On May 14, 2026 Sangamo Therapeutics, Inc. (OTCQB Venture Market: SGMO), a genomic medicine company, reported recent business highlights and first quarter 2026 financial results.

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"During the first quarter, we advanced our rolling BLA submission for ST-920 and continued to progress our differentiated neurology pipeline," said Sandy Macrae, Chief Executive Officer of Sangamo Therapeutics. "We remain focused on executing against our regulatory and clinical priorities while pursuing opportunities to secure additional funding and support the long-term potential of our pipeline."

Recent Business Highlights

Corporate Updates
•Transitioned to trading on the OTCQB Venture Market, operated by OTC Markets Group, following the receipt of a delisting determination from The Nasdaq Capital Market due to non-compliance with Nasdaq’s minimum bid requirements. Sangamo intends to appeal the delisting determination at a hearing before Nasdaq, scheduled for June 9, 2026.
•Sangamo’s common stock began trading on the OTCQB Venture Market on May 5, 2026, under the same trading symbol, SGMO.
Fabry Disease
•The rolling submission to the FDA of a BLA seeking approval of isaralgagene civaparvovec, or ST-920, a wholly owned gene therapy product candidate for the treatment of Fabry disease under an Accelerated Approval pathway, remains in progress.
•The preclinical and clinical modules have been submitted to the FDA for review. In addition, the antibody assay companion diagnostic, which is designed to screen patients for eligibility with isaralgagene civaparvovec, has been submitted to, and accepted by, the FDA’s Center for Devices and Radiological Health (CDRH), seeking Premarket Approval (PMA).
•Isaralgagene civaparvovec has a clear pathway to accelerated approval from the FDA, using mean annualized estimated glomerular filtration rate (eGFR) slope at 52-weeks across all dosed patients in the study. The FDA has recently affirmed to us that two-year eGFR data may serve as confirmatory evidence for traditional approval.
•In February, presented detailed data from the registrational Phase 1/2 STAAR study via four platform and poster presentations at the 22nd Annual WORLDSymposiumTM in San Diego, California.
•Sangamo is advancing the Chemistry, Manufacturing and Controls (CMC) module, ahead of completion of the rolling BLA submission for isaralgagene civaparvovec, expected as early as the summer of 2026, subject to the ability to secure adequate additional funding, while continuing business development discussions for a potential Fabry commercialization agreement.

Core Neurology Pipeline
Chronic Neuropathic Pain – ST-503
•Six sites have been activated in the Phase 1/2 STAND study evaluating ST-503, an investigational epigenetic regulator for the treatment of intractable pain due to small fiber neuropathy (SFN), a type of chronic neuropathic pain.
•In March, a manuscript was published in Science Translational Medicine detailing the preclinical safety and pharmacology of ST-503 in human neurons, mice and nonhuman primates.
Prion Disease – ST-506
•Clinical Trial Application (CTA) enabling activities are in progress for ST-506, an investigational epigenetic regulator for the treatment of prion disease, leveraging STAC-BBB, Sangamo’s novel proprietary neurotropic adeno-associated virus (AAV) capsid.
•Held productive interaction with the MHRA, including alignment on diagnostic testing, analytical validation and nonclinical safety matters.
•The Good Laboratory Practice (GLP) toxicology study has been completed and analysis is ongoing.
29th ASGCT (Free ASGCT Whitepaper) Annual Meeting
•Participated in the 29th ASGCT (Free ASGCT Whitepaper) Annual Meeting, May 11-15, 2026, in Boston, MA, to present the progression of Sangamo’s neurology pipeline, including advances in zinc finger epigenetic regulation and developments in modular integrase technology. These presentations can be found on Sangamo’s website, in the Presentations section.
First Quarter 2026 Financial Results
Consolidated net loss for the first quarter ended March 31, 2026 was $31.0 million, or $0.08 per share, compared to a consolidated net loss of $30.6 million, or $0.14 per share, for the same period in 2025.
Revenues
Revenues for the first quarter ended March 31, 2026 were $1.4 million, compared to $6.4 million for the same period in 2025.
The decrease of $5.0 million in revenues was primarily attributable to $5.0 million in revenue relating to our collaboration agreement with Pfizer Inc. upon transfer of a specified sublicense in 2025, and a decrease of $0.8 million in revenue relating to our license agreement with Sigma-Aldrich Corporation. These decreases were partially offset by $0.5 million in revenue relating to our license agreement with Miltenyi Biotec B.V. & Co. KG.
GAAP and Non-GAAP Operating Expenses
(In millions)
Three Months Ended
March 31,
2026 2025
Research and development $ 26.6 $ 26.0
General and administrative 6.8 10.1
Total operating expenses 33.4 36.1
Depreciation and amortization (0.7) (1.0)
Stock-based compensation (1.0) (2.6)
Non-GAAP operating expenses $ 31.7 $ 32.5

