QNCX

EX-99.1

2 d163839dex991.htm

EX-99.1

EX-99.1

Exhibit 99.1

Quince Therapeutics Reports Second Quarter 2026 Financial Results and Corporate Update

Completed acquisition of Orphai Therapeutics, adding LAM-001, an inhaled formulation of rapamycin for the treatment of multiple serious, underserved pulmonary diseases, to pipeline

LAM-001

Phase 2b data in PH-ILD anticipated in the first quarter of 2028; Phase 2 data in BOS anticipated in the first quarter of 2027

Closed private placement financing, receiving $115 million in upfront gross proceeds, with potential for up to an additional $83 million upon exercise of warrants (including warrants issued to former Orphai stockholders)

Cash and cash equivalents of $116 million as of June 30, 2026, expected to fund operations through the end of 2028

South San Francisco, CA, August 14, 2026 – Quince Therapeutics, Inc. (Nasdaq: QNCX), a clinical stage biopharmaceutical company focused on the development of novel, disease modifying therapies for serious underserved diseases, today provided a business update and reported financial results for the second quarter ended June 30, 2026.

“This was a transformational quarter for the company with a renewed focus on a differentiated, late-stage pulmonary pipeline anchored by LAM-001 as well as a strengthened balance sheet to support our development plans,” said Dr. Brigette Roberts, former CEO of Orphai Therapeutics and Chief Corporate Affairs Officer of Quince Therapeutics. “We are pleased to have initiated the Phase 2b trial of LAM-001 for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), and look forward to releasing top line bronchiolitis obliterans syndrome post lung transplant (BOS) data in the first quarter of next year. Inhibition of the mTOR pathway via LAM-001 has the potential to offer PH-ILD and BOS patients a new treatment option that is designed to target and potentially reverse key elements of the underlying pathophysiology of these devastating diseases.”

Second Quarter and Recent Business Highlights

•

Completed Orphai acquisition and closed a concurrent $115 million private placement financing. On May 18, 2026, Quince completed a stock-for-stock merger to acquire Orphai, a clinical-stage biotechnology company, bringing Orphai’s lead program, LAM-001, an inhaled formulation of rapamycin (an mTOR inhibitor), into the pipeline. LAM-001 is being developed for the treatment of serious, underserved pulmonary diseases, including PH-ILD, BOS, and sarcoidosis-associated pulmonary hypertension (SAPH).

Concurrent with the acquisition, Quince entered into a definitive agreement for a private placement financing with gross upfront proceeds of $115 million, yielding net proceeds of $103.6 million after deducting placement agent and other offering expenses of $11.4 million, for the purchase of shares of Series C non-voting convertible preferred stock and up to an additional $83 million upon the exercise of warrants (including warrants issued to former Orphai stockholders).

•

Advancing the LAM-001 clinical program. Clinical sites have been

activated and the company is actively screening subjects for its Phase 2b trial of LAM-001 in PH-ILD. Topline data is anticipated in the first quarter of 2028. The company also continues to expect data from the Phase 2 trial of LAM-001 in BOS in the first quarter of 2027. The Phase 2 trial of LAM-001 in SAPH is anticipated to begin in late 2026, with data expected in the fourth quarter of 2028.

•

Presented new LAM-001 Phase 2a data at the American Thoracic Society

(ATS) Conference. Data from the Phase 2a trial of LAM-001 in 10 adult patients with PAH and PH-ILD demonstrated clinically meaningful improvement across functional, hemodynamic, and biomarker measures of disease. A mean improvement in six-minute walk distance (6MWD) of 67.4 meters and a mean reduction in pulmonary vascular resistance (PVR) (supine) of 33.9% at 24 weeks were seen in PH-ILD patients. A mean 6MWD improvement of 81.3 meters and a mean reduction in PVR (supine) of 28.1% were seen in the combined evaluable population of PAH and PH-ILD patients.The drug was generally well tolerated in both populations.

