Infinity Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Business Updates

MARIO-3 update in patients with 1-liter TNBC shows a 52 percent increase in one-year progression-free survival in the ITT patient population compared to the Impassion130 benchmark –

Business development talks are progressing with the aim of announcing a partnership in the first quarter of 2023 –

-Cash runway into 2024 with $47.2 million in cash and cash equivalents at the end of Q3 2022-

– Investor Conference Call Will Be Held Today at 8:30am ET –

CAMBRIDGE, Mass., November 14, 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 third quarter 2022 financial results, provided a business update and presented more mature data from the Phase 2 MARIO-3 1L TNBC clinical trial in a separate press release.

“Our top priority is to enter into a strategic partnership to advance the development of eganelisib and pave the way for eventual approval. Current business development discussions are aimed at an initial, focused development plan in a randomized, controlled environment. Our goal is to announce a partnership and the focus of the next clinical trial for eganelisib in Q1 2023,” said Adelene Perkins, Infinity’s Chief Executive Officer and Chair. “We are encouraged by the long-term benefits being seen in patients with TNBC at the forefront reported today by MARIO-3 These data are consistent with the long-term benefit seen in other indications in which eganelisib has been studied and give us multiple potential ways forward that need to be prioritized with a potential partner.”

MARIO-3 Clinical Update:

The Company today published an update of its MARIO-3 study of eganelisib in combination with atezolizumab and nab-paclitaxel in patients with frontline metastatic triple-negative breast cancer (TNBC): (press release here)

  • Encouraging one-year progression-free survival rates in the MARIO-3 1L TNBC study regardless of PD-L1 status

  • 52% increase in one-year progression-free survival rate in the ITT patient population compared to the IMpassion130 benchmark

  • No new safety signals were observed during the extended treatment period and the safety profile of MARIO-3 remained in line with expectations for the three-component medicinal products.

Third Quarter 2022 Financial Results:

  • As of September 30, 2022, Infinity had cash and cash equivalents totaling $47.2 million compared to $80.7 million as of December 31, 2021.

  • Research and development expenses for the third quarter of 2022 were $7.7 million compared to $7.1 million for the same period in 2021. The increase is primarily due to higher compensation expense from additional employees to support the future development of eganelisib.

  • General and administrative expenses were $3.5 million for the third quarter of 2022 compared to $3.8 million for the same period in 2021. The decrease is primarily due to a decrease in professional services.

  • Net loss for the third quarter of 2022 was $10.7 million, or basic and diluted loss per common share of $0.12, compared to a net loss of $10.7 million, or basic and diluted loss per common share Common stock of $0.12 for the same period in 2021.

Financial Outlook 2022:

Infinity financial guidance for 2022 remains as follows:

  • Net Loss: Infinity still expects net loss for 2022 to be between $40 million and $50 million.

  • Cash and Investments: Infinity continues to expect to end 2022 with cash and cash equivalents in the range of $35 million to $45 million, providing a cash reserve through 2024. Infinity’s financial guidance does not include any additional funding or business development activity, even as we move toward a strategic partnership on eganelisib, which we plan to announce in Q1 2023.

Information about the conference call

Infinity will host a conference call today, November 14, 2022 at 8:30 am ET to discuss these financial results and business updates. To participate in the conference call, please register at https://register.vevent.com/register/BId44f86e6a2af42faadbb2844131346a8. Upon registration, each participant receives call details and access codes. All participants are asked to register 10 minutes before the start time. A live webcast of the conference call can be accessed on the Events & Presentations page of the Investors/Media section of Infinity’s website at www.infi.com. An archived version of the webcast will be available on the Infinity website for 30 days after the event.

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, multi-target, macrophage reprogramming immuno-oncology therapeutic clinical studies a fundamental biological mechanism of immunosuppression in cancer. MARIO-3 is the first eganelisib combination study in first-line patients with advanced cancer, evaluating eganelisib in combination with Tecentriq® and Abraxane® at TNBC on the front lines and in combination with Tecentriq and Avastin® in the RCC at the forefront. MARIO-275 is a randomized controlled combination study of eganelisib in combination with Opdivo® in I/O naïve urothelial cancer. For more information about Infinity, visit 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 projections regarding net loss, cash and cash equivalents and liquidity position; plans to evaluate and build potential partnerships; and the Company’s ability to implement its strategic plans. Such statements are subject to numerous important factors, risks and uncertainties that could 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 the required preclinical and clinical development phases or that a strategic partnership for the further development of eganelisib will be successfully established. In addition, there can be no guarantee that positive developments in Infinity’s product portfolio will result in an increase in the share price. Management’s expectations, and therefore any forward-looking statements in this press release, could also be affected by risks and uncertainties related to a number of other factors, including the following: the cost, timing and results of clinical trials and other development activities that may occur through the COVID-19 pandemic or are otherwise delayed or disrupted; the content and timing of US FDA and other regulatory agency decisions; Infinity’s ability to obtain and maintain required regulatory approvals; unplanned cash requests and expenditures; Development of compounds by Infinity’s competitors for diseases for 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 that may affect management’s expectations are described in more detail under the heading “Risk Factors” in Infinity’s annual and quarterly reports filed with the Securities and Exchange Commission (SEC) and in others filed by Infinity with the SEC filings are 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 of this release, and Infinity undertakes no obligation and expressly disclaims any obligation to update any forward-looking statement, 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)

09/30/2022

December 31, 2021

Cash and cash equivalents

$

47,182

$

80,726

Other Current Assets

2.168

1,542

property, plant and equipment, net

906

1,241

Other non-current assets

1,335

1,276

total assets

$

51,591

$

84,785

Liabilities and Accrued Expenses

$

14,200

$

13,300

Liabilities related to the sale of future royalties, net1

47,753

48,727

Operating lease liability, net of current portion

480

917

Long-term liabilities

32

270

Total (deficit) equity of shareholders

(10,874

)

21,571

Total liabilities and equity (deficit).

$

51,591

$

84,785

1 The Company has no obligation to repay any liabilities associated with the sale of future royalties, however, these are recorded as a liability on the balance sheet in accordance with the accounting policies for royalties monetization.

INFINITY PHARMACEUTICALS, INC.

Condensed consolidated income statement

(in thousands, except share and per share amounts)

(unaudited)

Three months ended September 30th

Nine months ended September 30th

2022

2021

2022

2021

Income from royalties

$

712

$

428

$

2,050

$

1.407

Operating expenses:

Research and Development

7,663

7,073

25,448

23,231

General and administrative

3,501

3,847

10,672

10,911

royalties

429

258

1,236

848

business expenses

11,593

11.178

37,356

34,990

loss from operations

(10,881

)

(10,750

)

(35.306

)

(33,583

)

Other income (expenses):

investments and other income

209

82

302

107

Non-cash interest expense1

(45

)

(45

)

(135

)

(135

)

Total Other Income (Expenses)

164

37

167

(28

)

net loss

$

(10.717

)

$

(10.713

)

$

(35.139

)

$

(33.611

)

Basic and diluted loss per common share:

$

(0.12

)

$

(0.12

)

$

(0.39

)

$

(0.40

)

Basic and diluted weighted average number of common shares outstanding:

89.392.079

88.766.912

89.211.208

84.433.435

1 Liabilities associated with the sale of future royalties are amortized over the life of the agreements using the effective interest method.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221114005337/en/

contacts

Luke Heagle
real chemistry
[email protected]

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