On Monday, H.C. Wainwright maintained a Buy rating and a $28.00 stock price target for NASDAQ:CGEM, Cullinan Oncology Inc., following the company's presentation of positive data at a recent medical congress. The data, which concerns the company's key drug candidate, zipalertinib, was showcased at the European Society for Medical Oncology (ESMO) Congress held on September 14, 2024.
The pivotal Phase 2b REZILIENT1 clinical trial's Module C showed encouraging results for zipalertinib, an oral EGFR inhibitor, in treating non-small cell lung cancer (NSCLC) with specific mutations. The drug has already received breakthrough therapy designation from the FDA for NSCLC patients with EGFR exon 20 insertion mutations who did not respond to platinum-based chemotherapy.
Cullinan Oncology, in collaboration with Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co (OTC:OTSKY)., is conducting the REZILIENT1 study. The focus of Module C is to assess the drug's effectiveness and safety in patients who have progressed after treatment with Rybrevant (amivantamab). The study's main goals are to measure the overall response rate (ORR) and the duration of the response (DOR).
As of March 29, 2024, the trial had successfully enrolled 45 patients, surpassing the expected completion by year-end 2024. These patients had undergone several prior treatments, including platinum-based chemotherapy and anti-PD1/L1 therapy, among others.
Out of 30 patients evaluated for response by the cutoff date, the trial reported one complete response, 11 partial responses, and 15 instances of stable disease, translating to an ORR of 40% and a disease control rate (DCR) of 90%. At this point, the DOR remains unestimable, but the reported median progression-free survival was 9.7 months.
The analyst's reiteration of the Buy rating and price target reflects the promising outcomes of the REZILIENT1 clinical trial and the potential impact of zipalertinib on the treatment of NSCLC.
In other recent news, Cullinan Therapeutics reported better-than-expected first-quarter earnings, with a loss of $0.86 per share compared to the projected loss of $0.94. The company also announced the submission of an Investigational New Drug (IND) application to the FDA for its lupus treatment candidate, CLN-978.
In addition, Cullinan Therapeutics has appointed Mary Kay Fenton as its new Chief Financial Officer, while Anne-Marie Martin, Ph.D., and David Meek have been elected as Class I directors to the Board. This comes alongside the ratification of KPMG LLP as the independent registered accounting firm for the fiscal year ending December 31, 2024.
In analyst news, Morgan Stanley (NYSE:MS) reduced its price target for Cullinan Oncology to $38, maintaining an Overweight rating. The firm anticipates updated initial data on zipalertinib REZILIENT1 at the European Society for Medical Oncology conference in September. H.C. Wainwright, on the other hand, slightly adjusted its full-year 2024 EPS estimate for Cullinan, maintaining a Buy rating but lowering the price target to $28.
Stifel initiated coverage on Cullinan Oncology with a Buy rating and a price target of $40.00, while BTIG maintained a Buy rating and raised its share price target to $30. These recent developments reflect the ongoing activity surrounding Cullinan Therapeutics.
InvestingPro Insights
Following the positive clinical trial outcomes for Cullinan Oncology's drug candidate, zipalertinib, and the subsequent Buy rating from H.C. Wainwright, investors might consider the financial health and market performance of NASDAQ:CGEM.
With a market capitalization of approximately $1.04 billion, the company holds more cash than debt on its balance sheet, which is a reassuring sign for investors concerned about financial stability. This aligns with one of the InvestingPro Tips, which underscores the importance of a company's ability to cover its short-term obligations with liquid assets.
On the other hand, the company's P/E ratio stands at -5.92, reflecting its current lack of profitability, a detail that is also highlighted by another InvestingPro Tip indicating that analysts do not expect the company to be profitable this year.
Despite this, Cullinan Oncology has experienced a significant return over the last year, with a year-to-date price total return of 76.15% and a 1-year price total return of 80.22%, showcasing substantial investor confidence and market momentum for the company's stock.
For investors seeking a deeper dive into Cullinan Oncology's financials and market performance, there are additional InvestingPro Tips available. These tips provide further insights that can help investors make informed decisions based on real-time data and expert analysis. Visit InvestingPro for a comprehensive list of tips to guide your investment strategy in companies like Cullinan Oncology.
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