On August 13, 2026 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, reported financial results for the quarter ended June 30, 2026, and highlighted its recent corporate and pipeline progress.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our team delivered strong second-quarter execution: advancing our strategic priorities, strengthening our financial position, and sharpening our focus to accelerate the development of life-changing medicines for patients," said Eric Risser, President and Chief Executive Officer of MacroGenics. "With a significantly stronger financial foundation, we are well-positioned to advance our pipeline and deliver a catalyst-rich period ahead."

Advancement of Innovative Pipeline
MacroGenics is developing a portfolio of investigational agents, including both topoisomerase I inhibitor-based antibody-drug conjugates (ADCs) and T-cell engagers (TCEs).

•MGC026 is a novel ADC targeting B7-H3, a protein expressed across the tumor microenvironment, including tumor-associated stroma and vasculature. The dose-escalation portion of the ongoing Phase 1 study has been completed after evaluating doses ranging from 1 mg/kg to 9 mg/kg every three weeks (Q3W). A dose of 7.5 mg/kg Q3W is being further evaluated in four tumor-specific cohorts, including squamous cell carcinoma of the head and neck (SCCHN), endometrial cancer, melanoma and soft tissue sarcoma. MGC026 recently achieved an important milestone, with the SCCHN cohort meeting the pre-specified response threshold to advance into Stage 2. Interim results from the Phase 1 study have been accepted for poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2026 Congress in October.

•MGC028 is a first-in-class ADC targeting ADAM9, a protein that is overexpressed in multiple solid tumors. The dose escalation study of MGC028 is ongoing and the Company anticipates providing an update with preliminary clinical results in late 2026.

•MGC030 is a first-in-class ADC targeting an undisclosed antigen expressed across several solid tumors. The Company’s Investigational New Drug (IND) application was submitted ahead of schedule and cleared by the U.S. Food and Drug Administration (FDA) in the second quarter of 2026. The Company plans to commence a Phase 1 dose escalation study in the third quarter of 2026.

•Lorigerlimab is a PD-1 × CTLA-4 bispecific DART molecule being evaluated in patients with advanced gynecologic cancers. MacroGenics continues the Phase 2 LINNET study of lorigerlimab, with the interim data accepted for poster presentation at the ESMO (Free ESMO Whitepaper) 2026 Congress. The Company is enrolling 20 additional patients with clear cell gynecologic cancer (CCGC) at a dose of 3 mg/kg Q3W and anticipates reporting updated study results in the first half of 2027.

Future Pipeline

MacroGenics is advancing multiple preclinical programs that incorporate proprietary platforms for next-generation TCEs and ADCs. Following completion of preclinical proof-of-concept studies and preliminary toxicology in non-human primates, the Company recently nominated MGD032, a novel next-generation TCE against an undisclosed target. This molecule is now advancing in IND-enabling studies.

Partnership Updates

MacroGenics maintains partnerships with Incyte Corporation, Sanofi and Gilead Sciences, Inc. spanning multiple commercial, clinical and preclinical programs. Through these collaborations, the Company remains eligible to receive up to approximately $2.4 billion in aggregate future milestone payments, in addition to potential royalties on net product sales.

On August 11, the Company announced that Gilead had exercised its option to license a preclinical bispecific program under the companies’ 2022 collaboration agreement. This option exercise triggers a $10.0 million payment to MacroGenics. The Company remains eligible to earn additional milestones and royalties based on net product sales.

Corporate Update

Corporate Restructuring and Divestiture of Manufacturing Operations. In July, MacroGenics announced the completion of the sale of its GMP drug substance manufacturing operations to Bora Pharmaceuticals Co., Ltd. and Bora Biologics USA, LLC (collectively, Bora) for a previously disclosed base purchase price of $122.5 million. At closing, the Company received $119.6 million in cash consideration, reflecting adjustments for net working capital and indebtedness, before transaction fees and expenses. Approximately 140 previous MacroGenics employees were hired by Bora and, together with a concurrent restructuring, MacroGenics’ workforce is anticipated to be reduced to approximately 140 employees by year-end. As part of the transaction, MacroGenics entered into a supply agreement with Bora to support process development and drug substance production for the Company’s internal pipeline. MacroGenics’ transition to a fully-outsourced manufacturing model and a leaner organization is expected to enable greater focus on the advancement of its novel therapeutics pipeline, while providing increased flexibility and cost effectiveness.

Second Quarter 2026 Financial Results
•Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2026, were $173.3 million, compared with $189.9 million as of December 31, 2025. The balance as of June 30, 2026, included $60.0 million received from Sagard Healthcare Partners related to the monetization of ZYNYZ royalties. During the quarter, the Company also earned a $24.5 million regulatory milestone from Sanofi related to a U.S. approval of TZIELD, with payment expected in the third quarter of 2026. Subsequent to June 30, 2026, MacroGenics received cash consideration of $119.6 million from Bora in connection with the completed sale of the Company’s GMP manufacturing operations. In addition, in August, the Company achieved a $10.0 million milestone pursuant to Gilead’s exercise of its option to obtain an exclusive license for a preclinical bispecific program under the companies’ 2022 collaboration agreement. The Company’s pro forma cash, cash equivalents and marketable securities as of June 30, 2026, including net proceeds from Bora, Sanofi and Gilead, totaled $327 million.

•Revenue: Total revenue was $32.8 million for the quarter ended June 30, 2026, compared with $6.9 million for the quarter ended June 30, 2025. The increase was primarily due to achievement of the $24.5 million regulatory milestone from Sanofi related to U.S. approval of TZIELD.

•R&D Expenses: Research and development expenses were $38.8 million for the quarter ended June 30, 2026, compared with $40.8 million for the quarter ended June 30, 2025. The decrease was primarily due to decreased costs related to lorigerlimab and discontinued programs, partially offset by increased trial costs related to MGC026 and MGC028.

•G&A Expenses: General and administrative expenses were $7.9 million for the quarter ended June 30, 2026, compared with $9.3 million for the quarter ended June 30, 2025. The decrease was primarily due to lower personnel-related costs, including stock-based compensation expense.
•Net Income (Loss): Net income was $19.5 million for the quarter ended June 30, 2026, compared with net loss of $36.3 million for the quarter ended June 30, 2025. Net income for the quarter ended June 30, 2026,, reflects income from discontinued operations of $89.2 million related to the sale of the Company’s GMP manufacturing operations to Bora, and a $52.8 million non-cash loss on the extinguishment of the ZYNYZ royalty monetization liability.
•Shares Outstanding: Shares of common stock outstanding as of June 30, 2026, were 63,645,711.
•Cash Runway Guidance: MacroGenics anticipates that its pro forma cash, cash equivalents and marketable securities of $327 million as of June 30, 2026, plus other projected future payments from partners, will support the Company’s cash runway through 2028.

