1. Five Prime Therapeutics, Inc. (NASDAQ:FPRX) today announced that Tom Civik, President and Chief Executive Officer, and Helen Collins, M.D., Executive Vice President and Chief Medical Officer are scheduled to participate in a fireside chat at the virtual SVB Leerink 10th Annual Global Healthcare Conference on Thursday, February 25, 2021 at 10:00 a.m. ET / 7:00 a.m. PT.

    Live audio webcast of the presentation will be accessible and available for replay 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 30 days after the conference.

    About Five Prime Therapeutics

    Five Prime is a clinical stage biotechnology…

    Five Prime Therapeutics, Inc. (NASDAQ:FPRX) today announced that Tom Civik, President and Chief Executive Officer, and Helen Collins, M.D., Executive Vice President and Chief Medical Officer are scheduled to participate in a fireside chat at the virtual SVB Leerink 10th Annual Global Healthcare Conference on Thursday, February 25, 2021 at 10:00 a.m. ET / 7:00 a.m. PT.

    Live audio webcast of the presentation will be accessible and available for replay 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 30 days after the conference.

    About Five Prime Therapeutics

    Five Prime is a clinical stage biotechnology company relentlessly focused on rewriting cancer. By tackling the tough scientific questions and untapped pathways, we aim to offer new hope by developing novel, breakthrough therapies that have potential to alter the course of disease in cancers with few treatment options. This vision is what defines us and guides our research, clinical development and partnerships. To build a better tomorrow for people with cancer, we are teaming up with patients, physicians, scientists, and industry partners to make a meaningful difference in patients' lives. Five Prime collaborates with leading global pharmaceutical companies and has therapies in pre-clinical and clinical development. For more information, please visit www.fiveprime.com.

    Source: Five Prime Therapeutics, Inc.

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  2. Five Prime Therapeutics, Inc. (NASDAQ:FPRX) today announced that Tom Civik, President and Chief Executive Officer, and Helen Collins, M.D., Executive Vice President and Chief Medical Officer, are scheduled to participate in a fireside chat at the virtual Guggenheim Healthcare Talks: Oncology Day on Friday, February 12, 2021 at 1:00 p.m. ET/10:00 a.m. PT.

    Live audio webcast of the fireside chat will be accessible and available for replay 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 30 days after the conference.

    About Five Prime Therapeutics

    Five Prime is a clinical stage biotechnology company relentlessly…

    Five Prime Therapeutics, Inc. (NASDAQ:FPRX) today announced that Tom Civik, President and Chief Executive Officer, and Helen Collins, M.D., Executive Vice President and Chief Medical Officer, are scheduled to participate in a fireside chat at the virtual Guggenheim Healthcare Talks: Oncology Day on Friday, February 12, 2021 at 1:00 p.m. ET/10:00 a.m. PT.

    Live audio webcast of the fireside chat will be accessible and available for replay 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 30 days after the conference.

    About Five Prime Therapeutics

    Five Prime is a clinical stage biotechnology company relentlessly focused on rewriting cancer. By tackling the tough scientific questions and untapped pathways, we aim to offer new hope by developing novel, breakthrough therapies that have potential to alter the course of disease in cancers with few treatment options. This vision is what defines us and guides our research, clinical development and partnerships. To build a better tomorrow for people with cancer, we are teaming up with patients, physicians, scientists, and industry partners to make a meaningful difference in patients' lives. Five Prime collaborates with leading global pharmaceutical companies and has therapies in pre-clinical and clinical development. For more information, please visit www.fiveprime.com.

