp; Marketing Expenses and efficiency initiatives, adj. EBITDA was $16.2 million, far better than our $0.9 million estimate. Selling &amp; Marketing expenses were roughly $11 million lower than expected, accounting for the largest portion of the sizable "beat".



PC picking up Steam.&nbsp;Notably, management highlighted the launch of Pixel Gun 3D PC Edition to the Steam platform, the largest digital distribution platform for PC gaming. The launch of Pixel Gun 3D on Steam and a solid quarter for Hero Wars: Dominion Era led to PC revenue accounting for 42% of total revenue, up from 38% in the prior year period. The addition of Steam is viewed favorably given that PC players tend to spend more money and time playing than mobile users.



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

Monday, September 16, 2024



Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media &amp; 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.&nbsp;The company reported Q2 revenue of&nbsp;$105.8 million, which was in line with our $105.0 million estimate. Due to lower than expected Selling &amp; Marketing Expenses and efficiency initiatives, adj. EBITDA was $16.2 million, far better than our $0.9 million estimate. Selling &amp; Marketing expenses were roughly $11 million lower than expected, accounting for the largest portion of the sizable &#8220;beat&#8221;.



PC picking up Steam.&nbsp;Notably, management highlighted the launch of Pixel Gun 3D PC Edition to the Steam platform, the largest digital distribution platform for PC gaming. The launch of Pixel Gun 3D on Steam and a solid quarter for Hero Wars: Dominion Era led to PC revenue accounting for 42% of total revenue, up from 38% in the prior year period. The addition of Steam is viewed favorably given that PC players tend to spend more money and time playing than mobile users.



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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.&nbsp;NOTE: investment decisions should not be based upon the content of this research summary.&nbsp;Proper due diligence is required before making any investment decision.&nbsp;

GDEV Inc. (GDEV) - Revising Estimates Upward; Raising Price Target

Electronic Gaming &amp; Multimedia

GDEV

GDEV Inc.

Media and Entertainment

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 Monday, September 16, 2024



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



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



Pure play manufacturer.&nbsp;FreightCar America, Inc. is a diversified manufacturer of railroad cars and rail car components. The company designs and manufactures a broad variety of railroad car types for the transportation of bulk commodities and containerized freight products primarily in North America. The company recently reported strong second-quarter financial results and appears poised for greater scale and margin expansion as it increases its market share and expands its product suite.



Expected redemption of high-cost preferred stock.&nbsp;We have assumed the company could redeem its high-cost preferred shares using a private credit term loan. For the sake of simplicity, we have assumed this occurs just prior to 2025. Based on the company’s strong cash flow profile and outlook, we estimate the rate on a $100 million private credit term loan could approximate the secured overnight financing rate (SOFR) plus 600 basis points or 11.33%.&nbsp;We note that the amount of the term loan and the interest rate could vary from our estimates. If the loan amount or interest rate is lower, interest expense could be lower.&nbsp;



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Monday, September 16, 2024



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



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



Pure play manufacturer.&nbsp;FreightCar America, Inc. is a diversified manufacturer of railroad cars and rail car components. The company designs and manufactures a broad variety of railroad car types for the transportation of bulk commodities and containerized freight products primarily in North America. The company recently reported strong second-quarter financial results and appears poised for greater scale and margin expansion as it increases its market share and expands its product suite.



Expected redemption of high-cost preferred stock.&nbsp;We have assumed the company could redeem its high-cost preferred shares using a private credit term loan. For the sake of simplicity, we have assumed this occurs just prior to 2025. Based on the company’s strong cash flow profile and outlook, we estimate the rate on a $100 million private credit term loan could approximate the secured overnight financing rate (SOFR) plus 600 basis points or 11.33%.&nbsp;We note that the amount of the term loan and the interest rate could vary from our estimates. If the loan amount or interest rate is lower, interest expense could be lower.&nbsp;



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FreightCar America (RAIL) - Raising Price Target Based on Expected Lower Cost of Capital

FreightCar America

Industrial

RAIL

Railroad

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Noble Capital Markets Research Morning Call

