INFI Infinity Pharmaceuticals Inc.

1
+0.02  (+2%)
Previous Close 0.98
Open 0.98
52 Week Low 0.6
52 Week High 1.68
Market Cap $58,685,208
Shares 58,870,651
Float 39,369,660
Enterprise Value $66,690,125
Volume 232,297
Av. Daily Volume 729,768
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Upcoming Catalysts

Drug Stage Catalyst Date
IPI-549 + Nivolumab (MARIO-1)
Solid tumors
Phase 1
Phase 1
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IPI-549 + Nivolumab (MARIO-275)
Urothelial cancer
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
IPI-549 + Tecentriq and Abraxane and IPI-549 + Tecentriq and Avastin (MARIO-3)
Front-line triple negative breast cancer (TNBC); Renal cell cancer (RCC)
Phase 2
Phase 2
Phase 2 enrollment completion is expected in the RCC cohort by the end of 2020 and the TNBC cohort by the end of 1Q 2021.
AB298 + IPI-549 + Doxil
Triple negative breast cancer (TNBC) and ovarian cancer
Phase 1
Phase 1
Phase 1 initiation announced September 4, 2019.
Duvelisib (IPI-145)
Rheumatoid arthritis
Phase 2
Phase 2
Phase 2 failed to meet endpoint - Jan 2015
Duvelisib (IPI-145) DYNAMO
Indolent non-Hodgkin lymphoma
Phase 2
Phase 2
Phase 2 data released June 2016 - short of expectations

Latest News

  1. – MARIO-275 Dose Reduction Effective in Reducing Liver Enzyme Elevations. Interim Efficacy Analysis Expected by Year End. –

    – Encouraging Early Clinical Activity in MARIO-3 Front-Line Triple Negative Breast Cancer Cohort to be Presented by Year End –

    – Cash Runway into 2H2021 –

    Infinity Pharmaceuticals, Inc. (NASDAQ:INFI) today announced its second quarter 2020 financial results and provided an update on the company, including its second quarter progress with eganelisib (also known as IPI-549), the company's first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition.

    "We have made important clinical progress…

    – MARIO-275 Dose Reduction Effective in Reducing Liver Enzyme Elevations. Interim Efficacy Analysis Expected by Year End. –

    – Encouraging Early Clinical Activity in MARIO-3 Front-Line Triple Negative Breast Cancer Cohort to be Presented by Year End –

    – Cash Runway into 2H2021 –

    Infinity Pharmaceuticals, Inc. (NASDAQ:INFI) today announced its second quarter 2020 financial results and provided an update on the company, including its second quarter progress with eganelisib (also known as IPI-549), the company's first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition.

    "We have made important clinical progress this quarter including the generation of early, but encouraging signals of clinical activity in the triple negative breast cancer cohort of MARIO-3," said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "While these data are preliminary, we are excited by the potential to bring eganelisib to the front-line setting for the deadliest form of breast cancer and plan to present these data later this year."

    Ms. Perkins continued, "We are also pleased that the dose reduction implemented for MARIO-275 from 40mg QD to 30mg QD has enabled the continued treatment of patients previously enrolled in the study. We will conduct an interim efficacy analysis on these patients by the end of the year which will inform next steps."

    Key Q2 2020 Updates:

    Clinical and Regulatory:

    • MARIO-275: MARIO-275 is the company's ongoing controlled, randomized Phase 2 study evaluating eganelisib in combination with Opdivo® in platinum-refractory, I/O naïve patients with advanced urothelial cancer (aUC), in collaboration with Bristol Myers Squibb, or BMS.
      • Infinity implemented a dose reduction from 40mg QD to 30mg QD which has reduced the reversible liver enzyme elevations which were reported at the first scheduled MARIO-275 Independent Data Monitoring Committee (IDMC) meeting. Infinity will continue treatment of the currently enrolled patients and conduct an interim efficacy analysis by the end of the year which will inform next steps.
    • MARIO-3: MARIO-3 is the company's ongoing Phase 2 study in collaboration with Roche/Genentech to evaluate eganelisib in novel triple combination in the front-line setting with Tecentriq® and Abraxane® in triple negative breast cancer (TNBC) and with Tecentriq and Avastin® in renal cell cancer (RCC).
      • Early, encouraging clinical activity has been observed in the TNBC cohort of MARIO-3. Infinity plans to present these initial clinical data later this year.
      • The majority of identified sites are up and running. Infinity has observed an increase in site initiation and patient screening, and Infinity is working closely with the CRO on enrollment initiatives.
      • Enrollment completion is expected in the RCC cohort by the end of 2020 and the TNBC cohort by the end of Q1 2021.
    • MARIO-1: Infinity plans to share clinical and translational data from MARIO-1 later this year.
    • Arcus Collaboration: A Phase 1b collaboration study with Arcus Biosciences, which is being conducted by Arcus, is evaluating a checkpoint-inhibitor free, novel triple-combination regimen of eganelisib + AB928 (dual adenosine receptor antagonist) + Doxil® in up to approximately 40 advanced TNBC patients.
    • COVID-19 Impact: As the situation with COVID-19 continues to evolve, the company is diligently evaluating impacts on enrollment, site initiations, patient treatment and protocol compliance. Infinity continues to work closely with trial sites to support the continued treatment of patients in compliance with study protocols and is proactively working to mitigate disruptions to enrollment and trial timelines.

