CPTx to present preclinical proof-of-principle of its DNA-based in vivo CAR T platform at ASGCT Annual Meeting

On May 4, 2026 CPTx, a company developing next-generation non-viral in vivo CAR T therapies, reported that it will deliver an oral presentation showing in vivo proof-of-principle of its immune-quiet, single-stranded DNA-based delivery platform, as well as present two poster presentations at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, taking place in Boston, MA, from May 11-15.

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The oral presentation, by Head of Strategy and R&D Matthias Bozza, will include early readouts from preclinical testing of the company’s proprietary immune-quiet DNA + targeted lipid nanoparticle (tLNP) delivery system, which comprises a fully non-viral, systemically administered platform for in vivo generation of chimeric antigen receptor (CAR) T cells.

The therapeutic relevance of this approach was evaluated in a mouse model. Upon systemic administration, tLNPs loaded with CAR-encoding DNA achieved more durable tumor control relative to mRNA-based particles, consistent with the expectation that DNA-based payloads can provide a more sustained and controllable expression profile compared to transient mRNA-driven transgene expression.

"These data being presented at ASGCT (Free ASGCT Whitepaper) demonstrate strong progress towards efficient in vivo CAR T engineering using our immune-quiet DNA vectors, delivered via a targeted LNP platform. We are establishing a translational path toward off-the-shelf, in vivo-generated cell therapies that eliminate the need for individualized manufacturing. By shifting CAR T therapy from an ex vivo product to an in vivo medicine using our unique DNA-based vectors, this platform has the potential to substantially expand patient access, and we are excited to be advancing it towards first-in-human clinical evaluation." said Hendrik Dietz, CEO of CPTx.

Details of the presentations:

Oral Presentation 341: Programming CAR T cells in vivo with immune-silent ssDNA
Session: In vivo engineering of CAR T cells for autoimmune disease
Presenter: Matthias Bozza
Time: Thursday, May 14, 11:00 AM – 11:15 AM ET
Location: Westin Seaport Grand Ballroom CDE (Concourse Level)

Poster 3084: Targeted lipid nanoparticles deliver immune-silent ssDNA to generate CAR T cells
Time: Thursday, May 14, 05:00 PM – 06:30 PM ET
Location: MCEC Exhibit and Poster Hall (Halls B2-C, Exhibit Level)

Poster 3124: ssDNA vectors mitigate DNA-induced inflammation to support non-viral gene delivery
Time: Thursday, May 14, 05:00 PM – 06:30 PM ET
Location: MCEC Exhibit and Poster Hall (Halls B2-C, Exhibit Level)

(Press release, CPTx Bio, MAY 4, 2026, View Source [SID1234665070])

PTC Therapeutics to Participate in Upcoming Investor Conferences

On May 4, 2026 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that its executives will speak at the following conferences:

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Bank of America Securities Health Care Conference 2026
Tuesday, May 12 at 8:40 a.m. PDT / 11:40 a.m. EDT

RBC Capital Markets 2026 Global Healthcare Conference
Wednesday, May 20 at 10 a.m. EDT

Goldman Sachs 47th Annual Global Healthcare Conference
Tuesday, June 9 at 9:20 a.m. EDT

The presentations will be webcast live on the Events and Presentations page under the Investor section of PTC Therapeutics’ website at View Source and will be archived for 30 days following the presentation.

(Press release, PTC Therapeutics, MAY 4, 2026, View Source [SID1234665052])

Fortress Biotech to Participate in the H.C. Wainwright 2nd Annual Royalty Company Virtual Conference

On May 4, 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 that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 2nd Annual Royalty Company Virtual Conference, taking place on Wednesday, May 6, 2026. The fireside chat is scheduled to begin at 12:30pm ET.

