On May 13, 2026 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients for broad accessibility, reported financial results for the first quarter ended March 31, 2026, and provided a business update.

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"We are incredibly excited and focused on initiating RECLAIM-LN, our Phase 2 potentially registrational clinical trial of FT819 for the treatment of lupus nephritis to provide eligible trial patients a truly accessible CAR T-cell treatment option," said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics. "Our acceptance into the FDA’s highly competitive CDRP Program, combined with our RMAT designation, reflects a recognition of the strength of our initial Phase 1 clinical data and provides a powerful regulatory foundation as we advance FT819 along an accelerated clinical pathway. With planned clinical advancement of FT819 on multiple fronts, next generation CAR T-cell programs entering clinical trials, a strong cash balance supporting our runway into 2028 and a team that continues to execute at the highest level, we believe 2026 will be a defining year for Fate Therapeutics."

Clinical Development & Program Updates

RECLAIM-LN, Phase 2 potentially registrational clinical trial of FT819 in patients with refractory moderate-to-severe SLE with lupus nephritis

The Company anticipates commencing patient dosing in FT819-201, RECLAIM – LN (NCT07570862), a Phase 2 potentially registrational clinical trial of FT819 in patients with refractory moderate-to-severe SLE with lupus nephritis, in the second half of 2026. The planned open-label, single-arm study was developed during interactions with the FDA under the RMAT designation for FT819, and is expected to enroll approximately 53 patients, evaluating a single dose of FT819 administered at 900 million cells following bendamustine conditioning, with complete renal response (CRR) at six months as the primary endpoint. The conditioning regimen selected for RECLAIM – LN is unique and less-intensive than most CAR T-cell clinical trials that incorporate up to 3 days of co-administration of cyclophosphamide and fludarabine, a combination that was perceived as less desirable to patients and clinicians during the Company’s Phase 1 clinical study. Based on enrollment cadence in the Phase 1 clinical trial and current clinical site engagement, the unique on-demand availability of FT819, and the option for outpatient treatment with reduced conditioning chemotherapy requirements, the Company aims to complete the enrollment of the RECLAIM – LN clinical study approximately 15 months from commencement.

CDRP program selection for FT819 to align CMC plans with the FDA early in the development process

FT819 has been selected for participation in the FDA’s Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) Program, a highly selective initiative designed to accelerate development of investigational therapies for serious diseases with unmet medical need through enhanced FDA engagement on CMC-related activities. Participation in the program enables increased interaction with the Agency, including additional CMC-focused Type B meetings with FDA review staff intended to help clarify development strategies, address key manufacturing questions, align CMC readiness and support a more efficient regulatory review process. The Company believes participation in the CDRP Program, in addition to its previously received Regenerative Medicine Advanced Therapy (RMAT) designation, has the potential to accelerate the registration pathway of FT819 in SLE.

FT819-102 Phase 1 clinical trial now enrolling in 18 clinical sites globally

The Company’s ongoing multi-center Phase 1 clinical trial of FT819 (NCT06308978) evaluates the safety, pharmacokinetics, and efficacy of FT819 administered under either Regimen A, a fludarabine-free less-intensive conditioning regimen consisting of bendamustine or cyclophosphamide, or Regimen B, where FT819 is added to background maintenance therapy without conditioning chemotherapy. The study is enrolling patients across four autoimmune disease indications: systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myositis (IIM), and anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV). As of May 5, 2026, enrollment stands at:

Nineteen SLE patients across the two regimens have been treated
Eight patients have been treated across SSc, IIM and AAV
Of these 27 patients, 8 have been treated in an outpatient setting
Clinical enrollment across the study indications continues to accelerate with a focus on bringing on-demand accessibility of FT819 and outpatient treatment to community hospitals and infusion centers, and advancing the clinical development of various autoimmune indications and study cohorts, including Regimen B of SLE, where FT819 is uniquely demonstrating meaningful reduction in lupus disease activity and improvement in quality of life without the use of conditioning chemotherapy. This week at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, the Company showed in Regimen B of the FT819-102 Phase 1 study that a single dose of FT819 without the use of conditioning chemotherapy demonstrated meaningful clinical responses at dose level 1 (360 million cells) in patients with active SLE, with 3 of 3 patients achieving systemic lupus erythematosus responder index (SRI-4) and 2 of 3 patients achieving lupus low disease activity state (LLDAS) (data cutoff of April 9, 2026). The Company is now treating patients at dose level 2 (900 million cells) in Regimen B and exploring a repeat-dose paradigm without the use of conditioning chemotherapy.

