Newron

Newron Pharmaceuticals provides clinical and business update

All evenamide pre-clinical studies requested by FDA completed and first clinical safety study initiated; on track to initiate evenamide Phase III program in 2021
In advanced evaluation of opportunities to broaden pipeline of treatments for central and peripheral nervous system diseases
International conference call for investors and analysts today at 3:00 PM CET/9:00 AM ET
Milan, Italy and Morristown, NJ, USA, August 11, 2020 - Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today provided a clinical and business update.

Evenamide

“Newron has made considerable progress with our lead clinical program, evenamide, potentially the first add-on therapy for the treatment of patients with symptoms of schizophrenia,” said Stefan Weber, Newron’s Chief Executive Officer. “Earlier this year we reached agreement with the U.S. Food and Drug Administration (FDA) on the design and conduct of evenamide explanatory studies to address potential safety issues they had raised. I am pleased to announce that we have now successfully completed the preclinical part of these studies and no toxicity issues were reported. Newron has now initiated the first clinical safety study (008).”

Explanatory study 008 is a four-week, randomized, double-blind placebo controlled study designed to evaluate the safety, tolerability, EEG effects and preliminary efficacy of two fixed doses of evenamide (7.5 mg and 15 mg BID) in outpatients suffering from chronic schizophrenia receiving treatment with one of the leading second generation atypical antipsychotics. Newron intends to recruit approximately 120 patients into the study at study centers in the United States and India. As anticipated, the initiation of the study was delayed due to the limitations imposed by COVID-19. Nevertheless, enrollment is progressing well and investigators have already enrolled over 40 patients into the study. Contingent on COVID-19 restrictions not further constraining enrollment, results from the study are currently expected in Q1 2021 and, if positive, will form part of the package to prepare for the planned Phase III program with evenamide.

Ravi Anand, Newron’s Chief Medical Officer, added: “Enrollment to study 008 is proceeding rapidly despite the first site being initiated only a few weeks ago. Results from the study supporting good tolerability of evenamide in patients will be submitted to the FDA, once we have the data and as soon as feasible thereafter. Together with the preclinical results confirming absence of toxicity that have been submitted to the FDA already, the extensive explanatory study package should deliver robust, convincing clinical data to proceed with the next, pivotal phase of clinical development. We remain confident that the Phase III studies with evenamide will be initiated in Q2 2021. Study 008 is also designed to provide further evidence of efficacy for evenamide as an add-on therapy in patients suffering from chronic schizophrenia who are worsening on another second-generation antipsychotic. Evenamide, by its complementary and unique mechanism of action, involving modulation of abnormal glutamate release, is expected to enhance the efficacy of their current treatment.”

In May 2019, the FDA requested that Newron complete additional short-term explanatory studies in rats and human subjects to address concerns on findings from a recently completed study of evenamide in rats, as well as CNS events observed following high dose administration of evenamide in dogs.

Subject to the successful completion of these studies, Newron has agreement with the FDA that it may commence its proposed Phase III clinical trial program with evenamide for patients with schizophrenia experiencing worsening of psychosis on atypical antipsychotics, and for treatment-resistant patients not responding to clozapine. Clozapine is the only antipsychotic approved worldwide for treatment-resistant schizophrenia.

Newron is currently evaluating potential options for partnering/co-developing the further development of evenamide.

Pipeline

In addition, Newron is in advanced evaluation of a select number of opportunities to broaden its pipeline of novel therapies for patients with diseases of the central and peripheral nervous system. The market will be updated upon successful completion of any of the ongoing discussions.

Xadago®/safinamide

The Company reports that progress has been made in discussions with Newron’s partner Zambon relating to the performance of a potentially pivotal efficacy study to evaluate the effects of Xadago®/safinamide in patients with Parkinson’s disease levodopa-induced dyskinesia (PD LID). The study would be performed in the US, Europe and Asia/Australia. Zambon has acknowledged Newron’s experience in the development of Xadago in patients with Parkinson’s disease and agreed that Newron should be the party responsible for conducting the study, Zambon will remain associated with the study. Once discussions should be successfully completed, Newron will submit the final study design to the key regulatory authorities for approval and start preparations towards initiation of the study.

