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– Favorable clinical data in PD-(L)1 resistant patients –

– Dose expansion enrollment complete with full data expected by year-end 2025 –

– Cash runway into the second quarter of 2026 –

BOSTON, May 06, 2025 (GLOBE NEWSWIRE) — Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, today reported financial results for the first quarter 2025, and provided corporate updates.

“This was a breakthrough quarter for Sensei,” said John Celebi, President and CEO. “We observed favorable signs of clinical activity in patients with PD-(L)1-resistant cancers from our dose expansion cohort—patients who face poor odds and few options. Beyond the responses we have observed, what’s striking is the emerging potential for prolonged benefit, with some PD-(L)1-resistant patients approaching a year on study. In a population with historically low response rates and fleeting benefit from PD-(L)1 rechallenge, we observed response rates nearly three times higher than what would typically be expected in this setting. With dose expansion enrollment now complete, we’re laser-focused on finalizing a Phase 2 strategy for solnerstotug, guided by the full dataset we plan to present later this year.”

Highlights and Milestones

Solnerstotug (formerly SNS-101) is a conditionally active antibody designed to selectively target the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation) within the tumor microenvironment. VISTA is implicated in numerous cancer indications and its expression correlates with low survival rates.

Sensei is conducting a multi-center Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of solnerstotug as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo^® (cemiplimab) in patients with advanced solid tumors.

Recent updates include:

• In March, Sensei announced preliminary data from the dose expansion stage of its ongoing Phase 1/2 trial, showing favorable activity in patients with PD-(L)1 resistant “hot” tumors.
• Enrollment is now complete with a total of 63 patients:
  • 10 MSS CRC patients in the monotherapy arm
  • 53 patients in the cemiplimab combination arm consisting of 10 MSS CRC patients and 43 PD-(L)1 resistant “hot” tumor patients.
• Full dose expansion data from the Phase 1/2 study expected by year-end 2025.

A replay of the March 2025 webcast related to these preliminary results, featuring study investigator Dr. Shiraj Sen, is available on the Sensei website.

Other corporate highlights included:

• Canaccord Genuity Horizons in Oncology Virtual Conference: On April 7, 2025, John Celebi, President and CEO of Sensei Biotherapeutics, participated in a panel discussion titled “New Radiotherapy and Targeted Therapy Approaches.” The panel focused on emerging innovations in cancer treatment and Sensei’s approach to selectively modulating the tumor microenvironment. A replay of the discussion is available on the conference website.
• Oppenheimer’s 35th Annual Healthcare Life Sciences Conference: On February 11, 2025, Mr. Celebi delivered a presentation at Oppenheimer’s 35th Annual Healthcare Life Sciences Conference. The presentation provided insights into the company’s clinical progress and strategic direction. A webcast of the presentation is available in the Investors section of the Sensei website.

First Quarter 2025 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $34.3 million as of March 31, 2025, as compared to $41.3 million as of December 31, 2024. Sensei expects its current cash balance to fund operations into the second quarter of 2026.

Research and Development (R&D) Expenses: R&D expenses were $3.7 million for the quarter ended March 31, 2025, compared to $4.9 million for the year ended March 31, 2024. The decrease in R&D expenses was primarily attributable to lower personnel costs, and lower facilities and lab supply costs, partially offset by increased expense associated with clinical trials.

General and Administrative (G&A) Expenses: G&A expenses were $3.5 million for the quarter ended March 31, 2025, compared to $3.8 million for the quarter ended March 31, 2024. The decrease in G&A expense was due to lower personnel costs partially offset by higher consulting fees.

Net Loss: Net loss was $6.9 million for the quarter ended March 31, 2025, compared to $8.0 million for the quarter ended March 31, 2024.

About Sensei Biotherapeutics 
Sensei Biotherapeutics (Nasdaq: SNSE) is a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients. Through its TMAb™ (Tumor Microenvironment Activated biologics) platform, Sensei develops conditionally active therapeutics designed to disable immunosuppressive signals or activate immunostimulatory signals selectively in the tumor microenvironment to unleash T cells against tumors. Sensei’s lead product candidate is solnerstotug, a conditionally active antibody designed to block the V-domain Ig suppressor of T cell activation (VISTA) checkpoint selectively within the low pH tumor microenvironment, where VISTA acts as a suppressor of T cells by binding the receptor PSGL-1. For more information, please visit www.senseibio.com, and follow the company on X @SenseiBio and LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “believe”, “designed to,” “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Sensei’s current beliefs and expectations. These forward-looking statements include expectations regarding the development and potential therapeutic benefits of Sensei’s product candidates, the timing of Sensei’s Phase 1/2 clinical trial of solnerstotug, including reporting of data therefrom, and its belief that its existing cash and cash equivalents will be sufficient to fund its operations into the second quarter of 2026. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the development of therapeutic product candidates, such as the risk that any one or more of Sensei’s product candidates will not be successfully developed or commercialized; the risk of delay or cessation of any planned clinical trials of Sensei’s product candidates; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical studies and clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Sensei’s product candidates; the risk that Sensei’s product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that Sensei anticipates; risks associated with Sensei’s dependence on third-party suppliers and manufacturers, including sole source suppliers, over which Sensei may not always have full control; risks regarding the accuracy of Sensei’s estimates of expenses, capital requirements and needs for additional financing; and other risks and uncertainties that are described in Sensei’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on May 6, 2025 and Sensei’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Sensei as of the date of this release, and Sensei assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Michael Biega
Senior Director, Investor Relations
Sensei Biotherapeutics
[email protected]

Media Contact:

Joyce Allaire
LifeSci Advisors
[email protected]

‒ Q1 2025 Net Revenue of $39.1mm; Adjusted EBITDA of $23.6mm ‒

Conference Call Scheduled for Today at 8:30 a.m. Eastern Time

BERKELEY HEIGHTS, NJ., May 06, 2025 (GLOBE NEWSWIRE) — CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced financial results for the first quarter ended March 31, 2025 and provided an update on its business.