    Corporate:

    • Dr. Brian Schwartz joined Infinity in a consulting Chief Physician role in April. He is actively providing guidance and insight across Infinity's clinical programs, leveraging his deep experience in clinical development, particularly in oncology. Dr. Schwartz brings an impressive track record of experience and success, most recently serving as Chief Medical Officer at ArQule up until its acquisition by Merck. Dr. Schwartz is providing guidance and insight across Infinity's clinical programs, leveraging his deep experience in clinical development, particularly in oncology.

    Second Quarter 2020 Financial Results:

    • At June 30, 2020, Infinity had total cash, cash equivalents and available-for-sale securities of $42.7 million, compared to $50.3 million at March 31, 2020.
    • Research and development expense for the second quarter of 2020 was $6.1 million, compared to $6.1 million for the same period in 2019.
    • General and administrative expense was $2.9 million for the second quarter of 2020, compared to $3.8 million for the same period in 2019. The decrease is primarily related to a decrease in consulting and stock compensation.
    • Net loss for the second quarter of 2020 was $9.5 million, or a basic and diluted loss per common share of $0.16, compared to a net loss of $10.5 million, or a basic and diluted loss per common share of $0.18 for the same period in 2019.

    2020 Financial Outlook:

    Net Loss: Infinity expects net loss for 2020 to range from $35 million to $45 million.

    Cash and Investments: Infinity expects to end 2020 with a year-end cash, cash equivalents and available-for-sale securities balance ranging from $20 million to $30 million.

    Cash Runway: Based on its current operational plans, Infinity expects that its existing cash, cash equivalents and available-for-sale securities, will be adequate to satisfy the company's capital needs into 2H2021. Infinity's financial guidance does not include potential additional funding or business development activities, a potential $5 million milestone payment from BVF based on PellePharm's ongoing Phase 3 clinical trial of patidegib topical gel in Gorlin Syndrome, or any milestones from, or the sale of the company's equity interest in, PellePharm.

    Conference Call Information

    Infinity will host a conference call today, July 30, 2020, at 4:30 p.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity's website at www.infi.com. To participate in the conference call, please dial (877) 316-5293 (domestic) and (631) 291-4526 (international) five minutes prior to start time. The conference ID number is 7893533. An archived version of the webcast will be available on Infinity's website for 30 days.

    About Infinity and Eganelisib

    Infinity is an innovative biopharmaceutical company dedicated to advancing novel medicines for people with cancer. Infinity is advancing eganelisib, a first-in-class, oral immuno-oncology development candidate that selectively inhibits PI3K-gamma, in multiple clinical studies. MARIO-275 is a global, 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 RCC. In collaboration with Arcus Biosciences, Infinity is evaluating a checkpoint inhibitor-free, novel combination regimen of eganelisib plus AB928 (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; plans to present data; planned analyses in MARIO-275; clinical trial enrollment projections; the impact of the COVID-19 pandemic on the company's clinical studies, business operations and financial guidance; the timing of further clinical trial updates from the company; 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 outcome of the company's risk/benefit review of its MARIO-275 clinical trial; the content and timing of decisions made by the U.S. FDA and other regulatory authorities; Infinity's ability to obtain and maintain requisite regulatory approvals; unplanned cash requirements and expenditures; development of agents by Infinity's competitors for diseases in which Infinity is currently developing or intends to develop eganelisib; and Infinity's ability to obtain, maintain and enforce patent and other intellectual property protection for eganelisib. These and other risks which may impact management's expectations are described in greater detail under the caption "Risk Factors" included in Infinity's annual report and quarterly reports filed with the Securities and Exchange Commission (SEC), and in other filings that Infinity makes with the SEC, available through the company's website at www.infi.com. Any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity does not undertake and expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

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

    Tecentriq® and Avastin® are registered trademarks of Roche.

    Abraxane® is a registered trademark of Celgene.

    Doxil® is a registered trademark of Janssen Products.

    Copiktra® is a registered trademark of Verastem, Inc.

     

    INFINITY PHARMACEUTICALS, INC.

    Condensed Consolidated Balance Sheets

    (in thousands)

    (unaudited)

     

     

    June 30, 2020

     

    December 31, 2019

    Cash, cash equivalents and available-for-sale securities

    $

    42,730

     

     

     

    $

    42,444

     

    Other current assets

    2,064

     

     

     

    2,137

     

    Property and equipment, net

    1,951

     

     

     

    2,186

     

    Other long-term assets

    1,911

     

     

     

    2,247

     

    Total assets

    $

    48,656

     

     

     

    $

    49,014

     

     

     

     

     

    Accounts payable and accrued expenses

    $

    8,877

     

     

     

    $

    9,698

     

    Liability related to sale of future royalties, net1

     

    28,721

     

     

     

    29,626

     

    Liability related to sale of future royalties to a related party, net2

    20,366

     

     

     

     

    Operating lease liability, less current portion

    1,688

     

     

     

    1,926

     

    Long-term liabilities

    388

     

     

     

    38

     

    Total stockholders' equity (deficit)

    (11,384

    )

     

     

    7,726

     

    Total liabilities and stockholders' equity (deficit)

    $

    48,656

     

     

     

    $

    49,014

     

    1 In the first quarter of 2019, Infinity recognized $30.0 million in gross cash proceeds received from the HealthCare Royalty Partners III, L.P. (HCR) agreement as a liability on the balance sheet in accordance with accounting guidance for royalty monetization. While recognized as a liability, the company is not obligated to repay the $30.0 million from HCR.