Financials

Newron´s total available funds including the EIB loan funds not yet drawn, complemented by its royalty income and Italian R&D tax credits, will cover the pursuit of Newron’s development programs and operations, as currently contemplated, well into 2022.

Conference call

Newron management will hold an international conference call today, August 11, 2020, 3:00 PM CET, 9:00 AM ET to provide an update and to answer questions.
 
Per me il raddoppio delle quotazioni in soli 2 giorni dipende dall'effetto Relief Terapeutics (crescita impetuosa negli ultimi giorni, salvo oggi perdere il 50%).
La notizia di oggi in tempi normali avrebbe fatto scendere il titolo, invece si sale.
Io sono fuori e resto alla finestra, troppo lontano l'inizio della fase III dell'Evenamide.
 
Mi piacerebbe sapere chi ha comprato nei giorni scorsi sino a 3,30 chf. Saranno solo speculatori (che hanno fallito) o dei lungimiranti investitori ?
L'inizio previsto della fase III dell'Evenamide è previsto per il secondo trimestre 2021, ma sappiamo benissimo che alla Newron non rispettano mai i tempi. Mi domando anche se i soldi in cassa saranno sufficienti per finanziare la fase III, o se si dovrà ricorrere ad un aumento di capitale, con relativa diluizione. Insomma, io sono fuori e ci resto sino a quando tutte queste cose non saranno chiarite.
 
ciao io ti leggo sempre....non mi informo mai su questo titolo ma ho piacere leggere i tuoi commenti...io sono dentro a 9 .....dopo aver fatto entrate e uscite quando era a 30 ....ora le ho lo e aspetto. non abbandonare 👋
 
Ciao Derrik, purtroppo io non ho altre fonti di informazione, se non i comunicati stampa ufficiali della Newron.
Al momento sono fuori e aspetto un mio personale target per rientrare; purtroppo per me, la fiammata dei giorni scorsi ha scombussolato i miei piani; ora dovrò come minimo aspettare molto di più. Certo che i sogni di gloria di un tempo sono svaniti, ora punto solo ad una quotazione decente grazie alle vendite dello Xadago.
 
io non posso uscire ....devo attendere sperando in una risalita.....come ti dicevo non stancarti di postare ....💪
 
Non ne vuole proprio sapere di scendere sotto i 2 chf.
Quado volevo che salisse, scendeva; ora che voglio che scenda, sale.
Io resto comunque in attesa del mio prezzo di ingresso prefissato.
 
Sembra che il supporto a 2 chf sia stato sconfitto.
Davvero un gran brutto titolo.
 
E' una dura lotta quella che si sta combattendo a ridosso dei 2 chf; quando sembra scendere negli abissi, ha un sussulto, quando sembra risalire, ridiscende. Io sono in posizione di avvoltoio, pronto a gettarmi sulla carcassa di Newron, cioè quando diverrà una penny stock.
Forza venditori fatela scendere, io vi aspetto a braccia aperte al mio prezzo.
 
Niente da fare, non ne vuole proprio sapere di scendere. Sembra che ci sia qualcuno che sostiene la quotazione. All'annuncio del fallimento del Sarizotan il prezzo scese sotto il franco; mi aspetto che lo rifaccia.
 
Milan, Italy, September 15, 2020 – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational progress for the half-year ended June 30, 2020.

Highlights:

Evenamide (Schizophrenia)

All evenamide pre-clinical studies requested by the US Food and Drug Administration (FDA) completed with no toxicity concerns identified
First clinical safety study initiated despite industry wide delays caused by COVID-19
Newron on track to initiate its pivotal Phase III program in 2021
Newron currently evaluating potential options for partnering/co-developing evenamide
Xadago®/safinamide (Parkinson’s disease)

Newron noted Supernus Pharmaceuticals’ acquisition of US WorldMeds’ CNS portfolio, including the US rights to Xadago®/safinamide, effective June 2020
Progress made in plans to perform the levodopa-induced dyskinesia (PD LID) study with Xadago
Zambon previously held discussions with the FDA on the design of a potentially pivotal efficacy study to evaluate the effects of Xadago®/safinamide in patients with PD LID
Intention is to perform the study in the US, Europe and Asia/Australia
Zambon acknowledges Newron’s experience in the development of Xadago in patients with Parkinson’s disease; discussions to have Newron as the party responsible for conducting the study; Zambon will remain associated with the study
Financial terms to stay unchanged
Sarizotan (Rett syndrome)

