-- Cash runway extended into Q2 2024 --
-- Company to host call at
Third Quarter and Recent Business Updates
- Q3 2023 revenue of
$143 thousand , compared to$196 thousand in Q3 2022, the decrease due to the expiration of the Patient Therapy Access Program (“PTAP”) onJune 30, 2023 . - Operating cash burn of
$2.5 million in Q3 2023, a decrease of$1.4 million compared to Q3 2022, reflecting continued focus on cash management. - Ended the quarter with
$7.0 million of cash, cash equivalents, and proceeds receivable from warrant exercises, extending the Company’s cash runway into Q2 2024. - Received universal product code (“UPC”) numbers from
Wolters Kluwer Health – Medi-Span® (“Medi-Span”) for the Portable Neuromodulation Stimulator (“PoNS®”) system and mouthpiece. Together with the previously announced Durable Medical Equipment, Prosthetics, Orthotics and Supplies (“DMEPOS”) accreditation, the UPC numbers allow for dual paths of reimbursement. - Received a letter of intent (“LOI”) from the Québec
Ministry of Health and Social Services (“MSSS”) for the purchase of up to 30 PoNS systems across multiple sites to be used to evaluate the benefit of PoNS TherapyTM and determine reimbursement opportunities for stroke patients. - Received an order for 10 PoNS Systems from the
School of Rehabilitation at the Université deMontréal (“UdeM”) to be used to evaluate the benefit and health economic value of PoNS Therapy in the treatment of stroke patients. - Added sixth Center of Excellence to the PoNS Therapeutic Experience Program (“PoNSTEP”), a multi-center, company-sponsored, open label observational interventional trial designed to evaluate the impact of adherence to PoNS Therapy in patients with multiple sclerosis (“MS”).
- Announced the release of a white paper published by
Pacific Blue Cross (“PBC”) and HealthTech Connex (“HTC”) demonstrating that PoNS TherapyTM can drastically decrease disability and improve the likelihood of returning to work for patients suffering from traumatic brain injury (“TBI”).
“We are pleased with the tremendous progress we made in the third quarter and recent weeks,” said
We also developed relationships with two important
Andreeff continued, “Finally, we were thrilled by the study results from the white paper recently published by
“With what we’ve set in motion during 2023, and a cash runway that will take us into the second quarter of next year, we are excited about the road ahead, and the chance to help more people with MS, TBI, and stroke who suffer from balance and gait impairment,” concluded Andreeff.
Third Quarter 2023 Financial Results
Total revenue for the third quarter of 2023 was
Cost of revenue increased to
Selling, general and administrative expenses for the third quarter of 2023 were
Research and development expenses for the third quarter of 2023 decreased slightly to
Total operating expenses for the third quarter of 2023 decreased to
Operating loss for the third quarter of 2023 decreased
Net loss was
Cash and Liquidity
Cash used in operating activities for the three months ended
As of
The Company had no debt outstanding as of
Conference Call
As previously announced, management will host a conference call as follows:
Date: | |
Time: | |
Toll free: | 800-225-9448 |
International: | 203-518-9708 |
Conference ID: | HSDTQ323 |
Webcast: | Click Here |
The webcast will be archived under the Newsroom section of the Company’s investor relations website.
About
About the PoNS Device and PoNS Therapy
The Portable Neuromodulation Stimulator (“PoNS”) is an innovative, non-implantable, orally applied therapy that delivers neurostimulation through a mouthpiece connected to a controller and it’s used, primarily at home, with physical rehabilitation exercise, to improve balance and gait. The PoNS device, which delivers mild electrical impulses to the tongue, is indicated for use in
PoNS has shown effectiveness in treating gait or balance and a significant reduction in the risk of falling in stroke patients in
Cautionary Disclaimer Statement
Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the
There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include uncertainties associated with the Company’s capital requirements to achieve its business objectives, disruptions in the banking system and financial markets, lingering impacts of the COVID-19 pandemic, the effect of macroeconomic conditions and the Company’s ability to access capital markets, the Company’s ability to train physical therapists in the supervision of the use of the PoNS Treatment, the Company’s ability to secure contracts with rehabilitation clinics, the Company’s ability to obtain national Medicare coverage and to obtain a reimbursement code so that the PoNS device is covered by Medicare and Medicaid, the Company’s ability to build internal commercial infrastructure, secure state distribution licenses, build a commercial team and build relationships with Key Opinion Leaders, neurology experts and neurorehabilitation centers, market awareness of the PoNS device, availability of funds, manufacturing, labor shortage and supply chain risks, disruptions in the manufacturing process of the PoNS device due to the transition to a new manufacturer, the Company’s ability to maintain and enforce our intellectual property rights, clinical trials and the clinical development process, the product development process, the regulatory submission review and approval process, the Company’s operating costs and use of cash, and our ability to achieve significant revenues, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended
The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.
