Dynavax Urges Stockholders to Support Its Director Nominees at June 11 Annual Meeting

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Dynavax’s Strategy is Delivering Significant Long-Term Stockholder Value

Dynavax’s Nominees Are Vastly Superior to Deep Track’s Candidates Across Every Critical Area

Follow Recommendations of Proxy Advisory Firms ISS and Egan-Jones and Vote “FOR” All Four of Dynavax’s Director Nominees on the GOLD Proxy Card Today


EMERYVILLE, Calif.
, June 9, 2025 /PRNewswire/ — Dynavax Technologies Corporation (Nasdaq: DVAX) (“Dynavax” or the “Company”), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today issued the following statement reiterating to stockholders its recommendation to vote “FOR” all four of Dynavax’s highly qualified directors standing for election – Brent MacGregor, Scott Myers, Lauren Silvernail and Elaine Sun – at the Company’s upcoming Annual Meeting of Stockholders on June 11, 2025 (the “2025 Annual Meeting”).

Since 2019, Dynavax has successfully executed a strategic repositioning of our business, and our refreshed Board is executing a plan that is delivering significant stockholder value. In direct contrast, Deep Track – which has no experience developing and executing corporate strategy, operations, or finance – is insistent on implementing its strip-mining plan for Dynavax, jeopardizing a strong platform with significant long-term growth opportunities for a near-term payoff of a considerably lower value. Simply put: there is no case for change, and changing course to Deep Track’s purported plan will destroy long-term value and is not in the best interests of all stockholders.

Re-electing all four of our nominees is essential to our ability to continue driving value for all stockholders. Without Brent MacGregor, Scott Myers, Lauren Silvernail and Elaine Sun, the Board would be deprived of essential strategic leadership, vaccine expertise, senior public biotechnology and M&A experience, as well as deep industry financial expertise – qualifications that none of Deep Track’s candidates can adequately match. Deep Track’s principal, Brett Erkman, is beholden to his own hedge fund investors – not our stockholders – and has demonstrated an inability to be open-minded. Donald Santel lacks vaccine industry experience and his public company executive experience ended ten years ago. In short, Deep Track’s nominees are far less qualified than all of our current directors.  

Make no mistake – Deep Track is attempting to gain control of Dynavax to implement its flawed plan, which would be detrimental to the long-term value we are generating for our stockholders.

Independent proxy advisory firms Institutional Shareholder Services (“ISS”) and Egan-Jones agree and recommend that stockholders support all of Dynavax’s director nominees. ISS noted that Deep Track has failed to present a compelling case for change and called attention to Deep Track’s cherry picked and highly misleading materials throughout its campaign – “There are serious concerns with the dissident’s presentation of TSR…The dissident’s attempt to suggest otherwise through a blatantly distorted TSR analysis has only diminished its credibility.”1 Glass, Lewis & Co. (“Glass Lewis”) acknowledged the significant stockholder returns we have been generating, our differentiated capital allocation plan, and the meaningful refreshment and high caliber Board we have in place. Perhaps most importantly, Glass Lewis put a fine point on the legitimate concerns stockholders should have in electing Mr. Erkman to the Board – noting that “his fiduciary experience in a boardroom setting remains untested” and “may raise legitimate questions about Mr. Erkman’s ability to balance Deep Track’s position with the broader interests of all shareholders.”2

Here’s why we encourage you to vote for ALL four of Dynavax’s nominees:

  • The strategy Dynavax has in place, and is successfully executing against, is working. We positioned HEPLISAV-B® to be the market-leading hepatitis B vaccine, and are consistently delivering record financial results, including most recently a few weeks ago when we reported Q1 2025 results, and have delivered 203% total return to stockholders over the last five years3. We are far outperforming vaccine peers, which have returned 9%, and the S&P Biotechnology Select Industry Index, which has declined 17%. This is the result of consistent operational execution, skilled business development which generated over $950 million in revenue between 2020 and 2022, and a disciplined capital allocation plan that, as of May 5, 2025, included execution of over 85% of the $200 million share repurchase program authorized in November 2024.

  • The directors Dynavax needs at this time are already on the Board. The Board has been thoughtfully reshaped in recent years with new, independent directors – following the Annual Meeting, the Board will be comprised of nine directors, with six of eight independent directors having been appointed since 2020 – who bring highly specialized skillsets that are directly aligned to our long-term strategic plan. Our directors, including those up for re-election, are renowned experts in their fields within biotech and vaccines across operations, finance/capital markets, business development M&A, commercialization, R&D, public health and more. Replacing any Dynavax directors with Deep Track’s underqualified nominees would disrupt the momentum of our clearly successful long-term strategy and put stockholder value at risk.

With our 2025 Annual Meeting fast approaching on June 11, it is extremely important that you vote as soon as possible, no matter how many shares you own. We urge you to vote “FOR” all four of Dynavax’s director nominees Brent MacGregor, Scott Myers, Lauren Silvernail and Elaine Sun – on the GOLD proxy card today.

Dynavax stockholders who need assistance in voting their shares may call the Company’s proxy solicitor, MacKenzie Partners, at 1-800-322-2885.

Advisors

Goldman Sachs & Co. LLC is serving as financial advisor to Dynavax and Cooley LLP is serving as legal counsel.

About Dynavax

Dynavax is a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases. The Company has two commercial products, HEPLISAV-B® vaccine (Hepatitis B Vaccine (Recombinant), Adjuvanted), which is approved in the U.S., the European Union and the United Kingdom for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older, and CpG 1018® adjuvant, currently used in HEPLISAV-B and multiple adjuvanted COVID-19 vaccines. For more information about our marketed products and development pipeline, visit www.dynavax.com.

Forward-Looking Statements

This communication contains “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to a number of risks and uncertainties. All statements that are not historical facts are forward-looking statements. Forward-looking statements can generally be identified by the use of words such as “continue,” “expect,” “will,” “plan,” “would,” and similar expressions, or the negatives thereof, or they may use future dates. Forward-looking statements made in this document include statements regarding expected contributions from our current directors, expectations regarding delivering value for our stockholders, market share and size of the market, our business strategy and long-term performance. Actual results may differ materially from those set forth in this communication due to the risks and uncertainties inherent in our business, including, the risk that circumstances surrounding or leading up to our 2025 Annual Meeting may change, risks relating to our ability to commercialize and supply HEPLISAV-B, the risks that market size or actual demand for our products may differ from our expectations, risks related to the timing of completion and results of current clinical studies, risks related to the development and pre-clinical and clinical testing of vaccines containing CpG 1018 adjuvant, and risks related to the implementation of our long-term growth objectives, as well as other risks detailed in the “Risk Factors” section of our Quarterly Report on Form 10-Q for the three months ended March 31, 2025 and any periodic filings made thereafter, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the U.S. Securities and Exchange Commission. These forward-looking statements are made as of the date hereof, are qualified in their entirety by this cautionary statement and we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax’s website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.

Important Additional Information and Where to Find It

On April 17, 2025, the Company filed a definitive proxy statement on Schedule 14A (the “Proxy Statement”) and form of accompanying GOLD proxy card with the U.S. Securities and Exchange Commission (the “SEC”) in connection with its 2025 Annual Meeting and its solicitation of proxies for the Company’s director nominees and for other matters to be voted on. The Company may also file other relevant documents with the SEC regarding its solicitation of proxies for the 2025 Annual Meeting. This communication is not a substitute for any proxy statement or other document that the Company has filed or may file with the SEC in connection with any solicitation by the Company. STOCKHOLDERS OF THE COMPANY ARE STRONGLY ENCOURAGED TO READ THE PROXY STATEMENT, ACCOMPANYING GOLD PROXY CARD AND OTHER RELEVANT DOCUMENTS FILED WITH, OR FURNISHED TO, THE SEC CAREFULLY AND IN THEIR ENTIRETY AS THEY CONTAIN IMPORTANT INFORMATION. Stockholders may obtain a copy of the Proxy Statement, accompanying GOLD proxy card, any amendments or supplements to the Proxy Statement and any other relevant documents filed by the Company with the SEC at no charge at the SEC’s website at www.sec.gov. Copies will also be available at no charge at the Company’s website at https://investors.dynavax.com/sec-filings.

