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Edison Investment Research is terminating coverage on Crossject (ALCJ). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant.

Edison Investment Research is terminating coverage on Crossject (ALCJ). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant.

Crossject recently reported FY17 results and that it remains on track for regulatory filings for several programmes in 2019, including Zeneo Sumatriptan, Midazolam, Epinephrine/Adrenaline, Hydrocortisone, and Naloxone with Terbutaline and Methotrexate in 2020. A key upcoming catalyst would be a US licensing agreement for Zeneo Sumatriptan for the treatment of acute migraine, which could come in H118.

Crossject recently reported FY17 results and that it remains on track for regulatory filings for several programmes in 2019, including Zeneo Sumatriptan, Midazolam, Epinephrine/Adrenaline, Hydrocortisone, and Naloxone with Terbutaline and Methotrexate in 2020. A key upcoming catalyst would be a US licensing agreement for Zeneo Sumatriptan for the treatment of acute migraine, which could come in H118.

Crossject - On track for filings next year

Crossject has developed a deep pipeline of products that are based on its proprietary needle-free injection system, Zeneo, across a variety of indications, with a focus on emergency-related areas. In addition to avoiding needles, Zeneo provides a simple and quick (~1/10th of a second) delivery of the drug. Recently, the company has added Zeneo Terbutaline for the acute treatment of exacerbations in severe asthmatics. This is a large market (~2.5m in the US) in need of better choices for patients.

Crossject has developed a deep pipeline of products that are based on its proprietary needle-free injection system, Zeneo, across a variety of indications, with a focus on emergency-related areas. In addition to avoiding needles, Zeneo provides a simple and quick (~1/10th of a second) delivery of the drug. Recently, the company has added Zeneo Terbutaline for the acute treatment of exacerbations in severe asthmatics. This is a large market (~2.5m in the US) in need of better choices for patients.

Crossject recently announced that it has received regulatory approval to launch the bioequivalence study for Zeneo Midazolam (being developed for the acute treatment of epileptic seizures) in healthy volunteers. This puts the company on track for the expected H218 EU filing and the H119 US filing. Due to this milestone, Crossject has received &#8364;2.9m from Bpifrance as part of the Programme des Investissements d&#8217;Avenir (PIAVE). Also, the company has successfully completed a &#8364;5m rights offering.

Crossject recently announced that it has received regulatory approval to launch the bioequivalence study for Zeneo Midazolam (being developed for the acute treatment of epileptic seizures) in healthy volunteers. This puts the company on track for the expected H218 EU filing and the H119 US filing. Due to this milestone, Crossject has received &#8364;2.9m from Bpifrance as part of the Programme des Investissements d&#8217;Avenir (PIAVE).  Also, the company has successfully completed a &#8364;5m rights offering.

As part of its revised strategic plan, Crossject has expanded its partnership with CENEXI to fill and finish all of Crossject&rsquo;s products in all regions for a period of five years, with a potential extension up to 10 years. Also, the timelines for its expected regulatory submissions have shifted across the board; most notably, the EU filing for ZENEO Methotrexate has been pushed back from H216 to H218 due to its non-emergency nature and higher requirement for manufacturing resources than other products. As a result, we reduce our valuation to &euro;9.91 per share (from &euro;12.07).

As part of its revised strategic plan, Crossject has expanded its partnership with CENEXI to fill and finish all of Crossject&rsquo;s products in all regions for a period of five years, with a potential extension up to 10 years. Also, the timelines for its expected regulatory submissions have shifted across the board; most notably, the EU filing for ZENEO Methotrexate has been pushed back from H216 to H218 due to its non-emergency nature and higher requirement for manufacturing resources than other products. As a result, we reduce our valuation to &euro;9.91 per share (from &euro;12.07).

France

Crossject SA develops needle-free injection systems for liquid medicines. The Company product ZENEO is tailored to deliver drugs intra-dermally, subcutaneously and intramuscularly.

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