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    • All three efficacy endpoints (PFS, OS and ORR) in the FIGHT Phase 2 trial met pre-specified statistical significance
    • 2021 priorities for the bemarituzumab program include collaborating with regulatory agencies on next steps, initiating a global Phase 3 trial in gastric and GEJ cancers and evaluating bemarituzumab in other epithelial cancers that overexpress FGFR2b
    • Results presented today in a late-breaking oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Virtual Annual Symposium
    • Five Prime to host webcast and conference call today at 1:30pm PST / 4:30pm EST

    Five Prime Therapeutics, Inc. (NASDAQ:FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled…

    • All three efficacy endpoints (PFS, OS and ORR) in the FIGHT Phase 2 trial met pre-specified statistical significance
    • 2021 priorities for the bemarituzumab program include collaborating with regulatory agencies on next steps, initiating a global Phase 3 trial in gastric and GEJ cancers and evaluating bemarituzumab in other epithelial cancers that overexpress FGFR2b
    • Results presented today in a late-breaking oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Virtual Annual Symposium
    • Five Prime to host webcast and conference call today at 1:30pm PST / 4:30pm EST

    Five Prime Therapeutics, Inc. (NASDAQ:FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. Trial results were presented in a late-breaking oral presentation today by UCLA Health's Zev Wainberg, M.D., at the 2021 ASCO Gastrointestinal Cancers Virtual Annual Symposium (ASCO GI). The ASCO GI presentation slides are available on the company's website.

    The FIGHT trial evaluated bemarituzumab plus chemotherapy (mFOLFOX6) versus placebo plus chemotherapy in patients with fibroblast growth factor receptor 2b-positive (FGFR2b+), non HER2 positive frontline advanced gastric or GEJ cancer. The trial enrolled 155 patients in 15 countries across Asia, the European Union, and the United States, with 77 patients randomized to the bemarituzumab arm and 78 patients to the placebo arm.

    The Phase 2 trial met all three efficacy endpoints and demonstrated statistically significant and clinically meaningful improvements in the primary endpoint of progression-free survival (PFS) and secondary endpoints of overall survival (OS) and overall response rate (ORR). Additional analysis showed a positive correlation between benefit and the percentage of FGFR2b+ tumor cells, confirming both the importance of the FGFR2b target and the activity of bemarituzumab against this target.

    "Systemic chemotherapy is the standard of care for this deadly and aggressive form of gastric cancer. We are strongly encouraged by these data and the potential for a frontline targeted treatment that can improve overall survival," said Zev A. Wainberg, M.D., Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center. "The FIGHT trial results demonstrate that treatment with bemarituzumab in combination with chemotherapy can deliver a significant reduction in the risk of disease progression and death in gastric cancer patients whose tumors overexpress FGFR2b."

    "The Phase 2 FIGHT clinical trial results validate our pioneering work on the role of FGFR2b overexpression in gastric cancer, and we're excited about the implications of this new scientific understanding for other cancers," said Helen Collins, M.D., Five Prime's Executive Vice President and Chief Medical Officer. "With these data in hand, we plan to continue to collaborate with regulatory agencies on next steps, initiate a global Phase 3 trial in gastric cancer and begin studying bemarituzumab in other epithelial cancers that overexpress FGFR2b."

    Phase 2 FIGHT Trial: Summary of Efficacy*

     

    Control Arm

    Placebo + mFOLFOX6

    Investigational Arm

    Bema + mFOLFOX6

    Statistical Measures

    Median PFS, months

    All patients (n=155)

    7.4

    9.5

    HR (95% CI): 0.68

    (0.44, 1.04); p=0.073

    IHC 2+/3+ ≥ 5% (n=118)

    7.3

    10.2

    HR (95% CI): 0.54 (0.33, 0.87)

    IHC 2+/3+ ≥ 10% (n=96)

    7.3

    14.1

    HR (95% CI): 0.44 (0.25, 0.77)

    Median OS, months

    All patients (n=155)

    12.9

    Not Reached

    HR (95% CI): 0.58; (0.35, 0.95); p=0.027

    IHC 2+/3+ ≥ 5% (n=118)

    12.5

    Not Reached

    HR (95% CI): 0.52 (0.30, 0.91)

    IHC 2+/3+ ≥ 10% (n=96)

    11.1

    Not Reached

    HR (95% CI): 0.41 (0.22, 0.79)

    ORR, %

    ORR (Intent to Treat)

    33

    47

    Improved by 13.1%

    (p=0.106)

    ORR (measurable disease at baseline)