The Company anticipates providing further updates on its clinical progress at European Alliance of Associations for Rheumatology (EULAR) Annual Congress in June of 2026 as well as in other scientific conferences in the second half of 2026.

Clinical Data Presented at Pediatric Rheumatology Symposium (PRSYM) and Congress of Clinical Rheumatology CCR-East continue to demonstrate meaningful and durable clinical responses, broad accessibility, and a favorable emerging safety profile of FT819 in SLE

Highlights of the presentation included clinical safety, efficacy and translational data from 13 SLE patients with a data cutoff of December 23, 2025, with data showing clinically meaningful improvements in disease activity and patient-reported outcome measures following treatment with FT819 using less-intensive conditioning chemotherapy in Regimen A. These responses were observed early and were maintained over time, as demonstrated by i) SLEDAI-2K: Scores decreased by 13 points (mean) from baseline at Month 6, ii) PGA: Scores decreased by 1.75 points (mean) from baseline at Month 6 ​; iii) UPCr: Levels decreased by 0.90 and 1.14 mg/mg (mean) from baseline at Months 3 and 6, respectively, and iv) FACIT-Fatigue: Scores improved by 23.4 points (mean) from baseline at Month 3 with continued meaningful improvement over time. The data presented continue to support the clinical advancement of FT819.

The Company believes the strength of its FT819 Phase 1 clinical data, combined with two significant regulatory recognitions, provides a compelling foundation for the RECLAIM – LN study and future pivotal programs. FT819 has demonstrated progressive and durable reductions in disease activity, clinically meaningful reductions in urine protein-to-creatinine ratio in patients with lupus nephritis, effective B-cell depletion with immune remodeling, a notable drop in FACIT-Fatigue score resulting in profound improvements in quality of life for treated patients, and a favorable tolerability profile.

FT839: Next-generation Off-the-Shelf CAR T-cell Program Designed to co-target CD19 and CD38 and Armed with Novel Sword & Shield Technology Designed to Eliminate the Need for Conditioning Chemotherapy

The Company plans to submit an Investigational New Drug (IND) application to the FDA to support a Phase 1 basket autoimmune study to evaluate FT839 in combination with standard of care therapies across SLE, SSc, AAV, IIM, and rheumatoid arthritis (RA), including without the use of conditioning chemotherapy, and expects to commence enrollment in the Phase 1 study in the second half of 2026. Preclinical data for FT839 was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2026, highlighting the ability of FT839 to simultaneously target and eliminate multiple pathogenic immune cell types across a broad range of autoimmune diseases and hematologic malignancies. FT839 preclinical data in autoimmune disease are expected to be presented at the 2026 American Society of Gene and Cell Therapy Annual Meeting and at the 2026 EULAR Annual Congress, further discussing the scientific rationale for the differentiated dual-CAR approach of FT839 in conditions where complex, multi-compartment immune dysregulation has resulted in hard-to-treat diseases.

The breadth of the therapeutic potential of FT839 is reflected in the range of clinical collaboration opportunities in discussion with leading academic centers, including in autoimmune disease and in hematological malignancies, including multiple myeloma and diffuse large B-cell lymphoma. The Company believes this growing network of academic partnerships underscores the scientific community’s recognition of the potential of FT839 to address serious diseases across both autoimmune and oncology settings.

The Company will provide further updates on FT839 at American Society of Gene and Cell Therapy Annual Meeting in May of 2026.

FT836 Next-generation Off-the-Shelf CAR T-cell Program Designed to Uniquely Target Broadly Expressed Stress Cancer Antigens MICA/B and Armed with Novel Sword & Shield Technology

The Company is currently enrolling patients in a Phase 1 study of FT836, its multiplex-engineered CAR T-cell product candidate uniquely targeting major histocompatibility complex (MHC) proteins A (MICA) and B (MICB) which are expressed on many types of cancer cells with limited detection on healthy tissue. The Phase 1 study is designed to assess the tolerability and activity of FT836 without administration of conditioning chemotherapy for the treatment of advanced solid tumors. As of April 20, 2026, nine patients have been treated with FT836 in the Phase 1 basket solid tumor study, including patients in the cetuximab combination (Regimen C) and trastuzumab combination (Regimen E) arms. To date, FT836 has been well-tolerated with no ICANS, GvHD, CRS, or dose-limiting toxicities at dose level 1 of Regimen C, supporting its potential as a broadly accessible treatment with a favorable emerging safety profile. The Company expects to present updated FT836 clinical data across a larger patient cohort at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2026. Additionally, the FDA has cleared an IND for an investigator-initiated trial for FT836 in combination with daratumumab for a novel treatment strategy in multiple myeloma to be conducted at the Medical College of Wisconsin. Patient treatment in this IIT is expected to commence in mid-2026.

