A clinical-stage Biogen, but intensely focused on one novel Alzheimer's drug.

An early-stage Eli Lilly, aiming to innovate in Alzheimer's and other degenerative diseases with a breakthrough compound.

• Atuzaginstat (COR388) for Alzheimer's disease: A lead drug candidate in Phase II/III clinical trials for treating mild to moderate Alzheimer's disease.
• Atuzaginstat (COR388) for Oral Squamous Cell Carcinoma: This drug candidate is also being developed for the treatment of oral squamous cell carcinoma.
• Atuzaginstat (COR388) for Periodontitis: This drug candidate is being investigated for its use in treating periodontitis.
• Atuzaginstat (COR388) for Coronavirus Infection: This drug candidate is also in development for the treatment of coronavirus infection.

As a clinical-stage biopharmaceutical company, IRulya Therapeutics (Cortexyme, Inc.) is primarily focused on the research and development of drug candidates. Its lead drug candidate, atuzaginstat (COR388), is currently in Phase II/III clinical trials. Therefore, the company does not yet have commercially available products and, consequently, does not have major customers in the traditional sense of selling goods or services to individuals or other companies.

Brigette Roberts, M.D. Chief Executive Officer & Board Member

Dr. Roberts was appointed Chief Executive Officer of IRulya Therapeutics, Inc. effective October 8, 2026. She also continues to serve on the company's Board. An experienced biotech investor and company builder, Dr. Roberts previously transformed Orphai Therapeutics into a differentiated pulmonary-focused company centered on LAM-001, which led to its merger with Quince Therapeutics. Prior to this role, she served as Chief Executive Officer of Orphai Therapeutics, Inc. from May 2021 to May 2026 and as a Board Member and Chief Corporate Affairs Officer of Quince Therapeutics. Dr. Roberts holds a B.A. in Physics and Chemistry from Harvard University and an M.D. from New York University.

John Militello, CPA Chief Financial Officer

Mr. Militello was appointed Chief Financial Officer of IRulya Therapeutics, Inc. effective October 8, 2026. He brings over 25 years of experience in public accounting, including 12 years as a senior financial officer in publicly listed biotech companies, providing an extensive background in financial oversight and management. Mr. Militello previously served as Head of Finance at Quince Therapeutics. Before that, he held senior financial roles at Rocket Pharmaceuticals, Inc., including Vice President of Finance, Senior Controller, Treasurer, and Principal Accounting Officer. He was also a Senior Manager in the biotech practice of BDO USA, LLP, serving multi-national publicly listed companies. Mr. Militello is a Certified Public Accountant and earned his Bachelor of Science degree in Accounting from St. Joseph's College.

Keith R. Fandrick, Ph.D. Chief Operating Officer

Dr. Fandrick was appointed Chief Operating Officer of IRulya Therapeutics, Inc. effective October 8, 2026. With over 18 years of experience in the pharmaceutical and biotech industries, he possesses deep scientific, operational, and developmental expertise in clinical-stage development and commercialization. Dr. Fandrick previously served as Head of Technical Operations at Quince Therapeutics and as Chief Operating Officer of Orphai Therapeutics. Prior to his work at Orphai, he held positions of increasing responsibility in Chemical Development at Boehringer-Ingelheim.

IRulya Therapeutics (symbol: IRLA), which operates as Cortexyme, Inc. as per the provided background, focuses on developing therapeutics for various degenerative and infectious diseases. The addressable markets for its main products are as follows:

• Alzheimer's Disease Therapeutics: The global Alzheimer's disease therapeutics market was estimated at approximately USD 5.38 billion in 2025 and is projected to reach around USD 17.98 billion by 2033, growing at a compound annual growth rate (CAGR) of 14.32% during the forecast period of 2026-2033. Other estimates place the global market at USD 6.49 billion in 2025, expanding to approximately USD 38.61 billion by 2035 with a CAGR of 19.52% from 2026 to 2035. North America is a dominant region in this market.
• Oral Squamous Cell Carcinoma Treatment: The global oral cancer treatment market, which includes oral squamous cell carcinoma as the predominant type, was valued at USD 2.1 billion in 2025 and is expected to reach USD 3.3 billion by 2034, exhibiting a CAGR of 4.76% during 2026-2034. Another report estimated the global market at USD 3.27 billion in 2024, projected to reach USD 4.99 billion by 2033 at a CAGR of 4.8%. The market for Head and Neck Squamous Cell Carcinoma (which encompasses oral squamous cell carcinoma) was valued at approximately USD 850 million in 2025 and is projected to reach nearly USD 2,560 million by 2036, expanding at a CAGR of 10.5% during the 2026–2036 forecast period. North America holds a dominant position in the oral cancer treatment market.
• Periodontitis Treatment: The global periodontal disease treatment market size was estimated at USD 2.94 billion in 2025 and is predicted to increase to approximately USD 6.23 billion by 2035, with a CAGR of 7.80% from 2026 to 2035. Specifically for periodontal disease therapeutics, the global market is estimated to reach $2.1 billion in 2033, expanding at a CAGR of 9.8% over the forecast period. Another estimate values the global periodontal therapeutics market at approximately USD 849.2 million in 2023, growing to $1.6 billion by 2032 with a CAGR of 7.7%.
• Coronavirus Infection Therapeutics: The global COVID-19 therapeutics market shows varying estimates. Some sources indicate a contraction, with a market size of US$ 30.7 billion in 2021, projected to reach more than US$ 16.2 billion by the end of 2031 with a CAGR of -8.3%. However, other analyses suggest significant growth, with the global COVID-19 treatment market valued at US$ 42.47 billion in 2025 and expected to reach US$ 112.97 billion by 2034, at a CAGR of 11.48% during the forecast period of 2026-2034. The total addressable market (TAM) for COVID-19 treatment during 2026-2034 is projected to reach approximately US$ 684.34 billion. Another report indicates the global COVID-19 Infection market size was valued at USD 30.25 billion in 2025 and is expected to reach USD 79.28 billion by 2033, at a CAGR of 12.80%.

Capital Allocation Decisions for IRulya Therapeutics (IRLA) (Last 3-5 Years)

Share Issuance

• In May 2026, the company completed a private placement financing with gross upfront proceeds of approximately $115 million, which included the purchase of Series C non-voting convertible preferred stock and warrants.
• On October 6, 2026, stockholders approved the issuance of common shares upon the conversion of Series C preferred stock and related warrants, as well as the exercise of options from the Orphai Therapeutics merger.
• Effective October 6, 2026, the authorized common stock was increased from 250,000,000 to 275,000,000 shares.

Inbound Investments

• A private placement financing in May 2026 generated approximately $115 million in gross upfront proceeds, with net proceeds of $103.6 million, aimed at strengthening the company's financial position.

Outbound Investments

• In May 2022, Cortexyme (then operating as Quince Therapeutics) acquired Novosteo, Inc., a privately held biotech company.
• Quince Therapeutics completed an all-stock merger to acquire Orphai Therapeutics on May 18, 2026.

Capital Expenditures

• As of June 30, 2026, the company held a cash balance of $116 million, which is anticipated to fund its operations, including future capital expenditures, through the end of 2028.
• Research and development (R&D) expense was $5.5 million for the three months ended June 30, 2026, a decrease from $6.6 million in the prior year's comparable quarter, primarily due to the wind-down of the eDSP program.
• General and administrative (G&A) expense significantly increased to $16.6 million for the three months ended June 30, 2026, compared to $3.3 million for the same period in 2025, largely driven by non-cash stock-based compensation and professional fees related to restructuring and the Orphai acquisition.