<figure class="wp-block-table"><table class="has-fixed-layout"><tbody><tr><td>Key Points: - The U.S. dollar hits its lowest level in over a year against the yen, driven by expectations of a larger-than-expected Fed rate cut. - Market pricing now reflects a 61% chance of a 50-basis-point cut at this week's Federal Reserve meeting. - This volatility comes as other central banks, like the Bank of Japan and Bank of England, are expected to hold rates, creating a global divergence in monetary policy.</td></tr></tbody></table></figure>



The U.S. dollar has plummeted to its lowest level in over a year against the Japanese yen, fueled by growing market speculation that the Federal Reserve may adopt a more aggressive approach to rate cuts. Following reports from The Wall Street Journal and Financial Times, traders are increasingly betting on a 50-basis-point (bp) cut during the Fed’s policy meeting this week, up from the previously anticipated 25-bp cut. This shift has caused ripples across the currency and bond markets, with investors closely monitoring the broader impact on global markets and the U.S. economy.



The U.S. Federal Reserve’s monetary policy decisions have far-reaching effects, not only on domestic markets but also on global financial stability. As the central bank weighs its options, the potential for a larger-than-expected rate cut is being driven by concerns about weakening inflation data and slowing economic growth. Last week’s softer Consumer Price Index (CPI) numbers added to the narrative that the Fed might be willing to move more aggressively to support the economy, despite earlier hawkish signals.



As expectations for a 50-bp cut grow, the U.S. dollar has seen a sharp decline against key currencies, including the Japanese yen. The dollar fell as low as 139.58 yen during Monday’s Asian trading hours, marking the lowest point since July 2023. This drop reflects the mounting concern that the dollar will weaken further if the Fed makes an aggressive cut, narrowing the interest rate gap between the U.S. and other countries like Japan, which has kept its rates low for an extended period.



Currency markets have been particularly sensitive to central bank actions, and the U.S. dollar's recent dip is a prime example of this. The divergence in monetary policies between the Federal Reserve, the Bank of Japan (BOJ), and the Bank of England (BoE) has created a complex dynamic. While the Fed is now considering rate cuts to stimulate the economy, the BOJ is expected to hold rates steady at 0.25% at its policy meeting later this week. Meanwhile, the Bank of England is also expected to keep its key rate at 5% after initiating a small rate cut in August.



This growing disparity in interest rates is driving the yen higher, as investors unwind yen-funded carry trades—investments made by borrowing in yen to purchase higher-yielding foreign assets. The narrowing interest rate gap between Japan and the U.S. has caused these trades to lose their appeal, pushing the yen higher and the dollar lower. The broader foreign exchange (FX) market has also seen major currencies like the euro and the British pound rise against the dollar, signaling global uncertainty about the U.S. economic outlook.



The potential for a 50-bp Fed rate cut presents both opportunities and risks for investors. On one hand, lower interest rates could spur economic activity by making borrowing cheaper and encouraging investment. This could provide a boost to stock markets, particularly in sectors like technology and consumer goods, which tend to benefit from looser monetary policy.



On the other hand, a weaker dollar could create challenges for U.S. companies with significant international operations. As the dollar falls, the cost of imported goods rises, leading to potential inflationary pressures. Additionally, for companies that generate significant revenue abroad, a weaker dollar could erode profit margins when converting foreign earnings back into U.S. dollars.



As the Federal Reserve’s September meeting approaches, all eyes will be on how policymakers navigate this delicate balance. A 50-bp cut, if it happens, would represent a significant shift from the Fed’s earlier signals of a more gradual approach to rate reductions. Traders are pricing in a 61% chance of this larger cut, compared to just 15% last week, highlighting the rapid change in market expectations.



Meanwhile, the global financial system will continue to adjust to the diverging monetary policies of major central banks. Investors, particularly those involved in currency trading or holding international assets, will need to remain vigilant as the Fed’s decision could prompt further volatility across markets.



In the near term, the U.S. dollar’s performance against major currencies will serve as a key indicator of investor sentiment. If the Fed opts for a less aggressive cut, the dollar could regain some strength. However, if the central bank signals a prolonged period of rate cuts, the dollar’s weakness may persist, especially against currencies like the yen and the euro, which are being supported by their respective central banks' policies.

