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Delaware
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000-31141
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33-0655706
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(State or other jurisdiction
of incorporation)
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(Commission File Number)
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(IRS Employer
Identification No.)
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1100 Massachusetts Avenue, Floor 4, Cambridge, MA
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02138
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(Address of principal executive offices)
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(Zip Code)
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Title of Class
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Trading Symbol
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Name of Exchange on Which Registered
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Common Stock, $0.001 par value
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INFI
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Nasdaq Global Select Market
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Exhibit No.
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Description
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INFINITY PHARMACEUTICALS, INC.
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Date: March 3, 2020
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By:
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/s/ Seth A. Tasker
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Seth A. Tasker
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Chief Business Officer
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•
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In January 2020, completed a $20 million non-dilutive asset-backed financing with BVF Partners L.P. with sole recourse in potential royalty payments due on future sales of patidegib, a hedgehog pathway inhibitor discovered by Infinity and licensed to PellePharm in 2013. In addition, Infinity is eligible to receive from BVF an additional $5 million payment upon positive data from PellePharm’s Phase 3 trial in patients with Gorlin Syndrome. PellePharm completed enrollment of its Phase 3 trial in 2019.
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•
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Completed a royalty monetization with HealthCare Royalty Partners (HCR) for the right to receive certain royalty payments based on worldwide annual net sales of COPIKTRA® (duvelisib), payable by Verastem. Under the agreement, HCR paid Infinity a $30 million upfront payment.
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•
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Extended cash runway with approximately $62 million cash at January 8, 2020 to fund all current IPI-549 trials to key data readouts in over 500 patients throughout 2020 and into mid-2021.
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•
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Initiated MARIO-275, the company’s ongoing global, randomized, controlled Phase 2 study in collaboration with Bristol-Myers Squibb, to evaluate IPI-549 in combination with Opdivo® in platinum-refractory, I/O naïve patients with advanced urothelial cancer. Completion of enrollment is expected in 2020 with data mid-2021.
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•
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Initiated MARIO-3, the company’s ongoing Phase 2 study in collaboration with Roche/Genentech to evaluate IPI-549 in novel triple combination front-line therapies with Tecentriq® and Abraxane® in triple negative breast cancer (TNBC) and with Tecentriq and Avastin® in renal cell cancer (RCC). Enrollment completion and initial data are expected in 2020.
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•
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Initiated a Phase 1b collaboration study with Arcus Biosciences, which is being conducted by Arcus, evaluating a checkpoint-inhibitor free, novel triple-combination regimen of IPI-549 + AB928 (dual adenosine receptor antagonist) + Doxil® in advanced TNBC patients. Enrollment in the expansion cohort of up to 40 patients is ongoing.
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•
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Completed enrollment in MARIO-1, the company’s ongoing Phase 1/1b study of IPI-549 as a monotherapy and in combination with Opdivo in patients with advanced solid tumors. Additional data are expected in 2020.
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•
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Established Clinical Advisory Board with the following initial members:
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◦
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Chair: Sam Agresta, MD, Infinity Board Member and Chief Medical Officer of Foghorn Therapeutics. Previously Dr. Agresta was responsible for the development and approval of several important drugs including of TIBSOVO® and IDHIFA® for patients with IDH1 and IDH2 mutation positive AML while at Agios and, while at Genentech, he played a key role in the global development of KADCYLA®, which is approved for HER2 positive breast cancer. Dr. Agresta also played a key role in designing the Infinity trials now underway and is actively engaged with the company in advancing these trials.
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◦
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Padmanee (Pam) Sharma, MD, PhD, co-leader of the MD Anderson Cancer Center’s immunotherapy platform and T.C. and Jeanette Hsu Endowed Chair in Cell Biology, Department of Genitourinary Medical Oncology. Dr. Sharma was the principal investigator on the BMS Checkmate 275 study that first demonstrated the association of high MDSCs to significantly lower overall survival in patients with UC and which provided the inspiration for our MARIO-275 study to which Dr Sharma will bring unique insight.
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◦
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Toni Choueiri, MD, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute/Brigham and Women’s Hospital and the Jerome and Nancy Kohlberg Chair and Professor of Medicine at Harvard Medical School and a recognized thought leader in the GU field who has done extensive work in the development of better treatments for patients with RCC and will bring great insight to the interpretation of our data from MARIO-3 in RCC and the development of next steps.
