FALSE000111314800011131482022-03-252022-03-25

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 25, 2022
Infinity Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware000-3114133-0655706
(State or other jurisdiction
of incorporation)		(Commission File Number)(IRS Employer
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:
Title of ClassTrading SymbolName of Exchange on Which Registered
Common Stock, $0.001 par valueINFINasdaq 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 March 29, 2022, Infinity Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its results for the year ended December 31, 2021 and will conduct a previously announced, publicly available conference call to discuss those results. 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 (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 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 5.02.     Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
(d) On March 25, 2022, the Board of Directors (the “Board”) of the Company, upon recommendation from the Nominating and Corporate Governance Committee of the Board, expanded the size of the Board from seven to eight members and appointed Mr. Sujay Kango as a director of the Company and as a member of the Compensation Committee of the Board (the “Compensation Committee”). His term will commence on March 30, 2022 (the “Commencement Date”) and will, unless reelected, expire at the Company’s 2022 Annual Meeting of Stockholders or upon his earlier death, resignation or removal.
There are no arrangements or understandings between Mr. Kango and any other persons pursuant to which he was elected as a director. Mr. Kango has no family relationships with any of the Company’s directors or executive officers. In addition, there are no transactions and no proposed transactions between Mr. Kango and the Company that would be required to be disclosed pursuant to Item 404(a) of Regulation S-K.
In accordance with the Company’s director compensation program, Mr. Kango will be eligible to receive an annual cash retainer of $42,000 for service on the Board. Mr. Kango will also be eligible to receive an annual cash retainer of $7,500 for service as a member of the Compensation Committee. For Mr. Kango’s service through the 2022 Annual Meeting of Stockholders, he will receive payments of $10,512.10 for service as a director and as a member of the Compensation Committee. These amounts are payable on the Commencement Date and are pro-rated based on the length of his initial term.
In addition, under the Company’s director compensation program, Mr. Kango will be awarded on the Commencement Date an option to purchase up to 90,000 shares of the Company’s common stock at a price equal to the closing price of the Company’s common stock on the Nasdaq Global Select Market on the Commencement Date (the “Initial Grant”). The Initial Grant will be granted under the Company’s 2019 Equity Incentive Plan, as amended by Amendment No. 1 to the 2019 Equity Incentive Plan (“Amendment No. 1”). The Initial Grant will vest and become exercisable over a period of two years in equal quarterly installments beginning at the end of the first quarter after the Commencement Date, provided that Mr. Kango continues to serve as a director. For additional information regarding Amendment No. 1, please see Exhibit 10.1 to this Form 8-K.
Item 9.01.    Financial Statements and Exhibits.
(d)    Exhibits



