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Classified in: Health, Science and technology, Business, Covid-19 virus
Subjects: EARNINGS, Conference Call, Webcast, Business Update

Infinity Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Business Update


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 second quarter 2022 financial results, unveiled new positive data from the Phase 2 MARIO-275 clinical trial, and provided a business update.

"Today, we are pleased to announce positive survival data that shows approximately a doubling of patient survival at the two-year landmark analysis, a durable benefit for urothelial cancer patients being treated with eganelisib plus nivolumab versus standard-of-care nivolumab monotherapy. This impressive magnitude of benefit is particularly meaningful given this is a second line patient population whose cancer has progressed following treatment with a platinum-based chemotherapy," said Robert Ilaria, Jr., MD, Chief Medical Officer of Infinity.

"Based on the positive eganelisib data generated to-date in several indications and settings, we remain in discussions with multiple parties regarding potential partnerships to further advance the development of eganelisib," said Adelene Perkins, Chief Executive Officer and Chair of Infinity. "At this stage in eganelisib's clinical development, and given the current market environment, we have decided to prioritize establishing potential partnerships before beginning new efficacy studies, including MARIO-4 in TNBC and the MARIO-P platform study. Infinity has a track record of fiscal discipline, and this approach allows us to focus our current resources on ongoing clinical trials, extend our cash runway into 2024, and provide the flexibility to accommodate potential partners' input on the prioritization and design of our next studies. These initiatives support our commitment to advancing development of eganelisib across multiple oncology indications to maximize value for patients and shareholders."

Positive MARIO-275 Clinical Trial Results in Second Line Urothelial Cancer:

Second Quarter 2022 Financial Results:

Conference Call Information

Infinity will host a conference call today, August 9, 2022, at 4:30 PM EDT to discuss these financial results and business 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 (800) 715-9871 (domestic) and (646) 307-1963 (international) five minutes prior to start time. The conference ID number is 3032412. 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-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. 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 the Company's guidance with respect to net loss, cash and cash equivalents and cash runway; plans to evaluate and establish potential partnerships; 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 or will be successful in establishing a strategic partnership to further the development of eganelisib. 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)

 

 

June 30, 2022

 

December 31, 2021

Cash, cash equivalents and available-for-sale securities

$

56,575

 

 

$

80,726

Other current assets

 

3,035

 

 

 

1,542

Property and equipment, net

 

1,017

 

 

 

1,241

Other long-term assets

 

1,230

 

 

 

1,276

Total assets

$

61,857

 

 

$

84,785

 

 

 

 

Accounts payable and accrued expenses

$

14,339

 

 

$

13,300

Liabilities related to sale of future royalties, net1

 

47,955

 

 

 

48,727

Operating lease liability, less current portion

 

633

 

 

 

917

Long-term liabilities

 

37

 

 

 

270

Total stockholders' (deficit) equity

 

(1,107

)

 

 

21,571

Total liabilities and stockholders' (deficit) equity

$

61,857

 

 

$

84,785

 

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.

INFINITY PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Operations

(in thousands, except share and per share amounts)

(unaudited)

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

2022

 

2021

 

2022

 

2021

Royalty revenue

$

686

 

 

$

512

 

 

$

1,338

 

 

$

979

 

Operating expenses:

 

 

 

 

 

 

 

Research and development

 

8,795

 

 

 

7,957

 

 

 

17,785

 

 

 

16,158

 

General and administrative

 

3,495

 

 

 

3,498

 

 

 

7,171

 

 

 

7,064

 

Royalty expense

 

414

 

 

 

308

 

 

 

807

 

 

 

590

 

Total operating expenses

 

12,704

 

 

 

11,763

 

 

 

25,763

 

 

 

23,812

 

Loss from operations

 

(12,018

)

 

 

(11,251

)

 

 

(24,425

)

 

 

(22,833

)

Other income (expense):

 

 

 

 

 

 

 

Investment and other income

 

77

 

 

 

27

 

 

 

93

 

 

 

25

 

Non-cash interest expense1

 

(45

)

 

 

(45

)

 

 

(90

)

 

 

(90

)

Total other expense

 

32

 

 

 

(18

)

 

 

3

 

 

 

(65

)

Net loss

$

(11,986

)

 

$

(11,269

)

 

$

(24,422

)

 

$

(22,898

)

Basic and diluted loss per common share:

$

(0.13

)

 

$

(0.13

)

 

$

(0.27

)

 

$

(0.28

)

Basic and diluted weighted average number of common shares outstanding:

 

89,161,777

 

 

 

88,661,934

 

 

 

89,158,562

 

 

 

82,230,784

 

 

1 The liabilities related to sale of future royalties will be amortized using the effective interest method over the life of the arrangements.

 


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