On May 8, 2025 ALX Oncology Holdings Inc., ("ALX Oncology" or "the Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported financial results for the first quarter ended March 31, 2025, and provided a corporate update (Press release, ALX Oncology, MAY 8, 2025, View Source [SID1234652720]).

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"In the first quarter of the year, we focused our development strategy for evorpacept on the anti-cancer antibody combinations, as we now have proof-of-concept for this mechanism in gastric cancer, breast cancer and NHL," said Jason Lettmann, Chief Executive Officer of ALX Oncology. "In addition to the evorpacept program, we diversified our pipeline by moving our in-house ADC candidate, ALX2004, through IND clearance and look forward to beginning clinical trial enrollment by mid-year for this potentially first- and best-in-class EGFR ADC. We also made the difficult but critical decision to streamline the company and, by doing so, extended cash runway into Q4 2026. We are now hyper-focused on pursuing the validated mechanism of action for evorpacept in combination with anti-cancer antibodies and delivering data in breast cancer in combination with HERCEPTIN, in colorectal cancer in combination with ERBITUX, as well as from ALX2004, in 2026."

ALX Oncology Q1 2025 Highlights and Recent Developments

Received Investigational New Drug (IND) clearance for ALX2004 from the U.S. Food and Drug Administration (FDA). ALX2004 is a potential best- and first-in-class ADC for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors that was fully designed and developed in-house by ALX Oncology scientists utilizing the Company’s proprietary linker-payload platform. Phase 1 clinical trials of ALX2004 are expected to initiate in mid-2025, with initial safety data available in 1H 2026. ALX Oncology will host a webcast highlighting the research program, clinical progress and novel mechanism of action for ALX2004 on May 20, 2025.
Continued progress with the Phase 2 ASPEN-Breast and Phase 1 ASPEN-CRC clinical studies evaluating evorpacept in combination with anti-cancer antibodies and chemotherapy in breast and colorectal cancers based on strong supporting data that, when combined with an anti-cancer antibody, evorpacept generates durable responses and a consistent safety profile. First patient dosing for both trials is anticipated mid-year 2025.
The randomized Phase 2 ASPEN-Breast clinical trial will evaluate evorpacept with HERCEPTIN (trastuzumab) and single-agent chemotherapy in patients with HER2-positive metastatic breast cancer after prior treatment with ENHERTU (fam-trastuzumab deruxtecan-nxki).
The Phase 1 ASPEN-CRC clinical trial will evaluate evorpacept with ERBITUX (cetuximab) and FOLFIRI in patients with second-line metastatic colorectal cancer.
Announced encouraging final results from the Phase 1 trial evaluating evorpacept with standard-of-care RITUXAN (rituximab) and lenalidomide (R2) treatment in patients with B-cell non-Hodgkin Lymphoma (B-NHL) presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025. The trial was conducted by Paolo Strati, M.D., Associate Professor of Lymphoma-Myeloma at The University of Texas MD Anderson Cancer Center, and colleagues at MD Anderson.
As previously published, the combination of evorpacept plus R2 was well tolerated and demonstrated promising anti-tumor activity, generating complete responses (CR) in 83% of patients with indolent relapsed or refractory B-NHL comparing favorably to the 34% historical CR rate with R2 alone.
The Phase 2 portion of the trial in patients with previously untreated indolent NHL is ongoing and has completed enrollment.
Reported topline results from the ASPEN-03 and ASPEN-04 Phase 2 trials evaluating evorpacept with a checkpoint inhibitor, which did not meet their primary endpoints. In the trials, efficacy data did not support advancing evorpacept in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), into a registrational study. The combination of evorpacept and pembrolizumab with or without chemotherapy in ASPEN-03 and ASPEN-04 demonstrated a manageable safety profile and was consistent with what has been previously reported for pembrolizumab and chemotherapy in this setting.
Received guidance from the U.S. FDA that the ASPEN-06 Phase 2 trial data evaluating evorpacept in combination with trastuzumab, ramucirumab and paclitaxel was not eligible for submission for accelerated approval given the availability of ENHERTU. A Phase 3 versus ENHERTU trial would be needed to pursue a regulatory approval of evorpacept in the second-line setting for HER2-positive gastric and gastroesophageal cancers. Given the Company’s disciplined focus and the allocation of its resources, ALX Oncology will not pursue a U.S. registrational path with a Phase 3 trial in gastric cancer and will consider exploring development partnerships to advance this program in gastric cancer.
The Company made the decision to discontinue its evaluation of evorpacept in combination with PADCEV (enfortumab vedotin-ejfv) in urothelial cancer based on the final data analysis showing that, in the ASPEN-07 trial, the addition of evorpacept to treatment with PADCEV did not meet the bar for improved efficacy. Aligned to these data and consistent with recent guidance, ALX Oncology maintains its focus on continuing to progress its trials of evorpacept with anti-cancer antibodies, where there is demonstrated proof-of-concept across multiple clinical settings.
Through previously announced strategic reprioritization efforts, the Company extended its cash runway into Q4 2026. Data milestones that are expected across the three studies evaluating evorpacept and ALX2004 are included in cash runway.
Upcoming Clinical Milestones

