FPRX Five Prime Therapeutics Inc.

4.03
+0.06  (+2%)
Previous Close 3.97
Open 3.97
52 Week Low 1.75
52 Week High 7.34
Market Cap $147,610,538
Shares 36,627,925
Float 27,918,345
Enterprise Value $65,949,862
Volume 258,813
Av. Daily Volume 275,410
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Upcoming Catalysts

Drug Stage Catalyst Date
FPT155
Solid tumors
Phase 1
Phase 1
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FPA144 + chemo (FIGHT)
Gastric and gastro-esophageal junction cancer
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
FPA150
Solid tumors
Phase 1
Phase 1
No plans to independently advance the clinical development.
Cabiralizumab (FPA008)
Pigmented Villonodular Synovitis (PVNS)
Phase 1/2
Phase 1/2
Phase 2 complete. Phase 3 development will not be pursued.
Cabiralizumab (FPA008) and Opdivo (nivolumab)
Pancreatic cancer
Phase 2
Phase 2
Phase 2 trial did not meet primary endpoint - February 18, 2020.

Latest News

  1. Pipeline Therapeutics, a biopharmaceutical company focused on the development and commercialization of first-in-class small molecules for neuroregeneration, today announced the appointment of Lori Lyons-Williams to the company's Board of Directors. Ms. Lyons-Williams brings more than 20 years of executive and operational experience to Pipeline.

    "I am thrilled that Lori will be joining the Pipeline board as an independent director," said Carmine Stengone, President & CEO of Pipeline Therapeutics. "Lori is an industry leader, and a respected sales and marketing professional. Her experience working on highly successful product launches and pharmaceutical brands will help inform our clinical strategy, as we position Pipeline's portfolio of neuroregenerative

    Pipeline Therapeutics, a biopharmaceutical company focused on the development and commercialization of first-in-class small molecules for neuroregeneration, today announced the appointment of Lori Lyons-Williams to the company's Board of Directors. Ms. Lyons-Williams brings more than 20 years of executive and operational experience to Pipeline.

    "I am thrilled that Lori will be joining the Pipeline board as an independent director," said Carmine Stengone, President & CEO of Pipeline Therapeutics. "Lori is an industry leader, and a respected sales and marketing professional. Her experience working on highly successful product launches and pharmaceutical brands will help inform our clinical strategy, as we position Pipeline's portfolio of neuroregenerative development candidates."

    "I'm excited to be joining Pipeline's Board of Directors not long after the company's lead development candidate, PIPE-505, entered the clinic," said Ms. Lyons-Williams. "I believe Pipeline is uniquely positioned to potentially transform the lives of people living with neurodegenerative conditions, and I look forward to working with Carmine and the team to deliver on our collective mission."

    Ms. Lyons-Williams recently served as the Chief Commercial Officer of Dermira, Inc., prior to its acquisition by Eli Lilly, where she was responsible for developing and implementing the commercial strategy for Dermira's lead product candidates, including QBREXZA® and lebrikizumab. Previously, she spent 15 years in positions of increasing responsibility at Allergan, with extensive experience in neurotoxins across many indications for BOTOX®. Ms. Lyons-Williams was a member of the Allergan Commercial Leadership Team as well as the Operational Leadership Team.

    In addition to her operational experience, Ms. Lyons-Williams is a director of Five Prime Therapeutics (NASDAQ:FPRX), where she serves as a member of the Audit and Compensation Committees.

    Ms. Lyons-Williams holds a B.A. in Interdisciplinary Studies with a Pre-Medicine Concentration from Virginia Tech and an M.B.A. from the University of Minnesota's Carlson School of Management. She is a member of Executive Women in Bio's Boardroom Ready program, an executive leadership platform helping to diversify life science corporate boards by championing women from the C-suite to the boardroom.

    About Pipeline Therapeutics

    Pipeline Therapeutics is a biopharmaceutical company focused on the development and commercialization of first-in-class small molecules for neuroregeneration, including synaptogenesis, remyelination and axonal repair. The company's lead clinical program, PIPE-505, is currently enrolling patients in a phase 1/2a study to treat sensorineural hearing loss (SNHL) associated with speech-in-noise disability. The company also has a portfolio of programs addressing a range of neurological disorders, including development candidate PIPE-307 which is focused on remyelination to treat multiple sclerosis. For more information, please visit www.pipelinetherapeutics.com.

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  2. Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, today announced that Tom Civik, Chief Executive Officer of Five Prime Therapeutics, and Helen Collins, M.D., Executive Vice President and Chief Medical Officer of Five Prime Therapeutics, will participate in a fireside chat at the 2020 Wells Fargo Virtual Healthcare Conference on Thursday, September 10th at 9:00am Pacific Time / 12:00pm Eastern Time.