    2 In the first quarter of 2020, Infinity recognized $20.0 million in gross cash proceeds received from the Biotech Value Fund Partners, L.P. (BVF) funding agreement as a liability on the balance sheet in accordance with accounting guidance for royalty monetization. While recognized as a liability, the company is not obligated to repay the $20.0 million from BVF.

     

    INFINITY PHARMACEUTICALS, INC.

    Condensed Consolidated Statements of Operations

    (in thousands, except share and per share amounts)

    (unaudited)

     

     

    Three Months Ended June 30,

     

    Six Months Ended June 30,

     

    2020

     

    2019

     

    2020

     

    2019

    Collaboration revenue

    $

     

     

     

    $

     

     

     

    $

     

     

     

    $

    2,000

     

     

    Royalty revenue

    360

     

     

     

    257

     

     

     

    788

     

     

     

    399

     

     

    Total revenues

    360

     

     

     

    257

     

     

     

    788

     

     

     

    2,399

     

     

    Operating expenses:

     

     

     

     

     

     

     

    Research and development

    6,125

     

     

     

    6,076

     

     

     

    13,470

     

     

     

    11,842

     

     

    General and administrative

    2,937

     

     

     

    3,771

     

     

     

    6,261

     

     

     

    7,169

     

     

    Royalty expense1

    217

     

     

     

    155

     

     

     

    475

     

     

     

    6,916

     

     

    Total operating expenses

    9,279

     

     

     

    10,002

     

     

     

    20,206

     

     

     

    25,927

     

     

    Loss from operations

    (8,919

    )

     

     

    (9,745

    )

     

     

    (19,418

    )

     

     

    (23,528

    )

     

    Other income (expense):

     

     

     

     

     

     

     

    Investment and other income

    50

     

     

     

    318

     

     

     

    235

     

     

     

    607

     

     

    Interest expense

    (39

    )

     

     

    (1,087

    )

     

     

    (77

    )

     

     

    (1,391

    )

     

    Related party interest expense2

    (565

    )

     

     

     

     

     

    (1,099

    )

     

     

     

     

    Total other expense

    (554

    )

     

     

    (769

    )

     

     

    (941

    )

     

     

    (784

    )

     

    Loss before income taxes

    (9,473

    )

     

     

    (10,514

    )

     

     

    (20,359

    )

     

     

    (24,312

    )

     

    Income taxes benefit

     

     

     

     

     

     

     

     

     

    54

     

     

    Net loss

    $

    (9,473

    )

     

     

    $

    (10,514

    )

     

     

    $

    (20,359

    )

     

     

    $

    (24,258

    )

     

    Basic and diluted loss per common share:

    $

    (0.16

    )

     

     

    $

    (0.18

    )

     

     

    $

    (0.35

    )

     

     

    $

    (0.43

    )

     

    Basic and diluted weighted average number of common shares outstanding:

    57,442,322

     

     

     

    56,942,033

     

     

     

    57,392,965

     

     

     

    56,933,521

     

     

    1 In the first quarter of 2019, Infinity recognized $6.7 million of royalty expense, which reflects Takeda's share of the $30.0 million gross proceeds received from HCR for the monetization of Copiktra royalties.

    2 In the first quarter of 2020, Infinity recognized $20.0 million in gross cash proceeds received from the BVF funding agreement as a liability that will be amortized using the effective interest method over the life of the arrangement, in accordance with accounting guidance for royalty monetization.

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  2. Infinity Pharmaceuticals, Inc. (NASDAQ:INFI) will host a conference call on July 30, 2020 at 4:30 p.m. ET to review its second quarter 2020 financial results and provide an update on the company.

    A live webcast of the conference call can be accessed in the Investors/Media section of Infinity's website at www.infi.com. To participate in the conference call, please dial (877) 316-5293 (domestic) and (631) 291-4526 (international) five minutes prior to start time. The conference ID number is 7893533. An archived version of the webcast will be available on Infinity's website for 30 days.

    About Infinity and IPI-549
    Infinity is an innovative biopharmaceutical company dedicated to advancing novel medicines for people with cancer. Infinity is advancing…

    Infinity Pharmaceuticals, Inc. (NASDAQ:INFI) will host a conference call on July 30, 2020 at 4:30 p.m. ET to review its second quarter 2020 financial results and provide an update on the company.

    A live webcast of the conference call can be accessed in the Investors/Media section of Infinity's website at www.infi.com. To participate in the conference call, please dial (877) 316-5293 (domestic) and (631) 291-4526 (international) five minutes prior to start time. The conference ID number is 7893533. An archived version of the webcast will be available on Infinity's website for 30 days.