Breast Cancer: Patient dosing anticipated to initiate for ASPEN-BREAST Phase 2 clinical trial in mid-year 2025. Interim results from this trial are anticipated in 2H 2026.
Colorectal Cancer: Patient dosing anticipated to initiate for ASPEN-CRC Phase 1b clinical trial in mid-year 2025. Safety and early efficacy data are anticipated in 1H 2026.
ALX2004: Patient dosing anticipated to initiate in mid-2025, following IND clearance from the FDA in April 2025. Safety data are anticipated in 1H 2026.
Breast Cancer: Topline results from Phase 1b I-SPY clinical trial of evorpacept with ENHERTU are anticipated in 2H 2025.
First Quarter 2025 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of March 31, 2025, were $107.0 million. The Company believes its cash, cash equivalents and investments are sufficient to fund planned operations into Q4 of 2026.
Research and Development ("R&D") Expenses: R&D expenses consist primarily of preclinical, clinical and development costs related to the development of the Company’s current lead product candidate, evorpacept, and R&D personnel-related expenses including stock-based compensation. R&D expenses for the three months ended March 31, 2025, were $23.9 million compared to $31.7 million for the prior-year period or a decrease of $7.8 million. This decrease was primarily attributable to a decrease of $7.0 million in clinical and development costs primarily due to less manufacturing of clinical trial materials to support active clinical trials for our lead product candidate, evorpacept, and a decrease in stock-based compensation expense slightly offset by increased personnel and related costs.
General and Administrative ("G&A") Expenses: G&A expenses consist primarily of administrative personnel-related expenses, including stock-based compensation and other costs such as legal and other professional fees, patent filing and maintenance fees, and insurance. G&A expenses for the three months ended March 31, 2025, were $7.9 million compared to $6.0 million for the prior year period or an increase of $1.9 million. This increase was primarily attributable to an increase in personnel and related costs.
Net loss: GAAP net loss was ($30.8) million for the three months ended March 31, 2025, or ($0.58) per basic and diluted share, as compared to a GAAP net loss of ($35.6) million for the three months ended March 31, 2024, or ($0.71) per basic and diluted share. The lower net loss is primarily attributed to lower R&D expenses. Non-GAAP net loss was ($25.5) million for the three months ended March 31, 2025, as compared to a non-GAAP net loss of ($28.5) million for the three months ended March 31, 2024. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.

On May 8, 2025 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported financial results for the first quarter ended March 31, 2025 and recent business highlights (Press release, Akebia, MAY 8, 2025, View Source [SID1234652719]).

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"We are tremendously encouraged by the early progress of the Vafseo (vadadustat) launch, having generated $12.0 million in net product revenues in the first quarter. We believe the early success reflects the excitement among physicians of having an alternative treatment for anemia available for their dialysis patients," said John P. Butler, Chief Executive Officer of Akebia. "We believe the introduction of Vafseo is one of the strongest drug launches into the dialysis market in many years, certainly since the adoption of transitional drug add-on payment adjustment (TDAPA) reimbursement, and we continue to believe that Vafseo could be a new standard of care for the treatment of anemia due to chronic kidney disease (CKD). Initial usage as expected is in the small and mid-sized dialysis providers and we look forward to continuing to drive adoption across all dialysis providers, large and small."

