Pre-recorded Convention Name to Comply with at 1:30 p.m. PDT/4:30 p.m EDT
FREMONT, Calif.–(BUSINESS WIRE)–Tivic Well being ® Methods, Inc. (Nasdaq: TIVC), a well being tech firm that develops and commercializes bioelectronic drugs, at the moment introduced third quarter and nine-months ended September, 30, 2024 monetary outcomes and mentioned development methods primarily based on its novel, patent-pending vagus nerve stimulation (VNS) science and system know-how.
This quarter we made important progress on every of the three prongs of our technique for delivering shareholder worth,” stated Jennifer Ernst, CEO of Tivic Health. “The primary prong is the aggressive steps we have now taken to enhance the economics of the ClearUP product line — our commercially obtainable handheld, trigeminal nerve stimulation system for sinus and allergy circumstances. This quarter, we accomplished the redesign of our provide chain, and, web of one-time prices, noticed upwards of 70% gross margin within the months following the transition.
“The second leg, and most necessary ingredient of our technique, is our improvement of a non-invasive vagus nerve stimulation system that has the potential to catalyze Tivic’s long-term worth. In a Part 1 trial earlier this yr, we demonstrated clinically significant modifications in autonomic, cardiac and neurologic techniques utilizing a patent-pending method to non-invasive VNS. This positions the corporate to enter considerably greater worth markets. This quarter we started the scientific optimization of our system, working with trade specialists on the Feinstein Institute of Bioelectronic Drugs.
“In parallel, we have also engaged a leading growth consulting firm to work closely with our clinical team on prioritizing these high value use cases based on the needs of patients, providers and payers. Already we have identified several multi-billion dollar market opportunities for the program. We expect to reach a significant inflection point in the business in the next twelve months as we build out our VNS medical device program,” concluded Ernst.
Third Quarter and Subsequent Weeks Enterprise and Operational Updates
Within the third quarter 2024 and subsequent weeks, the corporate introduced the next:
- Began and accomplished enrollment of sufferers in a Part 1a optimization research designed to establish system parameters that optimally affect autonomic nervous system (ANS) operate.
- Partnered with Fletcher Spaght (FSI), a number one healthcare development technique agency, to speed up improvement of Tivic’s business technique for non-invasive cervical VNS (ncVNS).
- Appointed Lisa Wolf as interim CFO, efficient October 1, changing Kimberly Bambach, who will proceed to offer particular challenge work and strategic consulting to the corporate.
- Accomplished provide chain redesign to drive elevated profitability of ClearUP™ product line.
Monetary Efficiency
- Income (web of returns) for the three and 9 months ended September 30, 2024 was $126,000 and $600,000, respectively, a lower of $219,000, or 27%, in contrast with the primary 9 months of 2023 primarily attributable to a 36% lower in unit gross sales, offset by a 13% improve within the per unit common gross sales value.
- Price of gross sales for the three and 9 months ended September 30, 2024 was $82,000 and $359,000, respectively, a lower of $178,000, or 34%, in contrast with the primary 9 months of 2023.
- Gross revenue within the three and 9 months ended September 30, 2024 was $44,000 and $241,000, respectively, in contrast with $108,000 and $282,000 in 2023.
- Whole (EPA:) working bills yr so far 2024 have been decreased by $1.9 million in comparison with the 9 months ended September 30, 2023. For 3 months ended September 30, 2024 working bills totaled $1.5 million, down from $1.9 million a yr in the past. For the 9 months ended September 30, 2024 whole working bills have been $4.4 million, down from $6.3 million in 2023.
- Through the three months ended September 30, 2024 firm incurred a web lack of $1.4 million, in contrast with $1.8 million for a similar interval in 2023. Internet loss for the primary 9 months of 2024 was $4.2 million, a lower of $1.8 million in comparison with the identical interval in 2023.
