Assure & Danam Postpone Corporate Update Call & Webcast Scheduled for May 16




Assure & Danam Postpone Corporate Update Call & Webcast Scheduled for May 16

DENVER, May 15, 2024 (GLOBE NEWSWIRE) — Assure Holdings Corp. (the “Company” or “Assure”) (NASDAQ: IONM), a provider of intraoperative neuromonitoring (“IONM”) and remote neurology services, announced today that the joint corporate update call with Danam scheduled for Thursday, May 16, 2024 at 4 p.m. Eastern Time has been postponed.

The Company plans to reschedule the conference call at a later date.

About Assure Holdings

Assure Holdings Corp. is a best-in-class provider of outsourced intraoperative neuromonitoring and remote neurology services. The Company delivers a turnkey suite of clinical and operational services to support surgeons and medical facilities during invasive procedures that place the nervous system at risk including neurosurgery, spine, cardiovascular, orthopedic and ear, nose, and throat surgeries. Assure employs highly trained technologists that provide a direct point of contact in the operating room. Physicians employed through Assure subsidiaries simultaneously monitor the functional integrity of patients’ neural structures throughout the procedure communicating in real-time with the surgeon and technologist. Accredited by The Joint Commission, Assure’s mission is to provide exceptional surgical care and a positive patient experience. For more information, visit the company’s website at www.assureneuromonitoring.com.

Cautionary Statements Regarding Forward-Looking Statements

This press release contains forward-looking statements based upon the current expectations of Assure and Danam. Forward-looking statements involve risks and uncertainties and include, but are not limited to, statements about the structure, timing and completion of the proposed transactions; the listing of the combined company on Nasdaq after the closing of the proposed merger; expectations regarding the ownership structure of the combined company after the closing of the proposed merger; the expected executive officers and directors of the combined company; the expected cash position of each of Assure and Danam and the combined company at the closing of the proposed merger; the future operations of the combined company; and other statements that are not historical fact. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: (i) the risk that the conditions to the closing of the proposed transaction are not satisfied, including the failure to timely obtain stockholder approval for the transaction, if at all; (ii) uncertainties as to the timing of the consummation of the proposed transaction and the ability of each of Assure and Danam to consummate the proposed merger, as applicable; (iii) risks related to Assure’s ability to manage its operating expenses and its expenses associated with the proposed transactions pending closing; (iv) risks related to the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the proposed transactions; (v) the risk that as a result of adjustments to the exchange ratio, Assure stockholders and Danam stockholders could own more or less of the combined company than is currently anticipated; (vi) risks related to the market price of Assure’s common stock; (vii) unexpected costs, charges or expenses resulting from either or both of the proposed transaction; (viii) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the proposed transactions; (ix) risks related to the inability of the combined company to obtain sufficient additional capital to continue to advance its business plan; and (x) risks associated with the possible failure to realize certain anticipated benefits of the proposed transactions, including with respect to future financial and operating results. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These and other risks and uncertainties are more fully described in periodic filings with the SEC, including the factors described in the section titled “Risk Factors” in Assure’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC, and in other filings that Assure makes and will make with the SEC in connection with the proposed transaction, including the proxy statement/prospectus described under “Additional Information and Where to Find It.” You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of the dates indicated in the forward-looking statements. Except as required by law, Assure expressly disclaims any obligation or undertaking to update or revise any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Investor Relations Contact

Brett Maas, Managing Principal
Hayden IR
ionm@haydenir.com
(646) 536-7331

Inhibikase Therapeutics Reports First Quarter Financial Results and Highlights Recent Period Activity




Inhibikase Therapeutics Reports First Quarter Financial Results and Highlights Recent Period Activity

Company to host conference call on Thursday, May 16, 2024 at 8:00 a.m. ET

BOSTON and ATLANTA, May 15, 2024 (GLOBE NEWSWIRE) — Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease (“PD”), Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, today reported financial results for the first quarter ended March 31, 2024 and highlighted recent developments.

“2024 is shaping up to be a year of clinical and regulatory execution as we advance our core programs towards important inflection points,” said Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase. “The Phase 2 201 trial for Risvodetinib (“risvo”) in untreated Parkinson’s disease is 83% enrolled as of May 10, 2024 and we anticipate enrolling the final patient in June with biomarker and functional assessment results to be reported in the second half of the year. On the regulatory front, we had positive interactions with the FDA for IkT-001Pro in gastrointestinal and hematological cancers and cardiopulmonary disease. As we look ahead, we believe our work to date supports the continued development of both risvo and 001Pro, and we are excited to continue on this journey to bring transformative treatments for patients in need.”

Recent Developments and Upcoming Milestones:

• Completed Pre-NDA Meeting with the FDA for IkT-001Pro in oncology: On February 12, 2024, Inhibikase received final Meeting Minutes from the FDA Review Team (“Review Team”) from the Division of Hematologic Malignancies discussing the requirements for a 505(b)(2) NDA submission for IkT-001Pro in up to 11 blood and stomach cancer indications. Following receipt of the meeting minutes, the Company is considering the study of the 1200 mg dose of IkT-001Pro that is expected to lead to exposures equivalent to 800 mg imatinib as well as conduct an additional analysis comparing IkT-001Pro and imatinib mesylate in gut absorption. Inhibikase will request milestone-based meetings as it completes the necessary preclinical, clinical, manufacturing and quality control processes to ensure the Company and the Review Team remain aligned throughout the process of NDA submission.

• Completed Pre-IND meeting with the FDA for IkT-001Pro in Pulmonary Arterial Hypertension: On April 5, 2024, the Company met with the Office of Cardiology, Hematology, Endocrinology and Nephrology in the Division of Cardiology and Nephrology at the FDA for a Pre-IND meeting to discuss the potential of using IkT-001Pro as a treatment for pulmonary arterial hypertension (PAH). Final Meeting Minutes were provided by the FDA on May 3, 2024 and confirmed that IkT-001Pro would be classified as a novel chemical entity and eligible for exclusivity designations even though it could be approved under the 505(b)(2) statute. The FDA supported our initial Phase 2/3 design and has requested that the Company conduct a pre-clinical hERG study in comparison to imatinib prior to submitting the IND. This cell culture-based 7-day experiment is expected to be completed in the current quarter.

• Expect to complete enrollment for the 201 Trial of Risvodetinib in the second quarter 2024: As of May 10, 2024, 99 participants have been enrolled, 15 prospective participants are in medical screening and 22 potential participants are being evaluated for suitability to initiate medical screening across all 32 clinical sites. 44 participants have completed the 12-week dosing period and 25 mild and 3 moderate adverse events that may have been related to risvo have been reported as of May 10, 2024. The Company expects to report topline data results in the second half of 2024, including measurement of novel biomarker data as it relates to alpha-synuclein aggregates and the effect of risvo on the underlying pathology for Parkinson’s disease. Following completion of the double-blinded phase of the 201 trial, Inhibikase will request an end of Phase 2 meeting with the FDA. In addition, the Company hopes to initiate enrollment in its 12-month extension study of risvo in 2024, subject to available resources.

First Quarter Financial Results

Net Loss: Net loss for the quarter ended March 31, 2024 was $4.6 million, or $0.73 per share, compared to a net loss of $4.5 million, or $0.98 per share in the quarter ended March 31, 2023.

R&D Expenses: Research and development expenses were $2.8 million for the quarter ended March 31, 2024 compared to $2.9 million in the quarter ended March 31, 2023. The $0.1 million decrease in research and development expenses was due to a decrease of $0.7 million in IkT-001 Pro expenses offset by a $0.6 million increase in Risvodetinib expenses.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended March 31, 2024 were $2.0 million compared to $1.9 million for the quarter ended March 31, 2023. The $0.1 million increase was primarily driven by a $0.18 million increase legal and consulting fees, and a $0.08 million net decrease in all other normal selling, general and administrative expenses.

Cash Position: Cash, cash equivalents and marketable securities were $9.7 million as of March 31, 2024. The Company expects that existing cash and cash equivalents will be sufficient to fund operations through November 2024.