MACROGENICS, INC.
SELECTED CONSOLIDATED BALANCE SHEET DATA
(Amounts in thousands)
June 30, 2026 December 31, 2025
(unaudited)
Cash, cash equivalents and marketable securities $ 173,305 $ 189,913
Total assets 345,409 256,846
Deferred revenue 55,503 56,779
Total stockholders’ equity 42,873 55,591

MACROGENICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(Unaudited)
(Amounts in thousands, except share and per share data)
Three Months Ended June 30, Six Months Ended June 30,
2026 2025 2026 2025
Revenues:
Collaborative and other agreements $ 25,488 $ 5,558 $ 26,058 $ 12,157
Royalty revenue 7,344 1,311 13,495 1,754
Total revenues 32,832 6,869 39,553 13,911
Costs and expenses:
Research and development 38,780 40,791 73,754 80,489
General and administrative 7,904 9,302 17,614 20,020
Total costs and expenses 46,684 50,093 91,368 100,509
Loss from operations (13,852) (43,224) (51,815) (86,598)
Loss on extinguishment of royalty monetization liability (52,762) — (52,762) —
Interest and other income 1,368 1,414 2,922 3,093
Interest and other expense (4,396) (802) (9,285) (894)
Loss before income taxes (69,642) (42,612) (110,940) (84,399)
Income tax provision — 105 — 105
Net loss from continuing operations (69,642) (42,717) (110,940) (84,504)
Net income from discontinued operations, net of taxes 89,157 6,466 93,681 7,217
Net income (loss) 19,515 (36,251) (17,259) (77,287)
Other comprehensive income (loss):
Unrealized gain (loss) on investments 12 (6) (47) (12)
Comprehensive income (loss) $ 19,527 $ (36,257) $ (17,306) $ (77,299)
Net income (loss) per common share – basic
Net loss from continuing operations $ (1.10) $ (0.67) $ (1.75) $ (1.34)
Net income from discontinued operations 1.40 0.10 1.47 0.11
Net income (loss) per share – basic $ 0.31 $ (0.57) $ (0.27) $ (1.23)
Net income (loss) per common share – diluted
Net loss from continuing operations $ (1.10) $ (0.67) $ (1.75) $ (1.34)
Net income from discontinued operations 1.40 0.10 1.47 0.11
Net income (loss) per share – diluted $ 0.31 $ (0.57) $ (0.27) $ (1.23)
Weighted average common shares outstanding
Basic and diluted 63,594,453 63,136,057 63,522,516 63,051,207

(Press release, MacroGenics, AUG 13, 2026, View Source [SID1234670068])

On August 13, 2026 Kyntra Bio (Nasdaq: KYNB) reported financial results for the second quarter 2026 and provided an update on the company’s recent developments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continue to make progress across our oncology and rare disease portfolio and remain laser-focused on advancing toward our goal of initiating a pivotal Phase 3 trial of roxadustat in LR-MDS in the fourth quarter of this year and conducting an interim analysis of the Phase 2 trial of FG-3246 in mCRPC, also in the fourth quarter of this year," said Thane Wettig, Chief Executive Officer of Kyntra Bio. "We believe we have the substrate that will enable us to create significant value for patients and stakeholders as we advance our pipeline and look forward to providing additional updates in the coming months."

Key Highlights of Second Quarter, Recent Developments, and Upcoming Milestones

FG-3246 (CD46 Targeting ADC) and FG-3180 (CD46 Targeting PET Imaging Agent)

•
Enrollment in the Phase 2 monotherapy trial of FG-3246, a potential first-in-class ADC targeting CD46 in mCRPC continues; interim analysis is on track for the fourth quarter of 2026.
Roxadustat

•
Pivotal Phase 3 trial protocol of roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden (HTB) has been finalized.
•
Additional data from the Phase 3 MATTERHORN study were presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress 2026.
o
In a post hoc analysis of the Phase 3 MATTERHORN study, patients treated with roxadustat showed a clinically meaningful improvement in transfusion independence (TI) in patients with LR-MDS and HTB compared to placebo.
o
Similar rates of TI for patients treated with roxadustat were observed in both ring sideroblast positive (RS+) and ring sideroblast negative (RS-) disease.
•
Company continues to explore the opportunity to develop roxadustat internally or with a strategic partner, with the goal of initiating the Phase 3 trial in the fourth quarter of 2026.

Financial

•
Total revenue from continuing operations for the second quarter of 2026 was $(1.5) million, as compared to $1.3 million for the second quarter of 2025.
•
Net income from continuing operations for the second quarter of 2026 was $12.0 million, or $2.96 net income per basic and diluted share, compared to a net loss of $13.7 million, or $3.38 net loss per basic and diluted share, one year ago.
•
As of June 30, 2026, Kyntra Bio reported $95.7 million in cash, cash equivalents, investments, and accounts receivable.
•
The Company expects its cash, cash equivalents, investments, and accounts receivable to be sufficient to fund operating plans into 2028.

Conference Call and Webcast Presentation

Kyntra Bio management team will host a conference call and webcast presentation to discuss the financial results and provide a business update. A live Q&A session will follow the brief presentation. Interested parties may access a live audio webcast of the conference call here. To access the call by phone, please register here, and you will be provided with dial in details. A replay of the webcast will also be available for a limited time on the Events & Presentations page on Kyntra Bio’s website.

About FG-3246 and FG-3180

FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by Kyntra Bio for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies. FG-3180 is a companion diagnostic PET imaging agent, using the same CD46-targeting antibody together with an 89Zr tracer. To date, FG-3180 demonstrated specific uptake in CD46 positive tumors and is currently being evaluated as a biomarker for its potential to inform patient selection.

About Roxadustat

Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin.

Roxadustat is approved in Europe, Japan, China, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Kyntra Bio has the sole rights to roxadustat in the United States, Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas. Astellas and Kyntra Bio are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa.

