On May 13, 2026 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, reported its financial results for the quarter ended March 31, 2026, and provided a corporate update highlighting significant scientific and clinical advancements across its pipeline.

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"Plinabulin continues to demonstrate the ability to enhance both efficacy and tolerability in ADC-based regimens, supporting its positioning as a potential backbone agent across a rapidly evolving treatment landscape," said Dr. Lan Huang, Co-Founder, Chair, and Chief Executive Officer of BeyondSpring. "Data presented at AACR (Free AACR Whitepaper) 2026 further highlights the expanding value of our pipeline and reinforces our strategy of advancing highly differentiated therapies with the potential to address significant unmet medical needs. We believe Plinabulin has the potential to become a foundational combination agent that unlocks the full clinical and commercial value of ADC therapies."

Dr. Huang continued, "At SEED, the advancement of ST-01156, a novel RBM39 molecular glue degrader, into clinical development in oncology indications, coupled with a biomarker-driven approach, underscores the strength and scalability of our RITE3 platform. These milestones reflect disciplined execution across our portfolio and position us to unlock meaningful long-term value through multiple clinical and strategic partnership opportunities."

Recent Clinical Highlights

Plinabulin: Expanding Role as a Potentially Foundational Combination Therapy

AACR 2026 data demonstrated that Plinabulin significantly enhances both efficacy and tolerability of topoisomerase inhibitor–based ADC regimens, with or without immune checkpoint inhibitors
Preclinical findings showed:
Improved complete response rate and survival outcomes
Improved tolerability
Enhanced CD8+ T cell / Treg ratio – shifting the tumor immune environment from suppression to attack
These preclinical results suggest Plinabulin’s potential to address key limitations of current ADC therapies, including limited durability and dose-limiting safety concerns, and support Plinabulin’s positioning as a potential backbone agent across a broad range of ADC combination regimens
SEED Therapeutics: Advancing precision oncology through molecular glue degraders

ST-01156 (RBM39 molecular glue degrader) advanced into Phase 1 clinical development, with the first dose cohort completed
AACR 2026 data demonstrated:
Complete tumor eradication in a neuroblastoma in vivo model
Identification of MYC overexpression and CDKN2A/B deletion as potential predictive biomarkers
This program represents a biomarker-driven precision oncology approach and highlights the productivity of SEED’s proprietary RITE3 platform for targeted protein degradation
First Quarter Financial Results1

Continuing operations:

R&D expenses were $1.1 million for the three months ended March 31, 2026 compared to $0.9 million for the three months ended March 31, 2025. The $0.2 million increase was primarily driven by increased drug manufacturing activities to prepare for potential future study initiation, partially offset by lower regulatory filing advisory and personnel expenses
G&A expenses were $1.1 million for the three months ended March 31, 2026 compared to $1.7 million for the three months ended March 31, 2025. The $0.6 million decrease was primarily driven by lower personnel and legal advisory expenses
Net loss was $2.4 million for the three months ended March 31, 2026 compared to $2.6 million for the three months ended March 31, 2025
Cash, cash equivalents, and short-term investments were $7.9 million as of March 31, 2026
Discontinued operations:

Net loss was $4.3 million for the three months ended March 31, 2026, compared to net income of $3.8 million for the three months ended March 31, 2025
Current assets were $5.3 million as of March 31, 2026
Note 1. As a result of BeyondSpring entering into definitive agreements to sell a portion of its Series A-1 Preferred Shares of SEED, SEED’s operations met the criteria as discontinued operations under ASC 205-20 for financial reporting purposes.

(Press release, BeyondSpring Pharmaceuticals, MAY 13, 2026, View Source [SID1234665625])

On May 13, 2026 Azitra, Inc. ("Azitra" or the "Company") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported financial results for the quarter ended March 31, 2026, and provided a business update.

