Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 21)

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Kann man hier noch einsteigen? Was meint ihr?

[Ville7]

Antwort auf Beitrag Nr.: 55.460.322 von 123fly am 04.08.17 16:31:37

Nein, SPI-2012 heißt inzwischen ROLONTIS.

[123fly]

Antwort auf Beitrag Nr.: 55.460.226 von Ville7 am 04.08.17 16:23:46

Hallo Ville7

Danke für die hilfreiche Antwort. Bin auch überhaupt noch dabei, weil ich bei Kauf die Pipeline vielversprechend fand. In erster Linie SPPI2012. Bin aber im Nachhinein zu früh eingestiegen. Habe aber die Firma gar nicht mehr aktiv verfolgt, da beim Tiefpunkt um die 3 Dollar ich faktisch nur noch mit relativ wenig drin war.

Ist denn poziotinib der vermarktete Name von SPPI2012?

[Ville7]

123fly, es wird sich ändern...tut es ja auch schon seit Monaten. big money positioniert sich hier bereits, da es vielleicht hier was zu holen gibt...

Im September ist m.E. bereits zweistellig möglich - Stichwort ESMO 2017. Wenn alles gut geht nächstes Jahr noch weit höher.

Spectrum hat mit poziotinib einen potentiellen Winner im Depot, der nächstes Jahr breakthrough therapy status bekommen könnte - für exon 20 Mutationen in Lungenkrebs. Zudem wird Hamni auf ESMO 2017 Anfang September wahrscheinlich hervorragende Daten von poziotinib in Brustkrebs präsentieren - die Präsentationskategorie ist mit "proffered paper" die zweithöchst mögliche und die gibts nur bei hervoragenden Daten. Dazu noch Rolontis. Also in 2019 könnte Spectrum zwei Medikamente auf den Markt bringen, jedes davon mit Pontential von mehreren 100 Millionen USD im Peak. Wenn das so kommt ist eine Bewertung der Börse wie aktuell natürlich viel zu niedrig.

Kann mich aber wie immer auch irren. Wir werden sehen...

[123fly]

Antwort auf Beitrag Nr.: 55.458.294 von Ville7 am 04.08.17 12:27:01

Meine älteste Depotleiche erwacht zu neuen Leben, nach Jahren steh ich sogar wieder im Plus

Daran hätte ich ja selber kaum mehr gedcht

Was genau steht im Bericht, dass wir so steigen? Hab irgendwie nicht mal mehr Lust das selber zu lesen, die Aktie war mir so egal. Vielleicht ändert sich das ja bald.

[Ville7]

> +20% heute, wahrscheinlich eine Menge Momentum ab jetzt bis in 2018 rein und keiner dabei

...so gefällt mir das.

[Ville7]

expected newsflow ( (c) Ville ):

2017-09-09 11:00 - 12:30: poziotinib Hanmi Her2 BC trial "proffered paper" presentation at http://www.esmo.org/Conferences/ESMO-2017-Congress in Madrid

2017-10-15 - 2017-10-18: pozitinib EGFR/HER exon20 single agent "initial clinical data" from MD Anderson trial at http://wclc2017.iaslc.org/ in Yokohama

Q3 2017: Start ROLONTIS RECOVER trial (218 patients)

Q3 2017: Start QAPZOLA trial 8mg 2:1 (425 patients)

Q3 2017: Start SPPI sponsored multicenter trial pozitinib EGFR/HER exon20 single agent

Q1 2018: Enrollment completion for ROLONTIS RECOVER trial

Q1 2018: Topline Data for ROLONTIS ADVANCE trial (405 patients)

Q1 2018: Try to get "breakthrough designation" for pozitinib in EGFR/HER exon20 NSCLC on basis of MD Anderson trial

Q2 2018: Data for ROLONTIS ADVANCE trial at ASCO

Q3 2018: Topline Data for ROLONTIS RECOVER trial

Q4 2018: File BLA for ROLONTIS on basis of ADVANCE and RECOVER

[Ville7]

Cash-Situation: Ende Q2 2017: $138.6 million + Verwässerung $23.7 million im Juli 2017 = ca. $160 million

Cashburn je Quartal ca. $20 million

Firma wird versuchen Cashbestand stets über $100-$120 million zu belassen (wegen debt, das 2018 fällig ist). D.h. weitere Verwässerungen absehbar.

[Ville7]

August 3, 2017
Spectrum Pharmaceuticals Reports Second Quarter 2017 Financial Results and Pipeline Update
ROLONTIS™ (eflapegrastim):
BLA filing expected next year.
Enrollment completed in registrational ADVANCE Study under a Special Protocol Assessment (SPA) with the FDA. Topline results expected in Q1 2018.
A second smaller study RECOVER is enrolling patients in EU and U.S. Enrollment completion expected in Q1 2018.
Poziotinib:
Interim results are expected before year end from an ongoing Phase 2 study in non-small cell lung cancer patients with exon 20 insertion mutations in EGFR or HER2. This study is being conducted at The University of Texas MD Anderson Cancer Center.
Following discussions with the FDA, the Company is initiating an additional multicenter clinical trial to expedite the development of poziotinib in this patient population.
Financials:
Q2 revenues were $34.3 million, including $31.2 million in product sales.
FOLOTYN® (pralatrexate injection) was recently approved in Japan and the Company expects multiple related milestone payments totaling approximately $5 million from Mundipharma in the second half of the year.
HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today financial results for the three-month period ended June 30, 2017.