Certain Information Regarding Participants

This communication is neither a solicitation of a proxy or consent nor a substitute for any proxy statement or other filings that may be made with the SEC. The Company, its directors, its director nominees and certain of its executive officers and employees may be deemed to be participants in the solicitation of proxies for the 2025 Annual Meeting. Information regarding the names of such persons and their respective direct or indirect interests in the Company, by securities holdings or otherwise, is available in the Proxy Statement, which was filed with the SEC on April 17, 2025, including in the sections captioned “Compensation Discussion and Analysis,” “Summary Compensation Table,” “Grants of Plan Based Awards,” “Outstanding Equity Awards at Fiscal Year End,” “Pay Ratio Disclosure,” “Director Compensation,” “Certain Transactions,” “Security Ownership of Certain Beneficial Owners and Management,” and “Supplemental Information Regarding Participants in the Solicitation.” To the extent that the Company’s directors and executive officers have acquired or disposed of securities holdings since the applicable “as of” date disclosed in the Proxy Statement, such transactions have been or will be reflected on Statements of Changes in Ownership of Securities on Form 4 or Initial Statements of Beneficial Ownership of Securities on Form 3 filed with the SEC. These documents are or will be available free of charge at the SEC’s website at www.sec.gov.

For Investors:

Paul Cox

[email protected]

510-665-0499

Or

MacKenzie Partners, Inc.
Bob Marese / John Bryan
Toll-Free: 1-800-322-2885
[email protected] 

For Media:

Dan Moore / Tali Epstein
[email protected] 

1 Source: ISS report dated May 23, 2025. Permission to use quotes neither sought nor obtained.
2 Source: Glass Lewis report dated June 3, 2025. Permission to use quotes neither sought nor obtained.
3 As of April 17, 2025, the date Dynavax filed its definitive proxy.

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SOURCE Dynavax Technologies

Acurx Pharmaceuticals Announces Presentation of Results from Leiden University Medical Center Public-Private Partnership for Its DNA pol IIIC Inhibitors at the Federation of American Societies for Experimental Biology Scientific Conference

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Results are from Acurx’s ongoing scientific collaboration with Leiden University Medical Center (LUMC) partially under a grant from Health Holland to further study the mechanism of action of 
DNA pol IIIC inhibitors

LUMC highlighted Acurx’s new class of promising antimicrobials, ibezapolstat and related analogues
Novel chemotype specifically targeting gram-positive bacteria through an unexploited target
Ibezapolstat ready to enter pivotal Phase 3 clinical trials for C. difficile Infection (CDI), with no cross resistance reported to date

Ibezapolstat has previously been granted FDA QIDP and Fast-Track Designations and has received SME (Small and Medium-sized Enterprise) designation by the EMA

STATEN ISLAND, N.Y., June 9, 2025 /PRNewswire/ — Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) (“Acurx” or the “Company”) is a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. Its lead antibiotic candidate, ibezapolstat (IBZ), is ready to advance to international pivotal Phase 3 clinical trials for treatment of patients with C. difficile infection (CDI).

The Company today announced that a presentation of a poster and an oral presentation regarding Acurx’s overall DNA pol IIIC inhibitor platform was presented at a scientific conference on May 21 by Mia Urem, PhD, from Leiden University Medical Center in the Netherlands entitled: “A Unique Inhibitor Conformation Selectively Targets the DNA Polymerase PolC of Gram-Positive Priority Pathogens“.  This scientific conference is sponsored by the Federation of American Societies for Experimental Biology and is the premier venue for the newest research and technological trends in molecular “machines” inside the human body that ensure DNA replication and expression of genes to create proteins that make up a cell. The distinctive non-planar conformation of ACX-801 and IBZ, together with high conservation of the induced binding pocket in PolC, suggests that this is a general mechanism for this class of inhibitor and is conserved in Gram-positive bacteria.

According to Dr. Wiep Klaas Smits, Associate Professor/Principal Investigator, Leiden University Medical Center: “Our findings with regards to the structural biology of DNA pol IIIC in complex with inhibitors have important implications for the development of this novel class of antibiotics to treat high priority, multi-drug resistant, gram-positive infections.”

Acurx’s Executive Chairman, Bob DeLuccia, stated: “This research outcome provides a deeper understanding of the mechanism of action and selectivity of ibezapolstat in the gut. These data will guide the rational design of new compounds with improved inhibitory activity and drug-like characteristics that will be crucial in addressing the pandemic of antimicrobial resistance.”

POSTER AND PRESENTATION ARE ON ACURX WEBSITE www.acurxpharma.com

About the Federation of American Societies for Experimental Biology
Since its inception 20 years ago, this conference has been the premier venue for the newest research and technological trends that aid in studying the molecular “machines” inside the human body. These biological elements ensure faithful DNA replication and expression of genes to create the many proteins that make up a cell. The Machines on Genes scientific conference covers all aspects that govern the central building blocks of life, DNA replication, transcription, and translation, as well as activities that impact these processes such as DNA repair, DNA editing, and RNA editing. There is special emphasis on how they work, how they interact with one another, and how they may be used as diagnostic tools or as targets for novel therapies.

About Leiden University Medical Center
Antimicrobial resistant microorganisms are a major threat to global health and pose a significant economic burden. Increasing resistance to multiple agents and resistance to so called last-resort antibiotics underscore the necessity to develop therapeutics that have a novel mode of action. DNA replication is a process that can be successfully targeted by small molecules. Ibezapolstat, an inhibitor of the replicative DNA polymerase pol IIIC from Gram-positive bacteria identified by screening library of dGTP analogues, has shown promising results for the treatment of Clostridioides difficile Infection in a recent Phase 2a clinical trial, but the molecular basis of selective inhibition is not fully characterized as no structural information is available on pol IIIC proteins from pathogens. Ongoing research project will determine the structure of pol IIIC from the multidrug-resistant organisms methicillin resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococci (VRE) and/or penicillin resistant Streptococcus pneumoniae (PRSP) in the absence and presence of lead compounds. These results will reveal the structural space of inhibitor-binding and guide the rational design of inhibitors with optimal pharmacological properties and organism-specificity that will be demonstrated by in vitro polymerase inhibition assays and in vivo minimal inhibitory concentration determination.

Leiden University was the first university to be established in the Netherlands. Its motto is praesidium libertatis – bastion of freedom.  The University wishes to create an increasingly attractive and challenging working climate for top academics and young researchers that is guided by quality and excellence. Leiden University Medical Center (LUMC) research aims to meet the highest international standards of quality and academic integrity. LUMC promotes excellent research through greater collaboration, both disciplinary and interdisciplinary; stronger positioning and greater scope for top talent; and better supervision and more support for young researchers.

The presented research was performed in part as a public-private partnership that includes the Dutch Top Sector Life Sciences and Health (‘Topconsortium voor Kennis en Innovatie’ or ‘TKI’ Life Sciences and Health) and is represented by Stichting Life Sciences Health – TKI (aka, Health~Holland). This foundation is tasked by the Dutch government to promote and stimulate public-private partnerships (PPPs) to undertake R&D projects in the life sciences. To promote such partnerships, the Minister of Economic Affairs and Climate Policy has allocated certain funds to Stichting LSH-TKI, to grant allowances to projects under the TKI-programme Life Sciences & Health. Stichting LSH-TKI has designated the Board of Directors of LUMC as delegated grantor for the PPP allowance allocated to the LUMC.

Together with Acurx Pharmaceuticals the PPP has led to the research project entitled “Bad bugs, new drugs: elucidation of the structure of DNA polymerase C of multidrug resistant bacteria in complex with novel classes of antimicrobials.” The collaboration project was co-funded by the PPS Allowance made available by Health~Holland, Top Sector Life Sciences & Health, to stimulate public-private partnerships.

Acurx previously announced that it had received positive regulatory guidance from the EMA during its Scientific Advice Procedure which confirmed that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted to EMA supports advancement of the ibezapolstat Phase 3 program and if the Phase 3 program is successful, supports the submission of a Marketing Authorization Application (MAA) for regulatory approval in Europe.  The information package submitted to EMA by the Company to which agreement has been reached with EMA included details on Acurx’s two planned international Phase 3 clinical trials, 1:1 randomized (designed as non-inferiority vs vancomycin), primary and secondary endpoints, sample size, statistical analysis plan and the overall registration safety database. With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program.

The primary efficacy analysis will be performed using a Modified Intent-To-Treat (mITT) population. This will result in an estimated 450 subjects in the mITT population, randomized in a 1:1 ratio to either ibezapolstat or standard- of-care vancomycin, enrolled into the initial Phase 3 trial. The trial design not only allows determination of ibezapolstat’s ability to achieve Clinical Cure of CDI as measured 2 days after 10 days of oral treatment, but also includes assessment of ibezapolstat’s potential effect on reduction of CDI recurrence in the target population. In the event non-inferiority of ibezapolstat to vancomycin is demonstrated, further analysis will be conducted to test for superiority.