- At September 30, 2024 money and money equivalents totaled $2.2 million, in contrast with $3.4 million at December 31, 2023. Throughout October and November 2024, the Firm raised web proceeds of $775,000 via gross sales of widespread inventory pursuant to an Fairness Distribution Settlement.
Convention Name and Webcast Info
Administration will host a webcast/convention name at the moment, November 14, at 1:30 PM PST / 4:30 PM EST to debate the corporate’s third quarter 2024 monetary outcomes and supply a enterprise replace.
Convention Name Particulars:
Toll Free: 877-545-0523
Worldwide: 973-528-0016
Entry Code: 507355
Webcast Hyperlink
https://www.webcaster4.com/Webcast/Web page/2865/51524
An audio replay of the decision can be obtainable for the subsequent 90 days from the investor web page on the Tivic Well being web site at https://tivichealth.com/investor/.
About Tivic Well being
Tivic Well being is a business well being tech firm advancing the sphere of bioelectronic drugs. Tivic Well being’s know-how platforms leverage stimulation of the trigeminal, sympathetic, and vagus nerve constructions. Tivic Well being’s non-invasive and focused method to the therapy of inflammatory persistent well being circumstances offers shoppers and suppliers drug-free therapeutic options with excessive security profiles, low threat, and broad functions. Tivic Well being’s first business product ClearUP™ is an FDA permitted, award-winning, handheld bioelectronic sinus system. ClearUP™ is clinically confirmed, doctor-recommended, and is obtainable via on-line retailers and business distributors. For extra data go to http://tivichealth.com @TivicHealth
Ahead-Trying Statements
This press launch could comprise forward-looking statements which might be topic to substantial dangers and uncertainties. All statements, aside from statements of historic reality, contained on this press launch are forward-looking statements. Ahead-looking statements contained on this press launch could also be recognized by means of phrases similar to anticipate, consider, ponder, may, estimate, anticipate, intend, search, could, would possibly, plan, potential, predict, challenge, goal, intention, ought to, will would, or the unfavourable of those phrases or different comparable expressions, though not all forward-looking statements comprise these phrases. Ahead-looking statements are primarily based on Tivic Well being Methods, Inc.’s present expectations and are topic to inherent uncertainties, dangers, and assumptions which might be tough to foretell. Additional, sure forward-looking statements are primarily based on assumptions as to future occasions that will not show to be correct. Precise outcomes may differ materially from these contained in any forward-looking assertion on account of varied components, together with, with out limitation: the longer term improvement of ncVNS therapy; Tivic Well being’s potential to commercialize merchandise arising out of the ncVNS therapy and Tivic Well being’s plans to hunt regulatory approval for such scientific merchandise; Tivic Well being’s continued deal with creating ncVNS therapy, together with within the epilepsy, post-traumatic stress dysfunction, and/or ischemic stroke house; anticipated scientific utility, together with which affected person populations could also be pursued; market and different circumstances; provide chain constraints; macroeconomic components, together with inflation; Tivic Well being’s potential to lift further capital on favorable phrases, or in any respect, when wanted; Tivic Well being’s potential to take care of its Nasdaq itemizing; and surprising prices, prices or bills that scale back Tivic Well being’s capital assets. Given these dangers and uncertainties, you’re cautioned to not place undue reliance on such forward-looking statements. For a dialogue of different dangers and uncertainties, and different necessary components, any of which may trigger Tivic Well being’s precise outcomes to vary from these contained within the forward-looking statements, see Tivic Well being’s filings with the SEC, together with, its Annual Report on Kind 10-Okay for the yr ended December 31, 2023, filed with the SEC on March 29, 2024, beneath the heading Danger Elements; in addition to the corporate’s subsequent filings with the SEC. Ahead-looking statements contained on this press launch are made as of this date, and Tivic Well being Methods, Inc. undertakes no obligation to replace such data besides as required by relevant legislation.
