On Friday, BTIG, a financial services firm, upgraded its stock price target for Spyre (NASDAQ: SYRE) to $40.00 from the previous target of $32.00, while maintaining a Buy rating on the stock.
This adjustment follows the completion of a 28-day GLP toxicology study in non-human primates (NHPs) for Spyre's drug candidate SPY001, which identified the highest dose tested as the no-observed-adverse-effect-level (NOAEL).
The company has also finished the chemistry, manufacturing, and control (CMC) activities for the program, keeping the Phase 1 trial initiation on schedule for the second quarter of 2024.
The updated preclinical data, which was presented at the European Crohn’s and Colitis Organisation (ECCO) 2024 conference, revealed that SPY001 has a half-life of approximately 22 days in NHPs. This is significantly longer than the ~6 days observed for vedolizumab, suggesting a potential threefold increase in half-life when compared to vedolizumab in humans.
The firm anticipates pharmacokinetic data from the ongoing healthy volunteer study by the end of 2024 to support a proposed dosing interval of every eight to twelve weeks (Q8W-Q12W).
In addition to SPY001, Spyre is developing SPY002, which has shown a half-life of about 24 days, indicating a two to three times increase compared to other clinical stage anti-TL1A programs. This supports a similar Q8W-Q12W dosing interval. Spyre plans to initiate first-in-human (FIH) studies for SPY002 candidates in the second half of 2024, with interim data expected in the first half of 2025 to guide further clinical development.
Spyre's preclinical efforts for SPY003, an IL-23 inhibitor focusing on the p19 subunit, are ongoing. The company aims to nominate a development candidate for SPY003 in mid-2024 and proceed to IND-enabling studies later in the second half of the year.
Spyre's unique position includes having in-house anti-α4β7, anti-TL1A, and anti-IL-23 targeted therapies, which are expected to have high potential in combination treatments for inflammatory bowel disease (IBD). Management has indicated that Phase 2 evaluations of these therapeutic combinations in IBD patients are planned to begin in 2025.
The financial update from Spyre indicated that as of the end of the first quarter of 2024, the company had $485.0 million in cash and equivalents. The funds are expected to be sufficient to support its operations into 2027.
The increase in the stock price target to $40 reflects a lowered discount rate to 15.0% from 17.5%, acknowledging the reduced risk associated with Spyre's broad platform and the company's strong financial position.
InvestingPro Insights
As Spyre (NASDAQ: SYRE) continues to make strides in its clinical programs, investors and analysts are keeping a close eye on the company's financial health and market performance. According to InvestingPro data, Spyre holds a market capitalization of $1.42 billion.
Despite not being profitable in the last twelve months and showing a significant revenue decline of nearly 62%, the company's stock price has experienced a remarkable return over the last year, with a 758.29% increase. This suggests that investor sentiment may be buoyed by the company's potential and recent progress in its drug development pipeline.
InvestingPro Tips highlight that Spyre's balance sheet is in a strong position, with cash reserves exceeding its debt, which aligns with the company's reported $485.0 million in cash and equivalents.
Furthermore, the company's liquid assets surpass its short-term obligations, providing financial stability as it advances its clinical trials. However, potential investors should be aware of the stock's volatility and the analysts' view that profitability may not be on the horizon for this year.
For those considering an investment in Spyre, additional insights are available on InvestingPro. There are 11 more detailed InvestingPro Tips that could help refine your investment strategy. To access these tips and more in-depth analysis, visit https://www.investing.com/pro/SYRE and remember to use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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