On May 14, 2026 SN BioScience Inc., a clinical-stage biotechnology company based in South Korea, reported that it has initiated the first patient dosing in its global Phase 1b/2 clinical trial evaluating SNB-101 (API: SN-38), a nanoparticle anticancer agent, in patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC).

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This multi-center trial, conducted across sites globally including the United States and Europe, will enroll up to 135 patients. The study is designed in three sequential stages: a Phase 1b dose-escalation phase using a 3+3 design to determine the Maximum Tolerated Dose (MTD) at dose levels of 50–70 mg/m², followed by a two-part Phase 2 consisting of Phase 2a and Phase 2b. Phase 2a will conduct dose optimization to identify the optimal therapeutic dose, after which Phase 2b will proceed with dose expansion at the optimized dose to further evaluate clinical activity across a broader patient population. Across Phase 2, key efficacy endpoints including objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) will be assessed to generate the clinical evidence necessary to support regulatory review process.

The advancement into Phase 2 is supported by encouraging prior Phase 1 results conducted in Korea, in which SNB-101 demonstrated a favorable safety profile with no Grade 3 or higher diarrhea events, a disease control rate (DCR) of 83.3% in high-dose cohorts, and a mean progression-free survival (PFS) of 6.3 months in SCLC patients. These findings compare favorably with outcomes historically reported for currently available later-line treatment options, including Zepzelca and Topotecan.

Based on its Phase 1 results, SNB-101 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for SCLC. Together with Orphan Drug Designation from the FDA and EMA, these designations reflect that SNB-101 has fully established the regulatory framework necessary to pursue accelerated approval.

As a monotherapy, SNB-101 has demonstrated encouraging clinical activity together with a favorable tolerability profile in previously treated SCLC patients. The company believes these findings support the continued clinical development of SNB-101 as a potential treatment option for patients with relapsed SCLC, particularly in later-line settings where tolerability and efficacy remain an important unmet need.

In parallel with the ongoing monotherapy program, SN BioScience is actively expanding the development of SNB-101 into combination strategies with immunotherapy agents (including anti-PD-1, anti-PD-L1, and DLL3-targeted BiTE T-cell engager therapies) currently used in standard SCLC treatment. The company has already obtained EMA approval for a clinical study evaluating SNB-101 in combination with one immunotherapy agent and is planning to submit an additional CTA within this year for a separate study involving another immunotherapy combination.

In addition, SN BioScience is pursuing the expansion of SNB-101 into additional solid tumor indications, including gastric and pancreatic cancers, through ongoing collaborations and strategic discussions with global pharmaceutical companies.

(Press release, SN BioScience, MAY 14, 2026, View Source [SID1234665735])

On May 14, 2026 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies for high unmet need diseases, reported new preclinical data from its PBGENE-DMD program in an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting in Boston, Massachusetts. The new data show that treatment with PBGENE-DMD in early-juvenile mice resulted in significantly higher efficacy across key skeletal and respiratory muscles than treatment in late-juvenile mice over a comparable timeframe. This new data further supports evaluating PBGENE-DMD in younger DMD patient populations, including the 2- to 3-year-old patients, who are a key demographic of the ongoing Phase 1/2 FUNCTION-DMD trial evaluating PBGENE-DMD in boys ages 2 to 7.

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The greater efficacy observed in early-juvenile mice is also expected to be an important point of differentiation for PBGENE-DMD versus microdystrophin approaches. With microdystrophin approaches the AAV dilution effect driven by muscle growth and turnover would be expected to be even more pronounced in younger DMD patients.

"These new data give us a clear preclinical rationale for treating DMD as early as possible. By directly comparing early- and late-juvenile mice, we showed that intervening earlier translated into substantially greater dystrophin restoration in the skeletal and respiratory muscles that matter most for long-term outcomes. This is important because the FUNCTION-DMD trial is designed to treat children between the ages of two and seven years," said Cassie Gorsuch, Ph.D., Chief Scientific Officer of Precision BioSciences. "These results also reinforce a meaningful point of differentiation for PBGENE-DMD. Because we are correcting the gene rather than delivering a synthetic transgene, the durability of effect would not be expected to be subject to the AAV dilution that affects microdystrophin approaches as young patients grow, a limitation that becomes more pronounced the younger the patient."