Exhibit No.Description
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.
INFINITY PHARMACEUTICALS, INC.
Date: March 29, 2022By:/s/ Seth A. Tasker
Seth A. Tasker
Chief Business Officer
Exhibit 10.1
AMENDMENT NO. 1 TO
2019 EQUITY INCENTIVE PLAN
OF
INFINITY PHARMACEUTICALS, INC.
The 2019 Equity Incentive Plan, as amended (the “Plan”) of Infinity Pharmaceuticals, Inc. is hereby amended as follows:
1.    Section 4(c) of the Plan is hereby deleted and new Sections 4(c) is inserted in lieu thereof which shall read as follows:
“(c) Awards to Non-Employee Directors.
1.Initial Grant. Upon the commencement of service on the Board by any individual who is not then an employee of the Company or any subsidiary of the Company, such person shall automatically be granted a Nonstatutory Stock Option (as defined below) to purchase 90,000 shares of Common Stock (subject to (i) adjustment under Sections 4(c)(5), 4(c)(6) and 10 and (ii) the limitations set forth in Section 4(b)).
2.Annual Grant. On the date of each annual meeting of stockholders of the Company, each member of the Board of Directors of the Company who is both serving as a director of the Company immediately prior to and immediately following such annual meeting and who is not then an employee of the Company or any of its subsidiaries, shall automatically be granted a Nonstatutory Stock Option to purchase 45,000 shares of Common Stock (subject to (i) adjustment under Sections 4(c)(5), 4(c)(6) and 10 and (ii) the limitations set forth in Section 4(b)); provided, however, that a director shall not be eligible to receive an option grant under this Section 4(c)(2) unless such director served on the Board on the last day of the immediately preceding calendar year.
3.Additional Grants. Upon the commencement of service in the following positions by any individual who is not then an employee of the Company or any of its subsidiaries, and each anniversary thereafter that such individual is continuing to serve in such position, such person shall automatically be granted a Nonstatutory Stock Option to purchase the number of shares of Common Stock (subject to (i) adjustment under Sections 4(c)(5), 4(c)(6) and 10 and (ii) the limitations set forth in Section 4(b)) indicated below:
(A) if the individual serves as chair of the Board, a Nonstatutory Stock Option to purchase 12,000 shares of Common Stock; and
(B)if the individual serves as lead outside director of the Board and is not also chair of the Board, a Nonstatutory Stock Option to purchase 10,000 shares of Common Stock.
4.Terms of Director Options. Options granted under this Section 4(c) shall (i) have an exercise price equal to the Grant Date Fair Market Value of the Common Stock (as defined below), (ii) vest in equal quarterly installments (with respect to one-eighth (1/8th) of the shares subject to the Option grant in the case of Initial Grants under Section 4(c)(1) and with respect to one-fourth (1/4th) of the shares subject to the option grant in the case of Annual Grants and Additional Grants under Sections 4(c)(2) and (3) respectively) on the last day of each calendar quarter provided that the individual is serving on the Board or in the positions listed in Section 4(c)(3), as applicable, on such date, provided that no additional vesting shall take place after the Participant ceases to serve as a director and further provided that the Options granted under this Section 4(c) shall immediately vest in the case of death, disability or change in control, (iii) expire on the earlier of 10 years

Exhibit 10.1
from the date of grant or one year following cessation of service on the Board and (iv) contain such other terms and conditions as the Board shall determine.
5.Board Discretion. The Board retains specific authority to increase or decrease from time to time the number of shares subject to the Options granted under this Section 4(c).
6.Non-Exclusive Grants. The Board retains the specific authority to grant other Awards in addition to or in lieu of some or all of the Options provided for in this Section 4(c).
Except as set forth above, the remainder of the Plan remains in full force and effect.

Adopted by the Board of Directors on March 25, 2022.
Exhibit 99.1
headera03a.jpg

Infinity Pharmaceuticals Reports Full Year 2021 Financial Results and Provides Company Highlights

– MARIO-4, the first eganelisib registration-enabling trial, in front-line metastatic triple negative breast cancer expected to initiate by the end of 2022 –

–MARIO-P, a study designed to expand eganelisib development in additional solid tumor indications, expected to initiate on a rolling basis in 3Q 2022 –

– Ended 2021 with ~ $81 million of cash and cash equivalents –

– Mr. Sujay Kango appointed to Infinity Board of Directors –

– Investor conference call to be held today at 4:30 pm EDT –

CAMBRIDGE, Mass., March 29, 2022 /Business Wire/ -- Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) (“Infinity” or the “Company”), a clinical-stage biotechnology company developing eganelisib, a first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, today announced its full year 2021 financial results and provided corporate highlights.

“Based on the strength and breadth of eganelisib’s activity across mTNBC and mUC as well as ovarian cancer, SCCHN, and melanoma, we raised $92 million in early 2021 to advance eganelisib to its first registration-enabling study by the end of this year. We have prioritized front-line TNBC based on prolonged progression-free survival in both PD-L1(+) and PD-L1(-) patients relative to the IMPassion130 reference benchmark. In addition, encouraging overall survival data from a randomized, controlled study in patients with second line urothelial cancer provides another attractive future registrational path. Importantly, in both TNBC and UC, supporting translational data show on-mechanism modulation of the tumor microenvironment to reduce immune suppression,” said Adelene Perkins, Chief Executive Officer and Chair of Infinity.