The Company plans to provide further updates on FT836 at American Society of Gene and Cell Therapy Annual Meeting and at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in May of 2026.

First Quarter 2026 Financial Results

Cash & Investment Position: Cash, cash equivalents, and investments as of March 31, 2026 were $174.8 million.
Total Revenue: Revenue was $1.3 million for the first quarter of 2026, which was derived from the conduct of preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under the Company’s collaboration with Ono Pharmaceutical.
Total Operating Expenses: Total operating expenses were $34.3 million for the first quarter of 2026, including research and development expenses of $24.7 million and general and administrative expenses of $9.6 million. Such amount included $3.9 million of non-cash stock-based compensation expense.
Shares Outstanding: As of March 31, 2026, common shares outstanding were 116.3 million, pre-funded warrants outstanding were 3.9 million, and preferred shares outstanding were 2.8 million. Each preferred share is convertible into five common shares.
Financial Guidance

Operating runway into 2028, supported by $174.8 million in cash, cash equivalents, and investments.
About FT819

FT819 is an off-the-shelf CD19-targeting chimeric antigen receptor (CAR) T-cell product engineered to improve safety and efficacy. Analogous to master cell banks used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master induced pluripotent stem cell (iPSC) bank serves as the starting cell source to manufacture FT819, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. FT819 is well-defined and uniform in composition, produced at a low cost of goods, and can be stored in inventory for off-the-shelf, on-demand availability to enable access for a broad patient population. This research was additionally made possible by funding from the California Institute for Regenerative Medicine (CIRM), a state agency in California that supports research in regenerative medicine, stem cell therapy, gene therapy, and clinical trials. (Grant number: CLIN2-16303)

About FT839

FT839 is the Company’s first multi-antigen dual-CAR T-cell product candidate that is designed to express two unique CARs: a first CAR targeting the B-cell lineage marker CD19 and the second CAR targeting the immune activation marker CD38, which is often found on aberrant T, NK and B cells. FT839 is the second program to contain the Company’s Sword and ShieldTM technology. At the 2025 ASH (Free ASH Whitepaper) Annual Meeting, the Company presented preclinical data demonstrating the ability of FT839, with its dual-CAR mechanism and unique ability to synergize with monoclonal antibodies and T-cell engagers through its incorporated hnCD16 Fc receptor and CD3 fusion receptor, respectively, to specifically eliminate a variety of pathogenic immune cell types without requiring conditioning chemotherapy, suggesting its potential to broadly treat complex autoimmune diseases and hematologic malignancies. The Company has created the FT839 master cell bank and is completing IND-enabling activities to support initial clinical investigation of FT839 for the treatment of autoimmune diseases and hematologic malignancies in 2026.

About FT836

FT836 is the Company’s multipoint-edited CAR T-cell product candidate uniquely targeting major histocompatibility complex (MHC) proteins A (MICA) and B (MICB). The expression of MICA/B cell-surface proteins is induced by cellular stress or malignant transformation and is detectable across many types of cancer cells with limited expression on healthy tissue. At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual meeting held in November 2025, the Company presented preclinical data showing FT836 exhibited potent and durable CAR-dependent antigen-driven proliferation with robust activity across diverse solid tumors and that FT836 can be combined with standard of care chemotherapy to induce MICA/B surface expression for enhanced target recognition and additive antitumor activity. In addition, the Company presented immunohistochemistry analysis showing that MICA/B is expressed throughout tumor tissue in biopsy samples obtained from patients with various cancers, including colorectal cancer. FT836 is also the Company’s first product candidate to incorporate the novel Sword & ShieldTM technology, which utilizes the Company’s novel alloimmune defense receptor (ADR) alongside CD58 knockout (KO), to both target and evade host alloreactive immune cells for a comprehensive strategy to avoid the need for conditioning chemotherapy. In January 2025, the Company secured a $4 million award from the California Institute of Regenerative Medicine (CIRM) to support IND-enabling activities for FT836.

