On Thursday, H.C. Wainwright reaffirmed a Buy rating and a $28.00 price target for NASDAQ:CGEM, Cullinan Oncology Inc., following the announcement that the FDA cleared the company's Investigational New Drug (IND) application. This clearance allows Cullinan to proceed with its global Phase 1 clinical trial for CLN-978, a promising new treatment for systemic lupus erythematosus (SLE).
Cullinan's CLN-978 is being developed as a potential first-in-class, off-the-shelf, subcutaneous treatment for autoimmune diseases, which may offer a differentiated safety profile. The company aims to address the needs of patients with moderate to severe SLE who have not responded adequately to at least two other treatments, including one immunosuppressive or biologic standard-of-care agent.
The global Phase 1 trial, which received Human Research Ethics Committee (HREC) approval in Australia on September 17, 2024, will enroll patients with a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of 8 or greater. The study is structured in two parts: Part A for dose escalation to identify the target dose and Part B for dose expansion to investigate various dose schedules.
The primary goal of the trial is to assess the safety of CLN-978 in treating active SLE, with secondary objectives including pharmacokinetics (PK), B-cell kinetics, immunogenicity, and preliminary efficacy. According to the CDC, over 160,000 people in the U.S. are affected by SLE, and Cullinan estimates the addressable U.S. patient population to be approximately 122,000. The company projects an over $11 billion market opportunity for the treatment of moderate to severe SLE patients in the U.S.
Cullinan Oncology's stock valuation currently does not include CLN-978, but the firm's reiterated Buy rating and $28 price target reflect confidence in the company's ongoing developments.
In other recent news, Cullinan Therapeutics has received FDA approval to proceed with Phase 1 clinical trials for its lupus drug candidate, CLN-978, in the United States. The company has also reported a lower-than-expected Q1 loss of $0.86 per share, beating the projected loss of $0.94. Analyst firms H.C. Wainwright and BTIG have reaffirmed their Buy ratings for Cullinan, with price targets of $28 and $30 respectively. Morgan Stanley has maintained an Overweight rating for the company, despite reducing its price target to $38.
Furthermore, Cullinan Oncology has presented promising clinical trial data for its drug zipalertinib, showing a 40% objective response rate in treating non-small cell lung cancer. This data has been supported by TD Cowen and H.C. Wainwright, both maintaining a Buy rating on the company.
In leadership changes, Cullinan Oncology has welcomed Mary Kay Fenton as its new Chief Financial Officer and elected Anne-Marie Martin, Ph.D., and David Meek as Class I directors to the Board.
InvestingPro Insights
Recent InvestingPro data provides additional context to Cullinan Oncology's financial position and market performance. The company's market capitalization stands at $1.02 billion, reflecting investor interest in its potential. Despite the promising developments with CLN-978, InvestingPro Tips indicate that Cullinan is not currently profitable, with a negative P/E ratio of -7.2 over the last twelve months as of Q2 2024. This aligns with the company's focus on research and development in the competitive oncology and autoimmune disease spaces.
Interestingly, Cullinan's stock has shown significant momentum, with an InvestingPro Tip highlighting a 95.23% price return over the past year. This substantial gain suggests strong market optimism about the company's pipeline, including the recently FDA-cleared CLN-978 program. Additionally, the company holds more cash than debt on its balance sheet, which could provide financial flexibility as it advances its clinical trials.
For investors seeking a deeper understanding of Cullinan Oncology's potential, InvestingPro offers 8 additional tips that could inform investment decisions in this dynamic biotech stock.
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