Avalo Therapeutics, Inc. (AVTX)
Avalo Therapeutics, Inc. is a clinical-stage precision medicine company focused on discovering, developing, and commercializing targeted therapeutics. Their pipeline addresses unmet needs in immunology, immuno-oncology, and rare genetic diseases.
Company Overview
Avalo Therapeutics pioneers precision medicines for immunology, immuno-oncology, and rare genetic diseases, offering investors a high-potential, clinical-stage opportunity focused on unmet needs and a robust pipeline including AVTX-002 and AVTX-801, targeting multi-billion dollar markets.
Investment Thesis
Avalo Therapeutics presents a compelling investment opportunity due to its focus on precision medicine and rare genetic diseases, areas with significant unmet needs. The company's pipeline, featuring AVTX-002 and AVTX-801, holds substantial promise. Positive Phase II trial results for AVTX-002 in non-eosinophilic asthma could drive significant value. Successful Phase III trials for AVTX-801 in PGM1-CDG could lead to accelerated regulatory approval and market entry. With a market capitalization of $0.16 billion and a beta of 0.89, Avalo offers a potentially high-growth investment, albeit with inherent risks associated with clinical-stage biotech companies. Key value drivers include clinical trial progress, regulatory milestones, and potential partnerships. The company's gross margin of 54.7% indicates strong potential profitability upon commercialization.
Key Highlights
- Market capitalization of $0.16 billion reflects the company's current valuation and growth potential.
- Gross margin of 54.7% indicates potential for strong profitability upon successful commercialization of pipeline products.
- Beta of 0.89 suggests lower volatility compared to the overall market.
- Focus on precision medicine and rare genetic diseases addresses areas with significant unmet clinical needs.
- Pipeline includes AVTX-002 in Phase II/III trials and AVTX-801/803 in Phase III trials, indicating near-term potential for clinical and regulatory milestones.
Competitors
Strengths
- Strong focus on precision medicine and rare diseases.
- Promising pipeline with multiple clinical-stage assets.
- Experienced management team with drug development expertise.
- Orphan drug designations provide market exclusivity.
Weaknesses
- Clinical-stage company with no currently approved products.
- High cash burn rate and reliance on future financing.
- Concentrated pipeline with potential for setbacks.
- Negative profit margin of -52019.8%.
Catalysts
- Upcoming: Phase II trial results for AVTX-002 in non-eosinophilic asthma.
- Upcoming: Phase III trial results for AVTX-801 in PGM1-CDG.
- Upcoming: Potential FDA approval and market launch of AVTX-801.
- Ongoing: Enrollment and progress in ongoing clinical trials.
- Ongoing: Potential for strategic partnerships and collaborations.
Risks
- Potential: Clinical trial failures could significantly impact valuation.
- Potential: Regulatory delays or rejections could delay market entry.
- Ongoing: High cash burn rate requires continuous financing.
- Ongoing: Competition from established pharmaceutical companies.
- Potential: Intellectual property challenges and patent disputes.
Growth Opportunities
- AVTX-002 for Non-Eosinophilic Asthma: The market for asthma therapeutics is substantial, with a growing segment of patients suffering from non-eosinophilic asthma. Positive Phase II trial results could position AVTX-002 as a leading treatment option, capturing a significant share of this market. Timeline for potential market entry is estimated at 2-3 years pending successful trial outcomes and regulatory approvals.
- AVTX-002 for Inflammatory Bowel Disease (IBD): IBD, including Crohn's disease and ulcerative colitis, represents a significant market opportunity. AVTX-002's potential to address the underlying inflammatory pathways in IBD could lead to substantial market penetration. Clinical trials are ongoing, with potential for market entry within 3-4 years pending positive results and regulatory approvals.
- AVTX-801 for Phosphoglucomutase 1 Deficiency (PGM1-CDG): PGM1-CDG is a rare genetic disease with limited treatment options. AVTX-801's Phase III trial represents a near-term opportunity for regulatory approval and market launch. Given the orphan drug designation, Avalo could benefit from market exclusivity and premium pricing. Potential launch within 1-2 years.