About the Ibezapolstat Phase 2 Clinical Trial
The completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2bat 28 US clinical trial sites which together comprise the Phase 2 clinical trial. This Phase 2 clinical trial was designed to evaluate the clinical efficacy of ibezapolstat in the treatment of CDI including pharmacokinetics and microbiome changes from baseline. from study centers in the United States. In the Phase 2a trial segment,10 patients with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28± 2 days. Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment (100% cured infection at End of Treatment (10 of 10).

In the Phase 2b trial segment, 32 patients with CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence of CDI. The two treatments were identical in appearance, dosing times, and number of capsules administered to maintain the blind.

In the Phase 2b trial, the Clinical Cure rate in patients with CDI was 96% (25 out of 26 patients), based on 10 out of 10 patients (100%) in Phase 2a in the Modified Intent to Treat Population, plus 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population, who experienced Clinical Cure during treatment with ibezapolstat. 

Notably, in the combined Phase 2 trial, 100% (25 of 25) ibezapolstat-treated patients ) who had Clinical Cure at EOT) (End of Treatment) remained cured through one month after EOT, as compared to 86% (12 of 14) for the vancomycin patient group.  Ibezapolstat was well-tolerated, with no serious adverse events assessed by the blinded investigator to be drug- related. The Company is confident that based on the pooled Phase 2 ibezapolstat Clinical Cure rate of 96%, Sustained Clinical Cure Rate of 100% and the historical vancomycin Clinical Cure Rate range of 70% to 92% and a Sustained Clinical Cure historical range of 42% to 74%, we will demonstrate non-inferiority of ibezapolstat to vancomycin in Phase 3 trials, in accordance with the applicable FDA Guidance for Industry (October 2022), with favorable differentiation in both Clinical Cure and Sustained Clinical Cure.

In the Phase 2 clinical trial (both trial segments), the Company also evaluated pharmacokinetics (PK) and microbiome changes and test for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota Actinobacteria and Firmicute phylum species during and after therapy. Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy. Very importantly, emerging data show an increased concentration of secondary bile acids during and following ibezapolstat therapy which is known to correlate with colonization resistance against C. difficile. A decrease in primary bile acids and the favorable increase in the ratio of secondary-to-primary bile acids suggest that ibezapolstat may reduce the likelihood of CDI recurrence when compared to vancomycin. The company also reported positive extended clinical cure (ECC) data for ibezapolstat (IBZ), its lead antibiotic candidate, from the Company’s recently completed Phase 2b clinical trial in patients with CDI. This exploratory endpoint showed that 5 of 5 IBZ patients followed for up to three months following Clinical Cure experienced no recurrence of infection. Furthermore, ibezapolstat-treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients.

About Ibezapolstat
Ibezapolstat is the Company’s lead antibiotic candidate planning to advance to international Phase 3 clinical trials to treat patients with C. difficile infection. Ibezapolstat is a novel, orally administered antibiotic, being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat’s unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome.

In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In 2019, FDA granted “Fast Track” designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.

About Clostridioides difficile Infection
According to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community. C. difficile is one of the most common causes of health care- associated infections in U.S. hospitals (Lessa, 2015, NEJM). Recent estimates suggest C. difficile approaches 500,000 infections annually in the U.S. and is associated with approximately 20,000 deaths annually. (Guh, 2020, NEJM. Based on internal estimates, the recurrence rate for the antibiotics currently used to treat CDI is between 20% and 40% among approximately 150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of approximately 9.3%.

About the Microbiome in C. difficile Infection and Bile Acid Metabolism

C. difficile can be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the C. difficile can thrive and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020.) TcdA and TcdB are exotoxins that bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa. Bile acids perform many functional roles in the GI tract, with one of the most important being maintenance of a healthy microbiome by inhibiting C. difficile growth. Primary bile acids, which are secreted by the liver into the intestines, promote germination of C. difficile spores and thereby increase the risk of recurrent CDI after successful treatment of an initial episode. On the other hand, secondary bile acids, which are produced by normal gut microbiota through metabolism of primary bile acids, do not induce C. difficile sporulation and therefore protect against recurrent disease. Since ibezapolstat treatment leads to minimal disruption of the gut microbiome, bacterial production of secondary bile acids continues which may contribute to an anti-recurrence effect. Beneficial effects of bile acids include a decrease in primary bile acids and an increase in secondary bile acids in patients with CDI, which was observed in the Company’s Ph2a trial results and previously reported (Garey, CID, 2022). In the Ph2b trial, ibezapolstat-treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients.

About Acurx Pharmaceuticals, Inc.
Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company’s approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram-positive specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin- resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug- resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen). Acurx’s lead product candidate, ibezapolstat, for the treatment of C. difficile Infection is Phase 3 ready with plans in progress to begin international clinical trials next year. The Company’s preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled anthrax is being planned in parallel.

To learn more about Acurx Pharmaceuticals and its product pipeline, please visit www.acurxpharma.com.

Forward-Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the FDA or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other risks and uncertainties described in the Company’s annual report filed with the Securities and Exchange Commission on Form 10-K for the year ended December 31, 2024, and in the Company’s subsequent filings with the Securities and Exchange Commission. Such forward- looking statements speak only as of the date of this press release, and Acurx disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.

Investor Contact:

Acurx Pharmaceuticals, Inc.;

David P. Luci, President & CEO 

Tel: 917-533-1469;

Email: [email protected] 

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SOURCE Acurx Pharmaceuticals, Inc.

SUNSTONE HOTEL INVESTORS ANNOUNCES THE DISPOSITION OF HILTON NEW ORLEANS ST. CHARLES

PR Newswire

Recycles Sale Proceeds into Accretive Share Repurchases


ALISO VIEJO, Calif.
, June 9, 2025 /PRNewswire/ — Sunstone Hotel Investors, Inc. (the “Company” or “Sunstone”) (NYSE: SHO) today announced that it has completed the sale of the 252-room Hilton New Orleans St. Charles (the “Hotel”) for a gross sale price of $47 million, or approximately $187,000 per key. The sale price represents a 10.1x multiple on 2024 Hotel Adjusted EBITDAre and an 8.7% cap rate on 2024 Hotel Net Operating Income. The Company anticipates that the Hotel will require a cyclical renovation to maintain its competitive position and sustain its current level of earnings. Inclusive of the Company’s estimate of required near-term capital expenditures, the gross sale price represents a 13.4x multiple on Hotel Adjusted EBITDAre and a 6.6% cap rate on Hotel Net Operating Income for 2024. The Company will provide additional details on the sale including the impact to its previously provided 2025 outlook as part of its second quarter earnings release.  

In anticipation of the sale of the Hotel, the Company took advantage of market conditions to fully recycle the proceeds from the disposition into additional share repurchases. Year to date as of June 6, 2025, the Company has repurchased 6.8 million shares of its common stock at an average purchase price of $8.84 per share for a total repurchase amount before expenses of $60 million. Since the beginning of 2022, the Company has deployed $252 million and repurchased 25.8 million shares of its common stock, representing nearly 12% of shares outstanding at the start of the period, at an average price of $9.77 per share. The implied cash flow multiple and discount to NAV achieved by the repurchase activity represent an accretive allocation of capital and significant value creation for the Company’s shareholders.

Bryan Giglia, Chief Executive Officer, stated, “We are pleased to announce the disposition of the Hilton New Orleans St. Charles. We were able to divest the hotel at attractive pricing, eliminate near-term defensive capital expenditures and recycle the proceeds into a higher yielding investment through the repurchase of our stock at a compelling discount. New Orleans remains an attractive lodging market for group events and leisure travel, and we will continue to benefit from exposure to the city through our ownership of the well-located JW Marriott. While we maintain capacity to grow the portfolio and are evaluating hotel investment opportunities, the value we can realize through the repurchase of our stock near current levels will generally represent a more accretive allocation of capital for our shareholders. Knowing that the environment is uncertain and can change quickly, the team remains nimble and ready to pivot between capital allocation opportunities as the landscape evolves from here.”

About Sunstone Hotel Investors

Sunstone Hotel Investors, Inc. is a lodging real estate investment trust (“REIT”). Sunstone’s strategy is to create long-term stakeholder value through the acquisition, active ownership, and disposition of well-located hotel and resort real estate. For further information, please visit Sunstone’s website at www.sunstonehotels.com.