•

Formed Scientific Advisory Board (SAB). Appointed five internationally recognized experts in pulmonary medicine to an SAB – Dr. Paul Yu, Dr. Aaron Waxman, Dr. Steven Nathan, Dr. Steve Hays, and Dr. Robert Baughman – who Quince believes will be instrumental in helping to progress the development of LAM-001 across multiple pulmonary indications.

Second Quarter 2026 Financial Results

Cash position: Cash and cash equivalents were $116 million as of June 30, 2026, which reflects the $103.6 million in net upfront proceeds from the private placement. The Company expects that its cash position will be sufficient to fund operations through the end of 2028.

Research and development (R&D) expense: R&D expense for the three months ended June 30, 2026 was $5.5 million, compared t

8-K

false 0001662774 0001662774 2026-02-12 2026-02-12

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 12, 2026

Quince Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware

001-38890

90-1024039

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

611 Gateway Boulevard

Suite 273

South San Francisco, California

94080

(Address of Principal Executive Offices)

(Zip Code) Registrant’s Telephone Number, Including Area Code: (415) 910-5717

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.001 per share

QNCX

Nasdaq Global Select Market Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition.

As of December 31, 2025, Quince Therapeutics, Inc. (the “Company” or “we”) had approximately $5.8 million of cash and cash equivalents and $11.9 million of short-term investments, and $16.4 million outstanding on its unsecured line of credit between Quince Therapeutics, S.p.A and the European Investment Bank (the “EIB Loan”). The foregoing estimates are preliminary and unaudited and reflects the Company’s preliminary estimates with respect to its cash and short-term investments and balance of its EIB Loan at December 31, 2025, based on currently available information and is subject to completion of its year-end financial closing procedures. This estimate should not be viewed as a substitute for the Company’s annual financial statements prepared in accordance with U.S. generally accepted accounting practices. Neither the Company’s independent auditors, nor any other independent accountants, have audited, reviewed, compiled, examined, or performed any procedures with respect to this preliminary financial information. Further, the Company’s preliminary estimated results are not necessarily indicative of the results to be expected for any future period as a result of various factors.

Item. 8.01 Other Events.

The Company is updating certain disclosures about its business and the risk factors applicable to its business contained in its prior public filings, including its Annual Report on Form 10-K for the year ended December 31, 2024 and its Quarterly Reports on the Form 10-Q for the period ended September 30, 2025 filed with the Securities and Exchange Commission. Preliminary Financial Data as of December 31, 2025 The information contained above in Item 2.02 is hereby incorporated by reference into this Item 8.01.

Strategic Alternatives On February 9, 2026, we engaged LifeSci Capital as our exclusive financial advisor to assist in restructuring activities and an evaluation of strategic alternatives aimed at maximizing shareholder value. Based on our initial evaluation, we plan to focus our efforts with respect to strategic alternatives, including effecting a reverse merger. We do not currently have any agreements or commitments to effect any such transactions and may not be able to execute such transactions on terms favorable to us and our stockholders, or at all. While we may also sell assets relating to our previous product candidates, we do not expect to receive any meaningful consideration from such sale, if any. In order to fund our current efforts to pursue strategic alternatives, including a reverse merger, we intend to obtain additional funding through available financing sources, which may include additional public offerings of common stock, including sales of common stock, under a Controlled Equity OfferingSM Sales Agreement, dated December 18, 2024, with Cantor Fitzgerald & Co. and H.C. Wainw

8-K

0001662774false00016627742025-11-122025-11-12

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 12, 2025

Quince Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware

001-38890

90-1024039

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

611 Gateway Boulevard Suite 273

South San Francisco, California

94080

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (415) 910-5717

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.001 per share

QNCX

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition. On November 12, 2025, Quince Therapeutics, Inc. (the “Company”) announced its financial results for the quarter ended September 30, 2025 and provided recent business highlights. A copy of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information contained in Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such filing. Item 9.01 Financial Statements and Exhibits. (d) Exhibits.

