Lyra Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update




Lyra Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update

– Company plans new, confirmatory Phase 3 clinical trial of LYR-210 for treatment of chronic rhinosinusitis (CRS) without nasal polyps, on path to NDA submission –

WATERTOWN, Mass., Nov. 12, 2025 (GLOBE NEWSWIRE) — Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting, anti-inflammatory sinonasal implants for the treatment of chronic rhinosinusitis (CRS), today reported its financial results for the third quarter ended September 30, 2025 and provided a corporate update. 

“We are now focused on putting all the components in place for a new, confirmatory Phase 3 clinical trial to make progress toward a New Drug Application (“NDA”) for LYR-210 as a six-month treatment for CRS patients without nasal polyps,” said Maria Palasis, Ph.D., President and CEO, Lyra Therapeutics. “We are excited to move forward with our business strategy and to advance LYR-210 as a novel therapeutic option for millions of CRS patients who fail current medical therapy.”

Recent Business Highlights

• Lyra has established a clinical development plan to conduct an additional trial, based on meeting with FDA, to support the submission of an NDA for LYR-210 for the treatment of chronic rhinosinusitis (CRS) without nasal polyps.
• Lyra presented the positive ENLIGHTEN 2 Phase 3 results as a Late-Breaking Scientific Oral Presentation at the Annual Meeting of the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) in October 2025.

Third Quarter 2025 Financial Highlights

Cash and cash equivalents as of September 30, 2025 were $22.1 million, compared with cash and cash equivalents of $40.6 million at December 31, 2024. Based on our current business plan, we anticipate that our cash and cash equivalents balance is sufficient to fund our operating expenses and capital expenditures into the third quarter of 2026.

Research and development expenses decreased by $1.9 million from $5.9 million to $4.0 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024.

The decrease in research and development expenses for the three months ended September 30, 2025 was primarily attributable to a decrease in clinical related costs of $2.1 million as we completed the ENLIGHTEN 2 trial for LYR-210 and a decrease of $0.1 million in employee related costs primarily driven by the effect of a reduction in force that commenced in May 2024, partially offset by an increase in professional and consulting fees of $0.2 million and an increase of $0.1 million in product development and manufacturing costs.

General and administrative expenses decreased by $1.7 million from $3.9 million to $2.2 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024.

The decrease in general and administrative expenses for the three months ended September 30, 2025 was primarily driven by a decrease in employee related costs of $1.6 million and a $0.3 million decrease in allocation, support and depreciation costs, as we scaled back costs subsequent to announcing in May 2024 that the ENLIGHTEN 1 trial did not meet its primary endpoint, partially offset by a $0.2 million increase in professional, consulting and public company fees.

We incurred a restructuring credit in the amount of $21 thousand primarily related to severance and retention costs for the three months ended September 30, 2025 compared to a restructuring charge of $2.8 million for the same period in 2024.

Net loss for the third quarter 2025 was $6.0 million, compared to $11.9 million for the same period in 2024. 

About LYR-210

LYR-210 is an investigational product candidate for the treatment of chronic rhinosinusitis (CRS) in patients who have failed current therapies and require further intervention. LYR-210 is a bioabsorbable nasal implant designed to be inserted in a simple, in-office procedure. LYR-210 is intended to deliver six months of continuous anti-inflammatory therapy, mometasone furoate, to the sinonasal passages to treat CRS. LYR-210 was evaluated in the ENLIGHTEN pivotal Phase 3 clinical program.

About Lyra Therapeutics

Lyra Therapeutics, Inc. is a clinical-stage biotechnology company developing long-acting, anti-inflammatory sinonasal implants for the treatment of chronic rhinosinusitis (CRS). Lyra Therapeutics is developing therapies for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities. LYR-210, the company’s lead product, is a bioabsorbable nasal implant designed to be administered in a simple, in-office procedure and is intended to deliver six months of continuous anti-inflammatory drug therapy (7500µg mometasone furoate) to the sinonasal passages for the treatment of CRS with a single administration. LYR-210, which is being evaluated in the ENLIGHTEN Phase 3 clinical program, is intended for patients with and without nasal polyps. The company’s therapies are intended to treat the estimated four million CRS patients in the United States who fail medical management each year. For more information, please visit www.lyratx.com and follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “believe,” “may,” “will,” “plan”, “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the Company’s plans for conducting a third Phase 3 trial to evaluate LYR-210, the Company’s cash runway into the third quarter of 2026, whether LYR-210 could potentially benefit patients with CRS with or without polyps, the Company’s business strategy and plans; and the timing of any of the foregoing. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the Company’s failure to meet its primary endpoint in its ENLIGHTEN 1 Phase 3 clinical trial; the fact that the Company has incurred significant losses since inception and expects to incur additional losses for the foreseeable future; the Company’s need for additional funding, which may not be available, including, without limitation, to conduct the Company’s proposed third Phase 3 trial; the Company’s ability to continue as a going concern; the Company’s limited operating history; the fact that the Company has no approved products; the fact that clinical trial data is subject to change until the completion of the applicable clinical study report; the fact that clinical trials required for LYR-210 are expensive and time-consuming, and their outcome is uncertain; effects of recently enacted and future legislation; the possibility of system failures or security breaches; effects of significant competition; the Company’s reliance on third parties to conduct its clinical trials; failure to obtain and maintain or adequately protect the Company’s intellectual property rights; failure to retain key personnel; the fact that the price of the Company’s common stock may be volatile and fluctuate substantially; significant costs and required management time as a result of operating as a public company and any securities class action litigation. These and other important factors discussed under the caption “Risk Factors” in the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 12, 2025 and its other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change.

