INFINITY PHARMACEUTICALS, INC. Form 8-K Current Event Report
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SECURITIES AND EXCHANGE COMMISSION FORM 8-K Current report filing Filing Date: 2021-07-27 | Period of Report: 2021-07-27 SEC Accession No. 0001113148-21-000018 (HTML Version on secdatabase.com) FILER INFINITY PHARMACEUTICALS, INC. Mailing Address Business Address 1100 MASSACHUSETTS 1100 MASSACHUSETTS CIK:1113148| IRS No.: 330655706 | State of Incorp.:DE | Fiscal Year End: 1231 AVENUE AVENUE Type: 8-K | Act: 34 | File No.: 000-31141 | Film No.: 211115925 FLOOR 4 FLOOR 4 SIC: 2834 Pharmaceutical preparations CAMBRIDGE MA 02138 CAMBRIDGE MA 02138 6174531000 Copyright © 2021 www.secdatabase.com. All Rights Reserved. Please Consider the Environment Before Printing This Document 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 27, 2021 Infinity Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 000-31141 33-0655706 (State or other jurisdiction (Commission File Number) (IRS Employer of incorporation) Identification No.) 1100 Massachusetts Avenue, Floor 4, Cambridge, MA 02138 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: (617) 453-1000 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: Copyright © 2021 www.secdatabase.com. All Rights Reserved. Please Consider the Environment Before Printing This Document Title of Class Trading Symbol Name of Exchange on Which Registered Common Stock, $0.001 par value INFI 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 July 27, 2021, Infinity Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its results for the quarter ended June 30, 2021. A copy of this press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The information contained on the websites referenced in the press release is not incorporated herein. This information and Exhibit 99.1 hereto 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 (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such a filing. Item 7.01. Regulation FD Disclosure. On July 27, 2021, the Company intends to present a slide presentation on a conference call reviewing data from MARIO-275, the Company’s randomized, placebo-controlled Phase 2 clinical trial evaluating the efficacy and safety of eganelisib in combination with nivolumab (Opdivo®) in platinum-refractory, I/O naïve patients with advanced urothelial cancer, as well as data from MARIO-3, the Company’s Phase 2 clinical trial evaluating eganelisib in a triple combination in the front-line setting with Tecentriq® (atezolizumab) and Abraxane® (nab-paclitaxel) in patients with unresectable locally advanced or metastatic triple negative breast cancer. A copy of this slide presentation, dated July 27, 2021, is attached as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. This information and Exhibit 99.2 hereto shall not be deemed “filed” for purposes of Section 18 of 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 or the Exchange Act, except as expressly set forth by specific reference in such a filing. Item 8.01. Other Events. On July 27, 2021, the Company issued a press release announcing data from MARIO-275 and MARIO-3 clinical trials. A copy of this press release is filed as Exhibit 99.3 to this Current Report on Form 8-K and is incorporated herein by reference. The information contained on websites referenced in the press release is not incorporated herein. *** Forward-Looking Statements This Current Report on Form 8-K and the exhibits attached hereto contain forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that the Company makes due to a number of important factors, including those Risk Factors discussed in the Company’s annual and quarterly reports filed with the Securities and Exchange Commission (“SEC”), and its other filings with the SEC, available through the Company’s website at www.infi.com. Any forward-looking statements contained in Copyright © 2021 www.secdatabase.com. All Rights Reserved. Please Consider the Environment Before Printing This Document this Current Report on Form 8-K speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Copyright © 2021 www.secdatabase.com. All Rights Reserved. Please Consider the Environment Before Printing This Document Item 9.01. Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press release dated July 27, 2021 99.2 Presentation dated July 27, 2021 99.3 Press release dated July 27, 2021 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) Copyright © 2021 www.secdatabase.com. All Rights Reserved. Please Consider the Environment Before Printing This 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. INFINITY PHARMACEUTICALS, INC. Date: July 27, 2021 By: /s/ Seth A. Tasker Seth A. Tasker Chief Business Officer Copyright © 2021 www.secdatabase.com. All Rights Reserved. Please Consider the Environment Before Printing This Document Exhibit 99.1 Infinity Pharmaceuticals Reports Second Quarter 2021 Financial Results and Provides Company Update – New clinical data from MARIO-275 and MARIO-3 suggest that the addition of eganelisib to standard of care regimens provides patient benefit – – Increases seen in overall survival in 2L urothelial cancer (UC) and in progression free survival in 1L triple negative breast cancer (TNBC), in both cases regardless of PD-L1 status – – Stéphane Peluso, Ph.D., returns to Infinity as Chief Scientific Officer – – Cash balance of $97.3M to fund eganelisib development – – MARIO-275 and MARIO-3 data update on KOL webcast event today, 8:00AM ET – CAMBRIDGE, Mass., July 27, 2021 /Business Wire/ -- Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) (“Infinity” or the “Company”), a clinical-stage biotechnology company developing eganelisib (IPI-549), a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, today announced its second quarter 2021 financial results and provided a corporate update. Adelene Perkins, Chief Executive Officer and Chair, Infinity Pharmaceuticals, said, “Today we report data indicating that eganelisib re- programs macrophages in the tumor microenvironment, turning pro-tumor, M2, macrophages into anti-tumor, M1, macrophages and improves outcomes for patients in two distinct types of cancer. Specifically, when combined with current standard of care therapies, the data showed that eganelisib increased overall survival in patients with metastatic urothelial cancer and prolonged progression free survival in patients with TNBC. These data provide preliminary, but compelling evidence of eganelisib’s potential to improve outcomes for patients with these two types of cancer. Validation of the fundamental biologic hypothesis of eganelisib, and the resulting prospect of patient benefit, gives us great confidence in the future of eganelisib, Infinity and our ability to realize our vision of bringing better therapies to patients. In the months ahead, Infinity plans to work with investigators, key opinion leaders and regulatory authorities to carefully choose the most appropriate clinical paths forward and expects to provide an update by year end, together with an update on our maturing TNBC data.” Ms. Perkins continued, “We’re thrilled to have Dr. Peluso return to Infinity in the role of Chief Scientific Officer during this exciting time for Infinity. Stéphane served as a valued member of Infinity’s