Palvella Therapeutics, Inc.
- Open
- 147.39
- Day high
- 158.08
- Day low
- 145.79
- Prev close
- 147.77
- Volume
- 256K
- Mkt cap
- $2.3B
- P/E (TTM)
- —
- EPS (TTM)
- —
- P/B
- 9.7
- P/S
- —
- Yield
- —
- Per share
- —
- ▼Insiders net selling -$952K over the last 3 months (0 open-market buys, 6 sales)
- 🏛Institutions accumulating (13F)
Palvella Therapeutics, Inc. (PVLA) is a Healthcare company listed on NASDAQ. The stock is up 433% over the past year. Over the trailing 3 months, insiders filed 0 open-market buys and 6 sales (SEC Form 4).
Palvella Therapeutics, Inc. (PVLA) financials & analyst ratings
Fundamentals (TTM)
Analyst consensus · 2 analysts
Source: exchange market data + company filings. Figures are trailing-twelve-month or as most recently reported. For informational purposes only — not investment advice.
PVLA earnings date, history & EPS estimates
| Report date | EPS est | EPS actual | Surprise | Revenue | Rev. surprise |
|---|---|---|---|---|---|
| May 7, 2026 | $-0.90 | $-1.20 | -33.3% | — | — |
| Mar 31, 2026 | $-0.91 | $-1.08 | -18.5% | — | — |
| Nov 11, 2025 | $-0.85 | $-1.03 | -21.2% | — | — |
| Aug 14, 2025 | $-0.78 | $-0.86 | -10.3% | — | — |
| May 15, 2025 | $-3.40 | $-0.74 | +78.2% | — | — |
| Mar 31, 2025 | $-0.39 | $4.00 | +1125.6% | — | — |
| Aug 14, 2024 | $-2.40 | $-2.76 | -15.0% | — | — |
| May 15, 2024 | $-4.80 | $-2.00 | +58.3% | — | — |
| Nov 14, 2023 | $-8.80 | $-8.70 | +1.1% | $20M | +152.1% |
| Aug 10, 2023 | $-12.54 | $3.62 | +128.9% | $20M | +399.0% |
PVLA insider trading activity (SEC Form 4)
| Date | Insider | Type | Shares | Price |
|---|---|---|---|---|
| Jul 1, 2026 | Pauls Matthewdirector | Grant | 6,000 | $154.84 |
| Jun 22, 2026 | Goin Kathleenofficer: Chief Operating Officer | Option | 2,154 | $7.14 |
| Jun 22, 2026 | Goin Kathleenofficer: Chief Operating Officer | Sell | 25 | $112.23 |
| Jun 22, 2026 | Goin Kathleenofficer: Chief Operating Officer | Sell | 1,887 | $111.31 |
| Jun 22, 2026 | Goin Kathleenofficer: Chief Operating Officer | Sell | 2,390 | $110.26 |
| Jun 22, 2026 | Goin Kathleenofficer: Chief Operating Officer | Option | 2,148 | $9.08 |
| Jun 16, 2026 | Korenberg Matthew Eofficer: CFO, Treasurer | Option | 1,000 | $13.60 |
| Jun 12, 2026 | JENKINS GEORGE Mdirector | Grant | 3,000 | $102.19 |
| Jun 12, 2026 | HERON ELAINE Jdirector | Grant | 3,000 | $102.19 |
| Jun 12, 2026 | Doux Johndirector | Grant | 3,000 | $102.19 |
| Jun 12, 2026 | Davis Todd Cdirector | Grant | 3,000 | $102.19 |
| Jun 12, 2026 | Wessel Tadd S.director | Grant | 3,000 | $102.19 |
| Jun 12, 2026 | KIRITSY CHRISTOPHER Pdirector | Grant | 3,000 | $102.19 |
| May 22, 2026 | Goin Kathleenofficer: Chief Operating Officer | Option | 2,154 | $7.14 |
| May 22, 2026 | Goin Kathleenofficer: Chief Operating Officer | Option | 2,148 | $9.08 |
Source: PVLA SEC Form 4 filings, latest Jul 1, 2026. For informational purposes only — not investment advice.
See the full PVLA insider & 13F page →Palvella Therapeutics, Inc. company profile
Overview
Palvella Therapeutics, Inc. (NASDAQ:PVLA) is a clinical-stage biopharmaceutical company founded in 2015 and based in Wayne, Pennsylvania. The company specializes in developing novel therapies for patients with serious and rare genetic skin diseases. Since its inception, Palvella has focused on advancing its lead product candidate through clinical trials, with a particular emphasis on treating conditions driven by the mTOR (mechanistic target of rapamycin) pathway. The company went public in 2015 and continues to operate as a development-stage biotechnology firm without commercial revenue.
Business
Palvella Therapeutics operates in the specialized biotechnology sector, focusing on rare genetic skin diseases known as genodermatoses. These are inherited conditions that affect the skin and often involve abnormal cell growth and vascular development. The company's primary focus is on diseases driven by the mTOR pathway, which is a critical cellular signaling mechanism that regulates cell growth, metabolism, and survival. The company's lead product candidate is QTORIN 3.9% rapamycin anhydrous gel, a topical formulation of rapamycin (also known as sirolimus). Rapamycin is an immunosuppressive drug that works by inhibiting the mTOR pathway, thereby reducing abnormal cell proliferation and growth. QTORIN is specifically formulated as a gel for direct application to affected skin areas, allowing for targeted treatment with potentially fewer systemic side effects compared to oral medications. Currently, QTORIN is being evaluated in clinical trials for two primary indications. The most advanced program involves treating microcystic lymphatic malformations, which are abnormal clusters of lymphatic vessels that form cyst-like structures in the skin and can cause significant cosmetic and functional problems. This indication is currently in Phase 3 clinical trials, representing the final stage before potential regulatory approval. Additionally, the company is conducting Phase 2 trials for cutaneous venous malformations, which are abnormal blood vessel formations in the skin that can cause pain, bleeding, and disfigurement. Beyond these primary indications, Palvella is exploring QTORIN's potential for treating other mTOR-driven skin diseases, leveraging the broad applicability of mTOR pathway inhibition in various dermatological conditions.
