Pulse Biosciences Reports Business Updates and Fourth Quarter & Full Year 2025 Financial Results

On February 19, 2026 Pulse Biosciences, Inc. (Nasdaq: PLSE), developer of the novel nPulse technology using proprietary Nanosecond Pulsed Field Ablation (nanosecond PFA or nsPFA) energy, reported business updates and financial results for the fourth quarter and full year ended December 31, 2025.

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Recent Business Highlights

Endocardial Catheter AF Ablation

● Highlighted 100% procedural success, or freedom from atrial fibrillation (AF), at 6 months and 96% procedural success at one year, of evaluable patients, following treatments with the nPulse Cardiac Catheter System in the first-in-human feasibility study which was presented as late-breaking data at the 31st Annual AF Symposium Meeting.
● Received FDA approval to commence a pivotal IDE study for the treatment of paroxysmal atrial fibrillation with the nPulse Cardiac Catheter System in Q4 2025. The first patient is expected to be enrolled in the next few months and the last patient is expected to be enrolled in Q4 2026.

Surgical AF Ablation

● Continued enrollment in the nPulse Cardiac Surgery System IDE pivotal study, NANOCLAMP AF, for the treatment of AF, representing the first PFA study approved by the FDA for a surgical cardiac ablation device in concomitant surgical procedures.
● Expanding and accelerating IDE site activation to support patient enrollment completion in 2026.

Soft Tissue Ablation

● Generated $264 thousand of revenue in a highly controlled commercial launch.
● Continued enrollment of the PRECISE-BTN study, for the treatment of benign thyroid nodules (BTN) with the nPulse Vybrance percutaneous electrode system, and plan to complete enrollment of 50 patients in the next few months and expand enrollment to 100 patients over the ensuing two quarters.
● Initiated a research collaboration with University of Texas MD Anderson Cancer Center to evaluate the use of nsPFA for the treatment of both benign and malignant thyroid tumors.

"2025 was a highly productive year for Pulse Biosciences as we achieved notable milestones in each of our market development programs. Most importantly, we have advanced our nsPFA platform into late-stage clinical development to treat atrial fibrillation in both electrophysiology and cardiac surgery, receiving FDA IDE approvals to initiate both pivotal studies," said Paul LaViolette, CEO of Pulse Biosciences. "I am thrilled in particular with the compelling clinical evidence being developed by our programs, especially the best-in-class procedural success rates treating paroxysmal AF from our large feasibility study. Our focus in 2026 is on clinical trial execution, including completing pivotal enrollment in both cardiac programs."

Fourth Quarter 2025 Financial Results

Total revenue was $264 thousand for the fourth quarter of 2025, including both nPulse capital and Vybrance disposables sales, compared to $86 thousand in the third quarter of 2025.

Total GAAP costs and expenses, representing cost of product revenue, research and development, and selling, general, and administrative expenses, for the three months ended December 31, 2025, were $18.5 million, a decrease of $1.7 million compared to $20.3 million in the prior year period. The decrease was primarily driven by non-recurring legal and severance costs in the prior year period, partially offset by expenses related to the expanding organization to support advancement of nsPFA device clinical trials and commercialization. Non-GAAP costs and expenses for the three months ended December 31, 2025, were $13.3 million, an increase of $2.0 million compared to $11.3 million in the prior year period.

GAAP net loss for the three months ended December 31, 2025 was ($17.4) million compared to ($19.4) million for the three months ended December 31, 2024. Non-GAAP net loss for the three months ended December 31, 2025 was ($12.2) million compared to ($10.4) million for the three months ended December 31, 2024.

Full year 2025 Financial Results

Total revenue was $350 thousand for the full year 2025.

Total GAAP costs and expenses, representing cost of product revenue, research and development, and selling, general, and administrative expenses, for the full year ended December 31, 2025, were $77.3 million, an increase of $21.0 million compared to $56.3 million in the prior year. The increase was primarily driven by expenses related to the expanding organization to support advancement of the nsPFA device clinical trials and commercialization. Non-GAAP costs and expenses for the year ended December 31, 2025, were $55.4 million, an increase of $15.8 million compared to $39.6 million in the prior year period.

GAAP net loss for the full year 2025 was ($72.8) million compared to ($53.6) million for the prior year. Non-GAAP net loss for the year ended December 31, 2025 was ($50.8) million compared to ($36.9) million for the year ended December 31, 2024.