For Additional Information

Aaron Reyes

Chief Financial Officer
Sunstone Hotel Investors, Inc.
(949) 382-3018

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws and regulations. These forward-looking statements are identified by their use of terms and phrases such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “should,” “will” and other similar terms and phrases, including opinions, references to assumptions and forecasts of future results. Forward-looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results to differ materially from those anticipated at the time the forward-looking statements are made. These risks include, but are not limited to: we own upper upscale and luxury hotels located in urban and resort destinations in an industry that is highly competitive; events beyond our control, including economic slowdowns or recessions, uncertainty in connection with certain international economic and political relationships, including political disputes and the imposition of tariffs affecting commodity costs, pandemics, natural disasters, civil unrest and terrorism; inflation may adversely affect our financial condition and results of operations; system security risks, data protection breaches, cyber-attacks and systems integration issues, including those impacting the Company’s suppliers, hotel managers or franchisors; a significant portion of our hotels are geographically concentrated so we may be disproportionately harmed by economic conditions, competition, new hotel supply, real and personal property tax rates or natural disasters in these areas of the country; we face possible risks associated with the physical and transitional effects of climate change; uninsured or underinsured losses could harm our financial condition; the operating results of some of our hotels are significantly reliant upon group and transient business generated by large corporate customers, and the loss of such customers for any reason could harm our operating results; the increased use of virtual meetings and other similar technologies could lessen the need for business-related travel, and, therefore, demand for rooms in our hotels may be adversely affected; our hotels require ongoing capital investment and we may incur significant capital expenditures in connection with acquisitions, repositionings and other improvements, some of which are mandated by applicable laws or regulations or agreements with third parties, and the costs of such renovations, repositionings or improvements, including commodity cost increases resulting from inflation or the implementation of international tariffs, and delays due to supply chain disruptions, may exceed our expectations or cause other problems; delays in the acquisition, renovation or repositioning of hotel properties may have adverse effects on our results of operations and returns to our stockholders; accounting for the acquisition of a hotel property or other entity involves assumptions and estimations to determine fair value that could differ materially from the actual results achieved in future periods; volatility in the debt and equity markets may adversely affect our ability to acquire, renovate, refinance or sell our hotels; we may pursue joint venture investments that could be adversely affected by our lack of sole decision-making authority, our reliance on a co-venturer’s financial condition and disputes between us and our co-venturer; we may be subject to unknown or contingent liabilities related to recently sold or acquired hotels, as well as hotels we may sell or acquire in the future; we may seek to acquire a portfolio of hotels or a company, which could present more risks to our business and financial results than the acquisition of a single hotel; the sale of a hotel or portfolio of hotels is typically subject to contingencies, risks and uncertainties, any of which may cause us to be unsuccessful in completing the disposition; the illiquidity of real estate investments and the lack of alternative uses of hotel properties could significantly limit our ability to respond to adverse changes in the performance of our hotels; we may issue or invest in hotel loans, including subordinated or mezzanine loans, which could involve greater risks of loss than senior loans secured by income-producing real properties; if we make or invest in mortgage loans with the intent of gaining ownership of the hotel secured by or pledged to the loan, our ability to perfect an ownership interest in the hotel is subject to the sponsor’s willingness to forfeit the property in lieu of the debt; one of our hotels is subject to a ground lease with an unaffiliated party, the termination of which by the lessor for any reason, including due to our default on the lease, could cause us to lose the ability to operate the hotel altogether and may adversely affect our results of operations; because we are a REIT, we depend on third-parties to operate our hotels; we are subject to risks associated with our operators’ employment of hotel personnel; most of our hotels operate under a brand owned by Marriott, Hyatt, Hilton, Four Seasons or Montage, and should any of these brands experience a negative event, or receive negative publicity, our operating results may be harmed; our franchisors and brand managers may adopt new policies or change existing policies which could result in increased costs that could negatively impact our hotels; future adverse litigation judgments or settlements resulting from legal proceedings could have an adverse effect on our financial condition; claims by persons regarding our properties could affect the attractiveness of our hotels or cause us to incur additional expenses; the hotel business is seasonal and seasonal variations in business volume at our hotels will cause quarterly fluctuations in our revenue and operating results; changes in the debt and equity markets may adversely affect the value of our hotels; certain of our hotels have in the past become impaired and additional hotels may become impaired in the future; laws and governmental regulations may restrict the ways in which we use our hotel properties and increase the cost of compliance with such regulations, and noncompliance with such regulations could subject us to penalties, loss of value of our properties or civil damages; corporate responsibility, specifically related to environmental sustainability, social responsibility and corporate governance, or ESG, factors and commitments, may impose additional costs and expose us to new risks that could adversely affect our results of operations, financial condition and cash flows; our franchisors and brand managers may require us to make capital expenditures pursuant to property improvement plans or to comply with brand standards; termination of any of our franchise, management or operating lease agreements could cause us to lose business; the growth of alternative reservation channels could adversely affect our business and profitability; the failure of tenants in our hotels to make rent payments or otherwise comply with the material terms of our retail and restaurant leases may adversely affect our results of operations; we rely on our corporate and hotel senior management teams, the loss of whom may cause us to incur costs and harm our business; we could be harmed by inadvertent errors, misconduct or fraud that is difficult to detect; if we fail to maintain effective internal control over financial reporting and disclosure controls and procedures, we may not be able to accurately report our financial results or identify and prevent fraud; we have outstanding debt which may restrict our financial flexibility; our debt agreements contain various covenants, restrictions, requirements and other limitations, and should we default, we may be required to pay additional fees, provide additional security or repay the debt; defaulting on existing debt may limit our ability to access additional debt financing in the future; certain of our unsecured term loans are subject to variable interest rates, which creates uncertainty in the amount of interest expense we will incur in the future and may negatively impact our operating results; we may not be able to refinance our debt on favorable terms or at all; our stock repurchase program may not enhance long-term stockholder value, could cause volatility in the price of our common and preferred stock and could diminish our cash reserves; and other risks and uncertainties associated with the Company’s business described in its filings with the Securities and Exchange Commission. Although the Company believes the expectations reflected in such forward-looking statements are based upon reasonable assumptions, it can give no assurance that the expectations will be attained or that any deviation will not be material. All forward-looking information provided herein is as of the date of this release, and the Company undertakes no obligation to update any forward-looking statement to conform the statement to actual results or changes in the Company’s expectations.

This release should be read together with the consolidated financial statements and notes thereto included in our most recent reports on Form 10-K and Form 10-Q. Copies of these reports are available on our website at www.sunstonehotels.com and through the SEC’s Electronic Data Gathering Analysis and Retrieval System (“EDGAR”) at www.sec.gov.

Non-GAAP Financial Measures

We present the following non-GAAP financial measures that we believe are useful to investors as key supplemental measures of our operating performance: hotel earnings before interest expense, taxes, depreciation and amortization for real estate, adjusted as discussed below, or Hotel Adjusted EBITDAre; and Hotel Net Operating Income. These measures should not be considered in isolation or as a substitute for measures of performance in accordance with GAAP. In addition, our calculation of these measures may not be comparable to other companies that do not define such terms exactly the same as the Company. These non-GAAP measures are used in addition to and in conjunction with results presented in accordance with GAAP. They should not be considered as alternatives to net income (loss), cash flow from operations, or any other operating performance measure prescribed by GAAP. These non-GAAP financial measures reflect additional ways of viewing our operations that we believe, when viewed with our GAAP results and the reconciliations to the corresponding GAAP financial measures, provide a more complete understanding of factors and trends affecting our business than could be obtained absent this disclosure. We strongly encourage investors to review our financial information in its entirety and not to rely on a single financial measure.

We present EBITDAre in accordance with guidelines established by the National Association of Real Estate Investment Trusts (“Nareit”), as defined in its September 2017 white paper “Earnings Before Interest, Taxes, Depreciation and Amortization for Real Estate.” We believe EBITDAre is a useful performance measure to help investors evaluate and compare the results of our operations from period to period in comparison to our peers. Nareit defines EBITDAre as net income (calculated in accordance with GAAP) plus interest expense, income tax expense, depreciation and amortization, gains or losses on the disposition of depreciated property (including gains or losses on change in control), impairment write-downs of depreciated property and of investments in unconsolidated affiliates caused by a decrease in the value of depreciated property in the affiliate, and adjustments to reflect the entity’s share of EBITDAre of unconsolidated affiliates.

We make additional adjustments to EBITDAre when evaluating our performance because we believe that the exclusion of certain additional items described below provides useful information to investors regarding our operating performance, and that the presentation of Hotel Adjusted EBITDAre, when combined with the primary GAAP presentation of net income, is beneficial to an investor’s complete understanding of our operating performance. In addition, we use both EBITDAre and Adjusted EBITDAre as measures in determining the value of hotel acquisitions and dispositions.