Vafseo U.S. Commercial Updates:
•Vafseo net product revenue in Q1 2025 totaled $12.0 million.
•Through the end of March, more than 640 prescribers wrote a prescription for Vafseo and each prescriber, on average, had written nearly 12 prescriptions. About 1/3 of all prescriptions written were refills and refill data demonstrate an increase in average dose per patient.
•Through the end of April, the top five dialysis organizations placed Vafseo orders, though most revenue continues to be driven by mid-sized dialysis organizations.
•Akebia estimates that it has at least 12 months of Vafseo inventory on hand in the U.S. free of potential incremental tariff payments based on its current operating plan.
Additional Key Business Highlights:
•In March, completed an underwritten public offering of 25 million shares priced at $2.00 per share, raising gross proceeds of $50 million.
•U.S. Renal Care continues enrollment in VOICE, a collaborative clinical trial of Vafseo designed to assess mortality and hospitalization in patients treated with Vafseo compared to current standard of care. Enrollment is now at 75% of the planned trial enrollment of approximately 2,200 patients.
•Plan to initiate a Phase 3 clinical trial (VALOR) to study the use of vadadustat for treating anemia in late-stage CKD patients who are not on dialysis. Expect the VALOR clinical trial to begin in the second half of 2025.
•In January, Vafseo was recommended for symptomatic anemia in adults undergoing dialysis for CKD by the United Kingdom (U.K.) National Institute for Health and Care Excellence (NICE), a distinction especially relevant for practitioners and commissioners making care choices for patients in the U.K. and of interest globally. Akebia’s partner Medice launched Vafseo in the U.K.
•Auryxia (ferric citrate) net product revenue in Q1 2025 totaled $43.8 million. In January 2025, phosphate binders, including Auryxia, were added to the bundled payment for dialysis services and qualified for TDAPA, providing an additional payment for each service in which Auryxia is used. Loss of Auryxia market exclusivity occurred on March 20, 2025. To date, no Abbreviated New Drug Application has been approved for Auryxia, and there is only one authorized generic for Auryxia.
•In April, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending the European Commission to approve XOANACYL (Ferric Citrate as Coordination Complex) for the treatment of concomitant elevated serum phosphorous and iron deficiency in adult patients with CKD.
Financial Results
•Revenues: Total revenues were $57.3 million in the first quarter of 2025 as compared to $32.6 million in the first quarter of 2024, driven by initial sales of Vafseo in the U.S. and an increase in sales of Auryxia.

▪Vafseo net product revenues were $12.0 million in the first quarter of 2025. Vafseo was launched into the U.S. market in the first quarter of 2025.
▪Auryxia net product revenues were $43.8 million in the first quarter of 2025 as compared to $31.0 million in the first quarter of 2024.
▪License, collaboration and other revenues were $1.5 million in the first quarter of 2025 as compared to $1.6 million in the first quarter of 2024.

•Cost of Goods Sold: Cost of goods sold was $7.6 million in the first quarter of 2025 as compared to $11.6 million in the first quarter of 2024. A key driver of this decrease was the fact that Akebia carried a non-cash intangible amortization charge of $9.0 million per quarter through the fourth quarter of 2024. Of note, Vafseo-related cost of goods sold is derived from pre-launch inventory which does not include the full cost of manufacturing, as a portion of those inventory-related costs were recorded as R&D expenses in the period incurred prior to Vafseo’s approval in the U.S. Also, during the first quarter of 2024, Akebia realized a $3.7 million benefit due to its ability to sell Auryxia inventory previously written down as excess inventory.

•Research & Development Expenses: Research and development expenses were $9.8 million in the first quarter of 2025 as compared to $9.7 million in the first quarter of 2024.

•Selling, General & Administrative Expenses: Selling, general and administrative expenses were $25.7 million in the first quarter of 2025 as compared to $25.4 million in the first quarter of 2024.

•Net Income (Loss): Net income was $6.1 million in the first quarter of 2025 compared to a net loss of $18.0 million in the first quarter of 2024. Net income in the first quarter of 2025 was driven by the increase in net product revenues, including the introduction of Vafseo sales in the U.S., which was partially offset by $5.4 million in interest expense related to the settlement royalty liability in connection with the July 2024 Vifor Termination and Settlement Agreement.

•Cash Position: Cash and cash equivalents as of March 31, 2025 were approximately $113.4 million compared to $51.9 million at December 31, 2024, which includes $46.5 million in net proceeds raised from an underwritten public offering of common stock completed in March. Akebia believes that it is financed to achieve profitability based on its current operating plan, which includes pursuing label expansion for Vafseo and advancing other existing programs.

Conference Call

Akebia will host a conference call on Thursday, May 8 at 8:00 a.m. Eastern Time to discuss first quarter 2025 earnings. To access the call, please register by clicking on this Registration Link, and you will be provided with dial in details. To avoid delays and ensure timely connection, we encourage dialing into the conference call 15 minutes ahead of the scheduled start time.

