Recent News
On October 13, 2025 Denali announced the FDA extended the PDUFA target date for its BLA seeking accelerated approval of tividenofusp alfa (DNL310) for MPS II from January 5, 2026 to April 5, 2026 after the company submitted updated clinical pharmacology information classified as a Major Amendment.
On November 6, 2025 Denali disclosed board and leadership changes, including a new board appointment and the planned transition of its Chief Medical Officer to another company, with an acting Chief Medical Officer named to cover development responsibilities.
Technical Analysis
ADX reads 17.86, which indicates no established trend presently; momentum lacks directional strength and suggests price moves may stay range‑bound until trend strength increases.
Directional indicators show DI+ at 24.75 with a dip & reversal and DI‑ at 22.02 with a peak & reversal; both signals align with a bullish shift in directional bias and support the view that upside attempts carry higher probability than renewed selling pressure in the near term.
MACD registers 0.15 with a dip & reversal while the signal line sits at 0.19; the dip & reversal points to bullish momentum developing, but the MACD remains below its signal line, so momentum lacks a confirmed technical crossover.
MRO stands at 8.23 with a peak & reversal; the positive MRO indicates price currently sits above the target and suggests a modest potential for consolidation or pullback given the oscillator’s positioning.
RSI at 53.92 with a dip & reversal places momentum in the center band and favors continued buying on strength, though the indicator does not signal overbought conditions.
Price sits at $17.58 above the 12‑day EMA ($15.81), 20‑day average ($15.83), 50‑day average ($15.13) and 200‑day average ($15.37), and 12‑day EMA shows a dip & reversal; the relationship between price and moving averages supports a constructive short‑term bias while volatility remains moderate.
Bollinger placement sits between the 1x and 2x upper bands (upper 1x = $16.80; upper 2x = $17.77) with the close near the upper band, indicating short‑term strength but also a higher likelihood of short consolidations when compared to mid‑band price.
Fundamental Analysis
Earnings: Reported EPS of -$0.74 versus an estimate of -$0.76 produced an EPS surprise of +2.63%, reflecting a slight beat against consensus expectations. Operating loss (EBIT) registers at -$137,434,000 and net income at -$126,902,000, consistent with late‑stage R&D spending patterns rather than commercialization margins.
Cash and liquidity: Cash and short‑term investments total $848,204,000. Current ratio equals 9.79, and cash ratio equals 9.41, indicating ample near‑term liquidity to fund operations and planned launch activities without reliance on new debt; total debt stands at $44,404,000, producing a debt‑to‑assets ratio of 4.21% and debt‑to‑equity of 4.79%.
Cash flow: Operating cash flow shows -$127,139,000 and free cash flow -$105,918,000, with a free cash flow yield of -4.75%. Free cash flow growth per period reads 33.10% while free cash flow growth YoY shows -196.36%, reflecting volatility in cash generation tied to R&D timing and program activity.
R&D and pipeline: Research and development expense totals $101,950,000, aligned with late‑stage development and prelaunch manufacturing build‑out; the company continues to advance tividenofusp alfa and other TV‑enabled programs, which frame near‑term commercial planning despite regulatory timing shifts.
Profitability and returns: Return on assets registers -11.42% and return on equity -13.70%, with QoQ and YoY improvements indicated (ROA QoQ +12.17%, ROA YoY +57.54%; ROE QoQ +13.37%, ROE YoY +68.52%), signaling operational metrics improving from prior periods while still negative overall.
Market multiples: P/B stands at 2.41, below the industry peer mean of 7.44 and industry peer median of 6.06; P/E sits at -20.56 reflecting negative earnings, versus an industry peer mean of 23.03. PEG and forward PE remain negative given expected negative forward EPS. WMDST values the stock as over‑valued, driven by the combination of limited near‑term revenue, negative earnings, and valuation multiples that reflect future expectation rather than current cash‑flowing operations.