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To register for the conference, visit View Source

(Press release, Fortress Biotech, MAY 4, 2026, View Source [SID1234665071])

Pulse Biosciences Reports Business Updates and First Quarter 2026 Financial Results

On May 4, 2026 Pulse Biosciences, Inc. (Nasdaq: PLSE), developer of novel nPulse technology using proprietary Nanosecond Pulsed Field Ablation (nanosecond PFA or nsPFA) energy, reported business updates and financial results for the first quarter ended March 31, 2026.

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Recent Business Highlights

Endocardial Catheter AF Ablation

Announced strategic prioritization of the nPulse Cardiac Catheter System following landmark clinical data, presented at AF Symposium, demonstrating exceptional procedure efficiency and durable outcomes.

Presented late-breaking data at Heart Rhythm 2026. The expanded data set included increased evaluable patient counts from the first-in-human European feasibility study showing sustained 100% procedural success by Holter monitor at 6 months (95/95 evaluable patients), 96% procedural success by Holter monitor at 12 months (51/53), and 90% Kaplan-Meier estimate of freedom from atrial arrythmias (AF/AFL/AT) at 12 months.


Commenced enrollment in NANOPULSE-AF, the U.S. IDE pivotal clinical trial, with first patients treated in early April 2026. Enrollment is now anticipated to be completed in early-Q4 2026.


Added key leadership with Dr. David Kenigsberg transitioning to full-time Chief Medical Officer and Liane Teplitsky joining as Chief Operating Officer to support pivotal trial execution and commercial preparation.

Surgical AF Ablation

Continued to progress the NANOCLAMP-AF, U.S. IDE pivotal trial for concomitant surgical AF ablation, with enrollment expected to be completed by the end of the first half of 2027.


Treated over 60 patients to date across three sites in the first-in-human European feasibility study. Electroanatomical mapping results from the three months follow up on 34 patients were presented at the European Heart Rhythm Association 2026 showing 94% durable and consistent pulmonary vein isolations, 100% posterior box isolation, and 41 second average total ablation time, consistent with the positive clinical data reported in October 2025.

Soft Tissue Ablation

Generated $0.4 million in revenue from nPulse Vybrance capital and disposables.


Presented data at NASIT demonstrating 74% benign thyroid nodule volume reduction rate with no regrowth at 15-22 months follow-up.


Completed enrollment of first 50 patients in PRECISE-Benign Thyroid Nodule study, and expanded potential enrollment to 100 patients.


Enrolled first patients in first-in-human feasibility study for papillary thyroid microcarcinoma in collaboration with MD Anderson Cancer Center, with enrollment expected to complete by year-end 2026.

"This was a defining quarter for Pulse Biosciences. We sharpened our strategic focus on electrophysiology based on landmark clinical outcomes that reinforced the durability and efficiency of AF treatment with the nPulse catheter and commenced enrollment in our U.S. IDE pivotal trial of our nPulse Cardiac Catheter System," said Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences. "Based on high investigator enthusiasm and early pivotal study progress, we are pleased to update our anticipated enrollment completion timing to early-Q4, 2026. The momentum we are building positions us to advance critical clinical and regulatory milestones that will bring the transformative potential of nanosecond PFA technology to patients and physicians globally."

Ms. Liane Teplitsky joined Pulse Biosciences as Chief Operating Officer and brings a wealth of experience in electrophysiology at this consequential moment of our strategic focus. Her impact on the nPulse Cardiac Catheter program will enable accelerated clinical development, and her impact is already evident through relationships with leading physicians as well as internal and external business leaders.

First Quarter 2026 Financial Results

Total revenue for the three months ended March 31, 2026 was $0.4 million, including both capital and disposable sales.

Total GAAP costs and expenses, representing cost of product revenue, research and development, and selling, general and administrative expenses, for the three months ended March 31, 2026, were $19.6 million, an increase of $1.6 million compared to $18.0 million in the prior year period. The increase was primarily driven by increased investment in clinical programs, partially offset by lower stock-based compensation expense. Non-GAAP costs and expenses for the three months ended March 31, 2026, were $17.4 million, an increase of $4.7 million compared to $12.7 million in the prior year period.