CONTACT: Contact Information:
Jason Cavalier, Chief Financial Officer
917.584.7668
jcavalier@lyratx.com 

Media Contact:
Kathryn Morris, The Yates Network LLC
914.204.6412
kathryn@theyatesnetwork.com 

Journey Medical Corporation Reports Third Quarter 2025 Financial Results and Recent Corporate Highlights




Journey Medical Corporation Reports Third Quarter 2025 Financial Results and Recent Corporate Highlights

Third quarter 2025 net revenues were $17.6 million

Emrosi™ total prescriptions increased 146% over the second quarter of 2025

Emrosi net revenues were $4.9 million

Company to hold conference call today at 4:30 p.m. ET to discuss the financial results and provide a business update

SCOTTSDALE, Ariz., Nov. 12, 2025 (GLOBE NEWSWIRE) — Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical,” “the Company,” “we” or “our”), a commercial-stage pharmaceutical company primarily focused on selling and marketing FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced financial results and recent corporate highlights for the third quarter ended September 30, 2025.

Claude Maraoui, Journey Medical’s Co-Founder, President and Chief Executive Officer, said, “Our third quarter 2025 results reflect continued strong execution and accelerating commercial momentum, with revenue increasing 21% year-over-year to $17.6 million. Emrosi™ continues to drive growth, generating $4.9 million in net sales in the third quarter alone, supported by robust market adoption and payer access that continues to expand. We anticipate the growth of Emrosi and our established dermatology commercial infrastructure to generate significant operating leverage going forward.”

Mr. Maraoui added, “Emrosi’s clinical differentiation was further validated this quarter through a pooled Phase 3 efficacy analysis presented at the Fall Clinical Dermatology Conference, which confirmed statistically significant clinical superiority over both Oracea^® and placebo. As Emrosi gains recognition among both dermatologists and patients, we believe it is well-positioned to become the preferred treatment for inflammatory lesions of rosacea.”

Financial Results for the Third Quarter 2025:

• Revenues totaled $17.6 million in the third quarter of 2025, representing a 21% increase compared to $14.6 million in the third quarter of 2024, driven by incremental net product revenue related to the U.S. commercial launch of Emrosi.
• Gross margin⁽¹⁾ continues to improve from quarter to quarter in 2025 (Q1-63.5%; Q2-67.1%; Q3-67.4%), driven by net revenues from Emrosi and Qbrexza, our higher-margin products, and lower overall inventory period costs. Gross margin was 67.4% in the third quarter of 2025 compared to 69.4% in the third quarter of 2024. The higher gross margin in the third quarter of 2024 was primarily due to the favorable impact of one-time non-operational adjustments and product mix in the third quarter of 2024.
• Selling, general and administrative (SG&A) expenses were $12.1 million for the third quarter of 2025, reflecting a 6% increase compared to $11.4 million in the third quarter of 2024. The increase is primarily due to the incremental operational activities related to the launch and commercialization of Emrosi. SG&A for the three-month periods ended September 30, 2025, and 2024 includes non-cash stock compensation of $1.9 million and $1.5 million, respectively.
• Net loss was $2.3 million for the third quarter of 2025, compared to a net loss of $2.4 million for the third quarter of 2024, or $(0.09) per share basic and diluted or $(0.12) per share basic and diluted, respectively.
• EBITDA and Adjusted EBITDA:
  
  • For the third quarter ended September 30, 2025, EBITDA was a negative $0.5 million, compared to a negative $1.0 million for the third quarter of 2024, reflecting an improvement of $0.5 million. Adjusted EBITDA for the quarter was a positive $1.7 million, versus a positive $0.3 million in the prior-year quarter, reflecting an improvement of $1.4 million.
• EBITDA and Adjusted EBITDA are non-GAAP financial measures, each of which is reconciled to the most directly comparable financial measures calculated in accordance with GAAP in the table below under “Use of Non-GAAP Measures.”
• At September 30, 2025, the Company had $24.9 million in cash and cash equivalents, as compared to $20.3 million at December 31, 2024.

Recent Corporate Highlights:

• In October 2025, efficacy data from a pooled analysis of the two Phase 3 multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, Minocycline Versus Oracea^® in Rosacea-1 (MVOR-1) and Minocycline Versus Oracea in Rosacea-2 (MVOR-2), evaluating Emrosi™ (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) (or “DFD-29”) for the treatment of inflammatory lesions of rosacea in adults, were presented at the 2025 Fall Clinical Dermatology Conference. Emrosi demonstrated superior efficacy in Investigator’s Global Assessment (“IGA”) treatment success rates and inflammatory lesion count reduction versus both placebo and doxycycline (P<0.001 for all comparisons).
• In July 2025, Journey Medical announced expanded payer access with over 100 million commercial lives in the United States for Emrosi. This compares to 54 million commercial lives in May 2025. Full commercial launch began on April 7, 2025.

Conference Call and Webcast Information:

Journey Medical management will conduct a conference call and audio webcast on November 12, 2025, at 4:30 p.m. ET.