Recent Corporate Highlights:

• CorMedix announces net sales of $39.1 million for the first quarter of 2025, largely driven by successful implementation by its outpatient dialysis customers. The Company’s first quarter of 2025 was profitable and cash flow positive, with net income of $20.6 million, adjusted EBITDA of $23.6 million, and cash from operations of $19.7 million.
• The Company’s dedicated inpatient sales team is now fully staffed, trained, and operational in the field. DefenCath inpatient institutional shipments have doubled over the past three months and the Company anticipates continued inpatient growth throughout 2025.
• CorMedix commenced its Phase 3 study for the reduction of Central Line Associated Blood Stream Infections (CLABSIs) in adult patients receiving Total Parenteral Nutrition (TPN) through a central venous catheter. The first site is operational and actively screening patients.
• CorMedix expects to be at the high-end of the previously announced first half net sales guidance of $62 million to $70 million, based on latest order trends and inventory tracking with current purchasing customers.
• Cash and short-term investments, excluding restricted cash, at March 31, 2025 amounted to $77.5 million.

First Quarter 2025 Financial Highlights

For the first quarter of 2025, CorMedix recorded $39.1 million in net revenue from sales of DefenCath, and recorded net income of $20.6 million, or $0.32 per share, compared with a net loss of $14.5 million, or $0.25 per share, in the first quarter of 2024. The net income was driven primarily by net sales of DefenCath in the period.

Operating expenses in the first quarter of 2025 were $17.4 million, compared with $15.9 million in the first quarter of 2024, an increase of approximately 9%. The increase was driven by higher research and development (R&D) expenses of $3.2 million, compared with $0.8 million for the same period in 2024. The increase in R&D was primarily due to the increase in personnel and clinical trial services in support of the ongoing clinical programs.

General and administrative expenses increased approximately 11% to $9.7 million in first quarter of 2025, driven primarily by non-cash charges for stock-based compensation. Selling and marketing expense decreased approximately 29% to $4.5 million in first quarter of 2025. This decrease is considered temporary due to the timing of onboarding the outsourced sales force during first quarter. The Company expects these costs to be normalized for the second quarter of 2025 and to be more closely in-line with the comparison period.

The Company reported cash and short-term investments of $77.5 million at March 31, 2025, excluding restricted cash. The Company believes that it has sufficient resources to fund operations for at least twelve months from the issuance of the Company’s Quarterly Report on Form 10-Q.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, May 6, 2025, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows:

About CorMedix

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath^® (taurolidine and heparin) which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and in outpatient settings in July 2024. CorMedix is commencing clinical studies in adult Total Parenteral Nutrition (TPN) patients and pediatric hemodialysis (HD) patient populations in 2025 and also intends to develop DefenCath as a catheter lock solution for use in other therapeutic areas. For more information visit: www.cormedix.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the 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, that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Non-GAAP Financial Measures

This release includes certain non-GAAP financial measures, including EBITDA, adjusted EBITDA, which are intended as supplemental measures of the Company’s performance that are not required by or presented in accordance with GAAP. Management uses these non-GAAP measures internally to evaluate and manage the Company’s operations and to better understand its business because they facilitate a comparative assessment of the Company’s operating performance relative to its performance based on results calculated under GAAP. These non-GAAP measures also isolate the effects of some items that vary from period to period without any correlation to core operating performance and eliminate certain charges that management believes do not reflect the Company’s operations and underlying operational performance.

The Company believes that these non-GAAP measures also provide useful information to investors regarding certain financial and business trends relating to the Company’s financial condition and operating results facilitates an evaluation of the financial performance of the Company and its operations on a consistent basis. Providing this information therefore allows investors to make independent assessments of the Company’s financial performance, results of operations and trends while viewing the information through the eyes of management.

These non-GAAP measures are subject to limitations. The non-GAAP measures presented in this release may not be comparable to similarly titled measures used by other companies because other companies may not calculate one or more in the same manner. Additionally, the non-GAAP performance measures exclude significant expenses and income that are required by GAAP to be recorded in the Company’s financial statements; do not reflect changes in, or cash requirements for, working capital needs. Further, our historical adjusted results are not intended to project our adjusted results of operations or financial position for any future period. To compensate for these limitations, management presents and considers these non-GAAP measures in conjunction with the Company’s GAAP results; no non-GAAP measure should be considered in isolation from or as alternatives to any measure determined in accordance with GAAP. Readers should review the reconciliations included below, and should not rely on any single financial measure to evaluate the Company’s business.

Investor Contact:

Dan Ferry
Managing Director
LifeSci Advisors
[email protected]
(617) 430-7576

— Continued progress in the PIKture-01 trial; on track to report additional data in the second half of 2025, including mature single agent and initial combination data

— Expansion of the Company’s PI3K
a
franchise with the planned announcement of a pan-mutant selective development candidate in Q2 2025

— $96.7M in cash and cash equivalents expected to be sufficient to fund operations through multiple anticipated milestones into Q4 2026

BOULDER, Colo., May 06, 2025 (GLOBE NEWSWIRE) — OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on developing novel precision medicines in oncology, today reported financial results for the quarter ended March 31, 2025, and provided business highlights.

“OnKure looks to define a new standard of performance for precision targeted agents. We designed OKI-219 and our ongoing PIKture-01 trial to set a high bar for achieving considerable selectivity in targeting oncogenic PI3Kα^H1047R. Late last year, we announced preliminary data that showed OKI-219 was well tolerated across all dose levels, allowing us to complete the dose escalation portion of the study up to 1500 mg BID. We anticipate presenting a mature clinical update in the second half of 2025 that could demonstrate a clear and meaningful benefit in treating this very challenging patient population. This exciting next step in our program would further solidify OnKure’s place as a leader in developing PI3Ka inhibitors,” said Nick Saccomano, Ph.D., President and Chief Executive Officer of OnKure.

“Building on the advancement of our initial candidate, our research and development team is advancing towards a second development candidate in the second quarter of 2025; a true pan-mutant inhibitor with a selectivity profile that augurs well for rendering all major PI3Ka mutants actionable.”

Business Highlights and Upcoming Anticipated Milestones

• PIKture-01 trial Part A Monotherapy – The Company has completed dose escalating and closed enrollment in Part A with dose limiting toxicities observed in only one patient to date and at the highest dose level.   OnKure expects to provide a mature clinical update in the second half of 2025.

  OnKure previously announced encouraging preliminary safety, tolerability, and pharmacokinetic (“PK”) data from the part A single-agent arm of the PIKture-01 trial, with a data cut-off of October 28, 2024. These preliminary data showed OKI-219 was well tolerated across all dose levels, with no hyperglycemia, stomatitis, or rash observed. Additionally, only grade 1 treatment-related adverse events (“TRAEs”) were reported with no dose interruptions, delays, reductions, or discontinuations reported for any adverse events.