"During the second quarter we made significant progress in our highest priority clinical programs and achieved solid performance across our commercial business," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "We completed enrollment in ROLONTIS's ADVANCE registrational Phase 3 study ahead of schedule and enrollment in a second international study RECOVER is well under way in Europe and U.S. We are also very excited about the prospects of poziotinib in cancer patients with exon 20 insertion mutations and expect interim results from the Phase 2 lung cancer study before the end of the year. We are driven to bring our novel drugs to patients with unmet medical needs and look forward to multiple near-term development catalysts that could shape the Company's future."

Pipeline Update:

ROLONTIS (eflapegrastim), a novel long-acting GCSF: A registrational Phase 3 study ADVANCE was initiated under an SPA with the FDA last year to evaluate ROLONTIS in the management of chemotherapy-induced neutropenia. The Company has completed enrollment in the ADVANCE study with 405 patients randomized and expects to report topline data in Q1 2018. To strengthen the regulatory package in the Europe and U.S., the Company is currently enrolling the 218-patient international RECOVER study. The Company continues to expect to file the BLA next year.
Poziotinib, a potential best-in-class, novel, pan-HER inhibitor: An investigator sponsored trial is currently enrolling at the University of Texas MD Anderson Cancer Center in non-small cell lung cancer patients with exon 20 insertion mutations in EGFR or HER2. The study is expected to yield interim results before year end. Following discussions with the FDA, the Company is initiating an additional multicenter study in a similar patient population. Spectrum is also conducting a Phase 2 breast cancer study in the third-line setting in the U.S., based on promising Phase 1 study efficacy data in breast cancer patients who had failed multiple HER2-directed therapies. The Company is in discussions with the FDA about a combination trial of poziotinib and standard of care therapy in HER2+ breast cancer patients in the second-line setting.
QAPZOLA™, a potent tumor-activated drug for bladder cancer is being investigated for low and intermediate risk non-muscle invasive bladder cancer: The Company has an SPA from the FDA for a new Phase 3 study incorporating learnings from the previous studies, as well as recommendations from the FDA. Compared to the previous program, this new Phase 3 study will include fewer evaluable patients (n=425 versus 1,557 patients), use a higher dosage of QAPZOLA (8 mg versus 4 mg), and will evaluate time-to-recurrence as the primary endpoint. Approximately 50 sites have been selected thus far for enrolling patients in the Phase 3 study and patients are currently being screened.
Three-Month Period Ended June 30, 2017 (All numbers are approximate)

GAAP Results

Total product sales were $31.2 million in the second quarter of 2017. Product sales in the second quarter included: FUSILEV® (levoleucovorin) net sales of $2.1 million, FOLOTYN® (pralatrexate injection) net sales of $11.2 million, ZEVALIN® (ibritumomab tiuxetan) net sales of $2.3 million, MARQIBO® (vinCRIStine sulfate LIPOSOME injection) net sales of $2.2 million, BELEODAQ® (belinostat) for injection net sales of $3.4 million, and EVOMELA® (melphalan) for injection net sales of $10.1 million.

Spectrum recorded a net loss of $20.5 million, or $0.26 per basic and diluted share in the three-month period ended June 30, 2017, compared to a net loss of $24.3 million, or $0.35 per basic and diluted share in the comparable period in 2016. Total research and development expenses were $15.1 million in the quarter, as compared to $14.3 million in the same period in 2016. Selling, general and administrative expenses were $17.1 million in the quarter, compared to $27.6 million in the same period in 2016.

Our June 30, 2017 cash and equivalents balance is $138.6 million. In July 2017, we sold and issued 3.2 million shares of our common stock for net proceeds of $23.7 million under our ATM. These shares and proceeds are not included in our June 30, 2017 financial statements. We have now fully utilized the ATM facility.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $8.6 million, or $0.11 per basic and diluted share in the three-month period ended June 30, 2017, compared to non-GAAP net loss of $3.7 million, or $0.05 per basic share and diluted share in the comparable period in 2016. Non-GAAP research and development expenses were $14.6 million, as compared to $12.9 million in the same period of 2016. Non-GAAP selling, general and administrative expenses were $14.5 million, as compared to $16.1 million in the same period in 2016

[Ville7]

Erste Daten ("initital clinical data") zum NSCLC exon 20 (HER/EGRF) Trial in mit poziotinib sind in 71 Tagen hier zu erwarten ("oral presetantion"):

http://wclc2017.iaslc.org/

findet vom 15.-18.Oktober 2017 in Yokohama statt.

June 21, 2017
Abstract Submission Deadline

July 26, 2017
Abstract Notifications

August 4, 2017
Early Registration Deadline

August 31, 2017
Regular Registration & Housing Deadline

August 31, 2017
Late Breaking Abstract Submission Deadline