Tivic Health Systems (TIVC) stock doubled on Tuesday following promising discussions with the FDA about its drug development.
The biotech firm announced it had met with senior officials at the White House and the Food and Drug Administration (FDA) to discuss its drug pipeline, including one aimed at treating acute radiation syndrome (ARS).
Last week, Tivic briefed White House leaders on potential military and defense applications for Entolimod, its ARS treatment candidate.
The company noted it has already received “significant funding” for the program from government agencies, including the Department of Defense and NASA.
In a separate meeting, Tivic also spoke with FDA officials about potentially accelerating the approval process for Entolimod, its second-generation follow-up Entolasta, and a novel, non-invasive device called ncVNS (non-invasive cervical vagus nerve stimulation), currently in development to treat post-traumatic stress disorder (PTSD).
“We deeply appreciated the opportunity to discuss the importance of our clinical pipeline in potentially protecting and healing both active and retired military personnel, first responders, as well as U.S. citizens and our allies,” Tivic CEO Jennifer Ernst said in a statement.
“While these meetings were informal in nature, we expect to continue these discussions as Entolimod and our ncVNS medical programs progress toward potential FDA approval.”
Following the news, shares of TIVC surged more than 100%, bringing its year-to-date gain to 21.2%.
Tivic Health Systems aims to diversify its drug lineup
Despite Tuesday’s rally, Tivic’s stock is still down 65% over the past year. In March, the board approved a 1-for-17 reverse stock split to help the company regain compliance with Nasdaq’s $1 minimum bid requirement.
On the company’s earnings call last month, interim CFO Lisa Wolf pointed to the intense capital needs of early-stage biotech firms as the reason behind the move.
“One of the greatest challenges of drug and device development is the need for constant capital infusions over time until full commercialization occurs,” she said.
“We feel confident that with the progress we’ve made on meeting Nasdaq requirements and reshaping the company to become a more diversified organization, we are well positioned for growth opportunities ahead.”
Tivic currently sells an FDA-approved device called ClearUp, which is used to treat sinus pain and pressure. The company hopes its pipeline of ARS and PTSD treatments will unlock broader opportunities once approved.
In 2024, Tivic generated $800,000 in revenue, down 33.3% from $1.2 million the year prior. The company attributed the drop to a 41% decline in unit sales driven by reduced marketing spend.
As of year-end, Tivic reported $2.4 million in working capital and no debt. Ernst also disclosed that the company has secured a $25 million line of credit to fund its new drug pipeline.
Your email address will not be published. Required fields are markedmarked