Ms. Perkins continued, “With the additions of Dr. Robert Ilaria as our CMO and Dr. Stéphane Peluso as our CSO, in 2022 we are leveraging our data and financial resources to initiate MARIO-4, a randomized, double-blind Phase 3 study of eganelisib in a triplet combination regimen in front-line mTNBC. In parallel, we plan to initiate MARIO-P, our platform study to evaluate eganelisib in additional combinations and indications where eganelisib may increase the effectiveness of available therapies. As we prepare for the initiation of our first eganelisib registration study, we are very pleased to have Sujay Kango rejoining Infinity. He previously served as our executive vice president and chief commercial officer and now will be providing commercial insights as a member of our board of directors.”
Key 2021 Updates:
MARIO-3: Updated data from the Company’s ongoing Phase 2 study evaluating eganelisib in a novel triple combination with Tecentriq® (atezolizumab) and Abraxane® (nab-paclitaxel) in unresectable locally advanced mTNBC was presented at SABCS in December 2021. This included 50 patients enrolled and evaluable for safety and 44 evaluable for efficacy as of the October 2, 2021 data cutoff date, with a median duration of follow-up of 9.9 months.

•Tumor reduction:

◦Of evaluable patients, tumor reduction was observed in 92.8% patients with PD-L1 (+) tumors and 85.2% patients with PD-L1 (-) tumors.

•Progression free survival (PFS):

◦In patients with PD-L1(+) tumors, median PFS in MARIO-3 was 11.0 months, a 47% improvement in mPFS compared to the 7.5 months reported for atezolizumab and nab-paclitaxel in IMpassion130.



◦In patients with PD-L1(-) tumors, median PFS in MARIO-3 was 7.3 months, a 30% improvement compared to the 5.6 months reported for atezolizumab and nab-paclitaxel in IMpassion130.

•Safety:

◦MARIO-3 safety profile was consistent with expectations for the three component drugs and did not show any new safety signals compared to the IMpassion130 benchmark trial.

MARIO-275: Updated data from the Company’s randomized, placebo-controlled Phase 2 study evaluating the efficacy and safety of eganelisib in combination with Opdivo® (nivolumab) in platinum-refractory, I/O naïve patients with locally advanced or metastatic urothelial cancer (UC) were presented at ASCO GU in February 2021 with OS data in July 2021 and January 2022.

•Median overall survival (mOS) in the PD-L1(-) population (30 patients) was 15.4 months (4.7, NE) on the eganelisib plus nivolumab combination arm and 7.9 months (1.9, NE) on the control arm of nivolumab alone, with a hazard ratio of 0.60 (0.21, 1.71), reflecting a 40% lower probability of death on the combination arm, which was subsequently updated in January 2022 to a hazard ratio of 0.58, reflecting a 42% lower probability of death on the combination arm.

◦At the one-year landmark, 59% of patients in the ITT population receiving the eganelisib plus nivolumab combination remained alive, compared to 32% in the nivolumab control arm.
2021-2022 Corporate Updates:
•Appointed Stéphane Peluso, Ph.D., as Chief Scientific Officer, joining Infinity from Ipsen.

•Appointed Robert Ilaria, Jr., M.D. as Chief Medical Officer, joining Infinity from Bristol Myers Squibb.

•Appointed Brian Schwartz, M.D., to Board of Directors, transitioning from consulting Chief Physician to the Board.

•Appointed Mr. Sujay Kango to Board of Directors effective March 30, 2022. Mr. Kango is an experienced executive with more than 25 years of experience in the pharmaceutical and biotechnology industries. He has been instrumental in successfully transforming earlier stage organizations to later-stage development and commercial global biotech companies. He joined Acceleron Pharma in 2018, where he most recently served as the executive vice president and chief commercial officer. Under his leadership the team launched luspatercept, led multiple rare disease franchises, and established N.America and international presence for Acceleron. He played a key leadership role in Acceleron’s $11.5B acquisition by Merck in the second half of 2021. Mr. Kango has additionally led multiple global product launches across several therapeutic areas including oncology-hematology, rare diseases, immunology, and virology. Previously Mr. Kango was vice president of global commercial development for oncology at AbbVie and the co-chair of the oncology therapy area committee, prior to which he served as the executive vice president and chief commercial officer at Infinity Pharmaceuticals. Mr. Kango also served as vice president, global marketing, and sales operations at Onyx Pharmaceuticals, an Amgen subsidiary. Prior to Onyx, he held several leadership positions including vice president hepatitis franchise and integrated oncology business unit at Merck & Co., global commercial leader-Procrit®/Eprex® at Ortho-Biotech, and various sales and marketing positions at Schering-Plough. Mr. Kango also serves as a director of MEI Pharma. Mr. Kango earned a B.S. in Microbiology and an M.B.A. from McNeese State University.

