Pulse Biosciences Reports Business Updates and Third Quarter 2024 Financial Results
Pulse Biosciences (PLSE) reported Q3 2024 financial results and business updates. The company placed nsPFA Percutaneous Electrode Systems at seven U.S. sites and treated 9 patients in their atrial fibrillation study. They also treated over 50 patients with their nano-PFA 360° Cardiac Catheter. Financial highlights include GAAP costs of $13.7M (up from $11.3M YoY), GAAP net loss of $12.7M (vs $10.6M YoY), and cash position of $79.0M as of September 30, 2024. The company raised $60M through a rights offering in July 2024, with potential for additional $66M through warrant exercises.
Pulse Biosciences (PLSE) ha riportato i risultati finanziari e gli aggiornamenti aziendali per il terzo trimestre del 2024. L'azienda ha installato i sistemi di elettrodo percutaneo nsPFA in sette siti negli Stati Uniti e ha trattato 9 pazienti nel loro studio sulla fibrillazione atriale. Inoltre, hanno trattato oltre 50 pazienti con il loro catetere cardiaco nano-PFA a 360°. Punti salienti finanziari includono costi GAAP di 13,7 milioni di dollari (in aumento rispetto agli 11,3 milioni di dollari dell'anno precedente), una perdita netta GAAP di 12,7 milioni di dollari (rispetto ai 10,6 milioni di dollari dell'anno precedente) e una posizione di liquidità di 79 milioni di dollari al 30 settembre 2024. L'azienda ha raccolto 60 milioni di dollari tramite un'offerta di diritti a luglio 2024, con possibilità di ulteriori 66 milioni di dollari tramite esercizio di warrant.
Pulse Biosciences (PLSE) informó sobre los resultados financieros y las actualizaciones del negocio del tercer trimestre de 2024. La empresa instaló sistemas de electrodos percutáneos nsPFA en siete sitios de EE. UU. y trató a 9 pacientes en su estudio sobre fibrilación auricular. También trataron a más de 50 pacientes con su catéter cardíaco nano-PFA de 360°. Aspectos financieros destacados incluyen costos GAAP de 13,7 millones de dólares (aumento desde 11,3 millones de dólares en el año anterior), una pérdida neta GAAP de 12,7 millones de dólares (frente a 10,6 millones de dólares en el año anterior), y una posición de efectivo de 79 millones de dólares a fecha del 30 de septiembre de 2024. La empresa recaudó 60 millones de dólares a través de una oferta de derechos en julio de 2024, con la posibilidad de otros 66 millones de dólares a través del ejercicio de garantías.
펄스 바이오사이언스 (PLSE)는 2024년 3분기 재무 결과 및 비즈니스 업데이트를 발표했습니다. 이 회사는 미국의 7개 사이트에 nsPFA 경피적 전극 시스템을 설치하고 심방세동 연구에서 9명의 환자를 치료했습니다. 또한, 그들은 360도 나노-PFA 심장 도관으로 50명 이상의 환자를 치료했습니다. 재무 하이라이트에는 1,370만 달러(전년 대비 1,130만 달러 증가)의 GAAP 비용, 1,270만 달러(전년 대비 1,060만 달러) GAAP 순손실, 2024년 9월 30일 기준 7,900만 달러의 현금 보유액이 포함됩니다. 이 회사는 2024년 7월에 권리 제공을 통해 6천만 달러를 모집했으며, 워런트 실행을 통해 추가적으로 6천6백만 달러를 모집할 가능성이 있습니다.
Pulse Biosciences (PLSE) a annoncé ses résultats financiers et ses mises à jour commerciales pour le troisième trimestre 2024. L'entreprise a installé des systèmes d'électrodes pércutanés nsPFA dans sept sites aux États-Unis et a traité 9 patients dans son étude sur la fibrillation auriculaire. Ils ont également traité plus de 50 patients avec leur cathéter cardiaque nano-PFA à 360°. Points forts financiers : coûts GAAP de 13,7 millions de dollars (contre 11,3 millions de dollars l'année précédente), perte nette GAAP de 12,7 millions de dollars (contre 10,6 millions de dollars l'année précédente) et position de liquidités de 79 millions de dollars au 30 septembre 2024. L'entreprise a levé 60 millions de dollars grâce à une offre de droits en juillet 2024, avec un potentiel de 66 millions de dollars supplémentaires grâce à des exercices de bons de souscription.
