Cenegermin-BKBJ

Appointments Further Strengthen Spruce’s Commercial and Financial Capabilities as the Company Approaches a Potential U.S. FDA Approval and Commercial Launch of Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) for the Treatment of Sanfilippo Syndrome Type B (MPS IIIB) SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today announced the appointments of Eric Jordan as Vice President, Marketing and Tina Gullotta, CPA, as Vice President, Finance and Corporate Controller. “We are delighted to welcome both Eric and Tina, two accomplished leaders with deep biotech experience, to the Spruce executive team,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences. “Eric brings a proven track record of building rare disease brands and orchestrating successful launches, and Tina brings the finance and accounting expertise critical to operating as a commercial-stage organization. We look forward to working closely with them as we prepare for the potential U.S. FDA approval and commercial launch of TA-ERT.” Mr. Jordan brings more than 20 years of strategic marketing leadership experience in the pharmaceutical and biotech industries, with deep expertise in rare disease launch preparation and execution. Most recently, he served as Marketing Team Lead at BridgeBio, where he led marketing and launch planning for encaleret, an investigational treatment for a rare endocrine disorder. Prior to BridgeBio, Mr. Jordan served as Vice President, Marketing at Dompé Pharmaceuticals, where he led the U.S. launch and commercialization of Oxervate for neurotrophic keratitis, growing it into a $1 billion brand. Earlier, he served as Marketing Director, HCP Marketing at Aimmune Therapeutics (acquired by Nestlé Health Science), where he led pre-launch marketing for the company’s peanut allergy therapy, and as Marketing Director, Cardiology and Hospital at ZS Pharma (acquired by AstraZeneca), where he led strategic and tactical launch planning for a hyperkalemia therapy. Mr. Jordan began his pharmaceutical career at Genentech, where he held positions of increasing responsibility across BioOncology and Nutropin marketing, ultimately serving as Associate Director, Business Unit Operations and Chief of Staff to the SVP, Sales and Marketing of an approximately $2 billion business unit. Mr. Jordan earned his MBA from the Haas School of Business at the University of California, Berkeley and his BS in Marketing from Pennsylvania State University. Ms. Gullotta brings more than 25 years of senior finance leadership experience in life sciences, with a proven track record of guiding biotechnology organizations through clinical growth, capital raises, operational transformation, and public-company readiness. Most recently, she served as Vice President, Finance at Frontier Medicines Corporation, where she led the Finance and Accounting organization and served as a strategic partner to the CEO, CFO, and Board. Prior to Frontier, Ms. Gullotta served as Vice President, Finance and Chief Accounting Officer (and previously Senior Director, Corporate Controller) at Sunesis Pharmaceuticals, where she oversaw SEC reporting, technical accounting, SOX 404 compliance, and treasury, and supported fundraising and capital markets activities. Earlier, she served as Senior Director, Corporate Controller at Atara Biotherapeutics, where she participated in the company’s IPO and follow-on offerings and led SEC reporting, audit, and SOX 404 programs. Ms. Gullotta is a Certified Public Accountant and earned her B.S. in Commerce, Accounting from Santa Clara University. “Spruce is on the cusp of delivering what could be the first disease-modifying treatment option for patients with Sanfilippo Syndrome Type B, and the opportunity to help launch a therapy with this kind of potential impact is exactly what drew me to the team,” said Mr. Jordan. “I look forward to building the marketing foundation needed to bring TA-ERT to the patients and families who have been waiting for it.” “I am thrilled to join Spruce at such a pivotal moment in the company’s evolution,” said Ms. Gullotta. “I look forward to partnering with the leadership team to scale the finance and accounting organization, strengthen our controls and reporting infrastructure, and support Spruce’s transition to a commercial-stage company.” Inducement Awards In connection with their employment with Spruce, on June 15, 2026, Mr. Jordan and Ms. Gullotta were each granted restricted stock units (RSUs) for 3,500 shares of Spruce’s common stock. The Compensation Committee of the Board of Directors approved the awards as inducements material to Mr. Jordan’s