Latest news with #Entolimod™
Business Wire
14-05-2025
- Business
- Business Wire
Tivic Health Enters GMP Manufacturing Validation Agreement with Scorpius BioManufacturing in Preparation for FDA Submission
FREMONT, Calif.--(BUSINESS WIRE)-- Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today it has entered a definitive agreement with Scorpius BioManufacturing to complete the GMP manufacturing validation of the lead candidate from its TLR5 program, Entolimod™, for treatment of Acute Radiation Syndrome, or ARS, in preparation for filing a Biological Licensing application, or BLA, with the U.S. Food & Drug Administration. Scorpius BioManufacturing, Inc. is an integrated contract development and manufacturing organization (CDMO) and subsidiary of Scorpius Holdings Inc. (OTC:SCPX), which will be the primary U.S. manufacturer for Entolimod™. Scorpius plans to utilize its scientific and technical expertise to validate the commercial manufacturing process for Tivic's lead candidate, Entolimod™. The GMP Validation Program is valued at approximately $4.1 million and is inclusive of the following activities: cell line verification, legacy process verification, GMP scale-up production, drug product fill and finish, analytical development and qualification, and finally upstream and downstream optimization of the process. All of these activities are designed to ensure Tivic submits to the FDA a complete CMC (chemistry, manufacturing, and control) package for its Entolimod BLA. Jennifer Ernst, CEO of Tivic, commented, 'We believe that Scorpius' specialized focus on manufacturing of biologicals and its experience with Department of Defense programs makes them the perfect partner for completing our GMP manufacturing validation for our FDA BLA filing as well as for commercial production, subject to FDA approval.' Scorpius plans to validate the manufacturing process for Entolimod™ utilizing its facility in San Antonio, Texas. The use of this domestic facility offers a leaner supply chain, ensures the end product is manufactured in the U.S., and provides a streamlined path toward the goal of commercial success. Tivic believes that Entolimod is uniquely positioned for ARS and follow-on applications, as it is potentially the only therapy that can prevent and treat radiation-related damage to both human hematopoietic and gastrointestinal cells. 'We welcome the opportunity to contribute our scientific and technical expertise to delivering the successful manufacture of this important therapy,' said Jeff Wolf, CEO of Scorpius. 'We look forward to working closely with Tivic and reinforcing Scorpius' reputation as a trusted and innovative biomanufacturing partner.' 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: Scorpius BioManufacturing, Inc. Scorpius BioManufacturing, Inc. is an integrated contract development and manufacturing organization (CDMO) focused on rapidly advancing biologic programs to the clinic and beyond. Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX. With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing. For more information, please 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 and include statements regarding Scorpius serving as the primary U.S. manufacturer for Entolimod; Scorpius utilizing its scientific and technical expertise to validate the commercial manufacturing process for Tivic's lead candidate, Entolimod; Scorpius' plans to validate the manufacturing process for Tivic's lead candidate utilizing its facility in San Antonio, TX; the use of the domestic facilities enabling leaner supply chains; Entolimod being uniquely positioned to be the only therapy that can potentially prevent and treat damage to human hematopoietic and gastrointestinal cells due to radiation exposure; Tivic's ability to realize near-term value for their shareholders and patients. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including the ability of Scorpius to successfully manufacture Entolimod; Tivic Health's interactions with and receipt of guidance from the FDA; potential failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; Tivic Health's future development of Entolimod and Entolasta; changes to the companies' business strategies timing and success of clinical trials and study results; regulatory requirements and pathways for approval; consummation of any strategic transactions; Tivic Health's need for, and ability to secure when needed, additional working capital; and Tivic Health's ability to maintain its Nasdaq listing. 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 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.