Conference Call Information
The conference call is scheduled to begin at 8:00am ET on May 16, 2024. Participants should dial 1-877-407-0789 (United States) or 1-201-689-8562 (International). A live webcast may be accessed using the link here, or by visiting the investors section of the Company’s website at www.inhibikase.com. After the live webcast, the event will be archived on Inhibikase’s website for approximately 90 days after the call.

About Inhibikase (www.inhibikase.com)
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical company developing therapeutics for Parkinson’s disease and related disorders. Inhibikase’s multi-therapeutic pipeline has a primary focus on neurodegeneration and its lead program Risvodetinib, an Abelson Tyrosine Kinase (c-Abl) inhibitor, targets the treatment of Parkinson’s disease inside and outside the brain as well as other diseases that arise from Abelson Tyrosine Kinases. Its multi-therapeutic pipeline is pursuing Parkinson’s-related disorders of the brain and GI tract, orphan indications related to Parkinson’s disease such as Multiple System Atrophy, and drug delivery technologies for kinase inhibitors such as IkT-001Pro, a prodrug of the anticancer agent imatinib mesylate that the Company believes will provide a better patient experience with fewer on-dosing side-effects. The Company’s RAMP™ medicinal chemistry program has identified several follow-on compounds to Risvodetinib that could potentially be applied to other cognitive and motor function diseases of the brain. Inhibikase is headquartered in Atlanta, Georgia with offices in Lexington, Massachusetts.

Social Media Disclaimer
Investors and others should note that the Company announces material financial information to investors using its investor relations website, press releases, SEC filings and public conference calls and webcasts. The Company intends to also use X, Facebook, LinkedIn and YouTube as a means of disclosing information about the Company, its services and other matters and for complying with its disclosure obligations under Regulation FD.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking terminology such as “believes,” “expects,” “may,” “will,” “should,” “anticipates,” “plans,” or similar expressions or the negative of these terms and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Inhibikase’s current expectations and assumptions. Such statements are subject to certain risks and uncertainties, which could cause Inhibikase’s actual results to differ materially from those anticipated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include our ability to enroll and complete the 201 Trial evaluating Risvodetinib in untreated Parkinson’s disease, to successfully apply for and obtain FDA approval for IkT-001Pro in blood and stomach cancers or other indications, to successfully conduct clinical trials that are statistically significant and whether results from our animal studies may be replicated in humans, as well as such other factors that are included in our periodic reports on Form 10-K and Form 10-Q that we file with the U.S. Securities and Exchange Commission. Any forward-looking statement in this release speaks only as of the date of this release. Inhibikase undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.

Contacts:

Company Contact:
Milton H. Werner, PhD
President & CEO
678-392-3419
info@inhibikase.com

Investor Relations:
Alex Lobo
SternIR, Inc.
alex.lobo@sternir.com

See accompanying notes to condensed consolidated financial statements.

See accompanying notes to condensed consolidated financial statements.

DiagnaMed Announces LIFE Offering of up to $650,000




DiagnaMed Announces LIFE Offering of up to $650,000

TORONTO, May 15, 2024 (GLOBE NEWSWIRE) — DiagnaMed Holdings Corp. (“DiagnaMed” or the “Company”) (CSE: DMED) (OTCQB: DGNMF), a healthcare technology company focused on brain health using AI, is pleased to announce that it is arranging a private placement of a minimum of $400,000 and a maximum of $650,000 of units (each, a “Unit”), at a price of $0.04 per Unit; (the “Offering”). The Offering is being led by EMD Financial Inc.

Each Unit will be comprised of one common share (“Common Share”) in the capital of the Company and one (1) Common Share purchase warrant (“Warrant”) of the Company. Each Warrant will entitle the holder thereof to acquire one additional Common Share at a price of $0.05 for a period of thirty-six (36) months from the closing date (the “Closing Date”) of the Offering.

There is an offering document (the “Offering Document”) related to the Offering that can be accessed under the Company’s profile at www.sedarplus.ca and on the Company’s website at https://www.diagnamed.com. Prospective investors should read the Offering Document before making an investment decision.

As disclosed in the Offering Document, the Company intends to use the net proceeds from the Offering for the research, development and commercialization of its BRAIN AGE® Brain Health AI Platform, and for general corporate and working capital purposes.

In connection with the Offering, the Company will pay finder’s fees and issue finder’s warrants to EMD Financial Inc., as well as any other registrant participating in the Offering, consisting of: (i) cash finder’s fees of up to 8% of the gross proceeds of the Offering; and (ii) finder’s warrants in an amount equal to up to 8% of the number of Units issued pursuant to the Offering. Each finder’s warrant is exercisable into one common share at a price of $0.05 for a period of thirty-six (36) months following the Closing Date.

The Units offered as a part of the Offering will be offered to purchasers resident in all provinces of Canada, except Québec, pursuant to the listed issuer financing exemption under Part 5A of NI 45-106 (the “Listed Issuer Financing Exemption”). The Company may issue up to an aggregate of 16,250,000 Units for maximum aggregate gross proceeds of $650,000 under the Listed Issuer Financing Exemption. Units offered under the Listed Issuer Financing Exemption will not be subject to resale restrictions pursuant to applicable Canadian securities laws.

The Offering is anticipated to close on or about June 10, 2024, or such later date as the Company may determine. The closing is subject to certain conditions including, but not limited to, the receipt of all necessary regulatory and other approvals, including the approval of the Canadian Securities Exchange (CSE).

About BRAIN AGE®

BRAIN AGE® Brain Health AI Platform is a world-first consumer brain health and wellness AI solution that estimates brain age and provides a brain health score. Based on research and development at Drexel University and the University of Miami, BRAIN AGE® Brain Health AI combines a brain age estimation and brain health assessment tool with the aim to ‘raise a red flag’ for potential brain health issues. BRAIN AGE® Brain Health AI can assess if a brain is aging more quickly or more slowly than is typical for healthy individuals. Brain age is estimated by collecting neural activity data of the brain with a low-cost and easy-to-use electroencephalogram headset and calculating the data with a proprietary machine-learning model. In addition, BRAIN AGE® Brain Health AI can assess if a person has a healthy brain or is in the early stage of cognitive decline. Brain health is scored by taking a clinically validated assessment for brain resilience, vulnerability and performance functions. Individuals can seek out personalized diagnostics and interventions, such as medication or lifestyle changes, that may help to decrease the development or progression of cognitive decline.

About DiagnaMed

DiagnaMed Holdings Corp. (CSE: DMED) (OTCQB: DGNMF) is a healthcare technology company focused on brain health using AI. DiagnaMed is commercializing BRAIN AGE® Brain Health AI Platform, a world-first consumer brain health and wellness AI solution that estimates brain age and provides a brain health score. Visit DiagnaMed.com.

For more information, please contact:

Fabio Chianelli
Chairman and CEO
DiagnaMed Holdings Corp.
Tel: 416-800-2684
Email: info@diagnamed.com
Website: www.diagnamed.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

Certain statements in this news release are forward-looking statements, including with respect to future plans, and other matters. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations or intentions regarding the future. Such information can generally be identified by the use of forwarding-looking wording such as “will”, “may”, “expect”, “could”, “can”, “estimate”, “anticipate”, “intend”, “believe”, “aims”, and “continue” or the negative thereof or similar variations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company, including but not limited to, business, economic and capital market conditions, the ability to manage operating expenses, and dependence on key personnel. Such statements and information are based on numerous assumptions regarding present and future business strategies and the environment in which the Company will operate in the future, anticipated costs, and the ability to achieve goals. Factors that could cause the actual results to differ materially from those in forward-looking statements include, the continued availability of capital and financing, litigation, failure of counterparties to perform their contractual obligations, loss of key employees and consultants, and general economic, market or business conditions. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the three months ended December 31, 2023 (“MD&A”), dated February 29, 2024, which is available on the Company’s profile at www.sedarplus.ca. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The reader is cautioned not to place undue reliance on any forward-looking information. The forward-looking statements contained in this news release are made as of the date of this news release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

This news release does not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of any of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful, including any of the securities in the United States of America. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “1933 Act”) or any state securities laws and may not be offered or sold within the United States or to, or for account or benefit of, U.S. Persons (as defined in Regulation S under the 1933 Act) unless registered under the 1933 Act and applicable state securities laws, or an exemption from such registration requirements is available.

