Axsome Therapeutics, Inc. AXSM reported second-quarter 2020 loss per share of 49 cents, narrower than the Zacks Consensus Estimate of a loss of 54 cents but wider than the year-ago quarter’s loss of 41 cents.

Axsome currently does not have any approved product in its portfolio. As a result, the company is yet to generate any revenues from the same.

Shares of Axsome have declined 20.8% in the year so far against the industry’s increase of 5.4%.

Quarter in Detail

Research and development (R&D) expenses were $10.5 million in the quarter, down 4.5% from the year-ago period owing to completion of several studies on the pipeline candidates.

General and administrative (G&A) expenses were $7.2 million, significantly up year over year due to increased stock compensation expenses and commercial costs.

As of Jun 30 2020, Axsome had cash worth $190.7 million compared with $197.3 million as of Mar 31, 2020. Management believes that its cash balance as of June-end will be enough to fund its anticipated operations for at least a couple of years.

Pipeline Updates

Axsome’s central nervous system (CNS) pipeline candidates including AXS-05, AXS-07, AXS-09, AXS-12 and AXS-14 are currently being developed for multiple indications.

AXS-05 is being developed for treating major depressive disorder (MDD), treatment-resistant depression (TRD) and agitation associated with Alzheimer’s disease (AD).

In July 2020, the company completed a successful pre-new drug application (NDA) meeting with the FDA authorities on one of its lead pipeline candidates AXS-05 for the treatment of MDD. The company remains on track to submit the planned NDA in the fourth quarter of 2020.

If successfully developed and approved, AXS-05 will be the first orally administered N-methyl-D-aspartate (NMDA) receptor antagonist to get a regulatory nod for the treatment of MDD.

AXS-05 is also being evaluated in the pivotal phase II/III ADVANCE-1 study for treating agitation associated with AD. In June, the FDA granted a Breakthrough Therapy tag for the above-mentioned indication. It was based on the recent positive results from the pivotal phase II/III ADVANCE-1 study, which evaluated AXS-05 for the given indication. Axsome plans to initiate a second phase III study on AXS-05 to treat AD agitation in the second half of this year.

Additionally, AXS-05 is being investigated in the phase III STRIDE-1 study to address patients with TRD. Notably, Axsome is conducting three phase II open-label efficacy sub-studies, which are evaluating the efficacy and safety of AXS-05 in three clinically pertinent MDD patient populations. Those are namely, the COMET-TRD study for treatment resistant MDD (TRD), the COMET-AU study for antidepressant unresponsive MDD and the COMET-SI study for MDD with suicidal ideation. Efficacy results from all these studies are expected to be reported in the fourth quarter of 2020.

Further, Axsome is evaluating AXS-07 in the phase III MOMENTUM study as an acute treatment of migraine and in the phase III INTERCEPT study as an early treatment of migraine. Notably, the NDA for AXS-07 as an acute treatment of migraine is also expected to be filed in the fourth quarter of 2020.

In April 2020, AXS-07 met two regulatory co-primary endpoints in the phase III INTERCEPT study that evaluated the candidate for an early treatment of migraine. The co-primary goals were freedom from migraine pain and freedom from most bothersome symptoms compared to placebo in the study.

This apart, Axsome’s AXS-12 is being developed to treat narcolepsy. Earlier this month, the FDA granted a Breakthrough Therapy designation to AXS-12 for the Treatment of narcolepsy. The company plans to begin a phase III study on AXS-12 for the given indication in the second half of 2020.

Zacks Rank & Stocks to Consider

Axsome currently carries a Zacks Rank #4 (Sell).

Better-ranked stocks in the healthcare sector include Emergent BioSolutions Inc. EBS, Horizon Therapeutics Public Limited Company HZNP Pacira BioSciences, Inc. PCRX, all sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Emergent’s earnings estimates have moved 71.2% and 99.1% north for 2020 and 2021, respectively, over the past 60 days. The stock has skyrocketed 141.3% year to date.

Horizon’s earnings estimates have been revised 22% and 19.8% upward for 2020 and 2021 each over the past 60 days. The stock has rallied 109.5% year to date.

Pacira’s earnings estimates have been revised 12.4% and 13.5% upward for 2020 and 2021 each over the past 60 days. The stock has soared 34.6% year to date.

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