New preclinical data: strong efficacy in early-juvenile mice (age 2 weeks, equivalent to a patient population aged 2–3 years)

PBGENE-DMD in early-juvenile mice achieved up to 3x higher dystrophin protein restoration in skeletal muscle, and up to 12x higher dystrophin protein restoration in respiratory muscle, compared with late-juvenile mice at equivalent dose levels.
Strong efficacy which exceeded the expected dystrophin protein restoration therapeutic threshold of 5% was observed in respiratory muscle tissues, with mice achieving up to 12% dystrophin restoration in the diaphragm and up to 30% in the intercostals, muscles whose function is critical to preventing respiratory failure in patients with DMD.
PBGENE-DMD drove high levels of dystrophin-positive fibers in early-juvenile mice, with levels 2–3x higher in skeletal and respiratory muscle tissues than in late-juvenile mice after three months, reaching up to 70% dystrophin-positive fibers.
Similar therapeutic efficacy was achieved in cardiac muscle in both early- and late-juvenile mice.
Building on a growing body of preclinical evidence

These new data extend Precision’s previously reported preclinical findings supporting the safety, efficacy, and durability profile of PBGENE-DMD:

A toxicology study in a humanized DMD mouse model showed that PBGENE-DMD treatment led to greater than 45% reduction in serum creatine kinase across multiple dose levels, alongside improvements in muscle pathology relative to vehicle-treated controls, supporting the safety profile of the program.
Beyond safety, PBGENE-DMD has demonstrated sustained efficacy over time through dystrophin protein restoration and dystrophin-positive myofibers, translating into durable muscle function. Treated mice maintained up to 92% of the maximum force output of non-diseased animals, while untreated, diseased mice showed progressively declining force output.
Presentation details

Abstract title: PBGENE-DMD gene editing drives safe, efficacious, and durable functional improvement in a humanized Duchenne muscular dystrophy mouse model

Session: Emerging molecular therapeutic strategies for muscular dystrophies

Presenter: Adam Mischler, Ph.D., DMD Research Lead, Precision BioSciences

Date and time: Thursday, May 14, 2026, 8:45 A.M. ET

About PBGENE-DMD, A Muscle-Targeted Excision Program

PBGENE-DMD is Precision’s development program for the treatment of Duchenne Muscular Dystrophy (DMD), a devastating genetic disease caused by mutations in the dystrophin gene that prevents production of the dystrophin protein, which is essential for maintaining muscle structural integrity and function. DMD affects approximately 15,000 patients in the U.S. alone, and there are currently no approved therapies capable of driving significant, durable functional improvements over time.

PBGENE-DMD is designed to durably improve function for approximately 60% of patients with DMD by employing two complementary ARCUS nucleases, delivered using a single AAV, to excise exons 45-55 of the dystrophin gene, restoring expression of a near full-length dystrophin protein. Compared with DMD, deletion of exons 45-55 is often associated with a more mild prognosis for patients. This protein more closely resembles normal dystrophin than synthetic, truncated microdystrophin approaches, which currently offer minimal proven functional benefit. Precision’s Phase 1/2 FUNCTION-DMD study is expected to enroll ambulatory DMD patients with mutations between exons 45 and 55, which impact approximately 60% of boys with DMD. The clinical trial will employ an appropriate immune modulation regimen and safety monitoring program to treat patients at world class specialized DMD clinical sites.

PBGENE-DMD was granted Orphan Drug Designation by the FDA in July 2025. The PBGENE-DMD program is eligible for a Priority Review Voucher (PRV) via the Rare Pediatric Disease Priority Review Voucher (PRV) program, which was signed into law on February 3, 2026, as part of the Consolidated Appropriations Act of 2026. PBGENE-DMD received Fast Track designation from the FDA in February 2026.

Further details on the trial can be found on Precision’s website and clinicaltrials.gov identifier NCT07429240.

(Press release, Precision Biosciences, MAY 14, 2026, View Source [SID1234665710])

On May 14, 2026 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company") reported financial results for the first quarter of 2026. The biopharmaceutical company has two programs in ongoing clinical trials.