    About Infinity and IPI-549

    Infinity is an innovative biopharmaceutical company dedicated to advancing novel medicines for people with cancer. Infinity is advancing IPI-549, a first-in-class, oral immuno-oncology development candidate that selectively inhibits PI3K-gamma, in multiple clinical studies. MARIO-275 is a global, randomized, controlled combination study of IPI-549 combined with Opdivo® in I/O naïve urothelial cancer. MARIO-3 is the first IPI-549 combination study in front-line advanced cancer patients and is evaluating IPI-549 in combination with Tecentriq® and Abraxane® in front-line TNBC and in combination with Tecentriq and Avastin® in front-line RCC. In collaboration with Arcus Biosciences, Infinity is evaluating a checkpoint inhibitor-free, novel combination regimen of IPI-549 plus AB928 (dual adenosine receptor antagonist) plus Doxil® in advanced TNBC patients. In 2019, Infinity completed enrollment in MARIO-1, a Phase 1/1b study evaluating IPI-549 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 IPI-549 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.

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

    Tecentriq® and Avastin® are registered trademarks of Roche.

    Abraxane® is a registered trademark of Celgene.

    Doxil® is a registered trademark of Janssen Products.

    View Full Article Hide Full Article
  3. – The date and time of the 2020 Annual Meeting remain 8:30 a.m. ET on June 17, 2020 –

    – To participate in the virtual meeting, stockholders must register by 11:59 ET on June 15, 2020 –

    Infinity Pharmaceuticals, Inc. (the "Company") (NASDAQ:INFI) today announced that, due to the public health impact of the novel coronavirus (COVID-19) outbreak and governmental restrictions limiting the number of people who may gather together, and to support the health and well-being of its stockholders, employees and communities, the Company has changed the format of its 2020 Annual Meeting of Stockholders (the "Annual Meeting") to be a virtual-only meeting. The Annual Meeting will be held at 8:30 a.m. ET on June 17, 2020, as previously disclosed in the…

    – The date and time of the 2020 Annual Meeting remain 8:30 a.m. ET on June 17, 2020 –

    – To participate in the virtual meeting, stockholders must register by 11:59 ET on June 15, 2020 –

    Infinity Pharmaceuticals, Inc. (the "Company") (NASDAQ:INFI) today announced that, due to the public health impact of the novel coronavirus (COVID-19) outbreak and governmental restrictions limiting the number of people who may gather together, and to support the health and well-being of its stockholders, employees and communities, the Company has changed the format of its 2020 Annual Meeting of Stockholders (the "Annual Meeting") to be a virtual-only meeting. The Annual Meeting will be held at 8:30 a.m. ET on June 17, 2020, as previously disclosed in the Company's proxy material, but will be held via live audio webcast. Stockholders will be able to participate in the Annual Meeting only via the webcast.

    Advance Registration

    As described in the proxy materials for the Annual Meeting previously distributed, stockholders are entitled to attend and vote at the Annual Meeting if they were a stockholder at the close of business on the record date, April 20, 2020, or hold a legal proxy for the meeting provided by the stockholder's bank or brokerage firm as of such record date. To attend and participate in the Annual Meeting, stockholders must register at https://viewproxy.com/infi/2020/ (the "Meeting Registration Website") prior to 11:59 p.m. ET on June 15, 2020. To register, shareholders must provide their contact information and the control number found on their proxy card, voting instruction form, or the notice that was previously received. Upon completing registration, eligible participants will receive further instructions via email, including unique links that will allow such eligible participants to access the meeting. Stockholders may submit questions at registration or during the Annual Meeting through the virtual meeting platform. Those stockholders without a control number may attend as guests of the meeting but will not have the option to vote during the virtual meeting. A list of registered stockholders will also be available to record holders during the Annual Meeting. For additional information regarding how stockholders may attend, participate in and/or vote at the Annual Meeting, please refer to the Company's additional proxy material filed today with the U.S. Securities and Exchange Commission, which can also be accessed on the Company's website at www.infi.com.

    Technical Support

    Eligible participants who have difficulty accessing the Meeting Registration Website or the virtual meeting may reach out to the technical support at or call 1-866-612-8937.

    Voting in Advance

    Stockholders of record may vote prior to the meeting by the following means if received prior to 11:59 p.m. ET on June 16, 2020:

    1. By internet at www.proxyvote.com;
    2. By telephone using a touch-tone telephone at 1-800-690-6903; or
    3. By marking, signing and dating the proxy card and returning it in the postage-paid envelope provided to Vote Processing, c/o Broadridge, 51 Mercedes Way, Edgewood, NY 11717.

    Please note that the proxy card included with previously distributed proxy materials will not be updated to reflect the change from an in-person meeting to a virtual-only meeting and may be used to vote shares in connection with the Annual Meeting. Whether or not stockholders plan to attend the virtual-only annual meeting, the Company urges stockholders to vote and submit their proxies in advance of the meeting by one of the methods described in the proxy materials. Stockholders who have previously registered to attend and participate at the Meeting Registration Website may also vote online during the Annual Meeting by following the instructions available on the annual meeting website.