Spectral AI Announces Voting Results from 2024 Annual Meeting of Stockholders and the Appointment of Erich Spangenberg to the Board of Directors




Spectral AI Announces Voting Results from 2024 Annual Meeting of Stockholders and the Appointment of Erich Spangenberg to the Board of Directors

DALLAS, May 15, 2024 (GLOBE NEWSWIRE) — Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced results from its 2024 Annual Meeting of Stockholders held on May 14, 2024 (the “AGM”). At the AGM, stockholders overwhelmingly approved each of the four proposals set forth by the Company.

The voting results are detailed below.

Six directors were elected to serve until the next Annual Meeting of Stockholders:

• Richard Cotton, Chairman of the Company’s Board of Directors
• Peter M. Carlson, Chief Executive Officer of the Company
• Dr. J. Michael DiMaio, MD, a founder of the Company, and Chief of Staff and a practicing board-certified general, cardiac and thoracic surgeon at Baylor Scott & White-The Heart Hospitals
• Martin Mellish, founding director of Aspen Advisory Services Ltd.
• Deepak Sadagopan, Chief Operating Officer of Population Health at Providence St. Joseph Health
• Marion Snyder, a newly elected member of the Board of Directors. Ms. Snyder is Senior Director, Corporate Accounts at Shockwave Medical, a medical device company focused on the treatment of cardiovascular disease. She is the founder of Lakeview Healthcare Consulting, which offers strategic guidance on the market access landscape in the US Healthcare market. Ms. Snyder spent nine years at MiMedx Group, where she served as Chief of Staff to the CEO, Senior Vice President of Government Affairs, and Senior Vice President of Market Access. Prior to her time at MiMedx Group, Ms. Snyder spent thirteen years at Pfizer, Inc where she continued to take on roles of increasing responsibility. 

Stockholders also ratified the adoption of the Spectral AI, Inc. 2023 Long Term Incentive Plan and the appointment of KPMG LLP as the Company’s independent registered public accounting firm for the 2024 fiscal year; and authorized the reservation and issuance of shares of common stock of the Company pursuant to the Standby Equity Purchase Agreement, dated March 20, 2024.

Following the AGM, the Board of Directors unanimously approved the expansion of the Board from six to seven members and appointed Erich Spangenberg to the Board of Directors. Mr. Spangenberg has been the longest-tenured Board member of the Company and after declining to stand for reelection at the AGM, the Board of Directors was pleased that Mr. Spangenberg affirmatively responded to their request for his appointment to serve the Company as a Director.

About Spectral AI
Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns and diabetic foot ulcers. The Company is working to revolutionize the management of wound care by “Seeing the Unknown^®” with its DeepView^® System. DeepView^® is a predictive medical device that offers clinicians an objective and immediate assessment of a wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal to change current standard of care in the future, DeepView^® is expected to provide faster and more accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs. For more information about DeepView^®, visit www.spectral-ai.com.

Forward Looking Statements
Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s strategy, plans, objectives, initiatives and financial outlook. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements.

These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Company’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, readers are cautioned not to place undue reliance on any forward-looking statements.

Investors should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” sections of the Company’s filings with the SEC, including the Registration Statement and the other documents filed by the Company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.

Vaccinex Reports First Quarter 2024 Financial Results and Provides Corporate Update




Vaccinex Reports First Quarter 2024 Financial Results and Provides Corporate Update

Last patient last visit in randomized, double-blind, SIGNAL-AD Phase 2a study of pepinemab treatment for Alzheimer’s Disease is scheduled for early June 2024

ROCHESTER, N.Y., May 15, 2024 (GLOBE NEWSWIRE) — Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of Semaphorin 4D (SEMA4D), today announced financial results for the first quarter ended March 31, 2024, and provided a corporate update on its key program for Alzheimer’s disease.

Treatment with pepinemab believed to halt or slow progression of neurodegenerative disease:

Vaccinex expects to complete the planned 12-months of treatment of the last patients enrolled in its randomized, double-blind, Phase 2a SIGNAL-AD trial of pepinemab anti-SEMA4D antibody for mild Alzheimer’s disease (NCT04381468) in early June 2024. Database lock will follow by early July to enable final analysis of the major study outcomes.

Of interest to investors:

• Vaccinex’s lead product, pepinemab, is designed to block astrocyte activation that is otherwise triggered by SEMA4D upregulation on stressed or damaged neurons in the brain during progression of Alzheimer’s Disease (AD) and Huntington’s Disease (HD).
• Astrocytes, which are key brain cells that support the health and function of neurons, express high affinity receptors for SEMA4D and undergo substantial changes in morphology and gene expression when SEMA4D binds to these receptors. As a result, they switch from normal supportive functions to neurotoxic inflammatory activity that is believed to accelerate and aggravate progression of neurodegenerative diseases.
• The Company’s hypothesis, which is being tested in the SIGNAL-AD study, is that treating with pepinemab antibody can block signaling by SEMA4D and prevent some or all damaging consequences of astrocyte activation.
• The Company has previously reported that antibody blockade of SEMA4D appears to protect and restore healthy astrocyte functions and, by some measures, also appears to slow or prevent cognitive decline in Huntington’s disease.
• The Company believes that the prevalence of AD (6 million people diagnosed with AD in the US alone) and current concerns about the limitations of treatment with anti-Aβ amyloid antibodies could make pepinemab, if approved, attractive as a potential alternative treatment or possibly for use in combination with anti-Aβ to enhance the benefit to patients. Pepinemab has, to date, been well-tolerated in clinical trials that enrolled a total of more than 600 patients, with no evidence of amyloid-related imaging abnormalities (ARIA).

Of further interest to the medical and research communities:

• Deposition of Aβ amyloid in the brain is recognized as the earliest event in the pathologic cascade for AD. However, the observation that many elderly, cognitively normal subjects also evidence deposition of Aβ amyloid in their brains suggests that this is not of itself sufficient for disease progression and that a sequence of subsequent events, including astrocyte activation and formation of toxic tau tangles in neurons, is required. Others have recently shown that Aβ deposition in combination with astrocyte activation is associated with increased plasma levels of phosphorylated tau peptide (p-tau 217).
• Key outcomes of the SIGNAL-AD study will include impact of pepinemab treatment on brain metabolic activity, an important biomarker of clinical progression in AD, together with other biomarkers of disease progression including plasma levels of glial fibrillary acidic protein (GFAP) released by reactive astrocytes, and phosphorylated tau peptide. Exploratory evaluation of treatment effects on cognitive decline will employ several validated cognitive scales. Topline data will be presented at a major Alzheimer’s medical conference.
• The SIGNAL-AD study was funded in part by two investments from the Alzheimer’s Drug Discovery Foundation (ADDF) for a total of $4.75 million, and by an $0.75 million grant from the Alzheimer’s Association.

Financial Results for the Quarter Ended March 31, 2024:

Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on March 31, 2024, were $3.0 million, as compared to $1.5 million as of December 31, 2023.

On February 8, 2024, and March 28, 2024, the Company completed private placements of common stock with accompanying warrants to purchase common stock to certain investors, including entities controlled by Albert D. Friedberg, the chairman of the Company’s board of directors and Maurice Zauderer, the Company’s President and CEO, for gross proceeds of $4.94 million. On March 29, 2024 the Company raised an additional $1.50 million in a public offering and also received a $1.75 million investment from the ADDF in a private placement of preferred stock together with common warrants to purchase common stock. ADDF has been a leading and visionary supporter of research in AD for 25 years and this was the second such award received by Vaccinex from this distinguished foundation. Details of all these transactions are available in 8-K and other periodic reports filed with the Securities and Exchange Commission (SEC).