A live webcast of the conference call will be available via the "Investors" section of Akebia’s website at: View Source/." target="_blank" title="View Source/." rel="nofollow">View Source An online archive of the webcast can be accessed via the Investors section of Akebia’s website at View Source approximately two hours after the event.

On May 8, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) (OTC Pink: AIMI) ("AIM" or the "Company") reported the presentation of clinical trial data involving AIM’s drug Ampligen by Pawel Kalinski, MD, PhD, at the recent Annual Meeting of the American Association of Immunologists held May 3-7, 2025, in Honolulu, HI (Press release, AIM ImmunoTech, MAY 8, 2025, View Source [SID1234652718]).

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The paper, titled "Systemic Infusion of dsRNA (Rintatolimod) plus IFN Promotes Selective Influx of CTLs (but not Treg) into the TME – Counteracting Chemokine Heterogeneity of the TME," discussed the unique two-level selectivity of action of Ampligen when used as a part of chemokine modulation and combined with PD-1 blockade or chemotherapy. Dr. Kalinski discussed the preclinical data and data from recently completed clinical trials showing the ability of Ampligen to selectively induce the desirable CTL-attracting chemokines, but not the counterproductive Treg-attracting chemokines, which differentiated it from poly-I:C. The second level of selectivity was the preferential activation of cancer tissues, rather than healthy tissues. The mechanistic data discussed by Dr. Kalinski indicate that the selectivity of Ampligen’s impact on the tumor microenvironment result from its avoidance of helicase-dependent activation of NFkB. This allows Ampligen to avoid the induction of TNFα and other NFkB-dependent undesirable inflammatory and suppressive factors, which are commonly induced by poly-I:C and other TLR ligands, and to focus its impact on the tumor tissues, which display elevated levels of endogenous NFkB.

AIM CEO Thomas K. Equels commented: "These findings and Dr. Kalinski’s analysis further support our belief in the potential of Ampligen as a powerful therapeutic for unmet medical needs, including deadly cancers."

On May 8, 2025 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported its financial results for the first quarter of 2025 and provided a corporate update (Press release, Aclaris Therapeutics, MAY 8, 2025, View Source [SID1234652717]).

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"We are entering into a potentially transformative multi-year period for Aclaris, with important milestones throughout our business that we believe will position us for future growth," stated Dr. Neal Walker, Chief Executive Officer and Chair of the Board of Directors of Aclaris. "Ensuring successful and timely execution of our clinical programs is our priority, and given the realities of today’s financial market environment, it’s imperative that we continue to do so in a manner that efficiently utilizes our capital. As such, we’ve announced that further global development of bosakitug – our uniquely potent anti-TSLP monoclonal antibody – in respiratory indications will be dependent on partnerships. Regarding our internal programs, we expect to initiate new clinical trials with bosakitug; ATI-2138, our highly selective oral ITK/JAK3 inhibitor; and ATI-052, our potential best-in-class bispecific anti-TSLP/IL-4R antibody, for which we recently received IND clearance from the FDA. Work is also ongoing toward next-generation small molecule kinase inhibitors and biologic antagonists of immuno-inflammatory pathways to further expand our pipeline and continue our innovative work in I&I."

"Importantly, we have the cash we believe we need to execute our plan," continued Dr. Walker. "Our expected cash runway now extends through the first half of 2028, and we will continue to practice rigorous financial stewardship with a goal of extending our runway further by exploring additional non-dilutive opportunities."

First Quarter 2025 Highlights and Recent Updates

Pipeline:

Bosakitug (ATI-045): Investigational Anti-TSLP monoclonal antibody

Aclaris Expects to Initiate Enrollment in Placebo-Controlled Two-Arm Phase 2 Trial in Atopic Dermatitis (AD) in the Second Quarter of 2025: Based on the potency of bosakitug observed in preclinical and clinical studies to date, including the compelling results of the Phase 2a single arm trial in AD, Aclaris intends to initiate a two-arm placebo-controlled Phase 2 trial of bosakitug in approximately 90 patients with moderate-to-severe AD in the second quarter of 2025. This trial is designed to evaluate the Company’s anti-TSLP therapeutic in a placebo-controlled setting in a time- and cost-efficient manner.
Results from CTTQ’s Phase 2 Trials in Respiratory Indications Support Further Development: The totality of the results received to date from Aclaris’ regional partner, Chia Tai Tianqing Pharmaceutical Group, Co., Ltd. (CTTQ) from their Phase 2 trials of bosakitug in Chinese patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and severe asthma provide additional clinical evidence of the enhanced potency of bosakitug. CTTQ has announced that they are conducting Phase 3 clinical trials of bosakitug in both indications and are currently conducting a Phase 2 trial in chronic obstructive pulmonary disease (COPD). CTTQ is responsible for the disclosure and presentation of the results of their clinical trials.
Aclaris Intends to Seek Partners to Develop Bosakitug in Respiratory Indications: Aclaris’ clinical focus for bosakitug will remain on dermatological immuno-inflammatory indications. Further global (excluding China) development in respiratory indications is dependent on entering into potential partnerships.

ATI-2138: Investigational oral covalent ITK/JAK3 inhibitor

Top Line Results from Phase 2a Trial in AD Expected in June 2025: Dosing is complete in the single arm Phase 2a open-label trial of ATI-2138 designed to investigate the safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics of ATI-2138 in patients with moderate-to-severe AD. The Company expects to report top line results in June 2025. Potential target indications under consideration include alopecia areata (AA) and vitiligo.

ATI-052: Investigational bispecific anti-TSLP/IL4R monoclonal antibody

Announced Clearance of ATI-052 Investigational New Drug (IND) Application and Plan to Initiate Phase 1 Trial: Aclaris announced that the U.S. Food and Drug Administration cleared its IND application for ATI-052 in April 2025. The Company expects to initiate the placebo-controlled Phase 1a/1b trial evaluating single and multiple ascending doses of ATI-052, followed by a proof-of-concept portion in an undisclosed indication, in the second quarter of 2025. (press release here)

Next Generation Kinase and Cytokine Signaling Pathway Inhibitor Development:

Confirmed Plan for Next IND Submission: Preclinical work is ongoing to develop next-generation ITK inhibitors, which the Company expects to provide the basis for new INDs starting in 2026.
Development of Novel Bispecific Antibodies Targeting Certain Cytokine Pathways Underway: Preclinical work is ongoing to develop next-generation bispecific antibodies utilizing the bosakitug anti-TSLP binding region paired with binding fragments targeting other undisclosed cytokine signaling pathways.
Corporate:

Expected Cash Runway Extends Through the First Half of 2028 and Fully Funds Preclinical and Clinical Development Plans: During the first quarter of 2025, Aclaris took certain steps to focus its pipeline investments while extending its cash runway further. In doing so, the Company continues to prioritize clinical execution and achievement of development milestones, all of which Aclaris expects to be funded by the Company’s current cash runway. Aclaris ended the first quarter of 2025 with $190.5 million in cash, cash equivalents, and marketable securities providing balance sheet strength to execute on its development plan. Aclaris’ cash management policy is focused on capital preservation and holding a portfolio of securities with short-term maturities. The investment portfolio is composed of fixed income securities, primarily high-credit quality corporate debt and U.S. government securities.
Injunction Against Sun Pharmaceuticals Lifted, Providing Aclaris with a Potential Additional Opportunity for Non-Dilutive Financing: In 2023, Aclaris granted Sun Pharma exclusive rights under certain patents for, among other things, the use of deuruxolitinib, Sun Pharma’s JAK inhibitor, to treat AA. The agreement included an upfront payment of $15.0 million, regulatory and commercial milestones, and royalties. In 2024, Incyte Corporation was granted a preliminary injunction against Sun Pharma, blocking Sun Pharma from launching its product LEQSELVI. In April 2025, a U.S. Appeals Court lifted the injunction. As Aclaris has successfully executed similar financings in the past, the Company may seek to monetize this financial asset to provide additional non-dilutive financing.
Provided Update on Senior Leadership: Jesse W. Hall, M.D. has been appointed as Chief Medical Officer.
Dr. Hall brings decades of experience in all phases of drug development, from early development through global regulatory filings and approvals, Phase IV post-marketing surveillance obligations, and commercial launch support to Aclaris. He most recently served as Chief Medical Officer for AltruBio where he was responsible for leadership of all clinical and medical functions. (press release here)

First Quarter 2025 Financial Results

As of March 31, 2025, Aclaris had cash, cash equivalents and marketable securities of $190.5 million compared to $203.9 million as of December 31, 2024. The Company believes that its cash, cash equivalents and marketable securities will be sufficient to fund its operations through the first half of 2028, without giving effect to any potential business development transactions or financing activities.

