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 Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") reported its financial results for the first quarter of fiscal year 2025 (Press release, Illumina, MAY 8, 2025, View Source [SID1234652745]).

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"I’m proud that the Illumina team delivered strong Q1 revenue and EPS, a good start to the year in an increasingly dynamic business environment," said Jacob Thaysen, Chief Executive Officer. "Our outlook for the year has weakened due to shifting policy and geopolitical developments and we have taken swift incremental actions to protect our earnings. Our strategic focus remains on customer collaboration, driving differentiated innovations, and delivering on our long-term financial targets of growth and profitability."

First quarter Core Illumina segment results

GAAP Non-GAAP (a)
Dollars in millions, except per share amounts
Q1 2025 Q1 2024 Q1 2025 Q1 2024
Revenue (b) $ 1,041 $ 1,056 $ 1,041 $ 1,056
Gross margin (c) 65.6 % 65.7 % 67.4 % 67.1 %
Research and development (R&D) expense $ 252 $ 241 $ 241 $ 237
Selling, general and administrative (SG&A) expense $ 267 $ 336 $ 248 $ 254
Operating profit
$ 164 $ 116 $ 212 $ 218
Operating margin 15.8 % 11.0 % 20.4 % 20.6 %
Tax provision $ 51 $ 45 $ 44 $ 54
Tax rate 27.9 % 39.3 % 22.0 % 25.7 %
Net income $ 131 $ 70 $ 154 $ 155
Diluted EPS $ 0.82 $ 0.44 $ 0.97 $ 0.98

(a)See tables in "Results of Operations – Non-GAAP" section below for GAAP and non-GAAP reconciliations.
(b)Revenue for Q1 2024 included intercompany revenue of $7 million prior to the spin-off of GRAIL.
(c)Increase in gross margin was driven by execution of our operational excellence initiatives, that continue to deliver cost savings and improve productivity, and lower strategic partnership revenue that is lower margin, offset by lower product margins, primarily due to reduced pricing, and an increase in field service costs.

Capital expenditures for free cash flow purposes were $32 million for Q1 2025. Cash flow provided by operations was $240 million, compared to $284 million in the prior year period. Free cash flow (cash flow provided by operations less capital expenditures) was $208 million for the quarter, compared to $251 million in the prior year period. Depreciation and amortization expense was $69 million for Q1 2025. At the close of the quarter, the company held $1.24 billion in cash, cash equivalents and short-term investments.

Share repurchases for Q1 2025 were $200 million and the company intends to repurchase incremental shares over the course of the year as part of our ~$1.2 billion authorization remaining at the end of the quarter.

Key announcements since our last earnings release
•Instituted an incremental $100 million cost reduction program to mitigate the impact of a range of potential scenarios for a reduction in revenue and related operating income from the company’s Greater China business
•Unveiled first-of-its-kind spatial transcriptomics technology; Broad Institute to collaborate on flagship project
•Announced collaboration with Broad Clinical Labs to rapidly streamline and scale single-cell projects with cutting-edge tools and workflows
•Unveiled a series of roadmap innovations spanning genomics, spatial transcriptomics, single cell analysis, CRISPR technologies, epigenetics, and data analytics software
•Sequenced 250,000 whole genomes for the Alliance for Genomic Discovery (AGD) initiative
•Announced partnership with Tempus to accelerate clinical adoption of next-generation sequencing tests through novel evidence generation
•Dr. Scott Gottlieb elected as Board Chair, Keith Meister joined Board of Directors
•Named for the sixth year in a row to the Dow Jones Best-in-Class World Index and the Dow Jones Best-in-Class North America Index

A full list of recent announcements can be found in the company’s News Center.

Financial outlook and guidance
For fiscal year 2025, we expect:
◦Core Illumina revenue to decline between (1%) and (3%) on a constant currency basis year over year, down from low single digit growth previously
▪Revenue outside of the Greater China region expected to grow between 0% and 2% in 2025 on a constant currency basis year over year and includes our estimate reflecting changes in the research funding environment as well as the projected benefit from pricing actions
▪Reported revenue from the Greater China region expected to be $165 – $185 million in 2025 (with $72 million in revenue recognized in Q1 2025)
◦$85 million in tariff related costs which after actions is an approximate 125 bps reduction in fiscal year 2025 operating margin and $0.25 of EPS
◦Non-GAAP operating margin of approximately 21.5% – 22.0%, down from approximately 23% previously; and non-GAAP diluted EPS in the range of $4.20 – $4.30, a reduction from our March guidance of approximately $4.50, primarily due to the net impact of tariffs

The company provides forward-looking guidance on a non-GAAP basis, including on a constant currency basis for revenue and revenue growth rates. The company is unable to provide a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP reported financial measures because it is unable to predict with reasonable certainty the impact of items such as acquisition-related expenses, fair value adjustments to contingent consideration, gains and losses from strategic investments, potential future asset impairments, restructuring activities, the ultimate outcome of pending litigation, and currency exchange rate fluctuations without unreasonable effort. These items are uncertain, inherently difficult to predict, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the company is unable to address the significance of the unavailable information, which could be material to future results.