Pulse Biosciences (PLSE) hat die finanziellen Ergebnisse und Unternehmensupdates für das dritte Quartal 2024 veröffentlicht. Das Unternehmen hat nsPFA perkutane Elektrodensysteme an sieben US-Standorten installiert und 9 Patienten in seiner Studie zur Vorhofflimmern behandelt. Zudem behandelten sie über 50 Patienten mit ihrem 360° Nano-PFA Herzkatheter. Finanzielle Highlights umfassen GAAP-Kosten von 13,7 Millionen Dollar (im Vergleich zu 11,3 Millionen Dollar im Vorjahr), einen GAAP-Nettoverlust von 12,7 Millionen Dollar (gegenüber 10,6 Millionen Dollar im Vorjahr) sowie eine Liquiditätsposition von 79 Millionen Dollar zum 30. September 2024. Das Unternehmen hat im Juli 2024 durch ein Bezugsangebot 60 Millionen Dollar eingeworben, mit der Möglichkeit, durch die Ausübung von Warrants weitere 66 Millionen Dollar zu generieren.
- Raised $60M through rights offering with potential for additional $66M through warrants
- Strong cash position of $79.0M as of September 30, 2024
- Expanded clinical trials with 50+ patients treated with nano-PFA 360° Cardiac Catheter
- Placed systems at seven U.S. sites for commercial pilot program
- Increased GAAP net loss to $12.7M from $10.6M YoY
- Higher operating expenses: GAAP costs up to $13.7M from $11.3M YoY
- Cash burn of $8.5M in Q3 2024
Insights
The Q3 2024 results reveal significant operational expansion but growing losses. Total GAAP expenses increased to
The company's strategic focus on three nano-PFA devices and planned pivotal trials in 2025 suggests substantial upcoming R&D investments. The potential for additional
Quarterly cash burn remains stable at
The clinical progress across three therapeutic areas shows promising momentum. The pilot program for the Percutaneous Electrode System in thyroid nodules and the expansion of AF trials demonstrate advancing commercialization efforts. Key developments include:
- Treatment of 9 patients in the surgical AF study
- Over 50 patients treated with the nano-PFA 360° Cardiac Catheter
- Seven U.S. sites participating in the percutaneous electrode pilot program
The addition of prominent medical advisors Dr. Kenigsberg and Dr. Natale strengthens the company's clinical expertise. The planned 2025 pivotal trials for all three devices represent critical milestones for FDA approval and market entry. Early clinical data suggesting superior cell eradication compared to existing treatments could position nano-PFA as a disruptive technology in ablation therapies.
Recent Business Highlights
Soft Tissue Ablation
-
Placed nsPFA Percutaneous Electrode Systems with seven sites in the
U.S. as part of a pilot program for clinical assessment with commercial use expected to begin in the coming quarters. -
The Company expects to commence a pivotal clinical trial in mid-2025 to support a specific labeling indication to commercialize the Percutaneous Electrode System in
the United States as a treatment for benign thyroid nodules. - Clinical data from the European feasibility study on using nano-PFA to treat benign thyroid nodules will be presented at the American Thyroid Association Conference as an oral abstract on October 31, 2024.
Surgical AF Ablation
-
Treated 9 patients and opened a second study site as part of the multi-center, first-in-human atrial fibrillation (AF) feasibility study underway in
Europe . -
The Company expects to submit an IDE, enabling it to commence its pivotal clinical trial in mid-2025 to support a premarket approval (PMA) application for FDA approval to commercialize the nano-PFA Cardiac Surgical System in
the United States as a treatment for AF.
Endocardial Catheter AF Ablation
- Treated over 50 patients with the nano-PFA 360° Cardiac Catheter and engaged two additional European clinical study sites in the first-in-human feasibility study for the treatment of AF.
- Announced the appointment of Dr. David Kenigsberg as Chief Medical Officer for Electrophysiology and the addition of Dr. Andrea Natale to its electrophysiology medical advisory board, joining existing advisors Dr. Vivek Reddy and Dr. Jacob Koruth.
-
The Company expects to commence a
U.S. IDE pivotal clinical study sometime in the middle of 2025.