and Ms. Gullotta’s entering into employment with the company in accordance with Nasdaq Listing Rule 5635(c)(4). Each of the RSUs will vest over four years, with 25% of the underlying shares vesting on each anniversary of June 15, 2026, subject to the new employee’s continued service relationship with Spruce Biosciences through the applicable vesting date. The awards will be subject to the terms and conditions of the 2026 Inducement Plan and the terms and conditions of the applicable award agreement covering the grant. About Spruce Biosciences Spruce Biosciences is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need. Spruce’s lead product candidate, tralesinidase alfa enzyme replacement therapy (TA-ERT), is in late-stage development for the treatment of mucopolysaccharidoses type IIIB (MPS IIIB), or Sanfilippo Syndrome Type B, a devastating pediatric neurodegenerative disorder for which there are no FDA-approved therapies. TA-ERT has received Breakthrough Therapy Designation, Rare Pediatric Disease Designation, Fast Track Designation and Orphan Drug Designation from the FDA, as well as Orphan Drug Designation in the European Union. To learn more, visit and follow us on X , LinkedIn , Facebook and YouTube . Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the impact of new management hires, the fulfillment of Spruce’s strategic business objectives, potential regulatory approval, commercial launch of TA-ERT, and TA-ERT’s potential to be the first disease-modifying treatment option for MPS IIIB. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “plan,” “will,” “believe,” “could,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Spruce’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Spruce’s business in general, the impact of geopolitical and macroeconomic events, and the other risks described in Spruce’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Spruce undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Contacts Media Carolyn Hawley Inizio Evoke Comms Carolyn.Hawley@inizioevoke.com media@sprucebio.com Investors Monique Kosse Gilmartin Group Monique@GilmartinIR.com investors@sprucebio.com

Affecting fewer than 200,000 people in the U.S., persistent corneal epithelial defect (PCED) is a rare condition with a high unmet clinical need, as current treatment options remain limited. PCED occurs when the corneal surface fails to heal despite standard treatment and remains open or damaged for more than two weeks. The Phase 3 trial, named “Orunea,” will enroll 150 adult patients to evaluate whether Cenegermin-bkbj — a recombinant human Nerve Growth Factor (rhNGF) — can achieve complete epithelial healing of the cornea. MILAN & SAN MATEO, Calif.--(BUSINESS WIRE)--Dompé, a leading biopharmaceutical company with operations in Italy and the U.S., announced the first patient has been dosed in the US in a Phase 3 study of cenegermin-bkbj ophthalmic solution for the treatment of persistent corneal epithelial defect (PCED). The Phase 3 trial, “Orunea” is a multicenter, randomized, double-masked study comparing cenegermin-bkbj against placebo in achieving complete healing of PCED. “Expanding research into PCED builds on our established experience in neurotrophic keratitis and reflects our continued effort to explore how rhNGF may address a broader spectrum of corneal diseases." - Marcello Allegretti, Chief Scientific Officer “At Dompé, our mission is to ensure that people living with rare and debilitating eye diseases have access to innovative treatments that can meaningfully improve their lives,” said Marcello Allegretti, Chief Scientific Officer at Dompé. “Expanding research into PCED builds on our established experience in neurotrophic keratitis and reflects our continued effort to explore how rhNGF may address a broader spectrum of corneal diseases.” The cornea is the clear, protective outer layer of the eye. Its surface is made up of specialized cells that constantly renew themselves, to keep the eye healthy and to heal injuries. When this healing process fails and a defect persists for more than two weeks despite standard treatment, it is called PCED. This condition may cause significant pain and blurred vision, and if left untreated, it can lead to serious complications like severe infection, permanent scarring, and partial or complete loss of vision. Affecting fewer than 200,000 people in the U.S., PCED represents a serious, rare disease with a high, unmet clinical need.1 “Advancing cenegermin-bkbj into a Phase 3 program for PCED reflects the strength of the underlying science and the consistency of the rhNGF mechanism across corneal pathologies