On Thursday, Canaccord Genuity adjusted its price target for Clene Inc. (NASDAQ:CLNN) shares, reducing it to $83 from the previous $86, while reaffirming a Buy rating for the stock. This decision follows Clene's third-quarter earnings report released on Wednesday and a critical meeting with the FDA earlier in November to discuss the company's new drug application for CNM-Au8, a treatment for amyotrophic lateral sclerosis (ALS).
The analyst from Canaccord Genuity highlighted that the meeting with the FDA, which took place on November 1, 2024, was attended by all expected FDA representatives, but Clene has not yet characterized the outcome as they await written feedback. The minutes from the meeting are expected to be available 30 days post-meeting, which will likely act as a significant catalyst for the stock.
Clene's CNM-Au8 has shown promising data and has maintained a solid safety record, which has been recognized by experts. Despite the high unmet need in ALS treatment, the analyst acknowledged the difficulty in anticipating the FDA's decision. The company has enough cash to last until the first quarter of 2025, signaling a risk that Canaccord Genuity recognizes.
The analyst remains optimistic about the potential for Clene's stock, suggesting that the current price offers a chance for significant upside, especially if the FDA views Clene's data favorably. The firm maintains its Buy rating based on this potential, despite the lowered price target reflecting the acknowledged risks.
In other recent news, Clene Inc. has been making significant strides in the biopharmaceutical sector. The company recently secured approximately $7.3 million through stock and warrant sales. The funds are expected to support the clinical development of Clene's lead drug candidate, CNM-Au8, a potential treatment for amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS).
Clene has also modified its loan agreement with Avenue Venture Opportunities Fund, L.P., reducing the principal payment due in October 2024 from $3.33 million to $2 million. Moreover, the company has implemented a 1-for-20 reverse stock split, reducing the common stock from approximately 128.7 million shares to around 6.4 million shares.
In terms of analyst ratings, Clene Inc. has received Buy ratings from EF Hutton, and H.C. Wainwright, with price targets set at $86.00, $23.00, and $31.00 respectively. Clene's drug, CNM-Au8, has shown promising results in Phase 2 clinical trials for treating ALS and Rett Syndrome.
Lastly, Clene Inc. anticipates an in-person meeting with the FDA before the end of November to discuss the potential submission of a new drug application (NDA) for CNM-Au8 through the accelerated approval pathway. These are the recent developments for Clene Inc.
InvestingPro Insights
Recent InvestingPro data and tips offer additional context to Clene Inc.'s (NASDAQ:CLNN) current financial situation and market performance, complementing Canaccord Genuity's analysis.
According to InvestingPro, Clene's market capitalization stands at $38.38 million, reflecting its status as a small-cap biotech company. The company's revenue for the last twelve months as of Q2 2024 was $0.44 million, with a concerning revenue growth decline of -43.62% over the same period. This aligns with the InvestingPro Tip that analysts anticipate a sales decline in the current year.
Despite the optimism from Canaccord Genuity, InvestingPro Tips highlight that Clene is "quickly burning through cash" and "not profitable over the last twelve months." This corroborates the analyst's concern about the company's cash runway extending only to Q1 2025. The stock's recent performance has been challenging, with InvestingPro data showing a -18.17% return over the past week and a -44.91% return over the past year.
It is worth noting that InvestingPro Tips indicate that two analysts have revised their earnings upwards for the upcoming period, which could be related to the potential of CNM-Au8. However, analysts do not anticipate the company will be profitable this year, underscoring the speculative nature of the investment.
For investors considering Clene, it's important to note that InvestingPro offers 8 additional tips for CLNN, providing a more comprehensive analysis of the company's financial health and market position.
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