    About Infinity and IPI-549

    Infinity is an innovative biopharmaceutical company dedicated to advancing novel medicines for people with cancer. Infinity is advancing IPI-549, a first-in-class, oral immuno-oncology development candidate that selectively inhibits PI3K-gamma, in multiple clinical studies. Infinity's study MARIO-275 is a global, randomized, controlled combination study of IPI-549 combined with Opdivo® in I/O naïve urothelial cancer. MARIO-3 is the first IPI-549 combination study in front-line advanced cancer patients and is evaluating IPI-549 in combination with Tecentriq® and Abraxane® in front-line triple-negative breast cancer, or 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 IPI-549 plus AB928 (dual adenosine receptor antagonist) plus Doxil® in advanced TNBC patients. In 2019, Infinity completed enrollment in MARIO-1, a Phase 1/1b study evaluating IPI-549 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 IPI-549 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 IPI-549, 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 IPI-549 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 U.S. FDA and other regulatory authorities; Infinity's ability to obtain and maintain requisite regulatory approvals; unplanned cash requirements and expenditures; development of agents by Infinity's competitors for diseases in which Infinity is currently developing or intends to develop IPI-549; and Infinity's ability to obtain, maintain and enforce patent and other intellectual property protection for IPI-549. These and other risks which may impact management's expectations are described in greater detail under the caption "Risk Factors" included in Infinity's annual report and quarterly reports filed with the Securities and Exchange Commission (SEC), and in other filings that Infinity makes with the SEC, available through the company's website at www.infi.com. Any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity does not undertake and expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

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

    Tecentriq® and Avastin® are registered trademarks of Roche.

    Abraxane® is a registered trademark of Celgene.

    Doxil® is a registered trademark of Janssen Products.

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  4. – Fast Track Designation Granted for IPI-549 Plus Opdivo® in Patients with Advanced Urothelial Cancer –

    – Infinity Voluntarily Pausing Enrollment on MARIO-275 to Evaluate the Risk/Benefit for Patients –

    – Completion of Enrollment for MARIO-275 and MARIO-3 Delayed with Outlook for Completion of Enrollment and Impact on Data Readouts to Be Updated by 2Q Earnings Webcast –

    – $20M Asset Backed Financing with BVF in January; Cash Runway into 2H2021 –

    Infinity Pharmaceuticals, Inc. (NASDAQ:INFI) today announced its first quarter 2020 financial results and provided an update on the Company, including its first quarter progress with IPI-549, the Company's first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated…

    – Fast Track Designation Granted for IPI-549 Plus Opdivo® in Patients with Advanced Urothelial Cancer –

    – Infinity Voluntarily Pausing Enrollment on MARIO-275 to Evaluate the Risk/Benefit for Patients –

    – Completion of Enrollment for MARIO-275 and MARIO-3 Delayed with Outlook for Completion of Enrollment and Impact on Data Readouts to Be Updated by 2Q Earnings Webcast –

    – $20M Asset Backed Financing with BVF in January; Cash Runway into 2H2021 –

    Infinity Pharmaceuticals, Inc. (NASDAQ:INFI) today announced its first quarter 2020 financial results and provided an update on the Company, including its first quarter progress with IPI-549, the Company's first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition.

    "While COVID-19 has created challenges for Infinity and the broader life sciences community, it has also highlighted the dedication, commitment and innovation that is allowing the continued advancement of desperately needed treatments for patients," said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "Infinity remains committed to our clinical strategy which is designed to demonstrate the potential benefit of IPI-549 treatment for the patients in our trials who have some of the most challenging cancers and poor prognoses. It is imperative that these patients have continued access to treatment and that we advance the development of potentially promising new therapies. I am particularly proud of our team at Infinity, along with our collaborators and investigators, for prioritizing the safety of our patients while still enabling our progress in the clinic to continue. To this end, following an initial meeting with the MARIO-275 Independent Data Monitoring Committee, we are voluntarily pausing enrollment of patients in MARIO-275 to ensure patient safety while evaluating the potential benefit of IPI-549 plus Opdivo in patients with advanced urothelial cancer. The magnitude of the unmet need and the potential of IPI-549 plus Opdivo to improve outcomes for these patients is reflected in the Fast Track Designation we recently received for this combination in this patient population. Across all our studies, we are working closely with our clinical research organizations to leverage learnings from early patient enrollment and the impact of COVID-19 to address delays in new site initiation and enrollment. While the potential duration of delays in the enrollment of our trials are still being quantified, we anticipate the need for additional financial resources to fund our trials through key data readouts. We expect to provide additional updates on trial status including timelines for enrollment and data readouts as well as financial guidance by our 2Q webcast."