• PIKture-01 Part B Fulvestrant Combination – OnKure is actively enrolling patients in Part B of the PIKture-01 trial, evaluating OKI-219 in combination with fulvestrant in patients with PI3Kα^H1047R mutated HR+/HER2- metastatic breast cancer. The Company is nearing the end of the dose escalation portion of Part B, with no dose limiting toxicities observed to date. OnKure expects to report initial combination data with fulvestrant in the second half of 2025. It is anticipated that the dose escalation portion of Part B will be completed at the time of the presentation.
• Pan-mutant Program – OnKure believes that to be truly “pan-mutant”, a candidate should be highly selective against each of the most common PI3Ka mutations with a favorable safety and tolerability profile. OnKure is targeting approximately 10-fold selectivity against each of the most common mutations (PI3Kα^H1047X, PI3Kα^E542K, and PI3Kα^E545K) over wild type with its pan-mutant development candidate, which it expects to announce in the second quarter of 2025.

First Quarter 2025 Financial Results

Cash and cash equivalents were approximately $96.7 million as of March 31, 2025.

Research and development (R&D) expenses were $13.0 million for the first quarter of 2025, compared with $8.6 million for the first quarter of 2024. The increase in R&D expenses was primarily due to increases in personnel-related costs, including share-based compensation charges, clinical trial and outsourced manufacturing expenses, and outsourced research as OnKure seeks to advance multiple programs.

General and Administrative (G&A) expenses were $4.0 million for the first quarter of 2025, compared with $1.3 million for the first quarter of 2024. The increase in G&A expenses was primarily due to increased personnel-related costs, including share-based compensation charges, and increases in legal expenses, board, consulting, and other professional service fees.

Net loss and net loss per share for the first quarter of 2025 were $15.9 million and $1.19 per share, compared with $9.5 million, and $30.37 per share, for the first quarter of 2024.

About OnKure Therapeutics

OnKure Therapeutics, Inc. (Nasdaq: OKUR) is a clinical-stage biopharmaceutical company focused on the discovery and development of best-in-class precision medicines that target biologically validated drivers of cancers that are underserved by available therapies. Using a structure-based drug design platform, OnKure is building a pipeline of tumor-agnostic candidates that are designed to achieve optimal efficacy and tolerability. OnKure is currently developing OKI-219, a selective PI3Kα^H1047R inhibitor, as its lead program. OnKure aims to become a leader in targeting oncogenic PI3Kα and has multiple programs designed to enable best-in-class targeting of this key oncogene.

For more information about OnKure, visit us at www.onkure.com and follow us on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our future financial condition, results of operations, business strategy and plans, and objectives of management for future operations, as well as statements regarding industry trends, are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of, and expectations regarding, OnKure’s current and potential future product candidates and programs, including OKI-219 and the pan-mutant program; OnKure’s ability to advance additional programs; expected milestones and timing of such milestones, including additional data for OKI-219 from the PIKture-01 trial, anticipated development candidate announcements and advancement of OnKure’s discovery stage programs; and statements regarding OnKure’s financial position, including its liquidity, cash runway and the sufficiency of its cash resources. In some cases, you can identify forward-looking statements by terminology such as “estimate,” “intend,” “may,” “plan,” “potentially” “will” or the negative of these terms or other similar expressions.

We based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things, OnKure’s limited operating history; the significant net losses incurred since inception; the ability to raise additional capital to finance operations; the risk that actual uses of cash and cash equivalents differ from the assumptions underlying our expected cash runway; the ability to advance product candidates through preclinical and clinical development; the ability to obtain regulatory approval for, and ultimately commercialize, OnKure’s product candidates; the outcome of preclinical testing and early clinical trials for OnKure’s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements, timing of regulatory reviews and approvals, and the potential that the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials; OnKure’s limited resources; the risk of adverse events, toxicities or other undesirable side effects; potential delays or difficulties in the enrollment or maintenance of patients in clinical trials; the decision to develop or seek strategic collaborations to develop OnKure’s current or future product candidates in combination with other therapies and the cost of combination therapies; OnKure’s limited experience in designing clinical trials and lack of experience in conducting clinical trials; the substantial competition OnKure faces in discovering, developing, or commercializing products; OnKure’s ability to protect its intellectual property and proprietary technologies; developments relating to OnKure’s competitors and its industry, including competing product candidates and therapies; reliance on third parties, contract manufacturers, and contract research organizations; legislative, regulatory, political and economic developments and general market conditions; and those risks described in the section entitled “Risk Factors” in documents that OnKure files from time to time with the Securities and Exchange Commission (“SEC”), including our Annual Report on Form 10-K filed with the SEC on March 10, 2025 and any subsequent filings with the SEC. These risks are not exhaustive. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this press release.

Contact:

Dan Ferry
LifeSci Advisors
[email protected]

CELEBRATION, Fla., May 06, 2025 (GLOBE NEWSWIRE) — Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living with rare disease, today announced it will report corporate and financial results for the first quarter 2025 on Tuesday, May 13, 2025. The Company will issue a news release after the market closes and host a conference call/audio webcast at 4:30 p.m. ET that day.

A link to the audio webcast will be accessible on the “Events & Presentations” page in the Investor Relations section of Zevra’s website at https://investors.zevra.com/.

To join via telephone, please use the following dial-in information:

• (800) 245-3047 (United States)
• +1 (203) 518-9765 (International)
• Conference ID: ZVRAQ125

A replay of the webcast will be available for 90 days beginning at approximately 5:30 p.m. ET. The replay will be accessible on the “Events & Presentations” page of Zevra’s website at https://investors.zevra.com/.

About Zevra Therapeutics, Inc.

Zevra Therapeutics, Inc. is a commercial-stage company combining science, data, and patient need to create transformational therapies for rare diseases with limited or no treatment options. Our mission is to bring life-changing therapeutics to people living with rare diseases. With unique, data-driven development and commercialization strategies, the Company is overcoming complex drug development challenges to make new therapies available to the rare disease community.

For more information, please visit www.zevra.com or follow us on X and LinkedIn.

