Helus Pharma (NASDAQ:HELP) is a clinical-stage biotech developing therapies for depression and anxiety, with Phase 3 data on deck and a new CEO who built one of pharma’s biggest franchises.

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Somewhere between your morning coffee and your third scroll through market futures, a peer-reviewed study dropped in Nature Medicine.[1]

The company behind it? Helus Pharma (NASDAQ:HELP). Trading around $6. With $195 million in cash. And an FDA Breakthrough Therapy Designation on its lead oral program for depression.[2]

Earlier this month, Jefferies initiated coverage with a BUY rating and a $22 price target.[3] That implies over 250% upside from here.

Let that sit for a second.

Meet the Pharma Poised to Change the Paradigm in Treatment of Serious Mental Health Conditions

Here’s what most people miss about Helus Pharma:

It’s a clinical-stage pharmaceutical company developing engineered proprietary serotonergic compounds through FDA-regulated pathways.

Their lead asset, HLP003, designed for controlled pharmacokinetics is in Phase 3 trials for major depressive disorder. It carries FDA Breakthrough Therapy Designation. And it’s the only oral, adjunctive serotonergic therapy at this stage, meaning patients don’t have to stop their existing antidepressants to use it.[4]

That adjunctive angle is a big deal for psychiatrists. No med washout. No disruption to current treatment plans. Just a potential add-on.

Why Helus Pharma Deserves a Closer Look

FDA Breakthrough Therapy Designation for HLP003, their compound targeting MDD. This is the FDA’s accelerated regulatory pathway, reserved for therapies addressing serious conditions with substantial clinical evidence.[5]
Jefferies initiated BUY coverage with a $22 price target, citing upcoming catalysts and the differentiated clinical profile. That’s 250%+ upside from current levels.[6]
$195.1 million in cash as of December 31, 2025. Well-funded through both Phase 3 data readouts expected this year.[7]
Second catalyst imminent: HLP004 Phase 2 topline data for Generalized Anxiety Disorder expected Q1 2026.[8] That’s any day now.

The Science: Published, Peer-Reviewed, and Real

Getting published in Nature Medicine is not a participation trophy. It’s one of the most rigorous peer-reviewed journals on the planet. And now the publication has validated the mechanism behind Helus Pharma’s HLP004 platform.

The Phase 2a trial (SPL026, an IV DMT formulation) showed rapid, durable antidepressant effects from a single dose. A 35% response rate versus 12% for placebo. Remission in 29% of patients versus 12%.[9]

That IV formulation itself isn’t being advanced. But the data supports the biological rationale for HLP004 which is engineered for intramuscular delivery.

HLP004: The Second Shot on Goal

While HLP003 gets the headlines, Helus Pharma’s second clinical asset is quietly approaching a major readout. HLP004 is being studied for Generalized Anxiety Disorder.[10]

Phase 2 topline data is expected this quarter. If positive, it would give Helus two distinct clinical programs with data in two of the most prevalent mental health conditions in the world.

Two shots on goal. One stock price.

The New CEO: A Commercialization Signal You Can’t Ignore

On February 10, Helus Pharma appointed Michael Cola as CEO.[11]

Cola spent decades in CNS pharma. As President of Shire Specialty Pharma, he helped build Vyvanse into a multi-billion dollar franchise and grew the company’s market cap from $5 billion to $20 billion.

That trajectory contributed to Takeda’s $62 billion acquisition of Shire.[12]

He’s also served as CEO of Avalo Therapeutics, Chairman of Phathom Pharma, and sat on the board of Sage Therapeutics.

You don’t hire a commercialization executive to run a science experiment.

You hire one when you believe you have something to sell.

The Road Ahead: 2026 Catalysts

Q1 2026 (imminent): HLP004 Phase 2 topline data in Generalized Anxiety Disorder
Q4 2026: HLP003 APPROACH Phase 3 topline data in Major Depressive Disorder
Ongoing: EMBRACE Phase 3 enrollment and EXTEND long-term safety/durability data collection
Patent protection through at least 2041

Stay Ahead of the Curve

Helus Pharma is approaching a defining stretch. Phase 3 data, a second clinical readout, and a new CEO with a track record of turning clinical assets into commercial blockbusters.

For the latest updates, visit helus.com and sign up for investor alerts at ir.helus.com.

DISCLAIMER:

Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. This article is being distributed by USA News Group on behalf of Market IQ Media Group Inc. (“MIQ”). MIQ has been paid a fee for Helus Pharma advertising and digital media from Creative Digital Media Group (“CDMG”). There may be 3rd parties who may have shares of Helus Pharma, and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ/BAY does not own any shares of Helus Pharma but reserve the right to buy and sell, and will buy and sell shares of Helus Pharma at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved on behalf of Helus Pharma by CDMG; this is a paid advertisement, we currently own shares of Helus Pharma and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.

Sources:

[1] https://www.nature.com/articles/s41591-025-04154-z

[2] https://ir.helus.com/investors/news/news-details/2026/Helus-Pharma-Appoints-Michael-Cola-as-Chief-Executive-Officer-to-Lead-Next-Phase-of-Scale-and-Execution/default.aspx

[3] https://www.investing.com/news/analyst-ratings/jefferies-initiates-helus-pharma-stock-with-buy-rating-on-upcoming-catalysts-93CH-4477830

[4] https://ir.helus.com/investors/news/news-details/2026/HELUS-Pharma-Propels-Therapeutic-Innovation-in-Mental-Health-and-Commences-Trading-on-Nasdaq/default.aspx

[5] https://www.helus.com/hlp003/

[6] https://www.investing.com/news/analyst-ratings/jefferies-initiates-helus-pharma-stock-with-buy-rating-on-upcoming-catalysts-93CH-4477830

[7] https://ir.helus.com/investors/news/news-details/2026/HELUS-Pharma-Reports-Third-Quarter-Fiscal-Year-2026-Financial-Results-and-Recent-Business-Highlights/default.aspx

[8] https://ir.helus.com/investors/news/news-details/2026/HELUS-Pharma-Propels-Therapeutic-Innovation-in-Mental-Health-and-Commences-Trading-on-Nasdaq/default.aspx

[9] https://ir.helus.com/investors/news/news-details/2026/Nature-Medicine-Publishes-Helus-Pharmas-Randomized-Placebo-Controlled-Phase-2a-Trial-of-SPL026-in-Major-Depressive-Disorder/default.aspx

[10] https://ir.helus.com/investors/news/news-details/2026/HELUS-Pharma-Propels-Therapeutic-Innovation-in-Mental-Health-and-Commences-Trading-on-Nasdaq/default.aspx

[11] https://ir.helus.com/investors/news/news-details/2026/Helus-Pharma-Appoints-Michael-Cola-as-Chief-Executive-Officer-to-Lead-Next-Phase-of-Scale-and-Execution/default.aspx