Research and Development Expenses. Research and development expenses for the quarter ended March 31, 2024, were $3.4 million as compared to $3.8 million for the comparable period in 2023.

General and Administrative Expenses. General and administrative expenses for the quarter ended March 31, 2024, were $1.8 million as compared to $1.7 million for the comparable period in 2023.

Comprehensive loss/Net loss per share. The Comprehensive Loss and Net loss per share for the quarter ended March 31, 2024, were $3.9 million and $(2.94) compared to $5.0 million and $(20.89) for the comparable period in 2023.

Total Stockholders’ Equity. Stockholders’ Equity as of March 31, 2024, was $2.7 million on March 31, 2024, as compared to a deficit of $(2.3) million on December 31, 2023. The 2023 discrepancy between the stockholder’s equity balance and the Nasdaq listing requirement was largely due to a determination that the terms of warrants issued on October 3, 2023 did not meet all the requirements for classification as equity and were, therefore, classified as liabilities. The Company brought this matter to the attention of all Vaccinex warrant holders in March 2024, and the holders of 89% of all outstanding warrants agreed to modification of terms of their warrants resulting in the ability to classify the modified warrants as equity on our balance sheet as of March 31, 2024. On April 11, 2024, the Company received a letter from the Listing Qualifications staff of The Nasdaq Stock Market advising that based on the financial statements contained in its Form 10-K for the year-ended December 31, 2023, the Company no longer complied with the requirement to maintain a minimum of $2.5 million in stockholders’ equity for continued listing on the Nasdaq Capital Market (the Equity Standard). The letter from Nasdaq was not a notice of delisting and had no immediate effect on the Company’s listing on the Nasdaq Capital Market. However, Nasdaq required the Company to submit a plan by May 13, 2024, describing how it would regain compliance with the Equity Standard. The Company has submitted the required plan, and while the Company is confident that its plan is promising and feasible, the Company cannot provide assurances that Nasdaq will accept the plan or that the Company will maintain compliance with the Equity Standard.

Financial tables are included below. The Company effected a 1-for-14 reverse stock split on February 20 2024. All share and share amounts have been retroactively restated to give effect to the reverse stock split. For further details on Vaccinex’s financials and the reverse stock split, please refer to its Form 10K filed April 1, 2024, with the SEC.

About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can trigger collapse of the actin cytoskeleton and loss of homeostatic functions of astrocytes and other glial cells in the brain and dendritic cells in immune tissue. Over 600 patients have been treated or enrolled in clinical trials of pepinemab in different indications and pepinemab appears to be well-tolerated with a favorable safety profile.

About Vaccinex Inc. 
Vaccinex, Inc. is pioneering a differentiated approach to treating slowly progressive neurodegenerative diseases and cancer through the inhibition of semaphorin 4D (SEMA4D). The Company’s lead drug candidate, pepinemab, blocks SEMA4D, a potent biological effector that it believes triggers damaging inflammation in chronic diseases of the brain and prevents immune infiltration into tumors. Pepinemab is being studied as a monotherapy in the Phase 1/2a SIGNAL-AD study in Alzheimer’s Disease, with ongoing exploration of potential Phase 3 development in Huntington’s disease. In oncology, pepinemab is being evaluated in combination with KEYTRUDA® in the Phase 1b/2 KEYNOTE-B84 study in recurrent or metastatic head and neck cancer (HNSCC) and in combination with BAVENCIO® in a Phase 1b/2 study in patients with metastatic pancreatic adenocarcinoma (PDAC). The oncology clinical program also includes several investigator-sponsored studies in solid tumors including breast cancer and melanoma.

Vaccinex has global commercial and development rights to pepinemab and is the sponsor of the KEYNOTE-B84 study which is being performed in collaboration with Merck Sharp & Dohme Corp, a subsidiary of Merck and Co, Inc.  Kenilworth, NJ, USA. Additional information about the study is available at: clinicaltrials.gov.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., Kenilworth, NJ, USA.   BAVENCIO®/avelumab is provided by Merck KGaA, Darmstadt, Germany, previously as part of an alliance between the healthcare business of Merck KGaA, Darmstadt, Germany and Pfizer.

Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Vaccinex, Inc. (“Vaccinex,” “we,” “us,” or “our”), they are forward-looking statements reflecting management’s current beliefs and expectations. Such statements include, but are not limited to, statements about expectations and objectives with respect to the results and timing of the SIGNAL-AD clinical trial; expectations with respect to compliance with Nasdaq listing standards; our plans, expectations and objectives with respect to the results and timing of the KEYNOTE-B84 clinical trial; the use and potential benefits of pepinemab in R/M HNSCC, lung cancer, metastatic pancreatic adenocarcinoma (PDAC) and other indications; the potential for benefits as compared to single agent KEYTRUDA® or BAVENCIO®; expectations with respect to the collaboration of Merck, the potential to initiate a Phase 3 trial in Huntington’s disease; and other statements identified by words such as “anticipate,” “believe,” “schedule,” “being,” “will,” “appears,” “expect,” “ongoing,” “potential,” “suggest”, and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). Forward-looking statements involve substantial risks and uncertainties that could cause the outcome of our research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties inherent in the execution, cost and completion of preclinical studies and clinical trials, that interim and preliminary data may not be predictive of final results and does not ensure success in later clinical trials, uncertainties related to regulatory approval, risks related to our dependence on our lead product candidate pepinemab, the possible delisting of our common stock from Nasdaq if the Company is unable to regain compliance with the Nasdaq listing standards, and other matters that could affect our development plans or the commercial potential of our product candidates. Except as required by law, the Company assumes no obligation to update these forward-looking statements. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled “Risk Factors” in our periodic reports filed with the Securities and Exchange Commission and the other risks and uncertainties described in the Company’s annual year-end Form 10-K and subsequent filings with the SEC.

Investor Contact
Elizabeth Evans, PhD
Chief Operating Officer, Vaccinex, Inc.
(585) 271-2700
eevans@vaccinex.com

VACCINEX, INC.

Condensed Balance Sheets (Unaudited)
(in thousands, except share and per share data)

VACCINEX, INC.

Condensed Statements of Operations and Comprehensive Loss (Unaudited)
(in thousands, except share and per share data)

Extendicare Announces 2024 First Quarter Results




Extendicare Announces 2024 First Quarter Results

MARKHAM, Ontario, May 15, 2024 (GLOBE NEWSWIRE) — Extendicare Inc. (“Extendicare” or the “Company”) (TSX: EXE) today reported results for the three months ended March 31, 2024. Results are presented in Canadian dollars unless otherwise noted.

First Quarter 2024 Highlights

• Adjusted EBITDA⁽¹⁾ excluding one-time items improved by $8.0 million to $20.3 million, largely driven by home health care volume growth, rate increases and growth in managed services.
• Home health care growth continued, with Q1 average daily volume (“ADV”) increasing to 29,007, up 11.4% from Q1 2023.
• LTC average occupancy increased 90 basis points (“bps”) to 97.5% from 96.6% Q1 2023.
• Extendicare Assist beds under management grew to 9,777, up 64.1% from Q1 2023, and SGP third-party and joint venture serviced beds increased by 23.7% from Q1 2023 to approximately 138,300 beds, driven by the Revera and Axium transactions.
• Countryside, a newly built Axium JV 256-bed LTC home in Sudbury, opened in March 2024.

Subsequent to Q1

• Completed the sale of a 256-bed LTC redevelopment project in Orleans, Ontario to Axium JV, for cash proceeds of $20.1 million, net of Extendicare’s 15% retained managed interest and other closing adjustments, resulting in an estimated gain of $2.5 million net of taxes, certain closing and other costs.
• Completed the sale of the land and building associated with the former Class C LTC home in Sudbury that closed in March 2024 with the opening of Countryside, for proceeds of $5.3 million, resulting in an estimated gain of $4.1 million, net of taxes, certain closing and other costs.

