OMER Back In Focus, INNT Moving Ahead, Keep An Eye On EARS

mar 22 down 032218

The following are some of today's top gainers in the pharma/biotech sector.

1. Omeros Corporation (OMER)

Gained 35.31% to close Thursday's (Mar.22) trading at $15.75.

News: The omnibus spending bill released last night mentions that the pass-through period for some drugs shall be extended for another 2 years, beginning October 1, 2018. The Company's eye drug OMIDRIA is sure to be benefited if the bill is passed because the pass-through status allows for additional reimbursement for the drugs.

OMIDRIA lost its pass-through status on January 1, 2018, resulting in a decrease in the per unit price received for OMIDRIA.

OMIDRIA revenues in 2017 were $64.8 million, a 56.4 percent increase over 2016.

Early this month, the Company said that the uncertainty around OMIDRIA reimbursement following expiration of pass-through status had resulted in reduced first quarter sell-through.

Now that there is mention about extending the pass-through period in the spending bill, the sales of the OMIDRIA may stage a rebound.

2. Innovate Biopharmaceuticals Inc. (INNT)

Gained 18.16% to close Thursday's trading at $21.34.

News: No news


The lead drug candidate is Larazotide acetate (INN-202), which has successfully met its primary endpoint in a phase 2b efficacy clinical trial for celiac disease. Also in the pipeline is INN-108, indicated for mild to moderate ulcerative colitis, which is entering Phase 2 trials this year, and INN-329, entering phase 3 for Magnetic Resonance Cholangiopancreatography (MRCP).

Near-term Catalyst:

-- Larazotide acetate is expected to move into phase III clinical trials in celiac disease in Q2 2018.

3. Auris Medical Holding AG (EARS)

Gained 35.31% to close Thursday's (Mar.22) trading at $15.75.

News: The Company provided a business update and announced financial results for the fourth quarter and full year ended December 31, 2017.

Net loss for the fourth quarter of 2017 narrowed to CHF 4.6 million or CHF 0.10 per share from CHF 5.6 million or CHF 0.16 per share for the fourth quarter of 2016.
Total operating expenses for the fourth quarter of 2017 declined to CHF 5.4 million from CHF 6.3 million for the fourth quarter of 2016.

Near-term Catalyst:

-- Data from a further 31 patients who enrolled in the ASSENT trial with profound acute hearing loss are expected towards the end of the first quarter of 2018.

ASSENT is a phase III trial, similar in design as that of HEALOS phase III clinical trial that investigated AM-111 in the treatment of acute inner ear hearing loss.
While the HEALOS trial had not met the primary efficacy endpoint in the overall study population, the post-hoc analyses of top-line data revealed a clinically and statistically significant hearing improvement with AM-111 from baseline to Day 28 in the subpopulation of patients with profound hearing loss, according to the Company.

ASSENT trial was terminated early as it was considered not adequate for testing AM-111.

4. Bellerophon Therapeutics Inc. (BLPH)

Gained 35.31% to close Thursday's (Mar.22) trading at $15.75.

News: No news

Clinical Trials & Near-term Catalysts:

-- A phase III INOvation-1 study evaluating INOpulse in patients with pulmonary arterial hypertension is underway. Readout of the interim analysis of this trial is expected in mid-2018, with top-line data from the full study anticipated around the end of 2018.
-- A phase 2b study evaluating INOpulse to assess the safety and efficacy of pulsed, inhaled nitric oxide versus placebo in patients with pulmonary hypertension associated with Interstitial Lung Disease (PH-ILD) is also ongoing. Top-line results from this study are expected to be available by the end of 2018.
-- The Company recently announced positive results from its phase 2 study for INOpulse in pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD). The next clinical program is being planned.

5. Titan Pharmaceuticals Inc. (TTNP)

Gained 14.02% to close Thursday's trading at $1.22.

News: Privately-held Molteni has acquired Titan Pharma's European intellectual property related to Probuphine, including the Marketing Authorization Application under review by the European Medicines Agency.

Probuphine, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence, was approved by the FDA in May 2016.

Titan received an initial payment of €2.0 million (approx. $2.4 million) for the purchased assets and will receive potential additional payments totaling up to €4.5 million (approx. $5.5 million) upon the achievement of certain regulatory and product label milestones. Additionally, Titan is entitled to receive earn-out payments for up to 15 years on net sales of Probuphine in the Molteni Territory ranging in percentage from the low-teens to the mid-twenties.

As part of the transaction, Molteni also made an indirect strategic investment in Titan by purchasing $2.4 million of the outstanding $4.0 million principal balance owed under Titan's July 2017 loan agreement with Horizon Technology Finance Corporation.

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