“In the third quarter we made significant progress toward delivering the benefits of nano-PFA to patients and providers around the world. Our clinical work with each of our three devices continues to suggest that our differentiated nano-PFA technology has the potential to improve treatments for several disease states by eradicating cells in a better way than currently available modalities,” said Burke T. Barrett, President and Chief Executive Officer of Pulse Biosciences. “The work we have done to date positions us to begin pivotal clinical trials in the
Third Quarter 2024 Financial Results
Total GAAP costs and expenses, representing research and development and general and administrative expenses, for the three months ended September 30, 2024, were
GAAP net loss for the three months ended September 30, 2024 was
Cash and cash equivalents totaled
Cash used in the third quarter of 2024 was
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, October 30, 2024, beginning at 1:30 p.m. PT. Investors interested in listening to the conference call may do so by dialing 1-877-407-0752 for domestic callers or 1-201-389-0912 for international callers. A live and recorded webcast of the event will be available at https://investors.pulsebiosciences.com/.
About Pulse Biosciences®
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. The Company’s proprietary CellFX® nsPFA™ technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue. The Company is actively pursuing the development of its CellFX nsPFA technology for use in the treatment of atrial fibrillation and in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Pulse Biosciences is now headquartered in
Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS, nsPFA, CellFX nsPFA and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in
Non-GAAP Financial Measures
In this press release, in order to supplement the Company’s condensed consolidated financial statements presented in accordance with Generally Accepted Accounting Principles, or GAAP, management has disclosed certain non-GAAP financial measures for the statement of operations. The Company believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared in accordance with GAAP. As a result, the Company is disclosing certain non-GAAP results in order to supplement investors’ and other readers’ understanding and assessment of the Company’s financial performance. Company management uses these measurements as aids in monitoring the Company’s ongoing financial performance from quarter to quarter, and year to year, on a regular basis and for financial and operational decision-making. Non-GAAP adjustments include stock-based compensation, depreciation and amortization and restructuring charges. From time to time in the future, there may be other items that the Company may exclude if the Company believes that doing so is consistent with the goal of providing useful information to management and investors. The Company has provided a reconciliation of each non-GAAP financial measure used in this earnings release to the most directly comparable GAAP financial measure. Investors are cautioned that there are a number of limitations associated with the use of non-GAAP financial measures as analytical tools. Investors are encouraged to review these reconciliations, and not to rely on any single financial measure to evaluate the Company’s business.
Non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies, which could reduce the usefulness of the Company’s non-GAAP financial measures as tools for comparison. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most directly comparable GAAP measures set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP. Non-GAAP financial measures in this earnings release exclude the following:
Non-cash expenses for stock-based compensation. The Company has excluded the effect of stock-based compensation expenses in calculating the Company’s non-GAAP cost and expenses and net loss measures. Although stock-based compensation is a key incentive offered to employees, the Company continues to evaluate its business performance excluding stock-based compensation expenses. The Company records stock-based compensation expense related to grants of time-based and performance-based options, such as options that vest as a result of the Company’s market capitalization. Depending upon the size, timing and terms of the grants, as well as the probability of achievement of performance-based awards, this expense may vary significantly but will recur in future periods. The Company believes that excluding stock-based compensation better allows for comparisons from period to period.
Depreciation and amortization. The Company has excluded depreciation and amortization expense in calculating its non-GAAP cost and expenses and net loss measures. Depreciation and amortization are non-cash charges to current operations.
Restructuring charges. The Company has excluded restructuring charges in calculating its non-GAAP cost and expenses and net loss measures. Restructuring programs involve discrete initiatives designed to improve operating efficiencies and include employee termination, contract termination, and other exit costs associated with the restructuring program. The Company believes that excluding discrete restructuring charges allows for better comparisons from period to period.
Forward-Looking Statements
All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to the effectiveness of the Company’s CellFX nsPFA technology and CellFX System to non-thermally clear cells while sparing adjacent non-cellular tissue, statements concerning the Company’s future fundraising efforts and whether those efforts will be successful or allow the Company to continue current operations as planned, and statements concerning the Company’s future clinical and regulatory initiatives anywhere in the world, and other future events. These statements are not historical facts but rather are based on Pulse Biosciences’ current expectations, estimates, and projections regarding Pulse Biosciences’ business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences’ control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences’ filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.