Total operating expenses on a GAAP basis for the quarter ended March 31, 2026 were $33.4 million, compared to $36.1 million for the same period in 2025. Non-GAAP operating expenses, which exclude depreciation and amortization, and stock-based compensation expense, for the quarter ended March 31, 2026 were $31.7 million, compared to $32.5 million for the same period in 2025.
The decrease in total operating expenses on a GAAP basis was primarily driven by lower compensation and other personnel costs, mainly due to changes in variable compensation and lower headcount, and lower facilities and infrastructure-related expenses. These decreases were partially offset by an increase in manufacturing expenses, primarily due to BLA readiness activities for our Fabry disease program.

Cash and Cash Equivalents
As of March 31, 2026, we had cash and cash equivalents of $27.6 million, compared to cash and cash equivalents of $20.9 million as of December 31, 2025. Based on our current operating plan, including the implementation of potential additional cost reduction measures, we estimate that our cash and cash equivalents as of March 31, 2026, will be sufficient to fund our planned operations into the third quarter of 2026.
Financial Guidance for 2026
•On a GAAP basis, we expect total operating expenses in the range of approximately $110 million to $130 million in 2026, which includes estimated non-cash stock-based compensation expense, and depreciation and amortization.
•We expect non-GAAP total operating expenses, excluding estimated non-cash stock-based compensation expense of approximately $8 million, and estimated depreciation and amortization of approximately $2 million, in the range of approximately $100 million to $120 million in 2026.
•This financial guidance is subject to our ability to secure adequate additional funding for our current operating plan.
Conference Call
The Sangamo management team will hold a corporate call to further discuss program and financial updates on Thursday, May 14, at 4:30pm Eastern Time.
Participants should register for, and access, the call using this link. While not required, it is recommended you join 10 minutes prior to the event start. Once registered, participants will be given the option to either dial into the call with the number and unique passcode provided or to use the dial-out option to connect their phone instantly.
An updated corporate presentation is available in the Investors and Media section under Presentations.
The link to access the live webcast can also be found on the Sangamo website in the Investors and Media section under Events. A replay will be available following the conference call, accessible at the same link.

(Press release, Sangamo Therapeutics, MAY 14, 2026, View Source [SID1234665714])

On May 14, 2026 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported that Dean Schorno, the company’s chief financial officer, will present a company overview at the 2026 RBC Capital Markets Global Healthcare Conference on Tuesday, May 19, at 9:30 a.m. ET in New York, NY.

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To access the live webcast or archived recording, visit the Investor Relations section of the company’s website at www.rigel.com. Please connect to Rigel’s website prior to the start of the live webcast to allow for any software downloads.

(Press release, Rigel, MAY 14, 2026, View Source [SID1234665713])

On May 14, 2026 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported its financial results for the first quarter ended March 31, 2026, and is providing shareholders with a business update.

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"We made important strides in the first quarter of 2026 with strong commercial adoption of the TAMP platform enabled by RenovoCath, resulting in record quarterly revenue exceeding 50% of the revenue we generated in all of 2025," said Shaun Bagai, Chief Executive Officer of RenovoRx. "We generated Q1 revenue of $563,000, an increase of 136% compared to the fourth quarter of 2025, mainly driven by the growing number of active cancer centers and rising procedural utilization across our existing customer base. Additionally, we ended the quarter with $12.4 million in cash, which, we believe, is sufficient to fund our operations into at least the second half of 2027. With a solid sales pipeline, we are confident in sustaining growth as our business scales."

"Our commercial momentum is being driven by our focused and scalable expansion strategy into cancer centers," continued Mr. Bagai. "We have grown from 5 active commercial cancer center customers at the beginning of 2025 to 16 today, with 32 additional centers progressing through stages of evaluation, approval, and onboarding. Notably, we are seeing meaningful repeat utilization across our existing centers, which we believe reflects growing physician confidence and clinical utility. As we expand our footprint and deepen utilization, we believe that RenovoRx is building a durable commercial foundation with the potential for predictable, recurring revenue growth."