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Recent Corporate Highlights and Upcoming Milestones

INBRX-106
In May 2026, we announced updated interim data from our randomized, first-line Phase 2 portion of the HexAgon study. The trial evaluated the safety and efficacy of INBRX-106, a hexavalent OX40 agonist, in combination with pembrolizumab (the combination arm) versus pembrolizumab monotherapy (the control arm) in first-line patients with treatment-naïve, PD-L1 positive (Combined Positive Score (CPS) ≥ 20) metastatic or unresectable recurrent Head and Neck Squamous Cell Carcinoma (HNSCC).
We plan to announce progression-free survival (PFS) data from the randomized Phase 2 trial in HNSCC in combination with pembrolizumab in the fourth quarter of 2026.
ozekibart (INBRX-109)
In April 2026, we announced updated interim data from our Phase 1/2 study evaluating ozekibart (INBRX-109) in combination with FOLFIRI in patients with locally advanced or metastatic, unresectable colorectal cancer (CRC);
Additionally, in April 2026, we submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ozekibart in conventional chondrosarcoma; and
We plan to meet with the FDA in the second half of 2026 to discuss plans to initiate a first-line registrational trial in CRC. We also plan to discuss with the FDA the potential for accelerated regulatory pathways for ozekibart in fourth-line colorectal cancer and in refractory Ewing sarcoma.
Financial Results

Cash and Cash Equivalents. As of March 31, 2026, the Company had cash and cash equivalents of $161.7 million, as compared to $124.2 million as of December 31, 2025. The Company’s cash balance increased as a result of the receipt of gross proceeds of $75.0 million in March 2026 upon entering into the First Amendment to the Loan and Security Agreement (March 2026 Amendment) with Oxford Finance LLC (Oxford).
R&D Expense. Research and development expenses were $25.2 million for the first quarter of 2026, as compared to $36.9 million for the first quarter of 2025. This decrease was primarily related to lower clinical trial costs associated with ozekibart for the treatment of unresectable or metastatic conventional chondrosarcoma as the trial approached completion of enrollment, as well as a decrease in contract manufacturing expenses due to the timing and completion of certain manufacturing activities required to support our clinical trials. In addition, personnel-related expenses decreased as a result of a decrease in headcount in the current period.
G&A Expense. General and administrative expenses were $5.7 million during the first quarter of 2026, compared to $6.0 million during the first quarter of 2025. These expenses were consistent in each period with a slight decrease in personnel-related expenses as a result of a decrease in headcount in the current period.
Other Expense, Net. Other expense, net was $2.5 million during the first quarter of 2026, compared to $0.4 million during the first quarter of 2025. The increase reflects higher interest expense following the Company’s receipt of an additional $75.0 million in principal, bringing the outstanding loan balance from $100.0 million to $175.0 million during the first quarter of 2026, as well as lower interest income on the Company’s cash and money market balances reflecting lower average cash balances and a decline in short-term interest rates.
Net Loss. Net loss was $33.4 million during the first quarter of 2026, or $2.15 per share, basic and diluted, as compared to a net loss of $43.3 million during the first quarter of 2025, or $2.80 per share, basic and diluted.

(Press release, Inhibrx, MAY 14, 2026, View Source [SID1234665736])

On May 14, 2026 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, reported financial results for the quarter ended March 31, 2026, and highlighted continued advancement of the micvotabart pelidotin (MICVO) clinical development program.

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"Our team’s exceptional clinical and operational execution in the first quarter of 2026, combined with growing investigator enthusiasm for MICVO’s potential to positively impact the lives of patients with cancer, has positioned us to deliver key milestones for the MICVO program this year," said Tom Civik, Interim Chief Executive Officer and Director of Pyxis Oncology. "We remain on track to share updated monotherapy data in mid-year 2026 and updated combination data in the second half of 2026. The mid-year 2026 monotherapy update will focus on 2L+ R/M HNSCC patients treated at or below a dose cap, which we implemented in December 2025. The goal of moving to a dose cap was to maintain MICVO’s strong efficacy profile while improving safety and tolerability. In the Phase 1/2 dose escalation combination study with pembrolizumab, we have refined our focus to 1L R/M HNSCC patients. We believe these two datasets will help establish MICVO’s broad potential as a novel ADC for patients with difficult-to-treat cancers and substantial unmet need."

Pipeline & Corporate Updates

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Pyxis Oncology expects to report updated data from the ongoing MICVO Phase 1 monotherapy study for 2L+ R/M HNSCC in mid-year 2026. The mid-year 2026 update will focus on participants who were treated at 5.4 mg/kg IV Q3W, with a dose equivalent to or below a dose cap. Results will include detailed analyses of the impact of a dose cap on safety, tolerability and efficacy.