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◦
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Michael Postow, MD, Co-Lead Melanoma Disease Management Team at Memorial Sloan Kettering Cancer Center and assistant professor of medicine at Weill Cornell Medical College. Dr. Postow treats patients with advanced melanoma and was the principal investigator of a clinical trial which led to FDA approval of the nivolumab + ipilimumab immunotherapy combination to treat melanoma. He is currently leading clinical trials testing new immunotherapy combinations in patients with advanced melanoma and will bring tremendous insight to potential future paths for IPI-549 in melanoma.
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•
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Jeff Kutok, MD, PhD, will be stepping down as Chief Scientific Officer at the end of March to lead drug discovery at another life science company and will assume the role as Chair of Infinity’s Scientific Advisory Board.
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•
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Seth Tasker, J.D. was promoted from General Counsel to Chief Business Officer.
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•
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At December 31, 2019, Infinity had total cash, cash equivalents and available-for-sale securities of $42.4 million, compared to $58.6 million at December 31, 2018 and approximately $62 million at January 8, 2020.
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•
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Revenue during 2019 was $3.0 million, which primarily relates to the achievement of a $2.0 million milestone from PellePharm. Revenue during 2018 was $22.1 million, related to the amount received from Verastem for the approval by the FDA of COPIKTRA.
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•
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Research and development expense for 2019 was $27.1 million, compared to $19.8 million in 2018. The increase in R&D expense in 2019 compared to 2018 was primarily due to higher clinical development expenses for IPI-549.
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General and administrative expense was $14.3 million for 2019, compared to $14.2 million for 2018.
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•
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Royalty expense for 2019 was $7.3 million, which primarily reflects Takeda’s share of the $30 million gross proceeds received from HCR for the monetization of COPIKTRA royalties in 2019, which was recognized as a liability in accordance with relevant accounting guidance. While recognized as a liability, the company is not obligated to repay the $30 million from HCR.
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•
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Net loss for 2019 was $47.1 million, or a basic and diluted loss per common share of $0.83, compared to a net loss of $11.3 million, or a basic and diluted loss per common share of $0.20 for 2018. The increase in net loss was mostly driven by the $22 million milestone received from Verastem in 2018 for the approval of COPIKTRA and the $7.3 million royalty expense to Takeda in 2019 for their share of the COPIKTRA royalty monetization with HCR.
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•
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Net Loss: Infinity expects net loss for 2020 to range from $40 million to $50 million.
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•
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Cash and Investments: Infinity expects to end 2020 with a year-end cash, cash equivalents and available-for-sale securities balance ranging from $15 million to $25 million.
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Cash Runway: Based on its current operational plans, Infinity expects that its existing cash, cash equivalents and available-for-sale securities, including the $20.0 million received from BVF in January 2020, will be adequate to satisfy the company's capital needs into 2H 2021. Infinity's financial guidance does not include additional funding or business development activities or a potential $5 million milestone payment from BVF for positive patidegib Phase 3 data and any milestones from, or the sale of the company’s equity interest in, PellePharm.
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December 31, 2019
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December 31, 2018
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Cash, cash equivalents and available-for-sale securities
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$
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42,444
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$
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58,591
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Other current assets
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2,137
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1,227
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Property and equipment, net
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2,186
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28
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Other long-term assets
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2,247
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369
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Total assets
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$
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49,014
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$
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60,215
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Accounts payable and accrued expenses
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$
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9,698
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$
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7,718
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Liability related to sale of future royalties, net
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29,626
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—
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Operating lease liability, less current portion
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1,926
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—
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Long-term liabilities
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38
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38
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Total stockholders’ equity
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7,726
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52,459
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Total liabilities and stockholders’ equity
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$
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49,014
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$
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60,215
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Year Ended December 31,
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2019
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2018
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Collaboration revenue
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$
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2,000
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$
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22,000
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Royalty revenue
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1,049
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146
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Total revenues
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3,049
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22,146
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Operating expenses:
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Research and development
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27,116
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19,758
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General and administrative
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14,289
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14,248
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Royalty expense
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7,308
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69
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Total operating expenses
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48,713
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34,075
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Income (loss) from operations
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(45,664
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)
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(11,929
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)
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Other income (expense):
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Investment and other income
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1,116
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769
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Interest expense1
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(2,563
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)
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(93
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)
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Total other income (expense)
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(1,447
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)
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676
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Income (loss) before income taxes
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(47,111
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)
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(11,253
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)
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Income taxes benefit
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54
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—
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Net income (loss)
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$
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(47,057
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)
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$
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(11,253
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)
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Basic and diluted loss per common share
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$
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(0.83
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)
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$
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(0.20
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)
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Basic and diluted weighted average number of common shares outstanding
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56,983,652
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55,411,370
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