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Q1 2026 and Recent Business Highlights

Announced the addition of MD Anderson Cancer Center as a clinical site for Phase 1/2 trial of ATR-04 targeting EGFRi-associated skin rash.
Launched innovative protein and peptide programs for the cosmetic and cosmeceutical markets leveraging proprietary filaggrin technologies.
Secured new U.S. patent covering ATR-12, the Company’s lead product candidate being developed for Netherton syndrome.
Announced poster presentation at American Society of Gene and Cell Therapy Annual Meeting (ASGCT) (Free ASGCT Whitepaper) 2026 highlighting ATR-01 preclinical data and the broader potential of Azitra’s engineered live biotherapeutic platform.
Priced private placement financing of up to approximately $10.5 million, with up to an additional approximately $20.9 million upon exercise of warrants.
"The first quarter of 2026 marked a period of meaningful execution across our clinical and strategic priorities as we continue to advance Azitra’s leadership in precision dermatology," said Francisco Salva, CEO of Azitra. "Notably, we significantly grew the clinical footprint for our Phase 1/2 Trial of ATR-04 targeting EGFRi-associated skin rash by adding the world-renowned MD Anderson Cancer Center, which is one of the world’s premier oncology institutions. We believe the addition of MD Anderson will serve to enhance patient access and support efficient trial execution in EGFR inhibitor-associated rash—a condition impacting the majority of patients receiving these therapies."

Mr. Salva continued: "In parallel, we expanded our strategic footprint with the launch of our cosmeceutical initiative, leveraging our proprietary filaggrin protein and peptide technologies to potentially address large and growing consumer markets. Based on our preliminary research, we are confident that our technologies and expertise can offer an exciting new way to address the appearance of fine lines and wrinkles as well as dry sensitive skin and eczema-like rashes. As such, this program represents a compelling opportunity to extend our platform beyond therapeutics and create additional avenues for value creation."

Mr. Salva added: "We are also highlighting our platform this week at ASGCT (Free ASGCT Whitepaper) 2026, where we are presenting ATR-01 preclinical data that underscores the potential of our engineered live biotherapeutics. With this scientific visibility occurring alongside our quarterly update, we believe it reinforces the continued progress and relevance of our platform within the broader gene and cell therapy landscape."

Mr. Salva concluded: "We are also excited to report the recent issuance of a new U.S. patent providing broad protection for our lead product, ATR-12, which we are advancing in a Phase 1b clinical trial for Netherton syndrome. With a strengthened balance sheet, expanding clinical execution, and multiple near-term catalysts, we believe Azitra is well positioned to drive continued progress across both our therapeutic pipeline and emerging cosmeceutical platform."

Pipeline Achievements and Upcoming Milestones

ATR-COSF – New Consumer Initiative to Improve the Appearance of Fine Lines and Wrinkles

Results from synthesized filaggrin ingredients, repeat application study on explanted cosmetic surgery skin, expected mid-2026.
Human cosmetic application study planned for Q3 2026.
ATR-12 – Advancing Phase 1b Clinical Trial in Netherton Syndrome

In June 2025, Azitra reported promising safety data with 50% of patients enrolled.
ATR12-351, a live biotherapeutic product candidate has been generally safe and well-tolerated with occasional, transient, mild to moderate symptoms at application site to date.
Topline data from the Phase 1b trial is anticipated H2 2026.
ATR-04 – Addressing an Unmet Need for Cancer Patients in a Multi-billion Dollar Market Opportunity

Dosed first patient in Phase 1/2 Trial for ATR-04 program targeting oncology patients with EGFRi-associated rash in Q3 2025.
Topline data from first cohort of Phase 1/2 trial expected in H2-2026.
ATR-01 – Targeting Ichthyosis Vulgaris Which Impacts 1.3 million in the United States

Announced positive preclinical data for ATR-01 program in Q3 2025, demonstrating delivery of active, functional filaggrin through human stratum corneum and repair of damaged model skin.
IND-enabling studies continue in 2026.
Financial Results for the Quarter Ended March 31, 2026

Research and Development (R&D) expenses: R&D expenses for the quarter ended March 31, 2026, were $1.6 million compared to $1.3 million for the comparable period in 2025.
General and Administrative (G&A) expenses: G&A expenses for the quarter ended March 31, 2026, were $2.4 million compared to $1.9 million for the comparable period in 2025.
Net Loss was $3.9 million for the quarter ended March 31, 2026, compared to $3.1 million for the comparable period in 2025.
Cash and cash equivalents: As of March 31, 2026, Azitra had cash and cash equivalents of $10.1 million.

(Press release, Azitra, MAY 13, 2026, View Source [SID1234665624])

On May 13, 2026 Arbutus Biopharma Corporation (Nasdaq: ABUS) ("Arbutus" or the "Company"), a clinical-stage biopharmaceutical company focused on infectious disease, reported first quarter 2026 financial results and provided a corporate update.