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The ongoing MICVO Phase 1 monotherapy study is a multi-part study. Part 1 was a dose escalation study across multiple doses and tumor types, with initial results shared in November 2024. Part 2, a dose expansion study in 2L+ R/M HNSCC, is currently ongoing. Preliminary Phase 1 study results in 2L+ R/M HNSCC were shared in December 2025.
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The dose expansion study of the ongoing MICVO Phase 1 monotherapy study includes two arms: post platinum and anti-PD-(L)1 experienced patients (Arm 1) and post EGFRi and anti-PD-(L)1 experienced patients (Arm 2). Target enrollment for each arm of the study was n=~20. Total study target enrollment was completed in 1Q26.
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In December 2025, a dose cap was implemented for higher body weight patients. Based on internal PK simulation modeling indicating that MICVO exposures with dose capping and adjusted ideal bodyweight (AIBW) dosing are expected to be comparable, dose capping was prioritized due to its operational simplicity and speed of implementation.
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Dose capping and AIBW are both well-established approaches to modified weight-based dosing and have demonstrated improved tolerability without sacrificing clinical activity in studies of other ADCs[i].
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A protocol amendment permitting AIBW has been approved, and AIBW dosing has begun. AIBW will be selected as a go-forward dose strategy only if it offers a superior profile to dose capping.
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Pyxis Oncology expects to report updated data from the ongoing Phase 1/2 combination dose escalation study of MICVO and Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy KEYTRUDA (pembrolizumab) for 1L R/M HNSCC patients in 2H26.
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The ongoing MICVO Phase 1/2 study evaluating MICVO in combination with KEYTRUDA (pembrolizumab) is currently in dose escalation across multiple doses for the treatment of 1L R/M HNSCC. Preliminary positive results for the treatment of 1L/2L+ R/M HNSCC were shared in December 2025.
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The MICVO Phase 1/2 combination dose escalation study update in 2H26 will focus on 1L R/M HNSCC patients.
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In April 2026, Pyxis Oncology presented new preclinical data in a poster presentation at the 2026 AACR (Free AACR Whitepaper) Annual Meeting that showed treatment with a mouse analog of MICVO (maMICVO) in combination with anti-mouse PD-1 produced synergistic anti-tumor activity in an immune-refractory syngeneic preclinical model of HNSCC (MOC2). Additional key poster findings include:
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Monotherapy with maMICVO produced dose-dependent inhibition of tumor outgrowth.
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Monotherapy with maMICVO modulated the immune compartment toward a more favorable immune-permissive environment for immunotherapy. Treatment with maMICVO reduced the overall abundance of immune-suppressive regulatory T cells (Tregs) in MOC2 tumors, increased the CD8 T cell-to-Treg ratio and enhanced the abundance of a progenitor exhausted T cell subset that is highly responsive to anti-PD-1 therapy.
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Despite the MOC2 model being insensitive to anti-mouse PD-1 as a monotherapy, the combination of maMICVO and anti-mouse PD-1 resulted in greater tumor control and tumor growth inhibition than maMICVO monotherapy. Bliss independence analysis confirmed that maMICVO acted synergistically with anti-mouse PD-1 in a preclinical model unresponsive to anti-mouse PD-1 monotherapy.

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In May 2026, Pyxis Oncology announced the appointment of Nelson Azoulay as Chief Business Officer. Mr. Azoulay most recently served as Senior Vice President, Strategy and Business Development at Flagship Pioneering, where he spearheaded business development initiatives across select portfolio companies. Previously, he was Vice President of Corporate Development at ImmunoGen, where he helped shape the Company’s mid- to long-term strategy, led search and evaluation efforts, supported fundraising activities, and helped secure key transactions, including collaborations and partnerships with major pharmaceutical companies. He also played a role in ImmunoGen’s acquisition by AbbVie and subsequent integration in 2024. Earlier in his career, at PDL BioPharma, Mr. Azoulay led corporate restructuring and managed strategic divestitures. At Syneos Health Consulting, he advised global pharmaceutical and biotechnology companies on portfolio strategy, transactions and commercial planning. He holds an MBA from Columbia Business School, an MS in Neuroscience from McGill University and a BA from Wesleyan University.
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In February 2026, Pyxis Oncology announced the appointment of Thomas Civik as Interim Chief Executive Officer. Mr. Civik has been a member of Pyxis Oncology’s Board of Directors since October 2021 and is a highly experienced biotechnology executive with a proven track record in advancing cancer therapeutics. He most recently served as President and Chief Executive Officer of Five Prime Therapeutics, where he led the company through its acquisition by Amgen for $1.9 billion in April 2021. Mr. Civik previously served as Chairperson of the Board of ImCheck Therapeutics and Repare Therapeutics through their respective acquisitions by Ipsen and XOMA.