We adjust EBITDAre for the following items, which may occur in any period, and refer to this measure as Adjusted EBITDAre:

  • Amortization of deferred stock compensation: we exclude the noncash expense incurred with the amortization of deferred stock compensation as this expense is based on historical stock prices at the date of grant to our corporate employees and does not reflect the underlying performance of our hotels.
  • Amortization of contract intangibles: we exclude the noncash amortization of any favorable or unfavorable contract intangibles recorded in conjunction with our hotel acquisitions. We exclude the noncash amortization of contract intangibles because it is based on historical cost accounting and is of lesser significance in evaluating our actual performance for the current period.
  • Amortization of right-of-use assets and obligations; we exclude the amortization of our right-of-use assets and related lease obligations, as these expenses are based on historical cost accounting and do not reflect the actual rent amounts due to the respective lessors or the underlying performance of our hotels.
  • Gains or losses from debt transactions: we exclude the effect of finance charges and premiums associated with the extinguishment of debt, including the acceleration of deferred financing costs from the original issuance of the debt being redeemed or retired because, like interest expense, their removal helps investors evaluate and compare the results of our operations from period to period by removing the impact of our capital structure.
  • Other adjustments: we exclude other adjustments that we believe are outside the ordinary course of business because we do not believe these costs reflect our actual performance for the period and/or the ongoing operations of our hotels. Such items may include: lawsuit settlement costs; the write-off of development costs associated with abandoned projects; property-level restructuring, severance, and management transition costs; pre-opening costs associated with extensive renovation projects such as the work being performed at Andaz Miami Beach; debt resolution costs; lease terminations; property insurance restoration proceeds or uninsured losses; and other nonrecurring identified adjustments.

Hotel Adjusted EBITDAre and Hotel Net Operating Income Reconciliations


Plus:


Plus:


Equals:


Less:


Equals:


Hotel


Hotel Net


Total


Net


Adjusted


FF&E


Operating


Revenues


Income


Depreciation


EBITDAre


Reserve


Income

Full Year 2024

$

14,135

$

2,236

$

2,402

$

4,638

$

(565)

$

4,073

EBITDAre Multiple/Cap Rate (1)

10.1x

8.7

%

(1)

EBITDAre Multiple calculated as gross sale price divided by Hotel Adjusted EBITDAre. Cap Rate calculated as Hotel Net Operating Income divided by gross sale price.

Cision View original content:https://www.prnewswire.com/news-releases/sunstone-hotel-investors-announces-the-disposition-of-hilton-new-orleans-st-charles-302476007.html

SOURCE Sunstone Hotel Investors, Inc.

Palvella Therapeutics Receives Initial Proceeds from FDA Orphan Products Grant to Support Phase 3 SELVA Trial of QTORIN™ Rapamycin for Microcystic Lymphatic Malformations

FDA Orphan Products Grants are awarded based on rigorous scientific and technical review by rare disease and regulatory experts

Up to $2.6 million in non-dilutive funding anticipated over the grant period

Top-line data from SELVA expected in the first quarter of 2026

WAYNE, Pa., June 09, 2025 (GLOBE NEWSWIRE) — Palvella Therapeutics, Inc. (Nasdaq: PVLA), a clinical-stage biopharmaceutical company developing and commercializing novel therapies for serious, rare genetic skin diseases with no U.S. Food and Drug Administration (FDA)-approved treatments, today announced it has received the initial proceeds from a previously announced grant from the FDA Office of Orphan Products Development. The grant supports the Company’s ongoing Phase 3 SELVA trial of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs).

Out of 51 applications received by the FDA Orphan Products Grants Program in fiscal year 2024, Palvella’s Phase 3 SELVA trial was one of only seven new clinical trials selected for funding—and the only Phase 3 trial awarded. The SELVA trial is a 24-week, Phase 3, single-arm, baseline-controlled clinical trial of QTORIN™ rapamycin administered once daily for the treatment of microcystic LMs. Approximately 40 subjects age three or older are being enrolled at leading vascular anomaly centers across the U.S. The SELVA trial remains on track to report top-line results in the first quarter of 2026.

“We are honored to receive this prestigious FDA grant and the initial non-dilutive funding,” said Wes Kaupinen, Founder and Chief Executive Officer of Palvella. “There are currently no FDA-approved therapies for microcystic lymphatic malformations, a rare and chronically debilitating genetic disease. QTORIN™ rapamycin has the potential to become the first approved therapy—and a transformative new standard of care—for individuals living with this disease.”

The FDA Orphan Products Grants Program provides non-dilutive funding to advance the development of promising therapies for rare diseases. Grant applications are individually reviewed and scored for scientific and technical merit by an independent ad hoc panel of rare disease and regulatory experts and may involve consultation with the relevant FDA review division to help determine whether the proposed study will provide acceptable data that could contribute to product approval. Since inception, the program has supported clinical research leading to the approval of more than 85 products.

About Microcystic Lymphatic Malformations

Microcystic LMs are a rare, chronically debilitating genetic disease caused by dysregulation of the phosphatidylinositol 3-kinase (PI3K)/mammalian target of rapamycin (mTOR) pathway. The disease is characterized by malformed lymphatic vessels that protrude through the skin and persistently leak lymph fluid (lymphorrhea) and bleed, often leading to recurrent serious infections and cellulitis that can cause hospitalization. The natural history of microcystic LMs is persistent and progressive without spontaneous resolution, with symptoms generally worsening during life, including increases in the number and size of malformed vessels that lead to complications and lifetime morbidity. There are currently no FDA-approved treatments for the estimated more than 30,000 diagnosed patients with microcystic LMs in the United States.

About Palvella Therapeutics

Founded and led by rare disease drug development veterans, Palvella Therapeutics, Inc. (Nasdaq: PVLA) is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no FDA-approved therapies. Palvella is developing a broad pipeline of product candidates based on its patented QTORIN™ platform, with an initial focus on serious, rare genetic skin diseases, many of which are lifelong in nature. Palvella’s lead product candidate, QTORI™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin), is currently being evaluated in the Phase 3 SELVA clinical trial in microcystic lymphatic malformations and the Phase 2 TOIVA clinical trial in cutaneous venous malformations. For more information, please visit www.palvellatx.com or follow Palvella on LinkedIn or X (formerly known as Twitter).

QTORIN™ rapamycin is for investigational use only and has not been approved or cleared by the FDA or by any other regulatory agency for any indication.

Forward-Looking Statements

This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (Securities Act)). 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 management of Palvella, as well as assumptions made by, and information currently available to, the management of Palvella. 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,” and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding the expected timing of the presentation of data from ongoing clinical trials, Palvella’s clinical development plans and related anticipated development milestones, Palvella’s cash and financial resources and expected cash runway, and the potential of, and expectations regarding, Palvella’s programs, including QTORIN™ rapamycin, and its research-stage opportunities, including its expected therapeutic potential and market opportunity. 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 ability to raise additional capital to finance operations; the ability to advance product candidates through preclinical and clinical development; the ability to obtain regulatory approval for, and ultimately commercialize, Palvella’s product candidates, including QTORIN™ rapamycin; the outcome of early clinical trials for Palvella’s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; the fact that data and results from clinical studies may not necessarily be indicative of future results; Palvella’s limited experience in designing clinical trials and lack of experience in conducting clinical trials; the ability to identify and pivot to other programs, product candidates, or indications that may be more profitable or successful than Palvella’s current product candidates; the substantial competition Palvella faces in discovering, developing, or commercializing products; the negative impacts of global events on operations, including ongoing and planned clinical trials and ongoing and planned preclinical studies; the ability to attract, hire, and retain skilled executive officers and employees; the ability of Palvella to protect its intellectual property and proprietary technologies; reliance on third parties, contract manufacturers, and contract research organizations; and the risks and uncertainties described in the filings made by Palvella with the Securities and Exchange Commission (SEC), including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the SEC and available at www.sec.gov. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that Palvella may face. Except as required by applicable law, Palvella does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release.

