On May 12, 2026 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biotechnology company developing engineered natural killer (NK) cell therapies to treat autoimmune diseases, reported financial results for the first quarter ended March 31, 2026.

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"Putting patients first and providing access to care in a familiar setting close to home matters" said Paul J. Hastings, Chief Executive Officer of Nkarta. "In early April, we reached agreement with the FDA to amend our protocol to allow outpatient dosing in community settings as well as the option to re-dose patients if needed, the removal of overnight monitoring requirements, and the expansion of the Ntrust-2 study to include patients with rheumatoid arthritis. IRB approval of our protocol amendments has been secured across multiple sites, with additional approvals underway. These advancements will enable us to expand patient access beyond urban hubs and major academic centers by engaging community research centers and local rheumatology practices in the neighborhoods where most patients live. We look forward to providing our initial dataset in 2026."

NKX019 Clinical Program Progress and Upcoming Milestones

Enrollment continues across Ntrust-1 and Ntrust-2, our multi-center, open-label, dose-escalation clinical trials evaluating NKX019 in multiple autoimmune diseases.
IRB approval of our protocol amendments has been secured across multiple sites on outpatient dosing, re-dosing, ending overnight monitoring, and adding RA to Ntrust-2.
Patients are being dosed at 4 billion cells per dose x 3 doses (12 billion cells total) across all indications in Ntrust-1 and Ntrust-2.
Initial clinical data from Ntrust-1 and Ntrust-2 are planned for presentation at a medical conference in 2026.

First Quarter 2026 Financial Highlights

Nkarta had cash, cash equivalents, restricted cash, and investments in marketable securities of $266.7 million as of March 31, 2026.
Research and development (R&D) expenses were $25.0 million for the first quarter of 2026. Non-cash stock-based compensation expense included in R&D expense was $0.7 million for the first quarter of 2026.
General and administrative (G&A) expenses were $5.9 million for the first quarter of 2026. Non-cash stock-based compensation expense included in G&A expense was $1.2 million for first quarter of 2026.
Net loss was $27.8 million, or $0.37 per basic and diluted share, for the first quarter of 2026. This net loss includes non-cash charges of $3.4 million that consisted primarily of share-based compensation and depreciation expenses.

Financial Guidance

Nkarta expects its current cash and cash equivalents to fund its current operating plan into 2029.

About the Ntrust℠ Clinical Trials in Autoimmune Disease
Ntrust-1 (NCT06557265) and Ntrust-2 (NCT06733935) are multi-center, open label, dose escalation clinical trials in patients with autoimmune disease receiving lymphodepletion followed by CD19-targeted CAR-NK cell therapy. Both trials will assess the safety of NKX019 in people living with autoimmune diseases as well as its potential to achieve durable remission via a "reset" of the immune system through the elimination of pathogenic B cells.

The Ntrust trials are enrolling up to 12 patients per dose level per disease indication across systemic sclerosis, idiopathic inflammatory myopathy, ANCA-associated vasculitis, rheumatoid arthritis, lupus nephritis, and primary membranous nephropathy. Additional participants may be enrolled if needed to refine patient populations for further study.

In both studies, patients now receive a three-dose cycle of NKX019 on Days 0, 3, and 7 following lymphodepletion with fludarabine and cyclophosphamide or cyclophosphamide alone, if they have significant cytopenia at baseline. Leveraging the engineering of NKX019, no patients in either trial will receive supplemental cytokines or antibody-based therapeutics. This approach is designed to evaluate the single-agent activity of NKX019 and facilitate a more rapid path to regulatory approval. Patients in Ntrust-1 may also receive additional cycles, if needed, to restore response or enable a deeper response.

About NKX019
NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed chimeric antigen receptor (CAR) for enhanced cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal B cells as well as those implicated in autoimmune disease. Nkarta is evaluating NKX019 in multiple autoimmune conditions.

(Press release, Nkarta, MAY 12, 2026, View Source [SID1234665551])

On May 12, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) reported that it has received a clinical trial notice from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) approving the Investigational New Drug (IND) application for PD-1 x VEGF bispecific antibody SKB118 (also known as CR-001) for the treatment of advanced solid tumors.