GAAP net loss for the three months ended March 31, 2026 was ($18.6) million compared to ($16.8) million for the three months ended March 31, 2025. Non-GAAP net loss for the three months ended March 31, 2026 was ($16.4) million compared to ($11.4) million for the three months ended March 31, 2025.

Cash and cash equivalents totaled $68.3 million as of March 31, 2026, compared to $119.3 million as of March 31, 2025 and $80.7 million as of December 31, 2025. Cash used in operating activities in the first quarter of 2026 totaled $14.6 million, compared to $13.5 million used in the same period in the prior year, and $14.8 million used in the fourth quarter of 2025. The Company has an ATM program in effect with approximately $60 million of availability. In addition, the Company has an effective $200 million shelf registration statement.

Reconciliations of GAAP to Non-GAAP cost and expenses and net loss have been provided in the tables following the financial statements in this press release. An explanation of these measures is also included below under the heading "Non-GAAP Financial Measures."

Grant of Inducement Options

In May 2026, the Company granted options to four new employees of the Company to purchase a collective total of up to 15,000 shares of Company common stock. These awards were granted as an inducement material to their becoming employees of the Company in accordance with Nasdaq Listing Rule 5635(c)(4) and were approved by the Company’s Compensation Committee. The inducement awards were granted on May 2, 2026, pre-market. The options have a ten-year term and an exercise price of $20.83 per share, the closing price per share of the Company’s common stock as reported by Nasdaq on May 1, 2026, the last closing price prior to grant, and all will be subject to time-based vesting over four years, with 1/4 of each award vesting annually, subject to the employee’s continued employment with Pulse Biosciences. The options are subject to the terms and conditions of the 2017 Inducement Equity Incentive Plan, as amended to date, and the award agreements entered into with each recipient.

Webcast and Conference Call Information

Pulse Biosciences’ management will host a conference call Thursday, May 7, 2026, beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-800-715-9871 from the U.S. or 1-646-307-1963 internationally and providing Conference ID 2636693. A live and recorded webcast of the event will be available at View Source

(Press release, Pulse Biosciences, MAY 4, 2026, View Source [SID1234665053])

NextCure and Simcere Zaiming Initiate Dose Optimization for SIM0505 (CDH6 ADC) in Gynecologic Cancers

On May 4, 2026 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer and Simcere Zaiming Pharmaceutical Co., Ltd., (Simcere) an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), reported initiation of the dose optimization portion of the Phase 1 study of SIM0505, focusing on patients with platinum-resistant ovarian cancer. SIM0505 is an investigational antibody drug conjugate (ADC) comprised of an antibody that targets Cadherin-6 (CDH6) and a proprietary topoisomerase 1 inhibitor (TOPOi) payload.

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"Initiation of dose optimization highlights the promise of our novel CDH6-directed ADC and our focus on bringing SIM0505 to patients as quickly as possible. The dose optimization study is intended to help finalize dose selection and further de-risk advancement toward registrational studies. Additionally, we are accelerating development of the program by increasing the number of U.S. and China trial sites and expanding our clinical site footprint into Canada and Europe," said Michael Richman, President and CEO of NextCure. "We look forward to presenting Phase 1 data at the upcoming 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference as we continue to build momentum in the program."

About SIM0505

SIM0505 is a novel antibody drug conjugate (ADC) directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload. The ADC is designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. SIM0505 is being evaluated in an open-label, Phase 1 study (NCT06792552) for the potential treatment of advanced solid tumors, including ovarian cancer with an emphasis on platinum resistant ovarian cancer. The Food and Drug Administration granted Fast Track to SIM0505 for platinum-resistant ovarian cancer. NextCure holds exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming Pharmaceutical Co., Ltd.

About NextCure, Inc.

NextCure is a clinical-stage biopharmaceutical company focused on advancing innovative medicines to treat cancer patients through the use of targeted therapies including antibody-drug conjugates. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells within and beyond the tumor microenvironment, and the role each interaction plays in a biologic response.