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LNP Litigation

On March 3, 2026, Arbutus, along with its exclusive licensee, Genevant Sciences ("Genevant"), entered into a settlement agreement to resolve all global patent infringement litigation and patent revocation proceedings involving Moderna. As part of the settlement, Moderna will pay Arbutus and Genevant $950 million upfront in July 2026 (the "Noncontingent Settlement Payment") and an additional $1.3 billion contingent upon an appellate ruling that 28 U.S.C. §1498 does not bar Arbutus’ and Genevant’s claims against Moderna for patent infringement, except as to doses characterized by the district court as having gone to U.S. government employees. Under the Company’s license with Genevant, the Company expects to receive in July 2026 an estimated $178.7 million of the Noncontingent Settlement Payment, which includes reimbursement of the Company’s litigation costs. In addition, the Company owns approximately 16% of the outstanding common equity of Genevant. For more information about the terms and conditions of the settlement with Moderna, including the contingent payment, please refer to Arbutus’ Quarterly Report on Form 10-Q to be filed with the SEC on May 13, 2026 and Annual Report on Form 10-K filed with the SEC on March 23, 2026.

Corporate Updates

In April 2026, the U.S. Food and Drug Administration ("FDA") granted Fast Track designation for imdusiran for the treatment of chronic hepatitis B. The FDA’s Fast Track program is designed to facilitate the development and expedite the review of investigational therapies to treat serious conditions with unmet medical need. A drug granted Fast Track designation may be eligible for several benefits, including earlier and more frequent meetings and communications with the FDA and the potential for rolling review of its application. If relevant criteria are met, investigational therapies that receive Fast Track designation may also qualify for Accelerated Approval or Priority Review of a Biologics License Application or New Drug Application.

Financial Results

Cash, Cash Equivalents and Investments

As of March 31, 2026, the Company had cash, cash equivalents and investments in marketable securities of $95.2 million compared to $91.5 million as of December 31, 2025. During the three months ended March 31, 2026, the Company used $8.1 million in operating activities, which included one-time payments related to its restructuring efforts, and received $11.5 million of proceeds from the exercise of stock options.

Revenue

Total revenue was $179.1 million for the quarter ended March 31, 2026, compared to $1.8 million for the same period in 2025. The increase of $177.4 million was due to license revenue from Genevant related to the Company’s portion of the Noncontingent Settlement Payment.

Operating Expenses

Research and development expenses were $4.1 million for the quarter ended March 31, 2026, compared to $9.0 million for the same period in 2025. The decrease of $4.8 million was due primarily to cost savings from the Company’s decisions to reduce its workforce and discontinue in-house scientific research, as well as lower clinical trial costs as studies neared completion.

General and administrative expenses were $5.9 million for the quarter ended March 31, 2026, compared to $5.8 million for the same period in 2025. This increase was due primarily to higher legal fees driven by the settlement with Moderna, partially offset by cost-cutting efforts by the Company, which drove reductions in employee compensation-related expenses.

There were no restructuring costs in the quarter ended March 31, 2026, compared to $12.4 million for the same period in 2025.

Net Income/Loss

For the quarter ended March 31, 2026, the Company’s net income was $169.7 million, or income of $0.88 per basic and $0.87 per diluted common share, as compared to a net loss of $24.5 million, or a loss of $0.13 per basic and diluted common share, for the quarter ended March 31, 2025.

Outstanding Shares

As of March 31, 2026, the Company had 196.9 million common shares issued and outstanding, as well as 9.7 million stock options and unvested restricted stock units outstanding.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF INCOME AND LOSS
(in thousands, except share and per share data)

Three Months Ended March 31,
2026 2025
Revenue
Collaborations and licenses $ 204 $ 1,316
License revenue from Genevant 178,741 —
Non-cash royalty revenue 181 448
Total revenue 179,126 1,764
Operating expenses
Research and development 4,120 8,959
General and administrative 5,889 5,832
Change in fair value of contingent consideration 209 299
Restructuring costs — 12,373
Total operating expenses 10,218 27,463
Income (loss) from operations 168,908 (25,699 )
Other income
Interest income 815 1,197
Interest expense (17 ) (28 )
Foreign exchange (loss) gain (11 ) 4
Total other income 787 1,173
Net income (loss) $ 169,695 $ (24,526 )
Net income (loss) per common share
Basic $ 0.88 $ (0.13 )
Diluted $ 0.87 $ (0.13 )
Weighted average number of common shares
Basic 193,768,641 190,707,085
Diluted 195,214,067 190,707,085

