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Business Wire
14-08-2025
- Business
- Business Wire
Tivic Reports Second Quarter 2025 Financial Results
FREMONT, Calif.--(BUSINESS WIRE)-- Tivic Health® Systems, Inc. (NASDAQ: TIVC), a diversified immunotherapeutics company, today announced financial results for the second quarter and six months ended June 30, 2025. 'We have established a strong foundation for Tivic's strategic transformation with our expansion into biopharmaceuticals, making us unique in treating disease by addressing both the body's biochemical and bioelectronic systems,' stated Tivic CEO Jennifer Ernst. 'To maximize our focus on the compelling, late-stage clinical pipeline, we have increasingly shifted resources away from consumer healthtech and are now planning to exit the ClearUP business by the end of this year,' continued Ernst. 'I look forward to advancing the commercialization of these life-saving therapies, supporting our strategy to increase shareholder value through this transformation.' Corporate Highlights from the Second Quarter and Subsequent Weeks, included: Securing positive interest in potential military and defense applications for drug candidate Entolimod™ to treat ARS during briefings with the White House and U.S. Food & Drug Administration (FDA) officials. Extending the worldwide license of Entolimod™ to include the treatment of neutropenia, a condition that reduces the body's ability to combat infections and has a wide range of causes - from genetics to cancer treatments and age. Entering into a GMP manufacturing validation agreement with Scorpius Biomanufacturing, Inc. as part of preparing for the FDA biologics license application process. Completing all study visits in the Optimization Study for its patent-pending, non-invasive cervical vagus nerve stimulation (ncVNS) device. Raising $1.4 million from the first and second tranche of a preferred equity purchase agreement that provides for up to $8.4 million in total financing. Entering into a $25 million equity line of credit that generated net proceeds of $547,000. Receiving shareholder approval of key measures in support of Tivic transformation strategy. Expanding biopharmaceutical team with regulatory, clinical and business development staff. Naming Lisa Wolf as CFO following her nine-month tenure as interim CFO. Financial Performance: Revenue (net of returns) for the three and six months ended June 30, 2025 totaled $86,000 and $156,000, respectively, compared with $140,000 and $474,000 for 2024. The decreases are due to lower unit sales of ClearUP™ to treat sinus pain and pressure. The lower sales are attributable to decreases in advertising expenses as the company focused resources on accelerating its TLR5 program for the development of Entolimod™ for ARS. Gross profit in the three and six months ended June 30, 2025 was $54,000 and $104,000, respectively, compared to $30,000 and $197,000 in 2024. Gross margin was 67% in the six months ended June 30, 2025, compared to 42% in 2024. Operating expenses in the three and six months ended June 30, 2025 was $2.0 million and $3.5 million, respectively, compared to $1.3 million and $3.0 million in 2024. The increases were primarily due to the addition of the biopharma programs in February 2025. Net loss of $1.9 million for the three months ended June 30, 2025, compared to $1.3 million in the second quarter of 2024. Net loss of $3.4 million for the first half of 2025, compared to $2.7 million for the first half of 2024. At June 30, 2025, cash and cash equivalents totaled $1.2 million, compared with $2.0 million, at December 31, 2024. Subsequent to quarter's end, the Company raised a total of $0.9 million through utilization of its equity line of credit and the sale of Series B Preferred Stock pursuant to its preferred equity purchase agreement. The company has no debt on its balance sheet. Approximately $7.0 million remains available as a committed investment in Tivic through a preferred equity purchase agreement. The company believes the current and committed funding is sufficient to make meaningful progress toward manufacturing validation for Entolimod. Conference Call and Webcast Information Management will host a webcast/conference call today, Thursday, August 14, at 1:30 p.m. PT / 4:30 p.m. ET to discuss the company's second quarter 2025 financial results and provide a business update. Webcast Link An audio replay of the call will be available for the next 90 days from the investor page on the Tivic Health website at About Tivic Tivic's dual platform utilizes the body's biopharmaceutical and bioelectronic systems to treat unmet medical needs through targeting the immune system. Tivic's