Full Press Release Details
PULSE BIOSCIENCES QUARTERLY INVESTOR CONFERENCE CALL
Conference call today at 1:30 p.m. PDT / 4:30 p.m. EDT
HAYWARD, Calif. - (BUSINESS WIRE) Pulse Biosciences, Inc. (Nasdaq: PLSE) (the Company ), a novel bioelectric medicine company bringing to market its proprietary CellFX System, today reported recent corporate developments and financial results for the three- and nine-month periods ended September 30, 2019.
Recent Corporate Developments
Financial Highlights
Cash, cash equivalents, and investments totaled $34.5 million at September 30, 2019, compared to $59.6 million at December 31, 2018. Cash use totaled $8.1 million for the third quarter of 2019 compared to cash use of $10.2 million for the second quarter of 2019 and $6.8 million for the first quarter of 2019.
Operating expenses for the three-month period ended September 30, 2019 totaled $12.0 million, compared to $10.9 million for the three-month period ended September 30, 2018. Operating expenses for the three-month period ended September 30, 2019 included non-cash stock-based compensation of $2.7 million, compared to non-cash stock-based compensation of $3.4 million for the three-month period ended September 30, 2018.
Operating expenses for the nine-month period ended September 30, 2019 totaled $34.0 million, compared to $28.9 million for the nine-month period ended September 30, 2018. Operating expenses for the nine-month period ended September 30, 2019 included non-cash stock-based compensation of $7.7 million, compared to non-cash stock-based compensation of $10.0 million for the nine-month period ended September 30, 2018.
Net loss for the three-month period ended September 30, 2019 totaled $11.7 million compared to $10.8 million for the three-month period ended September 30, 2018. Net loss for the nine-month period ended September 30, 2019 totaled $33.2 million compared to $28.6 million for the nine-month period ended September 30, 2018.
Conference Call Details
Pulse Biosciences will host an investor call today at 1:30 p.m. PDT / 4:30 p.m. EDT. The telephone dial-in number for the call is (844) 494-0190 (U.S. toll-free) or (508) 637-5580 (international) using Conference ID 7381116. Listeners will also be able to access the call via webcast available on the Investors section of the Company's website at www.PulseBiosciences.com.
About Pulse Biosciences
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that improves and potentially extends the lives of patients. The CellFX System is the first planned commercial product to harness the distinctive advantages of the Company's proprietary Nano-Pulse Stimulation (NPS ) technology to treat a variety of applications for which an optimal solution remains unfulfilled. NPS technology delivers nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue. The cell-specific effects of NPS technology have been validated in a series of ongoing clinical trials. The CellFX System is preparing to launch in 2019 as a multi-application platform designed to address a broad range of dermatologic conditions. As part of the customer experience, the Company is offering a utilization-based revenue model and easy-access customer portal offering a suite of services. CellFX procedures offer customer value across an expanding spectrum of clinical applications. The initial commercial use will be in the clearance of common and difficult-to-treat skin lesions that share high demand among patients and practitioners for improved and durable aesthetic outcomes that lead to greater overall satisfaction.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding our CellFX System and the Company's commercialization of our CellFX System, including when and whether the Company will receive clearance from the FDA on its 510(k) submission, progress towards commercialization, and the timing of completion of enrollment in and the results of clinical study plans. These forward-looking statements are based on current expectations and estimates and involve a number of risks and uncertainties that could cause actual results to differ materially from those suggested or implied by the forward-looking statements. These forward-looking statements should, therefore, be considered in light of various important factors, including, but not limited to, the following: the ability of the Company to obtain sufficient funding; the loss of key management personnel and the ability to retain and recruit new personnel; the ability to adapt to rapidly changing technology; competition in the medical device industry and in the specific markets of aesthetics and dermatology in which the Company plans to operate; reliance on third parties; the ability to manage growth; the impact of governmental regulatory agencies, including the U.S. FDA, and regulatory approvals, clearances and restrictions or any dispute that may occur with any regulatory body; risks inherent to the planning, design, enrollment in and execution of clinical studies; domestic and regional economic conditions on aesthetic healthcare spending; the timing and success of product development and market acceptance of developed and approved products, including, but not limited to, the CellFX System; intellectual property positions and litigation; unanticipated manufacturing disruptions or the inability to meet demand for products; the results of legal proceedings to which the Company is or may become a party; product liability and other litigation claims; adverse publicity regarding the company and the safety of the
Company's products and adequacy of training; the impact of changes to tax legislation, guidance, and interpretations; and other risk factors under the heading Risk Factors in the Company's most recently filed quarterly report on Form 10-Q, as periodically updated by the Company's subsequent filings with the Securities and Exchange Commission. Statements using words such as estimates, projects, believes, anticipates, plans, expects, intends, may, will, could, should, would, targeted and similar words and expressions are intended to identify forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Pulse Biosciences, Inc. undertakes no obligation to publicly update or release any revisions to these forward-looking statements, except as required by law.