Revenue model
As a clinical-stage biopharmaceutical company, Palvella currently generates no commercial revenue, as evidenced by zero revenue reported across all recent financial periods. The company's business model is typical of development-stage biotechnology firms, relying on external funding through equity raises, grants, and potential partnerships to finance its research and development activities. Once QTORIN receives regulatory approval, Palvella's revenue model will likely center on product sales to healthcare providers, hospitals, and specialty pharmacies. The target customers will include dermatologists, pediatric specialists, and vascular anomaly centers that treat patients with rare genetic skin diseases. Given the rare disease focus, the company will likely pursue a specialty pharmaceutical pricing strategy, potentially commanding premium prices due to the limited treatment options available for these conditions. Several factors could significantly impact Palvella's future profitability. Regulatory approval success represents the most critical factor, as failure to demonstrate safety and efficacy in Phase 3 trials would eliminate the primary revenue opportunity. Market penetration rates will depend on physician adoption, insurance coverage decisions, and the company's ability to educate healthcare providers about the treatment. Competition from alternative therapies or new entrants could pressure pricing and market share. Additionally, manufacturing and supply chain costs for the specialized gel formulation will directly impact gross margins. The rare disease market dynamics generally favor companies with approved therapies, as limited competition and high unmet medical need can support premium pricing. However, the small patient populations inherent in rare diseases also limit the total addressable market size, requiring efficient commercial execution to achieve profitability.
Competitive moat
Palvella's competitive position is currently limited, as the company lacks significant moat characteristics typical of established pharmaceutical companies. The primary potential moat lies in regulatory exclusivity that would come with FDA approval, including potential orphan drug designation for rare diseases, which could provide seven years of market exclusivity in the United States. The company's formulation expertise in developing a stable, topical rapamycin gel represents some technical differentiation, as rapamycin is notoriously difficult to formulate for topical application due to stability issues. However, this technical advantage is not insurmountable, and larger pharmaceutical companies with greater resources could potentially develop competing formulations. Patent protection around the specific formulation and manufacturing process could provide some defensive positioning, though the strength and breadth of Palvella's intellectual property portfolio is not extensively detailed in available information. The company's focus on rare diseases does provide some natural protection from competition, as the limited market size may not attract significant investment from larger pharmaceutical companies. The most significant competitive threats come from established pharmaceutical companies that might develop alternative mTOR inhibitors or different therapeutic approaches for the same conditions. Additionally, off-label use of existing rapamycin formulations or other immunosuppressive drugs could limit market adoption. The company's small size and limited resources also make it vulnerable to larger competitors with more extensive clinical development capabilities and commercial infrastructure. Overall, Palvella's moat is relatively weak and primarily dependent on achieving regulatory approval and establishing first-mover advantage in its target indications.
Risks & safety
Palvella presents a mixed margin of safety profile typical of clinical-stage biotechnology companies, with strong liquidity but significant execution risk. **Liquidity and Solvency:** - Strong cash position of $83.6 million as of December 2024, representing a significant improvement from $7.4 million in 2023 - Current ratio of 7.33, indicating excellent short-term liquidity - Zero debt, eliminating solvency risk from leverage - Annual cash burn of approximately $10.8 million based on 2024 operating cash flow **Valuation Metrics:** - Trading at 0.43x book value, suggesting potential undervaluation relative to tangible assets - Negative earnings make traditional P/E ratios meaningless - Enterprise value reflects the clinical-stage nature with high uncertainty **Other Considerations:** - Approximately 7-8 years of cash runway at current burn rate provides substantial time for clinical development - Binary risk profile typical of clinical-stage biotech, with success heavily dependent on Phase 3 trial outcomes - Small market capitalization of approximately $281 million creates high volatility potential
Recent development
Based on the financial data, Palvella experienced significant developments in 2024, most notably a substantial increase in cash position from $7.4 million to $83.6 million, indicating a successful equity financing round. This capital infusion provides the company with extended runway to complete its Phase 3 clinical trial for microcystic lymphatic malformations and advance its Phase 2 program for cutaneous venous malformations. The company's operational focus has remained consistent on advancing QTORIN through clinical development. The cash burn rate has been relatively stable, with operating cash flow losses of $10.8 million in 2024 compared to $13.7 million in 2023, suggesting improved operational efficiency or timing differences in expenditures. The positive net income of $18.7 million reported in 2023 appears to be a one-time event, likely related to a gain on asset sale or similar non-operational item, as it contrasts sharply with the company's typical loss profile and negative operating cash flows. The return to losses in 2024 reflects the normal operating pattern for a clinical-stage company investing heavily in research and development. The company's strategic focus remains centered on the rare genetic skin disease market, with particular emphasis on mTOR-driven conditions where QTORIN's mechanism of action provides a targeted therapeutic approach.
PVLA company profile · for informational purposes only — not investment advice.
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