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)

March 31,
2026 December 31,
2025
Cash, cash equivalents and marketable securities, current $ 95,226 $ 91,471
License receivable from Genevant 178,741 —
Accounts receivable and other current assets 3,044 2,985
Total current assets 277,011 94,456
Property and equipment, net of accumulated depreciation and impairment 22 32
Other non-current assets 131 130
Total assets $ 277,164 $ 94,618

Accounts payable and accrued liabilities $ 4,474 $ 5,459
Lease liability, current 631 547
Total current liabilities 5,105 6,006
Liability related to sale of future royalties 3,278 3,442
Contingent consideration 8,604 8,395
Lease liability, non-current — 199
Total stockholders’ equity 260,177 76,576
Total liabilities and stockholders’ equity $ 277,164 $ 94,618

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)

Three Months Ended March 31,
2026 2025
Net income (loss) $ 169,695 $ (24,526 )
Non-cash items 1,061 5,866
License receivable from Genevant (178,741 ) —
Other changes in working capital (125 ) 5,269
Net cash used in operating activities (8,110 ) (13,391 )
Net cash provided by investing activities 2,199 11,349
Net cash provided by financing activities 11,619 2,784
Effect of foreign exchange rate changes on cash and cash equivalents (10 ) 4
Increase in cash and cash equivalents 5,698 746
Cash and cash equivalents, beginning of period 18,008 36,330
Cash and cash equivalents, end of period 23,706 37,076
Investments in marketable securities 71,520 75,631
Cash, cash equivalents and marketable securities, end of period $ 95,226 $ 112,707

About Imdusiran (AB-729)  

Imdusiran is an RNAi therapeutic specifically designed to reduce all hepatitis B viral proteins and antigens, including hepatitis B surface antigen ("HBsAg"), which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to control the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine delivery technology enabling subcutaneous delivery. In Arbutus’ Phase 2a clinical trials, eight patients with chronic hepatitis B ("cHBV") achieved functional cure following treatment with imdusiran and nucleos(t)ide analogue ("NA") therapy in combination with either pegylated interferon alfa-2a or low dose nivolumab plus an immunotherapeutic, with six out of the eight patients continuing to sustain functional cure for over two years. An additional 41 patients across the Company’s Phase 2a clinical trials were able to remain off NA therapy for at least 48 weeks during their Phase 2a clinical trials following treatment with imdusiran. Two additional patients who discontinued NA therapy in their Phase 2a clinical trials have now achieved functional cure during their participation in long-term follow-up. Functional cure is defined as sustained HBsAg seroclearance and hepatitis B virus deoxyribonucleic acid ("HBV DNA") less than the lower limit of quantification after 24 weeks off treatment, with or without anti-hepatitis B surface antibodies. Clinical data generated thus far has shown imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in HBsAg and HBV DNA.

About HBV  

Hepatitis B is a potentially life-threatening liver infection caused by hepatitis B virus ("HBV"). HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. cHBV infection represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from cHBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from cHBV infection. Approximately 1.1 million people die every year from complications related to cHBV infection despite the availability of effective vaccines and current treatment options.

(Press release, Arbutus Biopharma, MAY 13, 2026, View Source [SID1234665623])

On May 13, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers, reported financial results for the first quarter ended March 31, 2026, and provided a business update.

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"We are very encouraged by the progress made across both our clinical and corporate priorities during the first quarter of 2026, including two partial responses observed in the ACESOT-1051 trial evaluating APR-1051. One of these has been confirmed at a second imaging assessment and this patient remains on study," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "These efficacy results, coupled with the encouraging tolerability, support our precision medicine strategy and reinforce the potential of targeted therapies for patients who have limited treatment options. We look forward to presenting an update from ACESOT-1051 at ASCO (Free ASCO Whitepaper) 2026 and providing additional insight into APR-1051’s emerging clinical profile. The recent $30 million private placement significantly strengthens our balance sheet and enables us to meaningfully expand patient enrollment, generating the clinical data needed to inform the future clinical path for APR-1051. We are grateful for the trust and support of both new and existing investors, whose participation reflects confidence in our development strategy and the potential of our programs."