(Press release, Kyntra Bio, AUG 13, 2026, View Source [SID1234670067])

On August 13, 2026 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported financial results for the second quarter of 2026 and provided an update on the Company’s myelofibrosis program. Following continued constructive engagement with the U.S. Food and Drug Administration (FDA), the Company remains on track to submit its planned supplemental New Drug Application (sNDA) in August under the Accelerated Approval pathway for selinexor in combination with ruxolitinib for patients with myelofibrosis. Karyopharm intends to request Priority Review at the time of submission.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our planned submission under the Accelerated Approval pathway represents the beginning of an important new chapter for Karyopharm and an important milestone for the myelofibrosis community," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "If approved, selinexor plus ruxolitinib would become the first approved combination therapy for patients with myelofibrosis, introducing a novel therapeutic mechanism for the treatment of this disease within the multi-billion-dollar U.S. marketplace. Our planned submission follows productive engagements with the FDA and reflects the speed, focus, urgency and extraordinary commitment of our teams. We look forward to continuing to work closely with the FDA."

"Together with the continued scientific engagement we are seeing across the myelofibrosis community, we believe the strength and consistency of the SENTRY data reinforce the potential of selinexor to fundamentally change the treatment of patients with myelofibrosis," added Mr. Paulson.

Second Quarter 2026 and Recent Company Highlights

XPOVIO Commercial Performance

U.S. net product revenue was $30.8 million for the quarter ended June 30, 2026 compared to $29.7 million for the quarter ended June 30, 2025.
Demand for XPOVIO was relatively consistent in the second quarter of 2026 compared to the second quarter of 2025, amidst a highly competitive commercial landscape. The community setting continued to represent approximately 60% of net product revenue.
Expanded global patient access for selinexor is translating into growth in royalty revenue from Menarini, Antengene and other international partners. Royalty revenue increased to $2.5 million in the second quarter of 2026 compared to $1.6 million in the second quarter of 2025, with selinexor approved in more than 50 ex-U.S. countries and territories.
Research and Development (R&D) Highlights

Myelofibrosis

Planned sNDA submission under the Accelerated Approval pathway following multiple, productive engagements with the FDA, including Type B and Type C meetings, and received written feedback from the FDA that spleen volume reduction ≥ 35% (SVR35) appears to qualify as a reasonably likely surrogate endpoint (RLSE) to predict overall survival and can be used to support an sNDA submission.
Results from the Phase 3 SENTRY trial (NCT04562389) in myelofibrosis were presented in a Late-Breaking Oral Presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in the peer-reviewed Journal of Clinical Oncology demonstrating rapid, deep and sustained spleen responses, promising overall survival findings and evidence consistent with potential disease modification.
Additional analyses presented during a Late-Breaking Oral Presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress—where the abstract was selected as one of the six best abstracts presented at the meeting—provided additional evidence supporting SVR35 as a potential predictor of overall survival.
The Company continues active scientific exchange with investigators and treating physicians following the ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) presentations and publication of the SENTRY results in the Journal of Clinical Oncology.
Continue enrolling patients into the 40 mg cohort of the Phase 2 SENTRY-2 trial (NCT05980806), following completion of enrollment of the 60 mg cohort (n=29) earlier this year.
Endometrial Cancer

Announced topline results from the Phase 3 XPORT-EC-042 trial (NCT05611931), evaluating selinexor as a maintenance-only therapy compared to placebo in adult patients with TP53 wild-type advanced or recurrent endometrial cancer. The trial did not meet its primary endpoint of progression-free survival. A trend favoring the selinexor arm was observed in the modified intent to treat (mITT) population (n=236), with a median PFS of 12.75 months in the selinexor arm compared to 7.43 months in the placebo arm (hazard ratio=0.76 [95% CI: 0.51, 1.12]; one-sided p-value=0.0791). The safety and tolerability profile of selinexor was consistent with its established safety profile, with no new safety signals observed.
Following the Phase 3 topline results, the Company has prioritized future investment toward its myelofibrosis and multiple myeloma programs while continuing long-term follow-up of patients enrolled in XPORT-EC-042.
Multiple Myeloma

Patients enrolled in the Phase 3 XPORT-MM-031 trial (EMN29; NCT05028348) continue to be followed for progression-free survival events contributing towards the primary endpoint. The trial is being conducted in collaboration with the European Myeloma Network and is evaluating the all-oral combination of selinexor 40 mg, pomalidomide and dexamethasone (SPd40) in patients with previously treated multiple myeloma who received an anti-CD38 as their immediate prior line of therapy.
Anticipated Catalysts and Operational Objectives

Myelofibrosis

FDA acceptance of the Company’s planned August sNDA submission for selinexor in myelofibrosis, including potential Priority Review designation.
Planned advancement of global regulatory activities with the Company’s partners to support potential regulatory submissions outside the United States.
Potential inclusion of selinexor plus ruxolitinib in relevant compendia in the second half of 2026.
Topline data from the Phase 2 SENTRY-2 60 mg cohort expected in the second half of 2026.
Multiple Myeloma

Maintain the Company’s commercial foundation in the increasingly competitive multiple myeloma marketplace and drive increased XPOVIO revenues.

Support global launches by the Company’s partners following regulatory and reimbursement approvals for selinexor in ex-U.S. countries and territories.

Announce topline data from the event-driven Phase 3 XPORT-MM-031 (EMN29) trial expected in the second half of 2026.

2026 Financial Outlook

Based on its current operating plans, Karyopharm expects the following for full year 2026:

Total revenue to be in the range of $130 million to $150 million. Total revenue consists of U.S. XPOVIO net product revenue and license, royalty and milestone revenue earned from partners.
U.S. XPOVIO net product revenue to be in the range of $115 million to $130 million.
R&D and selling, general and administrative (SG&A) expenses to be in the range of $230 million to $245 million, excluding certain one-time costs that the Company may incur associated with its endometrial cancer program and evaluating financing opportunities and/or strategic transactions.
The Company, together with its financial advisor Centerview Partners and other advisors, is actively evaluating a range of financing opportunities and strategic alternatives with the objective of maximizing both near- and long-term value for stakeholders while preserving strategic flexibility as it advances its myelofibrosis program.

