Spectrum Pharmaceuticals - Chancen und Risiken? (Seite 11)

[DomRuinart]

Da ist aber jemand optimistisch:

Spectrum: Still Opportunistic But Laser Focused

Jun. 21, 2019 4:46 PM ET

Summary

In the late 2000s, Spectrum captured the heightened demand of leucovorin shortage with Fusilev. This benefits patients while conferring shareholders one of the most prosperous periods in the company's history.

After the new CEO (Joseph Turgeon) took the helm, the Chief removed the distractions from the product portfolio and thereby devotes corporate efforts on ensuring Rolontis and poziotinib's success.

Cohort 1 of the ZENITH trial studying poziotinib will report results by year end. It'll prompt a filing for accelerated approval for non-small cell lung cancer with Exon 20 mutation.

A notable investment theme is that a company rarely stays stagnant while growth tends to occur in spurts. This phenomenon is best illustrated in a young growth story like Spectrum Pharmaceuticals (SPPI). After years under the leadership of Dr. Rajesh Shrotriya, Spectrum shifted gears to be highly focused on advancing its late-stage medicines. At the same time, the company planted the seeds for future growth ahead. Accordingly, the lagging product portfolio was sold for a significant sum to fund further pipeline innovation. Having a strong balance sheet, Spectrum then purchased the FIT platform technology. Meanwhile, two flagship molecules (Rolontis and poziotinib) are advancing into their late stage. Amid strong catalysts, I'll present a fundamental update on Spectrum and provide my expectation on this opportunistic growth stock.

About The Company
As usual, I'll deliver a brief corporate overview for new investors. If you are familiar with the firm, I suggest that you skip to the subsequent section. Headquartered in Henderson Nevada, Spectrum is focused on the innovation and commercialization of therapeutics to serve the strong unmet need in oncology. Though the former and respectable CEO (Dr. Rajesh Shrotriya) left, Spectrum is still leveraging his "opportunistic growth" approach, but the company is trying to take it to the new height.

Instead of growing linearly, growth occurs in a series of spurts like certain flowers that bloom periodically with rain. For instance, Dr. Raj realized the opportunity during the leucovorin shortage in the late 2000s and thereby launched an aggressive campaign with Fusilev. Asides from alleviating the drug shortage for countless patients afflicted by cancers, Fusilev delivered great fortunes to shareholders.

New Growth Trajectory
Shifting gears, Spectrum is now run by the new Chief (Joseph Turgeon). In his new role, it seems that Mr. Turgeon still employs the opportunistic growth strategy. Be that as it may, Turgeon is laser focused. In focusing on a few things with great potentials, Turgeon positioned the company to potentially enjoy glorious success. That being said, he divested seven drugs to raise cash for other promising opportunities. After all, he must have realized the meager growth prospect of the commercialized portfolio.

Since the balance sheet is fattened with cash, Spectrum strategically in-licensed the FIT technology from the University of Los Angeles (UCLA) to innovate novel oncology medicine. As a fusion of antibody with interferon, FIT has wide applications against many cancers. Notably, Spectrum is investigating FIT medicines for two oncology indications (non-Hodgkin lymphoma and blood cancer) in a Phase 1 trial.

In a nutshell, the aforesaid growth strategy is like planting a series of gardens. It allows the reaping of fruits from mature trees to nurture other seedlings. As the advanced pipeline assets (Rolontis and poziotinib) progress into approval, there will be organic cash flow to support the development of early-stage FIT molecules.

Financial Assessment
Just as you would get an annual physical exam for your well-being, it's important to check up on the financial health of your stock. For instance, your health is affected by "blood flow" as your stock's viability is dependent on the "cash flow." With that in mind, I'll analyze the 1Q2019 earnings report for the period that ended on March 31. Since Spectrum sold its commercialized portfolio, there are no revenues. This is in-line within the industry norm, in which a young bioscience company without an approved medicine is not expected to deliver any sales. Therefore, let's check other more meaningful metrics.

As follows, the research and development (R&D) registered at $21.9M compared to $13.4M for the same period a year prior, thus representing a 63.4% year-over-year (YOY) increase. I believe that the higher R&D is attributed to the advancement of poziotinib in ZENITH as well as the spending committed to the new FIT program. I generally view an R&D increase positively because the money invested today can translate into blockbuster profits in the future. You have to plant a tree today in order to enjoy its fruits.

