Helus Pharma IR

Welcome to the official IR account of Helus Pharma ($HELP).

[Helus Pharma IR @HelusPharmaIR]

$HELP HLP003, which holds FDA Breakthrough Therapy Designation, now moves toward topline data expected in Q4 2026.

Learn more:
https://t.co/KqovycJXmk

[Helus Pharma IR @HelusPharmaIR]

$HELP Helus Pharma has completed enrollment in APPROACH, its Phase 3 pivotal study of HLP003 for the adjunctive treatment of major depressive disorder.

[Helus Pharma IR @HelusPharmaIR]

$HELP Completing enrollment is what allows a study to move toward data, reaching it ahead of schedule keeps the topline readout on track for Q4 2026. APPROACH enrolled 223 participants with moderate-to-severe MDD who respond inadequately to their current antidepressant treatment.

[Helus Pharma IR @HelusPharmaIR]

$HELP Helus Pharma has strengthened its scientific leadership with the addition of Dr. Freda Lewis-Hall, former Chief Medical Officer of Pfizer, to its Board as chair of the Scientific Advisory Board, and Dr. Robert Langer, co-founder of Moderna, to the Scientific Advisory Board.

[Helus Pharma IR @HelusPharmaIR]

$HELP In late-stage clinical development, leadership depth matters. Scientific and medical advisors influence how a program engages with regulators and how its data is interpreted on the path from readout to potential approval.

[Helus Pharma IR @HelusPharmaIR]

$HELP As the field matures, durability is becoming one of the clearer measures of a psychedelic therapy's real-world value, and a standard every serious program in the space will be measured against.

$ATAI $CMPS

[Helus Pharma IR @HelusPharmaIR]

$HELP Helus Pharma's Phase 3 PARADIGM program is structured this way, with the EXTEND long-term extension following participants over time alongside the APPROACH and EMBRACE pivotal studies.

[Helus Pharma IR @HelusPharmaIR]

$HELP A key question in this field is whether benefit lasts. The FDA's new guidance addresses it directly: for a chronic condition like major depressive disorder, it points to a double-blind assessment at 12 weeks, with longer blinded follow-up, typically 12 months,

[Helus Pharma IR @HelusPharmaIR]

$HELP described as the most informative design.

That is why late-stage programs are built around more than one study. Pivotal trials establish the initial effect; long-term extension studies build the durability record.

[Helus Pharma IR @HelusPharmaIR]

$HELP Helus Pharma is running its APPROACH pivotal study of HLP003 within that framework.

$ATAI $DFTX

[Helus Pharma IR @HelusPharmaIR]

$HELP One theme runs through the FDA’s new psychedelic guidance: because these therapies produce noticeable effects, trials have to work hard to stay unbiased. Patients and clinicians can sometimes tell who received active treatment, which can color results.

[Helus Pharma IR @HelusPharmaIR]

$HELP The field calls this functional unblinding.

The FDA’s answer is to hold the bar high: results should be strong and robust, supported by tools like independent blinded raters. In other words, the evidence has to be convincing on its own terms.

[Helus Pharma IR @HelusPharmaIR]

$HELP Clearer regulatory standards give every serious developer in the space a defined path to work toward. $ATAI $DFTX $CMPS

[Helus Pharma IR @HelusPharmaIR]

$HELP The FDA has issued final guidance on how psychedelic therapies should be studied. For a field that has grown quickly, a clear, formal framework from the regulator is a meaningful step: it defines how trials in this class are designed, run, and evaluated.

[Helus Pharma IR @HelusPharmaIR]

$HELP Helus Pharma is advancing HLP003 as an adjunctive treatment for major depressive disorder through its Phase 3 PARADIGM program, conducted under FDA oversight and within this framework.

[Helus Pharma IR @HelusPharmaIR]

$HELP while the EMBRACE pivotal study is enrolling and participants continue to enroll in the EXTEND long-term extension.

As these programs advance, Helus Pharma's focus remains on disciplined execution and regulatory alignment across each stage of development.

[Helus Pharma IR @HelusPharmaIR]

$HELP Clinical development is built around a sequence of milestones, not a single event. Pivotal studies, extension studies, regulatory interactions, and long-term follow-up each contribute to the evidence required for a potential New Drug Application.

[Helus Pharma IR @HelusPharmaIR]

$HELP Helus Pharma's Phase 3 PARADIGM program reflects that structure. The APPROACH pivotal study continues to advance toward completion of enrollment, with a topline data readout expected in Q4 2026,

[Helus Pharma IR @HelusPharmaIR]

$HELP The recent financing supports the company's ability to remain focused on clinical execution and upcoming regulatory milestones, including top line data readout of HLP003 in Q4 2026.

[Helus Pharma IR @HelusPharmaIR]

$HELP Advancing late-stage clinical programs requires more than positive data. It also requires the financial resources to execute each development milestone without interruption.

[Helus Pharma IR @HelusPharmaIR]

$HELP Following the successful closing of its US$50 million underwritten offering, Helus Pharma’s strengthened cash position provides additional flexibility as multiple clinical programs move forward.