To listen to the conference call, interested parties within the U.S. should dial 1-866-777-2509 (domestic) or 1-412-317-5413 (international). All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the Journey Medical conference call. Participants can register for the conference call here: https://dpregister.com/sreg/10204065/100324a2b1b. Please note that registered participants will receive their dial-in number upon registration.

A live audio webcast can be accessed on the News and Events page of the Investors section of Journey Medical’s website, www.journeymedicalcorp.com, and will remain available for replay for approximately 30 days after the meeting.

(1)   We define gross margin as net product revenue less cost of goods sold divided by net product revenue.
(2)   Oracea^® is a registered trademark of Galderma Holdings, S.A. Société Anonyme.

About Journey Medical Corporation
Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”) is a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions through its efficient sales and marketing model. The Company currently markets eight branded FDA-approved prescription drugs that help treat and heal common skin conditions. The Journey Medical team comprises industry experts with extensive experience in developing and commercializing some of dermatology’s most successful prescription brands. Journey Medical is located in Scottsdale, Arizona and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). Journey Medical’s common stock is registered under the Securities Exchange Act of 1934, as amended, and it files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). For additional information about Journey Medical, visit www.journeymedicalcorp.com.

Forward-Looking Statements
This press release may contain “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. As used below and throughout this press release, the words “the Company”, “we”, “us” and “our” may refer to Journey Medical. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. The words “anticipate,” “believe,” “continue,” “estimate,” “may,” “expect,” “will,” “could,” “project,” “intend,” “potential” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: the fact that our products and product candidates are subject to time and cost intensive regulation and clinical testing and as a result, may never be successfully developed or commercialized; a substantial portion of our sales derive from products that may become subject to third-party generic competition, the introduction of new competitor products, or an increase in market share of existing competitor products, any of which could have a significant adverse impact on our operating income; we operate in a heavily regulated industry, and we cannot predict the impact that any future legislation or administrative or executive action may have on our operations; our revenue is dependent mainly upon sales of our dermatology products and any setback relating to the sale of such products could impair our operating results; competition could limit our products’ commercial opportunity and profitability, including competition from manufacturers of generic versions of our products; the risk that our products do not achieve broad market acceptance, including by government and third-party payors; our reliance third parties for several aspects of our operations; our dependence on our ability to identify, develop, and acquire or in-license products and integrate them into our operations, at which we may be unsuccessful; the dependence of the success of our business, including our ability to finance our company and generate additional revenue, on the successful commercialization of our recently approved product, Emrosi^TM, and any future product candidates that we may develop, in-license or acquire; clinical drug development is very expensive, time consuming, and uncertain and our clinical trials may fail to adequately demonstrate the safety and efficacy of our current or any future product candidates; our competitors could develop and commercialize products similar or identical to ours; risks related to the protection of our intellectual property and our potential inability to maintain sufficient patent protection for our technology and products; our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or our third parties’ cybersecurity; the substantial doubt about our ability to continue as a going concern; the effects of major public health issues, epidemics or pandemics on our product revenues and any future clinical trials; our potential need to raise additional capital; Fortress controls a voting majority of our common stock, which could be detrimental to our other shareholders; as well as other risks described in Part I, Item 1A, “Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Reports on Form 10-Q, and our other filings we make with the SEC. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Company Contact:
Jaclyn Jaffe
(781) 652-4500
ir@jmcderm.com

Media Relations Contact:
Tony Plohoros
6 Degrees
(908) 591-2839
tplohoros@6degreespr.com  

Use of Non-GAAP Measures:

In addition to the GAAP financial measures as presented in our Form 10-Q that will be filed with the Securities and Exchange Commission (“SEC”), the Company has, in this press release, included certain non-GAAP measurements, including EBITDA, Adjusted EBITDA, Adjusted EBITDA per share basic and Adjusted EBITDA per share diluted. We define EBITDA as net income (loss) excluding interest, taxes and depreciation and we define Adjusted EBITDA as net income (loss) excluding interest, taxes and depreciation, less certain other non-cash and infrequent items not considered to be normal, recurring operating expenses, including, share-based compensation expense, amortization and impairments of acquired intangible assets, inventory step-ups from the purchases of intangibles assets and products, severance, short-term research and development expense and foreign exchange transaction losses. In particular, we exclude the following matters for the reasons more fully described below:

• Share-Based Compensation Expense:  We exclude share-based compensation from our adjusted financial results because share-based compensation expense, which is non-cash, fluctuates from period to period based on factors that are not within our control, such as our stock price on the dates share-based grants are issued.
• Non-core and Short-term Research and Development Expense:  We exclude research and development costs incurred principally in connection with Emrosi™, which was the only product in our portfolio not approved for marketing and sale during the prior-year reporting period, because we do not consider such costs to be normal, recurring operating expenses that are core to our long-term strategy. Instead, our long-term strategy is focused on the marketing and sale of our core FDA-approved dermatological products and the out licensing of our intellectual property and related technologies.
• Amortization and impairments of Acquired Intangible assets:  We exclude the impact of certain amounts recorded in connection with the acquisitions of intangible assets that are either non-cash or not normal, recurring operating expenses due to their nature, variability of amounts, and lack of predictability as to occurrence and/or timing. These amounts may include non-cash items such as the amortization impairments of acquired intangible assets and amortization of step-ups of acquisition accounting adjustments to inventories.

Adjusted EBITDA per share basic and Adjusted EBITDA per share diluted are determined by dividing the resulting Adjusted EBITDA by the number of shares outstanding on an actual and fully diluted basis.