Newron terminated development program, after the Sarizotan Treatment of Apneas in Rett Syndrome (STARS) clinical study did not demonstrate evidence of efficacy on the primary or secondary efficacy variables
Company to share learnings from the Rett Syndrome International Burden of Illness study, and is evaluating passing on the study to another pharmaceutical company for completion
Corporate

Newron received third tranche of EUR 7.5 million under financing agreement with the European Investment Bank (EIB)
In light of COVID-19 pandemic, Newron reiterated its commitment to health and safety of patients, caregivers and employees
Newron is evaluating opportunities to broaden its pipeline of treatments for central and peripheral nervous system diseases
Stefan Weber, Newron’s Chief Executive Officer, commented:

“The first half of 2020 has presented some obstacles, but we move forward excited by our current pipeline of novel drugs and are confident in our ability to advance these through the clinic and improve their positioning in the market. We look forward to progressing towards our Phase III clinical program, evaluating evenamide in schizophrenia, to complete preparations towards the new label study with Xadago, and to potentially broaden our central nervous system pipeline. Newron's total available funding, including the EIB funds not yet drawn down, in addition to our royalty income and Italian R&D tax credits, will fund the Company’s planned development programs and operations well into 2022.”

Evenamide

In January 2020, Newron reached an agreement with the US FDA on the design and conduct of additional short-term pre-clinical explanatory studies with evenamide, as well as the protocol for a first, four-week safety study in patients with schizophrenia. The requested pre-clinical studies have already been successfully completed, with no toxicity issues reported.

Despite anticipated delays associated with COVID-19, Newron has initiated the first clinical safety study, an explanatory four-week randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, EEG effects and preliminary efficacy of two fixed doses of evenamide in outpatients suffering from chronic schizophrenia receiving treatment with a second-generation atypical antipsychotic. Newron intends to recruit approximately 120 patients. Patient recruitment is progressing well at sites in the US and India, with more than 75 patients enrolled, and contingent on no further COVID-19 restrictions, results from the study are currently expected in Q1 2021.

Together with the pre-clinical results confirming absence of toxicity that have been submitted to the FDA, the extensive explanatory study package should deliver robust, convincing clinical data to proceed with the next, pivotal phase of clinical development. Newron remains confident that it is on track to initiate the Phase III studies with evenamide in Q2 2021.

In key territories, the Company continues to expect to commercialize evenamide itself in the treatment-resistant schizophrenia indication. For the indication of patients showing inadequate response to their current atypical antipsychotics and experiencing worsening of psychosis, Newron is currently evaluating potential options for partnering/co-development.

Xadago®/safinamide

In April 2020, we noted the agreement between US WorldMeds and Supernus Pharmaceuticals, under which Supernus intended to acquire US WorldMeds’ central nervous system (CNS) portfolio, including the US rights to Xadago®/safinamide. The transaction subsequently closed in June. Supernus’ focus is the development and commercialization of products for the treatment of CNS diseases.

Newron progresses in the plans to perform the LID study with Xadago: Zambon had previously held discussions with the FDA on the design of a potentially pivotal efficacy study to evaluate the effects of Xadago®/safinamide in patients with PD LID. The intention is to perform the study in the U.S., Europe and Asia/Australia.

Zambon acknowledges Newron’s experience in the development of Xadago in patients with Parkinson’s disease and there have been discussions to have Newron as the party responsible for conducting the study. Zambon will remain associated to the study. Financial terms will stay unchanged: Newron will make a fixed financial contribution to the study, in return for a one-time milestone payment and a greater share of royalties should the study lead to a label extension.

