TD Cowen on Amylyx Pharmaceuticals inc. (AMLX): 'continue to see AMLX as undervalued for the potential of avexitide alone'

TD Cowen analyst Joseph Thome reiterated a Buy rating on Amylyx Pharmaceuticals inc. (NASDAQ: AMLX)

The analyst comments "Amylyx held a KOL event to discuss new analyses from the avexitide Ph. II program presented at ENDO. The KOLs highlighted the high unmet need in PBH, as well as the transformative potential of avexitide as a new treatment option for the disease. We feel optimistic for avexitide's success in the Ph. III LUCIDITY study, and continue to see AMLX as undervalued for the potential of avexitide alone. Amylyx held a KOL event yesterday to discuss new analyses from the avexitide Ph. II program presented at the ENDO conference. Recall, Amylyx previously reported that avexitide generated a 53% and 66% reduction in level 2 and level 3 hypoglycemia events at the 90 mg once daily dose in a prior Ph. IIb study, and the company currently expects to have topline data from the Ph. III LUCIDITY trial in H1:26. A new PK model of avexitide plasma concentration over time presented at the ENDO conference (based on data collected from pts in the avexitide clinical program) suggested that a single administration of the 90 mg dose of avexitide results in plasma concentrations above avexitide's IC50 for the GLP-1 receptor for more than 24 hours (and above the IC90 from the start of the day to midnight). In a separate presentation, the company also showed that the 90 mg once-daily dose of avexitide resulted in a 64% reduction in the composite number of level 2 and level 3 events in the prior Ph. IIb study. Together, we believe the ENDO data reaffirm our confidence in avexitide (outlined in our initiation) and should help de-risk the results from the Ph. III LUCIDITY study, which will use the same 90 mg QD dose and composite event endpoint as its primary outcome measure. In addition to the ENDO data, the KOLs at the event emphasized the high unmet need for PBH patients. Recall, as no FDA-approved treatment option for PBH exists, physicians must rely upon a combination of dietary therapy and off-label medications in order to treat the disease. The KOL at the event indicated that pts with PBH often try dietary therapy as a "first-line" treatment option to control their hypoglycemia; however, as these diets often involve very restrictive measures, many pts either fail this approach or do not want to adhere. The KOL noted that pts can sometimes use glucagon rescue therapy to mitigate the effects of hypoglcyemia in conjunction with dietary therapy, though since these pts must go on low-carb diets in order to manage their disease, they typically do not have sufficient glycogen stores to make glucagon rescue therapy effective."

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Shares of Amylyx Pharmaceuticals inc. closed at $7.68 yesterday.

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