Management believes the use of these non-GAAP measures provides meaningful supplemental information regarding the Company’s performance because (i) it allows for greater transparency with respect to key measures used by management in its financial and operational decision-making, (ii) it excludes the impact of non-cash or, when specified, non-recurring items that are not directly attributable to the Company’s core operating performance and that may obscure trends in the Company’s core operating performance and (iii) it is used by institutional investors and the analyst community to help analyze the Company’s results. However, Adjusted EBITDA, Adjusted EBITDA per share basic, Adjusted EBITDA per share diluted and any other non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Further, non-GAAP financial measures used by the Company and the manner in which they are calculated may differ from the non-GAAP financial measures or the calculations of the same non-GAAP financial measures used by other companies, including the Company’s competitors.

The table below provides a reconciliation from GAAP to non-GAAP measures:

Ascendis Pharma Reports Third Quarter 2025 Financial Results




Ascendis Pharma Reports Third Quarter 2025 Financial Results

–   Q3 2025 revenue of €143.1 million for YORVIPATH^® and €50.7 million for SKYTROFA^®

–   Q3 2025 operating profit of €11.0 million

–   TransCon^® CNP (navepegritide) under FDA Priority Review for the treatment of children with achondroplasia with PDUFA date of November 30, 2025

–   Conference call today at 4:30 pm ET

COPENHAGEN, Denmark, Nov. 12, 2025 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND) today announced financial results for the third quarter ended September 30, 2025, and provided a business update.

“With our achievements in the third quarter and year to date, Ascendis is making great progress toward achieving Vision 2030. The ongoing strong global launch of YORVIPATH is transforming our financial profile and, based on positive feedback from physicians and patients, we expect to continue to build on this momentum,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. “With TransCon CNP now under FDA and EMA review, we are on the verge of bringing our third high-value medicine to patients, and we expect our engine for future innovation to drive sustainable growth for years to come.”

Select Highlights & Anticipated 2025 Milestones

• TransCon PTH:
  (palopegteriparatide, marketed as YORVIPATH)
  • YORVIPATH revenue for the third quarter of 2025 totaled €143.1 million, including a negative foreign currency impact of €3.6 million compared to the previous quarter.
  • Continued uptake from YORVIPATH in the U.S., with more than 4,250 unique patient enrollments and more than 2,000 prescribing health care providers as of September 30, 2025.
  • Outside the U.S., YORVIPATH is available commercially or through named patient programs in more than 30 countries.
  • Our strategic partner Teijin announced that YORVIPATH is now commercially available for prescription in Japan, expanding global access. In the third quarter, we recognized €12.9 million in milestone revenue related to the approval.
  • PaTHway60 trial, is ongoing as a single-arm safety and efficacy trial in adults with hypoparathyroidism to enable dose titration up to 60 mcg/day and is intended to support U.S. label expansion of YORVIPATH.
  • PaTHway Adolescent trial is planned to begin during the fourth quarter and is intended to support U.S. label expansion of YORVIPATH for the treatment of children with hypoparathyroidism, 12 to less than 18 years of age.
  • Presented pooled analysis of 3-year data from PaTHway and PaTH Forward trials at the American Society of Nephrology (ASN) Kidney Week 2025, reinforcing that treatment with TransCon PTH led to rapid and sustained improvements in kidney function in adults with hypoparathyroidism.

• TransCon hGH:
  (lonapegsomatropin, marketed as SKYTROFA^®)
  • SKYTROFA revenue for the third quarter of 2025 totaled €50.7 million, including a negative foreign currency impact of €1.6 million compared to the previous quarter.
  • The FDA approved our first label expansion for SKYTROFA in adult growth hormone deficiency, which represents the first of multiple additional label expansions we expect to pursue.
  • We initiated a basket trial for several established growth-hormone indications including idiopathic short stature (ISS), short stature homeobox-containing gene deficiency (SHOX deficiency), Turner syndrome, and small for gestational age (SGA).

• TransCon CNP:
  (navepegritide, FDA NDA and EMA MAA filed)
  • We recently completed our late-cycle meeting with the FDA, who accepted for priority review the New Drug Application (NDA) for the treatment of children with achondroplasia; Prescription Drug User Fee Act (PDUFA) goal date is November 30, 2025.
  • In Europe, our Marketing Authorisation Application (MAA) has been submitted and validated by the Committee for Medicinal Products for Human Use (CHMP) and is under review.
  • At the annual meeting of the American Society for Bone and Mineral Research (ASBMR), we presented new analyses from the pivotal ApproaCH Trial showing that children treated with TransCon CNP had improvements in the Physical Functioning domain of the Achondroplasia Child Experience Measure (ACEM-PF), with greatest benefits in younger children who had more severe genu varum (≥5°) at baseline, supporting benefits beyond linear growth.

• TransCon CNP + TransCon hGH Combination Therapy
  (navepegritide plus lonapegsomatropin)

• • Following a successful end-of-Phase 2 meeting with FDA, we plan to initiate a Phase 3 trial of TransCon CNP in combination with TransCon hGH this quarter.
  • Anticipate presenting 52-week data from the COACH Phase 2 trial of TransCon CNP + TransCon hGH in early 2026.
  • During the fourth quarter of 2025, we plan to submit an Investigational New Drug (IND) or similar to investigate TransCon CNP alone and in combination with TransCon hGH for the treatment of hypochondroplasia.

