Week Ahead In Pharma: Clinical Trial Readouts, FDA Decision (ETON, SELB, CRBP…)

In the week ended September 25, Kaleido Biosciences Inc. (KLDO), which surged over 51%, was the biggest weekly gainer in the healthcare sector. This clinical-stage healthcare company is developing KB109 for COVID-19, which is being evaluated in two studies in patients with mild-to-moderate COVID-19 disease, with topline data from one of the studies expected in the fourth quarter.

Owens & Minor Inc. (OMI), which jumped more than 40%, Zomedica Pharmaceuticals Corp. (ZOM), which returned nearly 40%, and Cardiff Oncology, Inc. (CRDF) that returned over 30% are some of the other top weekly gainers.

Now, let’s take a look at some of the stocks that are worth keeping an eye on in the week ahead.

1. Corbus Pharmaceuticals Holdings Inc. (CRBP)

Corbus Pharma is a clinical-stage pharmaceutical company developing novel therapeutics to treat inflammatory and fibrotic diseases.

The company’s lead product candidate is Lenabasum. On September 8, Corbus reported disappointing topline results from its phase III Study of Lenabasum for the treatment of systemic sclerosis, dubbed RESOLVE-1. The news sent the stock plunging more than 75% that day.

A phase III study of Lenabasum in dermatomyositis, dubbed DETERMINE, and a phase IIb study of Lenabasum in cystic fibrosis are underway.

Catalyst:

The topline results from the phase IIb study of Lenabasum in cystic fibrosis are due this quarter (Q3 2020).

Cash Position:

The company ended July 28, 2020, with cash and cash equivalents of approximately $101 million.

CRBP closed Friday’s trading at $1.56, up 1.62%.

2. Cyclerion Therapeutics Inc. (CYCN)

Cyclerion Therapeutics is a clinical-stage biopharmaceutical company whose lead programs include Olinciguat in phase II development for sickle cell disease, dubbed STRONG-SCD, and IW-6463 in clinical development for Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS) and Alzheimer’s Disease with Vascular pathology (ADv).

Catalysts:

— Topline data from the phase II study of Olinciguat in sickle cell disease are due this month.
— Topline data from the translational pharmacology study of IW-6463 are expected in late summer 2020.

Cash Position:

The company, which ended June 30, 2020, with cash of approximately $61 million, raised $24 million in an equity private placement on July 30.

CYCN closed Friday’s trading at $6.80, down 1.88%.

3. Eton Pharmaceuticals Inc. (ETON)

On September 25, Eton Pharma announced that its Alaway Preservative Free, also known as EM-100, an over-the-counter preservative-free formulation of ketotifen ophthalmic solution, was approved by the FDA for the treatment of ocular itching associated with allergic conjunctivitis.

Eton Pharma out-licensed EM-100 to Bausch Health Companies Inc. (BHC) in 2019. Eton is entitled to receive low double-digit royalty on Bausch Health’s sales of Alaway Preservative Free. The estimated market size of this product is over $75 million.

Another catalyst coming its way is the FDA decision on Alkindi Sprinkle, a taste-neutral granule formulation of hydrocortisone, expected on September 29, 2020.

Alkindi Sprinkle is proposed as replacement therapy for pediatric adrenal insufficiency (AI), including congenital adrenal hyperplasia (CAH) in infants to patients less than 17 years of age. Eton acquired U.S. marketing rights to Alkindi Sprinkle from Diurnal Group plc (DNL).

The market opportunity for Alkindi Sprinkle in the United States is estimated to be greater than $100 million annually. The product was approved in Europe in 2018 under the trade name Alkindi and is marketed by Diurnal in select countries throughout Europe.

ETON closed Friday’s trading at $8.28, up 1.22%.

4. Selecta Biosciences Inc. (SELB)

Selecta Biosciences is a clinical-stage biotechnology company developing biologic therapies based on its immune tolerance technology (ImmTOR) platform.

The company’s lead drug candidate is SEL-212 that is being developed to treat chronic refractory gout patients and resolve their debilitating symptoms, including flares and gouty arthritis.

A phase II trial evaluating the superiority of a once-monthly dose of Selecta’s SEL-212 against a bi-weekly dose of Horizon Pharma’s Krystexxa, the current FDA-approved uricase therapy for adult patients with chronic refractory gout, dubbed COMPARE, is ongoing.

A phase III clinical program of SEL-212 for chronic refractory gout, dubbed DISSOLVE, was initiated as recently as last week.

Catalyst:

The topline data from the ongoing head-to-head phase II COMPARE trial of SEL-212 is due this quarter (Q3 2020).

Cash Position:

Selecta had cash, cash equivalents, and restricted cash of $61.4 million as of June 30, 2020.

SELB closed Friday’s trading at $2.42, up 2.54%.

5. Viela Bio Inc. (VIE)

Viela Bio is a biotechnology company developing novel treatments for autoimmune and severe inflammatory diseases. The company has one approved drug – UPLIZNA for the treatment of adult patients with neuromyelitis optica spectrum disorder, which received the FDA nod in June of this year.

A phase II trial with VIB4920 in patients with kidney transplant rejection, a phase IIb trial with VIB4920 in Sjögren’s syndrome, and a phase Ib multiple ascending dose trial of VIB7734 in patients with cutaneous lupus erythematosus are underway.

Catalyst:

The final data analysis from the phase Ib study with VIB7734 in cutaneous lupus erythematosus is due to be completed this quarter (Q3, 2020). In May, the company reported positive interim data from this study, suggesting dose-dependent improvements in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) scores – with safety and tolerability comparable to placebo.

Cash Position:

As of June 30, 2020, Viela had cash of $448.4 million and no outstanding debt.

VIE closed Friday’s trading at $26.83, up 5.30%.

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