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 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the first quarter ended March 31, 2025 (Press release, Puma Biotechnology, MAY 8, 2025, View Source [SID1234652760]). Unless otherwise stated, all comparisons are for the first quarter of 2025 compared to the first quarter of 2024.

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Product revenue, net consists entirely of revenue from sales of NERLYNX, Puma’s first commercial product. Product revenue, net in the first quarter of 2025 was $43.1 million, compared to product revenue, net of $40.3 million in the first quarter of 2024.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $3.0 million, or $0.06 per basic and diluted share, for the first quarter of 2025, compared to net loss of $4.8 million, or $0.10 per basic and diluted share, for the first quarter of 2024.

Non-GAAP adjusted net income was $5.0 million, or $0.10 per basic and diluted share, for the first quarter of 2025, compared to non-GAAP adjusted net loss of $2.4 million, or $0.05 per basic share and diluted share, for the first quarter of 2024. Non-GAAP adjusted net income (loss) excludes stock-based compensation expense. For a reconciliation of GAAP net income (loss) to non-GAAP adjusted net income (loss) and GAAP net income (loss) per share to non-GAAP adjusted net income (loss) per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the first quarter of 2025 was $3.6 million, compared to $11.3 million provided by operating activities in the first quarter of 2024. At March 31, 2025, Puma had cash, cash equivalents and marketable securities of $93.2 million, compared to cash, cash equivalents and marketable securities of $101.0 million at December 31, 2024.

"We are pleased to report better than expected net income for the first quarter of 2025," said Alan H. Auerbach, Chairman, Chief Executive Officer, and President of Puma. "We recently presented new clinical data on neratinib at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 and we look forward to important updates from our ongoing alisertib clinical studies later this year."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) presentation of interim data from ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (H2 2025); and (ii) presentation of additional interim data from the ALI-4201/ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (H2 2025)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX and royalty revenue. For the first quarter ended March 31, 2025, total revenue was $46.0 million, of which $43.1 million was net product revenue and $2.9 million was royalty revenue. This compares to total revenue of $43.8 million in the first quarter of 2024, of which $40.3 million was net product revenue and $3.5 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $42.0 million for the first quarter of 2025, compared to $46.1 million for the first quarter of 2024.

Cost of Sales

Cost of sales was $10.6 million for the first quarter of 2025, virtually unchanged from $10.7 million for the first quarter of 2024.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $17.6 million for the first quarter of 2025, compared to $21.8 million for the first quarter of 2024. The $4.2 million decrease resulted primarily from a decrease of $3.6 million in professional fees and expenses, primarily legal fees; a decrease of $0.2 million in payroll and related costs; and a decrease of $0.2 million in stock-based compensation.

Research and Development Expenses

Research and development expenses were $13.8 million for the first quarter of 2025, compared to $13.6 million for the first quarter of 2024. The $0.2 million increase resulted primarily from increases of $0.2 million in clinical trial expenses; and $0.2 million in consultants and contractors; partially offset by a decrease of $0.1 million in stock-based compensation.

Total Other Income (Expenses)

Total other expenses were $0.7 million for the first quarter of 2025, compared to total other expenses of $2.3 million for the first quarter of 2024. The $1.6 million decrease resulted primarily from a lower debt balance, which reflects principal payments of approximately $11.1 million per quarter.

Second Quarter and Full Year 2025 Financial Outlook

Second Quarter 2025

Full Year 2025 (current)

Full Year 2025 (previous)

Net Product Revenue

$48–$50 million

$192–$198 million

$192–$198 million

Royalty Revenue

$2–$3 million

$20–$24 million

$20–$24 million

License Revenue

$0 million

$0 million

$0 million

Net Income/(Loss)*

$4–$6 million

$23–$28 million

$23–$28 million

Gross to Net Adjustment

20%–21.5%

20.5%–21.5%

20.5%–21.5%

*The outlook above does not include any adjustments for tax valuation allowance.

Conference Call

Puma Biotechnology will host a conference call to report its first quarter 2025 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PT/4:30 p.m. ET on Thursday, May 8, 2025. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.

On May 8, 2025 BioDlink, a leading global CDMO, reported that it congratulates its partner Junshi Biosciences (HKEX-1877; SSE-688180), on receiving Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) of China to initiate clinical trials for the JS212 injection — Junshi Biosciences’ first bispecific antibody-drug conjugate (ADC) (Press release, Shanghai Junshi Bioscience, MAY 8, 2025, View Source [SID1234652783]).

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JS212 represents a new class of bispecific ADCs that combine the humanized epidermal growth factor receptor and human epidermal growth factor receptor 3 bispecific antibody-drug conjugate to target both EGFR and HER3 — two proteins highly expressed in a variety of tumor cells, such as lung cancer, breast cancer, and head and neck cancer. As a bispecific ADC, JS212 has a key advantage over traditional ADCs that only target one protein: it can attack tumors via either EGFR or HER3, potentially increasing its effectiveness against a wider range of cancers and helping to overcome drug resistance.

Dr. Jun Liu, CEO and Executive Director of BioDlink, stated: "As a leader in ADC technology, BioDlink remains committed to technology innovation and one-stop solution platform for complex biologics. Our collaboration with Junshi Biosciences is built on mutual trust and deep experience in ADC research, development and manufacturing. The IND approval of JS212 — a technically demanding bispecific ADC —­ highlights our strong capabilities and strategic value we bring to partners pursuing next-generation biologics. We’re honored to support the advancement of this important program."

Dr. Jing Tong, Deputy Director of Junshi Biosciences’ Innovation Research Institute, shared: "We are very pleased with the ongoing and highly productive partnership with BioDlink. Their exceptional expertise and proven capabilities in ADC development and manufacturing have played a pivotal role in advancing JS212 to this important milestone. Throughout the collaboration, BioDlink has consistently demonstrated technical excellence, operational efficiency, and a deep understanding of complex bispecific ADCs. This approval marks a key collaboration milestone, and we look forward to deepening our cooperation as we work toward bringing innovative therapies to patients in the future."

BioDlink is committed to becoming a trusted CDMO biologics partner. The company operates a large-scale commercial biologics production site that meets international GMP standards and includes multiple integrated production lines for antibodies and ADCs.

With a comprehensive ADC platform supported by key R&D technologies, BioDlink enables efficient, centralized production of antibody intermediates, drug substances, and finished products. This setup accelerates timelines and reduces tech transfer costs. At the same time, BioDlink’s quality system is built according to international standards and has passed GMP audits in multiple countries, which can empower global customers.

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.

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.