• TransCon IL-2 β/γ
  (onvapegleukin alfa)

• • In our IL-Believe trial, 70 patients with late-stage platinum-resistant ovarian cancer (PROC) (median 4 prior lines of therapy; 67% previously treated with at least 2 lines of taxane-containing therapy) have been enrolled. Data continued to suggest that TransCon IL-2 β/γ dosed every three weeks in combination with weekly paclitaxel is generally well-tolerated, with the majority of TransCon IL-2 β/γ-related treatment-emergent adverse events (TEAEs) being Grade 1 or 2 in severity.
  • We expect to provide median overall survival (OS) data for this cohort of 70 patients in the first quarter of next year as the dataset continues to mature.

• Financial Update
  • Based on the continued growth of YORVIPATH, we achieved operating profitability. In the third quarter we recorded an operating profit of €11.0 million.
  • During the third quarter, our cash balance increased €45 million from €494 as of June 30, 2025, to €539 million as of September 30, 2025.

Third Quarter 2025 Financial Results
Total revenue for the third quarter of 2025 was €213.6 million, compared to €57.8 million during the same period in 2024. The year-over-year increase in revenue was primarily attributable to an increase in product revenue, which reflected a contribution of €134.6 million from YORVIPATH.

Research and development costs for the third quarter of 2025 were €66.9 million, compared to €73.5 million during the same period in 2024. The decrease was driven by the completion of clinical trials and development activities within our Endocrinology Rare Disease pipeline.

Selling, general, and administrative expenses for the third quarter of 2025 were €113.4 million, compared to €69.8 million during the same period in 2024. The increase was primarily due to the continued impact from global commercial expansion, including launch activities for YORVIPATH.

Total operating expenses for the third quarter of 2025 were €180.3 million, compared to €143.4 million during the same period in 2024.

Operating profit for the third quarter of 2025 was €11.0 million primarily attributable to higher revenue from the launch of YORVIPATH in the U.S., partly offset by higher operating expenses.

Net finance expense for the third quarter of 2025 was €60.9 million, including non-cash remeasurement loss of financial liabilities of €47.2 million, compared to €2.9 million net finance income during the same period in 2024.

For the third quarter of 2025, Ascendis Pharma reported a net loss of €61.0 million, or €1.00 per share basic and diluted compared to a net loss of €99.2 million, or €1.72 per share basic and diluted for the same period in 2024.

As of September 30, 2025, Ascendis Pharma had cash and cash equivalents totaling €539 million compared to €560 million as of December 31, 2024. As of September 30, 2025, Ascendis Pharma had 61,695,211 ordinary shares outstanding, including 597,055 ordinary shares represented by ADSs held by the company.

Conference Call and Webcast Information
Ascendis Pharma will host a conference call and webcast today at 4:30 pm Eastern Time (ET) to discuss its third quarter 2025 financial results.

Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://investors.ascendispharma.com. A replay of the webcast will be available in this section of the Ascendis Pharma website shortly after the conclusion of the event for 30 days.

About Ascendis Pharma A/S 
Ascendis Pharma is a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more. 

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) Ascendis’ progress toward Vision 2030; (ii) prospect of Ascendis’ financial profile; (iii) Ascendis’ expectation of bringing TransCon CNP to patients and continue sustainable growth; (iv) U.S. label expansion of YORVIPATH and Ascendis’ expectation to pursue additional label expansions; (v) Ascendis’ plan to begin PaTHway Adolescent trial; (vi) Ascendis’ plan to initiate a Phase 3 trial of TransCon CNP in combination with TransCon hGH; (vii) Ascendis’ expectation to present 52-week data from the COACH Phase 2 trial of TransCon CNP and TransCon hGH; (viii) Ascendis’ plan to submit an IND or similar application to investigate TransCon CNP alone and in combination with TransCon hGH for the treatment of hypochondroplasia; (ix) Ascendis’ ability to apply its TransCon technology platform to make a meaningful difference for patients; and (x) Ascendis’ application of its TransCon technologies to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on third party manufacturers, distributors and service providers for Ascendis’ products and product candidates; unforeseen safety or efficacy results in Ascendis’ development programs or on-market products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis’ development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis’ business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; and the impact of international economic, political, legal, compliance, social and business factors, including tariffs and trade policies. 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 Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 12, 2025, and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.

Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, TransCon, SKYTROFA^®, and YORVIPATH^® are trademarks owned by the Ascendis Pharma group.
© November 2025 Ascendis Pharma A/S.

FINANCIAL TABLES FOLLOW

Interpace Biosciences Announces Third Quarter 2025 Financial and Business Results




Interpace Biosciences Announces Third Quarter 2025 Financial and Business Results

PARSIPPANY, NJ, Nov. 12, 2025 (GLOBE NEWSWIRE) — Interpace Biosciences, Inc. (“Interpace” or the “Company”) (OTCQX: IDXG) today announced financial results for the third quarter ended September 30, 2025 and provided a business and financial update.

Third quarter Net Revenue was $8.8 million. Income from continuing operations in the third quarter of 2025 was $1.0 million. “The Company delivered record thyroid test volumes, revenue, and cash collections during the quarter, driven by higher testing volume activity and enhanced collection initiatives,” said Chris McCarthy, Chief Financial Officer. “Our continued focus on reimbursement improvements resulted in a 5% increase in average revenue per test and a 22% reduction in days sales outstanding.” McCarthy added, “Our strong cash position supported strategic investments in laboratory operational efficiency, leveraging AI and automation as part of our digital strategy. These initiatives also enabled us to strengthen our balance sheet through additional principal payments on our long-term debt.”