    The fireside chat will be webcast and may be accessed from the "Events & Presentations" section of the Company's website at: http://investor.fiveprime.com/events.cfm. Five Prime will maintain an archived replay of the webcast…

    Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, today announced that Tom Civik, Chief Executive Officer of Five Prime Therapeutics, and Helen Collins, M.D., Executive Vice President and Chief Medical Officer of Five Prime Therapeutics, will participate in a fireside chat at the 2020 Wells Fargo Virtual Healthcare Conference on Thursday, September 10th at 9:00am Pacific Time / 12:00pm Eastern Time.

    The fireside chat will be webcast and may be accessed from the "Events & Presentations" section of the Company's website at: http://investor.fiveprime.com/events.cfm. Five Prime will maintain an archived replay of the webcast on its website for approximately 30 days after the conference.

    About Five Prime Therapeutics

    Five Prime Therapeutics, Inc. discovers and develops innovative protein therapeutics to improve the lives of patients with serious diseases. Five Prime's product candidates have innovative mechanisms of action and address patient populations in need of better therapies. The company focuses on researching and developing immuno-oncology and targeted cancer therapies paired with companion diagnostics to identify patients who are most likely to benefit from treatment with Five Prime's product candidates. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and preclinical development. For more information, please visit www.fiveprime.com.

    Source: Five Prime Therapeutics, Inc.

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    • On track to generate Phase 2 data from the FIGHT trial by year-end or early next year and monotherapy safety and efficacy data for FPT155 by year-end
    • First patient dosed in the combination dose escalation of FPT155 and pembrolizumab in patients with NSCLC
    • Year-end cash guidance increased to the $80 to $85 million range from the $77 to $82 million range as a result of lower year-to-date cash burn

    Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, today announced results for the second quarter of 2020 in addition to providing an update on the company's recent activities.

    "We remain on track to generate data from the…

    • On track to generate Phase 2 data from the FIGHT trial by year-end or early next year and monotherapy safety and efficacy data for FPT155 by year-end
    • First patient dosed in the combination dose escalation of FPT155 and pembrolizumab in patients with NSCLC
    • Year-end cash guidance increased to the $80 to $85 million range from the $77 to $82 million range as a result of lower year-to-date cash burn

    Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, today announced results for the second quarter of 2020 in addition to providing an update on the company's recent activities.

    "We remain on track to generate data from the FIGHT Phase 2 trial by year-end or early next year and have monotherapy safety and efficacy data for FPT155 in-house by year-end," said Tom Civik, Chief Executive Officer of Five Prime Therapeutics. "The team has overcome many challenges since we began working from home five months ago and has done a remarkable job keeping our clinical trials on track as we prepare for two important data readouts for our bemarituzumab and FPT155 programs."

    Second Quarter 2020 Milestones

    Clinical Pipeline:

    Bemarituzumab (anti-FGFR2b) is a first-in-class isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) being studied in the FIGHT trial as a targeted therapy for gastric and gastroesophageal junction (GEJ) cancer that overexpresses FGFR2b.

    • The Phase 2 FIGHT study is expected to have a sufficient number of progression-free survival (PFS) and overall survival (OS) events to generate clinically meaningful and actionable data by the end of 2020 or in early 2021.
    • Converting FIGHT to a Phase 2 trial is the fastest path to generating informative data about bemarituzumab, the first agent to target FGFR2b-overexpressing gastric and GEJ cancer.

    FPT155 (CD80-Fc) is a first-in-class CD80-Fc fusion protein that directly engages CD28 and binds to CTLA-4, promoting T cell activation in the tumor microenvironment.

    • In the ongoing Phase 1 dose escalation study, a dose-dependent proliferation of memory T-cells has been identified, consistent with the mechanism of action of FPT155 observed in preclinical studies.
    • Patients with warm/hot tumor types are being enrolled with the aim of generating early clinical evidence of FPT155 single-agent activity by the end of 2020.
    • The first two patients have been dosed in a dose escalation of FPT155 in combination with pembrolizumab.

    FPA150 (anti-B7-H4) is a first-in-class antibody being studied as a treatment for patients with B7-H4-overexpressing tumors in a Phase 1a/1b clinical trial. Five Prime is in the process of completing the Phase 1a/1b study. The company does not currently plan to independently advance the clinical development of FPA150 as either a monotherapy or in combination with pembrolizumab.

    BMS-986258 (anti-TIM-3) is a fully human monoclonal antibody targeting TIM-3 (T cell immunoglobulin and mucin domain-3). It is the first clinical candidate from the discovery collaboration between Five Prime and Bristol-Myers Squibb (BMS) that includes targets in three immune checkpoint pathways. Five Prime has withdrawn its guidance that this trial may advance from Phase 1 to Phase 2 in 2020 as a result of the effect of the coronavirus pandemic on this oncology study.