Exhibit No.

Description

99.1

Press release issued by Quince Therapeutics, Inc. dated November 12, 2025

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

QUINCE THERAPEUTICS, INC.

Date:

November 12, 2025

By:

/s/ Dirk Thye

Name: Title:

Dirk Thye Chief Executive Officer and Chief Medical Officer

8-K

false000166277400016627742025-08-112025-08-11

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 11, 2025

Quince Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware

001-38890

90-1024039

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

601 Gateway Boulevard Suite 1250

South San Francisco, California

94080

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (415) 910-5717

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.001 per share

QNCX

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition. On August 11, 2025, Quince Therapeutics, Inc. (the “Company”) announced its financial results for the quarter ended June 30, 2025 and provided recent business highlights. A copy of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information contained in Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such filing. Item 9.01 Financial Statements and Exhibits. (d) Exhibits.

Exhibit No.

Description

99.1

Press release issued by Quince Therapeutics, Inc. dated August 11, 2025

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

QUINCE THERAPEUTICS, INC.

Date:

August 11, 2025

By:

/s/ Dirk Thye

Name: Title:

Dirk Thye Chief Executive Officer and Chief Medical Officer

qncx-202505130001662774false00016627742025-05-132025-05-13

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 13, 2025

QUINCE THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware001-3889090-1024039 (State or other jurisdiction of incorporation or organization) (Commission File Number) (I.R.S. Employer Identification No.)

601 Gateway Boulevard , Suite 1250 South San Francisco, California 94080 (Address of principal executive offices)(Zip Code) Registrant’s telephone number, including area code: (415) 910-5717

Not Applicable (Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

oPre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13d-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol(s)Name of each exchange on which registered

Common Stock, par value $0.001 per shareQNCXThe Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company o If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Item 2.02    Results of Operations and Financial Condition. On May 13, 2025, Quince Therapeutics, Inc. (the “Company”) announced its financial results for the quarter ended March 31, 2025 and provided recent business highlights. A copy of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information contained in Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits. (d) Exhibits.

Exhibit No.Description

99.1Press release issued by Quince Therapeutics, Inc. dated May 13, 2025

104Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

QUINCE THERAPEUTICS, INC.

By:/s/ Dirk Thye Date: May 13, 2025 Name:Dirk Thye Title:Chief Executive Officer and Chief Medical Officer

qncx-202503240001662774false00016627742025-03-242025-03-24

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 24, 2025

QUINCE THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware001-3889090-1024039 (State or other jurisdiction of incorporation or organization) (Commission File Number) (I.R.S. Employer Identification No.)

601 Gateway Boulevard , Suite 1250 South San Francisco, California 94080 (Address of principal executive offices)(Zip Code) Registrant’s telephone number, including area code: (415) 910-5717

Not Applicable (Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

oPre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13d-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol(s)Name of each exchange on which registered

Common Stock, par value $0.001 per shareQNCXThe Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company o If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Item 2.02    Results of Operations and Financial Condition. On March 24, 2025, Quince Therapeutics, Inc. (the “Company”) announced its financial results for the fiscal year ended December 31, 2024 and provided recent business highlights. A copy of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information contained in Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits. (d) Exhibits.

Exhibit No.Description

99.1Press release issued by Quince Therapeutics, Inc. dated March 24, 2025

104Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

QUINCE THERAPEUTICS, INC.

By:/s/ Dirk Thye Date: March 24, 2025 Name:Dirk Thye Title:Chief Executive Officer and Chief Medical Officer

qncx-202411130001662774false00016627742024-11-132024-11-13

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 13, 2024

QUINCE THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware001-3889090-1024039 (State or other jurisdiction of incorporation or organization) (Commission File Number) (I.R.S. Employer Identification No.)