MOST-RECENT QUARTERLY REPORT
| REPORT PERIOD ENDING: | 2025-09-30 |
| REPORT DATE: | 2025-11-06 |
| NEXT REPORT DATE: | 2026-02-05 |
| CASH FLOW | Begin Period Cash Flow | $ 144.3 M |
| Operating Cash Flow | $ -127.14 M | |
| Capital Expenditures | — | |
| Change In Working Capital | $ -6.22 M | |
| Dividends Paid | — | |
| Cash Flow Delta | $ -50.24 M | |
| End Period Cash Flow | $ 94.1 M | |
| INCOME STATEMENT | REVENUE | |
| Total Revenue | — | |
| Forward Revenue | — | |
| COSTS | ||
| Cost Of Revenue | — | |
| Depreciation | $ 3.9 M | |
| Depreciation and Amortization | $ 3.9 M | |
| Research and Development | $ 102.0 M | |
| Total Operating Expenses | $ 137.4 M | |
| PROFITABILITY | ||
| Gross Profit | — | |
| EBITDA | $ -133.57 M | |
| EBIT | $ -137.43 M | |
| Operating Income | $ -137.43 M | |
| Interest Income | $ 10.5 M | |
| Interest Expense | — | |
| Net Interest Income | $ 10.5 M | |
| Income Before Tax | $ -126.90 M | |
| Tax Provision | — | |
| Tax Rate | — | |
| Net Income | $ -126.90 M | |
| Net Income From Continuing Operations | $ -126.90 M | |
| EARNINGS | ||
| EPS Estimate | $ -0.76 | |
| EPS Actual | $ -0.74 | |
| EPS Difference | $ 0.02 | |
| EPS Surprise | 2.632 % | |
| Forward EPS | $ -0.69 | |
| BALANCE SHEET | ASSETS | |
| Total Assets | $ 1.1 B | |
| Intangible Assets | — | |
| Net Tangible Assets | $ 926.2 M | |
| Total Current Assets | $ 882.6 M | |
| Cash and Short-Term Investments | $ 848.2 M | |
| Cash | $ 91.0 M | |
| Net Receivables | — | |
| Inventory | — | |
| Long-Term Investments | $ 25.1 M | |
| LIABILITIES | ||
| Accounts Payable | $ 6.7 M | |
| Short-Term Debt | — | |
| Total Current Liabilities | $ 90.1 M | |
| Net Debt | — | |
| Total Debt | $ 44.4 M | |
| Total Liabilities | $ 129.4 M | |
| EQUITY | ||
| Total Equity | $ 926.2 M | |
| Retained Earnings | $ -1.92 B | |
| VALUATION & PER-SHARE METRICS | EQUITY & PER-SHARE METRICS | |
| Book Value Per-Share | $ 6.32 | |
| Shares Outstanding | 146.626 M | |
| Revenue Per-Share | — | |
| VALUATION | Market Capitalization | $ 2.2 B |
| Enterprise Value | $ 1.4 B | |
| Enterprise Multiple | -10.682 | |
| Enterprise Multiple QoQ | 11.847 % | |
| Enterprise Multiple YoY | -56.45 % | |
| Enterprise Multiple IPRWA | high: 136.347 median: 28.451 mean: 12.089 DNLI: -10.682 low: -131.459 |
|
| EV/R | — | |
| CAPITAL STRUCTURE | ||
| Asset To Equity | 1.14 | |
| Asset To Liability | 8.156 | |
| Debt To Capital | 0.046 | |
| Debt To Assets | 0.042 | |
| Debt To Assets QoQ | 5.361 % | |
| Debt To Assets YoY | 660.579 % | |
| Debt To Assets IPRWA | high: 0.843 mean: 0.247 median: 0.189 DNLI: 0.042 low: 0.0 |
|
| Debt To Equity | 0.048 | |
| Debt To Equity QoQ | 5.758 % | |
| Debt To Equity YoY | 687.192 % | |
| Debt To Equity IPRWA | high: 1.395 mean: 0.238 median: 0.106 DNLI: 0.048 low: -0.73 |
|
| PRICE-BASED VALUATION | ||
| Price To Book (P/B) | 2.408 | |
| Price To Book QoQ | 17.586 % | |
| Price To Book YoY | -16.314 % | |
| Price To Book IPRWA | high: 16.86 mean: 7.438 median: 6.057 DNLI: 2.408 low: -8.555 |
|
| Price To Earnings (P/E) | -20.559 | |
| Price To Earnings QoQ | 2.454 % | |
| Price To Earnings YoY | -50.903 % | |
| Price To Earnings IPRWA | high: 167.986 median: 47.207 mean: 23.027 DNLI: -20.559 low: -179.954 |
|
| PE/G Ratio | -7.401 | |
| Price To Sales (P/S) | — | |
| Price To Sales QoQ | — | |
| Price To Sales YoY | — | |
| Price To Sales IPRWA | — | |
| FORWARD MULTIPLES | ||
| Forward P/E | -20.88 | |
| Forward PE/G | -7.516 | |
| Forward P/S | — | |
| EFFICIENCY | OPERATIONAL | |
| Operating Leverage | — | |
| ASSET & SALES | ||
| Asset Turnover Ratio | — | |
| Asset Turnover Ratio QoQ | — | |
| Asset Turnover Ratio YoY | — | |
| Asset Turnover Ratio IPRWA | — | |
| Receivables Turnover | — | |
| Receivables Turnover Ratio QoQ | — | |
| Receivables Turnover Ratio YoY | — | |
| Receivables Turnover Ratio IPRWA | — | |