"Looking ahead, we remain focused on executing against both our near-term commercial priorities and our long-term clinical objectives," added Mr. Bagai. "We expect continued revenue growth throughout 2026, supported by ongoing cancer center activations and continued transition of Phase III TIGeR-PaC trial sites into commercial centers after full enrollment is complete. At the same time, TIGeR-PaC remains on track for complete enrollment in June 2026, reinforcing the strength of our dual-track strategy. With a strengthened balance sheet and growing commercial traction, we believe RenovoRx is well positioned to deliver meaningful value creation in the quarters ahead and continue to expand access to life-changing care for patients battling difficult-to-treat cancers."

RenovoCath Commercialization Update

RenovoRx saw further acceleration in the commercial rollout of RenovoCath during the first quarter of 2026, achieving its strongest quarterly revenue performance to date. Revenue totaled $563,000 for the quarter, representing a 136% quarter-over-quarter increase compared to the fourth quarter of 2025 and totaling more than 50% of the Company’s total revenue generated in 2025. This significant growth reflects continued expansion of active commercial cancer centers and increasing procedural utilization of RenovoCath across the Company’s installed base. The Company defines "active" commercial cancer centers as centers where doctors are actively treating patients with RenovoCath.

RenovoRx’s commercial model remains centered on active cancer center expansion, with additional centers driving increased procedures and revenue growth. RenovoRx began 2025 with 5 active commercial cancer centers, and by end of the year, we had grown to 8. As of May 6, 2026 we had 16 active centers. RenovoRx is also advancing a robust pipeline of 32 additional centers in various stages of evaluation, approval, and onboarding, representing a significant expansion of its near-term commercial footprint. In total, these 48 centers have approximately quadrupled the Company’s near-term commercial sales pipeline compared to the first quarter of 2025, reflecting the rapid expansion of RenovoRx’s commercial footprint year-over-year. Up to 15 TIGeR-PaC Phase III clinical trial sites that have previously utilized RenovoCath are expected to continue transitioning to commercial clinical use following completion of trial enrollment. These anticipated conversions represent a meaningful opportunity to drive incremental revenue growth in the second half of 2026. The Company continues to target 36 active commercial cancer centers by year-end 2026.

RenovoRx continues to observe organic repeat ordering behavior from existing customers, which the Company views as a key indicator of physician satisfaction and clinical utility. As physicians incorporate RenovoCath into routine clinical practice, repeat utilization is expected to drive sustained and compounding revenue growth. The combination of record quarterly revenue, rapid active cancer center expansion, and strong repeat ordering behavior demonstrates accelerating commercial momentum and supports the long-term opportunity for RenovoCath as both a standalone device and a foundational platform for future drug-device combination therapies.

RenovoRx continues to estimate that the initial total addressable market (TAM) for RenovoCath as a stand-alone device represents an approximately $400 million peak annual U.S. sales opportunity, with long-term, several-billion-dollar potential as the platform expands into additional solid tumor indications.

Clinical Research and Scientific Programs
Advancement of the ongoing Phase III TIGeR-PaC clinical trial evaluating intra-arterial delivery of gemcitabine (IAG) via the RenovoCath device for the treatment of locally advanced pancreatic cancer (LAPC) continued in the first quarter of 2026. Based on current projections, RenovoRx expects to send notification of closure of enrollment in the trial in the beginning of June, completing the Company’s milestone of finishing trial enrollment by the end of June 2026. As of May 14, 2026, 106 patients had been randomized in the trial, representing approximately 93% of the required 114 patients, and currently there are 12 enrolled patients in induction, which gives rise to the expectation that enrollment will be closed by the end of June. Seventy-four events (i.e., patient deaths) have been observed of the 86 events required to trigger the final analysis. The Company continues to anticipate final data in mid to late 2027.

During the first quarter of 2026, RenovoRx continued to execute on key operational priorities for TIGeR-PaC, including patient enrollment, site engagement, and maintaining protocol adherence across its clinical network. These efforts build on the successful completion of the second interim analysis in 2025, after which the independent Data Monitoring Committee recommended continuation of the trial without modification. In alignment with standard clinical trial practices and to preserve trial integrity, the Company has elected to defer publication of interim data until study completion.

