Infinity Pharmaceuticals Provides Company Update and Third Quarter 2020 Financial Results

– MARIO-275 IDMC Decided that Danger/Profit for Sufferers Warrants Resumption of Enrollment; Infinity to Decide Subsequent Steps by 12 months Finish –

– MARIO-3 Encouraging Knowledge in Entrance-Line Triple Detrimental Breast Most cancers Sufferers to be Introduced at San Antonio Breast Most cancers Symposium –

– MARIO-1 Melanoma and SCCHN Knowledge Introduced at SITC –

– Money Runway By 2021 –

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) at this time introduced its third quarter 2020 monetary outcomes and supplied an replace on the Firm, together with its third quarter progress with eganelisib (IPI-549), the Firm’s first-in-class, oral immuno-oncology product candidate focusing on immune-suppressive tumor-associated myeloid cells by selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition.

“We’re approaching an essential inflection level at Infinity, with anticipated knowledge readouts throughout our scientific applications within the subsequent few months that show the good thing about eganelisib throughout a number of indications, affected person populations and remedy settings.” stated Adelene Perkins, Chief Government Officer and Chair of Infinity Prescription drugs. “We’re happy that the IDMC helps the additional exploration of eganelisib in second-line metastatic urothelial most cancers. We’ll proceed to comply with the forty-nine sufferers beforehand enrolled by the rest of the 12 months and use these knowledge to find out the most effective path ahead, which can embrace the re-opening of enrollment of MARIO-275 or the initiation of a brand new research that leverages our scientific and translational insights from the sufferers enrolled up to now.”

Ms. Perkins continued, “As well as, encouraging knowledge from the MARIO-3 TNBC cohort counsel that eganelisib has the potential to be an essential part of a brand new remedy routine within the front-line setting, and we sit up for presenting these knowledge at SABCS subsequent month. This week we additionally shared knowledge from the melanoma and SCCHN cohorts of MARIO-1 at SITC.”

Story continues

Key Q3 2020 Updates:

Medical and Regulatory:

• MARIO-275 is the Firm’s ongoing managed, randomized Part 2 research evaluating eganelisib together with Opdivo^® in platinum-refractory, I/O naïve sufferers with superior urothelial most cancers (aUC), in collaboration with Bristol Myers Squibb.

  • The MARIO-275 Unbiased Knowledge Monitoring Committee (IDMC) decided that the chance/profit for sufferers warrants resumption of enrollment after the profitable implementation of a dose discount from 40mg QD to 30mg QD to scale back the reversible liver enzyme elevations, which had been reported after the primary scheduled MARIO-275 IDMC assembly.

  • Infinity is continuous to judge the forty-nine sufferers beforehand enrolled throughout security and time-to-event measures together with development free survival and total survival and can decide subsequent steps by 12 months finish. This will likely embrace the re-opening of enrollment of MARIO-275 or the initiation of a brand new research which leverages our findings from the sufferers enrolled up to now.

• Arcus Collaboration: A Part 1b collaboration research being carried out by Arcus Biosciences is evaluating a checkpoint-inhibitor free, novel triple-combination routine of eganelisib + etrumadenant (AB928, twin adenosine receptor antagonist) + Doxil^® in as much as roughly 40 superior TNBC sufferers.

Third Quarter 2020 Monetary Outcomes:

• At September 30, 2020, Infinity had whole money, money equivalents and available-for-sale securities of $41.3 million, in comparison with $42.7 million at June 30, 2020.

• Analysis and growth expense for the third quarter of 2020 was $6.1 million, in comparison with $7.1 million for a similar interval in 2019. The lower is primarily associated to a mix drug buy through the third quarter of 2019.

• Common and administrative expense was $2.9 million for the third quarter of 2020, in comparison with $3.6 million for a similar interval in 2019. The lower is primarily associated to a discount in skilled providers and consulting.

• Internet loss for the third quarter of 2020 was $9.5 million, or a fundamental and diluted loss per widespread share of $0.16, in comparison with a web lack of $11.4 million, or a fundamental and diluted loss per widespread share of $0.20 for a similar interval in 2019.

2020 Monetary Outlook:

Internet Loss: Infinity expects web loss for 2020 to vary from $35 million to $45 million.

Money and Investments: Infinity expects to finish 2020 with a year-end money, money equivalents and available-for-sale securities steadiness starting from $25 million to $35 million.

Money Runway: Based mostly on its present operational plans, Infinity expects that its present money, money equivalents and available-for-sale securities, can be enough to fulfill the Firm’s capital wants by 2021. Infinity’s monetary steering doesn’t embrace potential extra funding or enterprise growth actions, a possible $5 million milestone cost from BVF primarily based on PellePharm’s ongoing Part 3 scientific trial of patidegib topical gel in Gorlin Syndrome, or any milestones from, or the sale of the Firm’s fairness curiosity in, PellePharm.

Convention Name Info

Infinity will host a convention name at this time, November 9, 2020, at 4:30 p.m. ET to debate these monetary outcomes and firm updates. A reside webcast of the convention name will be accessed within the “Traders/Media” part of Infinity’s web site at www.infi.com. To take part within the convention name, please dial (877) 316-5293 (home) and (631) 291-4526 (worldwide) 5 minutes prior to start out time. The convention ID quantity is 1575996. An archived model of the webcast can be obtainable on Infinity’s web site for 30 days.