The Company expects its existing liquidity, including cash, cash equivalents and investments, together with anticipated cash flow from net product revenue and license and other revenue, to fund its current operating plans into September 2026. As discussed above, the Company is actively evaluating a range of financing opportunities and strategic alternatives with the objective of extending its cash runway, preserving strategic flexibility and maximizing long-term shareholder value as it advances its myelofibrosis program. On September 10, 2026, a $15.8 million principal payment is due under the Company’s senior secured term loan facility. If that payment is made without additional financing or a waiver from the Company’s lenders, the Company expects its cash, cash equivalents and investments would fall below its $10.0 million minimum liquidity covenant, which would constitute an event of default under the term loan.

Second Quarter 2026 Financial Results

Total revenue: Total revenue for the second quarter of 2026 was $33.4 million, compared to $37.9 million for the second quarter of 2025.

Net product revenue: Net product revenue was $30.8 million for the second quarter of 2026, compared to $29.7 million for the second quarter of 2025. Net product revenue for the three months ended June 30, 2026, reflects relatively consistent demand for XPOVIO in an increasingly competitive multiple myeloma marketplace.

License and other revenue: License and other revenue was $2.6 million for the second quarter of 2026, compared to $8.2 million for the second quarter of 2025. The decrease was primarily attributable to a $6.5 million reduction in development-related reimbursement revenue from Menarini following the expiration, on December 31, 2025, of Menarini’s annual $15.0 million research and development obligation.

Cost of sales: Cost of sales was $1.1 million for both the second quarter of 2026 and 2025.

R&D expenses: R&D expenses were $29.0 million for the second quarter of 2026, compared to $32.8 million for the second quarter of 2025. The decrease was driven by our continued prioritization, focus, and efficient spending while advancing our late-stage programs, with our Phase 3 trials having completed full enrollment.

SG&A expenses: SG&A expenses were $25.9 million for the second quarter of 2026, compared to $28.5 million for the second quarter of 2025. The decrease was primarily driven by proactive cost containment while maintaining disciplined alignment of pre-launch investments with clinical and regulatory milestones.

Loss from operations: Loss from operations was $22.5 million for the second quarter of 2026, compared to $24.4 million for the second quarter of 2025. The improvement reflects the benefit of cost reduction initiatives implemented over the past several years.

Interest income: Interest income was $0.7 million for the second quarter of 2026, compared to $0.6 million for the second quarter of 2025.

Interest expense: Interest expense was $13.1 million for the second quarter of 2026, compared to $11.2 million for the second quarter of 2025. The increase reflects higher outstanding debt and higher interest rates following the Company’s financing transactions executed in October 2025.

Other expense, net: Other expense, net was $32.1 million in the second quarter of 2026, compared to $2.2 million in the second quarter of 2025. This expense is primarily non-operational and non-cash due to fair value of embedded derivatives and liability-classified common stock warrants related to the refinancing transactions completed in the second quarter of 2024 and the fourth quarter of 2025. The fair value of these instruments is remeasured each reporting period and is impacted by various inputs, including changes in the Company’s share price.

Net loss: Net loss was $67.0 million, or $2.32 per basic and diluted share, for the second quarter of 2026, compared to $37.3 million, or $4.32 per basic and diluted share, for the second quarter of 2025. Net loss for the second quarter of 2026 reflects an operating loss of $22.5 million and $44.5 million in non-operating expense comprised of $13.1 million of interest expense and $32.1 million of other expense partially offset by $0.7 million of interest income.

Cash position: Cash, cash equivalents, restricted cash and investments as of June 30, 2026, totaled $65.4 million.

Conference Call Information

Karyopharm will host a conference call today, August 13, 2026, at 8:00 a.m. Eastern Time, to discuss the second quarter 2026 financial results, the financial outlook for 2026 and to provide other business updates. To access the conference call, please dial (800) 836-8184 (local) or (646) 357-8785 (international) at least 10 minutes prior to the start time and ask to be joined into the Karyopharm Therapeutics call. A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company’s website. An archived webcast will be available on the Company’s website approximately two hours after the event.

About the Phase 3 SENTRY Trial

SENTRY (XPORT-MF-034; NCT04562389) is a Phase 3 clinical trial evaluating a once-weekly dose of 60 mg of selinexor in combination with ruxolitinib compared to placebo plus ruxolitinib in JAKi-naïve myelofibrosis patients with platelet counts >100 x 109/L (N=353). Patients were randomized 2-to-1 to the selinexor arm. The co-primary endpoints for this trial are spleen volume reduction ≥ 35% (SVR35) at week 24 and the average change in absolute total symptom score (Abs-TSS) over 24 weeks relative to baseline. The results from the Phase 3 SENTRY trial were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and were simultaneously published in the peer-reviewed Journal of Clinical Oncology. In addition, the results were presented at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress, where the presentation was recognized as one of the six best abstracts at the meeting.

About Myelofibrosis

Myelofibrosis is a rare blood cancer that affects approximately 20,000 patients in the United States and 17,000 patients in the European Union1. The disease causes bone marrow fibrosis (scarring in the bone marrow), which makes it difficult for the bone marrow to make healthy blood cells, splenomegaly (enlarged spleen), progressive anemia which often leads to symptoms like fatigue and weakness, and other disease associated symptoms including abdominal discomfort, pain under the left ribs, early satiety, night sweats and bone pain. The only approved class of therapies to treat myelofibrosis are JAK inhibitors, including ruxolitinib.

1. Clarivate/DRG (2023)

About the Phase 3 XPORT-EC-042 Trial

EC-042 (XPORT-EC-042; ENGOT-EN20; GOG-3083; NCT05611931) is a global, Phase 3, randomized, double-blind, placebo-controlled clinical trial evaluating selinexor as a maintenance-only therapy following chemotherapy or chemotherapy plus a checkpoint inhibitor in patients with TP53 wild-type advanced or recurrent endometrial cancer (N=257). Patients were randomized 1:1 to receive either a 60 mg, once-weekly, administration of oral selinexor or placebo until disease progression. The trial includes two patient populations, for which the primary endpoint of progression-free survival was tested sequentially: 1) a modified intent to treat population (mITT) that includes patients with either, a) TP53 wild-type tumors with proficient mismatch repair status (pMMR); or, b) TP53 wild-type tumors with deficient mismatch repair status (dMMR), who are medically ineligible to receive checkpoint inhibitors; and, 2) the trial’s original intent to treat (ITT) population, which includes all patients enrolled in the trial whose tumors are TP53 wild-type, regardless of MMR status. Overall survival is a key secondary endpoint. The mITT population enrolled 236 patients. As of the data cut-off, 106 progression-free survival events as assessed by the investigator had been observed in the mITT population. In connection with the EC-042 trial, Karyopharm entered into a global collaboration with Foundation Medicine, Inc. to develop FoundationOneCDx, a tissue-based comprehensive genomic profiling test to identify and enroll patients whose tumors are TP53 wild-type. The trial is being conducted in collaboration with the European Network of Gynaecological Oncological Trial groups (ENGOT) and the GOG Foundation, Inc.