Key Business Updates and Upcoming Key Milestones

ACESOT-1051: A Biomarker Focused, Phase 1 Trial of Oral WEE1 inhibitor, APR-1051

APR-1051 is a potent and selective, oral small molecule WEE1 inhibitor designed to potentially address therapeutic window limitations observed with earlier WEE1 programs. APR-1051 is being evaluated as monotherapy in uterine serous carcinoma patients regardless of mutation, cyclin E-overexpressing platinum-resistant ovarian cancer, advanced solid tumors harboring CCNE1, CCNE2, PPP2R1A or FBXW7 mutations, colorectal cancer harboring KRAS & TP53 mutations and HPV+ head and neck squamous cell carcinoma. These patient populations are associated with poor prognosis and limited effective treatment options.
To date, two patients in ACESOT-1051 have achieved partial responses ("PR"). One uterine carcinosarcoma patient with PPP2R1A-mutation treated at the 220 mg dose level achieved a 50% reduction in target lesion size per RECIST v1.1 criteria and a significant reduction in CA-125 levels at the first imaging assessment. At the confirmatory, second imaging assessment, an additional 9.5% reduction in target lesion size was observed, along with a further decline in CA-125 to 40.2 U/mL from 362 U/mL at baseline. This patient remains on study with an ongoing PR. There has also been an unconfirmed PR in a second patient with PPP2R1A-mutated uterine serous carcinoma, treated at the 150 mg dose level.
A total of 28 patients have been treated in ACESOT-1051 to date at doses ranging from 10 mg to 300 mg once daily. Six patients have achieved best overall response of stable disease, including patients with colorectal cancer, HPV+ head and neck squamous cell carcinoma, and endometrial cancer.
Dose escalation is ongoing with enrollment currently underway in the 300 mg cohort (dose level 9). Additional eligible patients will be backfilled at 220 mg to further characterize safety, tolerability, and clinical activity, once dose level 9 is fully enrolled.
APR-1051 has been shown to be well tolerated; the two most common adverse events have been Grade 1 or 2 nausea and fatigue. No treatment-related class-limiting toxicities, including severe myelosuppression or severe gastrointestinal toxicity, have been observed to date.
Supported by the $30 million financing that closed on March 31, 2026, Aprea is expanding enrollment in ACESOT-1051 to include at least 50 patients with uterine serous carcinoma (USC), as well as patients with cyclin E-overexpressing, platinum-resistant ovarian cancer (PROC). The expansion is intended to provide additional safety, tolerability and preliminary efficacy data to inform the future clinical path for APR-1051. Completion of dose escalation is anticipated in the second quarter of 2027.
Further clinical updates from ACESOT-1051 are expected during Q2 2026. An abstract entitled "Early results from the first-in-human phase 1 study of WEE1 inhibitor APR-1051 in patients with advanced solid tumors (ACESOT-1051)" has been accepted for the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The poster will be presented on May 30, 2026, 1:30 – 4:30pm CT.
For more information on ACESOT-1051, refer to ClinicalTrials.gov NCT06260514.
ABOYA-119: Clinical Trial Evaluating ATR inhibitor, ATRN-119

ATRN-119 is a potent and highly selective first-in-class macrocyclic ATR inhibitor, designed and developed to be used in patients with tumors harboring mutations in DDR-related genes. Cancers with mutations in DDR-related genes represent a high unmet medical need. These patients often have a poor prognosis and currently lack effective therapeutics options.
During 2025 Aprea established 1,100 mg once daily as the recommended Phase 2 dose (RP2D) in the ABOYA-119 clinical trial. The Company strategically paused further enrollment and has started an orderly wind-down of certain clinical trial site activities associated with the monotherapy, as the Company explores ATRN-119 in potential combination approaches that may unlock greater clinical benefit. The Company is currently in discussions with leading academic institutions to evaluate ATRN-119 in combination with radiation in HPV+ head and neck cancer. Additional investigator-led studies evaluating ATRN-119 with immuno-oncology therapies and antibody-drug conjugates are also being explored.
For more information on ABOYA-119, please refer to clinicaltrials.gov NCT04905914.
Corporate