601 Gateway Boulevard , Suite 1250 South San Francisco, California 94080 (Address of principal executive offices)(Zip Code) Registrant’s telephone number, including area code: (415) 910-5717

Not Applicable (Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

oPre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13d-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol(s)Name of each exchange on which registered

Common Stock, par value $0.001 per shareQNCXThe Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company o If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Item 2.02    Results of Operations and Financial Condition. On November 13, 2024, Quince Therapeutics, Inc. (the “Company”) announced its financial results for the quarter ended September 30, 2024 and provided recent business highlights. A copy of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information contained in Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits. (d) Exhibits.

Exhibit No.Description

99.1Press release issued by Quince Therapeutics, Inc. dated November 13, 2024

104Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

QUINCE THERAPEUTICS, INC.

By:/s/ Dirk Thye Date: November 13, 2024Name:Dirk Thye Title:Chief Executive Officer and Chief Medical Officer

qncx-202408130001662774false00016627742024-08-132024-08-13

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 13, 2024

QUINCE THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware001-3889090-1024039 (State or other jurisdiction of incorporation or organization) (Commission File Number) (I.R.S. Employer Identification No.)

601 Gateway Boulevard , Suite 1250 South San Francisco, California 94080 (Address of principal executive offices)(Zip Code) Registrant’s telephone number, including area code: (415) 910-5717

Not Applicable (Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

oPre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13d-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol(s)Name of each exchange on which registered

Common Stock, par value $0.001 per shareQNCXThe Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company o If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Item 2.02    Results of Operations and Financial Condition. On August 13, 2024, Quince Therapeutics, Inc. (the “Company”) announced its financial results for the quarter ended June 30, 2024 and provided recent business highlights. A copy of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information contained in Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits. (d) Exhibits.

Exhibit No.Description

99.1Press release issued by Quince Therapeutics, Inc. dated August 13, 2024

104Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

QUINCE THERAPEUTICS, INC.

By:/s/ Dirk Thye Date: August 13, 2024Name:Dirk Thye Title:Chief Executive Officer and Chief Medical Officer

8-K

false 0001662774 0001662774 2023-07-21 2023-07-21 0001662774 us-gaap:CommonStockMember 2023-07-21 2023-07-21 0001662774 us-gaap:SeriesAPreferredStockMember 2023-07-21 2023-07-21

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 21, 2023

QUINCE THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-38890

90-1024039

(State or other jurisdiction of incorporation or organization)

(Commission File Number)

(I.R.S. Employer Identification No.)

601 Gateway Boulevard, Suite 1250 South San Francisco, California

94080

(Address of principal executive offices)

(Zip Code) Registrant’s telephone number, including area code: (415) 910-5717 Not Applicable (Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13d-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.001 per share

QNCX

The Nasdaq Stock Market LLC

Series A Junior Participating Preferred Purchase Rights

N/A

The Nasdaq Stock Market LLC Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company  ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

