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On Tuesday, Leerink Partners made significant adjustments to their outlook on Affimed Therapeutics (NASDAQ:AFMD), a biopharmaceutical company trading at $0.69 per share. The stock has experienced a dramatic 87% decline over the past year, with a particularly steep 82% drop in the last six months. Analyst Diana Graybosch reduced the price target on Affimed shares to $0.39, a substantial decrease from the previous target of $5.00. Additionally, the firm downgraded Affimed’s stock rating to Market Perform from Outperform.
The downgrade by Leerink Partners was based on concerns about Affimed’s ability to secure necessary funding for the continuation of its clinical programs. According to InvestingPro data, while the company maintains more cash than debt on its balance sheet, it’s quickly burning through available funds, with negative free cash flow of $86 million in the last twelve months. The company has been actively seeking partners for eight months under the leadership of new CEO Shawn Leland but has yet to secure a strategic or financial partner for its three clinical innate cell engager programs. These programs include treatments for classical Hodgkin’s Lymphoma, non-small cell lung cancer, and acute myeloid leukemia.
Despite the clinical promise shown by these programs, Leerink Partners suspects that potential partners may find the clinical signals less compelling upon closer inspection or that the market opportunities for these treatments may not be substantial enough to warrant investment. These factors have contributed to the reduced confidence in the company’s prospects.
In addition to funding concerns, Leerink Partners also cited changes in the regulatory landscape as a reason for the downgrade. The new leadership at the FDA’s Center for Biologics Evaluation and Research (CBER) is perceived to lessen the likelihood of accelerated approval for cell therapies, including Affimed’s. There are also regulatory questions regarding the contribution of components to Affimed’s therapy regimens, which adds to the uncertainty surrounding the company’s future.
Affimed’s stock rating downgrade and price target reduction by Leerink Partners reflect a reassessment of the company’s ability to advance its clinical programs and bring its cell therapies to market amidst a challenging funding and regulatory environment. With a market capitalization of just $11.4 million and an overall "WEAK" financial health score from InvestingPro, the company faces significant challenges ahead. Subscribers to InvestingPro can access 12 additional investment tips and a comprehensive Pro Research Report for deeper insights into Affimed’s financial position and market prospects.
In other recent news, Affimed N.V. has reported significant findings from an analysis of its drug AFM24 for treating non-small cell lung cancer. The study revealed that patients with higher exposure to AFM24 had improved response rates and longer progression-free survival, with no additional safety concerns. Specifically, the objective response rate was 33.3% in the high-exposure group compared to 5.6% in the low-exposure group, while the median progression-free survival was 7.3 months versus 2.9 months, respectively. These findings were presented at the 2025 Annual Meeting of the American Association for Cancer Research, highlighting the potential of AFM24 in improving outcomes for patients with advanced NSCLC.
Additionally, Affimed has been notified by Nasdaq that its stock price has not met the minimum bid requirement for continued listing. The company has been given until October 13, 2025, to regain compliance with the Minimum Bid Price Rule. If compliance is not achieved within this period, Affimed may transfer its securities to The Nasdaq Capital Market, potentially gaining an additional 180 days to meet the requirement. Currently, this notice does not affect the listing or trading of Affimed’s common shares on Nasdaq, and the company is considering its options to address the bid price issue.
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