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In December 2025, Kelun-Biotech and Crescent Biopharma ("Crescent") entered into a strategic collaboration for SKB118/CR-001. Under the collaboration, Crescent granted Kelun-Biotech exclusive rights to research, develop, manufacture and commercialize SKB118/CR-001 in Greater China (including Mainland China, Hong Kong, Macau, and Taiwan). In January 2026, Crescent announced the regulatory clearance of the IND application for SKB118/CR-001 by the U.S. Food and Drug Administration (FDA) to initiate its global ASCEND Phase I/II clinical trial (NCT07335497) for the treatment of locally advanced or metastatic solid tumors. The trial is ongoing and expected to initially enroll up to 290 patients.

Dr. Michael Ge, CEO of Kelun-Biotech, stated: "We are pleased to see the approval of the IND application for SKB118 in China, which marks the simultaneous advancement of clinical development in China and globally. Since entering into the collaboration with Crescent, we have worked closely and leveraged complementary advantages with each other to efficiently drive the R&D of the collaborative product candidates. Based on our ADC+IO strategies, we will actively explore the potential of combining SKB118 with our proprietary ADC assets to unlock the synergistic value of our portfolio and expand more treatment possibilities for cancer patients."

About SKB118 (also known as CR-001)

SKB118 is a tetravalent bispecific antibody being developed for the treatment of solid tumors that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed at restoring T cells’ ability to recognize and destroy tumor cells, and blocking VEGF is intended to reduce blood supply to tumor cells and to inhibit tumor growth. In preclinical studies, SKB118 demonstrated cooperative pharmacology with increased binding to PD-1 and signal blockade in the presence of VEGF as well as robust anti-tumor activity. SKB118’s anti-VEGF activity may also normalize the vasculature at the tumor site, which has the potential to improve the localization and effectiveness of combination therapies, such as in combination with antibody-drug conjugates (ADCs).

(Press release, Kelun, MAY 12, 2026, View Source [SID1234665567])

On May 12, 2026 Mereo BioPharma Group plc (NASDAQ: MREO) ("Mereo" or the "Company"), a clinical-stage biopharmaceutical company focused on rare diseases, reported financial results for the first quarter ended March 31, 2026, and provided an update on recent corporate developments.

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"Based on extensive analysis of data across the two global Phase 3 studies of setrusumab in osteogenesis imperfecta in collaboration with our partner Ultragenyx, we believe there is basis to engage with the regulatory agencies to determine if there is a path forward in pediatric patients. These interactions have been initiated, and we plan to provide updates once we have some definitive feedback. We continue to believe that setrusumab has the potential to provide meaningful benefit for people living with OI, a condition with no FDA or EMA approved therapies," said Denise Scots-Knight, Chief Executive Officer of Mereo. "We are engaged with potential partners for alvelestat in AATD-LD and believe alvelestat can quickly enter Phase 3 development following closing of a partnership transaction. Our other partnered program, vantictumab, is continuing to move forward with āshibio, who plan to initiate a Phase 2 trial in osteopetrosis in the second half of 2026. We continue to expect that our cash position, which totaled $36.2 million as of March 31, will provide runway into mid-2027, through several key inflection points expected during the remainder of this year."

Recent Corporate Developments and Anticipated Milestones

Setrusumab (UX143)

Further analyses of the data from the Orbit and Cosmic Phase 3 studies, including patient subgroups, have been completed.
While neither study achieved statistical significance against the primary endpoints of reduction in annualized clinical fracture rate compared to placebo (Orbit) or bisphosphonates (Cosmic), both studies achieved high statistical significance against the key secondary endpoint of improvement in bone mineral density versus control as well as reductions in vertebral fractures and improvements in patient reported outcomes (PROs) associated with disease severity, pain / discomfort and daily activities, with these PRO improvements achieving statistical significance in the Orbit study.
The safety profile of setrusumab was consistent with that observed in prior studies.
Based on the Phase 3 data analysis from both global Phase 3 studies and the safety profile of setrusumab, Mereo and its partner Ultragenyx believe there is a basis to engage regulatory agencies to determine if there is a path forward for setrusumab in pediatric patients. These interactions have been initiated.
Alvelestat (MPH-966)