Caution: Pulse Biosciences' CellFX System and Nano-Pulse Stimulation (NPS) technology are for investigational use only.
Pulse Biosciences, Inc.
President and Chief Executive Officer
Gitanjali Jain Ogawa, 646-378-2949
Nadine D. Tosk, 504-453-8344
PULSE BIOSCIENCES, INC.
Condensed Consolidated Balance Sheets
| September 30, | December 31, | |||||
| (in thousands) | 2019 | 2018 | ||||
| ASSETS | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 9,570 | $ | 51,103 | ||
| Investments | 24,928 | 8,480 | ||||
| Prepaid expenses and other current assets | 1,437 | 779 | ||||
| Total current assets | 35,935 | 60,362 | ||||
| Property and equipment, net | 2,428 | 2,173 | ||||
| Intangible assets, net | 4,713 | 5,213 | ||||
| Goodwill | 2,791 | 2,791 | ||||
| Right-of-use assets | 1,190 | |||||
| Other assets | 1,645 | 101 | ||||
| Total assets | $ | 48,702 | $ | 70,640 | ||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 1,816 | $ | 1,272 | ||
| Accrued expenses | 2,054 | 1,421 | ||||
| Deferred rent, current | 415 | |||||
| Lease liability, current | 177 | |||||
| Total current liabilities | 4,047 | 3,108 | ||||
| Deferred rent, net of current | 1,198 | |||||
| Lease liability, net of current | 3,674 | |||||
| Total liabilities | 7,721 | 4,306 | ||||
| Stockholders' equity: | ||||||
| Common stock and additional paid-in capital | 149,874 | 142,053 | ||||
| Accumulated other comprehensive loss | 8 | (1) | ||||
| Accumulated deficit | (108,901) | (75,718) | ||||
| Total stockholders' equity | 40,981 | 66,334 | ||||
| Total liabilities and stockholders' equity | $ | 48,702 | $ | 70,640 |
PULSE BIOSCIENCES, INC.
Condensed Consolidated Statements of Operations
| Three-Month Periods Ended | ||||||
| September 30, | ||||||
| (in thousands, except per share amounts) | 2019 | 2018 | ||||
| Revenue | $ | $ | ||||
| Operating expenses: | ||||||
| General and administrative | 5,606 | 5,675 | ||||
| Research and development | 6,192 | 5,038 | ||||
| Amortization of intangible assets | 166 | 166 | ||||
| Total operating expenses | 11,964 | 10,879 | ||||
| Other income: | ||||||
| Interest income | 218 | 118 | ||||
| Total other income | 218 | 118 | ||||
| Net loss | (11,746) | (10,761) | ||||
| Net loss per share: | ||||||
| Basic and diluted net loss per share | $ | (0.57) | $ | (0.64) | ||
| Weighted average shares used to compute net loss per common share basic and diluted | 20,774 | 16,927 |
PULSE BIOSCIENCES, INC.
Condensed Consolidated Statements of Operations
| Nine-Month Periods Ended | ||||||
| September 30, | ||||||
| (in thousands, except per share amounts) | 2019 | 2018 | ||||
| Revenue | $ | $ | ||||
| Operating expenses: | ||||||
| General and administrative | 15,153 | 16,230 | ||||
| Research and development | 18,371 | 12,174 | ||||
| Amortization of intangible assets | 500 | 499 | ||||
| Total operating expenses | 34,024 | 28,903 | ||||
| Other income: | ||||||
| Interest income | 841 | 311 | ||||
| Total other income | 841 | 311 | ||||
| Net loss | (33,183) | (28,592) | ||||
| Net loss per share: | ||||||
| Basic and diluted net loss per share | $ | (1.60) | $ | (1.69) | ||
| Weighted average shares used to compute net loss per common share basic and diluted | 20,728 | 16,883 |