Yahoo
21-03-2025
- Business
- Yahoo
Tivic Reports Year End 2024 Financial Results and Provides Overview of Strategy for Transformation and Growth
Pre-recorded Conference Call and Webcast to Follow Today at 1:30 PM PDT / 4:30 PM EDT FREMONT, Calif., March 21, 2025--(BUSINESS WIRE)--Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, today announced year end December 31, 2024 financial results, highlighted key developments in its clinical program expansion and discussed progress made across the company's operations. "The important strategic events of the past several months have been nothing short of transformative," stated Tivic Health Chief Executive Officer, Jennifer Ernst. "We have successfully reshaped the company by expanding Tivic's opportunities in the biotech sector by in-licensing a late-stage biologic immunotherapy and advancing our ongoing work on our next-generation non-invasive cervical vagus nerve stimulation (ncVNS) devices. "Our expansion into drug development with our newly licensed TLR5 agonist assets not only gives us a late-stage drug candidate in the target market of treating acute radiation syndrome, or ARS, but also lays the foundation for building a biopharmaceutical program with a robust pipeline focused on immune dysregulation. Simultaneously, work is progressing well on Tivic's ncVNS device program, having recently reported important study results that indicate our patent-pending personalized approach has the potential to treat inflammatory, cardiac and neurologic disorders without the need for invasive surgeries or pharmaceuticals," added Ernst. "As we look further into 2025 and the evolution of the company, our confidence grows as we prepare to move into disease-specific clinical trials for ncVNS later this year. We continue our focus on achieving upcoming key milestones and view this year as one of growth and progress that will continue to reshape Tivic for the benefit of patients in need and shareholders alike," concluded Ernst. In the fourth quarter 2024 and subsequent weeks, the company announced the following developments: Acquired from Statera Biopharma worldwide exclusive license rights to the late-stage TLR5 agonist Entolimod™ for the treatment of acute radiation syndrome (ARS), as well as the exclusive option to license five additional indications for Entolimod™ and its derivative, Entolasta™. Named former CEO, President and Chairman of Statera Biopharma, Michael Handley, to the newly created posts of Chief Operating Officer of Tivic Health and President of Tivic Biopharma. Handley will be responsible for establishing and leading Tivic Health's biopharmaceutical operations. Presented a poster at the Sixth Bioelectronic Medicine Summit showing that personalizing ncVNS resulted in optimized effects on autonomic nervous system activity. Tivic Health believes these findings strongly support its strategy of developing highly personalized neuromodulation devices that will better treat inflammatory, cardiac and neurologic disorders without the need for invasive surgeries or pharmaceuticals, both of which carry side effects and risks. The study is the result of an ongoing research collaboration with The Feinstein Institute for Medical Research. Completed enrollment for the optimization study for Tivic's patent pending, ncVNS device. The results of this study will be combined with the commercial and market research conducted by growth strategy firm, Fletcher Spaght, to inform the selection and prioritization of indications that Tivic expects to advance into disease-specific trials and product development in 2025. Further expanded the scope of the optimization study currently underway for its ncVNS device following positive findings related to achieving enhanced effects on autonomic nervous system function. Expanded its intellectual property portfolio, bringing the total number of patents issued and pending to 27. Separately, Tivic exclusively licensed rights under more than 60 patents from Statera related to Entolimod™ and Entolasta™. Executed a 1-for-17 reverse stock split of the company's issued and outstanding shares of common stock, which commenced trading on a post-split basis on March 7 and resulted in 10 days trading above Nasdaq minimum bid price on March 21. Appointed Lisa Wolf as interim CFO. She brings 30 years of financial leadership experience in both public and private companies across industries including served as chief accounting officer of Nasdaq-listed Resonant, Inc., where she played a pivotal role in the company's growth and successful acquisition in 2022. Invested in and deployed a new e-commerce web infrastructure for ClearUP® to enhance conversation rates, as well as upgraded the Tivic Health investor relations website. Secured access to a $25M equity line of credit to support the company's advance research programs, which, if fully utilized, would fully fund commercialization of Entolimod™. Decreased year-over-year net loss by 30 percent. Financial Results for the Year Ended December 31, 2024: Revenue (net of returns) totaled $0.8 million, compared to $1.2 million, for the year ended December 31, 2023. The decline was primarily due to a decrease in unit sales of 41 percent, in line with reductions in marketing spend. Cost of sales for the year