Tivic Health Names Biotech Industry Veteran Michael K. Handley to Executive Leadership Team
Tivic Health Systems (Nasdaq: TIVC) has appointed Michael K. Handley as President of Tivic Biopharma and Chief Operating Officer. Handley, former CEO of Statera Biopharma, will lead the company's newly formed biopharma division and oversee the development of Entolimod™, a recently licensed late-stage product candidate.
Throughout his career, Handley has contributed to the global commercialization of 17 drugs and devices generating approximately $7 billion in annual sales. His responsibilities will include building the biopharma team, advancing Entolimod through manufacturing validation, regulatory approval, and commercialization.
As part of his employment agreement, Tivic granted Handley 600,000 restricted stock units (RSUs) as an inducement award. The RSUs will vest over four years, with 25% vesting after one year and the remainder vesting in 12 quarterly installments, subject to continuous service.
Tivic Health Systems (Nasdaq: TIVC) ha nominato Michael K. Handley come Presidente di Tivic Biopharma e Direttore Operativo. Handley, ex CEO di Statera Biopharma, guiderà la nuova divisione biopharma dell'azienda e supervisionerà lo sviluppo di Entolimod™, un candidato prodotto in fase avanzata recentemente licenziato.
Nel corso della sua carriera, Handley ha contribuito alla commercializzazione globale di 17 farmaci e dispositivi, generando circa 7 miliardi di dollari in vendite annuali. Le sue responsabilità includeranno la costruzione del team biopharma, l'avanzamento di Entolimod attraverso la validazione della produzione, l'approvazione normativa e la commercializzazione.
Come parte del suo accordo di lavoro, Tivic ha concesso a Handley 600.000 unità di azioni vincolate (RSU) come premio di incentivo. Le RSU si matureranno nel corso di quattro anni, con il 25% che si matura dopo un anno e il resto che si maturerà in 12 rate trimestrali, soggetto a servizio continuo.
Tivic Health Systems (Nasdaq: TIVC) ha nombrado a Michael K. Handley como Presidente de Tivic Biopharma y Director de Operaciones. Handley, ex CEO de Statera Biopharma, liderará la nueva división biopharma de la empresa y supervisará el desarrollo de Entolimod™, un candidato a producto en fase avanzada recientemente licenciado.
A lo largo de su carrera, Handley ha contribuido a la comercialización global de 17 medicamentos y dispositivos, generando aproximadamente 7 mil millones de dólares en ventas anuales. Sus responsabilidades incluirán la construcción del equipo biopharma, el avance de Entolimod a través de la validación de fabricación, la aprobación regulatoria y la comercialización.
Como parte de su acuerdo de empleo, Tivic otorgó a Handley 600,000 unidades de acciones restringidas (RSU) como premio de incentivo. Las RSU se consolidarán durante cuatro años, con el 25% consolidándose después de un año y el resto consolidándose en 12 cuotas trimestrales, sujeto a servicio continuo.
티빅 헬스 시스템즈 (Nasdaq: TIVC)는 마이클 K. 핸들리를 티빅 바이오파마의 사장 겸 최고 운영 책임자로 임명했습니다. 핸들리는 이전에 스태테라 바이오파마의 CEO였으며, 회사의 새로 설립된 바이오파마 부서를 이끌고 최근 라이센스가 부여된 후기 단계 제품 후보인 엔톨리모드™의 개발을 감독할 것입니다.
그의 경력 동안 핸들리는 약 170억 달러의 연간 판매를 생성하는 17개의 약물 및 장치의 글로벌 상용화에 기여했습니다. 그의 책임에는 바이오파마 팀 구축, 엔톨리모드의 제조 검증, 규제 승인 및 상용화를 포함합니다.
고용 계약의 일환으로 티빅은 핸들리에게 600,000개의 제한 주식 단위(RSU)를 유인 보상으로 부여했습니다. RSU는 4년에 걸쳐 분할 지급되며, 1년 후 25%가 지급되고 나머지는 12회 분기별로 지급됩니다. 계속적인 서비스에 따라 달라집니다.
Tivic Health Systems (Nasdaq: TIVC) a nommé Michael K. Handley Président de Tivic Biopharma et Directeur des opérations. Handley, ancien PDG de Statera Biopharma, dirigera la nouvelle division biopharma de l'entreprise et supervisera le développement d'Entolimod™, un candidat produit récemment licencié en phase avancée.
Tout au long de sa carrière, Handley a contribué à la commercialisation mondiale de 17 médicaments et dispositifs générant environ 7 milliards de dollars de ventes annuelles. Ses responsabilités incluront la constitution de l'équipe biopharma, l'avancement d'Entolimod à travers la validation de la fabrication, l'approbation réglementaire et la commercialisation.
Dans le cadre de son contrat de travail, Tivic a accordé à Handley 600 000 unités d'actions restreintes (RSU) en tant que prime d'incitation. Les RSU seront acquises sur une période de quatre ans, avec 25 % acquises après un an et le reste acquis en 12 versements trimestriels, sous réserve d'un service continu.
Tivic Health Systems (Nasdaq: TIVC) hat Michael K. Handley zum Präsidenten von Tivic Biopharma und Chief Operating Officer ernannt. Handley, ehemaliger CEO von Statera Biopharma, wird die neu gegründete Biopharma-Abteilung des Unternehmens leiten und die Entwicklung von Entolimod™, einem kürzlich lizenzierten Produktkandidaten in der späten Phase, überwachen.
Im Laufe seiner Karriere hat Handley zur globalen Kommerzialisierung von 17 Arzneimitteln und Geräten beigetragen, die rund 7 Milliarden Dollar Jahresumsatz generieren. Zu seinen Aufgaben gehören der Aufbau des Biopharma-Teams, die Weiterentwicklung von Entolimod durch Herstellungsvalidierung, behördliche Genehmigung und Kommerzialisierung.
Im Rahmen seines Arbeitsvertrags hat Tivic Handley 600.000 eingeschränkte Aktieneinheiten (RSUs) als Anreiz gewährt. Die RSUs werden über einen Zeitraum von vier Jahren fällig, wobei 25 % nach einem Jahr fällig werden und der Rest in 12 vierteljährlichen Raten, vorbehaltlich einer kontinuierlichen Dienstleistung.
- Appointment of experienced executive with track record of commercializing 17 drugs/devices worth $7B in annual sales
- Strategic expansion into biopharma with late-stage product candidate Entolimod
- Executive's experience includes successful exits to Johnson & Johnson and Boston Scientific
- None.
Handley Joins as President of Tivic Biopharma and Chief Operating Officer of Tivic Health Following Its Licensing of Strategic Biopharma Assets From Statera Biopharma
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
“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: https://ir.tivichealth.com.
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.
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Investor Contact:
Hanover International, Inc.
ir@tivichealth.com
Source: Tivic Health Systems, Inc.
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