Contact Information

Investors

Wesley H. Kaupinen
Founder and CEO, Palvella Therapeutics
[email protected]

Media

Marcy Nanus
Managing Partner, Trilon Advisors LLC
[email protected]



LeddarTech Enters into Further Amendments to Credit Facility and Bridge Financing Offer and Announces the Return to Work of Certain Employees Following Furlough

QUEBEC CITY, Canada, June 09, 2025 (GLOBE NEWSWIRE) — LeddarTech® Holdings Inc. (“LeddarTech” or the “Company”) (Nasdaq: LDTC), an automotive software company that provides patented disruptive AI-powered low-level sensor fusion and perception software technology, LeddarVision™, today announced that it has entered into:

  • an eighteenth amending agreement (the “Eighteenth Amending Agreement”) with Fédération des caisses Desjardins du Québec (“Desjardins”) with respect to the amended and restated financing offer dated as of April 5, 2023 (the “Desjardins Credit Facility”), pursuant to which Desjardins has agreed to, among other things, temporarily postpone certain payments of interest and fees until January 31, 2026, subject to acceptable cash flow projected payments; and
  • a sixth amending agreement (the “Sixth Amending Agreement”) with the initial bridge lenders, certain members of management and the board of directors and FS Investment Management (collectively, the “Bridge Lenders”) with respect to the bridge financing offer dated as of August 16, 2024 (the “Bridge Financing Offer”) pursuant to which the Bridge Lenders have agreed to, among other things, extend the maturity of the bridge loan to January 31, 2026.

The Sixth Amending Agreement to the Bridge Financing Offer also provides for a new bridge to equity term loan by FS Investment Management in the amount of up to US$2,000,000 for the purposes of providing LeddarTech with the cash necessary to complete one or more equity investments or commercial transactions involving LeddarTech and its technology.

There is no certainty that LeddarTech will be able to raise additional funds or complete any commercial transaction and there can be no assurance that LeddarTech will be successful in pursuing and implementing any such alternatives, nor any assurance as to the outcome or timing of any such alternatives.

The foregoing descriptions of the Eighteenth Amending Agreement and the Sixth Amending Agreement do not purport to be complete and are qualified in their entirety by reference to such amendments, copies of which will be filed under LeddarTech’s SEDAR+ and EDGAR profiles at www.sedarplus.ca and www.sec.gov, respectively.

The term loan by FS Investment Management described above constitutes a “related-party transaction” within the meaning of Regulation 61-101respecting Protection of Minority Security Holders in Special Transactions (“Regulation 61-101”) as FS Investment Management is a related party of the Company under Regulation 61-101. The Company is relying on exemptions from the formal valuation requirements of Regulation 61-101 pursuant to section 5.5(a) and the minority shareholder approval requirements of Regulation 61-101 pursuant to section 5.7(1)(a) in respect of such related party’s participation as the fair market value of the transaction, insofar as it involves interested parties, does not exceed 25% of the Company’s market capitalization.

Return to Work of Certain Employees Following the Previously Announced Furlough

LeddarTech also announced a return to work, beginning on June 4th, of certain employees that had been affected by the previously announced workforce reduction. The employees that have resumed their functions are supporting various ongoing commercial activities. LeddarTech plans to progressively call back more of its employees that were furloughed in order to support such commercial activities. There can be no assurance as to the timing of such decision nor that such additional employees will be called back in the near term or at all.

About LeddarTech

A global software company founded in 2007 and headquartered in Quebec City with additional R&D centers in Montreal and Tel Aviv, Israel, LeddarTech develops and provides comprehensive AI-based low-level sensor fusion and perception software solutions that enable the deployment of ADAS, autonomous driving (AD) and parking applications. LeddarTech’s automotive-grade software applies advanced AI and computer vision algorithms to generate accurate 3D models of the environment to achieve better decision making and safer navigation. This high-performance, scalable, cost-effective technology is available to OEMs and Tier 1-2 suppliers to efficiently implement automotive and off-road vehicle ADAS solutions.

LeddarTech is responsible for several remote-sensing innovations, with over 190 patent applications (112 granted) that enhance ADAS, AD and parking capabilities. Better awareness around the vehicle is critical in making global mobility safer, more efficient, sustainable and affordable: this is what drives LeddarTech to seek to become the most widely adopted sensor fusion and perception software solution.

Additional information about LeddarTech is accessible at www.leddartech.com and on LinkedIn, Twitter (X), Facebook and YouTube.

Forward-Looking Statements

Certain statements contained in this Press Release may be considered forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (which forward-looking statements also include forward-looking statements and forward-looking information within the meaning of applicable Canadian securities laws), including, but not limited to, statements relating to LeddarTech’s anticipated strategy, future operations, prospects, objectives and financial projections and other financial metrics, its plans to call back employees who have been laid off as well as expectations regarding the anticipated performance, adoption and commercialization of its products. 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” and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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: (i) our ability to continue to maintain compliance with Nasdaq continued listing standards following our transfer to the Nasdaq Capital Market, (ii) our ability to timely access sufficient capital and financing on favorable terms or at all; (iii) our ability to maintain compliance with our debt covenants, including our ability to enter into any forbearance agreements, waivers or amendments with, or obtain other relief from, our lenders as needed; (iv) discussions regarding potential alternatives relating to refinancing, recapitalization or any commercial or other suitable transaction; (v) our ability to execute on our business model, achieve design wins and generate meaningful revenue; (vi) our ability to successfully commercialize our product offering at scale, whether through the collaboration agreement with Texas Instruments, a collaboration with a Tier 2 supplier or otherwise; (vii) changes in our strategy, future operations, financial position, estimated revenues and losses, projected costs and plans; (viii) changes in general economic and/or industry-specific conditions; (ix) our ability to retain, attract and hire key personnel; (x) potential adverse changes to relationships with our customers, employees, suppliers or other parties; (xi) legislative, regulatory and economic developments; (xii) the outcome of any known and unknown litigation and regulatory proceedings; (xiii) unpredictability and severity of catastrophic events, including, but not limited to, acts of terrorism, outbreak of war or hostilities and any epidemic, pandemic or disease outbreak, as well as management’s response to any of the aforementioned factors; and (xiv) other risk factors as detailed from time to time in LeddarTech’s reports filed with the U.S. Securities and Exchange Commission (the “SEC”), including the risk factors contained in LeddarTech’s Form 20-F filed with the SEC. The foregoing list of important factors is not exhaustive. Except as required by applicable law, LeddarTech does not undertake any 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.

Contact:

Chris Stewart, Chief Financial Officer, LeddarTech Holdings Inc.
Tel.: +1-514-427-0858, [email protected]

Leddar, LeddarTech, LeddarVision, LeddarSP, VAYADrive, VayaVision and related logos are trademarks or registered trademarks of LeddarTech Holdings Inc. and its subsidiaries. All other brands, product names and marks are or may be trademarks or registered trademarks used to identify products or services of their respective owners.

LeddarTech Holdings Inc. is a public company listed on the Nasdaq under the ticker symbol “LDTC.”



Nutriband Announces U.S. Patent Issued for Its Transdermal Abuse Deterrent Technology

Patent issuance expands United States patent coverage for AVERSA™ transdermal abuse deterrent technology

AVERSA™ transdermal abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

ORLANDO, Fla., June 09, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that the United States Patent and Trademark Office (USPTO) issued patent number 12,318,492 on June 3, 2025, entitled “Abuse and Misuse Deterrent Transdermal Systems.”
The issuance of this patent further expands Nutriband’s intellectual property protection in the United States for its portfolio of abuse deterrent transdermal products based on its proprietary Aversa™ abuse deterrent technology. This technology can be incorporated into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential.

The AVERSA™ abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

Nutriband’s lead product under development is Aversa™ Fentanyl, an abuse deterrent fentanyl transdermal system, with the potential to become the first abuse deterrent pain patch on the market with peak annual US sales estimated to be$80 million to $200 million.1

__________________________________________

1 Health Advances Aversa Fentanyl market analysis report 2022

About AVERSA™ Abuse-Deterrent Transdermal Technology

Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

About Nutriband Inc.

We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites or any other website is not part of this press release.

Forward-Looking Statements

Certain statements contained in this press release, including, without limitation, statements containing the words ‘’believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form S-1, Forms 10-K and 10-Q’s, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

Contact Information:

Nutriband Inc.
Phone: 407-377-6695
Email: [email protected]



Prairie Operating Co. Reaffirms $1 Billion Reserve Based Lending Facility with Citibank, N.A. Adds Bank of America, N.A. and West Texas National Bank to Syndicate

HOUSTON, TX, June 09, 2025 (GLOBE NEWSWIRE) — Prairie Operating Co. (Nasdaq: PROP) (the “Company” or “Prairie”), an independent energy company engaged in the development and acquisition of oil and natural gas resources in the Denver-Julesburg (DJ) Basin, today announced the reaffirmation of its multi-year Reserve-Based Lending (“RBL”) credit facility with Citibank, N.A., its lead arranger.