About Infinity and Eganelisib

Infinity is an modern biopharmaceutical firm devoted to advancing novel medicines for individuals with most cancers. Infinity is advancing eganelisib, a first-in-class, oral immuno-oncology growth candidate that selectively inhibits PI3K-gamma, in a number of scientific research. MARIO-275 is a worldwide, randomized, managed mixture research of eganelisib mixed with Opdivo^® in I/O naïve urothelial most cancers. MARIO-3 is the primary eganelisib mixture research in front-line superior most cancers sufferers and is evaluating eganelisib together with Tecentriq^® and Abraxane^® in front-line TNBC and together with Tecentriq and Avastin^® in front-line RCC. In collaboration with Arcus Biosciences, Infinity is evaluating a checkpoint inhibitor-free, novel mixture routine of eganelisib plus AB928 (twin adenosine receptor antagonist) plus Doxil^® in superior TNBC sufferers. In 2019, Infinity accomplished enrollment in MARIO-1, a Part 1/1b research evaluating eganelisib as a monotherapy and together with Opdivo (nivolumab) in sufferers with superior strong tumors together with sufferers refractory to checkpoint inhibitor remedy. With these research Infinity is evaluating eganelisib within the anti-PD-1 refractory, I/O-naïve, and front-line settings. For extra data on Infinity, please check with Infinity’s web site at www.infi.com.

Cautionary Observe Relating to Ahead-Trying Statements

This press launch comprises forward-looking statements inside the which means of The Non-public Securities Litigation Reform Act of 1995. Such forward-looking statements embrace these relating to: the therapeutic potential of eganelisib; plans to current knowledge; deliberate analyses in MARIO-275; scientific trial enrollment projections; the timing of additional scientific trial updates from the Firm; the Firm’s steering with respect to web loss, money and money equivalents and money runway; and the Firm’s capacity to execute on its strategic plans. Such statements are topic to quite a few essential components, dangers and uncertainties that will trigger precise occasions or outcomes to vary materially from the Firm’s present expectations. For instance, there will be no assure that eganelisib will efficiently full obligatory preclinical and scientific growth phases. Additional, there will be no assure that any constructive developments in Infinity’s product portfolio will end in inventory worth appreciation. Administration’s expectations and, subsequently, any forward-looking statements on this press launch may be affected by dangers and uncertainties referring to plenty of different components, together with the next: the price, timing and outcomes of scientific trials and different growth actions which may be delayed or disrupted by the COVID-19 pandemic or in any other case; the end result of the Firm’s overview of its MARIO-275 scientific trial; the content material and timing of choices made by the U.S. FDA and different regulatory authorities; Infinity’s capacity to acquire and preserve requisite regulatory approvals; unplanned money necessities and expenditures; growth of brokers by Infinity’s opponents for illnesses during which Infinity is at present growing or intends to develop eganelisib; and Infinity’s capacity to acquire, preserve and implement patent and different mental property safety for eganelisib. These and different dangers which can influence administration’s expectations are described in better element beneath the caption “Danger Elements” included in Infinity’s annual report and quarterly reviews filed with the Securities and Trade Fee (SEC), and in different filings that Infinity makes with the SEC, obtainable by the Firm’s web site at www.infi.com. Any forward-looking statements contained on this press launch converse solely as of the date hereof, and Infinity doesn’t undertake and expressly disclaims any obligation to replace any forward-looking statements, whether or not because of new data, future occasions or in any other case.

Opdivo^® is a registered trademark of Bristol Myers Squibb.

Tecentriq^® and Avastin^® are registered emblems of Roche.

Abraxane^® is a registered trademark of Celgene.

Doxil^® is a registered trademark of Janssen Merchandise.

Copiktra^® is a registered trademark of Verastem, Inc.

INFINITY PHARMACEUTICALS, INC.
Condensed Consolidated Steadiness Sheets
(in hundreds)
(unaudited)

¹ Within the first quarter of 2019, Infinity acknowledged $30.0 million in gross money proceeds acquired from the HealthCare Royalty Companions III, L.P. (HCR) settlement as a legal responsibility on the steadiness sheet in accordance with accounting steering for royalty monetization. Whereas acknowledged as a legal responsibility, the Firm just isn’t obligated to repay the $30.0 million from HCR.

² Within the first quarter of 2020, Infinity acknowledged $20.0 million in gross money proceeds acquired from the Biotech Worth Fund Companions, L.P. (BVF) funding settlement as a legal responsibility on the steadiness sheet in accordance with accounting steering for royalty monetization. Whereas acknowledged as a legal responsibility, the Firm just isn’t obligated to repay the $20.0 million from BVF.

INFINITY PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Operations
(in hundreds, besides share and per share quantities)
(unaudited)

¹ Within the first quarter of 2019, Infinity acknowledged $6.7 million of royalty expense, which displays Takeda’s share of the $30.0 million gross proceeds acquired from HCR for the monetization of Copiktra royalties.

² Within the first quarter of 2020, Infinity acknowledged $20.0 million in gross money proceeds acquired from the BVF funding settlement as a legal responsibility that can be amortized utilizing the efficient curiosity technique over the lifetime of the association, in accordance with accounting steering for royalty monetization.

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Contacts

Ashley Robinson
LifeSci Advisors, LLC
617-775-5956