characterized by impaired healing. This study is designed to rigorously evaluate whether targeting the biological drivers of epithelial repair can offer a clinically meaningful benefit for patients with limited therapeutic options,” Allegretti further noted. “PCED is a highly heterogenous condition, and many of the underlying corneal diseases associated with it have limited treatment options. This underscores an urgent need for novel therapies that directly stimulate epithelial cells involved in the corneal healing and defect closure,” said Ahmed Enayetallah, Chief Development Officer at Dompé. “This study underscores our long-standing commitment to translating the biology of rhNGF into meaningful therapies for patients with serious ocular diseases.” The study will enroll approximately 150 people with PCED aged 18 years and above and the primary endpoint will assess the proportion of responders achieving complete epithelial healing of the cornea. Cenegermin-bkbj is an investigational product for PCED, and its safety and efficacy for this indication have not been established or approved by any regulatory authority. More information about the current clinical trial can be found at www.clinicaltrials.gov (NCT07519902). About Dompé Dompé farmaceutici S.p.A. is a privately held, global biopharmaceutical company on a mission to bring the full potential of nerve growth factor (NGF) to patients. As the first company to unlock the therapeutic potential of NGF, Dompé developed the first FDA-approved NGF treatment. Today, our clinical pipeline reflects our commitment to redefining treatments across ophthalmic, neurological and pain-related conditions. Building on 130 years of independence, we are embracing the challenge to transform our science and ourselves by delivering first-in-class, disease-modifying therapies through NGF and other breakthrough molecules to help people improve their sight, support neurological recovery and manage pain effectively. Today, Dompé employs more than 1,100 employees worldwide and maintains a US commercial operations hub in the San Francisco Bay Area. Learn more at https://www.dompe.com/us/. About Nerve Growth Factor (NGF) Nerve Growth Factor (NGF) is a neurotrophin, a member of a family of proteins essential for the growth, maintenance and survival of neurons, with broad therapeutic potential. NGF was discovered by the Italian neurobiologist Professor Rita Levi-Montalcini and American biochemist Dr. Stanley Cohen, earning them the Nobel Prize in Physiology or Medicine in 1986. In their research, Drs. Levi-Montalcini and Cohen uncovered that NGF plays a crucial role in the proliferation, differentiation, and survival of sympathetic and sensory neurons. Dompé is the first company to unlock the therapeutic potential of NGF, building upon a Nobel Prize-winning discovery to deliver a breakthrough treatment for a rare neurotrophic eye disease. About Persistent Corneal Epithelial Defect (PCED) Persistent corneal epithelial defect (PCED) is when the surface of the eye (the cornea) doesn’t heal properly and stays open or damaged for more than two weeks. This can be caused by eye injuries, infections, dryness or chronic inflammation. Conditions like diabetes, nerve damage in the eye or severe allergic eye disease can also make it harder for the cornea to repair itself. Common symptoms of PCED include eye pain, redness, tearing, blurred vision and sensitivity to light. If it is not properly treated or managed, PCED can cause serious infection and permanent scarring of the cornea and loss of eyesight or blindness. About Oxervate OXERVATE® (cenegermin-bkbj) ophthalmic solution 0.002% is indicated for the treatment of neurotrophic keratitis. Important Safety Information: Contact lenses, either therapeutic or corrective, should be removed before applying OXERVATE. Contact lenses may be reinserted 15 minutes after OXERVATE administration. Eye Discomfort, such as eye pain, that can be mild to moderate can occur with OXERVATE. Patients should contact their health care provider if a more serious eye reaction occurs. The most common adverse reaction with OXERVATE (~16%) was eye pain. Other adverse reactions with OXERVATE (1% to 10%) included corneal deposits, foreign body sensation, ocular hyperemia, ocular inflammation, photophobia, tearing, and headache. References: Wirostko B, Rafii M, Sullivan DA, Morelli J, Ding J. Novel Therapy to Treat Corneal Epithelial Defects: A Hypothesis with Growth Hormone. Ocul Surf. 2015 Jul;13(3):204-212.e1. doi: 10.1016/j.jtos.2014.12.005. Epub 2015 Mar 28. PMID: 26045234; PMCID: PMC4498999. (Prevalence section pages 2-3)