CDMO Posts Q4 Profit, NMRD’s SugarBEAT Gears Up For Launch, MESO Has A Blast

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

1. Avid Bioservices Inc. (CDMO)

Gained 23.04% to close Tuesday’s (Jul 17) trading at $5.50.

News: The Company announced financial results for the fourth quarter and fiscal year (FY) 2018 ended April 30, 2018, and provided an update on its contract manufacturing operations, and other corporate highlights.

For the fourth quarter of FY 2018, the company turned to profit of $1.6 million or $0.03 per share, reversing a loss of $6.7 million or $0.16 per share in the comparable year-ago quarter.

Contract manufacturing revenue from Avid’s clinical and commercial biomanufacturing services for the fourth quarter of FY 2018 declined to $6.9 million from $17.9 million in the comparable year-ago quarter due to lower demand from one of its largest customers.

Looking ahead to fiscal year 2019 ending April 30, 2019, the Company expects revenue of $51.0 million to $55.0 million. Revenue in fiscal 2018 is $53.6 million.

2. Aquinox Pharmaceuticals Inc. (AQXP)

Gained 17.79% to close Tuesday’s trading at $2.98.

News: No news

Recent event:

On June 27, the Company announced that its phase III trial evaluating once-daily, oral Rosiptor for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS), dubbed LEADERSHIP 301, failed to meet its primary endpoint. The news sent the stock down nearly 85% to $2.34 that day.

3. Nemaura Medical Inc. (NMRD)

Gained 13% to close Tuesday’s trading at $2.52.

The Company is developing sugarBEAT for adjunctive use by diabetics as a non-invasive and needle-free continuous glucose monitoring (CGM) system. SugarBEAT consists of a disposable skin-patch connected to a rechargeable transmitter, and mobile app displaying glucose readings.

News: The Company has placed an initial order with its designated UK-based contract manufacturer for 12,500 sugarBEAT rechargeable transmitters, which will be supplemented with approximately 100,000 skin-patches per month, also manufactured in the UK, in preparation for the anticipated sugarBEAT product launch in the coming months.

The device is expected to be launched initially in the United Kingdom, upon CE Mark approval. A predecessor sugarBEAT device, based on a wired wrist-watch form factor, received CE Mark approval in 2016.

4. Zosano Pharma Corp. (ZSAN)

Gained 13.04% to close Tuesday’s trading at $4.68.

News: The Company announced positive data from a nonclinical evaluation of pharmacokinetics and skin tolerability study for ADAM technology for the delivery of Zolmitriptan.

ADAM zolmitriptan (formerly M207) is being developed as an acute treatment for migraine.

Pharmacokinetic studies have shown that the ADAM 1.9-mg zolmitriptan was delivered with high efficiency (85%) and high absolute bioavailability (77%).

Near-term Catalysts:

— A long-term safety study evaluating ADAM zolmitriptan, initiated last November, is underway.
— The NDA for ADAM zolmitriptan is expected to be filed in the fourth quarter of 2019.

5. Mesoblast Ltd. (MESO)

Gained 12.69% to close Tuesday’s trading at $6.75.

News: The Company has entered into a strategic alliance with Tasly Pharmaceutical Group to develop MPC-150-IM for the treatment or prevention of chronic heart failure and MPC-25-IC for the treatment or prevention of acute myocardial infarction.

Mesoblast’s MPC-150-IM is under phase III study for the treatment of heart failure, dubbed DREAM HF-1. MPC-25-IC is Mesoblast’s phase II product candidate for the treatment of acute myocardial infarction.

As per the deal terms, Tasly will receive exclusive rights and will fund all development, manufacturing and commercialization activities in China for MPC-150-IM and MPC-25-IC. In turn, Mesoblast will receive a US$20 million upfront technology access fee and US$20 million in an equity purchase. In addition, Mesoblast will receive US$25 million on product regulatory approvals in China, double-digit escalating royalties on net product sales, and six escalating milestone payments upon the product candidates reaching certain sales thresholds in China.


In addition to MPC-150-IM and MPC-25-IC, the other products in the pipeline are:

— MPC-06-ID, under phase III testing for the treatment of chronic low back pain (CLBP) due to disc degeneration.
— MSC-100-IV, a phase III product candidate, which is being developed for the treatment of acute Graft Versus Host Disease (aGVHD) following allogeneic bone marrow transplantation. MSC-100-IV is marketed as TEMCELL HS Inj for acute Graft Versus Host Disease (GVHD) in children and adults in Japan by Mesoblast’s licensee, JCR Pharmaceuticals.
— MPC-300-IV, under a phase II trial, in patients with biologic-refractory rheumatoid arthritis.

6. Vericel Corp. (VCEL)

Gained 11.35% to close Tuesday’s trading at $10.30.

The Company develops advanced cell therapies for the Sports Medicine and Severe Burn Care markets. The marketed products include MACI, a restorative cartilage repair product in the sports medicine market, and Epicel, the only FDA-approved permanent skin replacement in the severe burn care field.

News: No news

Recent events:

On May 8, the Company reported financial results for the first quarter ended March 31, 2018.

Net loss in the recent first quarter narrowed to $7.7 million or $0.21 per share from $9.8 million or $0.31 per share in the first quarter of 2017. The total net revenues were of $18.0 million in Q1, 2018 compared to $9.4 million in the first quarter of 2017.

by RTTNews Staff Writer

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