“We continued to see the benefits of our strategy in action in the first quarter, with double-digit growth across our home health care and managed services segments,” said Dr. Michael Guerriere, President and Chief Executive Officer. “Funding increases for long-term care included in the Government of Ontario budget announced in March will go a long way to restoring the financial stability of the sector and support our redevelopment program. The societal need for the critical services we deliver has never been more apparent, positioning us for continued growth in future quarters.”

Ontario Ministry of Long-Term Care Addresses Inflation Gap

Effective April 1, 2024, the Ontario Ministry of Long-Term Care (“MLTC”) implemented a 6.6% blended funding increase, consisting of an 11.5% increase in the other accommodation envelope and approximately 4.5% to the flow-through envelopes. The Company estimates these funding changes will result in incremental annual revenue of approximately $21.3 million, of which $12.0 million is applicable to the other accommodation envelope.

In March 2024, the MLTC provided LTC operators with one-time funding of $2,543 per bed to help relieve financial pressures and address key priorities, including capital and maintenance needs, redevelopment and other operating needs. As a result, the Company recognized approximately $12.2 million in one-time funding in Q1 2024, of which approximately $9.2 million is retroactive to April 1, 2023.

Continued Momentum in LTC Redevelopment

In March 2024, the MLTC announced a second time-limited supplemental construction funding subsidy (“CFS”) to support LTC redevelopment, helping to offset rising construction costs and higher interest rates. The supplemental CFS provides an additional $35.00 per bed per day to the existing base CFS and is available to eligible applicants who receive approval from the government to construct by November 30, 2024.

While the MLTC continues to demonstrate its commitment to building new LTC homes in Ontario, it has acknowledged that given the delays in redevelopment of the Class C LTC homes, their operating licenses will need to remain in service beyond their current expiration date of June 2025. In April 2024, the MLTC requested that LTC operators submit notice of their intentions regarding their Class C homes in order to qualify for license extensions of up to five years. The Company is seeking license extensions for all remaining Class C beds.

As at May 15, 2024 the joint ventures with Axium have five LTC redevelopment projects under construction in Ontario, consisting of 1,280 new beds, slated to replace 1,121 Class C beds. Four of the projects are replacing homes owned by Extendicare and the fifth project is replacing an existing Revera home that Extendicare is managing. The homes are being constructed exclusively with private and semi-private rooms, with substantial improvements in common areas available to the residents.

The Company continues to focus its efforts on progressing its remaining 15 redevelopment projects in Ontario, consisting of 3,032 new or replacement beds that would replace 2,211 Class C beds. With the enhanced CFS reintroduced and in place until November 2024, we are targeting to begin construction on up to four new projects in 2024, with tendered construction costs and receipt of applicable regulatory approvals largely determining if and when they proceed.

Home Health Care Funding Increases Support Service Expansion

In Q1 2024, the Company made a number of investments enabled by the 6.7% rate increase announced by the province of Ontario in Q4 2023. These consisted of enhancements to our wage and benefits programs, and further investments in recruiting, retention, training and technology. This resulted in the recognition of revenue and expense of $13.6 million related to a one-time compensation payment to all home health care staff, with no impact to NOI.

Q1 2024 Financial Highlights (all comparisons with Q1 2023)

• Revenue increased 13.1%, or $42.4 million to $367.1 million, driven primarily by LTC flow-through funding increases and improved occupancy; home health care ADV growth, rate increases and $13.6 million in retroactive funding to support one-time compensation costs incurred in the quarter; and growth in managed services; partially offset by lower prior period LTC funding.
• NOI⁽¹⁾ increased $0.2 million to $44.7 million; if we exclude a net recovery of COVID-19 costs of $12.1 million in Q1 2023 and the increase in prior period LTC funding of $3.2 million, NOI improved by $9.0 million to $34.9 million from $25.9 million, reflecting revenue growth partially offset by higher operating costs across all segments.
• Adjusted EBITDA⁽¹⁾ decreased $0.8 million to $30.1 million, reflecting the increase in NOI noted above offset by higher administrative costs of $1.0 million.
• Other expense of $1.9 million was down $1.7 million, reflecting a decline in strategic transformation costs in connection with the Revera and Axium transactions.
• Share of profit from joint ventures was $1.1 million, reflecting the impact of one-time funding for Ontario LTC homes in the quarter, of which $0.7 million related to prior periods.
• Net earnings increased $1.5 million to $13.1 million, driven by the share of profit from joint ventures, the decline in other expense and lower net finance costs, partially offset by the decrease in Adjusted EBITDA.
• AFFO⁽¹⁾ was $17.6 million ($0.21 per basic share) compared with $20.8 million ($0.24 per basic share in Q1 2023), largely reflecting the decline in Adjusted EBITDA, increased current taxes and higher maintenance capex. Excluding the year-over-year net reduction of $5.8 million in AFFO related to a net recovery of COVID-19 costs in Q1 2023 partially offset by out-of-period LTC funding and share of profit from joint ventures, AFFO improved by $2.6 million to $9.7 million ($0.12 per basic share) from $7.1 million ($0.08 per basic share) in the prior year.

Business Updates

The following is a summary of Extendicare’s revenue, NOI⁽¹⁾ and NOI margins⁽¹⁾ by business segment for the three months ended March 31, 2024 and 2023.

Long-term Care

LTC average occupancy increased to 97.5% in Q1 2024, up 90 bps from 96.6% in Q1 2023.

NOI and NOI margin in Q1 2024 were $25.3 million and 12.3%, down from $33.8 million and 16.3% in Q1 2023. Excluding a year-over-year net reduction in NOI of $8.9 million related to the net recovery of estimated COVID-19 costs of $12.1 million in Q1 2023 partially offset by an increase in prior period funding adjustments of $3.2 million ($9.8 million in the quarter versus $6.6 million in Q1 2023), NOI improved to $15.5 million in the quarter from $15.1 million in the prior period. NOI margins excluding one-time items were 7.9% in the quarter, down from 8.5% in the prior period, reflecting funding enhancements and increased occupancy, offset by higher operating costs.

Home Health Care

Home health care ADV of 29,007 in Q1 2024 was up 11.4% from Q1 2023.

Revenue was $143.5 million in Q1 2024, up 33.6% from Q1 2023, driven by growth in ADV and rate increases, including $13.6 million of funding recognized in Q1 2024 to support one-time compensation costs incurred in the quarter.

NOI and NOI margin were $10.8 million and 7.5% in Q1 2024, up from $6.4 million and 6.0% in Q1 2023, reflecting higher volumes and rates, partially offset by higher wages and benefits. Excluding the impact of the $13.6 million of one-time funding and compensation costs incurred in Q1 2024, the NOI margin was 8.3% in the quarter.

Managed Services

Extendicare Assist had management contracts with 71 homes comprising 9,777 beds at the end of Q1 2024, up from 50 homes and 5,959 beds at the end of Q1 2023, driven by the Revera and Axium transactions. Assist also provides a further 52 homes with consulting and other services. The number of third-party and joint venture beds served by SGP increased to approximately 138,300 at the end of Q1 2024, up 23.7% from Q1 2023.

Revenue increased by $7.4 million or 76.5% to $17.1 million from Q1 2023, due to the addition of managed homes as a result of the Revera and Axium transactions and new SGP clients, partially offset by Extendicare Assist clients that reduced their scope of services. NOI increased by $4.3 million to $8.7 million with an NOI margin of 50.7% in the quarter compared to 45.2% in Q1 2023.

Financial Position

Extendicare has strong liquidity with cash and cash equivalents on hand of $90.5 million and access to a further $68.0 million in undrawn demand credit facilities as at March 31, 2024.

Subsequent to Q1 2024, an additional $25.4 million in cash was received from the sale of the Orleans, Ontario 256-bed redevelopment project to Axium JV and sale of the land and buildings associated with the former Class C LTC home in Sudbury. Further proceeds are expected to be realized in 2024 from the pending sale of the Kingston Class C LTC land and building.

Select Financial Information

The following is a summary of the Company’s consolidated financial information for the three months ended March 31, 2024 and 2023.