PULSE BIOSCIENCES, INC. |
||||||||
Condensed Consolidated Balance Sheets |
||||||||
(In thousands, except per share amounts) |
||||||||
(Unaudited) |
||||||||
September 30, |
December 31, |
|||||||
2024 |
2023 |
|||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ |
79,033 |
|
$ |
44,365 |
|
||
Prepaid expenses and other current assets |
1,381 |
|
963 |
|
||||
Total current assets |
|
80,414 |
|
|
45,328 |
|
||
Property and equipment, net |
1,221 |
|
1,528 |
|
||||
Intangible assets, net |
1,386 |
|
1,886 |
|
||||
Goodwill |
2,791 |
|
2,791 |
|
||||
Right-of-use assets |
6,588 |
|
7,256 |
|
||||
Other assets |
646 |
|
365 |
|
||||
Total assets |
$ |
93,046 |
|
$ |
59,154 |
|
||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ |
1,727 |
|
$ |
1,836 |
|
||
Accrued expenses |
3,821 |
|
3,814 |
|
||||
Lease liability, current |
1,193 |
|
1,058 |
|
||||
Total current liabilities |
|
6,741 |
|
|
6,708 |
|
||
Lease liability, less current |
7,174 |
|
8,086 |
|
||||
Total liabilities |
|
13,915 |
|
|
14,794 |
|
||
Stockholders’ equity: |
||||||||
Preferred stock, |
— |
|
— |
|
||||
Common stock, |
62 |
|
55 |
|
||||
Additional paid-in capital |
450,184 |
|
381,220 |
|
||||
Accumulated other comprehensive income (loss) |
— |
|
— |
|
||||
Accumulated deficit |
(371,115 |
) |
(336,915 |
) |
||||
Total stockholders’ equity |
|
79,131 |
|
|
44,360 |
|
||
Total liabilities and stockholders’ equity |
$ |
93,046 |
|
$ |
59,154 |
|
PULSE BIOSCIENCES, INC. |
||||||||||||||||
Condensed Consolidated Statements of Operations and Comprehensive Loss |
||||||||||||||||
(In thousands, except per share amounts) |
||||||||||||||||
(Unaudited) |
||||||||||||||||
Three-Month Periods Ended |
Nine-Month Periods Ended |
|||||||||||||||
September 30, |
September 30, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
Revenues: |
||||||||||||||||
Product revenues |
$ |
— |
|
$ |
— |
|
$ |
— |
|
$ |
— |
|
||||
Total revenues |
— |
|
|
— |
|
|
— |
|
|
— |
|
|||||
Cost and expenses: |
||||||||||||||||
Research and development |
7,703 |
|
7,472 |
|
21,674 |
|
19,998 |
|
||||||||
General and administrative |
5,952 |
|
3,780 |
|
14,322 |
|
11,043 |
|
||||||||
Total cost and expenses |
|
13,655 |
|
|
11,252 |
|
|
35,996 |
|
|
31,041 |
|
||||
Loss from operations |
(13,655 |
) |
(11,252 |
) |
(35,996 |
) |
(31,041 |
) |
||||||||
Other income: |
||||||||||||||||
Interest income, net |
|
975 |
|
|
686 |
|
|
1,796 |
|
|
764 |
|
||||
Total other income |
975 |
|
686 |
|
1,796 |
|
764 |
|
||||||||
Net loss |
|
(12,680 |
) |
|
(10,566 |
) |
|
(34,200 |
) |
|
(30,277 |
) |
||||
Comprehensive loss |
$ |
(12,680 |
) |
$ |
(10,566 |
) |
$ |
(34,200 |
) |
$ |
(30,277 |
) |
||||
Net loss per share: |
||||||||||||||||
Basic and diluted net loss per share |
$ |
(0.21 |
) |
$ |
(0.19 |
) |
$ |
(0.60 |
) |
$ |
(0.64 |
) |
||||
Weighted average shares used to compute net loss per common share — basic and diluted |
|
61,066 |
|
|
56,866 |
|
|
57,169 |
|
|
47,288 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Three-Month Periods Ended |
Nine-Month Periods Ended |
|||||||||||||||
September 30, |
September 30, |