ended December 31, 2024 decreased 12 percent to $0.8 million from $0.9 million for the year ended December 31, 2023, primarily due to the 41 percent decrease in unit sales. Cost of sales for 2024 included inventory reserves of $354,000 compared with inventory reserves of $32,000 in 2023. Additionally, in 2024, the company incurred $21,000 of disposal costs related to returns received prior to the launch of ClearUP 2.0 in early 2024. Gross profit for the year ended December 31, 2024 was $2,000 compared with $287,000 for the year ended December 31, 2023. The lower 2024 gross profit was primarily due to $354,000 in inventory reserves recorded for the year ended December 31, 2024, compared to $32,000 a year ago. Reserves related to excess inventory purchased during supply chain shortages. Total operating expenses for the year ended December 31, 2024 was $5.7 million compared with $8.5 million for the year ended December 31, 2023. Going forward, Tivic plans to increase its research and development investments in its vagus nerve platform and clinical applications and to advance the development of Tivic's licensed TLR5 agonist programs, specifically, Entolimod™ and Entolasta™. Net loss for the year ended December 31, 2024 was $5.7 million, down from $8.2 million for the year ended December 31, 2023. Cash and equivalents at December 31, 2024 totaled $2.0 million, compared with $3.4 million at December 31, 2023. The company had working capital of $2.4 million at year end 2024. Conference Call and Webcast Information Tivic Health will make available a pre-recorded conference call and webcast today at 1:30 PM PDT / 4:30 PM EDT. Teleconference Details:Toll Free: 1-877-407-0779International: 1-201-389-0914Conference ID Code: 13752399 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 Health 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 to meaningfully improve treatment options in neurologic, cardiac and autonomic-related diseases. Tivic Health currently offers a bioelectronic, FDA-approved over-the-counter device, ClearUP®, that treats sinus pain, pressure and congestion. ClearUP® is available through online retailers, commercial distributors and at The bioelectronic portfolio today is primarily focused on non-invasive vagus nerve stimulation. Tivic Health's biologic program focuses on immunotherapeutics and the lead product candidate is the late-stage TLR5 agonist, Entolimod™, to treat acute radiation syndrome. The FDA has granted Fast Track and Orphan Drug designation to Entolimod™. 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: the future development of Tivic Health's products and product candidates; Tivic Health's plans to seek, and ability to obtain, regulatory approval for its product candidates; timing and progress of clinical development of its product candidates; Tivic Health's ability to commercialize products arising out of its ncVNS program and TLR5 program; Tivic Health's continued focus on developing its ncVNS treatment, including in the epilepsy, post-traumatic stress disorder, and/or ischemic stroke space; expected clinical utility of its product candidates, including which patient populations may be pursued; market and other conditions; macroeconomic factors, including tariffs and economic uncertainty arising from geopolitical tensions; Tivic Health's ability to raise additional capital on favorable terms, or at all, when needed; Tivic Health's ability to maintain its Nasdaq listing; uncertainties of intellectual property protection and litigation; 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, 2024, which will be filed with the SEC on or about March 21, 2025, under the heading "Risk Factors"; as well as the company's other 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 Balance Sheets (in thousands, except share and per share data) December 31, 2024 December 31, 2023 ASSETS Cash and cash equivalents $ 2,002 $ 3,395 Other current assets 637 1,257 TOTAL CURRENT ASSETS 2,639 4,652 PROPERTY AND EQUIPMENT, NET 119 122 NONCURRENT ASSETS 49 383 TOTAL ASSETS $ 2,807 $ 5,157 LIABILITIES AND STOCKHOLDERS' EQUITY Accounts payable and accrued expenses $ 272 $ 1,208 Other current liabilities — 193 TOTAL CURRENT LIABILITIES 272 1,401 TOTAL LONG-TERM LIABILITIES — 176 STOCKHOLDERS' EQUITY Common stock 1 — Additional paid in capital 46,075 41,466 Accumulated deficit (43,541 ) (37,886 ) TOTAL STOCKHOLDERS' EQUITY 2,535 3,580 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 2,807 $ 5,157 Tivic Health Systems, Inc. Condensed Statements of Operations (in thousands, except share and per share data) Year Ended December 31, 2024 2023 REVENUES $ 780 $ 1,176 COST OF SALES 778 889 GROSS PROFIT 2 287 OPERATING EXPENSES Research and development 1,313 1,655 Sales and marketing 1,187 2,125 General and administrative 3,163 4,752 TOTAL OPERATING EXPENSES 5,663 8,532 NET OPERATING LOSS (5,661 ) (8,245 ) NET LOSS $ (5,655 ) $ (8,244 ) NET LOSS PER SHARE - BASIC AND DILUTED $ (19.68 ) $ (176.80 ) WEIGHTED-AVERAGE NUMBER OF SHARES - BASIC AND DILUTED 287,370 46,650 View source version on Contacts Investor Contact:Hanover International,
Associated Press
24-02-2025
- Business
- Associated Press
Tivic Health Names Biotech Industry Veteran Michael K. Handley to Executive Leadership Team