RenovoRx expects that TIGeR-PaC trial sites will continue transitioning to commercial use following completion of enrollment, representing a meaningful potential driver of revenue growth in the second half of 2026. RenovoRx continues to view the TIGeR-PaC trial as an important long-term value driver, while emphasizing that its current commercial strategy is independent of the trial’s ultimate outcome and timeline.

RenovoRx continues to advance broader clinical programs by generating new data through the Company’s continued support of investigator-initiated trials (IIT) in borderline resectable and metastatic pancreatic cancer, use of other agents beyond gemcitabine (the chemotherapy being used in TIGeR-PaC), and use of TAMP in other solid tumors. Registry and IIT studies are capital-efficient studies providing meaningful data that may further broaden the application for the TAMP therapy platform which is enabled by RenovoCath.

In terms of scientific data, in January 2026, a pharmacokinetic subset study of the TIGeR-PaC trial was presented at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium by a TIGeR-PaC Investigator from the University of Pittsburgh Medical Center. The abstract offers insight that supports the potential effectiveness of the TAMP therapy platform in LAPC. The abstract concludes that TAMP and IAG resulted in reduced systemic levels of gemcitabine and increased levels of its inactive metabolite compared with IV gemcitabine. A full paper is submitted for publication later this year.

First Quarter 2026 and Subsequent Key Highlights
RenovoRx continued to execute on its dual clinical and commercial strategy during the first quarter of 2026, leveraging the operational foundation established in 2025 to drive measurable commercial progress. The Company’s lean commercial infrastructure is now actively supporting cancer center expansion and revenue growth, while physician-to-physician advocacy and real-world clinical experience continue to drive adoption.

Since receiving FDA 510(k) clearance in 2014, RenovoCath has been used in 750 successful procedures, underscoring the device’s growing clinical utility and physician acceptance. The Company was also bestowed with external recognition for its innovation, being named one of Fast Company’s "World’s Most Innovative Companies of 2026," in the Medical Devices category.

During the first quarter of 2026, RenovoRx strengthened its balance sheet through the successful completion of an oversubscribed private placement, generating approximately $10 million in gross proceeds. The financing reflects strong institutional investor demand and supports the Company’s ongoing clinical development and commercial expansion initiatives. Proceeds are expected to be used for working capital and general corporate purposes, providing additional flexibility as RenovoRx continues to scale its operations and advance its growth strategy.

Financial Highlights for the First Quarter Ended March 31, 2026

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Revenue for the three months ended March 31, 2026 was $563,000, compared to $197,000, year-over-year. The increase was driven by acceleration in the continued commercialization of RenovoCath and expanding adoption across U.S. cancer centers.
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Research and development expenses were approximately $1.2 million for the three months ended March 31, 2026, compared to approximately $1.6 million year-over-year. The decrease was primarily driven by higher receipts received from the TIGeR-PaC clinical trial.
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Selling, general and administrative expenses were approximately $2.7 million for the three months ended March 31, 2026, compared to approximately $1.6 million year-over-year, a reflection of the Company’s continued execution on its commercial infrastructure strategy.
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Net loss for the quarter ended March 31, 2026 was approximately $3.5 million, compared to approximately $2.4 million for the quarter ended March 31, 2025.
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Cash and cash equivalents were approximately $12.4 million as of March 31, 2026. During the first quarter, the Company strengthened its balance sheet with approximately $10 million in gross proceeds from a March 2026 private placement financing. The Company believes its current cash resources are sufficient to fund operations into at least the second half of 2027.
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Shares Outstanding: As of March 31, 2026, common shares outstanding totaled 45.05 million.
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Guidance: Reiterating full year 2026 revenue guidance of $3 to $4 million.

Conference Call Details
Event: RenovoRx First Quarter 2026 Financial Results and Business Highlights Call

Date: Thursday, May 14, 2026

Time: 4:30 P.M. ET

Live Call: 1-877-407-4018 (U.S. Toll Free) or 1-201-689-8471 (International)

Webcast: View Source

For interested individuals unable to join the conference call, a link to the recording will be available on RenovoRx’s Investor Relations website, and a dial-in replay will be available until May 28, 2026 and can be accessed by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671 (International) and entering replay pin number 13760238.

A question and answer session will occur at the end of the call, and a link to the recording of this presentation will be available on RenovoRx’s Investor Relations website after the event.

(Press release, Renovorx, MAY 14, 2026, View Source [SID1234665712])

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

•
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.
•
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:
•
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.
•
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.
•
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.
•
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 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])