Product Development - Quince Therapeutics is focused on developing EryDex, a treatment for A-T, with a global market opportunity exceeding $1 billion [145]. - The Phase 3 NEAT clinical trial for EryDex is expected to begin enrollment in Q2 2024, targeting approximately 86 patients aged 6 to 9 and 20 patients aged 10 and older [161]. - EryDex has received orphan drug designation from the U.S. FDA and EU EC for the treatment of A-T [163]. - The previous ATTeST Phase 3 trial involved 176 patients and evaluated two doses of EryDex, with a primary efficacy endpoint based on neurological symptoms measured by mICARS [166]. - The company plans to submit a New Drug Application (NDA) to the FDA in 2026, contingent on positive NEAT trial results [162]. - EryDex is designed to improve the pharmacokinetics and biodistribution of DSP, a corticosteroid, to enhance safety and efficacy [156]. - The company aims to explore additional indications for EryDex in rare diseases where corticosteroid treatment is standard but limited by safety concerns [154]. - The NEAT trial will be conducted under a Special Protocol Assessment (SPA) agreement with the FDA, facilitating NDA submission post-trial [162]. Financial Performance - Research and development expenses increased by 14.6% to $3.7 million for the three months ended March 31, 2024, compared to $3.2 million for the same period in 2023 [185]. - EryDex development costs rose by $2.7 million due to Phase 3 NEAT clinical trial start-up costs, primarily from a $2.4 million increase in clinical trial costs [186]. - General and administrative expenses increased by 29.9% to $5.0 million for the three months ended March 31, 2024, from $3.8 million for the same period in 2023 [190]. - A fair value adjustment for contingent consideration resulted in a $2.5 million charge for the three months ended March 31, 2024, related to the EryDel acquisition [191]. - Interest income increased by 26.7% to $0.887 million for the three months ended March 31, 2024, compared to $0.700 million for the same period in 2023 [185]. - The net loss for the three months ended March 31, 2024, was $11.149 million, a decrease of 9.0% from a net loss of $12.254 million for the same period in 2023 [185]. - No intangible asset impairment charges were recognized during the three months ended March 31, 2024, compared to a $5.9 million charge in the same period of 2023 [193]. - The company anticipates a significant increase in research and development expenses as it prepares to begin enrollment for the Phase 3 NEAT clinical trial [177]. - Personnel-related costs decreased by $0.4 million during the three months ended March 31, 2024, compared to the same period in 2023 [188]. - As of March 31, 2024, the company had an accumulated deficit of $330.8 million and incurred a net loss of $11.1 million for the three months ended March 31, 2024 [198]. Funding and Cash Flow - The company has financed operations through the issuance of convertible promissory notes and redeemable convertible preferred stock, receiving net proceeds of approximately $303.9 million since inception [199]. - Cash, cash equivalents, and short-term investments were $67.8 million as of March 31, 2024, down from $75.1 million as of December 31, 2023 [200]. - The company believes existing capital resources will fund operations into at least 2026, excluding costs associated with in-licensing activities [201]. - Substantial additional funding will be needed to support ongoing operations and development strategies, with potential reliance on equity or debt financing [202]. - Net cash used in operating activities was $8.4 million for the three months ended March 31, 2024, primarily due to the net loss [209]. - Cash provided by investing activities was $8.9 million for the three months ended March 31, 2024, mainly from maturities of short-term investments [211]. - Cash provided by financing activities was $0.2 million for the three months ended March 31, 2024, from the exercise of stock options [212]. - The fair value of long-term contingent consideration related to the EryDel acquisition is $60.3 million, with a short-term portion of $4.7 million as of March 31, 2024 [214]. - The company has approximately $14.3 million in cancellable future operating expense commitments based on existing contracts as of March 31, 2024 [214].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-38890 Quince Therapeutics, Inc. (Exact name of registrant as specified in its Charter) Delaware 90-1024039 (State or other jurisdicti ...