Sarizotan

Unfortunately, in May 2020 Newron announced that the Sarizotan Treatment of Apneas in Rett Syndrome (STARS) study did not demonstrate evidence of efficacy on the primary or secondary efficacy variables. The study was well-designed and executed, based on highly promising data from a genetic model of Rett syndrome in mice. The results of the study demonstrate the inherent difficulties in translating effects in animal models, even if genetic, to human clinical studies. As a consequence, Newron has decided to terminate this development program. However, as part of its long-time commitment to the Rett syndrome community, the Company is evaluating how to share the learnings from the Rett Syndrome International Burden of Illness study (potentially by passing on the study to another pharmaceutical company for completion).

Financials:

For the first six months of 2020, Newron reported a net loss of EUR 10.5 million, compared to EUR 14.0 million in the same period in 2019. The reduction is mostly due to the termination of the sarizotan development program in Rett syndrome.
Cash used in operating activities has decreased to EUR 7 million from EUR 14.7 million in 2019.
Xadago® revenues received from Zambon increased by 12.4% (EUR 2.5 million versus EUR 2.2 million in 2019).
Newron’s R&D expenses declined to EUR 7.8 million from EUR 10.3 million in 2019.
G&A expenses were EUR 4.4 million in the first six months of 2020 versus EUR 5.9 million in 2019.
Cash and Other current financial assets at June 30, 2020 were at EUR 39.4 million, compared to EUR 39.2 million at the beginning of the year.
 
Dunque lo Xadago fattura 2,5 milioni di € a semestre, molto meno di quanto previsto.
Il Sarizotan, dopo il fallimento, lo si vorrebbe cedere ad un'altra Biotech.
L'Evenamide passerà in fase clinica III a nostre spese, dato che proprio non riescono a trovare un partner per pagare gli studi.
 
Sono rimasto solo a scrivere, ma ci sono più di 700 lettori ogni mio post, direi che non sono proprio solo.
Comunque l'azienda esiste ancora e non si sa mia che l'Evenamide abbia successo.

700 persone che leggono anche me....
Chiaramente c'è gente che entra nel forum per sapere se c'è qualcuno che ne capisca qualcosa e che metta dei post utili.
Ma al di là di alcune news ufficiali della Società tra dottori o speudodottorini ho letto veramente poco d'interessante.

Però mi hanno fatto sempre tenerezza i tuoi commenti da innamorato tradito...

E momenti di comicità assoluta con Dollardollar....
 
Però mi hanno fatto sempre tenerezza i tuoi commenti da innamorato tradito...


Pensa che avevo già fatto conto che, grazie al Sarizotan, sarei potuto andare in pensione in anticipo di qualche anno. Altro che innamorato tradito, è stata una mazzata incredibile. Ora non ho più azioni Newron; se dovessero scendere sotto l'euro allora divento compratore.
 
Ma perché non scende ?
Le borse crollano e lei fa solo u misero -1%.
Cosa si aspettano a breve i compratori ?
Solo l'Evenamide è ancora in grado di dare una grossa spinta alle quotazioni, ma ce ne vorrà parecchio di tempo prima che, se tutto andrà bene, darà i suoi effetti.
 
Temo che dovremo attendere a lungo prima che l'Evenamide entri in fase clinica III;
faccio una stima di circa 5/6 mesi.
Anche per l'utilizzo dello Xadago per la discinesia i tempi non saranno brevi.
Insomma, a meno che non arrivi un'OPA, per mezzo anno saremo senza notizie di rilievo.
 
Pochi scambi e prezzo in lento calo. Disinteresse sull'azienda e sui suoi prodotti.
Io la aspetto sempre sotto un euro: vedremo se ci arriva.
 
Accidenti, quando ero azionista il prezzo scendeva a rotta di collo; adesso che sono fuori e che lo aspetto in basso, il prezzo tiene.
Il giorno del fallimento del Sarizotan era sceso sino a 0,90 chf; io lo aspetto li.
 
Periodo di movimento sull'azione Newron; io la aspettavo in basso e invece lei va verso l'alto.
Aspettiamo l'Evenamide e vediamo quanto fatturerà lo Xadago.
 
Il covid sta rallentando la tabella di marcia dell'Evenamide; i volontari hanno difficoltà a raggiungere gli ospedali e quindi le fasi propedeutiche al lancio della fase clinica III, sono in ritardo. Della serie, aspetta e spera.
 
Indietro