“The third quarter represented the first full quarter of the Company being a Thyroid-only diagnostics testing company”, said Tom Burnell, President and CEO. “We are excited about the Company’s continued growth in revenue, profitability and cash flow as a Thyroid- only clinical diagnostics business”, added Burnell. Further, Burnell said, “We believe our unique combination testing platform delivers the confidence of high performance with the convenience of simple specimen handling. ThyGeNEXT® evaluates the most common mutations in thyroid cancer, while the microRNA signatures assessed by ThyraMIR®v2 provide insights across both major and minor cancer-related signaling pathways. This comprehensive ‘panel-to-pathways’ approach supports physicians in making confident and informed patient-management decisions.”

Third Quarter 2025 Financial Performance

For the Third Quarter of 2025 as Compared to the Third Quarter of 2024 and Pro Forma 2024 Results¹

About Interpace Biosciences

Interpace Biosciences is an emerging leader in enabling personalized medicine, offering specialized services along the therapeutic value chain from early diagnosis and prognostic planning to targeted therapeutic applications.

Clinical services, through Interpace Diagnostics, provide clinically useful molecular diagnostic tests and bioinformatics and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for improved patient diagnosis and management. Interpace has two commercialized molecular tests: ThyGeNEXT for the diagnosis of thyroid cancer from thyroid nodules utilizing a next-generation sequencing assay and ThyraMIRv2, used in combination with ThyGeNEXT, for the diagnosis of thyroid cancer utilizing a proprietary microRNA pairwise expression profiler along with algorithmic classification.

For more information, please visit Interpace Biosciences’ website at www.interpace.com.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to the Company’s future financial and operating performance. The Company has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. These statements also involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results to be materially different from those expressed or implied by any forward-looking statements, including, but not limited to, the possibility that the Company’s estimates of future revenue and cash flows, as well as Pro Forma financial results and adjusted EBITDA may prove to be materially inaccurate, the Company’s prior history of operating losses, the Company’s ability to adequately finance its business and seek alternative sources of financing, the Company’s ability to repay borrowings from BroadOak, the Company’s dependence on sales and reimbursements from its clinical services, the Company’s ability to retain or secure reimbursement including its reliance on third parties to process and transmit claims to payers and the adverse impact of any delay, data loss, or other disruption in processing or transmitting such claims, the Company’s revenue recognition being based in part on estimates for future collections which estimates may prove to be incorrect, and the Company’s ability to continue to restructure itself in light of the loss of reimbursement for its PancraGEN product.

Additionally, all forward-looking statements are subject to the “Risk Factors” detailed from time to time in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as amended, Current Reports on Form 8-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

Contacts:

Investor Relations
Interpace Biosciences, Inc.
(855)-776-6419
Info@Interpace.com

INTERPACE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except per share data)

Selected Balance Sheet Data (Unaudited)
($ in thousands)

Selected Cash Flow Data (Unaudited)
($ in thousands)

* PancraGEN Direct Costs represent only direct costs associated with the operations of PancraGEN testing, with no allocations or estimates of corporate, shared, or overhead expenses included.

Reconciliation of Adjusted EBITDA (Unaudited)
($ in thousands)

Non-GAAP Financial Measures

In addition to the United States generally accepted accounting principles, or GAAP, results provided throughout this document, we have provided certain non-GAAP financial measures to help evaluate the results of our performance. We believe that these non-GAAP financial measures, when presented in conjunction with comparable GAAP financial measures, are useful to both management and investors in analyzing our ongoing business and operating performance. We believe that providing the non-GAAP information to investors, in addition to the GAAP presentation, allows investors to view our financial results in the way that management views financial results.

In this document, we discuss Adjusted EBITDA, a non-GAAP financial measure. Adjusted EBITDA is a metric used by management to measure cash flow of the ongoing business. Adjusted EBITDA is defined as income or loss from continuing operations, plus depreciation and amortization, non-cash stock-based compensation, severance expense, interest and taxes, and other non-cash expenses including change in fair values of notes payable. The table above includes a reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure. 

¹ Management uses a non-GAAP Pro Forma income statement to help evaluate the results of our performance. The Pro Forma income statement for 2024 reflects the Company’s current business structure as a thyroid-only diagnostics testing company and excludes revenue and related costs from PancraGEN, which was discontinued in May 2025. These adjustments are presented for comparability purposes only and do not represent GAAP financial measures. Investors should review GAAP results alongside these pro forma figures for a complete understanding of performance. A reconciliation of GAAP and these pro forma figures is presented below.

IPSEN – Buy-back programme – Art 5 of MAR – Week 45 – 2025




IPSEN – Buy-back programme – Art 5 of MAR – Week 45 – 2025

Attachment

• EN_IPSEN – Buy-back programme – Art 5 of MAR – Week 45_2025

MHRA Approves BetaGlue Therapeutics’ Clinical Trial Application for YntraDose™ in unresectable Locally Advanced Pancreatic Cancer (uLA-PDAC)




MHRA Approves BetaGlue Therapeutics’ Clinical Trial Application for YntraDose™ in unresectable Locally Advanced Pancreatic Cancer (uLA-PDAC)

MILAN, Nov. 12, 2025 (GLOBE NEWSWIRE) — BetaGlue^® Therapeutics (“BetaGlue” or the “Company”) a clinical-stage oncology company developing an innovative radiotherapy solution for the targeted treatment of solid tumours, announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) has approved the Clinical Trial Application for YntraDose™ in unresectable Locally Advanced Pancreatic Ductal Adenocarcinoma (LA-PDAC).