| Inventory Turnover | — | |
| Inventory Turnover Ratio QoQ | — | |
| Inventory Turnover Ratio YoY | — | |
| Inventory Turnover Ratio IPRWA | — | |
| Days Sales Outstanding (DSO) | — | |
| CASH CYCLE | ||
| Cash Conversion Cycle Days (CCC) | 0.0 | |
| Cash Conversion Cycle Days QoQ | — | |
| Cash Conversion Cycle Days YoY | -100.0 % | |
| Cash Conversion Cycle Days IPRWA | high: 520.898 median: 189.366 mean: 166.152 DNLI: 0.0 low: -314.885 |
|
| CAPITAL DEPLOYMENT | ||
| Cash Conversion Ratio | — | |
| CapEx To Revenue | — | |
| CapEx To Depreciation | — | |
| CAPITAL, LIQUIDITY & COVERAGE | CAPITAL STRUCTURE | |
| Total Capital | $ 926.2 M | |
| Net Invested Capital | $ 926.2 M | |
| Invested Capital | $ 926.2 M | |
| Net Tangible Assets | $ 926.2 M | |
| Net Working Capital | $ 792.5 M | |
| LIQUIDITY | ||
| Cash Ratio | 9.409 | |
| Current Ratio | 9.791 | |
| Current Ratio QoQ | -4.621 % | |
| Current Ratio YoY | -1.857 % | |
| Current Ratio IPRWA | high: 28.339 DNLI: 9.791 mean: 4.211 median: 2.871 low: 0.704 |
|
| Quick Ratio | — | |
| Quick Ratio QoQ | — | |
| Quick Ratio YoY | — | |
| Quick Ratio IPRWA | — | |
| COVERAGE & LEVERAGE | ||
| Debt To EBITDA | -0.332 | |
| Cost Of Debt | 0.022 % | |
| Interest Coverage Ratio | -13743.4 | |
| Interest Coverage Ratio QoQ | 1.831 % | |
| Interest Coverage Ratio YoY | 11.565 % | |
| Interest Coverage Ratio IPRWA | high: 394.576 mean: 56.228 median: 6.724 low: -345.499 DNLI: -13743.4 |
|
| Operating Cash Flow Ratio | -1.41 | |
| TIMING / LIQUIDITY | ||
| Days Payables Outstanding (DPO) | — | |
| DIVIDENDS | ||
| Dividend Coverage Ratio | — | |
| Dividend Payout Ratio | — | |
| Dividend Rate | — | |
| Dividend Yield | — | |
| PERFORMANCE | GROWTH | |
| Asset Growth Rate | -9.485 % | |
| Revenue Growth | -100.0 % | |
| Revenue Growth QoQ | -0.0 % | |
| Revenue Growth YoY | — | |
| Revenue Growth IPRWA | high: 171.467 % mean: 6.689 % median: 4.118 % DNLI: -100.0 % low: -106.305 % |
|
| Earnings Growth | 2.778 % | |
| Earnings Growth QoQ | -136.115 % | |
| Earnings Growth YoY | -59.027 % | |
| Earnings Growth IPRWA | high: 162.5 % DNLI: 2.778 % median: -6.667 % mean: -8.102 % low: -198.545 % |
|
| MARGINS | ||
| Gross Margin | — | |
| Gross Margin QoQ | — | |
| Gross Margin YoY | — | |
| Gross Margin IPRWA | — | |
| EBIT Margin | — | |
| EBIT Margin QoQ | — | |
| EBIT Margin YoY | — | |
| EBIT Margin IPRWA | — | |
| Return On Sales (ROS) | — | |
| Return On Sales QoQ | — | |
| Return On Sales YoY | — | |
| Return On Sales IPRWA | — | |
| CASH FLOW | ||
| Free Cash Flow (FCF) | $ -105.92 M | |
| Free Cash Flow Yield | -4.748 % | |
| Free Cash Flow Yield QoQ | 25.509 % | |
| Free Cash Flow Yield YoY | 185.852 % | |
| Free Cash Flow Yield IPRWA | high: 7.892 % median: 1.086 % mean: 0.615 % DNLI: -4.748 % low: -23.334 % |
|
| Free Cash Growth | 33.103 % | |
| Free Cash Growth QoQ | -179.342 % | |
| Free Cash Growth YoY | -196.356 % | |
| Free Cash Growth IPRWA | high: 204.738 % mean: 49.537 % DNLI: 33.103 % median: 31.092 % low: -240.252 % |
|
| Free Cash To Net Income | 0.835 | |
| Cash Flow Margin | — | |
| Cash Flow To Earnings | 1.002 | |
| VALUE & RETURNS | ||
| Economic Value Added | — | |
| Return On Assets (ROA) | -11.423 % | |
| Return On Assets QoQ | 12.166 % | |
| Return On Assets YoY | 57.537 % | |
| Return On Assets IPRWA | high: 22.947 % median: 3.613 % mean: -0.7 % DNLI: -11.423 % low: -52.808 % |
|
| Return On Capital Employed (ROCE) | -14.235 % | |
| Return On Equity (ROE) | -0.137 | |
| Return On Equity QoQ | 13.372 % | |
| Return On Equity YoY | 68.524 % | |
| Return On Equity IPRWA | high: 0.652 mean: 0.052 median: 0.047 DNLI: -0.137 low: -1.05 |
|
| DuPont ROE | — | |
| Return On Invested Capital (ROIC) | — | |
| Return On Invested Capital QoQ | — | |
| Return On Invested Capital YoY | — | |
| Return On Invested Capital IPRWA | — | |