biologics compounds activate an innate immune pathway to prevent cell death in the bone marrow and epithelial tissues across systems impacted by radiation and age. The company's lead drug candidate, Entolimod™ for acute radiation syndrome, is a novel TLR5 agonist that has been granted Fast Track designation and is in late stage development. Tivic's bioelectronic program is developing a novel, non-invasive medical device designed to target the neural pathways implicated in many prevalent and debilitating diseases. Early trials show promising signals that Tivic's approach may regulate specific biologic responses, and the company believes its early-stage vagus nerve stimulation device has the potential to deliver clinical outcomes similar to or better than those of surgically implanted devices. To learn more about Tivic, visit: Forward-Looking Statements This press release may contain 'forward-looking statements' that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as 'anticipate,' 'believe,' 'contemplate,' 'could,' 'estimate,' 'expect,' 'intend,' 'seek,' 'may,' 'might,' 'plan,' 'potential,' 'predict,' 'project,' 'target,' 'aim,' 'should,' 'will,' 'would,' or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems, Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including as a result of interactions with and guidance from the FDA and other regulatory authorities; changes to the company's relationship with the its partners; the failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations; the company's future development of its ncVNS treatment, Entolimod and Entolasta; changes to the company's business strategy; timing and success of clinical trials and study results; regulatory requirements and pathways for approval; consummation of any strategic transactions; the company's need for, and ability to secure when needed, additional working capital; the company's ability to maintain its Nasdaq listing; and changes in tariffs, inflation, legal, regulatory, political and economic risks. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 21, 2025, under the heading 'Risk Factors," as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law. Tivic Health Systems, Inc. Condensed Statements of Operations (in thousands, except share and per share data) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 REVENUES $ 86 $ 140 $ 156 $ 474 COST OF SALES 32 110 52 277 GROSS PROFIT 54 30 104 197 OPERATING EXPENSES Research and development 655 302 990 558 Sales and marketing 426 207 605 712 General and administrative 907 787 1,949 1,674 TOTAL OPERATING EXPENSES 1,988 1,296 3,544 2,944 NET OPERATING LOSS (1,934 ) (1,266 ) (3,440 ) (2,747 ) OTHER INCOME, NET 3 0 7 0 NET LOSS $ (1,931 ) $ (1,266 ) $ (3,433 ) $ (2,747 ) NET LOSS PER SHARE - BASIC AND DILUTED $ (2.19 ) $ (5.37 ) $ (4.64 ) $ (17.05 ) WEIGHTED-AVERAGE NUMBER OF SHARES - BASIC AND DILUTED 881,294 235,868 739,618 161,103 Expand
Yahoo
07-08-2025
- Business
- Yahoo
Tivic Health to Report Second Quarter 2025 Financial Results on August 14th Via Conference Call and Webcast
FREMONT, Calif., August 07, 2025--(BUSINESS WIRE)--Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified immunotherapeutics company developing treatments that stimulate immune pathways to treat disease, today announced that it will report its second quarter results for 2025 via pre-recorded conference call and webcast on Thursday, August 14, 2025 at 1:30 PM PT / 4:30 PM ET. Teleconference Details:Toll Free: 877-545-0523International: 973-528-0016Participant Access Code: 793820 Webcast Linkhttps:// About Tivic Health Systems, Inc. Tivic Health seeks to treat underserved medical conditions through biochemical and bioelectric therapies that modulate patients' immune system. The company's lead biopharma product candidate, the TLR5 agonist Entolimod™ under development for the treatment of acute radiation syndrome (ARS), has been granted Fast Track and Orphan Drug designation by the FDA. Tivic Health's bioelectronic program is developing non-invasive medical devices that personalize key stimulation to modulate the pathways implicated in many prevalent and debilitating diseases. Tivic Health's first FDA approved product ClearUP™ is proven to treat sinus pain and pressure, and is available through online retailers and commercial distributors. For more information about Tivic Health, visit: Forward-Looking Statements This press release may contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 21, 2025, under the heading "Risk Factors", as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and the company undertakes no duty to update such information except as required by applicable law. View source version on Contacts Investor Contact: Hanover International, Media Contact: Deanne Eagle or Laura Min Jacksonmedia@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