The clinical study is an early feasibility clinical investigation and will assess safety and performance in patients with unresectable locally advanced pancreatic ductal adenocarcinoma. LA-PDAC remains a significant health concern and an unmet medical need. The incidence of LA-PDAC has increased by 1.0% per year since the late 1990s, and it is projected to become the second-leading cause of cancer-related mortality by 2030.

“The approval by the MHRA represents a fundamental milestone in the clinical development of YntraDose™ and a meaningful step forward in our commitment to innovation in oncology,” said Alexis Peyroles, CEO of BetaGlue Therapeutics. “This authorization enables us to initiate our first clinical study in the UK in Q1 2026, marking a critical step toward delivering a novel therapeutic option for patients with unresectable locally advanced pancreatic cancer, one of the most aggressive and deadly malignancies. We are proud of the dedication shown by our team and Clinical Advisory Board and grateful for the collaborative engagement with regulatory authorities.”

About BetaGlue Therapeutics
BetaGlue^® Therapeutics is a clinical-stage oncology company developing a novel radiotherapy platform technology for the localised and targeted treatment of unresectable solid tumours called YntraDose^® which is currently being evaluated for LA-PDAC and has further potential in other indications.

About YntraDose
YntraDose device is a locoregional therapy (LRT) intended for the percutaneous radio-ablation of unresectable solid tumors. It represents a novel technology that aim to deliver a targeted radiation dose using Yttrium-90 microspheres injected directly into the tumour site, within a glue matrix holding the Y-90 microspheres in place.

Website: https://betaglue.com/ / Contact us: info@betaglue.com LinkedIn: Here

EssilorLuxottica: Disclosure of Share Capital and Voting Rights Outstanding as of October 31, 2025




EssilorLuxottica: Disclosure of Share Capital and Voting Rights Outstanding as of October 31, 2025

Disclosure of Share Capital and Voting Rights Outstanding
as of October 31, 2025

(Pursuant to Article L.233-8 II of the French Commercial Code and articles 221-1 and 223-16 of the General Regulations of the Autorité des Marchés Financiers)

Paris, France (November 12, 2025 – 6:00 pm) – As of October 31, 2025, shares and voting rights outstanding of EssilorLuxottica, the global leader in the design, manufacture and distribution of ophthalmic lenses, frames and sunglasses, breaks down as indicated below.

It is to be noted that voting rights are capped at 31%, applicable to any shareholder, in accordance with a formula contained in article 23 of EssilorLuxottica’s by-laws¹.

¹EssilorLuxottica’s by-laws are available on the Company’s website under the section Governance / Publications.

Attachment

• DOWNLOAD THE PRESS RELEASE

Standard Dental Labs Inc.: Investor Education Series — Part 2




Standard Dental Labs Inc.: Investor Education Series — Part 2

From Workbench to Workflow: Digitizing Craftsmanship at Scale

Digitizing craftsmanship—at scale.

ORLANDO, Fla., Nov. 12, 2025 (GLOBE NEWSWIRE) — Standard Dental Labs Inc. (OTCQB: TUTH) today published Part 2 of its Investor Education Series, focusing on how SDL’s operating model turns independent lab craftsmanship into a unified, technology-enabled workflow. The Company’s approach standardizes intake, production, and quality control across acquired labs, then channels volume through regional hubs to lower unit costs, improve turnaround times, and elevate consistency.

Part 2 details the integration roadmap, key operational KPIs, and the company’s people-first training strategy that scales artisan skill with modern tools.

“We’re not replacing artisans—we’re amplifying them,” said James Brooks, CEO of Standard Dental Labs. “A common digital backbone and SOPs let technicians do their best work faster, with fewer remakes and more predictable quality.”

Operational Pillars

• Digital intake: standardized case submission with support for intraoral scans; unified case management and tracking.
• SOPs & quality system: shared workflows, calibrated materials/equipment, documented QC checkpoints, and remake analytics.
• Regional hubs: consolidate high-throughput steps (milling/printing, finishing) to reduce overhead and turn-time variability.
• Centralized procurement: scale purchasing of alloys, ceramics, and logistics to expand gross margin.
• Secure data & compliance: HIPAA-aware handling of digital impressions and patient identifiers; vendor vetting and audit trails.

90‑Day Integration Playbook (Per Acquisition)

• Days 0–30: stabilize operations, map caseflow, preserve key client relationships, and align pricing/catalogs.
• Days 31–60: deploy digital tools, SOPs, and training; centralize select steps to pilot hub routing.
• Days 61–90: full SOP adoption, hub throughput ramp, and margin/cycle-time reporting to the roll-up dashboard.

KPI Dashboard for Shareholders

• Turnaround time (TAT) and on‑time delivery rate.
• Remake rate (by product line) and causes addressed.
• Gross margin expansion (materials, freight, labor leverage).
• Digital share of cases (intraoral-scanner adoption and CAD/CAM throughput).
• Technician productivity per shift and training completion.

Customer Value Proposition

• For clinicians: reliable quality, faster turns, single-standard experience across locations, and support for digital impressions.
• For lab owners joining SDL: liquidity plus access to better tools, training, and shared services; preserved local relationships.