On May 8, 2025 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported financial results and business highlights for the first quarter 2025 (Press release, Sana Biotechnology, MAY 8, 2025, View Source [SID1234652761]).

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"Type 1 diabetes (T1D) remains a large, unmet need, impacting the lives of over 9 million people, and we have made significant progress in 2025 toward a functional cure of this disease," said Steve Harr, Sana’s President and Chief Executive Officer. "We recently presented 12-week clinical data for UP421, showing that hypoimmune-modified pancreatic islets transplanted without any immunosuppression continue to evade immune detection and function three months after transplant, a result that we expect to continue over time and to be broadly generalizable across the population. Additionally, we have established the foundation for a genomically stable, gene-modified master cell bank, a difficult and essential step that clears the path toward an IND as early as 2026 and makes a scalable solution for people with T1D a realistic possibility."

Recent Corporate Highlights

Announced positive initial results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with hypoimmune platform (HIP) technology, into a patient with type 1 diabetes without the use of any immunosuppression.

UP421 is a primary human HIP-modified pancreatic islet cell therapy for patients with type 1 diabetes. The goal of this investigator-sponsored trial (IST) is to understand safety, immune evasion, islet cell survival, and beta cell function, as measured by C-peptide production, of HIP-modified pancreatic islet cells in type 1 diabetics without any immunosuppression. The trial is being conducted under a clinical trial authorization at Uppsala University Hospital with Dr. Per-Ola Carlsson as the principal investigator.
Results of the study through 12-weeks after cell transplantation demonstrate the survival and function of pancreatic beta cells as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels also increase with a mixed meal tolerance test during testing at these timepoints, consistent with insulin secretion in response to a meal. Magnetic resonance imaging scanning also demonstrates a sustained signal at the site of transplanted cells over time, which is consistent with graft survival. The study identified no safety issues, and the HIP-modified islet cells evaded immune detection.
Sana presented 12-week data at the New York Stem Cell Foundation (NYSCF) conference and expects to report additional data from this study, including longer-term follow-up, as the year progresses at scientific conferences and/or in a peer-reviewed publication.
Advancing our pipeline across multiple indications and modalities:

Type 1 Diabetes – Sana continues the clinical development of gene-modified primary islet cells (UP421) and the pre-clinical development of SC451, a HIP-modified, stem cell-derived pancreatic islet cell therapy. In addition to the human data for UP421 outlined above, Sana shared data for SC451 showing 15-month durability of glycemic control, with no histologic abnormalities, in a mouse model. Sana expects to share additional data in 2025 and file an IND for SC451 as early as 2026.
Allogeneic CAR T cells – The GLEAM study is a Phase 1 study evaluating SC291, a HIP-modified CD19-directed allogeneic CAR T cell therapy, in patients with B-cell mediated autoimmune diseases, including refractory systemic lupus erythematosus and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The VIVID study is a Phase 1 clinical trial evaluating SC262, a HIP-modified CD22-directed allogeneic CAR T cell therapy, in patients with relapsed and/or refractory B-cell malignancies who have received prior CD19-directed CAR T therapy.
Data from the suspended ARDENT trial evaluating SC291 in relapsed or refractory non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) demonstrated the ability to safely dose SC291 with the desired deep B-cell depletion. The goal in the GLEAM study is to demonstrate similar deep B-cell depletion with subsequent clinical benefit for patients with B-cell mediated autoimmune diseases.
Sana is enrolling patients in both the GLEAM and VIVID trials and expects to share data in 2025.
in vivo CAR T cells – SG299, which uses our fusogen platform, allows for cell-specific, in vivo delivery of various payloads. SG299 is a CD8-targeted fusosome that delivers to CD8+ T cells the genetic material to make CD19-directed CAR T cells while avoiding potentially troublesome delivery to tissues such as the liver and gonadal tissue. Sana shared data showing that an SG299 surrogate with another component can lead to deep B-cell depletion in non-human primates without the use of any lymphodepleting chemotherapy. Sana expects to file an IND for SG299 as early as 2026, and we look forward to developing it in a range of B-cell cancers and B-cell mediated autoimmune diseases.
First Quarter 2025 Financial Results