Item 1.01. Entry into a Material Definitive Agreement

On July 21, 2023 (the “Agreement Date”), Quince Therapeutics, Inc., a Delaware corporation (the “Company”), EryDel Italy, Inc., a Delaware corporation and wholly owned indirect subsidiary of the Company, EryDel S.p.A, a company with shares incorporated under the laws of Italy, (“EryDel”), holders of EryDel capital stock and the managers of EryDel (the “EryDel Shareholders”) and Shareholder Representative Services LLC, a Colorado limited liability company solely in its capacity as the representative, agent and attorney-in-fact of the EryDel Shareholders, entered into a Stock Purchase Agreement (the “Purchase Agreement”), pursuant to which, and subject to the terms and conditions set forth in the Purchase Agreement, the Company will indirectly acquire all of the outstanding equity interests of EryDel (the “EryDel Acquisition”). Upon completion of the EryDel Acquisition, (i) the Company will issue up to 7,250,352 shares of common stock of the Company to the EryDel Shareholders, subject to downward adjustment (the “Company Common Stock”), resulting in the EryDel Shareholders owning a maximum of approximately 16.7% of the outstanding common stock of the Company, and (ii) the EryDel Shareholders will have a contingent right to receive up to an aggregate of $485,000,000 in potential cash payments, comprised of up to $5,000,000 upon the achievement of a specified development milestone, $25,000,000 at NDA acceptance, up to $60,000,000 upon the achievement of specified approval milestones, and up to $395,000,000 upon the achievement of specified on market and sales milestones, with no royalties paid to EryDel. The Company will also assume in the transaction EryDel’s $13 million (€10 million in principal) European Investment Bank (EIB) loan with scheduled payments beginning in the second half of 2026. The completion of the EryDel Acquisition is subject to customary conditions, including: (a) the absence of any legal proceeding that has the effect of enjoining or otherwise making illegal the consummation of the EryDel Acquisition; (b) the approval for listing on the Nasdaq Stock Market shares of Company Common Stock issuable pursuant to the Purchase Agreement; (c) subject to certain exceptions, the accuracy of the representations and warranties of the other party and performance by each party in all material respects of its obligations under the Purchase Agreement; (d) the absence of a material adverse effect on the Company or EryDel; and (e) retention of certain key employees. The Company and EryDel are permitted under

8-K

false 0001662774 0001662774 2023-01-24 2023-01-24

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 24, 2023

QUINCE THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-38890

90-1024039

(State or other jurisdiction of incorporation or organization)

(Commission File Number)

(I.R.S. Employer Identification No.)

601 Gateway Boulevard, Suite 1250. South San Francisco, California

94080

(Address of principal executive offices)

(Zip Code) Registrant’s telephone number, including area code: (415) 910-5717 Not Applicable (Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13d-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.001 per share

QNCX

Nasdaq Global Select Market Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

ITEM 2.02 Results of Operations and Financial Condition. On January 30, 2023, Quince Therapeutics, Inc. (the “Company”) issued a press release relating to the Company’s development pipeline and business outlook for 2023. The Company also reported on a preliminary and unaudited basis its estimated cash, cash equivalents, and marketable securities of approximately $94 million as of December 31, 2022. The Company has not completed preparation of its financial statements for the fourth quarter or full year of 2022. The cash, cash equivalents and marketable securities presented as of December 31, 2022 are preliminary and unaudited and are thus inherently uncertain and subject to change as the Company completes its financial results for 2022. The Company is in the process of completing its customary year-end close and review procedures as of and for the year ended December 31, 2022, and there can be no assurance that its final results for this period will not differ from these preliminary, unaudited amounts. The Company’s independent registered public accounting firm has not audited, reviewed, compiled, or performed any procedures with respect to such preliminary data for the fourth quarter and year ended December 31, 2022. The information in Item 2.02 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing, regardless of any general incorporation language in such filing. ITEM 2.05 Costs Associated with Exit or Disposal Activities. On January 24, 2023, the Board of Directors (the “Board”) of the Company approved the cost reduction program (the “Plan”) to align operations with the changes in corporate strategy. Under the Plan, the Company is reducing headcount by approximately 47% through a reduction in its workforce. The reduction in force will begin in February 2023 and will be completed by April 2023. As a result, the Company expects to realize estimated annualized operating expense savings of approximately $9.5 million in the year ending December 31, 2023 (excluding share-based compensation and any one-time costs related to strategic actions). In connection with the Plan, the Company estimates that it will incur expenses of approximately $0.6 million to $0.8 million, substantially all of which will be cash expenditures and other costs relating to the Plan through August 2023. The Company may incur other charges, including contract termination costs, retirement of fixed assets and facility-related costs and will record these exp

8-K

CORTEXYME, INC. --12-31 false 0001662774 0001662774 2022-08-01 2022-08-01

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 1, 2022

QUINCE THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-38890

90-1024039

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(I.R.S. Employer

Identification No.)