    Key 2020 Updates:

    Clinical and Regulatory:

    • Fast Track Designation: Infinity received Fast Track Designation from the U.S. FDA for IPI-549 in combination with the checkpoint inhibitor Opdivo for the treatment of advanced urothelial cancer.
    • MARIO-275: MARIO-275 is the Company's ongoing controlled, randomized Phase 2 study evaluating IPI-549 in combination with Opdivo in platinum-refractory, I/O naïve patients with (aUC), in collaboration with Bristol Myers Squibb, or BMS. The objective of this controlled study is to evaluate the potential benefit of adding IPI-549 to Opdivo monotherapy, building on the exploratory biomarker data from the BMS CheckMate-275 study demonstrating an association between high baseline levels of myeloid-derived suppressor cells, or MDSCs, and lower median overall survival as well as Infinity's MARIO-1 study showing that treatment with IPI-549 reduced MDSC levels in the majority of patients treated.



      Independent Data Monitoring Committee (IDMC): Infinity and the MARIO-275 IDMC held the first scheduled IDMC meeting to review safety data on the initial 42 patients treated in the study. Liver enzyme elevations of Grade 3 or higher were seen in seven of 42 patients: five with Grade 3, two with Grade 4 (one is newly observed and has not yet been reviewed by the IDMC). Liver enzyme elevations from the six patients reviewed by the IDMC were reversible and have resolved without sequela. Of 17 patients evaluable for efficacy, objective responses have been observed in patients with Grade 3 and above liver enzyme elevations as well as in patients without these elevations. Infinity is continuing to review this data with the IDMC and plans to continue the treatment of patients now on study with modifications including additional patient monitoring and a dose reduction while voluntarily pausing enrollment and amending the protocol in order to ensure patient safety while evaluating the potential benefit of IPI-549 plus Opdivo.
    • MARIO-3: MARIO-3 is 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). The TNBC cohort of MARIO-3 is experiencing initial enrollment and site initiation delays, independent of a COVID-19 impact, which the Company is working closely with its CRO and investigators to evaluate.
    • MARIO-1: Additional data are expected in 2020 to the extent that they inform potential future IPI-549 development paths.
    • COVID-19: The Company is continuing to evaluate early enrollment trends in its studies as well as the impact of COVID-19 on its clinical programs. Patients enrolled on MARIO-275, MARIO-3 and MARIO-1 have continued treatment and study visits with limited disruption to date, and Infinity is working closely with trial sites to support the continued treatment of patients in compliance with study protocols. The pandemic is impacting new patient enrollment and site initiation across the Company's clinical programs. New patient screening and enrollment and new site initiation are being assessed on a case-by-case basis and are ongoing in MARIO-3. There are no anticipated disruptions to drug supply.
    • Arcus Collaboration: A Phase 1b collaboration study with Arcus Biosciences, which is being conducted by Arcus, is evaluating a checkpoint-inhibitor free, novel triple-combination regimen of IPI-549 + AB928 (dual adenosine receptor antagonist) + Doxil® in up to approximately 40 advanced TNBC patients.

    Financial:

    • In January 2020, completed a $20 million 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 an additional $5 million payment from BVF based on PellePharm's ongoing Phase 3 clinical trial of patidegib topical gel in Gorlin Syndrome. PellePharm completed enrollment of its Phase 3 trial in 2019.

    Corporate:

    • Appointed Richard Gaynor, M.D. to Board of Directors. Richard Gaynor, M.D. was most recently the President of Research and Development for Neon Therapeutics (NASDAQ:NTGN), a biotechnology company developing novel neoantigen-targeted T cell therapies. Prior to his tenure at Neon Therapeutics, Dr. Gaynor spent 15 years in a series of senior roles at Lilly Oncology, most recently as Senior Vice President Clinical Development and Medical Affairs.
    • Established Clinical Advisory Board with the following initial members:
      • Chair: Sam Agresta, MD, Infinity Board Member and Chief Medical Officer of Foghorn Therapeutics.
      • 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 myeloid-derived suppressor cells, or MDSCs, to significantly lower overall survival in patients with advanced urothelial cancer (aUC) that provided the inspiration for Infinity's MARIO-275 study to which Dr Sharma brings unique insight.
      • 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.
      • Michael Postow, MD, co-leader of the Melanoma Disease Management Team at Memorial Sloan Kettering Cancer Center and assistant professor of medicine at Weill Cornell Medical College.

    Updated Program and Financial Guidance:

    • Given that the Company is experiencing delays in MARIO-3 enrollment and site initiation and is voluntarily pausing enrollment in MARIO-275 while amending the MARIO-275 protocol to ensure patient safety, Infinity expects to provide additional updates on trial status including timelines for enrollment and data readouts as well as financial guidance by our 2Q webcast.
    • As a result of the delays in enrollment in its MARIO-3 and MARIO-275 clinical trials, Infinity anticipates that its existing financial resources will not be sufficient to fully fund the Company through key data readouts on all of its IPI-549 trials, and Infinity will need to find cost savings and/or seek additional capital resources in order to fund studies through key data readouts.

