Infinity Pharmaceuticals Reports Full Year 2021 Financial Results and Provides Company Highlights
Infinity Pharmaceuticals (NASDAQ: INFI) reported its full year 2021 results, highlighting the initiation of important trials for eganelisib. The MARIO-4 registration-enabling trial for front-line metastatic triple negative breast cancer (mTNBC) is set to start by the end of 2022, alongside the rolling initiation of MARIO-P for additional solid tumors in Q3 2022. Infinity ended 2021 with approximately $81 million in cash. The net loss for the year was $45.3 million, a slight increase from $40.5 million in 2020. The company expects a 2022 net loss between $45 million and $55 million.
- Initiation of MARIO-4 and MARIO-P trials expected to drive future growth.
- Cash reserves of approximately $81 million at year-end, providing operational runway.
- Net loss increased to $45.3 million in 2021, indicating financial strain.
- Projected net loss for 2022 remains between $45 million and $55 million, suggesting continued losses.
– 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 ~
– Mr.
– Investor conference call to be held today at
“Based on the strength and breadth of eganelisib’s activity across mTNBC and mUC as well as ovarian cancer, SCCHN, and melanoma, we raised
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
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Tumor reduction:
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Of evaluable patients, tumor reduction was observed in
92.8% patients with PD-L1 (+) tumors and85.2% patients with PD-L1 (-) tumors.
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Of evaluable patients, tumor reduction was observed in
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Progression free survival (PFS):
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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.
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In patients with PD-L1(+) tumors, median PFS in MARIO-3 was 11.0 months, a
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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
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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 inJanuary 2022 to a hazard ratio of 0.58, reflecting a42% 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 to32% in the nivolumab control arm.
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At the one-year landmark,
2021-2022 Corporate Updates:
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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 effectiveMarch 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 establishedN.America and international presence for Acceleron. He played a key leadership role in Acceleron’s acquisition by Merck in the second half of 2021.$11.5B Mr. Kango has additionally led multiple global product launches across several therapeutic areas including oncology-hematology, rare diseases, immunology, and virology. PreviouslyMr. 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 atInfinity Pharmaceuticals .Mr. Kango also served as vice president, global marketing, and sales operations atOnyx 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 atSchering-Plough .Mr. Kango also serves as a director of MEI Pharma.Mr. Kango earned a B.S. in Microbiology and an M.B.A. fromMcNeese State University .
Anticipated 2022 Milestones:
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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
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Investigator-sponsored study in head and neck squamous cell carcinoma patients sponsored by Dr.
Ezra Cohen
Full Year 2021 Financial Results:
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At
December 31, 2021 , Infinity had total cash, cash equivalents and available-for-sale securities of , compared to$80.7 million at$34.1 million December 31, 2020 . -
Research and development expense for 2021 was
, compared to$31.6 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.$26.8 million -
General and administrative expense was
for 2021, compared to$14.2 million for 2020. The increase in G&A expense is primarily due to an increase in stock compensation, professional services, and consulting expense.$12.4 million -
Net loss for 2021 was
, or a basic and diluted loss per common share of$45.3 million , compared to a net loss of$0.53 , or a basic and diluted loss per common share of$40.5 million in 2020.$0.68
Financial Outlook: Infinity’s 2022 financial guidance remains as follows:
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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 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.$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 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
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
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|
|
|
|
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Cash, cash equivalents and available-for-sale securities |
$ |
80,726 |
|
$ |
34,108 |
|
Other current assets |
|
1,542 |
|
|
1,912 |
|
Property and equipment, net |
|
1,241 |
|
|
1,710 |
|
Other long-term assets |
|
1,276 |
|
|
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 portion |
|
917 |
|
|
1,436 |
|
Long-term liabilities |
|
270 |
|
|
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
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Year Ended |
||||||
|
2021 |
|
2020 |
||||
Royalty revenue |
$ |
1,858 |
|
|
$ |
1,719 |
|
Operating expenses: |
|
|
|
||||
Research and development |
|
31,647 |
|
|
|
26,761 |
|
General and administrative |
|
14,174 |
|
|
|
12,418 |
|
Royalty expense1 |
|
1,120 |
|
|
|
1,037 |
|
Total operating expenses |
|
46,941 |
|
|
|
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 outstanding |
|
85,597,264 |
|
|
|
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.
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Investor Relations:
646-970-4681
ikoffler@lifesciadvisors.com
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