Extendicare’s disclosure documents, including its Management’s Discussion and Analysis (“MD&A”), may be found on SEDAR+ at www.sedarplus.ca under the Company’s issuer profile and on the Company’s website at www.extendicare.com under the “Investors/Financial Reports” section.

May Dividend Declared

The Board of Directors of Extendicare today declared a cash dividend of $0.04 per share for the month of May 2024, which is payable on June 17, 2024, to shareholders of record at the close of business on May 31, 2024. This dividend is designated as an “eligible dividend” within the meaning of the Income Tax Act (Canada).

Conference Call and Webcast

On May 16, 2024, at 11:30 a.m. (ET), Extendicare will hold a conference call to discuss its 2024 first quarter results. The call will be webcast live and archived online at www.extendicare.com under the “Investors/Events & Presentations” section. Alternatively, the call-in number is 1-844-763-8274. A replay of the call will be available approximately two hours after completion of the live call until midnight on May 31, 2024. To access the rebroadcast, dial 1-855-669-9658 followed by the passcode 0809#.

About Extendicare

Extendicare is a leading provider of care and services for seniors across Canada, operating under the Extendicare, ParaMed, Extendicare Assist, and SGP Purchasing Partner Network brands. We are committed to delivering quality care throughout the health continuum to meet the needs of a growing seniors’ population. We operate a network of 123 long-term care homes (52 owned/71 under management contracts), deliver approximately 10.2 million hours of home health care services annually, and provide group purchasing services to third parties representing approximately 138,300 beds across Canada. Extendicare proudly employs approximately 22,000 qualified, highly trained and dedicated team members who are passionate about providing high-quality care and services to help people live better.

Non-GAAP Measures

Certain measures used in this press release, such as “net operating income”, “NOI”, “NOI margin”, “Adjusted EBITDA”, “Adjusted EBITDA margin”, “AFFO”, and “payout ratio”, including any related per share amounts, are not measures recognized under GAAP and do not have standardized meanings prescribed by GAAP. These measures may differ from similar computations as reported by other issuers and, accordingly, may not be comparable to similarly titled measures as reported by such issuers. These measures are not intended to replace earnings (loss) from continuing operations, net earnings (loss), cash flow, or other measures of financial performance and liquidity reported in accordance with GAAP. Such items are presented in this document because management believes that they are relevant measures of Extendicare’s operating performance and ability to pay cash dividends.

Management uses these measures to exclude the impact of certain items, because it believes doing so provides investors a more effective analysis of underlying operating and financial performance and improves comparability of underlying financial performance between periods. The exclusion of certain items does not imply that they are non-recurring or not useful to investors.

Detailed descriptions of these measures can be found in Extendicare’s Q1 2024 MD&A (refer to “Non-GAAP Measures”), which is available on SEDAR+ at www.sedarplus.ca and on Extendicare’s website at www.extendicare.com.

Reconciliations for certain non-GAAP measures included in this press release are outlined below.

The following table provides a reconciliation of AFFO, which includes discontinued operations, to “net cash from operating activities”, which the Company believes is the most comparable GAAP measure to AFFO.

The following table provides a reconciliation of “net earnings before income taxes” to Adjusted EBITDA and “net operating income”, which excludes discontinued operations.

Forward-looking Statements

This press release contains forward-looking statements concerning anticipated future events, results, circumstances, economic performance or expectations with respect to Extendicare and its subsidiaries, including, without limitation, statements regarding its business operations, business strategy, growth strategy, results of operations and financial condition, including anticipated timelines and costs in respect of development projects; and statements relating to the agreements entered into with Revera, Axium and its affiliates, Axium JV and/or Axium JV II in respect of the acquisition, disposition, ownership, operation and redevelopment of LTC homes in Ontario and Manitoba. Forward-looking statements can often be identified by the expressions “anticipate”, “believe”, “estimate”, “expect”, “intend”, “objective”, “plan”, “project”, “will”, “may”, “should” or other similar expressions or the negative thereof. These forward-looking statements reflect the Company’s current expectations regarding future results, performance or achievements and are based upon information currently available to the Company and on assumptions that the Company believes are reasonable. The Company assumes no obligation to update or revise any forward-looking statement, except as required by applicable securities laws. These statements are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of the Company to differ materially from those expressed or implied in the statements. For further information on the risks, uncertainties and assumptions that could cause Extendicare’s actual results to differ from current expectations, refer to “Risks and Uncertainties” and “Forward-looking Statements” in Extendicare’s Q1 2024 MD&A filed by Extendicare with the securities regulatory authorities, available at www.sedarplus.ca and on Extendicare’s website at www.extendicare.com. Given these risks and uncertainties, readers are cautioned not to place undue reliance on Extendicare’s forward-looking statements.

Extendicare contact:
David Bacon, Senior Vice President and Chief Financial Officer
T: (905) 470-4000
E: david.bacon@extendicare.com
www.extendicare.com

Study Shows High Volume Exercise Unrelated to Progression of Coronary Artery Calcium




Study Shows High Volume Exercise Unrelated to Progression of Coronary Artery Calcium

DALLAS, May 15, 2024 (GLOBE NEWSWIRE) — New research from The Cooper Institute® and partners at University of Texas (UT) Southwestern Medical Center, The University of Texas at Tyler and University of Alabama at Birmingham, shows that exercising, even at very high levels, is not related to the progression of coronary artery calcium (CAC), a marker of atherosclerotic cardiovascular disease. Previous research on physical activity and CAC, which suggested that individuals who engage in high volume endurance training (such as marathoners and triathletes) have more sub-clinical atherosclerosis or CAC, has primarily relied on assessment at one point in time and was unable to track individual changes in CAC. This new study, published in the Journal of the American Medical Association Cardiology, shows that the progression of CAC over time is not associated with leisure-time aerobic physical activity measured at baseline and follow-up.

“These new insights suggest that being physically active, even at very high levels, does not appear to accelerate asymptomatic atherosclerosis progression, which might be good news for exercise enthusiasts,” said Kerem Shuval, PhD, Director of Epidemiology and Behavioral Science at The Cooper Institute and lead author of the study.

The study, which is part of the Cooper Center Longitudinal Study (CCLS), included 8,771 men and women who were 50 years old on average, at baseline (50.2 years for men and 51.1 for women). Their physical activity, CAC and other clinical measurements were determined during preventive medicine visits to Cooper Clinic in Dallas, Texas. Participants had at least two clinic visits between 1998 and 2019. Analysis of the data, which accounted for potential confounding factors, revealed that aerobic physical activity does not appear to elevate the rate of CAC progression.

“This study will assist health care providers who care for elite athletes, such as marathon runners, in managing and counseling their patients with subclinical atherosclerosis. They can feel safe in continuing to exercise as long as there are no symptoms or underlying issues,” said Laura DeFina, MD, FACP, FAHA, President, CEO and Chief Science Officer of The Cooper Institute.

“This study provides important new knowledge which will greatly assist in the care of Masters athletes and highly active people who have high coronary calcium scores. Although previous work from our research team showed that there was a greater risk of having clinically significant coronary calcium in highly active people, the present analysis is reassuring that sustaining high levels of physical activity do not accelerate the progression of atherosclerosis,” said co-author Benjamin Levine, MD, FACC, FAHA, FACSM, Professor of Internal Medicine at UT Southwestern Medical Center and director of the Institute for Exercise and Environmental Medicine, a collaboration between UT Southwestern and Texas Health Presbyterian Hospital Dallas.

ABOUT THE COOPER INSTITUTE 
Established in 1970, The Cooper Institute is a nonprofit dedicated to promoting life-long health and wellness worldwide through research and education. Founded by Kenneth H. Cooper, MD, MPH, The Cooper Institute translates the latest scientific findings into proactive solutions that improve population health. Key areas of focus are research and youth programs. Through these initiatives, The Cooper Institute helps people lead better, longer lives now and Well. Into the Future. To learn more, visit cooperinstitute.org.