Tivic Well being Methods, Inc. |
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Condensed Stability Sheets |
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(in 1000’s, besides share and per share information) |
|||||||
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September 30, 2024 |
December 31, 2023 |
|||||
|
(Unaudited) |
(Audited) |
|||||
ASSETS |
|
|
|
|
|||
Money and money equivalents |
$ |
2,189 |
|
$ |
3,395 |
|
|
Different present belongings |
|
974 |
|
|
1,257 |
|
|
TOTAL CURRENT ASSETS |
|
3,163 |
|
|
4,652 |
|
|
PROPERTY AND EQUIPMENT, NET |
|
119 |
|
|
122 |
|
|
NONCURRENT ASSETS |
|
112 |
|
|
383 |
|
|
TOTAL ASSETS |
$ |
3,394 |
|
$ |
5,157 |
|
|
|
|
|
|
|
|||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|||
Accounts payable and accrued bills |
$ |
560 |
|
$ |
1,208 |
|
|
Different present liabilities |
|
” |
|
|
193 |
|
|
TOTAL CURRENT LIABILITIES |
|
560 |
|
|
1,401 |
|
|
TOTAL LONG-TERM LIABILITIES |
|
” |
|
|
176 |
|
|
STOCKHOLDERS’ EQUITY |
|
|
|
|
|||
Frequent inventory |
|
1 |
|
|
” |
|
|
Further paid in capital |
|
44,897 |
|
|
41,466 |
|
|
Gathered deficit |
|
(42,064 |
) |
|
(37,886 |
) |
|
TOTAL STOCKHOLDERS’ EQUITY |
|
2,834 |
|
|
3,580 |
|
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ |
3,394 |
|
$ |
5,157 |
|
Tivic Well being Methods, Inc. |
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Condensed Statements of Operations |
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(in 1000’s, besides share and per share information) |
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Three Months Ended September 30, |
9 Months Ended |
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|
2024 |
2023 |
2024 |
2023 |
|||||||||||
REVENUES |
$ |
126 |
|
$ |
282 |
|
$ |
600 |
|
$ |
819 |
|
|||
COST OF SALES |
|
82 |
|
|
174 |
|
|
359 |
|
|
537 |
|
|||
GROSS PROFIT |
|
44 |
|
|
108 |
|
|
241 |
|
|
282 |
|
|||
OPERATING EXPENSES |
|
|
|
|
|
|
|
|
|||||||
Analysis and improvement |
|
422 |
|
|
337 |
|
|
980 |
|
|
1,295 |
|
|||
Gross sales and advertising and marketing |
|
234 |
|
|
480 |
|
|
946 |
|
|
1,390 |
|
|||
Basic and administrative |
|
819 |
|
|
1,051 |
|
|
2,433 |
|
|
3,598 |
|
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TOTAL OPERATING EXPENSES |
|
1,475 |
|
|
1,868 |
|
|
4,359 |
|
|
6,283 |
|
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NET OPERATING LOSS |
|
(1,431 |
) |
|
(1,760 |
) |
|
(4,118 |
) |
|
(6,001 |
) |
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OTHER EXPENSE |
|
” |
|
|
” |
|
|
60 |
|
|
” |
|
|||
NET LOSS |
$ |
(1,431 |
) |
$ |
(1,760 |
) |
$ |
(4,178 |
) |
$ |
(6,001 |
) |
|||
NET LOSS PER SHARE – BASIC AND DILUTED |
$ |
(0.23 |
) |
$ |
(1.48 |
) |
$ |
(1.07 |
) |
$ |
(10.60 |
) |
|||
WEIGHTED-AVERAGE NUMBER OF SHARES – BASIC AND DILUTED |
|
6,191,127 |
|
|
1,189,821 |
|
|
3,897,938 |
|
|
566,228 |
|
View supply model on businesswire.com: https://www.businesswire.com/information/residence/20241114160019/en/
Media Contact:
Morgan Luke
Morgan.Luke@tivichealth.com
Investor Contact:
Hanover Worldwide, Inc.
ir@tivichealth.com
Supply: Tivic Well being Methods, Inc.