About Endometrial Cancer

Endometrial cancer (EC) is the most common gynecologic malignancy in the U.S.1 In 2026, approximately 68,000 uterine cancers (predominantly endometrial) are expected to be diagnosed, with approximately 14,000 deaths.1 Worldwide there were about 420,368 cases with 97,723 deaths in 2022.2 Both incidence and mortality have continued to rise.3,4 Key risk factors include obesity, type 2 diabetes, high-fat diets, tamoxifen or oral estrogen use, and delayed menopause.5 TP53 is a well-recognized prognostic marker for EC; >50% of advanced or recurrent EC tumors are TP53wt (gene for tumor protein P53; wild-type), and ~40%-55% are both TP53wt and mismatch repair-proficient (pMMR).6-8 While immune checkpoint inhibitors have shown benefit in patients with mismatch repair–deficient (dMMR) and pMMR, the magnitude of benefit is greater for patients with dMMR tumors versus pMMR tumors.9-10 There remains an unmet need for targeted therapies for patients with pMMR EC.11

1. American Cancer Society. Cancer Facts & Figures 2026. View Source Accessed February 8, 2026

2. IARC GLOBOCAN 2022, Global Estimates

3. Lu KH, et al. N Engl J Med. 2020;383:2053-2064

4. NCI. Cancer stat facts: uterine cancer. View Source Accessed October 7, 2025

5. American Cancer Society, Endometrial Cancer Risk Factors, 2025

6. Leslie KK, et al. Gynecol Oncol. 2021;161(1):113-121.

7. Vergote I, et al. J Clin Oncol. 2023;41(35):5400-5410.

8. Mirza MR, et al. Presentation at: ESMO (Free ESMO Whitepaper) Congress; October 20-24, 2023

9. Mirza MR, et al. N Engl J Med. 2023; 388:2145-2158.

10. Eskander RN, et al. N Engl J Med. 2023;388:2159-2170.

11. Makker V, et al. Gynecol Oncol. 2024 Jun:185: 202-211

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor compound for the treatment of cancer. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein XPO1. XPOVIO is approved and marketed by Karyopharm in the U.S. in multiple oncology indications, including: (i) in combination with VELCADE (bortezomib) and dexamethasone (XVd) in adult patients with multiple myeloma after at least one prior therapy; and (ii) in combination with dexamethasone in adult patients with heavily pre-treated multiple myeloma. XPOVIO (also known as NEXPOVIO in certain countries) has received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including but not limited to the European Union, the United Kingdom, Mainland China, Taiwan, Hong Kong, Australia, South Korea, Singapore, Israel, and Canada. XPOVIO/NEXPOVIO is marketed in these respective ex-U.S. territories by Karyopharm’s partners: Antengene, Menarini, Neopharm, and FORUS. Selinexor is also being investigated in several other mid- and late-stage clinical trials across multiple high-unmet need cancer indications.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at: Tel: +1 (888) 209-9326; Email: [email protected]

XPOVIO (selinexor) is a prescription medicine approved:

In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (XVd).
In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti‐CD38 monoclonal antibody (Xd).
SELECT IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Thrombocytopenia: Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.
Neutropenia: Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony‐stimulating factors.
Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.
Hyponatremia: Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.
Serious Infection: Monitor for infection and treat promptly.
Neurological Toxicity: Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.
Embryo‐Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.
Cataract: Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract.

Adverse Reactions

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting. Grade 3‐4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia, and neutropenia. In the BOSTON trial, fatal adverse reactions occurred in 6% of patients within 30 days of last treatment. Serious adverse reactions occurred in 52% of patients. Treatment discontinuation rate due to adverse reactions was 19%.
The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea, and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of patients. Serious adverse reactions occurred in 58% of patients. Treatment discontinuation rate due to adverse reactions was 27%.
Use In Specific Populations
Lactation: Advise not to breastfeed.

For additional product information, including full prescribing information, please visit www.XPOVIO.com.
To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1‐888‐209‐9326 or FDA at 1‐800‐FDA‐1088 or www.fda.gov/medwatch.

(Press release, Karyopharm, AUG 13, 2026, View Source [SID1234670066])

On August 13, 2026 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty income, reported financial results and recent corporate highlights for the second quarter ended June 30, 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, "The second quarter of 2026 reflected continued momentum across our portfolio and further progress in unlocking long-term shareholder value. Our subsidiary Urica Therapeutics, Inc.’s ("Urica") equity position in Crystalys Therapeutics, Inc. ("Crystalys") was strengthened by Crystalys’ $130 million Series B financing, which will support the late-stage global development and commercialization preparation for dotinurad, a next-generation oral URAT1 inhibitor for gout, on which Urica is entitled to a 3% royalty on future net sales. Journey Medical also continues to scale Emrosi, securing a third major GPO contract that expanded payer access to over 150 million commercial lives. Coming off the momentum of ZYCUBO’s approval and the $205 million PRV sale in the first quarter, we enter the second half of 2026 with a favorable cash balance that positions us to continue executing on our pipeline and business development priorities."

Dr. Rosenwald added, "We continued to see encouraging clinical progress this quarter on our partnered programs. AstraZeneca reported additional prespecified subgroup analyses for anselamimab (formerly CAEL-101) showing a 62% improvement in survival and a 71% reduction in cardiovascular hospitalizations among kappa predominant light chain isotype patients in the CARES program, and indicated that it plans to submit these findings to regulatory authorities. Crystalys also continues to advance dotinurad’s two global Phase 3 trials while initiating a new Phase 2 study in difficult-to-treat gout, broadening the program’s potential patient population. With a diversified portfolio spanning commercial, late-stage, and development-stage programs, including royalties, milestones and equity, and a strengthened balance sheet following the ZYCUBO PRV monetization, we believe Fortress is well positioned to advance strategic initiatives and drive long-term value for our shareholders."