Following its semi-annual redetermination, the Company’s reserve-based credit facility was reaffirmed with a borrowing base of $475 million, a maximum facility size of $1.0 billion, and a maturity date of March 26, 2029.

“The reaffirmation of our borrowing base, along with the addition of Bank of America and West Texas National Bank to our syndicate, underscores the confidence our lenders have in the strength of our asset base and execution strategy,” said Edward Kovalik, Chairman and Chief Executive Officer. “This facility enhances our financial flexibility and supports our ongoing development activity and pursuit of accretive growth opportunities in the DJ Basin.”

In conjunction with the semi-annual redetermination, Bank of America, N.A. and West Texas National Bank have joined the lending syndicate, which includes Citibank, N.A., KeyBank National Association, MUFG Bank, Ltd., Truist Bank, UMB Bank, N.A., and Macquarie Bank Limited, further expanding Prairie’s banking relationships and strengthening its access to capital.

About Prairie Operating Co.

Prairie Operating Co. is a Houston-based publicly traded independent energy company engaged in the development and acquisition of oil and natural gas resources in the United States. The Company’s assets and operations are concentrated in the oil and liquids-rich regions of the Denver-Julesburg (DJ) Basin, with a primary focus on the Niobrara and Codell formations. The Company is committed to the responsible development of its oil and natural gas resources and is focused on maximizing returns through consistent growth, capital discipline, and sustainable cash flow generation. More information about the Company can be found at www.prairieopco.com.

Cautionary Statement about Forward-Looking Statements

The information included herein and in any oral statements made in connection herewith include “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of present or historical fact included herein, are forward-looking statements. When used herein, including any oral statements made in connection herewith, the words “could,” “should,” “will,” “may,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “project,” the negative of such terms and other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. These forward-looking statements are based on the Company’s current expectations and assumptions about future events and are based on currently available information as to the outcome and timing of future events. Except as otherwise required by applicable law, the Company disclaims any duty to update any forward-looking statements, all of which are expressly qualified by the statements in this section, to reflect events or circumstances after the date hereof. The Company cautions you that these forward-looking statements are subject to risks and uncertainties, most of which are difficult to predict and many of which are beyond the control of the Company. There may be additional risks not currently known by the Company or that the Company currently believes are immaterial that could cause actual results to differ from those contained in the forward-looking statements. Additional information concerning these and other factors that may impact the Company’s expectations can be found in the Company’s periodic filings with the Securities and Exchange Commission (the “SEC”), including the Company’s Annual Report on Form 10-K filed with the SEC on March 6, 2025, and any subsequently filed Quarterly Report and Current Report on Form 8-K. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov

Investor Relations Contact:

Wobbe Ploegsma
[email protected]
832.274.3449



PolyPid Announces Positive Topline Results from Phase 3 SHIELD II Trial: D-PLEX₁₀₀ Demonstrated Significant Reduction in Surgical Site Infections and Successfully Met Primary and All Key Secondary Endpoints

  • D-PLEX

    100

    successfully met the primary efficacy endpoint, with statistically significant results (p<0.005) in 798 patients with large abdominal surgery incisions.
  • The trial successfully met all key secondary efficacy endpoints, including a 58% reduction in the rate of surgical site infections (“SSI”) in patients treated with D-PLEX100 arm versus standard of care (“SoC”) arm (p<0.005).
  • The Company expects to
    submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) in early 2026, with a Marketing Authorization Application (“MAA”) in the E.U. to follow shortly thereafter.
  • PolyPid will conduct a conference call and webcast at 8:30 A.M. ET today.

PETACH TIKVA, Israel, June 09, 2025 (GLOBE NEWSWIRE) — PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced positive topline results from its pivotal SHIELD II Phase 3 trial of D-PLEX100 for the prevention of SSIs in patients undergoing abdominal colorectal surgery with large incisions, which has received Fast Track designation from the FDA.

“The positive results of our Phase 3 pivotal trial provide clear and compelling evidence of D-PLEX100’s ability to significantly reduce SSIs, a major burden on patients and healthcare systems, while improving clinical outcomes for both patients and physicians,” said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. “D-PLEX100 has the potential to meaningfully lower costs for hospitals and payers, and we believe it will be a valuable addition to the standard of care. Targeting a total addressable U.S. market of over 12 million annual surgeries and a significant unmet need, D-PLEX100 has the potential to make a substantial market impact. We remain on track for an NDA submission in early 2026 and believe these robust data will serve as a strong catalyst for advancing our global partnership discussions. We are deeply grateful to the patients, principal investigators, and study teams who made this milestone possible.”


Key findings from SHIELD II study include:

  • The primary efficacy endpoint of the study was successfully met, with a significantly lower proportion of primary endpoint events among patients who received D-PLEX100 plus SoC (n=405; 10.9%), compared to SoC alone (n=393; 18.1%), representing a 38% reduction (p<0.005). The primary endpoint is the combination of deep and superficial SSIs, all-cause mortality and surgical reinterventions at the same incision of the original index surgery.
  • SHIELD II included three key secondary endpoints:
    • The first key secondary endpoint was met, with a 58% reduction in deep and superficial SSI rates among patients who received D-PLEX100 plus SoC (3.8%) compared to those who received SoC alone (9.5%) (p<0.005).
    • The second key secondary endpoint showed statistical significance in favor of D-PLEX100 plus SoC over SoC alone (p<0.005). This efficacy endpoint combined SSI, mortality and reintervention as evaluated in the primary endpoint. This endpoint was assessed in the overall study population of 975 patients with an incision ≥7 cm, including laparoscopic surgery patients enrolled prior to the 2023 trial protocol change.
    • The third key secondary endpoint was met with a 62% reduction of patients with an ASEPSIS1 score >20 in D-PLEX100 plus SoC arm compared to SoC alone arm (p<0.05). The ASEPSIS score is a clinical tool used to objectively assess surgical wound infections.
  • There were no safety concerns raised by the independent Data Safety Monitoring Board in SHIELD II.

Image: SHIELD II Results on Primary Endpoint and First Key Secondary Endpoint

“The risk of surgical site infection in the colorectal patient population has recently been documented to approach 23%2 in patients with multiple comorbid risk factors,” said Charles E. Edmiston, Jr., MS, PhD, CIC, FIDSA, FSIS, FAPIC Emeritus Professor of Surgery. “These topline results provide clinical practitioners with a novel, innovative strategy for reducing postoperative infection risk in patients undergoing colorectal surgery with large wound incisions. Based on the trial findings, particularly the significant risk-reduction benefit by reducing in-wound sepsis risk, I anticipate D-PLEX100 technology will be rapidly embraced as a critical component to the current evidence-based surgical care bundle for colorectal surgery following FDA approval.”

Additional results from the SHIELD II trial will be presented at an upcoming medical conference.

Conference Call Dial-In & Webcast Information:

Date:  Monday, June 9, 2025
Time: 8:30 A.M. Eastern Time
Conference Call: https://register-conf.media-server.com/register/BIb5bb85aa1ffc4940b78f7191b278ca77
Webcast: https://edge.media-server.com/mmc/p/k6n5hrft

A replay of the presentation will be available on the Company’s Investor Relations Events and Presentations webpage following the event.

About SHIELD II

SHIELD II (Surgical site Hospital acquired Infection prEvention with Local D-PLEX) is a prospective, multinational, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with standard of care (“SoC”), which includes prophylactic systemic antibiotics, compared to SoC alone arm, in the prevention of post abdominal-surgery incisional infection in patients undergoing abdominal colorectal surgeries with large incisions. The primary endpoint of the trial is measured by the proportion of subjects with either a surgical site infection (“SSI”) event as determined by a blinded and independent adjudication committee, reintervention, or mortality for any reason within 30 days post-surgery. Patient safety will be monitored for an additional 30 days. The trial will enroll patients in centers in the United States, Europe and Israel.

About D-PLEX
100

D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 is currently in Phase 3 SHIELD II trial for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery with large incisions.

About PolyPid

PolyPid Ltd. (Nasdaq: PYPD) is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid’s proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPid’s lead product candidate D-PLEX100 is in a Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. In addition, the Company is currently in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma.
For additional Company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.

Forward-looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the safety, efficacy and benefits of D-PLEX100, D-PLEX100’s potential to meaningfully lower costs for hospitals and payers, the expected submissions of an NDA to the FDA and MAA and the timing thereof; the Company’s belief that the data results will serve as a strong catalyst for advancing its global partnership discussions; D-PLEX100 potential to make a substantial market impact; and the anticipation that D-PLEX100 technology will be rapidly embraced as a critical component to the current evidence-based surgical care bundle for colorectal surgery following FDA approval. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission, including, but not limited to, the risks detailed in the Company’s Annual Report on Form 20-F filed on February 26, 2025. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements.