Cash and cash equivalents totaled $80.7 million as of December 31, 2025, compared to $118.0 million as of December 31, 2024 and $95.2 million as of September 30, 2025. Cash used in operating activities in the fourth quarter of 2025 totaled $14.8 million, compared to $9.1 million used in the same period in the prior year, and $13.0 million used in the third quarter of 2025.

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."

Webcast and Conference Call Information

Pulse Biosciences’ management will host a conference call today, February 19, 2025, 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 7647402. A live and recorded webcast of the event will be available at View Source

(Press release, Pulse Biosciences, FEB 19, 2026, View Source [SID1234662791])

PTC Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2025 Financial Results

On February 19, 2026 PTC Therapeutics, Inc., (NASDAQ: PTCT) reported a corporate update and financial results for the fourth quarter and full year ending December 31, 2025.

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"We delivered another strong quarter and finish to 2025, building on the successful global launch of Sephience," said Matthew B. Klein, M.D., Chief Executive Officer of PTC Therapeutics. "With our robust commercial engine, innovative R&D programs, and strong financial position, we look forward to continued success as we approach cash flow breakeven."

Key Corporate Highlights

Full-year 2025 product and royalty revenue of $831 million, exceeding guidance
Global launch of Sephience off to strong start
Q4 2025 revenue of $92 million, including $81 million revenue in the US and $11 million revenue ex-US
Sephience total net revenue of $111 million in 2025 since launch
946 total patients on commercial therapy worldwide as of December 31, 2025
1,134 patient start forms received in the US as of December 31, 2025
Approval in Japan in December 2025; approval in Brazil in February 2026
Sephience global footprint expected to increase to 20 to 30 countries by end of 2026
In December 2025, PTC sold the remainder of its Evrysdi (risdiplam) royalty to Royalty Pharma for $240 million upfront and up to $60 million in sales-based milestones; PTC maintains the right to receive a $150 million milestone from Roche based on single-year Evrysdi sales of $2.5 billion
End-of-Phase 2 meeting with FDA held in Q4 2025 to discuss the votoplam Huntington’s disease (HD) program
Alignment reached on design of global Phase 3 trial, INVEST-HD, which is planned to initiate in 1H 2026
FDA confirmed openness for potential Accelerated Approval pathway given significant unmet need
Type C meeting with FDA held in December 2025 to discuss the vatiquinone Friedreich’s ataxia program; FDA indicated that an additional study would be necessary to support NDA resubmission and meeting minutes stated that this could be an open-label study with a natural history control group
Fourth Quarter and Full Year 2025 Financial Highlights

Total revenues were $164.7 million for the fourth quarter of 2025, compared to $213.2 million for the fourth quarter of 2024. Total revenues were $1,730.7 million for full year 2025, compared to $806.8 million for full year 2024. Included in total revenues is collaboration and license revenue of $998.4 million for the full year 2025, related to the votoplam license and collaboration agreement with Novartis, which closed in January 2025.
Total net product revenues were $184.0 million for the fourth quarter of 2025, compared to $150.1 million for the fourth quarter of 2024. Total net product revenues were $586.7 million for full year 2025, compared to $582.1 million for full year 2024.
Translarna (ataluren) net product revenues were $39.0 million for the fourth quarter of 2025, compared to $89.1 million for the fourth quarter of 2024. Translarna net product revenues were $235.3 million for full year 2025, compared to $321.1 million for full year 2024.
Emflaza (deflazacort) net product revenues were $27.1 million for the fourth quarter of 2025, compared to $50.5 million for the fourth quarter of 2024. Emflaza net product revenues were $146.4 million for full year 2025, compared to $207.2 million for full year 2024.
Roche reported Evrysdi full year 2025 sales of approximately 1,757 CHF million, resulting in royalty revenue of $244.2 million to PTC for full year 2025, compared to $203.9 million to PTC for full year 2024.
Based on U.S. GAAP (Generally Accepted Accounting Principles), GAAP R&D expenses were $133.1 million for the fourth quarter of 2025, compared to $124.8 million for the fourth quarter of 2024. GAAP R&D expenses were $455.2 million for full year 2025, compared to $534.5 million for full year 2024.
Non-GAAP R&D expenses were $124.3 million for the fourth quarter of 2025, excluding $8.8 million in non-cash, stock-based compensation expense, compared to $116.0 million for the fourth quarter of 2024, excluding $8.8 million in non-cash, stock-based compensation expense. Non-GAAP R&D expenses were $419.6 million for full year 2025, excluding $35.7 million in non-cash, stock-based compensation expense, compared to $497.9 million for full year 2024, excluding $36.6 million in non-cash, stock-based compensation expense.
GAAP SG&A expenses were $96.9 million for the fourth quarter of 2025, compared to $84.7 million for the fourth quarter of 2024. GAAP SG&A expenses were $347.1 million for full year 2025, compared to $300.9 million for full year 2024.
Non-GAAP SG&A expenses were $87.2 million for the fourth quarter of 2025, excluding $9.7 million in non-cash, stock-based compensation expense, compared to $76.3 million for the fourth quarter of 2024, excluding $8.4 million in non-cash, stock-based compensation expense. Non-GAAP SG&A expenses were $308.3 million for full year 2025, excluding $38.9 million in non-cash, stock-based compensation expense, compared to $262.9 million for full year 2024, excluding $38.0 million in non-cash, stock-based compensation expense.
Net loss was $135.0 million for the fourth quarter of 2025, compared to net loss of $65.9 million for the fourth quarter of 2024. Net income was $682.6 million for full year 2025, compared to net loss of $363.3 million for full year 2024.
Cash, cash equivalents, and marketable securities were $1,945.4 million on December 31, 2025, compared to $1,139.7 million on December 31, 2024.
Shares issued and outstanding as of December 31, 2025, were 81,474,366.
Full Year 2026 Financial Guidance

