Sempresto Announces Positive FDA Type B Pre-IND Meeting Response for Smartphone-Integrated Epinephrine Auto-Injector

FDA Feedback Aligns with Sempresto’s Proposed Development Strategy and Clarifies Path Forward

WESTON, Mass.--(BUSINESS WIRE)--Medical technology company Sempresto, developing a smartphone-integrated drug delivery platform designed to make rescue medications more readily available when needed, today announced a positive response to its Type B Pre-Investigational New Drug (Pre-IND) written submission to the U.S. Food and Drug Administration (FDA) regarding its investigational smartphone-integrated epinephrine auto-injector.

Sempresto submitted a comprehensive briefing package containing a series of 10 focused questions addressing certain key elements of the Company’s current development and regulatory strategy associated with its novel phone-integrated delivery platform.

In lieu of a meeting, the FDA provided positive and constructive written responses to the Company’s questions. The FDA’s comments were generally consistent with Sempresto’s development assumptions and provided additional clarity as the Company advances toward its planned New Drug Application (NDA) submission.

“We are extremely encouraged by the FDA’s thoughtful and constructive feedback in the written responses from our Type B Pre-IND Meeting,” said Elizabeth Reczek, PhD, Chief Executive Officer of Sempresto. “We submitted a focused set of questions designed to validate the assumptions underlying our development strategy and to identify any issues that could materially affect our regulatory pathway. The FDA’s comments provided important clarity as we move forward. We believe this interaction represents an important regulatory milestone for Sempresto and strengthens our confidence in the development plan for our smartphone-integrated epinephrine auto-injector.”

Sempresto is developing a novel drug-delivery platform designed to integrate rescue medication delivery with the smartphone, an item that most consumers routinely carry with them. The Company’s initial product candidate is an investigational epinephrine auto-injector designed to address a longstanding challenge in emergency allergy care: having epinephrine immediately available when anaphylaxis occurs.

The Company believes that integrating epinephrine delivery with the smartphone has the potential to address behavioral and logistical barriers associated with carrying conventional emergency medication devices. Sempresto’s platform is designed to combine drug delivery with the capabilities of the smartphone, creating the foundation for a broader ecosystem of connected rescue-medication products.

Based on the FDA’s responses, Sempresto intends to continue advancing its current development program, and other ongoing regulatory, technical, and manufacturing activities. The Company currently anticipates progressing toward a 505(b)(2) NDA submission, subject to completion of the applicable development activities and FDA review.

About Sempresto

Sempresto, Inc. is a medical device company led by a team of biotech and medical technology experts, many with firsthand experience managing severe allergies. Guided by its mission, “Always There, Always Connected,” Sempresto is committed to ensuring immediate access to life-saving treatments. The company’s flagship product, a smartphone-integrated epinephrine autoinjector, represents a transformative step forward in emergency preparedness and patient empowerment.

To learn more, visit www.sempresto.com.

Forward-Looking Statements

This press release contains forward-looking statements, identified by words such as “believe”, “intend” and “anticipate”. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. FDA written responses do not constitute FDA approval, clearance, authorization, or a determination that any product is safe or effective. In addition, FDA feedback is not binding and does not guarantee acceptance or approval of any future regulatory submission. The statements in this press release are as of September 16, 2026, and Sempresto undertakes no duty to update.