    2020 Corporate Highlights

    The company entered into a Sales Agreement with Cowen & Company today, pursuant to which the Company may from time to time sell through at-the-market offerings, with Cowen acting as sales agent, common shares with an aggregate offering price of up to $75 million.

    Summary of Second Quarter 2020 Financial Results and Cash Guidance:

    Cash Position: Cash, cash equivalents and marketable securities totaled $128.6 million as of June 30, 2020 compared to $157.9 million as of December 31, 2019. This decrease was primarily attributed to quarterly operating expenses that exceeded quarterly revenues.

    Revenue: Collaboration and license revenue for the second quarter of 2020 was $3.4 million, which was essentially on par with second quarter 2019 revenue of $3.3 million.

    R&D Expenses: Research and development expenses for the second quarter of 2020 decreased by $16.9 million, or 57%, to $12.6 million from $29.4 million for second quarter of 2019. The decrease was primarily due to lower compensation costs resulting from the October 2019 corporate restructuring, reduced clinical and research costs, and a gain on the sale of laboratory equipment.

    G&A Expenses: General and administrative expenses for the second quarter of 2020 decreased by $1.7 million, or 17%, to $8.0 million from $9.7 million for the second quarter of 2019. The decrease was primarily due to lower compensation costs, depreciation expense, and other miscellaneous general and administrative costs that were partially offset by an increase in allocated costs.

    Net Loss: Net loss for the second quarter of 2020 was $16.9 million, or $0.48 per basic and diluted share, compared to a net loss of $34.4 million, or $0.99 per basic and diluted share, for the second quarter of 2019.

    Shares Outstanding: Total shares outstanding were 35,481,224 as of June 30, 2020.

    Cash Guidance: Five Prime expects full-year 2020 net cash used in operating activities to be between $74 and $79 million and has raised guidance to end 2020 with cash, cash equivalents and marketable securities between $80 and $85 million.

    Conference Call Information

    Five Prime will host a conference call and live audio webcast today at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss its financial results and provide a corporate update. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 9799664. To access the live webcast please visit the "Events & Presentations" page under the "Investors" tab on Five Prime's website at www.fiveprime.com. An archived copy of the webcast will be available on Five Prime's website beginning approximately two hours after the conference call. Five Prime will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.

    About Five Prime Therapeutics

    Five Prime Therapeutics, Inc. discovers and develops innovative protein therapeutics to improve the lives of patients with serious diseases. Five Prime's product candidates have innovative mechanisms of action and address patient populations in need of better therapies. The company focuses on researching and developing immuno-oncology and targeted cancer therapies paired with companion diagnostics to identify patients who are most likely to benefit from treatment with Five Prime's product candidates. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and preclinical development. For more information, please visit www.fiveprime.com.

    Cautionary Note on Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Five Prime's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Forward-looking statements contained in this press release include statements regarding (i) the timing of progress and scope of clinical trials for Five Prime's product candidates; (ii) the potential use of Five Prime's product candidates, including in combination with other products, to treat certain patients; (iii) the timing of the presentation of data for Five Prime's product candidates; (iv) Five Prime's estimated full-year 2020 net cash used in operating activities; and (v) Five Prime's estimated cash, cash equivalents and marketable securities at the end of 2020. Actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during research, preclinical or clinical studies, changes in expected or existing competition, changes in the regulatory, pricing or reimbursement environment, and unexpected litigation or other disputes. In addition, while the company expects the COVID-19 pandemic to adversely affect its business operations and financial results, the extent of the impact on the company's ability to advance its manufacturing, clinical development and regulatory efforts and business and corporate development and other objectives and the value of and market for its common stock will depend on future developments that are highly uncertain, and the company cannot predict with confidence the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S. and in other countries and the effectiveness of actions taken globally to contain and treat COVID-19. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Five Prime's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" contained therein. Except as required by law, Five Prime assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

    Source: Five Prime Therapeutics, Inc.

    Five Prime Therapeutics, Inc.

    Condensed Balance Sheets

    (In Thousands)

    June 30,

     December 31,
    Balance Sheet Data  

    2020

     

    2020

    Cash, cash equivalents and marketable securities  

    $

    128,601

     

    $

    157,923

    Total assets  

     

    185,345

     

     

    224,142

    Total current liabilities (excluding deferred revenue)  

     

    19,458

     

     

    21,728

    Deferred revenue (in total, including short term portion)  

     

    2,746

     

     

    6,409

    Total stockholders' equity  

     

    119,944

     

     

    150,473

    Five Prime Therapeutics, Inc.
    Condensed Statements of Operations
    (In Thousands Except Per Share Amounts)
     

    Three Months Ended

    Six Months Ended

    June 30,

    June 30,

    2020

    2019

    2020

    2019

    License revenue

    $

     

    $

     

    $

    5,000

     

    $

     

    Collaboration revenue

     