- AVTX-803 for Leukocyte Adhesion Deficiency II (LADII): LADII, also known as SLC35C1-CDG, is another rare genetic disease with no approved therapies. AVTX-803's Phase III trial offers a similar opportunity to AVTX-801 for accelerated approval and market access. The limited competition in this space enhances Avalo's potential for success. Potential launch within 1-2 years.
- Expansion of Pipeline through Strategic Acquisitions: Avalo can leverage its expertise in precision medicine to acquire or in-license promising therapeutic candidates in immunology, immuno-oncology, and rare genetic diseases. This would diversify the pipeline and reduce reliance on current assets. The timeline for this growth opportunity is ongoing, dependent on available capital and strategic fit.
Opportunities
- Positive clinical trial results driving stock appreciation.
- Strategic partnerships for co-development and commercialization.
- Expansion into new therapeutic areas through acquisitions.
- Accelerated regulatory pathways for rare disease therapies.
Threats
- Clinical trial failures and regulatory rejections.
- Competition from larger pharmaceutical companies.
- Patent expirations and generic entry.
- Economic downturn impacting healthcare spending.
Competitive Advantages
- Proprietary drug candidates with patent protection.
- Focus on rare diseases provides market exclusivity.
- Precision medicine approach offers targeted efficacy.
- Clinical trial expertise and regulatory knowledge.
- Orphan drug designations provide incentives and market protection.
About
Avalo Therapeutics, Inc., founded in 2011 and headquartered in Rockville, Maryland, operates as a clinical-stage precision medicine company. Originally incorporated as Cerecor Inc., the company rebranded to Avalo Therapeutics in August 2021, signaling a refined focus on targeted therapeutics. Avalo's core mission is to discover, develop, and commercialize innovative treatments for patients grappling with unmet clinical needs across immunology, immuno-oncology, and rare genetic diseases. Their pipeline features AVTX-002, a fully human anti-LIGHT monoclonal antibody currently in Phase II clinical trials for non-eosinophilic asthma and inflammatory bowel disease (including Crohn's disease and ulcerative colitis), and in Phase III for COVID-19-related acute respiratory distress syndrome. Additionally, AVTX-007, an Anti-IL-18 monoclonal antibody, is in Phase I trials for Still's disease. The company is also advancing AVTX-801, a D-galactose substrate replacement therapy, and AVTX-803, an L-fucose substrate replacement therapy, both in Phase III trials for rare genetic diseases like phosphoglucomutase 1 deficiency (PGM1-CDG) and LADII (SLC35C1-CDG), respectively. Avalo's strategic focus on precision medicine and rare diseases positions them to address underserved patient populations and capitalize on targeted therapeutic approaches.
What They Do
- Discovers and develops targeted therapeutics.
- Focuses on precision medicine approaches.
- Addresses unmet clinical needs in immunology.
- Develops treatments for immuno-oncology indications.
- Creates therapies for rare genetic diseases.
- Conducts Phase I, II, and III clinical trials.
- Seeks regulatory approvals for novel therapies.
- Aims to commercialize innovative treatments.
Business Model
- Develops and patents novel therapeutic candidates.
- Conducts clinical trials to demonstrate safety and efficacy.
- Seeks regulatory approval from agencies like the FDA.
- Commercializes approved therapies through direct sales or partnerships.
- Generates revenue through product sales and licensing agreements.
Industry Context
Avalo Therapeutics operates within the biotechnology industry, characterized by rapid innovation and high-risk, high-reward drug development. The precision medicine market is experiencing substantial growth, driven by advancements in genomics and personalized therapies. The rare disease therapeutics market is also expanding, fueled by increased awareness and regulatory incentives. Avalo's focus on targeted therapies aligns with these trends. Competitors like AARD, BDTX, CHRS, CRBU, and ENTA are also pursuing novel therapies, but Avalo's specific pipeline and precision medicine approach differentiate it within the competitive landscape.
Key Customers
- Patients with immunological disorders.
- Patients with rare genetic diseases.
- Healthcare providers prescribing Avalo's therapies.
