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 –
-
- Cash balance of
- MARIO-275 and MARIO-3 data update on KOL webcast event today,
Corporate Update
-
Appointed
Stéphane Peluso , Ph.D, as Chief Scientific Officer. EffectiveAugust 2, 2021 ,Dr. Peluso returns to Infinity fromIpsen Bioscience where he was most recently Vice President, Global Head of Oncology External Innovation. Prior to Ipsen,Dr. Peluso worked at Infinity where he held positions of increasing responsibility in medicinal chemistry and drug discovery ultimately leading Infinity’s early discovery and pipeline expansion efforts through both internal R&D and business development.Dr. Peluso started his career as a medicinal chemist atMillennium Pharmaceuticals . He graduated from the Ecole Supérieure de Chimie Industrielle deLyon (ESCIL),France , obtained his Ph.D. from theUniversity of Lausanne ,Switzerland and completed postdoctoral studies at theMassachusetts Institute of Technology .
Recent Eganelisib Updates and Program Guidance – data updates from MARIO-275 and MARIO-3 during KOL event today at
Second Quarter 2021 Financial Results:
-
At
June 30, 2021 , Infinity had total cash, cash equivalents and available-for-sale securities of$97.3 million , compared to$106.8 million atMarch 31, 2021 . -
Research and development expense for the second quarter of 2021 was
$8.0 million , compared to$6.1 million in the same period in 2020. The increase is primarily related to clinical, development and consulting expenses to support continued development of eganelisib. -
General and administrative expense was
$3.5 million for the second quarter of 2021, compared to$2.9 million for the same period in 2020. The increase in general and administrative expense is primarily due to an increase in consulting expenses and stock compensation. -
Net loss for the second quarter of 2021 was
$11.3 million , or a basic and diluted loss per common share of$0.13 , compared to a net loss of$9.5 million , or a basic and diluted loss per common share of$0.16 , in the same period in 2020.
Financial Outlook: Infinity’s 2021 financial guidance, following the closing in
-
Net Loss: Infinity expects net loss for 2021 to range from
$40 million to$50 million . -
Cash and Investments: Infinity expects to end 2021 with a year-end-cash, cash equivalents and available for sale securities balance ranging from
$70 million to$80 million . Infinity’s financial guidance does not include any potential additional funding or business development activities.
KOL Event Information
In lieu of an earnings conference call, Infinity will host a KOL event today,
To register for the webinar, please click here.
About Infinity and Eganelisib
Infinity is a clinical-stage biotechnology company developing eganelisib (IPI-549), a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic which addresses a fundamental biologic mechanism of immune suppression in cancer in multiple clinical studies. MARIO-275 is a randomized, controlled combination study of eganelisib combined with Opdivo® in I/O naïve urothelial cancer. 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 renal cell carcinoma. In collaboration with Arcus Biosciences, Infinity is evaluating a checkpoint inhibitor-free, novel combination regimen of eganelisib plus etrumadenant (AB928, a dual adenosine receptor antagonist) plus Doxil® in advanced TNBC patients. In 2019, Infinity completed enrollment in MARIO-1, a Phase 1/1b study evaluating eganelisib as a monotherapy and in combination with Opdivo (nivolumab) in patients with advanced solid tumors including patients refractory to checkpoint inhibitor therapy. With these studies Infinity is evaluating eganelisib in the anti-PD-1 refractory, I/O-naïve, and front-line settings. 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; registrational trial planning; plans to present data; the timing of further clinical trial updates from the Company; the Company’s guidance with respect to net loss and cash and cash equivalents; 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
Opdivo® is a registered trademark of Bristol Myers Squibb.
Tecentriq® is a registered trademark of
Abraxane® is a registered trademark of
Avastin® is a registered trademark of
Doxil® is a registered trademark of
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
|
|
|
|
||||
Cash, cash equivalents and available-for-sale securities |
$ |
97,258 |
|
|
$ |
34,108 |
|
Other current assets |
2,419 |
|
|
1,912 |
|
||
Property and equipment, net |
1,471 |
|
|
1,710 |
|
||
Other long-term assets |
1,450 |
|
|
1,589 |
|
||
Total assets |
$ |
102,598 |
|
|
$ |
39,319 |
|
|
|
|
|
||||
Accounts payable and accrued expenses |
$ |
10,554 |
|
|
$ |
11,047 |
|
Liabilities related to sale of future royalties, net1 |
49,083 |
|
|
28,021 |
|
||
Liability related to sale of future royalties to a related party, net1 |
— |
|
|
21,559 |
|
||
Operating lease liability, less current portion |
1,188 |
|
|
1,436 |
|
||
Long-term liabilities |
233 |
|
|
245 |
|
||
Total stockholders’ equity (deficit) |
41,540 |
|
|
(22,989) |
|
||
Total liabilities and stockholders’ equity |
$ |
102,598 |
|
|
$ |
39,319 |
|
1 The company is not obligated to repay 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 the
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
|
Three Months Ended |
|
Six Months Ended |
|||||||||||||
|
2021 |
|
2020 |
|
2021 |
|
2020 |
|||||||||
Royalty revenue |
$ |
512 |
|
|
$ |
360 |
|
|
$ |
979 |
|
|
$ |
788 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|||||||||
Research and development |
7,957 |
|
|
6,125 |
|
|
16,158 |
|
|
13,470 |
|
|
||||
General and administrative |
3,498 |
|
|
2,937 |
|
|
7,064 |
|
|
6,261 |
|
|
||||
Royalty expense |
308 |
|
|
217 |
|
|
590 |
|
|
475 |
|
|
||||
Total operating expenses |
11,763 |
|
|
9,279 |
|
|
23,812 |
|
|
20,206 |
|
|
||||
Loss from operations |
(11,251) |
|
|
(8,919) |
|
|
(22,833) |
|
|
(19,418) |
|
|
||||
Other income (expense): |
|
|
|
|
|
|
|
|||||||||
Investment and other income (expense) |
27 |
|
|
50 |
|
|
25 |
|
|
235 |
|
|
||||
Non-cash interest expense1 |
(45) |
|
|
(39) |
|
|
(90) |
|
|
(77) |
|
|
||||
Non-cash related party interest expense1 |
— |
|
|
(565) |
|
|
— |
|
|
(1,099) |
|
|
||||
Total other expense |
(18) |
|
|
(554) |
|
|
(65) |
|
|
(941) |
|
|
||||
Net loss |
$ |
(11,269) |
|
|
$ |
(9,473) |
|
|
$ |
(22,898) |
|
|
$ |
(20,359) |
|
|
Basic and diluted loss per common share: |
$ |
(0.13) |
|
|
$ |
(0.16) |
|
|
$ |
(0.28) |
|
|
$ |
(0.35) |
|
|
Basic and diluted weighted average number of common shares outstanding: |
88,661,934 |
|
|
57,442,332 |
|
|
82,230,784 |
|
|
57,392,965 |
|
|
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.
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ikoffler@lifesciadvisors.com
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