ABOUT THE COOPER CENTER LONGITUDINAL STUDY
Developed in 1970, the Cooper Center Longitudinal Study is an ongoing, cohort study used to improve public health. Owned and operated by The Cooper Institute, it contains more than 300,000 patient records and is one of the world’s most extensive studies relating fitness to overall wellbeing. The study allows The Cooper Institute to uncover predictors of diseases such as cancer, heart disease, stroke, type 2 diabetes, hypertension, Alzheimer’s, osteoarthritis, metabolic syndrome and depression. To learn more, visit cooperinstitute.org/CCLS.

ABOUT UT SOUTHWESTERN MEDICAL CENTER
UT Southwestern, one of the nation’s premier academic medical centers, integrates pioneering biomedical research with exceptional clinical care and education. The institution’s faculty members have received six Nobel Prizes and include 25 members of the National Academy of Sciences, 21 members of the National Academy of Medicine, and 13 Howard Hughes Medical Institute Investigators. The full-time faculty of more than 3,100 is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide care in more than 80 specialties to more than 120,000 hospitalized patients, more than 360,000 emergency room cases, and oversee nearly 5 million outpatient visits a year. 

Media Contact: Pam Czerlinsky
972.560.3246
pczerlinsky@cooperaerobics.com 

HeartFlow’s Plaque Analysis Leading The Way: 95% Accuracy vs Invasive Imaging In Newly Published REVEALPLAQUE Study




HeartFlow’s Plaque Analysis Leading The Way: 95% Accuracy vs Invasive Imaging In Newly Published REVEALPLAQUE Study

MOUNTAIN VIEW, Calif., May 15, 2024 (GLOBE NEWSWIRE) — HeartFlow, Inc., a leader in non-invasive artificial intelligence (AI) heart care solutions, today announced that the data from its REVEALPLAQUE study, highlighting the accuracy of its Plaque Analysis, was published in the European Heart Journal Cardiovascular Imaging.

REVEALPLAQUE aimed to evaluate HeartFlow’s non-invasive plaque technology, an automated, deep learning-based method for identifying, characterizing, and segmenting plaque in the coronary arteries. Understanding the volume and composition of plaque allows physicians to ensure appropriate medical treatment, which could be life changing for patients.

Key Results: HeartFlow Plaque Analysis is highly accurate in determining total plaque volume and plaque volume by type vs. invasive imaging (IVUS)¹

• Total Plaque Volume vs. IVUS: 95% agreement
• Calcified Plaque Volume vs. IVUS: 95% agreement
• Non-Calcified Plaque Volume vs. IVUS: 93% agreement

HeartFlow Plaque Analysis is the only FDA cleared, AI-enabled plaque quantification tool validated in a prospective, international trial against the gold standard of invasive imaging (IVUS) using blinded core lab adjudication.¹

Heart disease is the leading cause of death for both men and women.² Four out of five of the deaths may be preventable with nutrition, lifestyle, and medication therapy changes for patients identified early.³ Now with HeartFlow Plaque Analysis, physicians can measure confidently and accurately, the volume by type. Ultimately, this supports patients in a technology forward way that hasn’t previously been possible.

“I’m thrilled to see such an overwhelming result showcasing that CT angiography, coupled with automated AI-driven Plaque Analysis is an effective way to assess plaque burden,” said Jagat Narula, M.D., Ph.D., co-principal investigator and and K. Lance Gould Distinguished University Chair of Coronary Pathophysiology at UTHealth Houston. “This is a futuristic step forward for patients and clinicians to have an accurate, non-invasive test that gives insights into their total plaque volume, and is every bit as good as the invasive reference standard. It will allow clinicians to feel more informed to deliver the best treatment recommendations possible for each patient.”

The REVEALPLAQUE trial was a large, global prospective study which enrolled 258 patients across 15 sites in the U.S. and Japan. This was an independent, blinded, core lab adjudicated study to determine the accuracy of HeartFlow’s AI Plaque Analysis compared head-to-head with IVUS.

“HeartFlow continues to be the clear market leader in developing clinically useful AI-powered tools for non-invasive diagnostic testing for coronary artery disease. What’s more, we continue to support clinicians by providing an overwhelming body of clinical evidence attesting to their utility and accuracy,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer of HeartFlow. “With the addition of the REVEALPLAQUE data, we’re pleased to highlight that we are the only platform that has conducted and published a head to head comparison vs. IVUS using the most rigorous approach possible. Our plaque assessment technology is highly accurate, giving clinicians confidence in the product to support their clinical decision making.”

The HeartFlow Plaque Analysis technology is an automated method which analyzes coronary computed tomography (CT) scans and enables clinicians to visualize, characterize, and quantify plaque. The plaque technology is based on HeartFlow’s proprietary deep learning-enabled algorithms, which have been trained on more than 15 million coronary CT images. This critical information is delivered seamlessly to physicians in the HeartFlow platform, and when paired alongside anatomy and physiology of the patient, enhances decision-making for the clinician. HeartFlow’s Plaque Analysis is FDA cleared and is commercially available. HeartFlow has been adopted by over 1,000 institutions globally and continues to strengthen its commercial presence to make cutting-edge solutions more widely available to an increasingly diverse patient population worldwide.

About HeartFlow, Inc.

HeartFlow is transforming precision coronary care with the only AI-powered non-invasive integrated heart care solution across the CCTA pathway. As the pioneer of FFR_CT, which is now supported by the ACC/AHA Chest Pain Guideline, HeartFlow continues to advance the diagnosis and management of CAD. HeartFlow’s suite of non-invasive technologies includes its FFR_CT Analysis, RoadMap™Analysis, and Plaque Analysis. To date, more than 500 peer-reviewed publications have validated our approach and, more importantly, our technologies have helped clinicians diagnose and manage over 250,000 patients. For more information, visit www.heartflow.com.

Reference:

¹ Narula et al. Prospective Deep Learning-based Quantitative Assessment of Coronary Plaque by CT Angiography Compared with Intravascular Ultrasound EHJ 2024.

² CDC.org

³ Wang et al. JAHA 2020

Media Contact:

Linly Ku
HeartFlow
media@heartflow.com

PHAXIAM provides Business and Financial Update for the First Quarter of 2024




PHAXIAM provides Business and Financial Update for the First Quarter of 2024

PHAXIAM provides Business and Financial Update
for the First Quarter of 2024

Webinar (in French) today, May 15, 2024, at 6.00 pm CEST

• Accelerated clinical efforts to roll-out PHAXIAM’s strategy in order to create a global phage-therapy leader in high-value indications
• Cash and cash equivalents of €5.8 million, as of March 31, 2024

Lyon (France) and Cambridge (MA, US), May 15, 2024, at 5.45 pm CEST – PHAXIAM Therapeutics (Euronext: PHXM; FR0011471135), a biopharmaceutical company developing innovative treatments for severe and resistant bacterial infections, today provides a business and financial update for the first quarter of 2024.

Thibaut du Fayet, Chief Executive Officer of PHAXIAM Therapeutics, stated: “Almost a year after the creation of PHAXIAM, the company is well on track to become a leading player in phage therapies targeting the most severe bacterial infections. Indeed, we have successfully refocused our clinical programs to indications of high medical needs to provide a therapeutic alternative mainly to patients with severe and resistant Staphylococcus aureus infections, often associated with high mortality and strong impact on healthcare budgets.

This is particularly the case for Prosthetic Joint Infections, where PHAXIAM plans to strengthen its leading competitive position through an upcoming first global Phase 2 study, but also for Endocarditis Infections, with the beginning, a couple of weeks ago, of a unique Phase 1 study in this indication with phage therapy.

Beyond these two strategic clinical studies, our technological platform and know-how enable us to evaluate our phages in additional indications, such as Diabetic Food Ulcer caused by S. aureus, and potentially later, Urinary Tract Severe Infections caused by E. coli, reinforcing our ambition to develop a unique portfolio of innovative therapies for patients who failed traditional antimicrobial treatments.”