- Hospitals and clinics administering treatments.
- Potential pharmaceutical partners for licensing and collaboration.
Financials
Recent Quarterly Results
| Quarter | Revenue | Net Income | EPS |
|---|---|---|---|
| Q4 2024 | $192,000 | -$35M | $-3.37 |
Source: Company filings
Chart & Info
Price Chart
Avalo Therapeutics, Inc. (AVTX) stock price: $16.03 (-0.99, -5.82%)
Why Bull
- •Recent insider buying suggests confidence in Avalo's future, indicating that key stakeholders believe in the company's potential.
- •Community sentiment has shifted positively, with discussions highlighting optimism around upcoming clinical trial results.
- •The company's focus on rare diseases positions it well within a niche market that often sees less competition and higher demand.
- •Recent collaborations with research institutions have sparked interest, showcasing Avalo's commitment to innovation and enhancing its credibility.
Why Bear
- •Concerns about the sustainability of funding for ongoing research have surfaced, leading to skepticism among some investors.
- •Recent social sentiment reflects caution, with discussions around the volatility of biotech stocks impacting confidence in Avalo's stability.
- •The competitive landscape in the biotech sector is intensifying, with new entrants potentially overshadowing Avalo's advancements.
- •Some community members express doubts about the company's ability to deliver on its promises, citing previous delays in drug development.
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Technical Analysis
Rationale
AI-generated technical analysis for AVTX including trend direction, momentum, and pattern recognition.
What to Watch
Key support and resistance levels, volume signals, and upcoming events.
Risk Management
Position sizing, stop-loss levels, and risk-reward assessment.
Community
Discussion
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Sentiment
Community sentiment and discussion activity for AVTX.
Make a Prediction
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Current price: $16.03
Analyst Consensus
Consensus Rating
Aggregated Buy/Hold/Sell recommendations from Benzinga, Yahoo Finance, and Finnhub for AVTX.
Price Targets
Median: $39.00 (+137.1% from current price)
Insider Flow (30d)
MoonshotScore
Score Factors
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Revenue Growth 2/100
Revenue declined -77.1% YoY, signaling shrinking demand or market headwinds.
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Gross Margin 8/100
Gross margin at 54.7% indicates good unit economics and healthy profitability per sale.
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Operating Leverage 4/100
Limited operating leverage due to slower revenue growth, keeping profit scaling constrained.
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Cash Runway 8/100
Strong cash reserves of $135M provide a solid financial cushion for growth investments and market downturns.
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R&D Intensity 10/100
Investing 11809.1% of revenue in R&D signals heavy commitment to innovation and future product pipeline.
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Insider Activity 6/100
No significant insider buying or selling recently, which is neutral for the stock outlook.
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Short Interest 7/100
Active trading at 4.33% daily turnover suggests elevated interest, which can increase volatility.
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Price Momentum 3/100
Weak momentum with few bullish signals. The stock may be in a downtrend or consolidation phase.
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News Sentiment 5/100
No sentiment data available
What does this score mean?
The MoonshotScore rates AVTX's growth potential on a scale of 0-100 across multiple factors including innovation, market disruption, financial health, and momentum.
Competitors & Peers
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Frequently Asked Questions
What does Avalo Therapeutics, Inc. do?
Avalo Therapeutics is a clinical-stage precision medicine company dedicated to discovering, developing, and commercializing targeted therapeutics for patients with unmet clinical needs. The company focuses on immunology, immuno-oncology, and rare genetic diseases. Avalo's pipeline includes AVTX-002, an anti-LIGHT monoclonal antibody in Phase II/III trials, and AVTX-801/803, substrate replacement therapies in Phase III trials for rare genetic disorders. Their business model centers on advancing these therapies through clinical development, securing regulatory approvals, and ultimately commercializing them to improve patient outcomes.
Is AVTX stock a good buy?
