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Actionable news in HRTX: HERON THERAPEUTICS INC,

Continued Derisking And Data Should Help Heron Take Flight

Summary

011 Data was good, and suggests potential SoC / Best-in-class post-op pain management franchise.

We address the bradycardia AE and discuss the competition's convenient trial.

SUSTOL approval provides a unique CINV product with a broad label. Derisking platform for future products.

A lot of significant new-hires suggest pipeline expansion, pending corporate milestones or results. These have largely been overlooked and unnoticed by market.

We will very briefly discuss Heron Therapeutics as a whole, and more dive into the data. This article is largely intended for those who at some point have already been interested in, or plan to invest in Heron.

Segments:

  1. Heron Therapeutics Introduction
  2. HTX-011 Data Summary
  3. HTX-011 & Bradychardia - Should we worry?
  4. SUSTOL Delay Explanation
  5. SUSTOL & Heron's Future

Introduction

Heron is a specialty biotech company working in the niche areas of chemotherapy-induced nausea and vomiting (CINV) and post-operative pain therapy. It has worked (and may continue) to bring to market existing drugs through the 505(B) regulatory pathway. This seeks to leverage off existing approval for fast (and inexpensive) FDA approval of old drugs for new indications.

They have the rights to the biochronomer platform, a delivery methodology that uses polymers to slowly release therapeutic agents by the dissolution of the polymer delivery encapsulate.

HTX-011 Data Summary

Recently, Heron Therapeutics (NASDAQ:HRTX) reported very encouraging top-line data on its leading pain management program, HTX-011, a unique and proprietary mix of Bupivacaine and meloxicam delivered on the back of the biochronomer platform.

This article will follow the data posted here.

The conference call can be located here. (Side note: This was an extremely early CC)

As is highlighted, HTX-011 aims to be the standard of care through:

While other current therapies are often recommended for off-label mixing, HTX-011 is meant to discourage this as it is effective alone.

By discouraging mixing (through effectiveness alone) this reduces toxicity, complexity, cost and complications. Since mixing & subsequent toxicity are easily documented and reported, repercussions from off-label mixing for CINV will have direct implications from the FDA and warning labels - something Heron is looking to avoid.

Additionally HTX-011 also requires no or minimal injection in order to prevent any venous adverse events. Coverage of a wide range of surgeries, including gender specific procedures, which target those seen as being most painful. Showing benefit over bupivacaine solution, the current standard of care.

To re-iterate and re-highlight the main portions of the recent data for HTX-011:

✔ Not encouraged to being mixed: This comes as one of the features of Heron's biochronomer platform and is further supported by the ongoing instillation vs injection trials. We would like to remind investors that this is a problem that has plagued liposomal bupivacaine previously.

Require no or minimal injection in order to prevent any venous adverse events: The company displayed this through instillation data, though the full and finalized data sets are due out in September through October.

Shows benefit over bupivacaine solution or ropivacaine, which the current dominant products for post-op care: HTX-011 demonstrates this, however there exist some non-significant cardiac AEs (<5%) which have held buyers and investors back. We will touch on this and why we don't believe it should be a concern, into HTX-011 P3.

✔ Covers a wide range of surgeries, especially those seen as being most painful: HTX-011 achieved very well sustained pain reduction over the initial 24 hours, and continued to have a lower pain intensity score through 78 hours post procedure. This is demonstrated in the following pain profiles: Bunionectomy (HTX-011B is the focus here, as Heron will not pursue 011A due to superior 011B PK/PD profiles)

Let's look at some DATA! Figure 1 shows pain for an extremely painful procedure - hernia repair - with HTX-011B compared to bupivacaine (and control).

(Figure 1)

In Figure 2 the efficacy again is clear the p values up to approximately 42 hours is around 1-2 pain intervals lower than placebo.

(Figure 2)

We believe the efficacy of HTX-011 is addressed in Clinically Sound Investor's Article here, an excellent write-up.

HTX-011 and Bradycardia

The topic of bradycardia and the impact it has had by holding down the pps after promising phase 2 data was released.

Bradycardia is a condition where a patient exhibits an abnormally slow heart rate. A normal person's heart rate at rest fluctuates between 60 and 100 beats per minute. An abnormally slow heart rate is thus considered any rate below 60 beats per minute. While bradycardia is normally a sign of problems within the heart, a very fit patient could exhibit a heart rate less than 60 beats per minute and be perfectly healthy. This fact must be taken into account when reviewing the incidence of...


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