Key Points:&#8211; The U.S. dollar hits its lowest level in over a year against the yen, driven by expectations of a larger-than-expected Fed rate cut.&#8211; Market pricing now reflects a 61% chance of a 50-basis-point cut at this week&#8217;s Federal Reserve meeting.&#8211; This volatility comes as other central banks, like the Bank of Japan and Bank of England, are expected to hold rates, creating a global divergence in monetary policy.



The U.S. dollar has plummeted to its lowest level in over a year against the Japanese yen, fueled by growing market speculation that the Federal Reserve may adopt a more aggressive approach to rate cuts. Following reports from The Wall Street Journal and Financial Times, traders are increasingly betting on a 50-basis-point (bp) cut during the Fed’s policy meeting this week, up from the previously anticipated 25-bp cut. This shift has caused ripples across the currency and bond markets, with investors closely monitoring the broader impact on global markets and the U.S. economy.



The U.S. Federal Reserve’s monetary policy decisions have far-reaching effects, not only on domestic markets but also on global financial stability. As the central bank weighs its options, the potential for a larger-than-expected rate cut is being driven by concerns about weakening inflation data and slowing economic growth. Last week’s softer Consumer Price Index (CPI) numbers added to the narrative that the Fed might be willing to move more aggressively to support the economy, despite earlier hawkish signals.



As expectations for a 50-bp cut grow, the U.S. dollar has seen a sharp decline against key currencies, including the Japanese yen. The dollar fell as low as 139.58 yen during Monday’s Asian trading hours, marking the lowest point since July 2023. This drop reflects the mounting concern that the dollar will weaken further if the Fed makes an aggressive cut, narrowing the interest rate gap between the U.S. and other countries like Japan, which has kept its rates low for an extended period.



Currency markets have been particularly sensitive to central bank actions, and the U.S. dollar&#8217;s recent dip is a prime example of this. The divergence in monetary policies between the Federal Reserve, the Bank of Japan (BOJ), and the Bank of England (BoE) has created a complex dynamic. While the Fed is now considering rate cuts to stimulate the economy, the BOJ is expected to hold rates steady at 0.25% at its policy meeting later this week. Meanwhile, the Bank of England is also expected to keep its key rate at 5% after initiating a small rate cut in August.



This growing disparity in interest rates is driving the yen higher, as investors unwind yen-funded carry trades—investments made by borrowing in yen to purchase higher-yielding foreign assets. The narrowing interest rate gap between Japan and the U.S. has caused these trades to lose their appeal, pushing the yen higher and the dollar lower. The broader foreign exchange (FX) market has also seen major currencies like the euro and the British pound rise against the dollar, signaling global uncertainty about the U.S. economic outlook.



The potential for a 50-bp Fed rate cut presents both opportunities and risks for investors. On one hand, lower interest rates could spur economic activity by making borrowing cheaper and encouraging investment. This could provide a boost to stock markets, particularly in sectors like technology and consumer goods, which tend to benefit from looser monetary policy.



On the other hand, a weaker dollar could create challenges for U.S. companies with significant international operations. As the dollar falls, the cost of imported goods rises, leading to potential inflationary pressures. Additionally, for companies that generate significant revenue abroad, a weaker dollar could erode profit margins when converting foreign earnings back into U.S. dollars.



As the Federal Reserve’s September meeting approaches, all eyes will be on how policymakers navigate this delicate balance. A 50-bp cut, if it happens, would represent a significant shift from the Fed’s earlier signals of a more gradual approach to rate reductions. Traders are pricing in a 61% chance of this larger cut, compared to just 15% last week, highlighting the rapid change in market expectations.



Meanwhile, the global financial system will continue to adjust to the diverging monetary policies of major central banks. Investors, particularly those involved in currency trading or holding international assets, will need to remain vigilant as the Fed’s decision could prompt further volatility across markets.



In the near term, the U.S. dollar’s performance against major currencies will serve as a key indicator of investor sentiment. If the Fed opts for a less aggressive cut, the dollar could regain some strength. However, if the central bank signals a prolonged period of rate cuts, the dollar’s weakness may persist, especially against currencies like the yen and the euro, which are being supported by their respective central banks&#8217; policies.

US Dollar Sinks to One-Year Low Against Yen Amid Growing Speculation of Aggressive Fed Rate Cut

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