GAAP Results

Cash Position: Cash, cash equivalents, and marketable securities as of March 31, 2025 were $104.7 million compared to $152.5 million as of December 31, 2024. The decrease of $47.8 million was primarily driven by cash used in operations of $48.7 million.
Research and Development Expenses: For the three months ended March 31, 2025, research and development expenses, inclusive of non-cash expenses, were $37.2 million compared to $56.4 million for the same period in 2024.The decrease of $19.3 million was primarily due to lower personnel-related, laboratory, and research costs due to a decrease in headcount and the portfolio prioritization announced in the fourth quarter of 2024, a decrease in clinical development costs primarily related to the suspension of the ARDENT trial in the fourth quarter of 2024 and clinical development milestones recorded in the first quarter of 2024 that did not recur in 2025, and a decrease in facility and other allocated costs primarily due to the portfolio prioritization announced in the fourth quarter of 2024. These decreases were partially offset by increased costs for third-party manufacturing. Research and development expenses include non-cash stock-based compensation of $4.6 million and $5.8 million for the three months ended March 31, 2025 and 2024, respectively.
Research and Development Related Success Payments and Contingent Consideration: For the three months ended March 31, 2025, Sana recognized a non-cash expense of $2.0 million compared to $38.0 million for the same period in 2024, in connection with the change in the estimated fair value of the success payment liabilities and contingent consideration in aggregate. The value of these potential liabilities fluctuates significantly with changes in Sana’s market capitalization and stock price.
General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2025, inclusive of non-cash expenses, were $11.5 million compared to $16.3 million for the same period in 2024. The decrease of $4.8 million was primarily due to lower personnel-related costs, including non-cash stock-based compensation, due to a decrease in headcount, and decreased legal and consulting fees. General and administrative expenses include non-cash stock-based compensation of $2.4 million and $3.2 million for the three months ended March 31, 2025 and 2024, respectively.
Net Loss: Net loss for the three months ended March 31, 2025 was $49.4 million, or $0.21 per share, compared to $107.5 million, or $0.49 per share, for the same period in 2024.
Non-GAAP Measures

Non-GAAP Operating Cash Burn: Non-GAAP operating cash burn for the three months ended March 31, 2025 was $46.6 million compared to $58.7 million for the same period in 2024. Non-GAAP operating cash burn is the decrease in cash, cash equivalents, and marketable securities, excluding cash inflows from financing activities, costs related to the portfolio prioritizations in the fourth quarters of 2024 and 2023, and the purchase of property and equipment.
Non-GAAP Net Loss: Non-GAAP net loss for the three months ended March 31, 2025 was $47.4 million, or $0.20 per share, compared to $69.5 million, or $0.32 per share, for the same period in 2024. Non-GAAP net loss excludes non-cash expenses and gains related to the change in the estimated fair value of contingent consideration and success payment liabilities.

On May 8, 2025 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches to precision T cell activation, reported that the first patient has been dosed in its STARt-002 clinical trial. The Phase 1b/2 study evaluates the safety and efficacy of Marengo’s lead clinical T cell agonist in combination with Trodelvy (sacituzumab govitecan-hziy), Gilead’s approved TROP2-directed antibody-drug conjugate (ADC), in patients with metastatic breast cancer (mBC) (Press release, Marengo Therapeutics, MAY 8, 2025, View Source [SID1234652784]).

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"The growing body of evidence supporting combinations of ADCs and immunotherapies is encouraging, including the recent success of the ASCENT-04 trial combining sacituzumab govitecan with pembrolizumab in metastatic TNBC," said Steven Isakoff, M.D., Ph.D., Medical Oncologist and Director of Breast Cancer Clinical Research at Massachusetts General Hospital. "Invikafusp alfa is a novel bi-specific immunotherapy designed as a dual T cell agonist, and the recent AACR (Free AACR Whitepaper) presentation highlighting its single-agent activity in PD-1 resistant tumors is particularly compelling. Coupled with preclinical evidence of efficacy in breast cancer models, this combination with an ADC offers a promising and innovative approach to expanding immunotherapy options for patients with both HR+/HER2- and triple-negative breast cancers."

STARt-002 (NCT06827613) is a Phase 1b/2 trial, beginning with a run-in phase to determine the optimal tolerated combined dose of the two agents, followed by dose expansion in two patient cohorts: metastatic triple-negative breast cancer (mTNBC) and hormone receptor-positive, HER2-negative (HR+/HER2−) metastatic breast cancer.

The study is currently enrolling patients at three leading North American cancer centers: Massachusetts General Hospital, Sarah Cannon Research Institute, and Princess Margaret Cancer Centre, with additional sites expected to join soon.

"As presented in recent SITC (Free SITC Whitepaper), EMSO IO and AACR (Free AACR Whitepaper) meetings, invikafusp clearly demonstrates promising monotherapy activity in PD-1 resistant tumors including MSS CRC and PD-1 negative NSCLC," said Kevin Chin, M.D., Chief Medical Officer of Marengo Therapeutics. "These data reinforce our belief that invikafusp could serve as a best-in-class immunotherapy backbone for multiple tumor types, particularly when paired with ADCs in immunologically cold tumors such as breast cancer. We are honored to partner with world-class clinical investigators to explore this promising combination for patients with high unmet needs."

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.