    40

    53

    Improved by 13%

    * All three efficacy endpoints in the FIGHT Phase 2 trial met pre-specified statistical significance (2-sided alpha of 0.20)

    The incidence of all grade adverse events was similar in the bemarituzumab and placebo arms of the study (100% vs 98.7%, respectively). Corneal events were reported more frequently in the bemarituzumab arm (67.1% vs 10.4%), with the most common corneal events in the bemarituzumab arm being dry eye (26.3%), keratitis (15.8%) and punctate keratitis (14.5%). Stomatitis (31.6% vs 13.0%) and elevated transaminases (34.2% vs 19.5%) were also more common in the bemarituzumab arm. Grade 3 and higher adverse events (82.9% vs 74.0%), serious adverse events (31.6% vs 36.4%) and deaths (6.6% vs 5.2%) were comparable across arms.

    Ocular events are common in therapies targeting FGFR and were also reported in the FIGHT trial. More patients in the FIGHT trial discontinued bemarituzumab compared to placebo due to an adverse event (34.2% vs 5.2%) and the majority of these patients (21 of 26 patients) discontinued due to an ocular event.

    The discontinuation of bemarituzumab due to an ocular event decreased the median duration of exposure to bemarituzumab by 3.2 weeks; from 25.3 weeks (n=55, range: 2.0 to 71.7 weeks) to 22.1 weeks (n=21, range: 12.0 to 46.7 weeks).

    In designing the Phase 3 trial, the company plans to incorporate findings from the FIGHT trial including baseline eye exams, prophylactic lubricating eye drops and close monitoring for signs and symptoms of corneal toxicity, including dry eye.

    Five Prime Webcast /Conference Call Information

    Five Prime Therapeutics will host a KOL conference call and live audio webcast following ASCO GI on Friday, January 15, 2021 at 4:30pm (EST) / 1:30pm (PST) to review the Phase 2 FIGHT clinical trial results and provide an update on the bemarituzumab program. The presentation will feature members of the Five Prime management team and Zev A. Wainberg, M.D., Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center, and an investigator in the trial.

    To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID: 2063209. To access the live webcast please visit https://investor.fiveprime.com/events-presentations.

    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 FGFR2b

    The fibroblast growth factor (FGF)/fibroblast growth factor receptor (FGFR) pathway is implicated in the development and growth of cancer cells. FGFR2b is a splice form of FGFR which can be found in tumors of epithelial origin. Data from the FIGHT trial suggests that approximately 30 percent of patients with non HER2 positive gastroesophageal cancers overexpress FGFR2b.1 Five Prime and Roche Tissue Diagnostics have also found that FGFR2b is overexpressed in numerous other cancers, including squamous non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), ovarian, pancreatic and intrahepatic cholangiocarcinoma.

    About Bemarituzumab

    Bemarituzumab (anti-FGFR2b) is a first-in-class targeted antibody that blocks fibroblast growth factors (FGFs) from binding and activating FGFR2b, inhibiting several downstream pro-tumor signaling pathways and potentially slowing cancer progression. Bemarituzumab is being developed in gastric and GEJ cancer as a targeted therapy for tumors that overexpress FGFR2b. The company is also evaluating the potential for bemarituzumab in other cancers that overexpress FGFR2b.

    Five Prime granted an exclusive license to Zai Lab to develop and commercialize bemarituzumab in Greater China, and Zai Lab collaborated with Five Prime on the Phase 2 FIGHT trial in Greater China.

    About Gastric Cancer and GEJ Cancer

    Gastric cancer, also known as stomach cancer, is the third most common cause of cancer death worldwide and, excluding non-melanoma skin cancer, the fifth most common cancer worldwide, with over 1,000,000 new cases diagnosed each year.2 For HER2 negative patients, frontline therapy available today is the same systemic chemotherapy available since the 1990s.3,4

