Hongli Group Inc. (HLP)
NASDAQ (CM) NASDAQ (CM) Primary 
Helus Pharma: A Buy Ahead Of The HLP003 Phase 3 Readout
Helus Pharma remains a buy, as HLP003's Phase 3 APPROACH topline data in 4Q26 is the key near-term catalyst. HLP003 targets adjunctive MDD with a differentiated intermittent dosing model; prior Phase 2 data showed a 23-point MADRS reduction and 71% remission at 12 months. HELP's $166.4M cash balance provides 12–14 months runway, but dilution risk persists given high operating outflows and the $100M ATM facility.
Helus Pharma Eyes Q4 Phase III Data for HLP-003 in Major Depression
Helus Pharma, formerly known as Cybin NASDAQ: HELP, outlined its late-stage development plans for HLP-003 in adjunctive major depressive disorder (MDD) and discussed its broader pipeline of serotonergic agonists during TD Cowen's Novel Mechanisms in Neuropsychiatry virtual summit.
Helus Pharma: An Undervalued Psychedelic Platform Approaching A Major Catalyst
Helus Pharma has built a proprietary psychedelic pipeline that currently spans MDD and GAD. The company has two clinical-stage assets and a broader serotonergic discovery platform. Early HLP003 (oral psilocin) and HLP004 (IM DMT) data suggest efficacy and durability when used as adjunctive therapies, although this comes from small trials. Helus is conducting a phase III trial for HLP003, which could validate its clinical profile and reduce the valuation discount relative to peers.
Helus Pharma: APPROACHing Inflection: Pivotal Readout Sets Up Asymmetric Upside
I initiate coverage of Helus Pharma with a speculative Buy, citing an attractive high-risk/high-reward setup ahead of the pivotal Phase 3 APPROACH readout in Q4 2026. HELP's lead asset HLP003, an oral deuterated psilocin analog for adjunctive MDD, shows compelling Phase 2 efficacy, FDA Breakthrough Therapy Designation, and a differentiated clinical profile. Current valuation (~$269M EV, ~$207M pro forma cash) under-credits the probability-weighted value of HLP003, with a risk-adjusted implied EV of ~$1.5B if Phase 3 succeeds.
HELUS Pharma: Transitioning From Psychedelic Research To Late-Stage Clinical Neuroscience
HELUS Pharma has rebranded and moved to Nasdaq, signaling a shift toward late-stage clinical development and commercial focus. Key 2026 catalysts include Phase 3 data for HLP003 in major depressive disorder and Phase 2 data for HLP004 in generalized anxiety disorder. HELP's cash burn accelerated to $36.7M in 3Q26, with $195M cash on hand and a $100M ATM facility providing runway through pivotal trial milestones.