Recent Corporate Highlights1:

Commercial Portfolio Updates

● Journey Medical Expands Payer Access for Emrosi. At the end of March 2025, our partner company Journey Medical Corporation ("Journey Medical") commercially launched Emrosi (40mg Minocycline Hydrochloride Modified-Release Capsules, consisting of 10mg immediate release and 30mg extended release pellets), also known as DFD-29, for inflammatory lesions of rosacea. Emrosi was approved by the FDA in November 2024 and is available by prescription at specialty pharmacy chains. In April 2026, Journey Medical announced that it secured a contract with a third major group purchasing organization (GPO) for Emrosi. As such, payer access for Emrosi expanded to over 150 million commercial lives as of April 1, 2026, which equates to approximately 85% of all commercial lives in the United States that have access to Emrosi. Journey Medical reported net product revenues of $17.8 million for the second quarter of 2026, compared to net product revenues of $15.0 million for the second quarter ended June 30, 2025.
● Royalties. In the second quarter of 2026, Cyprium Therapeutics, Inc. ("Cyprium") recognized $0.2 million in royalty revenue on net sales of ZYCUBO, and Fortress recognized $0.1 million in royalty income (contingent consideration) on net sales of UNLOXCYT, following their recent commercial launches.

Clinical Updates

● Phase 3 CARES Results for Anselamimab (CAEL-101); Regulatory Submission of Prespecified Subgroup Analysis Planned. In the second quarter of 2026, AstraZeneca announced additional prespecified subgroup analyses in patients with kappa predominant light chain isotype, showing that anselamimab (formerly known as CAEL-101) improved survival by 62%, measured by time to all-cause mortality (HR 0.38; 95% CI 0.17, 0.86; nominal p=0.012), and reduced the frequency of cardiovascular hospitalizations by 71% (incidence risk ratio 0.29; 95% CI 0.10, 0.87; nominal p=0.028) compared to placebo in the subgroup with kappa AL amyloidosis. Although anselamimab did not achieve statistical significance for the primary endpoint in its Phase III Cardiac Amyloid Reaching for Extended Survival ("CARES") clinical program for Mayo stages IIIa and IIIb AL amyloidosis patients, the drug showed clinically meaningful improvement in the prespecified subgroup and was well tolerated. AstraZeneca indicated that the company plans to submit the prespecified subgroup analysis from the CARES trials to regulatory authorities and disclosed regulatory submissions in the EU and Japan.
● Dotinurad Progresses in Phase 3 Development with Crystalys Series B Financing of $130 million; Initiation of Phase 2 Clinical Trial for Difficult-to-Treat Gout. In July 2026, Crystalys, in which our majority-owned and controlled subsidiary company Urica maintains an equity position, announced a $130 million Series B financing to support the late-stage global clinical development and commercialization preparation for dotinurad. Patients continue to be enrolled in Crystalys’ two randomized, double-blind, multicenter global Phase 3 trials evaluating dotinurad, a next-generation, once daily oral, URAT1 inhibitor with potential for best-in-class safety and efficacy for the treatment of gout. In the second quarter of 2026, Crystalys also announced the initiation of a Phase 2 study in difficult-to-treat gout.
● Other Portfolio Programs Continue to Advance with Potential Upcoming Data and Trial Initiations. Triplex is currently in multiple ongoing clinical trials for cytomegalovirus (CMV) treatment and prevention in solid organ and stem cell transplants, combination trials with CAR T cell therapies for hematologic malignancies, and a potential data readout by the end of 2026 for prevention and control of CMV in patients co-infected with HIV and CMV. A clinical trial evaluating MB-109, a combination CAR T cell therapy and oncolytic virus, is anticipated to initiate in the fourth quarter of 2026 for patients with IL13Rα2-positive recurrent glioblastoma and high-grade astrocytoma. There are also ongoing and planned regulatory interactions with the FDA on trial designs for ATX-04 (selective β2-adrenergic agonist) for patients with Pompe disease and FB-606 (membrane stabilizer) for patients with Duchenne muscular dystrophy.

Financial Results:

● As of June 30, 2026, Fortress’ consolidated cash and cash equivalents totaled $196.6 million, compared to $79.4 million as of December 31, 2025, an increase of $117.2 million year-to-date.
● Fortress’ consolidated cash and cash equivalents totaling $196.6 million as of June 30, 2026, includes $153.8 million attributable to Fortress and the private subsidiaries, $1.9 million attributable to Avenue, $15.1 million attributable to Mustang Bio and $25.6 million attributable to Journey Medical.
o Fortress’ consolidated cash and cash equivalents totaled $79.4 million as of December 31, 2025, and includes $35.2 million attributable to Fortress and private subsidiaries, $2.9 million attributable to Avenue, $17.3 million attributable to Mustang and $24.1 million attributable to Journey Medical.

● Fortress’ consolidated net revenue totaled $18.7 million for the second quarter ended June 30, 2026, $17.8 million of which was generated from our marketed dermatology products. This compares to consolidated net revenue totaling $16.4 million for the second quarter of 2025, $15.0 million of which was generated from our marketed dermatology products.
● Consolidated research and development expenses totaled $0.8 million for the second quarter ended June 30, 2026, compared to $8.1 million for the second quarter ended June 30, 2025.
● Consolidated selling, general and administrative costs were $20.8 million for the second quarter ended June 30, 2026, compared to $38.8 million for the second quarter ended June 30, 2025.
● Consolidated net loss attributable to common stockholders was $(2.5) million, or $(0.08) per share basic and diluted, for the second quarter ended June 30, 2026, compared to net income attributable to common stockholders of $13.4 million, or $0.50 per share basic, and $0.45 per share diluted, for the second quarter ended June 30, 2025.

