Biopharmaceutical company Annexon (ANNX) is showing promising results in developing treatments for inflammatory-related diseases. Its flagship candidate, ANX005, showed positive topline Phase 3 data for treating Guillain-Barré syndrome. In addition, its pipeline also includes ANX007, aimed at geographic atrophy, and ANX1502, designed for autoimmune indications, with both products undergoing Phase 3 and Phase 1 clinical trials, respectively. Further, ANX009 is in Phase I clinical trial for treating lupus nephritis.
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Despite the ongoing research and development activities, Annexon has remained financially stable. It reported a third-quarter 2024 GAAP EPS of -$0.25, beating expectations by $0.03.
A Rich Pipeline of Potential Candidates
Annexon, Inc. is a clinical-stage biopharmaceutical company that is discovering and developing treatments for inflammation-related diseases. The company recently reported positive top-line results for its primary candidate, ANX005, from a Phase 3 clinical trial to treat Guillain-Barré syndrome, an acute neuromuscular disease with no U.S. Food and Drug Administration-approved treatments. ANX005 is also in Phase II clinical trials for treating Huntington’s disease and Amyotrophic lateral sclerosis. The company is also developing various other medicines at different stages of clinical trials, including ANX007 for geographic atrophy treatment, ANX1502 for autoimmune indications, and ANX009 for treating lupus nephritis.
ANX005, a first-in-kind monoclonal antibody with recent Phase 3 data, demonstrated a higher probability of improved health in patients as early as week 1, with continued observation through 26 weeks. This treatment has been shown to expedite recovery, getting patients walking and off ventilation approximately a month earlier than usual. ANX005 is generally well-tolerated, with a safety profile equivalent to a placebo.
Moreover, ANX1502 is being developed for autoimmune conditions. This first-in-kind oral C1s inhibitor may offer upstream classical complement inhibition with the convenience and flexibility of oral administration. A completed bridging study showed a safety and pharmacokinetic profile similar to or better than previous studies, and an enteric-coated tablet has been created for improved patient experience and tolerability.
Cash Burn Runway Through 2026
The company reported results for Q3 2024, with a rise in Research and Development (R&D) and General and Administrative (G&A) costs. R&D expenses rose to $30.1 million from $27.9 million in Q3 2023. This increase in cost mirrors the company’s progress in priority programs, including GBS, GA, and ANX1502. G&A expenses also increased, reaching $9.3 million, up from $6.9 million in Q3 2023.
Annexon recorded a net loss of $34.8 million or $0.25 per share, exceeding expectations by $0.01 while marking a significant improvement from the $0.43 per share net loss for the same period in the previous year.
As of the quarter’s end, the company reported cash, cash equivalents, and short-term investments of $340.1 million. This cash position is projected to sustain the company’s planned operating expenses until the latter half of 2026.
Analysts See Strong Upside Potential
The stock has bounced around this year, climbing 15.20% year-to-date. It trades near the midpoint of its 52-week price range of $3.66 – $8.40 and shows mixed technical results. It shows positive price momentum over shorter time frames, like the 20-day moving average (5.19), though it still lags behind the longer moving averages, like the 50-day moving average (5.73).
Analysts following the company have been constructive on ANNX stock. For instance, H.C. Wainwright’s four-star analyst, Andrew Fein, recently reiterated a Buy rating with a price target of $30.00 on the shares. He noted the promising evidence for ANX005 in treating Guillain-Barré Syndrome (GBS), pointing to its potential approval.
Annexon Biosciences is rated a Strong Buy overall, based on the recent recommendations of six analysts. The average price target over the next 12 months for ANNX stock is $18.00, representing a potential upside of 244.17% from current levels.
Final Analysis on ANNX
Annexon is making significant strides with ANX005, which has shown encouraging results from Phase 3 trials for Guillain-Barré syndrome, an acute neuromuscular disease with no FDA-approved treatments. Other drugs in the pipeline, including ANX007 for geographic atrophy and ANX1502 for autoimmune conditions, also show promise in their respective clinical trials. The company’s cash position suggests it is well positioned to maintain stability as it ushers these treatments through clinical trials, with sufficient capital to cover operational costs until the second half of 2026.
With its solid pipeline, strong financial position, and positive analyst ratings, ANNX offers significant upside potential for investors interested in the high-risk, high-reward world of clinical-stage biopharma.