BUSINESS HIGHLIGHTS

a)  Important progress for the Staphylococcus aureus (S. aureus) program

• Prosthetic Joint Infections (PJI)
  • PHAXIAM is accelerating its PJI clinical development efforts through active preparations of a global Phase 2 proof-of-concept (POC) study.
  • The Phase 2 POC study is intended to be a multicentric, randomized, double-blind trial and is expected to include 100 patients in Europe and the US.
  • PHAXIAM confirms its objective to file a Clinical Trial Application (CTA) with the EMA and the FDA in 3Q 2024 in view of starting patient enrollment in early 2025.
  • The Company intends to capitalize on promising activity signals from real-life compassionate treatments and valuable insights from the PhagoDAIR pilot study, the data of which should be available by the end of 2024.
• Endocarditis Infections (EI)
  • PHAXIAM has recently initiated the enrolment of a phase 1 study (pharmacokinetic (PK) data) in Endocarditis Infections caused by S. aureus, its second sponsored clinical trial, to evaluate the safety of intravenous administration (IV) of its anti-S. aureus phages.
  • Preliminary clinical results are expected in 2H 2024.

b)  Complementary clinical trials and programs to confirm the versatility and the value of PHAXIAM’s phage-platform

• Diabetic Foot Ulcer (DFU): Phase 2 (POC) Investigator-Sponsored Trial
  • This clinical study is targeting DFU infections due to mono-bacterial S. aureus infection in 60 diabetic patients to be enrolled across 10 French hospitals.

• Escherichia coli (E. coli) program: Phase 1 PK Trial
  • Targeting patients having failed traditional antimicrobial treatment in complex mono-bacterial E. coli infections in the urinary tract due to neurogenic bladder.
  • PHAXIAM has received the validation from the ANSM (French Regulatory agency) to initiate this sponsored clinical trial in France, subject to available financing.

These complementary clinical studies are the opportunity to bring additional clinical POC data in other high-value indications.

1Q 2024 FINANCIAL INFORMATION

As of March 31, 2024, PHAXIAM had cash and cash equivalents totaling €5.8 million, compared with €10.5 million as of December 31, 2023. The €4.5 million decrease in cash position during the first quarter of 2024 was reflecting the R&D and regulatory activities from the newly integrated PHAXIAM team to advance the company’s pipeline, mostly in its S. aureus program.

The current cash position can fund PHAXIAM’s programs and planned operating expenses into August 2024. The Company is currently working on strengthening its financial position to support its clinical development efforts.

KEY NEWSFLOW AND MILESTONES EXPECTED OVER THE NEXT 12 MONTHS

• Preliminary PK data from the Phase 1 study in EI (3Q 2024)
• Global Phase 2 study in PJI Regulatory Approval (4Q 2024)
• PhagoDAIR pilot study in PJI clinical data (end 2024)
• Launch of the global Phase 2 study in PJI (1Q 2025)

1Q 2024 WEBINAR

PHAXIAM management will hold a webinar today, May 15, 2024, at 6.00 pm CEST to present 1Q 2024 financial information and provide an update on the Company’s activity and outlook. Thibaut du Fayet, CEO, and Eric Soyer, COO and CFO, will hold a brief presentation in French, followed by a Q&A session.

The webinar can be accessed via the following link: click here
A replay of the webinar will be available on the Company’s website in the following days.

FINANCIAL CALENDAR

• Annual General Meeting on June 28, 2024
• Business and Financial Update for the Second Quarter of 2024 on September 25, 2024

***

About PHAXIAM Therapeutics

PHAXIAM is a biopharmaceutical company developing innovative treatments for resistant bacterial infections, which are responsible for many serious infections. The company is building on an innovative approach based on the use of phages, natural bacterial-killing viruses. PHAXIAM is developing a portfolio of phages targeting 3 of the most resistant and dangerous bacteria, which together account for more than two-thirds of resistant hospital-acquired infections: Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa.

PHAXIAM is listed on the Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: PHXM). PHAXIAM is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes.

For more information, please visit www.phaxiam.com

Contacts

Forward-looking information

This press release contains forward-looking statements, forecasts and estimates with respect to the clinical programs, development plans, business and regulatory strategy and anticipated future performance of PHAXIAM and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. All statements contained in this press release other than statements of historical facts are forward-looking statements. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond PHAXIAM’s control. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Investor should carefully read the risk factors section of the Company which can be found in the Company’s regulatory filings with the French Autorité des Marchés Financiers (AMF), including in the Company’s 2023 Universal Registration Document (Document d’Enregistrement Universel) filed with the AMF on April 5, 2024 and future filings and reports by the Company. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. PHAXIAM disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in PHAXIAM’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by law.

Attachment

• PR_PHAXIAM_Q1-2024_EN_15-05-2024

Ezra Partners with Princeton Radiology for Proactive, Whole-Body MRI Screenings to Support Earlier Cancer Detection




Ezra Partners with Princeton Radiology for Proactive, Whole-Body MRI Screenings to Support Earlier Cancer Detection

NEW YORK, May 15, 2024 (GLOBE NEWSWIRE) — Ezra, the healthcare AI startup transforming early cancer detection through full body MRI screening, today announced a new partnership with Princeton Radiology Associates, based in Princeton, New Jersey. With this new relationship, Princeton Radiology will add Ezra‘s AI-powered whole-body MRI screening technology to its extensive offering of imaging services throughout its freestanding office network in Central and Northern NJ – bringing advanced early cancer detection technology to New Jersey residents.

Ezra’s end-to-end cancer screening platform monitors for cancer and 500+ other conditions – including fatty liver disease, endometriosis, and aneurysm – in up to 13 organs. In leveraging AI to speed up the scanning process without compromising quality or results, Ezra allows more individuals the ability to identify and monitor potential disease as early as possible.

“We recognize the emerging trend of patients and physicians seeking to proactively detect disease before symptoms arise, and we welcome this opportunity to serve that growing community,” said Jonathan Lebowitz, M.D., President of Princeton Radiology. “Bringing Ezra’s innovative scanning technology to Princeton Radiology exemplifies our dedication to patient-centric care and cutting-edge techniques.”

“At Ezra, our goal is to detect cancer and disease early for as many people as possible, empowering them with the knowledge they need to seek early treatment or monitor changes over time,” said Emi Gal, founder and CEO of Ezra. “Partnering with Princeton Radiology will allow us to reach more individuals, ensuring they have access to technology that can proactively address cancer and disease before it’s too late to cure.”

Ezra’s AI brings efficiency and effectiveness to key components of the cancer screening process, including imaging, analysis and reporting, and direct-to-consumer communication. Ezra Flash AI enables Ezra to acquire MRI scans faster and enhance their quality; Ezra Prostate AI assists radiologists in the analysis of MR images of the prostate; and Ezra Reporter AI creates an easily digestible translation of radiology reports that assist medical professionals in communicating screening results to people.

Patients can now schedule an Ezra full-body MRI scan at all Princeton Radiology locations. To obtain more information, including prices, visit ezra.com or call 888.402.3972.

About Ezra

Founded in 2018 by Emi Gal, Ezra is a New York-based healthcare AI company pioneering the use of full-body MRI to detect cancer and 500+ other conditions in up to 13 organs in the body. By advocating for early cancer detection as part of annual health screenings, Ezra is on a mission to create a new standard of preventative care, providing people with the necessary knowledge to make better decisions about their health.

About Princeton Radiology Associates
For more than 60 years, Princeton Radiology has been a regional leader in the diagnosis and treatment of disease. With 40board-certified and sub-specialized radiologists providing services at 10 imaging centers and two hospitals, Princeton Radiology is committed to providing patients and referring physicians with expert consultations and the latest technology and treatments available—including PET/CT, Wide-bore MRI, and Extremity MRI—all delivered by highly skilled, courteous staff in a comfortable setting. Princeton Radiology’s services are accredited by the American College of Radiology. Through the attentive care Princeton Radiology provides to patients before, during, and after every examination, Princeton Radiology has gained the respect of referring physicians, the trust of patients, and a prominent place in the community. For more information, please visit www.PrincetonRadiology.com.

Contact: claire.schillings@ezra.com