    First Quarter 2020 Financial Results:

    • At March 31, 2020, Infinity had total cash, cash equivalents and available-for-sale securities of $50.3 million, compared to $42.4 million at December 31, 2019.
    • During the first quarter of 2020, Infinity recognized the $20 million gross proceeds from BVF, net of transaction costs, as a liability that will be amortized using the effective interest method over the life of the arrangement, in accordance with relevant accounting guidance. While recognized as a liability for accounting purposes, the Company is not obligated to repay the $20 million from BVF.
    • Research and development expense for the first quarter of 2020 was $7.3 million, compared to $5.8 million for the same period in 2019. The increase in R&D expense in 2020 compared to 2019 was primarily due to an increase in clinical and development activities for IPI-549.
    • General and administrative expense was $3.3 million for the first quarter of 2020, compared to $3.4 million for the same period in 2019.
    • Net loss for the first quarter of 2020 was $10.9 million, or a basic and diluted loss per common share of $0.19, compared to a net loss of $13.7 million, or a basic and diluted loss per common share of $0.24 for the same period in 2019.

    2020 Financial Outlook:

    Net Loss: Infinity expects net loss for 2020 to range from $40 million to $50 million.

    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.

    Cash Runway: Based on its current operational plans, Infinity expects that its existing cash, cash equivalents and available-for-sale securities, will be adequate to satisfy the Company's capital needs into 2H2021. Infinity's financial guidance does not include potential additional funding or business development activities, a potential $5 million milestone payment from BVF based on PellePharm's ongoing Phase 3 clinical trial of patidegib topical gel in Gorlin Syndrome, or any milestones from, or the sale of the Company's equity interest in, PellePharm.

    Conference Call Information

    Infinity will host a conference call today, May 11, 2020, at 4:30 p.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity's website at www.infi.com. To participate in the conference call, please dial (877) 316-5293 (domestic) and (631) 291-4526 (international) five minutes prior to start time. The conference ID number is 1978798. An archived version of the webcast will be available on Infinity's website for 30 days.

    About Infinity and IPI-549

    Infinity is an innovative biopharmaceutical company dedicated to advancing novel medicines for people with cancer. Infinity is advancing IPI-549, a first-in-class, oral immuno-oncology development candidate that selectively inhibits PI3K-gamma, in multiple clinical studies. MARIO-275 is a global, randomized, controlled combination study of IPI-549 combined with Opdivo® in I/O naïve urothelial cancer. MARIO-3 is the first IPI-549 combination study in front-line advanced cancer patients and is evaluating IPI-549 in combination with Tecentriq® and Abraxane® in front-line TNBC and in combination with Tecentriq and Avastin® in front-line RCC. In collaboration with Arcus Biosciences, Infinity is evaluating a checkpoint inhibitor-free, novel combination regimen of IPI-549 plus AB928 (dual adenosine receptor antagonist) plus Doxil® in advanced TNBC patients. In 2019, Infinity completed enrollment in MARIO-1, a Phase 1/1b study evaluating IPI-549 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 IPI-549 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 IPI-549; ongoing discussions with the IDMC regarding additional patient monitoring, potential dose reduction and protocol amendment, the impact of a MARIO-275 protocol amendment, the impact of the COVID-19 pandemic on the company's clinical studies, including potential delays and disruptions in patient enrollment, site activation and data readouts, as well as the impact on the company's business operations, drug supply and financial guidance; the timing of further clinical trial updates from the company; the company's guidance with respect to net loss, cash and cash equivalents and its 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 IPI-549 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 outcome of the Company's risk/benefit review of its MARIO-275 clinical trial; the content and timing of decisions made by the U.S. FDA and other regulatory authorities; Infinity's ability to obtain and maintain requisite regulatory approvals; unplanned cash requirements and expenditures; development of agents by Infinity's competitors for diseases in which Infinity is currently developing or intends to develop IPI-549; and Infinity's ability to obtain, maintain and enforce patent and other intellectual property protection for IPI-549. These and other risks which may impact management's expectations are described in greater detail under the caption "Risk Factors" included in Infinity's annual report and quarterly reports filed with the Securities and Exchange Commission (SEC), and in other filings that Infinity makes with the SEC, available through the company's website at www.infi.com. Any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity does not undertake and expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

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

    Tecentriq® and Avastin® are registered trademarks of Roche.

    Abraxane® is a registered trademark of Celgene.

    Doxil® is a registered trademark of Janssen Products.

    Copiktra® is a registered trademark of Verastem, Inc.

       

    INFINITY PHARMACEUTICALS, INC.

    Condensed Consolidated Balance Sheets

    (in thousands)

    (unaudited)

       

     

    March 31, 2020

     

    December 31, 2019

    Cash, cash equivalents and available-for-sale securities

    $

    50,348

     

     

    $

    42,444

    Other current assets

    2,677

     

     

    2,137

    Property and equipment, net

    2,071

     

     

    2,186

    Other long-term assets

    1,992

     

     

    2,247

    Total assets

    $

    57,088

     

     

    $

    49,014

     

     

     

     

     

    Accounts payable and accrued expenses

    $

    8,463

     

     

    $

    9,698

    Liability related to sale of future royalties, net1

    28,926

     

     

    29,626

    Liability related to sale of future royalties to a related party, net2

    19,800

     

     

    Operating lease liability, less current portion

    1,808

     

     

    1,926

    Long-term liabilities

    343

     

     

    38

    Total stockholders' equity (deficit)

    (2,252

    )

     

    7,726

    Total liabilities and stockholders' equity (deficit)

    $

    57,088

     

     

    $

    49,014

    1 In the first quarter of 2019, Infinity recognized $30.0 million in gross cash proceeds received from the HCR agreement as a liability on the balance sheet in accordance with accounting guidance for royalty monetization. While recognized as a liability, the Company is not obligated to repay the $30.0 million from HCR.