References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

Contacts:

PolyPid Ltd. 
Ori Warshavsky
COO – US
908-858-5995
[email protected]

Investors:

Brian Ritchie
LifeSci Advisors
212-915-2578
[email protected]

1 ASEPSIS is an acronym of wound assessment and treatment parameters, which provides a numerical score during an inspection of the surgical site. The final score is interpreted by the severity of wound appearance and the clinical consequences of the infection. Parameters include: serous exudate, erythema, purulent exudate, separation of deep tissue and also antibiotic therapy, drainage of pus under local/general anesthesia, isolation of pathogenic bacteria and hospital stay as inpatient.
2 David J. Leaper, D.Sc., M.D., Chantal E. Holy, M.Sc., Ph.D., Maureen Spencer, M.Ed., Abhishek Chitnis, Ph.D., Andrew Hogan, M.Sc., George W.J. Wright, Ph.D., Brian Po-Han Chen, Sc.M., Charles E. Edmiston, Jr, Ph.D. Assessment of the Risk and Economic Burden of Surgical Site Infection Following Colorectal Surgery Using a US Longitudinal Database: Is There a Role for Innovative Antimicrobial Wound Closure Technology to Reduce the Risk of Infection? Dis Colon Rectum 2020; 63:1628-1638.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/1a883ef3-5e5a-4ffc-8532-b9f87784ef42



Alarum Technologies Updates Second Quarter 2025 Revenue and Adjusted EBITDA Outlook

TEL AVIV, Israel, June 09, 2025 (GLOBE NEWSWIRE) — Alarum Technologies Ltd. (Nasdaq, TASE: ALAR) (“Alarum” or the “Company”), a global provider of web data collection solutions, today announced an update to its revenue and Adjusted EBITDA outlook for the second quarter ending June 30, 2025, driven by enhanced momentum and demand from several existing customers since the previous guidance date, which has led to a significant increase in usage – resulting in higher-than-anticipated consumption of Alarum’s data collection products and services.

The Company now estimates to report second quarter 2025 revenue of approximately $8.8 million ±3%, compared to its previous estimate of $7.9 million ±3%. In addition, the Company now expects to report adjusted EBITDA ranging from $1.0 million to $1.5 million, compared to $0.5 million to $0.8 million.  As previously highlighted, the market in which the Company operates is still taking shape and at this point continues to be highly dynamic and unpredictable. Volatility may remain high, and the Company is planning accordingly.

The Company is unable to present a reconciliation of its estimated adjusted EBITDA to net profit as it is unable to predict with reasonable certainty, and without unreasonable effort, the impact and timing of certain expenses on the Company’s net profit. The financial impact of these expenses is uncertain and is dependent on various factors, including timing, and could be material to the Company’s consolidated statements of profit or loss and other comprehensive income (loss).

This update is provided in accordance with the Company’s internal policy of  issuing an update as its current quarterly revenue outlook is expected to deviate by at least 10% from the previously announced average of the outlook.  

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, Alarum is using forward-looking statements in this press release when it provides updated estimates regarding second quarter 2025 revenues and Adjusted EBITDA, whether the recent surge in usage will continue in subsequent periods and potential volatility. Because such statements deal with future events and are based on Alarum’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Alarum could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “Risk Factors” in Alarum’s annual report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025, and in any subsequent filings with the SEC. Except as otherwise required by law, Alarum undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Alarum is not responsible for the contents of third-party websites.

The Company is providing revenue and adjusted EBITDA estimates in this press release, rather than final amounts, primarily because the financial closing process and review are not yet complete and, as a result, the Company’s final results upon completion of its closing process and review may vary from these preliminary estimates.

INVESTOR RELATIONS CONTACT:


[email protected]



Plug Power and Allied Green Expand Strategic Collaboration with New 2 GW Electrolyzer Deal in Uzbekistan

Plug Power and Allied Green Leadership attending International Investment Forum to Execute the Agreement

Allied Green Continues to Make Meaningful Progress in its Green Ammonia Plant in Australia with Plug to supply 3GW of Electrolyzer Capacity Bringing the total opportunity between partners to 5GW globally

SLINGERLANDS, N.Y., June 09, 2025 (GLOBE NEWSWIRE) — Plug Power Inc. (NASDAQ: PLUG), a global leader in comprehensive hydrogen solutions, today announced a significant expansion of its partnership with Allied Green Ammonia (AGA), with a new 2 gigawatt (GW) electrolyzer opportunity tied to a sustainable fuels project in Uzbekistan. The deal will be executed during the Tashkent International Investment Forum, where Sanjay Shrestha, President of Plug, and Alfred Benedict, Managing Director of Allied Green, will be on site for the official signing.

Plug’s electrolyzer technology has been selected as the foundation of a new $5.5 billion green chemical production facility in Uzbekistan that will produce sustainable aviation fuel, green urea, and green diesel. The project is backed by the Government of Uzbekistan and further strengthens Plug’s position as the preferred electrolyzer provider for global-scale decarbonization initiatives.

“This latest expansion with Allied Green demonstrates how Plug is leading the global hydrogen transition with proven electrolyzer technology and execution at industrial scale,” said Andy Marsh, CEO of Plug. “With a 5 GW partnership now spanning two continents, this is a defining example of our ability to deliver for customers building the future of energy.”

“This agreement reflects our deep confidence in Plug’s team, technology, and ability to deliver on bold, world-class projects,” said Alfred Benedict of Allied Green Ammonia. “Together, we are creating meaningful momentum for global decarbonization—first in Australia, now in Uzbekistan, and in future regions to come.”

The Uzbekistan project builds on Allied Green’s previously announced 3 GW electrolyzer commitment for its flagship green ammonia facility in Australia. The project remains on track for a final investment decision in the fourth quarter of 2025.

“This continued collaboration with Allied Green reflects Plug’s ability to support ambitious decarbonization goals with scalable electrolyzer technology,” said Sanjay Shrestha, President of Plug. “As we look to expand our relationship, we see strong alignment in our shared vision for accelerating the global shift to low-carbon hydrogen across industries and regions.”

Plug’s technology is deployed or under development across five continents, supporting customers in the industrial, transportation, energy, and chemical sectors. As global companies invest in green hydrogen infrastructure, Plug continues to stand out as the most experienced and scalable partner—delivering the integrated hydrogen ecosystem necessary to power the energy transition.

About Plug Power

Plug is building the global hydrogen economy with a fully integrated ecosystem spanning production, storage, delivery, and power generation. A first mover in the industry, Plug provides electrolyzers, liquid hydrogen, fuel cell systems, storage tanks, and fueling infrastructure to industries such as material handling, industrial applications, and energy producers—advancing energy independence and decarbonization at scale.

With electrolyzers deployed across five continents, Plug leads in hydrogen production, delivering large-scale projects that redefine industrial power. The company has deployed over 72,000 fuel cell systems and 275 fueling stations and is the largest user of liquid hydrogen. Plug is rapidly expanding its generation network to ensure reliable, domestically produced supply, with hydrogen plants currently operational in Georgia, Tennessee, and Louisiana, capable of producing 39 tons per day.

With employees and state-of-the-art manufacturing facilities across the globe, Plug powers global leaders like Walmart, Amazon, Home Depot, BMW, and BP.

Safe Harbor

This communication contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve significant risks and uncertainties about Plug Power Inc. (“Plug”), including but not limited to statements about Plug’s commercial arrangements, agreements or contracts, if any, with Allied Green Ammonia (“AGA”), including actual execution of binding agreements, expected timing for any Plug delivery of any equipment, products or services under any commercial contracts or other arrangements or Plug’s ability to receive any revenue or payment on such product, equipment or services; AGA’s plans for its green ammonia production facility, including its ability to execute on any plans including stated production capacity and timing of FID, as well as any actual or continued government support for such projects or programs. Such statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in these statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Plug in general, see Plug’s public filings with the Securities and Exchange Commission (the “SEC”), including the “Risk Factors” section of Plug’s Annual Report on Form 10-K for the year ended December 31, 2024, Plug’s Quarterly Reports on Form 10-Q for the quarter ended March 31, 2025 and any subsequent filings with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements. The forward-looking statements are made as of the date hereof, and Plug undertakes no obligation to update such statements as a result of new information.

MEDIA CONTACT

Teal Hoyos
[email protected]