(Press release, Fate Therapeutics, MAY 13, 2026, View Source [SID1234665629])

On May 13, 2026 Lantern Pharma Inc. (NASDAQ: LTRN) ("Lantern" or the "Company"), a clinical-stage AI-driven precision oncology company developing targeted and transformative cancer therapies using its proprietary AI and machine learning platforms with multiple clinical stage drug programs, reported that it has entered into a definitive agreement for the purchase and sale of an aggregate of 2,135,923 shares of its common stock (or pre-funded warrants in lieu thereof) at a purchase price of $2.06 per share (or pre-funded warrant in lieu thereof) in a registered direct offering. In addition, in a concurrent private placement, the Company will issue unregistered warrants to purchase up to 2,135,923 shares of common stock. The warrants will have an exercise price of $2.27 per share, will be exercisable six months following the initial issuance date, and will expire five years following the initial exercise date. The closing of the offering is expected to occur on or about May 14, 2026, subject to the satisfaction of customary closing conditions.

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The Company has also communicated plans to create an independent business entity composed of the AI platform, withZeta.ai, and related technologies and personnel under the leadership of CEO Mr. Panna Sharma. The Company intends to separate its public facing clinically trained AI agent into an independent business entity in order to access dedicated funding sources and potentially realize valuation multiples separate from its drug development operations, which such entity the Company anticipates will become a newly listed company on a national stock exchange or market. Ryan Lane, from Empery Asset Management, whose funds led the financing round, commented: "We started using the AI platform shortly after its public release and have found the prompt results exceptionally useful for our in-house compound viability analysis versus generic LLM models. We believe with additional funding, withZeta will become a leading AI co-scientist for investors and biotech executives."

The Company plans on hosting a separate investor webinar and meeting to provide additional details in the coming month.

Rodman & Renshaw LLC is acting as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering are expected to be approximately $4.4 million, before deducting the placement agent fees and other offering expenses payable by the Company. The potential additional gross proceeds from the unregistered warrants, if fully exercised on a cash basis, will be approximately $4.85 million. No assurance can be given that any of the warrants will be exercised. The Company currently intends to use the net proceeds from the offering for working capital and other general corporate purposes.

The shares of common stock (or pre-funded warrants in lieu thereof) (but not the warrants issued in the private placement or the shares of common stock underlying such warrants) are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-279718) filed with the Securities and Exchange Commission ("SEC") on May 24, 2024, and became effective on June 10, 2024. The registered direct offering of the shares of common stock (or pre-funded warrants in lieu thereof) is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the shares of common stock (or pre-funded warrants in lieu thereof) being offered in the registered direct offering will be filed with the SEC and be available at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the registered direct offering may also be obtained, when available, by contacting Rodman & Renshaw LLC at 600 Lexington Avenue, 32nd Floor, New York, NY 10022, by telephone at (212) 540‑4414, or by email at [email protected].

The warrants described above are being issued in a concurrent private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Lantern Pharma, MAY 13, 2026, View Source;Announces-up-to-9-25-Million-Registered-Direct-Offering-with-Existing-Holders-and-a-Single-Institutional-Investor/default.aspx [SID1234665647])

On May 13, 2026 Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets while developing a diverse pipeline of novel, multifunctional biotherapeutics, reported that management will participate in the following upcoming investor conferences:

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2026 Stifel Virtual Targeted Oncology Forum: Zymeworks’ management will participate in one-on-one meetings and a fireside chat on May 20 at 9:00 am Eastern Time (ET) virtually.
TD Cowen 7th Annual Oncology Innovation Summit: Zymeworks’ management will participate in a fireside chat on May 27 at 4:30 pm ET virtually.
2026 Jefferies Global Healthcare Conference: Zymeworks’ management will participate in one-on-one meetings and a fireside chat on June 3 at 8:45 am ET in New York, NY.

(Press release, Zymeworks, MAY 13, 2026, View Source [SID1234665662])

On May 13, 2026 Aptose Biosciences Inc. ("Aptose" or the "Company") (TSX: APS and OTC: APTOF), a clinical-stage precision oncology company developing a tuspetinib (TUS)-based triple drug frontline therapy to treat patients with newly diagnosed acute myeloid leukemia (AML), reported financial results for the first quarter ended March 31, 2026, and provided a corporate update.