Caution Concerning Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation statements regarding upcoming events or Zevra’s participation at such events. Forward-looking statements are based on information currently available to Zevra and its current plans or expectations. They are subject to several known and unknown uncertainties, risks, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the “Risk Factors” section of Zevra’s Annual Report on Form 10-K for the year ended Dec. 31, 2024, and Zevra’s other filings with the Securities and Exchange Commission. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we cannot assure that such expectations will prove correct. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this press release.

Zevra Contact

Nichol Ochsner 
+1 (732) 754-2545 
[email protected]  

GAITHERSBURG, Md., May 06, 2025 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company, today announced that it will report its first quarter 2025 financial results on Tuesday, May 13, 2025.

Altimmune management will host a conference call at 8:30 am E.T. on May 13 to discuss financial results and provide a business update. The conference call will be webcast live on Altimmune’s Investor Relations website at https://ir.altimmune.com/investors.

Participants who would like to join the call may register here to receive the dial-in numbers and unique PIN to access the call. Shortly after the call, a replay will be available on the Investor Relations website for up to three months.

About Altimmune

Altimmune is a late clinical-stage biopharmaceutical company focused on developing innovative next-generation peptide-based therapeutics. The Company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of obesity, MASH, alcohol use disorder as well as alcohol related liver disease. For more information, please visit www.altimmune.com.

Follow @Altimmune, Inc. on

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Company Contact:

Greg Weaver
Chief Financial Officer
Phone: 240-654-1450
[email protected]

Investor Contact:

Lee Roth
Burns McClellan
Phone: 646-382-3403
[email protected]

Media Contact:

Jake Robison
Inizio Evoke, Biotech
Phone: 619-849-5383
[email protected]

This press release was published by a CLEAR® Verified individual.

• Q1
  reported revenue of
  $123.9 million
  declined
  4.3%
  ; Organic* revenue advanced
  5.0%
• First quarter net loss was
  $0.04
  per share compared to a loss of
  $0.08
  in the prior-year period
• Non-GAAP earnings* of
  $0.08
  per share increased
  33%
• Company reiterated revenue, Adjusted EBITDA* and Non-GAAP EPS* guidance for full year 2025

DURHAM, N.C., May 06, 2025 (GLOBE NEWSWIRE) — Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, today reported financial results for the three months ended March 29, 2025.

“Our Bioventus team delivered solid results to start the year and we are making substantial progress with executing our strategic plan,” said Rob Claypoole, Bioventus President and Chief Executive Officer. “We remain well positioned to navigate the uncertain macro-environment while achieving above-market revenue growth through a multitude of diverse growth drivers, enhancing profitability and accelerating cash flow to create significant shareholder value.”

First Quarter 2025 Financial Results:

For the first quarter, worldwide revenue of $123.9 million declined 4.3% from $129.5 million in the prior-year period. This performance reflects the impact from the prior-year divestiture of the Advanced Rehabilitation Business. Organic* revenue increased 5.0% as a result of positive organic* growth across all three businesses.

Net loss attributable to Bioventus Inc. of $2.6 million compares to a net loss attributable to Bioventus Inc. of $4.9 million in the prior-year period.

Adjusted EBITDA* of $19.2 million was lower than the prior-year period Adjusted EBITDA* of $22.6 million primarily due to the impact of the Advanced Rehabilitation divestiture and planned growth investments.

Loss per share of Class A common stock was $0.04 per share, compared to a loss of $0.08 in the prior-year period. Non-GAAP earnings per share of Class A common stock^* was $0.08 per share, reflecting an increase of 33% from $0.06 per share in the prior-year period.

Revenue By Business

The following table represents net sales by business and geographic region for the three months ended March 29, 2025 and March 30, 2024:

^(a) U.S. revenue from the Advanced Rehabilitation Business totaled $330 and $9,897 for the three months ended March 29, 2025 and March 30, 2024, respectively. International revenue from the Advanced Rehabilitation Business totaled $1,924 for the three months ended March 30, 2024.

Pain Treatments: Global revenue of $58.9 million increased 3.9% led by double-digit growth in demand for Durolane, a differentiated, single-injection hyaluronic acid therapy for knee osteoarthritis. Growth was impacted by reduced buying by certain distributors following higher purchases at the end of last year.

Surgical Solutions: Global revenue of $45.2 million increased 7.0% driven by double-digit growth from Ultrasonics as a result of strong capital equipment purchases in the U.S.

Restorative Therapies: Global revenue of $19.7 million declined 35.3% reflecting the Company’s divestiture of its Advanced Rehabilitation business at the end of 2024. On an organic^* basis, revenue grew 4.0% driven by improvement in commercial effectiveness and sales force execution with the EXOGEN Bone Stimulation System.

Recent Business Highlights

Bioventus continues to advance its strategic priorities with key achievements, including the following:

• Entered into a distribution agreement for the United States with APEX Biologix to distribute its XCELL PRP system. This partnership broadens Bioventus’ Pain Treatments portfolio and is synergistic with its patient-based mission, existing channels and call points.
• Strengthened its executive leadership team with the addition of Dave Venner, Senior Vice-President and General Manager of Surgical Solutions and Jeff Ciardi, Vice-President for Strategic Accounts and Market Access.

2025 Financial Guidance:

Bioventus reiterated its 2025 Financial Guidance initially provided on March 11, 2025, which now includes an estimated impact of tariffs, which is immaterial at this time. For the twelve months ending December 31, 2025, the Company continues to expect:

• Net sales of $560 million to $570 million. This reflects organic* growth of approximately 6.1% to 8.0% when including the impact of the Company’s divestiture of its Advanced Rehabilitation Business, which generated revenue of $45.4 million in 2024
• Adjusted EBITDA* of $112 million to $116 million, reflecting 100 basis points in Adjusted EBITDA Margin* growth compared to the 2024 Adjusted EBITDA Margin* of 19.0% when using the low end of the 2025 revenue and Adjusted EBITDA* guidance
• Non-GAAP EPS* of $0.64 to $0.68, reflecting an increase of 30.6% to 38.8%

The Company does not provide U.S. GAAP financial measures, other than net sales, on a forward-looking basis, because the Company is unable to predict with reasonable certainty the impact and timing of acquisition and divestiture related expenses, accounting fair-value adjustments, and certain other reconciling items without unreasonable efforts. These items are uncertain, depend on various factors, and could be material to the Company’s results computed in accordance with U.S. GAAP.