Investor Relations Contact
T: 212-452-2793
E: lwilson@insitecony.com
Unaudited Condensed Consolidated Statements of Operations | |||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Revenue | |||||||||||||||
Product sales, net | $ | 132 | $ | 195 | $ | 482 | $ | 497 | |||||||
Other revenue | 11 | 1 | 28 | 8 | |||||||||||
Total revenue | 143 | 196 | 510 | 505 | |||||||||||
Cost of revenue | 187 | 101 | 493 | 313 | |||||||||||
Gross profit (loss) | (44 | ) | 95 | 17 | 192 | ||||||||||
Operating expenses | |||||||||||||||
Selling, general and administrative expenses | 2,196 | 3,393 | 7,639 | 8,673 | |||||||||||
Research and development expenses | 722 | 751 | 2,292 | 3,468 | |||||||||||
Amortization expense | 32 | 47 | 109 | 141 | |||||||||||
159 | 757 | 159 | 757 | ||||||||||||
Total operating expenses | 3,109 | 4,948 | 10,199 | 13,039 | |||||||||||
Loss from operations | (3,153 | ) | (4,853 | ) | (10,182 | ) | (12,847 | ) | |||||||
Nonoperating income (expense) | |||||||||||||||
Interest income (expense), net | 68 | (919 | ) | 257 | (919 | ) | |||||||||
Change in fair value of derivative liability | (393 | ) | 5,489 | 2,051 | 5,489 | ||||||||||
Foreign exchange (loss) gain | (192 | ) | (747 | ) | 62 | (910 | ) | ||||||||
Other income (expense), net | 7 | — | 7 | 1 | |||||||||||
Nonoperating income (expense), net | (510 | ) | 3,823 | 2,377 | 3,661 | ||||||||||
Loss before provision for income taxes | (3,663 | ) | (1,030 | ) | (7,805 | ) | (9,186 | ) | |||||||
Provision for income taxes | — | — | — | — | |||||||||||
Net loss | $ | (3,663 | ) | $ | (1,030 | ) | $ | (7,805 | ) | $ | (9,186 | ) | |||
Loss per share | |||||||||||||||
Basic | $ | (5.49 | ) | $ | (2.90 | ) | $ | (13.60 | ) | $ | (53.77 | ) | |||
Diluted | $ | (5.49 | ) | $ | (2.90 | ) | $ | (13.60 | ) | $ | (53.77 | ) | |||
Weighted average number of common shares outstanding | |||||||||||||||
Basic | 667,809 | 355,754 | 573,950 | 170,823 | |||||||||||
Diluted | 667,809 | 355,754 | 573,950 | 170,823 | |||||||||||
Unaudited Condensed Consolidated Balance Sheets | |||||||
(in thousands, except share and per share data) | |||||||
ASSETS | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | 6,596 | $ | 14,549 | |||
Accounts receivable, net | 94 | 71 | |||||
Other receivables | 472 | 272 | |||||
Inventory, net | 521 | 589 | |||||
Prepaid expenses and other current assets | 893 | 1,216 | |||||
Total current assets | 8,576 | 16,697 | |||||
Property and equipment, net | 182 | 347 | |||||
Intangible assets, net | 31 | 140 | |||||
Operating lease right-of-use asset, net | 65 | 103 | |||||
Total assets | $ | 8,854 | $ | 17,287 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities | |||||||
Accounts payable | $ | 497 | $ | 627 | |||
Accrued and other current liabilities | 849 | 1,280 | |||||
Current portion of operating lease liabilities | 47 | 54 | |||||
Current portion of deferred revenue | 42 | 27 | |||||
Total current liabilities | 1,435 | 1,988 | |||||
Operating lease liabilities, net of current portion | 23 | 56 | |||||
Deferred revenue, net of current portion | 136 | 175 | |||||
Derivative liability | 4,239 | 6,917 | |||||
Total liabilities | 5,833 | 9,136 | |||||
STOCKHOLDERS’ EQUITY | |||||||
Class A common stock, | 1 | 1 | |||||
Additional paid-in capital | 162,391 | 159,645 | |||||
Accumulated deficit | (158,912 | ) | (151,107 | ) | |||
Accumulated other comprehensive loss | (459 | ) | (388 | ) | |||
Total stockholders' equity | 3,021 | 8,151 | |||||
Total liabilities and stockholders' equity | $ | 8,854 | $ | 17,287 | |||
Source:
2023 GlobeNewswire, Inc., source