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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Five Prime Therapeutics Inc | NASDAQ:FPRX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 38.00 | 38.01 | 38.00 | 0 | 01:00:00 |
2020 data milestones remain on track for proprietary programs
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 fourth quarter and year ended December 31, 2019, in addition to providing an update on the company’s recent activities.
“Our 2020 focus is on generating clinical data from three proprietary programs that will allow us to prioritize future pipeline investments,” said William Ringo, interim Chief Executive Officer and Chairman of the Board. “Additionally, we are advancing our novel late-stage research programs and plan to bring one new program into preclinical development later this year. We are also looking to acquire early-stage clinical assets that we can develop to generate actionable data in the near- to medium-term by utilizing our clinical development and translational expertise.”
2020 Milestones and Review of 2019 Business Highlights
Clinical Pipeline:
Bemarituzumab (anti-FGFR2b) is a first-in-class isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) in development as a targeted immunotherapy for tumors that overexpress FGFR2b. Bemarituzumab is being evaluated in combination with mFOLFOX6 in the Phase 3 FIGHT (FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) trial.
FPA150 (anti-B7-H4) is a first-in-class anti-B7-H4 antibody designed to target tumor cells by blocking B7-H4 from sending an inhibitory signal to CD8 T cells and by enhancing killing of B7-H4 overexpressing tumors through ADCC. B7-H4 is frequently overexpressed in breast, ovarian and endometrial cancers.
FPT155 (CD80-Fc) is a first-in-class CD80-Fc fusion protein that directly engages CD28 without superagonism and binds to CTLA-4, promoting T cell activation in the tumor microenvironment.
Cabiralizumab (FPA008) is an antibody that inhibits CSF1R and has been shown to block the activation and survival of tumor-associated macrophages.
BMS-986258 (anti-TIM-3) is a fully-human monoclonal antibody targeting TIM-3 (T cell immunoglobulin and mucin domain-3), an immune checkpoint receptor that may limit the duration and magnitude of T cell responses. This is the first clinical candidate from the discovery collaboration between Five Prime and BMS that includes targets in three immune checkpoint pathways.
2020 and 2019 Corporate Highlights
Summary of Fourth Quarter and Full Year 2019 Financial Results and 2020 Guidance:
Cash Position: Cash, cash equivalents and marketable securities totaled $157.9 million as of December 31, 2019, compared to $271.7 million as of December 31, 2018. The decrease was attributable to cash used in operating activities throughout the year.
Revenue: Collaboration and license revenue for the fourth quarter of 2019 decreased by $0.8 million, or 20%, to $3.2 million from $4.0 million for the fourth quarter of 2018. The decrease was primarily due to the completion of the research term of the company’s immuno-oncology research collaboration with BMS in March 2019.
Collaboration and license revenue for the year ended December 31, 2019 decreased by $35 million, or 70.1%, to $14.9 million from $49.9 million for the year ended December 31, 2018. Lower revenue was the result of a decrease in revenue recognized under several partner collaboration agreements, including the company’s October 2015 cabiralizumab collaboration agreement, November 2014 collaboration agreement, and immuno-oncology research collaboration agreement with BMS as well as lower collaboration revenues from the company’s partnerships with Zai Lab and UCB.
R&D Expenses: Research and development expenses for the fourth quarter of 2019 decreased by $8.8 million, or 25.4%, to $25.9 million from $34.7 million primarily due to lower compensation costs resulting from the January 2019 corporate restructuring, decreased clinical trial expenses related to the cabiralizumab trial, lower preclinical costs, reduced use of temporary resources, clinical services, specialty laboratory services, lower manufacturing costs for bemarituzumab and FPA150, and lower miscellaneous research and development costs. These decreases were partially offset by increased impairment charges for lab equipment and higher companion diagnostic expenses relating to bemarituzumab.