*See below under “Use of Non-GAAP Financial Measures” for more details.

About Bioventus

Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for Pain Treatments, Surgical Solutions and Restorative Therapies. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com and follow the Company on LinkedIn and Twitter. Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.

First Quarter 2025 Earnings Conference Call:

Management will host a conference call to discuss the Company’s financial results and provide a business update, with a question and answer session, at 8:30 a.m. Eastern Time on May 6, 2025. Those who would like to participate may dial 1-833-636-0497 (domestic and international) and refer to Bioventus Inc.

A live webcast of the call and any accompanying materials will also be provided on the investor relations section of the Company’s website at https://ir.bioventus.com/. 

The webcast will be archived on the Company’s website at https://ir.bioventus.com/ and available for replay until May 5, 2026.

Legal Notice Regarding Forward-Looking Statements

This press release 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. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements concerning our future financial results and liquidity; regarding our business strategy, including, without limitation, the impact of the divestiture of our Advanced Rehabilitation Business on our financial condition and operations; and expected sales trends, opportunities, market position and growth. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.

Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Important factors that may cause actual results to differ materially from current expectations include, among other things: the risks related to tariffs and unexpected changes in tariffs, trade barriers and regulatory requirements, export licensing requirements or other restrictive actions by the United States or retaliatory tariffs and other actions taken by foreign governments; the risk that we might not realize some or all of the benefits expected to result from the recently completed divestiture of our Advanced Rehabilitation Business; if we fail to properly manage growth or scale our business processes, systems, or data management, our business could suffer; our ability to maintain our competitive position depends on our ability to attract, retain and motivate our senior management team and highly qualified personnel necessary to execute our strategic plans; we may face issues with respect to the supply of our products or their components due to product quality and regulatory compliance issues, including increased costs, disruptions of supply, shortages, contamination or mislabeling; we might not meet certain of our debt covenants under our Credit and Guaranty Agreement and might be required to repay our indebtedness on an accelerated basis; there are restrictions on operations and other costs associated with our indebtedness; we might require additional capital to fund our current financial obligations and support business growth; failure to establish and maintain effective financial controls could adversely affect our business and stock price; we might not be able to complete acquisitions or successfully integrate new businesses, products or technologies in a cost-effective and non-disruptive manner; our cash is maintained at financial institutions, often in balance that exceed federally insured limits; we are subject to securities class action litigation and may be subject to similar or other litigation, in the future, which will require significant management time and attention, result in significant legal expenses or costs not covered by our insurers, and may result in unfavorable outcomes; we are highly dependent on a limited number of products; our long-term growth depends on our ability to develop, acquire and commercialize new products, line extensions or expanded indications; we may be unable to successfully commercialize newly developed or acquired products or therapies in the United States; demand for our existing portfolio of products and any new products, line extensions or expanded indications depends on the continued and future acceptance of our products by physicians, patients, third-party payers and others in the medical community; the proposed down classification of non-invasive bone growth stimulators, including our EXOGEN system, by the U.S. Food and Drug Administration (“FDA”) could increase future competition for bone growth stimulators and otherwise adversely affect the Company’s sales of EXOGEN; failure to achieve and maintain adequate levels of coverage and/or reimbursement for our products or future products, the procedures using our products, such as our hyaluronic acid (“HA”) viscosupplements, or future products we may seek to commercialize; pricing and other competitive factors; we may be unable to successfully commercialize newly developed or acquired products or therapies in the United States; governments outside the United States might not provide coverage or reimbursement of our products; we compete and may compete in the future against other companies, some of which have longer operating histories, more established products or greater resources than we do; if our HA products are reclassified from medical devices to drugs in the United States by the FDA, it could negatively impact our ability to market these products and may require that we conduct costly additional clinical studies to support current or future indications for use of those products; our failure to properly manage our anticipated growth and strengthen our brands; risks related to product liability claims; fluctuations in demand for our products; issues relating to the supply of our products or their components due to product quality and regulatory compliance issues, including increased costs, disruptions of supply, shortages, contamination or mislabeling; our reliance on a limited number of third-party manufacturers to manufacture certain of our products; if our facilities are damaged or become inoperable, we will be unable to continue to research, develop and manufacture certain of our products; economic, political, regulatory and other risks related to international sales, manufacturing and operations; failure to maintain contractual relationships; security breaches, unauthorized access to our disclosure of information, cyberattacks, or other incidents, or the perception that confidential information in our or our vendors’ or service providers’ possession or control is not secure; failure of key information technology and communications systems, process or sites; risks related to our future capital needs; failure to comply with extensive governmental regulation relevant to us and our products; we may be subject to enforcement action if we engage in improper claims submission practices and resulting audits or denials of our claims by government agencies could reduce our net sales or profits; the FDA regulatory process is expensive, time-consuming and uncertain, and the failure to obtain and maintain required regulatory clearances and approvals could prevent us from commercializing our products; if clinical studies of our future product candidates do not produce results necessary to support regulatory clearance or approval in the United States or elsewhere, we will be unable to expand the indications for or commercialize these products; unstable political or economic conditions; legislative or regulatory reforms; our business might experience adverse impacts due to public health outbreaks; risks related to intellectual property matters; the dilution of our Class A common stockholders upon an exchange of the outstanding common membership interests in Bioventus LLC could adversely affect the market price of our Class A common stock and the resale of such shares could cause the market price of our Class A common stock to fall; and other the other risks identified in our Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in Bioventus’ other filings with the SEC which are accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Bioventus’ website at https://ir.bioventus.com. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ materially from those set forth in the forward-looking statements.

Use of Non-GAAP Financial Measures

Organic Revenue Growth

The Company defines the term “organic revenue” as revenue in the stated period excluding the impact from business acquisitions and divestitures. The Company uses the related term “organic revenue growth” or “organic growth” to refer to the financial performance metric of comparing the stated period’s organic revenue with the comparable reported revenue of the corresponding period in the prior year. The Company believes that these non-GAAP financial measures, when taken together with GAAP financial measures, allow the Company and its investors to better measure the Company’s performance and evaluate long-term performance trends. Organic revenue growth also facilitates easier comparisons of the Company’s performance with prior and future periods and relative comparisons to its peers. The Company excludes the effect of acquisitions and divestitures because these activities can have a significant impact on the Company’s reported results, which the Company believes makes comparisons of long-term performance trends difficult for management and investors.