FREMONT, Calif.--(BUSINESS WIRE)--Feb 24, 2025-- Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today that Michael K. Handley, formerly Chief Executive Officer, President and Chairman of Statera Biopharma, Inc., has joined Tivic Health as the President of Tivic Biopharma, a newly formed division of Tivic Health. Additionally, he will assume the role of Chief Operating Officer of Tivic Health and will work closely with the CEO and other leadership team members to develop and operationalize company-wide strategies. His key responsibilities will include building and leading Tivic's Biopharma team, advancing Tivic's recently licensed, late-stage product candidate, Entolimod™, through manufacturing validation, regulatory approval processes and commercialization, and directing pipeline development activity. 'Mike brings to Tivic a rare blend of device and pharmaceutical background, as well as proven operational, business and scientific experience that sets Tivic up for a smooth and successful expansion into drug development,' stated Tivic Health Chief Executive Officer, Jennifer Ernst. 'With our recent licensing of the late-stage TLR5 agonist, Entolimod, from Statera Biopharma, and Mike's deep experience in immunology and biotech, we believe that he is the ideal leader to establish Tivic's biopharmaceutical capabilities and advance our therapeutics pipeline. In tandem, we continue to pursue the development and exciting promise of our non-invasive bioelectronic vagus nerve stimulation, creating a portfolio of device and drug therapeutics from which to build shareholder value,' added Ernst. Over the course of his career, Michael has successfully led or assisted in the global commercialization of 17 drugs and devices that represented ~$7 billion in annual sales. Additionally, he served as part of the management teams of successful exits to Johnson & Johnson and Boston Scientific. He has successfully led teams in a variety of capacities in high growth organizations. As CEO, President and Chairman of the Board of Statera, Michael created and executed the company's growth strategy, advanced clinical development and intellectual property strategies, and spearheaded the company's business development and financing activities. 'This is an exciting and critical time at Tivic Health, and I am thrilled to join the Tivic leadership team to continue the essential work of advancing Entolimod towards potential commercialization,' stated Handley. 'With compelling evidence of preventing death following a potential lethal dose of radiation and the opportunity to expand to adjacent indications in radiation toxicity and immune system dysregulation, I believe that Entolimod serves as a great foundation on which to build and potentially expand Tivic Health's biopharma pipeline.' Inducement Grants under Nasdaq Listing Rule 5635(c)(4) In connection with, and as a material inducement to, the hiring and appointment of Michael as Chief Operating Officer of Tivic Health and President of Tivic Biopharma, Tivic agreed to grant Michael 600,000 restricted stock units (RSUs), which shall vest over four years, with one fourth of the RSUs vesting on the one-year anniversary of the date of grant and the remaining RSUs vesting in 12 equal quarterly installments thereafter until fully vested. The vesting of shares of common stock underlying the RSUs will be subject to Michael's continuous service with Tivic through each applicable vesting date. The foregoing RSU grant was unanimously approved by Tivic's board of directors and the compensation committee of the board, and such grants were inducements material to Michael entering into employment with Tivic, in accordance with Nasdaq Listing Rule 5635(c)(4). The foregoing equity grant was made outside of Tivic's Amended and Restated 2021 Equity Incentive Plan or any other equity incentive plan of the company. About Tivic Health 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 takes a multi-pronged approach to treating diseases caused by immune and autonomic nervous system dysregulation. The complement of bioelectronic and biologic medicines allows Tivic to target disorders and disease via both neural pathways and molecular approaches. Tivic Health's first FDA approved product ClearUP™ is clinically 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 Tivic Health's development and advancement of Entolimod for the treatment of acute radiation syndrome (ARS) and any other indications that it may elect to license from Statera in the future; the future development of ncVNS treatment, Tivic Health's ability to commercialize products arising out of the license from Statera and Tivic Health's ncVNS treatment; the Tivic Health's plans to seek regulatory approval for such clinical products and Tivic Health's continued focus on developing Entolimod, including for the treatment of ARS and/or any other indications it may elect to license in the future, and its 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; the timing and success of clinical studies and trials; market and other conditions; macroeconomic factors; 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. Hanover International, Inc. SOURCE: Tivic Health Systems, Inc. Copyright Business Wire 2025. PUB: 02/24/2025 08:15 AM/DISC: 02/24/2025 08:15 AM