That aside, there was $39.8M ($0.36 per share) net loss versus $19.2M ($0.19 per share) decline for the same YOY comparison. On a per share basis, this underlies an 89.4% bottom line depreciation. The widening net loss is mostly due to the advancement of pioziotinib and higher R&D.

Pertaining to the balance sheet, there were $309.2M in cash, equivalents, and investments, thus signifying a 51.6% increase from $203.9M last year. The strong cash position stemmed from the divestiture of the commercialized portfolio. Based on the $37.8M quarterly operating expense (OpEx) rate, there is an aplenty of capital to fund operations into 1Q2021 prior to the need for additional financing. Hence, the chance of a near-term public offering is minimal.

Though I do not mind a public offering, it's important for you to determine if you are holding "serial diluter." A firm that uses dilution as a "cash cow" will render your investment essentially worthless. As the shares outstanding increased from 109.5M to 100.8M for Spectrum, my rough arithmetics yield the remarkable 8.6% dilution. At this rate, Spectrum easily cleared my 30% dilution cutoff for a profitable investment. And, it entails a company that is operating quite "lean."

Potential Risks
Since investment research is an imperfect science, there are always risks associated with a thesis regardless of its strength. At this point, in its growth cycle, the main risk for Spectrum is if poziotinib can generate positive clinical outcomes in ZENITH. Despite that, I ascribed a 65% (more than favorable) chance of success, there are still 35% odds of a negative clinical binary.

That aside, there is the concern that Rolontis might not gain FDA approval. I'm still puzzled as to why it takes Spectrum so long to file a BLA. If I have to make an educated guess, it's likely that there is a temporary issue with the new management. After all, the Phase 3 results for Rolontis are stellar. And, it's been a while since Rolontis' data was posted. The other concern is that FIT platform might not deliver positive clinical outcomes. In case of a negative clinical or regulatory binary, it's quite likely that the stock will tumble over 50% and vice versa.

Conclusion
In all, I maintain my strong buy recommendation on Spectrum Pharmaceuticals with the five out of five stars rating. In refocusing on growth, Spectrum got rid of its product portfolio. This allows the company to devote its efforts to the cream of the crops molecules (poziotinib and Rolontis). As 4Q2019 rolls in, I expect robust data for Cohort 1 of the ZENITH trial. The strong prior data should translate into more positive results. As a ramification, it'll enable the company to file for an NDA for accelerated approval of poziotinib for NSCLC with Exon 20 mutation. Furthermore, Cohort 2 has a very good chance of delivering excellent results to enable growth by label expansion. That aside, Rolontis will add more flavor to this cake. And, FIT medicines can take this story to an unprecedented high.

Quelle: Seeking Alpha

[DomRuinart]

Double Bottom mit Dezember-Tief confirmed!

[DomRuinart]

Keine schlechte Ergänzung:

Spectrum Announces Asset Purchase and License for a Novel Immuno-Oncology Platform including Two Early Stage Assets

May 9, 2019 at 7:00 AM EDT

· The Focused Interferon Therapeutics (FIT) platform is a proprietary targeted antibody-interferon fusion technology with potential broad application in oncology

· This asset purchase adds two innovative early-stage drug candidates to Spectrum’s existing pipeline and advances the oncology strategy

HENDERSON, Nev.--(BUSINESS WIRE)--May 9, 2019-- Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today the closure of an asset purchase and license agreement with ImmunGene, Inc., a privately held biotechnology company. The deal includes an exclusive license for the intellectual property related to the FIT antibody-interferon fusion technology drug delivery platform originally developed by scientists at UCLA.

The license also includes two novel assets derived from this platform. The first asset is an antibody-interferon fusion molecule directed against CD20 (Anti–CD20-IFNα). This drug candidate is in Phase 1 development for treating relapsed or refractory non-Hodgkin lymphoma, including diffuse large b-cell lymphoma patients where a considerable unmet medical need exists. Research for this program received financial support through the Therapy Acceleration Program® of The Leukemia & Lymphoma Society, Inc. (LLS), and an LLS research grant to UCLA. The second asset is an antibody-interferon fusion molecule directed against GRP94, a target for which currently there are no existing approved therapies. It has the potential for treating both solid and hematologic malignancies.

