- Spruce Biosciences, Inc. entered into a **Securities Purchase Agreement** on **October 7, 2025**, for a private placement of common stock and pre-funded warrants.  **[1683553_0001193125-25-234516_d36248dex101.htm:0]** **[1683553_0001193125-25-234516_d36248d8k.htm:2]** 
- The company will sell **502,181 shares of common stock** at **$68.00 per share** and pre-funded warrants to purchase up to **233,144 shares of common stock** at **$67.99 per warrant**.  **[1683553_0001193125-25-234516_d36248d8k.htm:2]** 
- The private placement is expected to close on or about **October 9, 2025**, with anticipated gross proceeds of approximately **$50.0 million**.  **[1683553_0001193125-25-234516_d36248d8k.htm:2]** 
- The company intends to use the proceeds to advance tralesinidase alfa enzyme replacement therapy (TA-ERT) for Sanfilippo Syndrome Type B (MPS IIIB), targeting a biologics license application submission in **Q1 2026** and potential U.S. commercial launch in **late 2026**.  **[1683553_0001193125-25-234516_d36248d8k.htm:5]**

Spruce Biosciences Announces $50 Million Private Placement

- **Spruce Biosciences** has entered into a definitive securities purchase agreement for a private placement, which is expected to generate gross proceeds of approximately **$50.0 million**.  **[1683553_0c81acef67f14f379426294b2da6e402_0]** 
- The financing is intended to advance **tralesinidase alfa enzyme replacement therapy (TA-ERT)** for Sanfilippo Syndrome Type B (MPS IIIB) through a biologics license application (BLA) submission in the **first quarter of 2026** and a potential U.S. commercial launch in **late 2026**.  **[1683553_0c81acef67f14f379426294b2da6e402_0]** 
- Investors will purchase approximately **502,181 shares** of common stock at **$68.00 per share**, and pre-funded warrants for up to **233,144 shares** of common stock at **$67.99 per warrant**.  **[1683553_0c81acef67f14f379426294b2da6e402_0]** 
- The private placement is expected to close on or about **October 9, 2025**.  **[1683553_0c81acef67f14f379426294b2da6e402_0]**

Spruce Biosciences Announces Private Placement Financing

- Spruce Biosciences received **Breakthrough Therapy Designation** from the FDA for its enzyme replacement therapy, **tralesinidase alfa (TA-ERT)**, targeting **Sanfilippo Syndrome Type B**.  **[1683553_1ca599e07e044b6ea4d2df5cbeb0cf8a]**  This designation is supported by clinical data showing **rapid and durable effects** and the FDA confirmed the biomarker could serve as a **surrogate endpoint** for potential accelerated approval.  **[1683553_1ca599e07e044b6ea4d2df5cbeb0cf8a]** 
- The company plans to submit its **Biologics License Application** for TA-ERT in **early 2026**.  **[1683553_1ca599e07e044b6ea4d2df5cbeb0cf8a]** 
- Despite facing **financial challenges**, including **negative profit margins** and **risk of bankruptcy**, Spruce Biosciences maintains **strong liquidity** with a current ratio and quick ratio both at **2.6**.  **[1683553_1ca599e07e044b6ea4d2df5cbeb0cf8a]** 
- Following the announcement, **Spruce's stock surged significantly**, reflecting investor optimism about the therapy's potential.  **[1683553_1ca599e07e044b6ea4d2df5cbeb0cf8a]**

Spruce Biosciences Gains FDA Breakthrough Therapy Designation for Sanfilippo Syndrome Drug

- **Spruce Biosciences** received U.S. FDA Breakthrough Therapy Designation (BTD) for its **tralesinidase alfa enzyme replacement therapy (TA-ERT)** for Sanfilippo Syndrome Type B (MPS IIIB).  **[1683553_c2d70aef849441dd9ece815fceeda53b_0]** 
- The BTD was supported by clinical data demonstrating **normalization in Cerebral Spinal Fluid Heparan Sulfate Non-Reducing End (CSF HS-NRE)**, which the FDA confirmed is a surrogate biomarker reasonably likely to predict clinical benefit and could serve as a basis for accelerated approval.  **[1683553_c2d70aef849441dd9ece815fceeda53b_0]** 
- The company remains on track to submit the Biologics License Application (BLA) for TA-ERT for MPS IIIB in the **first quarter of 2026**.  **[1683553_c2d70aef849441dd9ece815fceeda53b_0]** 
- TA-ERT is highlighted as a potentially transformative clinical impact as the **first disease-modifying therapy** for MPS IIIB, a fatal genetic disease with no current FDA-approved treatments.  **[1683553_c2d70aef849441dd9ece815fceeda53b_0]** **[1683553_c2d70aef849441dd9ece815fceeda53b_1]**

SPRUCE BIOSCIENCES (SPRB)