Mereo is actively engaged in discussions with potential partners for the Phase 3 development and commercialization of alvelestat.
Based on previous discussions with the FDA and EMA, Mereo anticipates a single Phase 3 trial enrolling approximately 220 early- and late-stage AATD-LD patients evaluating alvelestat over an 18-month treatment period will support regulatory submissions in both the U.S. and Europe.
The primary efficacy endpoint for potential U.S. approval will be the St. George’s Respiratory Questionnaire (SGRQ) Total Score, with lung density measured by CT scan serving as the primary endpoint for potential European regulatory approval. These are independent primary endpoints.
The Company believes initiation of the Phase 3 study could happen within 6 months of closing a potential partnership transaction.
Vantictumab (OMP18R5)

The Company’s development partner for vantictumab, āshibio, Inc., is continuing to advance toward initiation of a Phase 2 clinical trial in autosomal dominant osteopetrosis Type 2 (ADO2), which is expected to commence in the second half of 2026.
āshibio is responsible for funding the global clinical program and holds the right to commercialize vantictumab outside of Europe, where Mereo has retained commercial rights.
First Quarter 2026 Financial Results

Total research and development ("R&D") expenses increased by $0.8 million, from $3.9 million in the first quarter of 2025 to $4.7 million in the first quarter of 2026. The increase was primarily due to increases of $1.8 million in R&D expenses for setrusumab, partially offset by reductions of $0.9 million in R&D expenses for alvelestat. The increase in program expenses for setrusumab was primarily driven by recognition of a payable for our share of certain costs related to the cancellation of manufacturing slots by our partner, Ultragenyx, partially offset by reductions of, and delays to, investment in manufacturing and ongoing activities, including medical affairs activities in Europe during the first quarter of 2026. The decrease in program expenses for alvelestat was primarily due to completion of activities undertaken in preparation for the potential Phase 3 study in the first quarter of 2025.

General and administrative expenses decreased by $3.3 million, from $7.3 million in the first quarter of 2025 to $4.0 million in the first quarter of 2026. The decrease was primarily due to the recognition of a $1.9 million reduction in expenses in the first quarter of 2026 for amounts received from our depository to reimburse certain expenses incurred by us in respect of our ADR program, and a reduction of approximately $1.4 million driven by delays to investment in pre-commercial activities to lay the foundation for the potential commercial launch of setrusumab in Europe, if approved, and other realized cost savings.

Net loss for the first quarter of 2026 was $6.7 million, compared to $12.9 million for the first quarter of 2025, primarily reflecting an operating loss of $8.8 million and foreign currency transaction gain of $1.6 million.

As of March 31, 2026, the Company had cash and cash equivalents of $36.2 million, compared to $41.0 million as of December 31, 2025. The Company’s guidance remains unchanged, and it continues to expect, based on current operational plans, that its existing cash and cash equivalents balance will enable it to fund its currently committed clinical trials, operating expenses, and capital expenditure requirements into mid-2027. This guidance does not include any potential payments associated with business development activity around any of the Company’s programs.

Total ordinary shares issued as of March 31, 2026 were 798,078,829. Total ADS equivalents as of March 31, 2026 were 159,615,765, with each ADS representing five ordinary shares of the Company.

(Press release, Mereo BioPharma, MAY 12, 2026, View Source [SID1234665583])

On May 12, 2026 Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported financial results for the first quarter ended March 31, 2026, and provided a business update.

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"We are encouraged by what we have seen thus far in patients treated with BDC‑4182, a next‑generation Boltbody ISAC. BDC-4182 has a unique mechanism of action , that has the potential to combine the power of ADCs with the durability of T-cell engagers and unlock a new frontier in cancer treatment," said Willie Quinn, President and Chief Executive Officer. "We continue to enroll patients with gastric and gastroesophageal cancer in our ongoing clinical trial, and we look forward to reporting initial data in the third quarter of 2026."

