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Expert Financial Analysis and Reporting

Post archive for ‘Company Reports’

Antares: Pipeline is Bursting with Late Stage Products (ATRS, $2.77, Buy)

Key Points: Antares has an impressive portfolio of seven new products that could lead to explosive growth over the next four years. I am projecting that revenues of five partnered products could increase from $17.0 million in 2016 to $142.0 million in 2021 (a nearly five fold increase) and that revenues from two wholly owned […]

Cytokinetics: A Look at the Clinical Trial Programs Underway (CYTK, Buy, $13.00)

The Investment Thesis Is Based on Three Drugs in Late Stage Development In partnership with Amgen, Cytokinetics has advanced omecamtiv mecarbil into phase 3 development for congestive heart failure; topline data is projected for January 2021. Without a partner, Cytokinetics has progressed tirasemtiv into a late phase 3 ALS trial; topline data is projected for […]

Cytokinetics: Estimating a Potential 2025 Price Target of $220 Based Only on the Potential for Tirasemtiv (CYTK, Buy, $13.00)

Key Points: Cytokinetics is likely to report results from the phase 3 VITALITY-ALS trial in early December 2017. I believe that this trial has a good chance of hitting the primary endpoint of sustained vital capacity (SVC) and gaining approval. The economic consequences for CYTK shareholders are enormous. In this report, I estimate a 2025 […]

Cytokinetics: Estimating a Potential 2025 Price Target of $172 Based Only on the Potential for Omecamtiv Mecarbil and Ignoring Tirasemtiv and CK-107 (CYTK, Buy, $13.00)

Key Points: Amgen and Cytokinetics have begun enrolling the phase 3 GALACTIC-HF trial of omecamtiv mecarbil in congestive heart failure (CHF). Topline data is not expected until January 2021. However, in the event of strong efficacy, the trial could potentially be halted at an interim look in 2020. Between now and then there will be […]

Kite Pharma: Analysis of Six Month Data from ZUMA-1 That Led to 40% Price Increase (KITE, Underperform, $72.53)

Report Preface In the event that you are unfamiliar with acronyms used widely in this report such as CAR-T, DLBCL, TFL, ORR, CR etc. I would suggest that before going further that you click on this link for definitions. I often put what I consider to be key points, the investment opinion and target price at the […]

Northwest Biotherapeutics and Agenus: What Are The Implications for These Companies in the Aftermath of Two Recent Cancer Vaccine Trial Failures? (NWBO, $0.38, Buy) (AGEN, $3.99, Buy)

Two Recent Cancer Vaccine Trial Failures Spurred this Report On February 22, 2017, Argos reported that the Data Monitoring Committee for the phase 3 ADAPT trial of its cancer vaccine AGS-003 in combination with Sutent in metastatic renal cell carcinoma recommended that the trial should be discontinued. Following an interim analysis, the DMC concluded that […]

Northwest Biotherapeutics: 8-K Document Released Today Provides New and Very Interesting Data on Patients Treated with DCVax-L. (NWBO, Buy, $0.48)

Substance of 8-K Regulatory Document Northwest issued an 8-K today in response to shareholders’ questions about an issue that has been raised due to some postings on message boards. Negative blogs have contended that NWBO has included the clinical data from 32 pseudo-progressors in the clinical data base of 331 patients enrolled in the phase […]

Northwest Biotherapeutics: Partial Clinical Hold on Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma is Lifted (NWBO, Buy, $0.45)

Key Points: Lifting of the partial hold removes a cloud that has been overhanging the Company for the past 18 months. We may see topline data on the phase 3 trial by mid-summer or possibly in a late breaker paper at ASCO in May. Linda Liau, principal investigator on the phase 3 trial, is encouraged […]

AMAG Pharmaceuticals: Will FDA Approve Makena SC (AMAG, Neutral, $21.75)

Importance of Makena SC to AMAG? AMAG is engaged in a high stakes clinical development program in which it is endeavoring to gain approval of a subcutaneous dosage form of its key drug Makena. Management has guided that sales of Makena reached $333 to $336 million in 2016 (about 63% of total sales) and issued […]

Cytokinetics: Discussion of Financing Deal with Royalty Partners (CYTK, Buy, $11)

Terms and Implications of This Deal Cytokinetics announced that it had concluded a deal to sell a portion of the future royalty stream on omecamtiv to Royalty Partners, perhaps the leading purveyor of this type of financial instrument. Omecamtiv is partnered with Amgen and recently entered the phase 3 GALACTIC HF trial which will enroll […]