AVTX stock presents a speculative investment opportunity with high potential reward but also significant risk. The company's focus on precision medicine and rare diseases offers attractive growth prospects, particularly if clinical trials are successful and lead to regulatory approvals. However, as a clinical-stage company, Avalo is subject to the inherent risks of drug development, including trial failures and regulatory setbacks. Investors should carefully consider their risk tolerance and conduct thorough due diligence before investing, considering metrics like market cap ($0.16B) and gross margin (54.7%).
What are the main risks for AVTX?
The primary risks for Avalo Therapeutics revolve around the uncertainty inherent in clinical-stage drug development. Clinical trial failures for key pipeline assets like AVTX-002 or AVTX-801 would significantly impact the company's valuation. Regulatory delays or rejections by the FDA also pose a substantial risk. Furthermore, Avalo's high cash burn rate necessitates continuous financing, which could dilute existing shareholders. Competition from larger pharmaceutical companies with greater resources also presents a challenge, as does the potential for intellectual property disputes.
Is AVTX a good stock to buy?
Whether AVTX is a good investment depends on your financial goals, risk tolerance, and investment horizon. Review the Investment Thesis, SWOT analysis, and Risk sections on this page. Always do your own research and consult a financial advisor before investing.
What is the AVTX MoonshotScore?
MoonshotScore is our proprietary AI-powered rating system that evaluates stocks based on growth potential, financial health, market momentum, and risk factors. It helps investors quickly identify high-potential opportunities. Check the MoonshotScore badge on this page for the current rating.
How often is AVTX data updated?
Stock prices are updated in real-time during market hours (9:30 AM - 4:00 PM ET). Company fundamentals, analyst ratings, and AI insights are refreshed daily. News is updated continuously throughout the day.
What are the growth catalysts for AVTX?
Growth catalysts vary by company and may include new product launches, market expansion, earnings surprises, partnerships, or industry tailwinds. Check the Catalysts section on this page for specific drivers relevant to Avalo Therapeutics, Inc..
Who are AVTX's main competitors?
Avalo Therapeutics, Inc.'s competitors depend on its industry and market segments. Check the Competitors section on this page for a list of direct competitors and how AVTX compares.
What do analysts say about AVTX?
Analyst ratings and price targets for AVTX are aggregated from multiple sources. Check the Analyst Consensus tab for buy/hold/sell ratings and the current consensus price target.
What is AVTX's market cap?
Market capitalization reflects the total market value of AVTX's outstanding shares. Check the Key Statistics section at the top of this page for the current market cap and other key financial metrics.
How has AVTX stock performed recently?
Check the Chart & Info tab for AVTX's recent price action, including daily, weekly, and monthly performance charts with technical indicators.
What are the risks of investing in AVTX?
Every stock carries risk. Check the Risks and Weaknesses sections on this page for AVTX-specific risk factors. Consider macroeconomic conditions, industry trends, and company-specific challenges.
Are insiders buying or selling AVTX?
Insider activity can signal management confidence. Check the Insider Flow tab for recent insider buys, sells, and exercise transactions for AVTX.
Is AVTX a good stock for beginners?
Avalo Therapeutics, Inc. (AVTX) can be suitable for beginner investors depending on several factors. Look at the MoonshotScore on this page for an overall AI-powered assessment of growth potential and risk. Beginners should also check the company's market cap (larger companies tend to be less volatile), gross margin (higher margins mean stronger business fundamentals), and cash position (healthy cash reduces bankruptcy risk). Always start with a small position size and never invest money you cannot afford to lose.
How risky is AVTX for first-time investors?
Every stock carries risk, including Avalo Therapeutics, Inc. (AVTX). First-time investors should review the Risk Factors section on this page for company-specific risks. Key risk indicators include price volatility (check the chart for daily swings), insider selling activity (see Insider Flow tab), and cash runway (see MoonshotScore breakdown). A diversified portfolio with an index fund like the S&P 500 as a core holding is generally recommended before adding individual stocks like AVTX.
Disclaimer: This content is for informational purposes only and does not constitute investment advice. Always do your own research and consult a financial advisor.
Data provided for informational purposes only.
- Information is based on available data as of 2026-02-09.
- Investment decisions should be based on individual risk tolerance and thorough due diligence.
- Clinical trial outcomes are inherently uncertain.