“The FIT platform that we’ve acquired today represents a new class of biotherapeutics which may have the potential to make the administration of an antibody-interferon fusion protein feasible and allows Spectrum to harness this powerful immune activating cytokine,” said Francois Lebel, M.D., F.R.C.P.C., Chief Medical Officer of Spectrum Pharmaceuticals. “In pre-clinical models, anti–CD20-IFNα has been shown to have significant proapoptotic activity. Anti–CD20-IFNα is essentially a 2-pronged attack whereby both CD20 and IFNAR signaling pathways can be activated to induce tumor cell apoptosis. Although IFNα has potent biologic activities against B-cell malignancies, its clinical utility has been curtailed by systemic toxicities. Preclinical results suggest that anti–CD20-IFNα fusion proteins have an improved therapeutic index, while still exhibiting the ability to eradicate tumor cells.”

Originally developed by scientists at UCLA and licensed to Spectrum by UCLA Technology Development Group, the FIT platform fuses interferon with various monoclonal antibodies targeting various tumor antigens. Interferons are highly potent and well-established anticancer cytokines but have been associated with significant dose-related side effects. The FIT technology may be able to maintain the potency and efficacy of interferon while reducing toxicity traditionally associated with interferon therapy. FIT therapies have potential application as single agents or in combination with other therapies, such as checkpoint inhibitors.

“Adding a promising platform and two early stage assets is consistent with our commitment to serving the needs of cancer patients by developing innovative drugs for unmet need,” said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. “We are aggressively building a robust oncology pipeline anchored by our late-stage assets, poziotinib and ROLONTIS.”

Under the terms of the agreement, Spectrum will pay an upfront cash payment of approximately $3 million, up to $156 million in development and sales milestones, and royalties on net sales in the high-single digits.

About Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals is a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted drug products, with a primary focus in hematology and oncology. Spectrum has a strong track record of successfully executing across the biopharmaceutical business model, from in-licensing and acquiring differentiated drugs, clinically developing novel assets, successfully gaining regulatory approvals, and commercializing in a competitive healthcare marketplace. Spectrum has a late-stage pipeline with novel assets that serve areas of unmet need. This pipeline has the potential to transform the company in the near future.

About UCLA Technology Development Group

UCLA Technology Development Group (TDG) serves as a campus-wide gateway to Innovation, Research and Entrepreneurship. TDG promotes UCLA innovation, research, teaching and entrepreneurship to benefit society, creates economic value to support UCLA’s scholarly and educational missions and the State of California, and leads UCLA’s research community to bring innovation to market.

Quelle: Spectrum Pharmaceuticals, Inc.

[DomRuinart]

Zweiter Versuch

Habe die ja schon einmal empfohlen...und musst seit dem ganz schön bluten. Ich glaube jedoch weiterhin an ein gewaltiges Potential in den beiden Hauptprodukten POZIOTINIB in Phase 2 und noch mehr in ROLONTIS zur Behandlung von durch Chemotherapy verursachte Neutropenie in Phase 3.

Seit Februar haben einige institutionelle ganz schön aufgesattelt (SG Americas, Los Angeles Capital Mgt,BNP Paribas und Tibra Equities). Am 09. Mai kommen die Zahlen für das erste Quartal, bin mal gespannt...zu Jahresbeginn hatten die noch 200 Mio$ cash, im März haben Sie ihre 6 fertigen Medikamente für 150 Mio $ verkauft, also gehe ich mal davon aus, das die jetzt über 300 Mio $ cash haben dürften... denke hier noch vor dem 9. Mai wieder einzusteigen könnte eine gute Idee sein...

[Gustl24]

Antwort auf Beitrag Nr.: 59.120.141 von Gustl24 am 02.11.18 08:00:33

Zitat von Gustl24: ...wurde ja im ihub Board schon diskutiert, ein Einstieg bei 12$ erschien mir jetzt sinnvoll...

Oooh, zum Glück Depot im Bärenmarkt schon vor Tagen bereinigt und glattgestellt...very Bad news!
Nun heißt es warten bis Ende 2019 oder 2020...Kurs massiv eingebrochen a.h.

[Gustl24]

Antwort auf Beitrag Nr.: 59.077.580 von vanville am 28.10.18 15:24:53

...wurde ja im ihub Board schon diskutiert, ein Einstieg bei 12$ erschien mir jetzt sinnvoll...