Adjusted EBITDA, Non-GAAP Gross Profit, Non-GAAP Gross Margin, Non-GAAP Operating Income, Non-GAAP Operating Expenses, Non-GAAP R&D, Non-GAAP Operating Margin, Non-GAAP Net Income, and Non-GAAP Earnings per share of Class A Common Stock

We present Adjusted EBITDA, Non-GAAP Gross Profit, Non-GAAP (or Adjusted) Gross Margin, Non-GAAP Operating Income, Non-GAAP Operating Expenses, Non-GAAP R&D, Non-GAAP Operating Margin, Non-GAAP Net Income, and Non-GAAP Earnings per share of Class A common stock, all non-GAAP financial measures, to supplement our GAAP financial reporting because we believe these measures are useful indicators of our operating performance.

We define Adjusted EBITDA as net loss before depreciation and amortization, provision of income taxes and interest expense, net, adjusted for the impact of certain cash, non-cash and other items that we do not consider in our evaluation of ongoing operating performance. These items include acquisition and divestiture related costs, certain shareholder litigation costs, impairment of assets, restructuring and succession charges, equity-based compensation expense, financial restructuring costs and other items. See the table below for a reconciliation of net loss to Adjusted EBITDA. Our management uses Adjusted EBITDA principally as a measure of our operating performance and believes that Adjusted EBITDA is useful to our investors because it is frequently used by securities analysts, investors and other interested parties in their evaluation of the operating performance of companies in industries similar to ours. Our management also uses Adjusted EBITDA for planning purposes, including the preparation of our annual operating budget and financial projections.

Our management uses Non-GAAP Gross Profit, Non-GAAP Gross Margin, Non-GAAP Operating Income, Non-GAAP Operating Expense, Non-GAAP Operating Margin and Non-GAAP Net Income principally as measures of our operating performance and believes that these non-GAAP financial measures are useful to better understand the long term performance of our core business and to facilitate comparison of our results to those of peer companies. Our management also uses these non-GAAP financial measures for planning purposes, including the preparation of our annual operating budget and financial projections.

We define Non-GAAP Gross Profit as gross profit, adjusted for the impact of certain cash, non-cash and other items that we do not consider in our evaluation of ongoing operating performance. These items include depreciation and amortization included in the cost of goods sold and acquisition and divestiture related costs in the cost of goods sold. We define Non-GAAP Gross Margin as Non-GAAP Gross Profit divided by net sales. See the table below for a reconciliation of gross profit and gross margin to Non-GAAP Gross Profit and Non-GAAP Gross Margin.

We define Non-GAAP Operating Income as operating income, adjusted for the impact of certain cash, non-cash and other items that we do not consider in our evaluation of ongoing operating performance. These items include depreciation and amortization, acquisition and divestiture related costs, certain shareholder litigation costs, impairment of assets, restructuring and succession charges, financial restructuring costs and other items. Non-GAAP Operating Margin is defined as Non-GAAP Operating Income divided by net sales. See the table below for a reconciliation of operating income (loss) and operating margin to Non-GAAP Operating Income and Non-GAAP Operating Margin.

We define Non-GAAP Operating Expenses as operating expenses, adjusted to exclude certain cash, non-cash and other items that we do not consider in our evaluation of ongoing operating performance. These items include depreciation and amortization, acquisition and divestiture related costs, certain shareholder litigation costs, impairment of assets, restructuring and succession charges, financial restructuring costs and other items. See the table below for a reconciliation of operating expenses to Non-GAAP Operating Expenses.

We define Non-GAAP R&D as research and development, adjusted to exclude certain cash, non-cash and other items that we do not consider in our evaluation of ongoing operating performance. These items include depreciation and amortization, acquisition and divestiture related costs, restructuring and succession charges, and other items. See the table below for a reconciliation of operating expenses to Non-GAAP R&D.

We define Non-GAAP Net Income as Net Income, adjusted for the impact of certain cash, non-cash and other items that we do not consider in our evaluation of ongoing operating performance. These items include depreciation and amortization, acquisition and divestiture related costs, certain shareholder litigation costs, restructuring and succession charges, impairment of assets, financial restructuring costs, other items and the tax effect of adjusting items. See the table below for a reconciliation of Net loss to Non-GAAP Net Income.

We define Non-GAAP Earnings per Class A share as Earnings per Class A share, adjusted for the impact of certain cash, non-cash and other items that we do not consider in our evaluation of ongoing operating performance. These items include depreciation and amortization, acquisition and divestiture related costs, certain shareholder litigation costs, restructuring and succession charges, impairment of assets, financial restructuring costs, other items and the tax effect of adjusting items divided by weighted average number of shares of Class A common stock outstanding during the period. See the table below for a reconciliation of loss per Class A share to Non-GAAP Earnings per Class A share.

Net Sales, International Net Sales Growth and Constant Currency Basis

Net Sales, International Net Sales Growth and Constant Currency Basis are non-GAAP measures, which are calculated by translating current and prior year results at the same foreign currency exchange rate. Constant currency can be presented for numerous GAAP measures, but is most commonly used by management to facilitate the comparison of sales in foreign currencies to prior periods and analyze net sales performance without the impact of changes in foreign currency exchange rates.

Prior Period Recast

The Company identified an immaterial error in its equity-based compensation expense, which impacted annual and interim financial statements for the fiscal year 2024. Financial information relating to 2024 has been revised to correct this immaterial error. Refer to Note 1. Organization in the Company’s Form 10-Q for the period ended March 29, 2025, filed on May 6, 2025, for further details regarding the immaterial error in equity-based compensation.

Limitations of the Usefulness of Non-GAAP Measures

Non-GAAP financial measures have limitations as an analytical tool and should not be considered in isolation or as a substitute for, or as superior to, the financial information prepared and presented in accordance with GAAP. These measures might exclude certain normal recurring expenses. Therefore, these measures may not provide a complete understanding of the Company’s performance and should be reviewed in conjunction with the GAAP financial measures. Additionally, other companies might define their non-GAAP financial measures differently than we do. Investors are encouraged to review the reconciliation of the non-GAAP measures provided in this press release, including in the tables below, to their most directly comparable GAAP measures. Additionally, the Company does not provide U.S. GAAP financial measures on a forward-looking basis because the Company is unable to predict with reasonable certainty the impact and timing of acquisition and divestiture related expenses, accounting fair-value adjustments and certain other reconciling items without unreasonable efforts. These items are uncertain, depend on various factors, and could be material to the Company’s results computed in accordance with U.S. GAAP.