Anticipated 2022 Milestones:

•Initiate MARIO-4, a front-line metastatic TNBC randomized, double-blind, pivotal trial by year-end 2022



◦Infinity will finalize the MARIO-4 trial design following its meeting with global regulatory authorities

◦Progression free survival and overall survival as key endpoints
◦PD-L1 negative patients: eganelisib will be evaluated in combination with chemotherapy and a checkpoint inhibitor (the eganelisib triplet regimen) vs chemotherapy

◦PD-L1 positive patients: the eganelisib triplet regimen will be evaluated vs chemotherapy and a checkpoint inhibitor

•Initiate MARIO-P, a study to evaluate the clinical benefit of eganelisib in combination regimens in additional solid tumor indications, on a rolling basis in 3Q 2022

Additional Eganelisib Clinical and Translational Data Releases in 2H 2022:

•MARIO-3 study update in metastatic TNBC patients

•MARIO-275 study update in urothelial cancer patients

•MARIO-3 study in renal cell carcinoma patients

•Investigator-sponsored study in head and neck squamous cell carcinoma patients sponsored by Dr. Ezra Cohen
Full Year 2021 Financial Results:
•At December 31, 2021, Infinity had total cash, cash equivalents and available-for-sale securities of $80.7 million, compared to $34.1 million at December 31, 2020.

•Research and development expense for 2021 was $31.6 million, compared to $26.8 million in 2020. The increase is primarily related to an increase in clinical development expenses, an increase in compensation expense due primarily to new hires during the year, and an increase in consulting expense to support continued development of eganelisib.

•General and administrative expense was $14.2 million for 2021, compared to $12.4 million for 2020. The increase in G&A expense is primarily due to an increase in stock compensation, professional services, and consulting expense.

•Net loss for 2021 was $45.3 million, or a basic and diluted loss per common share of $0.53, compared to a net loss of $40.5 million, or a basic and diluted loss per common share of $0.68 in 2020.

Financial Outlook: Infinity’s 2022 financial guidance remains as follows:

•Net Loss: Infinity expects net loss for 2022 to range from $45 million to $55 million.

•Cash and Investments: Infinity expects to end 2022 with a year-end cash, cash equivalents and available for sale securities balance ranging from $25 million to $35 million. Infinity expects to have cash for at least 12 months from the filing of its annual report on Form 10-K. Infinity’s financial guidance does not include additional funding or business development activities.
Conference Call Information
Infinity will host a conference call today, March 29, 2022, at 4:30 PM EDT to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity's website at www.infi.com. To participate in the conference call, please dial (877) 316-5293 (domestic) and (631) 291-4526 (international) five minutes prior to start time. The conference ID number is 7567637. An archived version of the webcast will be available on Infinity's website for 30 days.