Research and development expenses for the year ended December 31, 2019 decreased by $42.3 million, or 27.0%, to $114.1 million from $156.4 million for the year ended December 31, 2018. The decrease was attributable principally to lower compensation costs resulting from the January 2019 corporate restructuring, lower preclinical program and clinical service expenses, decreased companion diagnostic clinical trial expense, the use of fewer temporary resources, lower allocated costs resulting from the restructurings, and milestone payments resulting from the dosing of the first patient in two clinical trials. These savings were partially offset by higher bioanalytic and specialty laboratory, and clinical trial expenses that were required to advance the bemarituzumab and FPA150 programs as well as an impairment charge for lab equipment.
G&A Expenses: General and administrative expenses for the fourth quarter of 2019 decreased by $0.2 million, or 2.1%, to $9.4 million from $9.6 million.
General and administrative expenses for the year ended December 31, 2019 increased by $3.0 million, or 7.8%, to $42.7 million from $39.7 million. The increase was primarily the result of higher allocated costs related to the corporate restructurings, higher compensation costs, and higher professional services fees that were partially offset by a reduction in the use of temporary resources.
Net Loss: Net loss for the fourth quarter of 2019 was $31.4 million, or $0.89 per basic and diluted share, compared to a net loss of $38.8 million, or $1.12 per basic and diluted share for the fourth quarter of 2018.
Net loss for the full year 2019 was $137.2 million, or $3.92 per basic and diluted share, compared to a net loss of $140.4 million, or $4.13 per basic and diluted share, for the full year 2019.
Shares Outstanding: Weighted average shares outstanding for the fourth quarter of 2019 was 35,175,624 as of December 31, 2019.
Cash Guidance: Five Prime expects full-year 2020 net cash used in operating activities to be between $77 and $82 million and estimates ending 2020 with cash, cash equivalents and marketable securities between $77 and $82 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 3872638. 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 or follow us on LinkedIn, Twitter and Facebook.
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, including the timing of the planned futility analysis for the FIGHT trial; (ii) the potential use of Five Prime’s product candidates, including in combination with other products, to treat certain patients; (iii) the extent of protein overexpression in certain patient populations; (iv) the timing of the presentation of data for Five Prime’s product candidates; (v) Five Prime's potential receipt of upfront and milestone payments and royalties under the license agreement with Seattle Genetics; (vi) the impact of the October 2019 restructuring on Five Prime’s cash runway and the data timelines of Five Prime’s clinical trials; (vii) Five Prime’s estimated full-year 2020 net cash used in operating activities; and (viii) 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. 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. Selected Balance Sheets Data (in thousands) December 31, December 31,2019
2018
Balance Sheet Data: Cash, cash equivalents and marketable securities$
157,923
$
271,681
Total assets
223,873
321,534
Total current liabilities (excluding deferred revenue)
21,727
26,059
Deferred revenue (in total, including short term portion)
6,141
11,893
Total stockholders' equity
150,473
265,139
Five Prime Therapeutics, Inc Condensed Statement of Operations (in thousands, except per share data) For The Three Months Ended For The Year Ended December 31 December 312019
2018
2019
2018
Collaboration and license revenue$
3,210
$
4,031
$
14,874
$
49,868
Operating expenses: Research and development
25,937
34,733
114,063
156,352
General and administrative
9,372
9,579
42,749
39,671
Total operating expenses
35,309
44,312
156,812
196,023
Loss from operations
(32,099
)
(40,281
)
(141,938
)
(146,155
)
Interest income and other loss, net
744
1,528
4,740
5,792
Other (lss)/gain), net
(2
)
-
(4
)
(84
)
Loss before income tax
(31,357
)
(38,753
)
(137,202
)
(140,447
)
Income tax provision
-
-
-
-
Net loss
$
(31,357
)
$
(38,753
)
$
(137,202
)
$
(140,447
)
Basic and diluted net loss per common share$
(0.89
)
$
(1.12
)
$
(3.92
)
$
(4.13
)
Weighted-average shares used to compute basic and diluted net loss per common share
35,175
34,675
34,967
33,976
View source version on businesswire.com: https://www.businesswire.com/news/home/20200227005890/en/
Media and Investor Contact Martin Forrest VP, Investor Relations & Corporate Communications Five Prime Therapeutics, Inc. 415-365-5625 martin.forrest@fiveprime.com
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