    About Five Prime Therapeutics

    Five Prime is a clinical stage biotechnology company relentlessly focused on rewriting cancer. By tackling the tough scientific questions and untapped pathways, we aim to offer new hope by developing novel, breakthrough therapies that have potential to alter the course of disease in cancers with few treatment options. This vision is what defines us and guides our research, clinical development and partnerships. To build a better tomorrow for people with cancer, we are teaming up with patients, physicians, scientists, and industry partners to make a meaningful difference in patients' lives. Five Prime collaborates with leading global pharmaceutical companies and has therapies in pre-clinical and clinical 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 potential advancement of the development of bemarituzumab; (ii) the potential use of bemarituzumab, including in combination with other products, to treat patients; (iii) the potential development of bemarituzumab in indications in addition to gastric and GEJ cancer; (iv) the timing of the presentation of data for bemarituzumab; and (v) the extent of FGFR2b protein overexpression in certain patient populations. 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 preclinical development and business and corporate development and other objectives 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.

    References

    1. Data on file. Five Prime Therapeutics; 2020.

    2. Bray F, Ferlay J, Soerjomataram I, et al: Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394-424. doi:10.3322/caac.21492

    3. Wagner AD, Syn NL, Moehler M, et al. Chemotherapy for advanced gastric cancer. Cochrane Database Syst Rev. 2017;8(8):CD004064. doi:10.1002/14651858.CD004064.pub4

    4. Drugs approved for stomach (gastric) cancer. Food and Drug Administration. Updated April 21, 2020. Accessed October 14, 2020. https://www.cancer.gov/about-cancer/treatment/drugs/stomach#1

    Source: Five Prime Therapeutics, Inc.

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    • Detailed results of the Phase 2 FIGHT trial have been accepted for late breaker presentation during the Esophageal and Gastric cancer oral abstract session on January 15, 2021
    • Company to host webcast and conference call on January 15 at 1:30pm PST / 4:30pm EST

    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 detailed results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating bemarituzumab plus mFOLFOX6 chemotherapy in patients with fibroblast growth factor receptor 2b-positive (FGFR2b+), non HER2 positive (non HER2+) advanced gastric and gastroesophageal…

    • Detailed results of the Phase 2 FIGHT trial have been accepted for late breaker presentation during the Esophageal and Gastric cancer oral abstract session on January 15, 2021
    • Company to host webcast and conference call on January 15 at 1:30pm PST / 4:30pm EST

    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 detailed results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating bemarituzumab plus mFOLFOX6 chemotherapy in patients with fibroblast growth factor receptor 2b-positive (FGFR2b+), non HER2 positive (non HER2+) advanced gastric and gastroesophageal junction (GEJ) cancer will be featured during an oral podium presentation on January 15, 2021, at the ASCO Gastrointestinal Cancers Symposium being held virtually from January 15-17, 2021.

    On November 10, 2020, Five Prime announced that the FIGHT trial met all three efficacy endpoints with bemarituzumab in combination with mFOLFOX6 chemotherapy providing statistically significant and clinically meaningful improvements in progression-free survival, overall survival, and objective response rate compared with mFOLFOX6 chemotherapy plus placebo in the front-line setting of patients with FGFR2b+, non HER2+ advanced gastric or GEJ cancer.

    Bemarituzumab is the first and only investigational treatment targeting FGFR2b+ tumors. FGFR2b is overexpressed in approximately 30 percent of non HER2+ gastric and GEJ cancers. For these patients, no new front-line therapies have been approved in over a decade and systemic chemotherapy remains the standard of care. Five Prime and Roche Tissue Diagnostics (formerly Ventana Medical Systems) have also found that FGFR2b is overexpressed in numerous other cancers, including squamous non-small cell lung cancer, triple negative breast cancer, ovarian cancer, pancreatic cancer and intrahepatic cholangiocarcinoma. This represents additional potential areas for development of bemarituzumab beyond gastric and GEJ cancer.

    The Company will host a conference call and live audio webcast on Friday, January 15, 2021 at 4:30pm (EST) / 1:30pm (PST) to review highlights from the presentation and will feature members of the Five Prime management team and Zev A. Wainberg, M.D., Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center, and a principal investigator of the trial.