About Infinity and Eganelisib
Infinity Pharmaceuticals, Inc. (“Infinity” or the “Company”), is a clinical-stage biotechnology company developing eganelisib (IPI-549), a first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic which is designed to address a fundamental biologic mechanism of immune suppression in cancer in multiple clinical studies. MARIO-4 is a front-line mTNBC randomized, double-blind, pivotal trial the Company expects to initiate by the end of 2022. MARIO-3 is the first eganelisib combination study in front-line advanced cancer patients and is evaluating eganelisib in combination with Tecentriq® and Abraxane® in front-line TNBC and in combination with Tecentriq and Avastin® in front-line RCC. MARIO-275 is a randomized, controlled combination study of eganelisib combined with Opdivo® in I/O naïve urothelial cancer. MARIO-P is a platform study to evaluate eganelisib to support the initiation of future registration focused studies across various solid tumor indications, which the Company expects to initiate on a rolling basis in 3Q 2022. For more information on Infinity, please refer to Infinity's website at www.infi.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding: the therapeutic potential of eganelisib; plans to initiate the MARIO-4 registration study and the MARIO-P platform study; design plans for MARIO-4 and MARIO-P; plans to present data; the Company’s guidance with respect to net loss, cash and cash equivalents and cash runway; and the Company's ability to execute on its strategic plans. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company's current expectations. For example, there can be no guarantee that eganelisib will successfully complete necessary preclinical and clinical development phases. Further, there can be no guarantee that any positive developments in Infinity's product portfolio will result in stock price appreciation. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: the cost, timing and results of clinical trials and other development activities that may be delayed or disrupted by the COVID-19 pandemic or otherwise; the content and timing of decisions made by the U.S. FDA and other regulatory authorities; Infinity's ability to obtain and maintain requisite regulatory approvals; unplanned cash requirements and expenditures; development of agents by Infinity's competitors for diseases in which Infinity is currently developing or intends to develop eganelisib; and Infinity's ability to obtain, maintain and enforce patent and other intellectual property protection for eganelisib. These and other risks which may impact management's expectations are described in greater detail under the caption "Risk Factors" included in Infinity's annual report and quarterly reports filed with the Securities and Exchange Commission (SEC), and in other filings that Infinity makes with the SEC, available through the Company’s website at www.infi.com. Any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity does not undertake and expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Opdivo® is a registered trademark of Bristol Myers Squibb.
Tecentriq® is a registered trademark of Genentech, Inc.
Abraxane® is a registered trademark of Abraxis BioScience, LLC., a wholly owned subsidiary of Bristol Myers Squibb Company.
Avastin® is a registered trademark of Genentech, Inc.




INFINITY PHARMACEUTICALS, INC.
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
December 31, 2021December 31, 2020
Cash, cash equivalents and available-for-sale securities$80,726 $34,108 
Other current assets1,542 1,912 
Property and equipment, net1,241 1,710 
Other long-term assets1,276 1,589 
Total assets$84,785 $39,319 
Accounts payable and accrued expenses $13,300 $11,047 
Liability related to sale of future royalties, net1
48,727 28,021 
Liability related to sale of future royalties to a related party, net1
— 21,559 
Operating lease liability, less current portion917 1,436 
Long-term liabilities270 245 
Total stockholders’ equity (deficit)21,571 (22,989)
Total liabilities and stockholders’ equity$84,785 $39,319 

1 The company is not obligated to repay any of the liabilities related to sale of future royalties but these are recorded as a liability on the balance sheet in accordance with accounting guidance for royalty monetization. During the first quarter of 2021, the liability related to sale of future royalties to a related party was reclassified to liability related to sale of future royalties since Biotechnology Value Fund, L.P. (BVF) is no longer considered a related party.


INFINITY PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
Year Ended December 31,
20212020
Royalty revenue$1,858 $1,719 
Operating expenses:
Research and development31,647 26,761 
General and administrative14,174 12,418 
Royalty expense1
1,120 1,037 
Total operating expenses46,941 40,216 
Loss from operations(45,083)(38,497)
Other income (expense):
Investment and other income 1 450 
Non-cash interest expense1
(180)(153)
Non-cash related party interest expense1
— (2,292)
Total other expense(179)(1,995)
Net loss$(45,262)$(40,492)
Basic and diluted loss per common share$(0.53)$(0.68)
Basic and diluted weighted average number of common shares outstanding85,597,264 59,857,860 

1 The liabilities related to sale of future royalties will be amortized using the effective interest method over the life of the arrangements. During the first quarter of 2021, the non-cash related party interest expense was reclassified to non-cash interest expense since BVF is no longer considered a related party.


Investor Relations:

Irina Koffler
LifeSci Advisors, LLC
646-970-4681
ikoffler@lifesciadvisors.com