Total product revenue of $700 to $800 million, representing a 19 to 36% increase from 2025, with the majority from Sephience
GAAP R&D and SG&A expense of $775 to $815 million
Non-GAAP R&D and SG&A expense of $680 to $720 million, excluding estimated non-cash, stock-based compensation expense of $95 million

(Press release, PTC Therapeutics, FEB 19, 2026, View Source [SID1234662790])

Protara Therapeutics to Participate in Upcoming Investor Conferences

On February 19, 2026 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported that management will participate in the following investor conferences:

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Oppenheimer 36th Annual Healthcare Life Sciences Conference. A fireside chat will take place virtually on Thursday, February 26 at 2:40 pm ET.
TD Cowen 46th Annual Health Care Conference. A fireside chat will take place on Tuesday, March 3 at 2:30 pm ET in Boston.
A live webcast of the events can be accessed by visiting the Events and Presentations section of the Company’s website: View Source The webcasts will be archived for a limited time following the presentation.

(Press release, Protara Therapeutics, FEB 19, 2026, View Source [SID1234662789])

Olema Oncology to Present at the TD Cowen 46th Annual Health Care Conference

On February 19, 2026 Olema Pharmaceuticals, Inc. ("Olema", or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported that Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer, will present at the TD Cowen 46th Annual Health Care Conference on Tuesday, March 3, 2026 at 2:30 p.m. ET.

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A live webcast and recording of this presentation will be available, as permitted by the event host, in the Events and Presentations section of Olema’s investor relations website at ir.olema.com.

(Press release, Olema Oncology, FEB 19, 2026, View Source [SID1234662788])

Moleculin Announces Exercise of Warrants for $8.3 Million Gross Proceeds

On February 19, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported it has entered into agreements with certain holders of its existing warrants for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 2,122,652 shares of common stock of the Company at an exercise price of $3.90 per share. The issuance or resale of the shares of common stock issuable upon exercise of the outstanding warrants has been registered pursuant to effective registration statements. The aggregate gross proceeds from the exercise of the existing warrants is expected to total approximately $8.3 million, before deducting financial advisory fees.

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Roth Capital Partners is acting as the Company’s financial advisor for this transaction.

In consideration for the immediate exercise of the warrants for cash, the Company will issue new unregistered warrants to purchase shares of common stock. The new warrants will be exercisable for an aggregate of up to 6,367,956 shares of common stock, at an exercise price equal to the lesser of $3.90 per share or the lowest volume weighted average price of the Company’s common stock on any trading day during the next five trading days, will be exercisable upon shareholder approval and for a term of five years from the date of shareholder approval.

The transaction is expected to close on or about February 20, 2026, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "1933 Act") and, along with the shares of common stock issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Moleculin, FEB 19, 2026, View Source [SID1234662787])