Recent Highlights and Anticipated Milestones

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Initial clinical data from BDC-4182 Phase 1/2 study for patients with gastric and gastroesophageal cancer expected in the third quarter of 2026. BDC-4182 is a next-generation BoltbodyTM ISAC targeting claudin 18.2, a clinically validated target with expression in gastric cancer, gastroesophageal junction cancer, pancreatic cancer, and other tumor types. In preclinical models, including cancer models with low claudin 18.2 expression, BDC-4182 demonstrated significant anti-tumor activity, induced immunological memory, and outperformed cytotoxic ADCs. Bolt has implemented step-up dosing, which has been successfully used commercially for T-cell engagers, as a strategy to get to higher doses safely. The clinical trial in gastric and gastroesophageal cancers is ongoing, and the Company expects to present initial clinical data in the third quarter of 2026.
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Next-generation Boltbody ISACs targeting CEA and PD-L1. Two additional ISAC programs in Bolt’s pipeline are currently on hold. Once BDC-4182 demonstrates proof-of-concept for the ISAC approach, Bolt plans to resume development of these programs. Both programs are close to clinical candidate selection.
o
Bolt’s CEA-targeted ISAC comprises a novel, fully human antibody with high affinity and selectivity to CEACAM5 (CEA) conjugated to a proprietary next-generation TLR7/8 agonist via a non-cleavable linker. Bolt’s CEA ISAC induced complete and durable anti-tumor responses in preclinical models and demonstrated superior activity versus a Topo1-based ADC. The CEA ISAC was well tolerated in a non-GLP toxicology study.
o
Bolt’s PD-L1 ISAC utilizes a novel human anti-PD-L1 antibody conjugated to a TLR7/8 agonist via a non-cleavable linker. This ISAC leverages a unique mechanism of action due to its ability to target both tumor and immune cells that express PD-L1. Preclinical results demonstrated that PD-L1 ISACs represent a compelling new approach to treat cancer, leveraging mechanisms that are distinct from and potentially complementary to conventional PD-1/PD-L1 blockade with the potential for enhanced immune activation and antitumor activity.

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Cash, cash equivalents, and marketable securities were $23.9 million as of March 31, 2026. Cash on hand is expected to fund operations into 2027.

First Quarter 2026 Financial Results

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Collaboration Revenue – Total collaboration revenue was $26,000 for the quarter ended March 31, 2026, compared to $1.2 million for the same quarter in 2025. Revenue in the comparative periods was generated from services performed under the R&D collaborations as we fulfill our performance obligations.

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Research and Development (R&D) Expenses – R&D expenses were $4.8 million for the quarter ended March 31, 2026, compared to $9.5 million for the same quarter in 2025. The decrease between the comparable periods was mainly due to a continued decrease in salary and related expenses primarily as a result of our restructuring, reduced clinical trial expenses and lower research and development expenses.

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General and Administrative (G&A) Expenses – G&A expenses were $2.8 million for the quarter ended March 31, 2026, compared to $3.8 million for the same quarter in 2025. The decrease between the comparable periods was mainly due to a continued decrease in salary and related expenses primarily as a result of our restructuring.

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Loss from Operations – Loss from operations was $7.6 million quarter ended March 31, 2026, compared to $12.1 million for the same quarter 2025.

(Press release, Bolt Biotherapeutics, MAY 12, 2026, View Source [SID1234665527])

On May 12, 2026 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the Company’s senior management team will participate in the following investor conferences in May:

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H.C. Wainwright 4th Annual BioConnect Investor Conference
Format: Fireside chat
Date: Tuesday, May 19, 2026
Time: 9:00 a.m. ET

RBC 2026 Global Healthcare Conference
Format: Fireside chat
Date: Tuesday, May 19, 2026
Time: 3:35 p.m. ET

A live webcast of the fireside chats can be accessed under "Events & Presentations" in the Investor section of the Company’s website, View Source, and will be available for replay following the event.

(Press release, Karyopharm, MAY 12, 2026, View Source [SID1234665542])