601 Gateway Blvd Ste 1250

South San Francisco, California

94080

(Address of principal executive offices)

(Zip Code) Registrant’s telephone number, including area code: (415) 910-5717 Cortexyme, Inc. (Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.001 par value per share

CRTX

Nasdaq Global Select Market Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition.

On August 1, 2022, Cortexyme, Inc. (“Cortexyme,” the “Company,” or “we”) reported that we had approximately $105 million in cash, cash equivalents and short-term investments as of June 30, 2022. These are preliminary estimates based on currently available information and do not present all necessary information for a complete understanding of the Company’s financial condition as of June 30, 2022 or the Company’s expectations for the results of operations for the year ending December 31, 2022, or any future annual or interim period. The information in Item 2.02 of this current report on Form 8-K is furnished and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Act of 1934, as amended, except as shall be expressly set forth by specific reference in any such filing, regardless of any general incorporation language in such filing.

Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.

Effective August 1, 2022, we changed our name from “Cortexyme, Inc.” to “Quince Therapeutics, Inc.” by filing a certificate of amendment (“Certificate of Amendment”) to our Certificate of Incorporation with the Secretary of State of the State of Delaware. We also amended and restated our bylaws to reflect the change to our name, effective August 1, 2022. The Certificate of Amendment and amended and restated bylaws are attached hereto as Exhibit 3.1 and Exhibit 3.2, respectively, and are incorporated herein by reference. In connection with the name change, our common stock will trade on The Nasdaq Global Select Market under the new ticker symbol “QNCX”. The new ticker symbol has become effective at the open of the market on August 1, 2022.

Item 8.01 Other Events.

On August 1, 2022, the Company issued a press release titled “Quince Therapeutics Details Strategic Growth Plan with Launch of New Corporate Name.” A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

Exhibit No.

Description

3.1

Certificate of Amendment to the registrant’s Certificate of Incorporation, effective August 1, 2022.

3.2

Amended and Restated Bylaws

99.1

Press Release Dated August 1, 2022.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

1

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Date: August 1, 2022

Quince Therapeutics, Inc.

By:

/s/ Dirk Thye

Dirk Thye, M.D.

Chief Executive Officer

2

8-K

false 0001662774 0001662774 2022-05-07 2022-05-07

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 7, 2022

CORTEXYME, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-38890

90-1024039

(State or other jurisdiction of incorporation)

(Commission File Number)

(I.R.S. Employer Identification No.)

269 East Grand Ave. South San Francisco, California

94080

(Address of principal executive offices)

(Zip Code) Registrant’s telephone number, including area code: (415) 910-5717 Not Applicable (Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.001 par value per share