First Quarter 2026 Financial Results

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As of March 31, 2026, Pyxis Oncology had cash and cash equivalents, including restricted cash, and short-term investments, of $42.5 million. The Company believes that its current cash, cash equivalents, and short-term investments will be sufficient to fund its operations into the fourth quarter of 2026.
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Research and development expenses were $20.0 million for the quarter ended March 31, 2026, compared to $17.0 million for the quarter ended March 31, 2025. The increase was primarily due to a $5.5 million increase in clinical trial related expenses including CMC, related to monotherapy and combination therapy of MICVO, offset by reduction in employee-related costs and other costs.
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General and administrative expenses were $4.4 million for the quarter ended March 31, 2026, compared to $5.9 million for the quarter ended March 31, 2025. The decrease was primarily due to lower employee-related costs including stock-based compensation.
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Net loss was $23.3 million, or ($0.37) per common share, for the quarter ended March 31, 2026, compared to $21.2 million, or ($0.35) per common share, for the quarter ended March 31, 2025. Excluding non-cash stock-based compensation expense, the net loss for the quarter ended March 31, 2026 was $22.1 million, compared to a net loss of $17.5 million for the quarter ended March 31, 2025.
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As of May 13, 2026, the outstanding number of shares of Common Stock of Pyxis Oncology was 63,355,482.

(Press release, Pyxis Oncology, MAY 14, 2026, View Source [SID1234665711])

On May 14, 2026 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported a new initiative with Bristol Myers Squibb (NYSE: BMY). This collaboration aims to leverage AI, multimodal real-world data and data science techniques to optimize clinical trial designs and enhance the Probability of Technical & Regulatory Success (PTRS) across five initial clinical trial programs.

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With Lens, Tempus’ AI-enabled analytical platform, BMS and Tempus are applying insights from a vast library of de-identified multimodal records to optimize clinical research and strengthen PTRS across BMS’ development portfolio. This collaboration combines unprecedented scale of real-world data with emerging AI-techniques to pressure test assumptions, characterize complex patient populations, validate control group assumptions, and pinpoint the optimal patient segments most likely to benefit from investigational therapies.

This new initiative is supporting key assets in solid tumor oncology, including lung, colon, and prostate cancers. Beyond oncology, the collaboration extends into neuroscience to accelerate drug development in Alzheimer’s Disease, demonstrating the versatility of the Tempus multimodal database across multiple therapeutic areas.

"Our collaboration with BMS aims to optimize clinical development by peering deeper into patient biology than ever before," said Ryan Fukushima, CEO of Data and Apps at Tempus. "Our multimodal data library allows us to connect the dots between clinical records and molecular subtypes. Together, we are doing more than just generating insights. We are uncovering the hidden biological signals of unmet patient need, which allows us to assess trial assumptions and stratify patient groups with unprecedented precision. We are moving past traditional approaches and creating a new level of data-driven confidence in the drug development process."

"This collaboration is about improving the quality of decisions we make in development, where the impact is greatest," said Bryan Campbell, Senior Vice President, Drug Development Strategy & Innovation at Bristol Myers Squibb. "By combining Tempus’ multimodal real-world data capabilities with our development expertise, we can rigorously pressure-test trial assumptions, better understand patient heterogeneity, and design studies with a higher probability of technical and regulatory success. This is a critical step toward more disciplined, data-driven development with the goal of bringing life-changing medicines to patients faster."

This initiative builds upon the existing work between Tempus and BMS, which includes the deployment of the Next Pathways program across 13 community-based health systems to address care gaps for patients with advanced non-small cell lung cancer (aNSCLC).

(Press release, Tempus, MAY 14, 2026, View Source [SID1234665737])