(a)   
Includes for the three months ended March 29, 2025
and
March 30, 2024, respectively, depreciation and amortization of
$10.3 million and $10.0 million in cost of sales and $1.6 million
and $1.8 million
in operating expenses presented in the consolidated statements of operations and
comprehensive loss
. 

The year ended
December 31, 2024
includes depreciation and amortization of $41.9 million in cost of sales and $7.7 million in operating expenses.

(b)   
Includes acquisition and integration costs related to completed acquisitions and changes in fair value of contingent consideration.

(c)   
Costs incurred as a result of certain shareholder litigation unrelated to our ongoing operations.

(d)   
Costs incurred were the result of adopting restructuring plans to reduce headcount, contract terminations, reorganize management structure and consolidate certain facilities.

(e)   
Includes compensation expense resulting from awards granted under our equity-based compensation plans.

(f)   
Financial restructuring costs include advisory fees and debt amendment related costs.

(g)   
Represents a non-cash impairment charge for intangible assets solely attributable to our Advanced Rehabilitation Business in 2024 due to our decision to divest the business.

(h)   
Represents the loss on the disposal of the Advanced Rehabilitation Business.

(i)   
Other items includes charges associated with strategic transactions, including potential acquisitions or divestitures and a transformative project to redesign systems and information processing. Other items during the
three months ended March 29, 2025
primarily consisted of
$0.5 million
of divestiture expenses related to the Advanced Rehabilitation Business sold on December 31, 2024.

During the
three months ended March 30, 2024, other items primarily consisted of: (i) s
trategic transactions and divestiture expenses of
$0.5 million
, primarily related to the Advanced Rehabilitation Business; and (ii) transformative project costs of
$0.8 million
.

During the year ended December 31, 2024, other items primarily consisted of: (i) divestiture costs of $4.7 million related to the Advanced Rehabilitation Business, including transactional fees; (ii) transformative project costs of $1.7 million; and (iii) strategic transaction costs of $0.4 million.

(a)   
The “Reported GAAP Measure” under the “Operating Expenses” column is a sum of all GAAP operating expense line items, excluding research and development.

(b)   
Includes for the three months ended March 29, 2025
and
March 30, 2024, respectively, depreciation and amortization of $10.3 million and $10.0 million in cost of sales and
$1.6 million and $1.8 million
in operating expenses presented in the consolidated statements of operations and
comprehensive loss
.

(c)   
Comprised of costs incurred as a result of certain shareholder litigation unrelated to our ongoing operations.

(d)   
Represents the loss on disposal of the Advanced Rehabilitation Business.

(e)   
Includes acquisition and integration costs related to completed acquisitions and changes in fair value of contingent consideration.

(f)   
Costs incurred were the result of contract terminations.

(g)   
Financial restructuring costs include advisory fees and debt amendment related costs.

(h)   
Other items includes charges associated with strategic transactions, including potential acquisitions or divestitures and a transformative project to redesign systems and information processing. Other items during the
three months ended March 29, 2025
primarily consisted of
$0.5 million
of divestiture expenses related to the Advanced Rehabilitation Business sold on December 31, 2024.

During the
three months ended March 30, 2024, other items primarily consisted of: (i) s
trategic transactions and divestiture expenses of
$0.5 million
, primarily related to the Advanced Rehabilitation Business; and (ii) transformative project costs of
$0.8 million
.

(i)   
An estimated tax impact for adjustments to Non-GAAP Net Income was c
alculated by applying a rate of
25.1%
for the
three months ended
March 29, 2025 and March 30, 2024.

(j)   
Adjustments are pro-rated to exclude the weighted average non-controlling interest ownership of 19.2% and 19.9%, respectively, for the
three months ended
March 29, 2025 and March 30, 2024.

Investor Inquiries and Media:

Dave Crawford
Bioventus
[email protected]

NEW YORK, May 06, 2025 (GLOBE NEWSWIRE) — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer’s disease, Parkinson’s disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced that it will issue financial results for its second fiscal quarter on Tuesday , May 13, 2025.

Management will host a conference call on Tuesday, May 13, at 8:30 am ET to review financial results and provide an update on the execution of the Company’s growth strategy. Following management’s remarks, there will be a question-and-answer session.

Webcast / Conference Call Information:

The live webcast of the conference call will be available on Anavex’s website at www.anavex.com.

The conference call can be also accessed by dialing 1 929 205 6099 for participants in the U.S. using the Meeting ID# 856 5033 5285 and reference passcode 014 352. A replay of the conference call will also be available on Anavex’s website for up to 30 days.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer’s disease, Parkinson’s disease, schizophrenia, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex’s lead drug candidate, ANAVEX^®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer’s disease, a Phase 2 proof-of-concept study in Parkinson’s disease dementia, and both a Phase 2 and a Phase 3 study in adult patients and one Phase 2/3 study in pediatric patients with Rett syndrome. ANAVEX^®2-73 is an orally available drug candidate designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. ANAVEX^®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson’s Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX^®2-73 for the treatment of Parkinson’s disease. We believe that ANAVEX^®3-71, which targets SIGMAR1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer’s disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX^®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company on Twitter,Facebook, Instagram, and LinkedIn.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

For Further Information:

Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: [email protected]

Investors:

Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: [email protected]

SCOTTSDALE, Ariz., May 06, 2025 (GLOBE NEWSWIRE) — Caliber (NASDAQ: CWD), a real estate investor, developer, and manager, today announced that it has entered into a Development Rights Agreement with an affiliate of Hyatt Hotels Corporation (NYSE: H) to develop 15 new Hyatt Studios hotels in the United States. Under the terms of the agreement, Caliber Hospitality Development (“CHD”) will receive exclusive development rights for future development of Hyatt Studios hotels in target market areas within Arizona, Colorado, Nevada, Texas and Louisiana. Construction on the first hotel, located in Georgetown, Texas, a city within the Austin metropolitan district, is expected to break ground in the fourth quarter of 2025. The second hotel within the agreement will be in Scottsdale, Arizona and is expected to break ground second quarter of 2026.