CRTX

Nasdaq Global Select Market Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 1.01 Entry into a Material Definitive Agreement. Overview of the Merger Agreement On May 9, 2022, Cortexyme, Inc. (“Cortexyme”, “Parent” or the “Company”) entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”) with Novosteo Inc., a Delaware corporation (“Novosteo”), Quince Merger Sub I, Inc., a Delaware corporation and wholly owned subsidiary of Parent (“Merger Sub I”), Quince Merger Sub II, LLC, a Delaware limited liability company and wholly owned subsidiary of Parent (“Merger Sub II”) and Fortis Advisors LLC, a Delaware limited liability company, solely in its capacity as the representative of the Participating Securityholders (as defined in the Merger Agreement). The Merger Agreement provides that, upon the terms and subject to the conditions set forth therein, Merger Sub I will merge with and into Novosteo (the “First Merger”), with Novosteo as the surviving entity in the First Merger (the “First Step Surviving Corporation”). Immediately following the First Merger, the First Step Surviving Corporation will merge with and into Merger Sub II, with Merger Sub II surviving the merger (the “Second Merger”, and together with the First Merger, the “Mergers”). The Merger Agreement also provides, among other things, that upon consummation of the First Merger, Parent will appoint Dirk Thye, M.D., the current Chief Executive Officer of Novosteo, as Chief Executive Officer of Parent, Karen Smith, M.D., Ph.D., the current Chief Medical Officer of Novosteo, as Chief Medical Officer of Parent and Brendan Hannah, the current Chief Operating Officer of Novosteo, as Chief Business Officer of Parent. In addition, Parent has agreed to expand Parent’s Board of Directors (the “Board”) to appoint Dr. Thye and Philip Low, Ph.D., each a current director of Novosteo, as a Class II and Class I director of the Board, respectively. Prior to the closing of the Mergers, all shares of Novosteo preferred stock will be converted into shares of Novosteo common stock. At the effective time of the First Merger: (i) each outstanding share of Novosteo common stock (other than certain specified shares, including shares held by any stockholder who has properly exercised and perfected such holder’s demand for appraisal rights under Delaware law) will be converted into the right to receive a certain number of shares of Parent common stock to be determined at the closing of the First Merger (such ratio, the “Exchange Ratio”); and (ii) each outstanding Novosteo stock option or unvested restricted stock award granted under Novosteo’s equity compensation plans will be converted into a corresponding award with respect to Parent’s common stock, with the number of shares underlying such award (and, in the case of stock options, the applicable exercise price) adjusted based on the Exchange Ratio. Each such converted equity award will continu

8-K

false 0001662774 0001662774 2022-01-28 2022-01-28

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 28, 2022

CORTEXYME, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-38890

90-1024039

(State or other jurisdiction of incorporation or organization)

(Commission File Number)

(I.R.S. Employer Identification No.)

269 East Grand Ave. South San Francisco, California

94080

(Address of principal executive offices)

(Zip Code) Registrant’s telephone number, including area code: (415) 910-5717 Not Applicable (Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13d-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.001 per share

CRTX

Nasdaq Global Select Market Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

ITEM 2.02     Results of Operations and Financial Condition. On February 1, 2022, Cortexyme, Inc. (the “Company”) issued a press release relating to the Company’s pipeline update and anticipated milestones for 2022. The Company also reported on a preliminary and unaudited basis its estimated cash, cash equivalents, and investments of $126.7 million as of December 31, 2021. The Company has not completed preparation of its financial statements for the fourth quarter or full year of 2021. The cash, cash equivalents and investments presented as of December 31, 2021 are preliminary and unaudited and are thus inherently uncertain and subject to change as the Company completes its financial results for 2021. The Company is in the process of completing its customary year-end close and review procedures as of and for the year ended December 31, 2021, and there can be no assurance that its final results for this period will not differ from these preliminary, unaudited amounts. The Company’s independent registered public accounting firm has not audited, reviewed, compiled, or performed any procedures with respect to such preliminary data for the fourth quarter and year ended December 31, 2021. The information in Item 2.02 of this Current Report on From 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing, regardless of any general incorporation language in such filing. ITEM 2.05    Costs Associated with Exit or Disposal Activities. On February 2, 2022, the Board of Directors (the “Board”) of the Company approved the previously announced cost reduction program (the “Plan”) to rationalize operations and to allow continued support for the needs of its business following the clinical hold on atuzaginstat’s (COR388) Investigational New Drug application (IND 134303). Under the Plan, the Company is reducing headcount by approximately 53% through a reduction in its workforce. A majority of the reduction in force will take place by March 2022, and the remainder will be completed by July 2022. As a result, the Company expects to realize estimated annualized operating expense savings of approximately $8.3 million in the year ending December 31, 2022 (excluding share-based compensation and any one-time costs related to strategic actions). In connection with the Plan, the Company estimates that it will incur expenses of approximately $1.9 million to $2.1 million, substantially all of which will be cash expenditures and other costs relating to the Plan through the first quarter of 2023. These estimates are subject to a number of assumpti

8-K

false 0001662774 0001662774 2021-01-26 2021-01-26

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 26, 2021

CORTEXYME, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-38890

90-1024039

(State or other jurisdiction of incorporation or organization)

(Commission File Number)

(I.R.S. Employer Identification No.)