    3,424

     

     

    3,333

     

     

    6,838

     

     

    8,680

     

    Total revenues

     

    3,424

     

     

    3,333

     

     

    11,838

     

     

    8,680

     

    Operating expenses:
    Research and development

     

    12,573

     

     

    29,425

     

     

    31,129

     

     

    61,178

     

    General and administrative

     

    7,995

     

     

    9,661

     

     

    18,486

     

     

    20,171

     

    Total operating expenses

     

    20,568

     

     

    39,086

     

     

    49,615

     

     

    81,349

     

    Loss from operations

     

    (17,144

    )

     

    (35,753

    )

     

    (37,777

    )

     

    (72,669

    )

    Interest income

     

    207

     

     

    1,363

     

     

    724

     

     

    2,896

     

    Other loss, net

     

     

     

    (1

    )

     

     

     

    (3

    )

    Loss before income tax

     

    (16,937

    )

     

    (34,391

    )

     

    (37,053

    )

     

    (69,776

    )

    Income tax (provision) benefit

     

     

     

     

     

     

     

     

    Net loss

    $

    (16,937

    )

    $

    (34,391

    )

    $

    (37,053

    )

    $

    (69,776

    )

    Basic and diluted net loss per common share

    $

    (0.48

    )

    $

    (0.99

    )

    $

    (1.05

    )

    $

    (2.00

    )

    Weighted average shares used to compute basic and diluted net loss per common share

     

    35,425

     

     

    34,909

     

     

    35,344

     

     

    34,852

     

     

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  3. Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, today announced that Tom Civik, Chief Executive Officer of Five Prime Therapeutics, and Helen Collins, M.D., Executive Vice President and Chief Medical Officer of Five Prime Therapeutics, will participate in a fireside chat at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Tuesday, August 11, 2020 at 10:10am Pacific Time (PT) / 1:10pm Eastern Time (ET)

    The fireside chat will be webcast and may be accessed from the "Events & Presentations" section of the Company's website at: http://investor.fiveprime.com/events.cfm. Five Prime will maintain an archived replay…

    Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, today announced that Tom Civik, Chief Executive Officer of Five Prime Therapeutics, and Helen Collins, M.D., Executive Vice President and Chief Medical Officer of Five Prime Therapeutics, will participate in a fireside chat at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Tuesday, August 11, 2020 at 10:10am Pacific Time (PT) / 1:10pm Eastern Time (ET)

    The fireside chat will be webcast and may be accessed from the "Events & Presentations" section of the Company's website at: http://investor.fiveprime.com/events.cfm. Five Prime will maintain an archived replay of the webcast on its website for approximately 30 days after the conference.

    About Five Prime

    Five Prime Therapeutics, Inc. develops innovative protein therapeutics to improve the lives of patients with cancer. Five Prime's product candidates have innovative mechanisms of action and address patient populations in need of better cancer therapies. The company focuses on developing immuno-oncology and targeted cancer therapies paired with companion diagnostics to identify patients who are most likely to benefit from treatment with Five Prime's product candidates. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and preclinical development. For more information, please visit https://www.fiveprime.com.

    Source: Five Prime Therapeutics, Inc.

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  4. Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, will report its second quarter 2020 operational and financial results on Thursday, August 6, 2020 after the U.S. financial markets close. Five Prime will also host a conference call and live audio webcast on Thursday, August 6, 2020 at 4:30 p.m. (ET) / 1:30 p.m. (PT) to provide a general business update and discuss the company's financial results.

    The live audio webcast may be accessed through the "Events & Presentations" page in the "Investors" section of the company's website at www.fiveprime.com. Alternatively, participants may dial (877) 878-2269 (domestic) or (253…

    Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, will report its second quarter 2020 operational and financial results on Thursday, August 6, 2020 after the U.S. financial markets close. Five Prime will also host a conference call and live audio webcast on Thursday, August 6, 2020 at 4:30 p.m. (ET) / 1:30 p.m. (PT) to provide a general business update and discuss the company's financial results.

    The live audio webcast may be accessed through the "Events & Presentations" page in the "Investors" section of the company's website at www.fiveprime.com. Alternatively, participants may dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID: 9799664.

    The archived conference call will be available on Five Prime's website beginning approximately two hours after the event and will be archived and available for replay for at least 30 days after the event.

    About Five Prime Therapeutics

    Five Prime Therapeutics, Inc. develops innovative protein therapeutics to improve the lives of patients with cancer. Five Prime's product candidates have innovative mechanisms of action and address patient populations in need of better cancer therapies. The company focuses on developing immuno-oncology and targeted cancer therapies paired with companion diagnostics to identify patients who are most likely to benefit from treatment with Five Prime's product candidates. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and preclinical development. For more information, please visit https://www.fiveprime.com.

    Source: Five Prime Therapeutics, Inc.

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