07-08-2025
- Business
- Business Wire
Tivic Health to Report Second Quarter 2025 Financial Results on August 14
FREMONT, Calif.--(BUSINESS WIRE)--Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified immunotherapeutics company developing treatments that stimulate immune pathways to treat disease, today announced that it will report its second quarter results for 2025 via pre-recorded conference call and webcast on Thursday, August 14, 2025 at 1:30 PM PT / 4:30 PM ET. Teleconference Details: Toll Free: 877-545-0523 International: 973-528-0016 Participant Access Code: 793820 Webcast Link About Tivic Health Systems, Inc. Tivic Health seeks to treat underserved medical conditions through biochemical and bioelectric therapies that modulate patients' immune system. The company's lead biopharma product candidate, the TLR5 agonist Entolimod™ under development for the treatment of acute radiation syndrome (ARS), has been granted Fast Track and Orphan Drug designation by the FDA. Tivic Health's bioelectronic program is developing non-invasive medical devices that personalize key stimulation to modulate the pathways implicated in many prevalent and debilitating diseases. Tivic Health's first FDA approved product ClearUP™ is proven to treat sinus pain and pressure, and is available through online retailers and commercial distributors. For more information about Tivic Health, visit: Forward-Looking Statements This press release may contain 'forward-looking statements' that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as 'anticipate,' 'believe,' 'contemplate,' 'could,' 'estimate,' 'expect,' 'intend,' 'seek,' 'may,' 'might,' 'plan,' 'potential,' 'predict,' 'project,' 'target,' 'aim,' 'should,' 'will,' 'would,' or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 21, 2025, under the heading 'Risk Factors', as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and the company undertakes no duty to update such information except as required by applicable law.
Yahoo
13-05-2025
- Business
- Yahoo
Tivic Expands VNS Intellectual Property Portfolio
- New patent protects methods for increasing efficacy via personalization of stimulation parameters and electrode positioning - FREMONT, Calif., May 13, 2025--(BUSINESS WIRE)--Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today it is expanding its non-invasive VNS patent portfolio with the filing of a new patent application with the United States Patent and Trademark Office. Patent No. 63,801,058 entitled "Vagus Nerve Stimulation System" expands the claims and protection around the technology that Tivic is developing and which it expects will redefine state-of-the art in non-invasive vagus nerve stimulation. "We continue to build a defensible position for our next generation VNS technology," said Blake Gurfein, Tivic Chief Scientific Officer. "This patent protects key learnings from our VNS optimization study, which is advancing the science of vagus nerve interventions. In fact, we believe we are moving the needle on what will become the state-of-the art treatment approach by delivering much greater and more consistent therapeutic effects compared to what is currently available." Jennifer Ernst, Tivic CEO, stated, "As we continue to advance our VNS program, protecting our proprietary and intellectual property is critical. Tivic's diversified portfolio of bioelectronic VNS and biologic immunotherapies represent a unique breadth of treatments to address health issues where immune system dysregulation is a significant underlying factor." About Tivic Health Systems, Inc. Tivic Health is a diversified therapeutics company harnessing the power of the immune and autonomic nervous systems to fight disease and restore health. Tivic Health's bioelectronic program is developing non-invasive medical devices that personalize key stimulation for the vagus nerve to deliver meaningful improvements in clinically relevant measures of the autonomous nervous system compared to current treatments, which are often invasive, ineffective or both. The company's lead biopharma product candidate, the TLR5 agonist Entolimod™ to treat ARS, has been granted Fast Track and Orphan Drug designation by the FDA. Tivic Health's first FDA approved product ClearUP™ is proven to treat sinus pain and pressure, and is available through online retailers and commercial distributors. For more information about Tivic Health, visit: Forward-Looking Statements This press release may contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: statements regarding the future development of ncVNS treatment, the Tivic Health's ability to commercialize products arising out of the ncVNS treatment and the Tivic Health's plans to seek regulatory approval for such clinical products and Tivic Health's continued focus on developing ncVNS treatment, including in the epilepsy, post-traumatic stress disorder, and/or ischemic stroke space; expected clinical utility including which patient populations may be pursued; market and other conditions; supply chain constraints; macroeconomic factors, including inflation; and unexpected costs, charges or expenses that reduce Tivic Health's capital resources. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Tivic Health's actual results to differ from those contained in the forward-looking statements, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, under the heading "Risk Factors"; as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law. View source version on Contacts Investor Contact: Hanover International, Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
13-05-2025
- Business
- Business Wire
Tivic Expands VNS Intellectual Property Portfolio
FREMONT, Calif.--(BUSINESS WIRE)-- Tivic Health ® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today it is expanding its non-invasive VNS patent portfolio with the filing of a new patent application with the United States Patent and Trademark Office. Patent No. 63,801,058 entitled ' Vagus Nerve Stimulation System ' expands the claims and protection around the technology that Tivic is developing and which it expects will redefine state-of-the art in non-invasive vagus nerve stimulation. 'We continue to build a defensible position for our next generation VNS technology,' said Blake Gurfein, Tivic Chief Scientific Officer. 'This patent protects key learnings from our VNS optimization study, which is advancing the science of vagus nerve interventions. In fact, we believe we are moving the needle on what will become the state-of-the art treatment approach by delivering much greater and more consistent therapeutic effects compared to what is currently available.' Jennifer Ernst, Tivic CEO, stated, 'As we continue to advance our VNS program, protecting our proprietary and intellectual property is critical. Tivic's diversified portfolio of bioelectronic VNS and biologic immunotherapies represent a unique breadth of treatments to address health issues where immune system dysregulation is a significant underlying factor.' About Tivic Health Systems, Inc. Tivic Health is a diversified therapeutics company harnessing the power of the immune and autonomic nervous systems to fight disease and restore health. Tivic Health's bioelectronic program is developing non-invasive medical devices that personalize key stimulation for the vagus nerve to deliver meaningful improvements in clinically relevant measures of the autonomous nervous system compared to current treatments, which are often invasive, ineffective or both. The company's lead biopharma product candidate, the TLR5 agonist Entolimod™ to treat ARS, has been granted Fast Track and Orphan Drug designation by the FDA. Tivic Health's first FDA approved product ClearUP™ is proven to treat sinus pain and pressure, and is available through online retailers and commercial distributors. For more information about Tivic Health, visit: Forward-Looking Statements This press release may contain 'forward-looking statements' that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as 'anticipate,' 'believe,' 'contemplate,' 'could,' 'estimate,' 'expect,' 'intend,' 'seek,' 'may,' 'might,' 'plan,' 'potential,' 'predict,' 'project,' 'target,' 'aim,' 'should,' 'will' 'would,' or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: statements regarding the future development of ncVNS treatment, the Tivic Health's ability to commercialize products arising out of the ncVNS treatment and the Tivic Health's plans to seek regulatory approval for such clinical products and Tivic Health's continued focus on developing ncVNS treatment, including in the epilepsy, post-traumatic stress disorder, and/or ischemic stroke space; expected clinical utility including which patient populations may be pursued; market and other conditions; supply chain constraints; macroeconomic factors, including inflation; and unexpected costs, charges or expenses that reduce Tivic Health's capital resources. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Tivic Health's actual results to differ from those contained in the forward-looking statements, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, under the heading 'Risk Factors'; as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law.