269 East Grand Ave. South San Francisco, California

94080

(Address of principal executive offices)

(Zip Code) Registrant’s telephone number, including area code: (415) 910-5717 Not Applicable (Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13d-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.001 per share

CRTX

Nasdaq Global Select Market Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company  ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

ITEM 2.02

RESULTS OF OPERATIONS AND FINANCIAL CONDITION

On January 26, 2021, Cortexyme, Inc. (the “Company”) issued a press release, which provided a pipeline update and anticipated milestones for 2021. The Company also reported on a preliminary and unaudited basis estimated cash and investments as of December 31, 2020 on a pro forma basis. These are preliminary estimates based on currently available information and do not present all necessary information for a complete understanding of the Company’s financial condition as of December 31, 2020, or the Company’s results of operations for the year ended December 31, 2020. A copy of the press release is furnished as Exhibit 99.1 to this report. The information in Item 2.02 of this Current Report on From 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing, regardless of any general incorporation language in such filing.

ITEM 8.01

OTHER EVENTS

On January 26, 2021, the Company issued a press release titled “Cortexyme Announces Pipeline Update and Anticipated 2021 Milestones.” A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

ITEM 9.01

FINANCIAL STATEMENTS AND EXHIBITS

(d) Exhibits

Number

Description

99.1

Press Release dated January 26, 2021.

104

Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

CORTEXYME, INC.

By:

/s/ Caryn G. McDowell

Date: January 26, 2021

Title:

Chief Legal and Administrative Officer and Corporate Secretary

8-K 1 d911699d8k.htm 8-K

8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT

REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 12, 2020

CORTEXYME, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-38890

90-1024039

(State or other jurisdiction

of incorporation or organization)

(Commission

File Number)

(I.RS. Employer

Identification No.)

269 East Grand Ave.South San Francisco, California

94080

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (415) 910-5717 Not Applicable

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13d-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange

on which registered

Common Stock, par value $0.001 per share

CRTX

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☒

Item 2.02. Results of Operations and Financial Conditions

On May 12, 2020, Cortexyme Inc., (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2020. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information set forth in this Item 2.02. (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing. Item 9.01. Financial Statements and Exhibits (d) Exhibits The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed:

ExhibitNo.

Description

99.1

Press release dated May 12, 2020 titled “ Cortexyme Announces First Quarter 2020 Financial Results and Provides Business Update.”

2

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

CORTEXYME, INC.

By:

/s/ Christopher Lowe

Date:    May 12, 2020

Title:

Chief Financial Officer

3

8-K 1 d902922d8k.htm 8-K

8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT

REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 17, 2020

CORTEXYME, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-38890

90-1024039

(State or other jurisdiction of

incorporation or organization)

(Commission

File Number)

(I.R.S. Employer

Identification No.)

269 East Grand Ave.

South San Francisco, California

94080

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (415) 910-5717 Not Applicable

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13d-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.001 per share

CRTX

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☒

Item 2.02. Results of Operations and Financial Conditions

On March 17, 2020, Cortexyme Inc., (the “Company”) issued a press release announcing its financial results for its fourth quarter and fiscal year ended December 31, 2019. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information set forth in this Item 2.02. (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits

(d) Exhibits

The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed:

Exhibit No.

Description

99.1

Press release dated March 17, 2020 titled “Cortexyme Announces Fourth Quarter and Full Year 2019 Financial Results and Provides Business Update.”

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

CORTEXYME, INC.

By:

/s/ Christopher Lowe

Date:

March 17, 2020

Title:

Chief Financial Officer

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