Acquisition and Strategic Focus - The company completed the acquisition of EryDel on October 20, 2023, issuing 6,525,315 shares, resulting in EryDel shareholders owning approximately 15.2% of the company[146]. - The company has shifted its strategic focus to rare diseases following the acquisition of EryDel, aiming to develop innovative therapeutics[143]. Financial Performance - The company incurred a net loss of $5.4 million and $22.5 million for the three and nine months ended September 30, 2023, respectively, with an accumulated deficit of $310.8 million[155]. - The net loss for the three months ended September 30, 2023, was $5.4 million, a reduction of 32.4% from a net loss of $7.9 million in the same period of 2022[173]. - The loss from operations for the nine months ended September 30, 2023, was $24.7 million, a decrease of 45.9% from a loss of $45.7 million in the same period of 2022[186]. - The company does not expect any additional expenses related to legacy assets COR388 and COR588 following their sale to Lighthouse in January 2023[189]. Cash and Investments - As of September 30, 2023, the company had cash, cash equivalents, and short-term investments totaling $83.2 million, which is expected to fund operations into at least 2026[153]. - The company anticipates that existing cash will be sufficient to fund operations through at least 2026, assuming positive results from the Phase 3 NEAT trial[199]. - Net cash used in operating activities was $12.2 million for the nine months ended September 30, 2023, primarily due to a net loss of $22.5 million[208]. - Net cash used by investing activities was $11.1 million, primarily related to the purchase of investments of $95.1 million[210]. Research and Development - The company plans to initiate a pivotal Phase 3 NEAT trial for EryDex in the second quarter of 2024, targeting approximately 86 A-T patients aged six to nine years and 20 additional patients aged 10 years or older[143]. - Research and development expenses decreased to $1.4 million for the three months ended September 30, 2023, down from $2.4 million in the same period of 2022, representing a decrease of 41.6%[175]. - Total research and development expenses for the nine months ended September 30, 2023, were $6.0 million, a decrease of 73.2% from $22.4 million in the same period of 2022[186]. - The costs for atuzaginstat (COR388) development decreased by $1.2 million for the nine months ended September 30, 2023, primarily due to reduced drug manufacturing and consulting costs[187]. - For the nine months ended September 30, 2023, costs for NOV004 increased by $0.9 million due to drug manufacturing costs in preparation for Phase 1 clinical trials, but will be minimal for the remainder of 2023[190]. - Other direct research costs decreased by $1.5 million primarily due to the winddown of pipeline development of legacy assets sold to Lighthouse in January 2023[191]. Cost Management - A cost reduction program was implemented in January 2023, resulting in a 47% reduction in workforce, with associated expenses of approximately $0.4 million[151]. - Personnel-related expenses decreased by $9.5 million, including a $4.9 million decrease in stock-based compensation and a $3.0 million reduction in headcount year over year[192]. - General and administrative expenses decreased approximately $9.7 million to $12.8 million, primarily due to a decrease in personnel-related expenses and legal fees[193]. - General and administrative expenses increased by $0.3 million to $4.7 million for the three months ended September 30, 2023, compared to $4.3 million for the same period in 2022, an increase of 7.3%[182]. Impairment and Charges - The company recorded a non-cash impairment charge of $5.9 million for intangible assets during the nine months ended September 30, 2023[186]. - An impairment charge of $5.9 million was recorded for the IPR&D intangible asset due to a significant decrease in fair value[194]. Interest Income - Interest income increased significantly by 204.4% to $959,000 for the three months ended September 30, 2023, compared to $315,000 in the same period of 2022[173]. - Interest income increased to $2.5 million for the nine months ended September 30, 2023, compared to $0.5 million for the same period in 2022, due to increased yields on the investment portfolio[195].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission File Number: 001-38890 Quince Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) ( State o ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission File Number: 001-38890 Quince Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Delaware ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 (Exact name of registrant as specified in its Charter) OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO (Mark One) Commission File Number 001-38890 Quince Therapeutics, Inc. Delaware 90-1024039 (State or other jurisdicti ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission File Number: 001-38890 Quince Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Dela ...

Advancing innovative precision therapeutics for debilitating and rare diseases CANACCORD GENUITY 42ND ANNUAL GROWTH CONFERENCE A u g u s t 1 1 , 2 0 2 2 Forward-looking statements 2 Statements in this presentation contain "forward-looking statements" that are subject to substantial risks and uncertainties. Forward-looking statements contained in this presentation may be identified by the use of words such as "expect," "will," "estimate," "project," "potential," "positioned," "advancing," "planned," "progres ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission File Number: 001-38890 Quince Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission File Number: 001-38890 Cortexyme, Inc. (Exact Name of Registrant as Specified in its Charter) ( State or other j ...