The following common stock equivalents were excluded from the calculation of net loss per share due to their anti-dilutive effect:

However, unless you know what too look for, you won’t find it. The impurities in question were also occurring at very low levels, so the product could still be 99.999% pure. It’s the 0.001% that’s the problem.

        Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Study design had to meet the following criteria: (1) randomized, placebo-controlled parallel or cross-over trial, (2) population enrolled: adults ≥ 18 years, and, (3) plasma ADMA levels at baseline and after statin administration were available.

At the end of the experiments, rats’ carotid aortas were sampled and fixed in 4% phosphate buffered formaldehyde for 2 to 3 days20. After paraffin embedding tissue blocks were cut in 4 μm slices and tissue sections collected on poly-L-lysine-coated glass slides were treated by microwave for antigen unmasking. anti-eNOS (phospho Ser1177) antibody (Abcam, cambridge, UK) were used as primary antibodies at dilutions of 1:100 (eNOS) incubated overnight at 4 °C, followed by incubation with the appropriate secondary horseradish-peroxidase labeled antibodies in accordance to the instructions of the LSAB + System HRP kit (DAKO, Hamburg, Germany) and development using DAB as chromogen. The sections were examined by light microscopy (Zeiss Axioscop 40, Jena, Germany).

Our general and administrative expenses amounted to approximately $3.8 million for the year ended December 31, 2017, representing an increase of approximately $0.7 million, or 23%, compared to approximately $3.1 million for the year ended December 31, 2016. The increase primarily resulted from an increase in salaries and benefits expenses of approximately $0.6 million as well as an increase in investor relations and business development expenses of approximately $0.2 million. 

In renal fibrogenesis, matrix-producing cells integrate various fibrogenic signals and regulate ECM production and assembly. These fibrogenic factors include TGF-β1, platelet-derived growth factor, fibroblast growth factor, connective tissue growth factor and angiotensin II15. Among these cytokines, TGF-β1 is the key contributor to EMT in tubular epithelial cells29. In the kidneys of patients with IgA nephropathy, P311 protein expression correlates with TGF-β expression and proteinuria30. Thus, we next examined whether TGF-β1 was involved in EMT related to P311-mediated renal fibrogenesis. As predicted, obstructed kidneys from P311−/− mice showed impaired TGF-β1 protein expression. Interestingly, there was no difference in TGF-β1 mRNA levels between the P311−/− and P311+/+ groups. These results differ from our previous observations in human fibroblasts, which showed that P311 transfection induces TGF-β1 mRNA expression and that interfering with P311 expression in fibroblasts decreases TGF-β1 mRNA expression10. The different models (in vivo versus in vitro) and different cell types (human fibroblasts versus mouse tubular epithelial cells) might be responsible for the discrepancy. P311 binds to latency-associated proteins to regulate TGF-β1 expression31. Recently, P311 was reported to bind to eukaryotic translation initiation factor 3 subunit b to promote TGF-β translation and to be the first pan-regulator of TGF-β expression under steady-state conditions8,32. These findings may explain our results.

        Any of these events could harm our business and operations and could negatively impact our stock price.

If we, or any future collaborators, experience any of a number of possible unforeseen events in connection with clinical trials of our product candidates, potential clinical development, marketing approval or commercialization of our product candidates could be delayed or prevented.

The following is a summary description of the material terms of those transactions with related parties to which we, or our subsidiaries, are party and which were in effect since January 1, 2018.

Zhejiang Huahai’s improved process replaced tributyltin azide with the more toxic compound, sodium azide, says André. As a result, the yield of tetrazole formation was much better. However, sodium nitrite was used to destroy the excess sodium azide that remained after the synthesis step. Sodium nitrite is often used as a decontaminating agent of sodium azide in acidic conditions, André says. However, under these conditions, it forms nitrous acid, which could react with the residue of dimethylamine in dimethylformamide, the solvent that is used in the tetrazole-forming reaction, to generate NDMA, says André. 

So actually if you use them all at once you’ll blast TOR pretty good and seemingly in an additive manner.