Infinity Pharmaceuticals Reports First Quarter 2022 Financial Results
Infinity Pharmaceuticals (NASDAQ: INFI) reported its Q1 2022 financial results, showing a net loss of $12.4 million, or $0.14 per share, compared to a loss of $11.6 million in Q1 2021. As of March 31, 2022, the company held $67.1 million in cash, down from $80.7 million at year-end 2021. Infinity plans to initiate the MARIO-4 trial for eganelisib in front-line metastatic triple negative breast cancer by year-end 2022 and the MARIO-P clinical program in Q3 2022, expanding its research into various solid tumors.
- Anticipated initiation of MARIO-4 trial in front-line metastatic TNBC by year-end 2022.
- Launch of MARIO-P program targeting multiple solid tumor indications in Q3 2022.
- Encouraging prior MARIO-3 study results supporting further eganelisib development.
- Net loss increased to $12.4 million in Q1 2022 from $11.6 million in Q1 2021.
- Total cash reserves decreased to $67.1 million, indicating reduced financial runway.
– MARIO-4, the first eganelisib registration-enabling trial, in front-line metastatic triple negative breast cancer (TNBC) expected to initiate by year-end 2022 –
– MARIO-P, a clinical program designed to expand eganelisib development in additional solid tumor indications, is planned to start in 3Q2022 –
– Investor conference call to be held
“We are pleased to further advance the development of eganelisib, building on our encouraging MARIO-3 results, by initiating our first registration study, MARIO-4, in front-line metastatic TNBC by the end of this year.”
Anticipated 2022 Clinical Studies:
- Initiate MARIO-4, a randomized, double-blind, registrational trial in front-line metastatic TNBC, by year-end 2022
- Complete the MARIO-4 trial design, including confirmation of key endpoints (e.g, progression free survival and overall survival), following meeting with global regulatory authorities
- Evaluate eganelisib in both PD-L1 negative and PD-L1 positive patients:
-Experimental arm: eganelisib triplet regimen (eganelisib + chemo + checkpoint inhibitor)
-PD-L1 (-) control arm: chemotherapy alone
-PD-L1 (+) control arm: chemotherapy plus checkpoint inhibitor
- Initiate MARIO-P, a clinical program designed to rapidly evaluate the clinical benefit of eganelisib in combination regimens in additional solid tumor indications, on a rolling basis starting in 3Q 2022. Expected tumor types to include ovarian cancer, non-small cell lung cancer, soft tissue sarcoma and prostate cancer
Eganelisib Clinical/Translational Data in 2H 2022:
- MARIO-3 study in metastatic TNBC patients
- MARIO-275 study 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
First Quarter 2022 Financial Results:
-
At
March 31, 2022 , Infinity had total cash, cash equivalents and available-for-sale securities of , compared to$67.1 million at$80.7 million December 31, 2021 . -
Research and development expense for the first quarter of 2022 was
, compared to$9.0 million in the same period in 2021. The increase is primarily related to an increase in compensation expense due primarily to new hires during the period, partially offset by a decrease in clinical development expenses to support continued development of eganelisib.$8.2 million -
General and administrative expense was
for the first quarter of 2022, compared to$3.7 million for the same period in 2021. The increase in G&A expense is primarily due to an increase in stock compensation, partially offset by a decrease in professional services.$3.6 million -
Net loss for the first quarter of 2022 was
, or a basic and diluted loss per common share of$12.4 million , compared to a net loss of$0.14 , or a basic and diluted loss per common share of$11.6 million in the same period in 2021.$0.15
Financial Outlook:
Infinity’s 2022 financial guidance remains as follows:
-
Net Loss: Infinity expects net loss for 2022 to range from
to$45 million .$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
to$25 million . Infinity’s financial guidance does not include additional funding or business development activities.$35 million
Conference Call Information
Infinity will host a conference call today,
About Infinity and Eganelisib
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 clinical program; 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
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Condensed Consolidated Balance Sheets (in thousands) (unaudited) |
|||||
|
|
|
|
||
Cash, cash equivalents and available-for-sale securities |
$ |
67,140 |
|
$ |
80,726 |
Other current assets |
|
2,960 |
|
|
1,542 |
Property and equipment, net |
|
1,137 |
|
|
1,241 |
Other long-term assets |
|
1,341 |
|
|
1,276 |
Total assets |
$ |
72,578 |
|
$ |
84,785 |
|
|
|
|
||
Accounts payable and accrued expenses |
$ |
13,394 |
|
$ |
13,300 |
Liabilities related to sale of future royalties, net1 |
|
48,377 |
|
|
48,727 |
Operating lease liability, less current portion |
|
777 |
|
|
917 |
Long-term liabilities |
|
48 |
|
|
270 |
Total stockholders’ equity |
|
9,982 |
|
|
21,571 |
Total liabilities and stockholders’ equity |
$ |
72,578 |
|
$ |
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.
Condensed Consolidated Statements of Operations (in thousands, except share and per share amounts) (unaudited) |
|||||||
|
Three Months Ended |
||||||
|
2022 |
|
|
2021 |
|
||
Royalty revenue |
$ |
652 |
|
|
$ |
467 |
|
Operating expenses: |
|
|
|
||||
Research and development |
|
8,990 |
|
|
|
8,201 |
|
General and administrative |
|
3,676 |
|
|
|
3,566 |
|
Royalty expense |
|
393 |
|
|
|
282 |
|
Total operating expenses |
|
13,059 |
|
|
|
12,049 |
|
Loss from operations |
|
(12,407 |
) |
|
|
(11,582 |
) |
Other income (expense): |
|
|
|
||||
Investment and other income (expense) |
|
16 |
|
|
|
(2 |
) |
Non-cash interest expense1 |
|
(45 |
) |
|
|
(45 |
) |
Total other expense |
|
(29 |
) |
|
|
(47 |
) |
Net loss |
$ |
(12,436 |
) |
|
$ |
(11,629 |
) |
Basic and diluted loss per common share: |
$ |
(0.14 |
) |
|
$ |
(0.15 |
) |
Basic and diluted weighted average number of common shares outstanding: |
|
89,155,311 |
|
|
|
75,728,176 |
|
1 The liabilities related to sale of future royalties will be amortized using the effective interest method over the life of the arrangements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220503005254/en/
Investor Relations:
646-970-4681
ikoffler@lifesciadvisors.com
Source:
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