(Press release, Fortress Biotech, AUG 13, 2026, View Source [SID1234670065])

On August 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 second quarter ended June 30, 2026, and provided a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Dosing of the first patient in RECLAIM-LN, our Phase 2 potentially registrational trial, is an exciting milestone as we work to address significant unmet medical needs in patients with lupus nephritis using our FT819 off-the-shelf CAR T-cell treatment," said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics. "The use of a clonally engineered master cell bank provided us the unique advantage of producing a FT819 pivotal CAR T-cell drug product batch that is uniform in composition and consistent with previously manufactured batches, a level of manufacturing consistency that can be challenging to achieve with patient- and donor-sourced CAR T-cell therapies. The clinical development of the FT819 franchise is further strengthened through its FDA RMAT designation and CDRP program inclusion. With our first patient treated, multiple clinical sites activated, and pivotal drug product inventory in distribution depots ready to be shipped to clinical sites on demand, we are building momentum to accelerate the clinical development of RECLAIM-LN. In addition to FT819, our next generation CAR T-cell programs include FT839, a novel 13-point edited CAR T-cell product candidate co-targeting CD19 and CD38, which is advancing to first patient treatment in rheumatoid arthritis and other autoimmune diseases, as well as FT836, CAR T-cell product candidate targeting the stress ligands MICA/B for pan-tumor treatment which is showing early anti-tumor activity in colorectal cancer without conditioning chemotherapy. With these advancements and a strong cash position, we believe Fate is positioned for strong execution across our portfolio."

Clinical Development & Program Updates

RECLAIM-LN, FT819 Phase 2 Potentially Registrational Trial in Lupus Nephritis

Lupus nephritis (LN) is among the most serious manifestations of systemic lupus erythematosus (SLE). Approximately 100,000 U.S. patients have refractory moderate-to-severe LN, a subset of LN not previously evaluated with currently available therapies. Of these patients, only approximately 10-20% are expected to achieve a complete renal response (CRR), underscoring the substantial unmet need that RECLAIM-LN is designed to address.

The RECLAIM-LN trial is an open-label, single-arm study developed following interactions with the FDA under the Company’s Regenerative Medicine Advanced Therapy (RMAT) designation. The Phase 2 potentially registrational clinical trial is expected to enroll approximately 53 patients and evaluate a single dose of FT819 administered at 900 million cells following bendamustine conditioning, with CRR at Week 26 as the primary endpoint. The conditioning regimen selected for RECLAIM-LN is less-intensive than other CAR T-cell clinical trials, which typically incorporate up to three days of co-administration of cyclophosphamide and fludarabine, a combination that was observed as less desirable to patients and clinicians during the Company’s Phase 1 clinical study, in part because of the potential increase in adverse events.

To date, the Company has achieved the following operational milestones in RECLAIM-LN:

•
First patient dosed in RECLAIM-LN. To the Company’s knowledge, this represents the first patient treated with an iPSC-derived off-the-shelf CAR T-cell therapy in a potentially registrational clinical trial in an autoimmune disease.
•
Notably, the patient was treated in an outpatient setting with same-day discharge and with a drug product that was available on-demand, supporting the Company’s goal of broadening patient access to CAR T cells.
•
Additional patients are in process for screening at several activated sites, a reflection of the enthusiasm treating clinicians have for RECLAIM-LN.
•
Received UK MHRA authorization to conduct RECLAIM-LN at UK clinical sites, broadening the reach of the clinical trial.
•
Further supporting broad access to CAR T cells in RECLAIM-LN, the first pivotal drug product batch of FT819 has been successfully manufactured and released, with drug product inventory positioned in depots for immediate, on-demand distribution to participating clinical sites.
•
The potency strategy supporting pivotal drug product release and several other key elements of the Company’s CMC readiness plan have been discussed and aligned with the FDA under the Company’s RMAT designation, with further discussions continuing under the FDA’s Chemistry, Manufacturing and Controls Development and Readiness Pilot (CDRP) Program.
Based on enrollment cadence observed in the Phase 1 clinical trial, current clinical site engagement, and the on-demand availability of FT819, the Company aims to complete enrollment of RECLAIM-LN in the first half of 2028.

Preliminary clinical data in SLE for FT819 presented at the EULAR 2026 Annual Meeting

The Company presented Phase 1 data for FT819 in SLE, with 21 patients treated as of the May 14, 2026 data cutoff, including outpatient administration with same-day discharge in community hospital settings. Among the 16 patients receiving FT819 with less-intensive conditioning (Regimen A), the therapy was well tolerated, with no dose-limiting toxicities, no Grade >2 cytokine release syndrome (CRS), no immune effector cell-associated neurotoxicity syndrome (ICANS), and no graft-versus-host disease (GvHD). FT819 drove rapid and sustained improvements across key disease measures, including clinical Systemic Lupus Erythematosus Disease Activity Index (cSLEDAI)-2K, urine protein-to-creatinine ratio (UPCr), Physician Global Assessment (PGA), and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, with bendamustine conditioning demonstrating the deepest and most durable responses and supporting its selection as the conditioning regimen for the RECLAIM-LN trial. Among 10 evaluable patients on background glucocorticoids, 7 achieved a dose of ≤5 mg/day, including 5 who discontinued steroids entirely. Treatment also produced deep and durable B-cell depletion, with a 74–96% reduction in the most expanded baseline B-cell clones that did not reappear through 12 months of follow-up, while protective vaccine titers were preserved.

Preliminary clinical data in systemic sclerosis for FT819 presented at the ISSCR 2026 Annual Meeting

In July, the Company presented preliminary clinical data from the systemic sclerosis (SSc) arm of the FT819-102 Phase 1 basket trial at the International Society for Stem Cell Research (ISSCR) 2026 Annual Meeting. The SSc cohort enrolls a treatment-refractory patient population, with eligibility requiring both prior treatment failure and ongoing active disease and permits enrollment of patients with up to 15 years of disease duration. As of the June 12, 2026 data cutoff, four SSc patients had been treated: three under Regimen A with less-intensive conditioning chemotherapy (cyclophosphamide or bendamustine alone) and one under Regimen B with no conditioning chemotherapy. Participants demonstrated preliminary clinical activity in multiple disease scoring categories, including a revised Composite Response Index in Systemic Sclerosis (rCRISS) of 25 or higher and meaningful mean improvement in the modified Rodnan Skin Score (mRSS) for all patients at three months post-treatment. Treatment was well tolerated, with no CRS, ICANS, GvHD, or hypogammaglobulinemia reported in SSc participants on study. The Company believes these data reinforce the favorable profile of FT819 in SSc and is exploring the opportunity to accelerate the advancement of its clinical development in this rare disease indication with high unmet medical needs.