On March 31, 2026, the Company closed an oversubscribed private placement, raising gross proceeds of $30 million. The private placement was led by Soleus Capital with participation from other new investors, including Vestal Point Capital and Squadron Capital Management, existing investors and certain insiders of the Company. Net proceeds will be used for general corporate purposes and research and development expenses, including the addition of more patients with USC (regardless of mutation status) into the ACESOT-1051 study and expansion into cyclin E-overexpressing PROC patients.
In February 2026, the Company appointed Eugene (Gene) Kennedy, MD, as Chief Medical Advisor. Dr. Kennedy is a highly accomplished physician scientist and biopharmaceutical executive with more than 20 years of experience spanning oncology clinical development, regulatory strategy, and senior corporate leadership across public and private biotechnology companies.
Select Financial Results for the First Quarter Ended March 31, 2026

As of March 31, 2026, the Company reported cash and cash equivalents of $46.5 million compared to $14.6 million as of December 31, 2025. The Company believes that its cash and cash equivalents as of March 31, 2026 will be sufficient to meet its currently projected operating expenses and capital expenditure requirements into the first quarter of 2028.

For the first quarter ended March 31, 2026, the Company reported an operating loss of $3.4 million, compared to an operating loss of $4.1 million in the first quarter of 2025.

Research and Development (R&D) expenses were $1.6 million for the quarter ended March 31, 2026, compared to $2.5 million for the first quarter of 2025. The decrease in R&D expense was primarily related to a decrease of $0.8 million related to the ABOYA-119 clinical trial to evaluate ATRN-119, our clinical-stage oral small molecule inhibitor of ATR, which was voluntarily paused in October 2025.

General and Administrative (G&A) expenses were $1.8 million for each of the quarters ended March 31, 2026 and 2025.

The Company reported a net loss of $3.3 million or ($0.22) loss per basic share on approximately 14.7 million weighted-average common shares outstanding for the quarter ended March 31, 2026, compared to a net loss of $3.9 million ($0.66) per basic share on approximately 6.0 million weighted average common shares outstanding for the comparable period in 2025.

(Press release, Aprea, MAY 13, 2026, View Source [SID1234665622])

On May 13, 2026 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported corporate updates and announced financial results for the quarter ended March 31, 2026.

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"We are encouraged by the interim results from our ALPHA3 trial, which highlight cema-cel’s potential to deliver meaningful MRD clearance with a favorable safety profile in the outpatient setting," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "These findings support our belief that an allogeneic approach can expand access to CAR T earlier in treatment and into community-based practices, where most patients are treated. We are also encouraged by investigator enthusiasm and rapid enrollment and dose escalation in the ALLO-329 RESOLUTION trial as we evaluate the optimal cell dose and lymphodepletion regimen. With the capital raised in April, we believe we are well positioned to execute across our clinical programs and key milestones."

Cema-Cel: Pivotal Phase 2 ALPHA3 1L Consolidation Trial in LBCL
The Company’s lead program, cemacabtagene ansegedleucel (cema-cel), is being evaluated in the ALPHA3 trial, the first pivotal, randomized Phase 2 study in LBCL designed to assess whether MRD-guided intervention before relapse can potentially delay or prevent recurrence. The study identifies high-risk patients using Natera’s CLARITY MRD assay which is powered by its phased variant MRD technology.

In April, the Company reported data from the planned interim futility analysis of ALPHA3. At the protocol-defined data cutoff, triggered when the 24th patient enrolled in the ongoing study arms completed the Day 45 MRD assessment, 58.3% (7/12) of patients in the cema-cel arm achieved MRD negativity compared to 16.7% (2/12) in the observation arm. This represents a 41.6% absolute difference in MRD clearance between the two arms. Published literature suggests that MRD clearance differences of 25-30% may lead to clinically meaningful improvement at study completion.

Cema-cel was well-tolerated as of the data cutoff with no treatment-related serious adverse events. There were no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) or graft-versus-host disease (GvHD), and there were no treatment-related hospitalizations. This profile compares favorably with the broader CAR T experience, where hospitalization for toxicity management remains common.

At the time of the interim analysis, community cancer centers accounted for approximately one-third of screening activity and cema-cel infusions, including sites with limited or no prior CAR T experience. The Company believes participation from these centers, where most patients with LBCL are treated, supports the potential for cema-cel to be delivered beyond specialized academic institutions.