    Oral Presentation Details:

    • Title: Randomized Double-blind Placebo-Controlled Phase 2 Study of Bemarituzumab Combined with Modified FOLFOX6 (mFOLFOX6) in 1st Line (1L) Treatment of Advanced Gastric/Gastroesophageal Junction Adenocarcinoma (FIGHT)
    • Abstract Number: 160
    • Oral Abstract Session: Esophageal and Gastric Cancer
    • Day and Time: Friday, January 15, 2021, 7:00am – 8:15am PST / 10:00am 11:15am EST
    • Author and Q&A Presenter: Zev A. Wainberg, M.D., Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center

    Conference Call Information

    Five Prime will host a conference call and live audio webcast on Friday, January 15, 2021 at 4:30pm EST / 1:30pm PST to discuss the detailed Phase 2 FIGHT trial results presented at ASCO GI. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID: 2063209. To access the live webcast please visit https://investor.fiveprime.com/events-presentations.

    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 the FIGHT Trial

    The FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment (FIGHT) trial (NCT03694522) was designed to evaluate the efficacy and safety of bemarituzumab in combination with modified FOLFOX6 (mFOLFOX6; leucovorin calcium, fluorouracil, and oxaliplatin) vs. mFOLFOX6 plus placebo in the front-line setting of patients with newly diagnosed FGFR2b positive, locally advanced or metastatic gastric and GEJ cancer.

    Patients' tumors were identified to be FGFR2b+ by immunohistochemistry and by FGFR2 gene amplification using a blood-based circulating tumor DNA assay. Testing was performed at a central laboratory.

    The trial enrolled 155 patients in 15 countries across Asia, the European Union, and the United States.

    About FGFR2b

    The fibroblast growth factor (FGF)/fibroblast growth factor receptor (FGFR) pathway is implicated in the development and growth of cancer cells. FGFR2b is a form of FGFR found in epithelial cells, such as those in the stomach and skin. Data from the FIGHT trial suggests that approximately 30% of patients with non HER2+ gastroesophageal cancers overexpress FGFR2b.1 Five Prime and Roche Tissue Diagnostics have also found that FGFR2b is overexpressed in numerous other cancers, including squamous non-small cell lung cancer (NSCLC), triple negative breast (TNBC), ovarian, pancreatic and intrahepatic cholangiocarcinoma.

    About Bemarituzumab

    Bemarituzumab (anti-FGFR2b, FPA144) is a first-in-class targeted antibody that blocks fibroblast growth factors (FGFs) from binding and activating FGFR2b, inhibiting several downstream pathways. Blocking FGFR2b activation is thought to slow cancer progression. Bemarituzumab is being developed in gastric and GEJ cancer as a targeted therapy for tumors that overexpress FGFR2b.

    Five Prime granted an exclusive license to Zai Lab to develop and commercialize bemarituzumab in Greater China, and Zai Lab collaborated with Five Prime on the Phase 2 FIGHT trial in Greater China.

    About Gastric Cancer and GEJ Cancer

    Gastric cancer, also known as stomach cancer, is the third most common cause of cancer death worldwide and, excluding non-melanoma skin cancer, the fifth most common cancer worldwide, with over 1,000,000 new cases diagnosed each year.2 For HER2- patients, front-line therapy available today is the same systemic chemotherapy available since the 1990s.3,4

    About Five Prime Therapeutics

    Five Prime is a clinical stage biotechnology company relentlessly focused on rewriting the narrative for people with cancer. By tackling the tough scientific questions and untapped pathways, we aim to offer new hope by developing novel, breakthrough therapies that have potential to alter the course of disease in cancers with few treatment options. This vision is what defines us, and guides our research, clinical development and partnerships. To build a better tomorrow for people with cancer, we are teaming up with patients, physicians, scientists, and industry partners to make a meaningful difference in patients' lives. Five Prime collaborates with leading global pharmaceutical companies and has therapies in pre-clinical and clinical 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 potential advancement of the development of bemarituzumab; (ii) the potential use of bemarituzumab, including in combination with other products, to treat patients; (iii) the potential development of bemarituzumab in indications in addition to gastric and GEJ cancer; (iv) the timing of the presentation of data for bemarituzumab; and (v) the extent of FGFR2b protein overexpression in certain patient populations. 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 preclinical development and business and corporate development and other objectives 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.