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"Our TUSCANY clinical trial of tuspetinib in combination with venetoclax (VEN) and azacitidine (AZA) for frontline treatment of newly diagnosed acute myeloid leukemia (AML) continues to deliver robust safety and response data, and we’re pleased that an update of our TUS+VEN+AZA triplet clinical data has been selected for an oral presentation at the upcoming EHA (Free EHA Whitepaper)2026 Congress in June," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. "Likewise, we are pleased that the expected acquisition of the Company by Hanmi Pharmaceutical will allow the continued development of tuspetinib for AML patients in need of a well-tolerated and broadly active therapy to treat those with even the most adverse of mutation profiles, including those with TP53-mutated disease."

Key Corporate Highlights

Update on Acquisition of Aptose by Hanmi Pharmaceutical – On April 30, 2026, Aptose announced that the closing of the previously announced arrangement (the "Arrangement") with Hanmi Pharmaceutical Co. Ltd. ("Hanmi") and HS North America Ltd., a wholly owned subsidiary of Hanmi (together with Hanmi, the "Hanmi Purchasers"), has been delayed as certain Korean regulatory approvals pertaining to the Arrangement remain under way (press release here). The parties do not anticipate that the regulatory reviews will prevent closing and continue to work toward completing the Arrangement that they target for the month of May. The Company will provide a further update when available.

Under the terms of the Arrangement Agreement, Aptose shareholders, other than the Hanmi Purchasers and their respective affiliates that hold any common shares of Aptose (the "Common Shares"), receive C$2.41 in cash per Common Share, which represents a premium of 28% over Aptose’s 30-day VWAP of C$1.88 on the Toronto Stock Exchange (TSX) at the date of the execution of the Arrangement Agreement.
Aptose Clinical Data to be Presented at EHA (Free EHA Whitepaper) in Oral Presentation – Data from Aptose’s Phase 1/2 TUSCANY trial in newly diagnosed patients treated with tuspetinib (TUS) in combination with standard of care dosing venetoclax and azacitidine (TUS+VEN+AZA triplet) has been selected for oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress (EHA 2026), being held June 11-14, 2026, in Stockholm, Sweden. The TUS+VEN+AZA triplet is being developed as a safe and mutation agnostic frontline therapy to treat large, mutationally diverse populations of newly diagnosed AML patients who are ineligible to receive induction chemotherapy. As reported prior, the first two dose cohorts at 40 mg of TUS or 80 mg of TUS in the TUS+VEN+AZA triplet, demonstrated safety, complete remissions, and MRD negativity across patients with diverse mutations, including TP53-mutated/CK AML and FLT3-wildtype AML patients. The oral presentation at EHA (Free EHA Whitepaper) will include updated data at the 80 mg and 120mg dose levels, as well as new data from the 160 mg dose of TUS, updated safety, complete remissions, minimal residual disease (MRD) and other clinical findings with a longer duration of follow up.

EHA session title: s446 Novel treatments in AML

Presentation title: TUSCANY Study of Safety and Efficacy of Tuspetinib Plus Standard of Care Venetoclax and Azacitidine in Study Participants with Newly Diagnosed AML Ineligible for Induction Chemotherapy

Live session date & time: June 14, 2026 (11:00 – 12:15 CEST)
Aptose Returns Luxeptinib License Rights to CGI – Aptose and CGI Invites Co., Ltd. ("CGI") have entered into a Termination of License Agreement relating to the exclusive license originally granted to Aptose under a 2016 agreement (updated in 2018) whereby Aptose returned the license rights to CG-806 to CGI. Under the license agreement, Aptose held exclusive rights from CGI to develop and commercialize the compound CG-806, also known as luxeptinib (LUX).

FINANCIAL RESULTS OF OPERATIONS
Aptose Biosciences Inc.
Statements of Operations Data
(unaudited)
($ in thousands, except for share and per share data)

Three Months Ended
March 31,
2026 2025
Operating expenses:
Research and development $ 3,621 $ 2,364
General and administrative 3,561 3,097
Total operating expenses 7,182 5,461
Total other expenses, net (452 ) (82 )
Net loss $ (7,634 ) $ (5,543 )
Net loss per common share, basic and diluted $ (2.99 ) $ (2.61 )

Weighted average number of common shares outstanding, basic and diluted 2,552,429 2,126,287


Net loss for the three months ended March 31, 2026 of $7.6 million increased $2.1 million as compared with a net loss of $5.5 million for the comparable period in 2025.