[vanville]

Antwort auf Beitrag Nr.: 57.697.071 von Ville7 am 04.05.18 17:05:33

2 sites only, adding

Hi Ville,

Was denkst du denn nun darüber dass die sites alle verschwunden sind? Hat es damit vielleicht nur damit zu tun dass die Studie auf first line ausgeweitet wurde und die sites daher nur neu registirert werden müssen? Ich denke daher hat sich auch der primary completion date um 2 Jahre verschoben. Oder die haben BTD schon eingerechnet der jetzt nicht kommt? Du hattest ja unter 17 nochmal nachgelegt. Würdest du jetzt nochmal kaufen?

SPPI sucks.....

Grüße

[DomRuinart]

Einstiegschance

Ich denke nicht, dass die Reaktion auf die gestrige Präsentation (-22%) gerechtfertigt war. Ich wollte schon geraume Zeit auf den Zug aufspringen und sehe jetzt eine gute Einstiegschance…Kurserholung hat heute bereits begonnen. Ich halte die Daten für gar nicht schlecht und sehe weiter gewaltiges Potential in den beiden Hauptprodukten POZIOTINIB in Phase 2 und noch mehr in ROLONTIS zur Behandlung von durch Chemotherapy verursachte Neutropenie in Phase 3.

Spectrum Pharmaceuticals Announces Release of Updated Poziotinib Data From MD Anderson Phase 2 Study in Non-Small Cell Lung Cancer Patients Nachrichtenquelle: Business Wire (engl.) 24.09.2018, 17:40

Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced preliminary poziotinib data from the University of Texas, MD Anderson Cancer Center Phase 2 non-small cell lung cancer (NSCLC) study which were released today during an oral presentation at the IASLC 19th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer. The MD Anderson study is the single largest data set of patients with an exon 20 mutation in EGFR or HER2.

“There are currently no approved targeted therapies for this hard-to-treat population,” said John Heymach, M.D., Ph.D., Chairman and Professor, Department of Thoracic/Head and Neck Medical Oncology, University of Texas, MD Anderson Cancer Center. “For this reason, it is especially exciting to observe that poziotinib is highly active, with a manageable safety profile, in these heavily pre-treated patients. The study is ongoing with nineteen EGFR patients remaining on treatment, six of which have been on drug for longer than a year. Poziotinib may offer a much needed option to NSCLC patients with exon 20 mutations in EGFR or HER2.”

In the interim analysis presented at the WCLC, the following observations were made:

This phase II study demonstrates high anti-tumor activity for poziotinib in metastatic, heavily pretreated EGFR exon 20 mutant NSCLC, a group for which no targeted agents have proven effective to date (other than patients bearing T790M or S768I mutations) with best response of PR in 55% of evaluable patients (43% confirmed ORR to date; 19 patients remain on treatment).
Median PFS 5.5m; durable responses observed with 6 treated for >1year thus far.
Compares favorably to historical ORR rates of <8% approved TKIs and <19% for standard of care 2L agents (docetaxel, PD-1/PD-L1 inhibitors).
Significant activity also observed in HER2 exon 20-mutant NSCLC with initial responses observed in 50% (6/12) evaluable patients and median PFS 5.1m.
EGFR-related toxicities (including rash, diarrhea, & paronychia) were manageable and required dose reductions in 60%. Discontinuation due to poor tolerance was rare (3%).
Encouraging activity has prompted a confirmatory, international, multicenter study in EGFR and HER2 exon 20 mutant NSCLC patients which is currently enrolling (NCT03318939), including a first-line cohort, and development of a separate pan-tumor basket study.
The poziotinib NSCLC clinical program for patients with EGFR or HER2 exon 20 insertion mutations currently consists of a Phase 2 investigator-initiated study at The University of Texas, MD Anderson Cancer Center and a Phase 2 pivotal, Spectrum-sponsored, multi-center, global study (ZENITH20) with active sites in the United States and future centers planned in Canada and Europe. The overall poziotinib clinical development program is focused on four pillars, including previously treated NSCLC, first-line treatment of NSCLC, combination therapy and treatment of other solid tumors.

About Poziotinib Poziotinib is a novel, orally available Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. Spectrum received an exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize worldwide, excluding Korea and China. Poziotinib is currently being investigated by Spectrum and Hanmi in several mid-stage trials in multiple solid tumor indications.

[vanville]

short article

Hallo Ville,

Hast du das gelesen:

https://seekingalpha.com/article/4204232-spectrum-pharmaceut…

Afatinib in her2 exon20??? Was ist eure Meinung dazu? Vielleicht kannst du es zu antihama rüberstellen?

Grüße

[vanville]

FYI

http://mct.aacrjournals.org/content/molcanther/17/8/1648.ful…