    2 In the first quarter of 2020, Infinity recognized $20.0 million in gross cash proceeds received from the BVF funding agreement as a liability on the balance sheet in accordance with accounting guidance for royalty monetization. While recognized as a liability, the Company is not obligated to repay the $20.0 million from BVF.

    INFINITY PHARMACEUTICALS, INC.

    Condensed Consolidated Statements of Operations

    (in thousands, except share and per share amounts)

    (unaudited)

     

     

     

    Three Months Ended March 31,

     

    2020

     

    2019

    Revenues:

     

     

     

    Collaboration revenue

    $

     

     

    $

    2,000

     

    Royalty revenue

    428

     

     

    142

     

    Total revenues

    428

     

     

    2,142

     

    Operating expenses:

     

     

     

    Research and development

    7,346

     

     

    5,766

     

    General and administrative

    3,324

     

     

    3,398

     

    Royalty expense1

    258

     

     

    6,761

     

    Total operating expenses

    10,928

     

     

    15,925

     

    Loss from operations

    (10,500

    )

     

    (13,783

    )

    Other income (expense):

     

     

     

    Investment and other income

    186

     

     

    289

     

    Interest expense

    (38

    )

     

    (304

    )

    Related party interest expense2

    (534

    )

     

     

    Total other expense

    (386

    )

     

    (15

    )

    Loss before income taxes

    (10,886

    )

     

    (13,798

    )

    Income taxes benefit

     

     

    54

     

    Net loss

    $

    (10,886

    )

     

    $

    (13,744

    )

    Basic and diluted loss per common share:

    $

    (0.19

    )

     

    $

    (0.24

    )

    Basic and diluted weighted average number of common shares outstanding:

    57,343,608

     

     

    56,924,914

     

    1 In the first quarter of 2019, Infinity recognized $6.7 million of royalty expense, which reflects Takeda's share of the $30.0 million gross proceeds received from HCR for the monetization of Copiktra royalties.

    2 In the first quarter of 2020, Infinity recognized $20.0 million in gross cash proceeds received from the BVF funding agreement as a liability that will be amortized using the effective interest method over the life of the arrangement, in accordance with accounting guidance for royalty monetization.

     

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  5. Infinity Pharmaceuticals, Inc. (NASDAQ:INFI) will host a conference call on Monday, May 11, 2020 at 4:30 p.m. ET to review its first quarter 2020 financial results and provide an update on the company.

    A live webcast of the conference call can be accessed in the Investors/Media section of Infinity's website at www.infi.com. To participate in the conference call, please dial (877) 316-5293 (domestic) and (631) 291-4526 (international) five minutes prior to start time. The conference ID number is 1978798. An archived version of the webcast will be available on Infinity's website for 30 days.

    About Infinity and IPI-549

    Infinity is an innovative biopharmaceutical company dedicated to advancing novel medicines for people with cancer. Infinity…

    Infinity Pharmaceuticals, Inc. (NASDAQ:INFI) will host a conference call on Monday, May 11, 2020 at 4:30 p.m. ET to review its first quarter 2020 financial results and provide an update on the company.

    A live webcast of the conference call can be accessed in the Investors/Media section of Infinity's website at www.infi.com. To participate in the conference call, please dial (877) 316-5293 (domestic) and (631) 291-4526 (international) five minutes prior to start time. The conference ID number is 1978798. An archived version of the webcast will be available on Infinity's website for 30 days.

    About Infinity and IPI-549

    Infinity is an innovative biopharmaceutical company dedicated to advancing novel medicines for people with cancer. Infinity is advancing IPI-549, a first-in-class, oral immuno-oncology development candidate that selectively inhibits PI3K-gamma, in multiple clinical studies. MARIO-275 is a global, randomized, controlled combination study of IPI-549 combined with Opdivo® (nivolumab) in I/O naïve urothelial cancer. MARIO-3 is the first IPI-549 combination study in front-line advanced cancer patients and is evaluating IPI-549 in combination with Tecentriq® and Abraxane® in front-line TNBC and in combination with Tecentriq and Avastin® in front-line RCC. In collaboration with Arcus Biosciences, Infinity is evaluating a checkpoint inhibitor-free, novel combination regimen of IPI-549 plus AB928 (dual adenosine receptor antagonist) plus Doxil® in advanced TNBC patients. In 2019, Infinity completed enrollment in MARIO-1, a Phase 1/1b study evaluating IPI-549 as a monotherapy and in combination with Opdivo in patients with advanced solid tumors including patients refractory to checkpoint inhibitor therapy. With these studies Infinity is evaluating IPI-549 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.

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

    Tecentriq® and Avastin® are registered trademarks of Roche.

    Abraxane® is a registered trademark of Celgene.

    Doxil® is a registered trademark of Janssen Products.

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