FT839: Next-generation off-the-shelf dual-CAR T-cell product candidate co-targeting CD19 and CD38 advancing in Phase 1/2 Trial

Also in July, the FDA cleared the Company’s IND application for FT839, a next-generation, off-the-shelf CAR T-cell product candidate uniquely engineered to co-target CD19 and CD38. FT839 has been engineered with 13 targeted genetic edits that together are intended to confer multi-antigen targeting, immune evasion, enhanced functional persistence, and an enhanced safety profile. By co-targeting CD19 and CD38, FT839 is designed to eliminate broad spectrum of aberrant, disease-driving immune cells, including B cells, plasma cells, macrophages and activated T cells, that underlie multicellular disease in many autoimmune disorders as well as in hematologic malignancies. FT839 incorporates the Company’s patented Sword & Shield technology, which is designed to support durable activity without dependence on conditioning chemotherapy, as well as a high-affinity, non-cleavable CD16 (hnCD16) Fc receptor and a CD3ε fusion receptor enabling combination with approved therapeutic monoclonal antibodies and T-cell engagers, respectively. Uniquely, FT839 is derived from a clonal iPSC master cell bank that has been precisely engineered to consistently and uniformly express the suite of genetic edits. The iPSC master cell bank serves as the starting cell source to manufacture FT839, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies.

COMPLETE (FT839-101) is a single-arm, open-label Phase 1/2 basket trial designed to evaluate FT839 across multiple autoimmune indications in combination with background therapy without the requirement for conditioning chemotherapy, with a starting dose level of 900 million cells. The Phase 1/2 design is intended to enable simultaneous assessment of safety and efficacy in a single trial to shorten the transition from Phase 1 to Phase 2. Following IND clearance, the Company has several clinical sites participating in accelerated activation, reflecting strong investigator interest for an off-the-shelf CAR T-cell with the potential to tackle complex autoimmune diseases. The Company plans to evaluate additional investigator-initiated trials of FT839 in multiple myeloma, diffuse large B-cell lymphoma, and type 1 diabetes. We look forward to providing an enrollment update later this year.

FT836: Next-generation off-the-shelf CAR T-cell product candidate targeting MICA/B demonstrates preliminary anti-tumor activity in colorectal cancer

At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June, the Company presented preliminary Phase 1 data for FT836, its multiplex-engineered CAR T-cell product candidate uniquely targeting major histocompatibility complex class I chain-related proteins A (MICA) and B (MICB). As of the April 20, 2026 data cutoff, nine patients had been enrolled across two regimens administered without conditioning chemotherapy (Regimen C: FT836 plus cetuximab, n=6; Regimen E: FT836 plus trastuzumab, n=3), with all patients evaluable for safety and five evaluable for initial efficacy assessment. Key findings included a favorable safety profile with no dose-limiting toxicities, CRS, ICANS, or GvHD observed across any patient or dose level; first-in-human evidence of FT836 trafficking to and persisting within tumor tissue without the use of conditioning chemotherapy, along with evidence of remodeling of the tumor immune microenvironment; and preliminary anti-tumor activity in two efficacy-evaluable, heavily pre-treated KRAS wild-type (KRASwt) metastatic colorectal cancer (mCRC) patients, each with seven prior lines of therapy, including meaningful reductions in target lesion size and decreases in tumor biomarkers such as carcinoembryonic antigen (CEA).

Based on these preliminary clinical results, the Company intends to focus subsequent clinical development of FT836 on the KRASwt colorectal cancer population. With the clinical dose established at 900M, in the next cohort the Company plans to combine FT836 multi-dosing with standard of care chemotherapy with the intent to drive further reduction of tumor volume and achieve higher overall response rates in KRASwt CRC patients. The Company expects to provide the next clinical update on FT836 in the first half of 2027. Separately, the FDA has cleared an IND for an investigator-initiated trial of FT836 in combination with daratumumab in multiple myeloma, to be conducted at the Medical College of Wisconsin.

Corporate Updates

Fate appointed Laura Hamill to its Board of Directors, adding more than three decades of global commercial and strategic leadership across the biopharmaceutical industry. Ms. Hamill’s appointment brings deep launch, market-access, and commercial-scaling expertise as the Company advances its pipeline toward later-stage development and initiates preparations for the potential transition to a commercial-stage company.

Second Quarter 2026 Financial Results

•
Cash & Investment Position: Cash, cash equivalents, and investments as of June 30, 2026 were $153.8 million, a quarterly decrease of $21 million.
•
Total Revenue: Revenue was $2.1 million for the second quarter of 2026, compared to $1.9 million for the second quarter of 2025. Revenue was derived from the conduct of preclinical development activities under the Company’s collaboration with Ono Pharmaceutical.
•
Total Operating Expenses: Total operating expenses were $33.2 million for the second quarter of 2026, including research and development expenses of $24.4 million and general and administrative expenses of $8.8 million. Such amount included $3.5 million of non-cash stock-based compensation expense.

•
Year-to-Date Operating Expense Reduction: Total operating expenses for the six months ended June 30, 2026 decreased by $14.3 million compared to the same period in 2025, reflecting a $7.5 million, 13% reduction in research and development expenses and a $6.8 million, 27% reduction in general and administrative expenses.
•
Net Loss: Net loss was $30.2 million, or $(0.25) per share, for the second quarter of 2026, compared to $34.1 million, or $(0.29) per share, for the second quarter of 2025.
•
Shares Outstanding: As of June 30, 2026, common shares outstanding were 116.7 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 driven by improvements to the expense structure of the organization, along with $153.8 million in cash, cash equivalents, and investments.
About FT819

FT819 is an off-the-shelf CD19-targeting chimeric antigen receptor (CAR) T-cell product candidate 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, designed to express two unique CARs: a first CAR targeting the B-cell lineage marker CD19 and a second CAR targeting the immune activation marker CD38, which is often found on aberrant T, NK and B cells. FT839 is a 13-point edited CAR T cell and the second program to incorporate the Company’s Sword & Shield technology. The FDA cleared the IND application for FT839 in July 2026, and the Company is conducting COMPLETE (FT839-101), a Phase 1/2 basket clinical trial evaluating FT839 across autoimmune indications in combination with standard-of-care therapy, without the requirement for conditioning chemotherapy .

About FT836

FT836 is the Company’s multipoint-edited CAR T-cell product candidate uniquely targeting major histocompatibility complex class I chain-related 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. FT836 is the Company’s first product candidate to incorporate the novel Sword & Shield technology, which utilizes the Company’s novel alloimmune defense receptor (ADR) alongside CD58 knockout, 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 for Regenerative Medicine (CIRM) to support IND-enabling activities for FT836.

(Press release, Fate Therapeutics, AUG 13, 2026, View Source [SID1234670064])