Net loss was $15.1 million for the first quarter of 2025 compared to $16.9 million for the first quarter of 2024.
Total revenue was $1.5 million for the first quarter of 2025 compared to $2.4 million for the first quarter of 2024. The decrease was primarily driven by the sale of a portion of royalty payments under the Company’s agreement with Eli Lilly and Company to OCM IP Healthcare Portfolio IP, an investment vehicle for Ontario Municipal Employees Retirement System (OMERS), in July 2024.

Research and development (R&D) expenses were $11.6 million for the quarter ended March 31, 2025 compared to $9.8 million for the prior year period. The increase was primarily driven by expenses related to the Company’s bosakitug program, specifically preclinical and clinical development expenses associated with startup activities for a Phase 2 trial in AD. The increase was partially offset by a reduction in development expenses for zunsemetinib and lepzacitinib and lower compensation-related expenses.

General and administrative (G&A) expenses were $6.1 million for the quarter ended March 31, 2025 compared to $6.8 million for the corresponding prior year period. The decrease was primarily due to a reduction in personnel expenses as a result of lower headcount and lower termination benefits.

On May 8, 2025 Photocure ASA (OSE:PHO) reported Hexvix/Cysview revenues of NOK 125.3 million in the first quarter of 2025 (Q1 2024: NOK 116.8 million), and an EBITDA of NOK 1.8 million (7.9) for the company. Photocure expects product revenue growth in the range of 7% to 11% and YoY EBITDA improvement in 2025 (Press release, PhotoCure, MAY 8, 2025, View Source [SID1234652664]). While the Company is not providing a specific EBITDA guidance range, Photocure expects continued operating leverage flow-through in its core commercial business and significant growth in milestone payments this year.

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"We delivered another quarter of growth and positive EBITDA, driven by the strong performance from our European franchise. In parallel, our North American team continues the solid business development with an increasing number of accounts adopting upgrades and new tower placements expecting to drive future revenue growth. We are able to offset the expected decline in flexible cystoscopy kits and expect the U.S. unit growth to accelerate in 2025 onwards. The completion of our share buy-back programme also highlighted our capital discipline commitment as the company continues to grow." says Dan Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 125.3 million in the first quarter of 2025 (NOK 118.0 million), and an EBITDA of NOK 1.8 million (7.9). The cash balance at the end of the period was NOK 259.5 million.

The company continued to execute on its plan to expand blue light cystoscopy use in Q1 2025 with the installation of 21 new Saphira towers in the U.S. — 8 new accounts and 13 blue light tower upgrades. There are now 337 active accounts in the U.S., an increase of 17% versus the first quarter of 2024.

In Europe, Photocure announced during the quarter that the availability of an Interim Flexible BLC solution to centers in all countries where System blue and Richard Wolf reusable flexible cystoscopes are cleared. The co-development with Richard Wolf for state of the art, HD Flexible cystoscope is progressing on plan. Photocure is also collaborating closely with Olympus on their recently launched high-definition Olympus Visera Elite-III equipment featuring blue light cystoscopy.

"30 Olympus systems have already been upgraded since launch, and we fully expect this new state-of-the art equipment to fuel Hexvix growth in the Nordic region and throughout continental Europe this year and beyond," Schneider adds.

Photocure believes that the benefits of Blue Light Cystoscopy with Hexvix/Cysview offering superior detection and management of bladder cancer will continue to be adopted and become the standard of care.

"Following an adequate stock of units already landed in the U.S, we have enough inventory to carry us through most of the year. Given our low cost of goods sold, tariffs represent a very limited impact on our U.S. profit and loss statement. Meanwhile, we remain focused on the growth of our business and investing in opportunities that can take us to the next level in 2025. In all, we delivered another quarter of growth and solid business development and reiterate our guidance of a product revenue growth in the range of 7% to 11% and year of year EBITDA improvement in 2025," Schneider concludes.

Please find the full financial report and presentation enclosed.

EBITDA* and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the first quarter 2025 financial report on page 25.

The quarterly report and presentation will be published at 07:00 CEST and will be publicly available at www.photocure.com. Dan Schneider, CEO and Erik Dahl, CFO, will host a live webcast at 14:00 CEST.

The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through https://channel.royalcast.com/landingpage/hegnarmedia/20250508_10/

The presentation is scheduled to conclude at 14:45 CEST.