|||||||||||||||
Stock Based Compensation Expense: |
2024 |
2023 |
2024 |
2023 |
||||||||||||
Research and development |
1,108 |
|
982 |
|
3,058 |
|
1,758 |
|
||||||||
General and administrative |
1,874 |
|
816 |
|
3,735 |
|
2,079 |
|
||||||||
Total stock-based compensation expense |
$ |
2,982 |
|
$ |
1,798 |
|
$ |
6,793 |
|
$ |
3,837 |
|
Reconciliation of GAAP to Non-GAAP Financial Measures |
|||||||||||||||
The following table presents the reconciliation of non-GAAP financial measures to the most directly comparable GAAP financial measures: |
|||||||||||||||
(In thousands) |
|||||||||||||||
(Unaudited) |
|||||||||||||||
Three-Month Periods Ended |
Nine-Month Periods Ended |
||||||||||||||
|
September 30, |
|
September 30, |
||||||||||||
|
2024 |
|
|
|
2023 |
|
|
2024 |
|
|
|
2023 |
|
||
Reconciliation of GAAP to non-GAAP Research and development: |
|||||||||||||||
GAAP Research and development |
$ |
7,703 |
|
$ |
7,472 |
|
$ |
21,674 |
|
$ |
19,998 |
|
|||
Less: Stock-based compensation expense |
(1,108 |
) |
(982 |
) |
(3,058 |
) |
(1,758 |
) |
|||||||
Less: Depreciation and amortization |
(47 |
) |
(55 |
) |
(152 |
) |
(172 |
) |
|||||||
Less: Restructuring |
— |
|
— |
|
— |
|
(38 |
) |
|||||||
Non-GAAP Research and development |
$ |
6,548 |
|
$ |
6,435 |
|
$ |
18,464 |
|
$ |
18,030 |
|
|||
Reconciliation of GAAP to non-GAAP General and administrative: |
|||||||||||||||
GAAP General and administrative |
$ |
5,952 |
|
$ |
3,780 |
|
$ |
14,322 |
|
$ |
11,043 |
|
|||
Less: Stock-based compensation expense |
(1,874 |
) |
(816 |
) |
(3,735 |
) |
(2,079 |
) |
|||||||
Less: Depreciation and amortization |
(246 |
) |
(242 |
) |
(740 |
) |
(730 |
) |
|||||||
Less: Restructuring |
— |
|
— |
|
— |
|
(5 |
) |
|||||||
Non-GAAP General and administrative |
$ |
3,832 |
|
$ |
2,722 |
|
$ |
9,847 |
|
$ |
8,229 |
|
|||
Reconciliation of GAAP to non-GAAP Cost and expenses: |
|||||||||||||||
GAAP Cost and expenses |
$ |
13,655 |
|
$ |
11,252 |
|
$ |
35,996 |
|
$ |
31,041 |
|
|||
Less: Stock-based compensation expense |
(2,982 |
) |
(1,798 |
) |
(6,793 |
) |
(3,837 |
) |
|||||||
Less: Depreciation and amortization |
(293 |
) |
(297 |
) |
(892 |
) |
(902 |
) |
|||||||
Less: Restructuring |
— |
|
— |
|
— |
|
(43 |
) |
|||||||
Non-GAAP Cost and expenses |
$ |
10,380 |
|
$ |
9,157 |
|
$ |
28,311 |
|
$ |
26,259 |
|
|||
Reconciliation of GAAP to non-GAAP Net loss: |
|||||||||||||||
GAAP Net loss |
$ |
(12,680 |
) |
$ |
(10,566 |
) |
$ |
(34,200 |
) |
$ |
(30,277 |
) |
|||
Add: Stock-based compensation expense |
2,982 |
|
1,798 |
|
6,793 |
|
3,837 |
|
|||||||
Add: Depreciation and amortization |
293 |
|
297 |
|
892 |
|
902 |
|
|||||||
Add: Restructuring |
— |
|
— |
|
— |
|
43 |
|
|||||||
Non-GAAP Net loss |
$ |
(9,405 |
) |
$ |
(8,471 |
) |
$ |
(26,515 |
) |
$ |
(25,495 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20241030332516/en/
Investors:
Pulse Biosciences, Inc.
Burke T. Barrett, President and CEO
IR@pulsebiosciences.com
or
Gilmartin Group
Philip Trip Taylor
415.937.5406
philip@gilmartinir.com
Source: Pulse Biosciences, Inc.
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