Approximately 80% of patients diagnosed with LBCL receive first-line treatment in the community setting, where autologous CAR T is not readily available. Despite strong clinical efficacy, access to autologous CAR T remains highly constrained, with only approximately 15% of eligible second-line patients receiving treatment.1 These well-documented barriers, including referral patterns, infrastructure requirements, management of adverse events, which requires hospitalization for a substantial portion of patients, and manufacturing constraints, underscore the need for a more accessible, scalable approach which ALPHA3 and cema-cel are designed to address.

MRD status post-treatment has emerged as a strong predictor of relapse in LBCL, creating a potential opportunity to intervene earlier in the course of disease, when disease burden is low, but the risk of progression remains high.2 3 Patients with LBCL who have completed curative-intent treatment in both front-line and later line settings, including autologous CAR T therapy, and achieve MRD-negative status have demonstrated improved progression-free survival (PFS) and EFS compared to those who do not.4 5

The study is currently enrolling across more than 60 sites in North America and is now expanding globally, with site activation and patient screening underway in South Korea and Australia, which will bring the trial to more than 80 sites worldwide. The study is expected to enroll approximately 220 patients, with enrollment anticipated to complete by the end of 2027. The study is powered to detect a 50% reduction in the risk of EFS events, which include the initiation of new anti-lymphoma therapy, disease progression, or death from any cause. The Company anticipates an interim EFS analysis in mid-2027 and the primary EFS analysis in mid-2028. If positive, these results could support a Biologics License Application (BLA) submission.

ALLO-329: Purpose-Built Allogeneic CAR T for Autoimmune Disease
ALLO-329 is a next-generation, dual-targeted CD19/CD70 AlloCAR T product incorporating the Company’s proprietary Dagger technology. Dagger is designed to provide built-in, targeted lymphodepletion by selectively eliminating activated CD70-positive T cells responsible for rejecting AlloCAR T products. This approach is intended to enable robust expansion of allogeneic CAR T cells, while potentially reducing or eliminating the need for conventional cytotoxic lymphodepletion.

The ongoing Phase 1 RESOLUTION trial is a 3+3 dose-escalation study enrolling patients across multiple autoimmune indications, including systemic lupus erythematosus, scleroderma, and inflammatory myositis. The trial is evaluating ALLO-329 following lymphodepletion with cyclophosphamide, with an option to add fludarabine, and a separate arm with no lymphodepletion.

Nine patients have been treated, including six patients across Dose Level 1 (20 million cells) and Dose Level 2 (40 million cells) following lymphodepletion with cyclophosphamide, and three patients across Dose Level 1 (20 million cells) with no lymphodepletion since enrollment began in November 2025. Initial observations at these early low dose levels show signs of clinical activity and favorable tolerability. For context, other CAR T programs in autoimmune trials are evaluating substantially higher dose levels ranging from approximately 100 million cells (autologous) to over 1 billion cells (allogeneic).

Enrollment continues to progress, supported by a strong pool of eligible patients and robust investigator interest in the program. The next update is expected in Q4 2026.

2026 First Quarter Financial Results

Research and development expenses were $32.0 million for the first quarter of 2026, which includes $2.7 million of non-cash stock-based compensation expense.
General and administrative expenses were $14.1 million for the first quarter of 2026, which includes $5.6 million of non-cash stock-based compensation expense.
Net loss for the first quarter of 2026 was $42.6 million, or $0.18 per share, including non-cash stock-based compensation expense of $8.3 million.
The Company had $266.9 million in cash, cash equivalents, and investments as of March 31, 2026.

In April 2026, the Company completed a public offering which resulted in aggregate gross proceeds of $200.4 million, before deducting underwriting discounts and commissions and estimated offering expenses. As a result, the Company has extended its cash runway into the first quarter of 2029. Based upon our current forecast for the overall timing of the ALPHA3 program, we are modestly increasing our guidance for operating cash expense in 2026 from approximately $150 million to $165 million. GAAP Operating Expenses are also expected to modestly increase from approximately $210 million to $225 million, including estimated non-cash stock-based compensation expense of approximately $35 million. These estimates exclude any impact from potential business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. PT / 5:00 p.m. ET to discuss financial results and provide a business update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

(Press release, Allogene, MAY 13, 2026, View Source [SID1234665621])