Aptose Biosciences Inc.
Balance Sheet Data
(unaudited)
($ in thousands)

March 31, December 31,
2026 2025
Cash and restricted cash $ 4,105 $ 4,096

Working capital (5,084 ) (2,860 )
Total assets 10,723 10,012
Long-term liabilities 34,156 27,873
Accumulated deficit (574,069 ) (566,435 )

Shareholders’ deficit (34,672 ) (27,167 )

Total cash and restricted cash as of March 31, 2026 was $4.1 million. The Company does not have sufficient cash to fund operations and relies on advances made by Hanmi to fund operations. The Company is actively deploying cost reduction efforts to extend cash runway.

As of May 8, 2026, there were 2,552,429 Common Shares issued and outstanding. In addition, there were 37,083 Common Shares issuable upon the exercise of outstanding stock options and 1,139,085 Common Shares issuable upon the exercise of outstanding warrants.

RESEARCH AND DEVELOPMENT EXPENSES

Research and development expenses for the three months ended March 31, 2026 and 2025 were as follows:

    Three Months Ended
    March 31,
(in thousands)   2026   2025

Program costs – Tuspetinib $ 2,880 $ 1,479
Program costs – Luxeptinib (5 ) 98
Personnel-related expenses 695 646
Stock-based compensation 51 141
Total $ 3,621 $ 2,364

Research and development expenses increased by $1.2 million to $3.6 million for the three months ended March 31, 2026 as compared to $2.4 million for the comparable period in 2025. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following activities:

Program costs for tuspetinib increased by $1.4 million to $2.9 million for the three months ended March 31, 2026 compared to $1.5 million for the comparable period in 2025. The higher program costs for tuspetinib in the current period are attributable to increased costs associated with the TUSCANY study as we continue the advancement of tuspetinib.

Program costs for luxeptinib decreased by approximately $0.1 million during the three months ended March 31, 2026 compared to the comparable period in 2025 due to a decrease in clinical trial costs as the trial is being wound down.

Personnel-related expenses remained relatively consistent during the three months ended March 31, 2026 compared to the comparable period in 2025 as headcount for research and development personnel remained consistent between periods.

Stock-based compensation decreased by $0.1 million for the three months ended March 31, 2026 compared to the comparable period in 2025. This decrease was primarily due to stock options forfeited and/or vested in prior periods that are no longer being expensed resulting in lower expense in the current period.

(Press release, Aptose Biosciences, MAY 13, 2026, View Source [SID1234665632])

On May 13, 2026 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported the successful completion of process tech transfer and product introduction to Thermo Fisher Scientific, the world leader in serving science, for IBTROZI (taletrectinib) to treat advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The transition was submitted as a supplement to the IBTROZI New Drug Application held by Nuvation Bio and is now complete.

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"Our commitment to unencumbered access to IBTROZI for appropriate patients with ROS1+ NSCLC starts at the manufacturing stage, where we work to ensure that our collaborators and processes deliver critical medicine with high quality," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "We are pleased to collaborate with Thermo Fisher, a leading contract manufacturer of pharmaceuticals, to bring IBTROZI manufacturing closer to the patients we serve."

Jennifer Cannon, President, Commercial Operations, Pharma Services at Thermo Fisher added, "We are pleased that Nuvation Bio has selected us for their final drug product manufacturing of IBTROZI in the United States. Our collaboration with Nuvation Bio builds on our commitment to work with both biotech and pharmaceutical companies alike to help ensure the availability and access to innovative treatments that address significant unmet medical needs for patients."

About ROS1+ NSCLC
Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases.

About IBTROZI
IBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved IBTROZI for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more at IBTROZI.com. 

Indication
IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC).

IMPORTANT SAFETY INFORMATION FOR IBTROZI (taletrectinib)

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months).

Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients.

Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients.

Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months).

ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients.

QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner.

In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade ≥3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients.

Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc.

Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade ≥3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients.

Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months).

Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation.

Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients.

Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman.

ADVERSE REACTIONS
Among patients who received IBTROZI, the most frequently reported adverse reactions (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%).

The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%).

DRUG INTERACTIONS

Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use.
Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI.
OTHER CONSIDERATIONS

Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity.
Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose.
Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible.
Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established.
Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation.
Please see accompanying full Prescribing Information.

(Press release, Nuvation Bio, MAY 13, 2026, View Source [SID1234665648])