Announced in 2023, Hyatt Studios is Hyatt’s first upper-midscale extended-stay brand, concepted in direct collaboration with owners and informed by guest feedback, featuring an efficient build cost, lean operating model, and design flexibility—all supported by Hyatt’s powerful commercial engine. Each Hyatt Studios hotel will include approximately 122 apartment-style suites equipped with in room kitchens, free high-speed fiber internet, EV charging stations, complimentary grab-and-go breakfast, a 24/7 market, self-service laundry, fitness studio, and pet friendly accommodations.

“Our new Hyatt Studios brand has been steadily growing since we announced it in 2023, and today we have more than 50 executed deals that will extend the Hyatt brand into more than 20 new markets,” said Jim Chu, Chief Growth Officer, Hyatt. “We are excited to be working with Caliber on the development of at least 15 new properties, many of which are expected to be located in new markets for Hyatt. This significant development agreement will advance Hyatt’s ongoing evolution, as we aim to make our brands even more profitable for owners and more desirable for travelers.”

“We are very excited about our new relationship with Hyatt, a world-class brand that shares our steadfast commitment to superior service for our guests,” said Chris Loeffler, CEO of Caliber. “As a hospitality investor and developer since 2013, Caliber has taken notice that hotel inventory across the United States is lower today than it was in January of 2020. This, combined with historically low new construction starts, and a recent return of demand for hotel rooms, makes the case to develop Hyatt Studios hotels in attractive, underserved markets. The Hyatt Studios brand offers Caliber the opportunity to capture a fundamental change in the way people work and their desire to stay in a hotel that feels like home for a longer trip,” continued Mr. Loeffler.

Caliber expects to develop 15 hotels over the course of the next three to five years, as the market bears opportunities, and will seek to expand the agreement if market conditions allow. Caliber expects these developments to deliver $400 million in additional assets under management (AUM) to the Platform, delivering an attractive operating margin and significant growth in annual and one-time Platform revenue.

The term “Hyatt” is used in this release for convenience to refer to Hyatt Hotels Corporation and/or one or more of its affiliates.

About


Caliber (CaliberCos


Inc.)


With more than $2.9 billion of managed assets, including estimated costs to complete assets under development, Caliber’s 15-year track record of managing and developing real estate is built on a singular goal: make money in all market conditions. Our growth is fueled by our performance and our competitive advantage: we invest in projects, strategies, and geographies that global real estate institutions do not. Integral to our competitive advantage is our in-house shared services group, which offers Caliber greater control over our real estate and visibility to future investment opportunities. There are multiple ways to participate in Caliber’s success: invest in Nasdaq-listed CaliberCos Inc. and/or invest directly in our Private Funds.

About


Caliber


Hospitality


Trust

Caliber Hospitality Trust (“CHT”), an externally advised private hospitality corporation, is a subsidiary of CaliberCos Inc. (NASDAQ: CWD). Led by an experienced team of agile entrepreneurs and specialists, CHT offers a unique opportunity in an UPREIT strategy for hotel owners and managers to access scale on a tax-deferred basis. CHT is targeting middle-market, full service, select service, extended stay, and lifestyle hotels in attractive geographic locations. CHT’s asset management technology enables management of mixed asset classes, top-tier brands, and third-party managers, who all interact via an integrated platform. More information at CaliberHospitality.com

About


Hyatt Hotels


Corporation


Hyatt Hotels Corporation, headquartered in Chicago, is a leading global hospitality company guided by its purpose – to care for people so they can be their best. As of March 31, 2025, the Company’s portfolio included more than 1,450 hotels and all-

inclusive properties in 79 countries across six continents. The Company’s offering includes brands in the Luxury Portfolio, including Park Hyatt®, Alila®, Miraval®, Impression by Secrets, and The Unbound Collection by Hyatt®; the Lifestyle Portfolio, including Andaz®, Thompson Hotels®, The Standard®, Dream® Hotels, The StandardX, Breathless Resorts & Spas®, JdV by Hyatt®, Bunkhouse® Hotels, and Me and All Hotels; the Inclusive Collection, including Zoëtry® Wellness & Spa Resorts, Hyatt Ziva®, Hyatt Zilara®, Secrets® Resorts & Spas, Dreams® Resorts & Spas, Hyatt Vivid Hotels & Resorts, Sunscape® Resorts & Spas, Alua Hotels & Resorts®, and Bahia Principe Hotels & Resorts; the Classics Portfolio, including Grand Hyatt®, Hyatt Regency®, Destination by Hyatt®, Hyatt Centric®, Hyatt Vacation Club®, and Hyatt®; and the Essentials Portfolio, including Caption by Hyatt®, Hyatt Place®, Hyatt House®, Hyatt Studios, Hyatt Select, and UrCove. Subsidiaries of the Company operate the World of Hyatt® loyalty program, ALG Vacations®, Mr & Mrs Smith, Unlimited Vacation Club®, Amstar® DMC destination management services, and Trisept Solutions® technology services. For more information, please visit www.hyatt.com.

Forward-Looking
Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on the Company’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the final prospectus related to the Company’s public offering filed with the SEC and other reports filed with the SEC thereafter. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.

CONTACTS:
Caliber:
Ilya Grozovsky
+1 480-214-1915
[email protected]

SAN DIEGO, May 06, 2025 (GLOBE NEWSWIRE) — Kura Oncology, Inc. (NASDAQ: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced its participation in Bank of America Securities 2025 Healthcare Conference. Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in a fireside chat at 6:00 p.m. ET / 3:00 p.m. PT on May 13, 2025. A live audio webcast of the fireside chat will be available in the Investors section of Kura’s website at www.kuraoncology.com, with an archived replay following the event.

About Kura Oncology

Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the treatment of relapsed/refractory (“R/R”) NPM1-mutant acute myeloid leukemia (“AML”). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed, and in the second quarter of 2025, the companies announced submission of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1-mutant AML. Kura Oncology and Kyowa Kirin are also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma. For additional information, please visit Kura’s website at https://kuraoncology.com/ and follow us on X and LinkedIn.

Contacts

Investors:
Patti Bank
Managing Director
(415) 513-1284
[email protected]

Media:
Alexandra Weingarten
Associate Director, Corporate Communications
& Investor Relations
(858) 500-8822
[email protected]