Series Navigation

Previously in this series → Part 1: The Roll-Up Flywheel. Next up → Part 3: Capital to Catalysts. All parts: https://sdl.care/investors.

About Standard Dental Labs Inc.

Standard Dental Labs Inc. (OTCQB: TUTH) is a dental laboratory consolidator focused on acquiring and integrating privately owned labs to create a leading, technology-enabled network delivering crowns, bridges, dentures, and related prosthetics to dental professionals. By combining localized craftsmanship with platform scale, SDL aims to be the partner of choice for lab owners and clinicians. Website: https://sdl.care.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding potential acquisitions (including LOIs), the acquisition pipeline, the likelihood and timing of definitive agreements and closings, expected financial impact of completed acquisitions, revenue run-rate targets, integration plans, operational efficiencies, capital availability, and the Company’s growth strategy. Forward-looking statements are based on current expectations and involve inherent risks and uncertainties that could cause actual results to differ materially.

These risks include, but are not limited to, outcomes of due diligence; the ability to negotiate and execute definitive agreements on favorable terms, or at all; the availability of financing for acquisitions; the ability to successfully integrate acquired businesses and realize anticipated synergies; market competition; and other risks and uncertainties described in the Company’s filings, including its Form 1-A/A and related amendments filed with the U.S. Securities and Exchange Commission and disclosures furnished to OTC Markets. Standard Dental Labs Inc. undertakes no obligation to update or revise any forward-looking statements, except as required by law.

Investor & Media Contact

Standard Dental Labs Inc.
424 E Central Blvd, Suite 308, Orlando, FL 32801
Phone: (407) 789-1923 • Email: info@sdl.care • Investors: https://sdl.care/investors
SOURCE: Standard Dental Labs Inc.

Mainz Biomed Showcases Innovative Cancer Detection Solutions at MEDICA 2025




Mainz Biomed Showcases Innovative Cancer Detection Solutions at MEDICA 2025

BERKELEY, Calif. and MAINZ, Germany, Nov. 12, 2025 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, is pleased to announce its participation in MEDICA 2025, one of the world’s leading healthcare trade shows, taking place from 17–20 November, 2025, in Düsseldorf, Germany.

With over 5,000 exhibitors from 70 countries and 80,000 visitors expected, MEDICA continues to serve as a pioneering international platform for innovation, communication, and business development across the entire medical technology value chain. The event consistently sets trends for the future of global healthcare.

Bringing together healthcare experts, industry leaders, policymakers, and commercial decision-makers, MEDICA features an extensive program of high-level forums, conferences, and special exhibitions.
The event provides an excellent opportunity to exchange insights, explore collaborations, and strengthen relationships with key opinion leaders shaping the future of cancer prevention and molecular diagnostics.

Mainz Biomed will present its current flagship product, ColoAlert®, a molecular stool-based screening test for the early detection of colorectal cancer, as well as further upcoming diagnostic solutions for early-stage cancer diagnosis. Attendees are invited to visit the Company at the joint booth of Rhineland-Pfalz, located in Hall 3, E92.

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information

Please follow us to stay up to date:
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About Mainz Biomed NV
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert® is marketed across Europe. The Company is currently running its eAArly DETECT 2 clinical study in preparation for its pivotal FDA study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in blood and stool samples.

To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.

For media inquiries
MC Services AG
Maximilian Schur / Simone Neeten
+49 211 529252 20
mainzbiomed@mc-services.eu

For investor inquiries, please contact ir@mainzbiomed.com

Forward-Looking Statements
Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on March 31, 2025 and its mid-year report on Form 6-K filed on September 26, 2025. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.

Evaxion announce 2026 financial calendar




Evaxion announce 2026 financial calendar

COPENHAGEN, Denmark, November 12, 2025 – Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, announces its financial calendar for 2026 as summarized below:

March 5, 2026: Business update and full year 2025 financial results

April 16, 2026: Annual General Meeting

May 7, 2026: Business update and first quarter 2026 financial results

August 20, 2026: Business update and second quarter 2026 financial results

November 19, 2026: Business update and third quarter 2026 financial results

The financial calendar can also be found on our website.

Contact information 
Evaxion A/S
Mads Kronborg
Vice President, Investor Relations & Communication
+45 53 54 82 96
mak@evaxion.ai

About Evaxion
Evaxion is a pioneering TechBio company based upon its AI platform, AI-Immunology™. Evaxion’s proprietary and scalable AI prediction models harness the power of artificial intelligence to decode the human immune system and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. Based upon AI-Immunology™, Evaxion has developed a clinical-stage oncology pipeline of novel personalized vaccines and a preclinical infectious disease pipeline in bacterial and viral diseases with high unmet medical needs. Evaxion is committed to transforming patients’ lives by providing innovative and targeted treatment options. For more information about Evaxion and its groundbreaking AI-Immunology™ platform and vaccine pipeline, please visit our website.

Forward-looking statement 
This announcement 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. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could,” and other words and terms of similar meaning identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including, but not limited to, risks related to: our financial condition and need for additional capital; our development work; cost and success of our product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; government regulation; protection of our intellectual property rights; employee matters and managing growth; our ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on our business from other significant geopolitical and macro-economic events; and other uncertainties affecting our business operations and financial condition. For a further discussion of these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission (SEC), which are available at www.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law.