    References

    1. Data on file. Five Prime Therapeutics; 2020.

    2. Bray F, Ferlay J, Soerjomataram I, et al: Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394-424. doi:10.3322/caac.21492

    3. Wagner AD, Syn NL, Moehler M, et al. Chemotherapy for advanced gastric cancer. Cochrane Database Syst Rev. 2017;8(8):CD004064. doi:10.1002/14651858.CD004064.pub4

    4. Drugs approved for stomach (gastric) cancer. Food and Drug Administration. Updated April 21, 2020. Accessed October 14, 2020. https://www.cancer.gov/about-cancer/treatment/drugs/stomach#1

    Source: Five Prime Therapeutics, Inc.

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  3. Underwriters Fully Exercise Option to Purchase Additional Shares

    Five Prime Therapeutics, Inc. (NASDAQ:FPRX) announced today the closing of its upsized underwritten public offering of 8,280,000 shares of its common stock, which includes 1,080,000 shares sold upon the underwriters' full exercise of their option to purchase additional shares, resulting in aggregate gross proceeds of approximately $173.9 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Five Prime.

    Cowen and SVB Leerink acted as joint book-running managers for the offering. Wedbush PacGrow acted as co-manager for the offering.

    The shares of common stock were offering pursuant to a "shelf" registration statement previously…

    Underwriters Fully Exercise Option to Purchase Additional Shares

    Five Prime Therapeutics, Inc. (NASDAQ:FPRX) announced today the closing of its upsized underwritten public offering of 8,280,000 shares of its common stock, which includes 1,080,000 shares sold upon the underwriters' full exercise of their option to purchase additional shares, resulting in aggregate gross proceeds of approximately $173.9 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Five Prime.

    Cowen and SVB Leerink acted as joint book-running managers for the offering. Wedbush PacGrow acted as co-manager for the offering.

    The shares of common stock were offering pursuant to a "shelf" registration statement previously filed with and declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus supplement and accompanying prospectus, copies of which may be obtained from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at , or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by telephone at (800) 808-7525, ext. 6132 or by e-mail at .

    This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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  4. Five Prime Therapeutics, Inc. (NASDAQ:FPRX), announced today the pricing of an underwritten public offering of 7,200,000 shares of its common stock at a price to the public of $21.00 per share. The size of the offering was upsized from 5,000,000 shares to 7,200,000 shares. Five Prime estimates that the net proceeds from the sale of the shares will be approximately $141.9 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by Five Prime. In addition, Five Prime has granted the underwriters in the offering a 30-day option to purchase up to 1,080,000 additional shares of common stock at the public offering price. The offering is expected to close on November 17, 2020, subject to customary closing…

    Five Prime Therapeutics, Inc. (NASDAQ:FPRX), announced today the pricing of an underwritten public offering of 7,200,000 shares of its common stock at a price to the public of $21.00 per share. The size of the offering was upsized from 5,000,000 shares to 7,200,000 shares. Five Prime estimates that the net proceeds from the sale of the shares will be approximately $141.9 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by Five Prime. In addition, Five Prime has granted the underwriters in the offering a 30-day option to purchase up to 1,080,000 additional shares of common stock at the public offering price. The offering is expected to close on November 17, 2020, subject to customary closing conditions.

    Five Prime plans to use the net proceeds of the offering, together with other available funds, to fund ongoing clinical development of bemarituzumab and FPT155, to advance FPA157 through preclinical and into clinical development, to advance its late-stage research programs and for working capital and general corporate purposes.

    Cowen and SVB Leerink are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as co-manager for the offering.

    The shares of common stock are being offered pursuant to a "shelf" registration statement previously filed with and declared effective by the Securities and Exchange Commission (SEC). Five Prime has filed a preliminary prospectus supplement and the accompanying prospectus related to the offering with the SEC, which are available on the SEC's website, located at www.sec.gov. Copies of the final prospectus supplement relating to this offering, when available, and the accompanying prospectus may be obtained from: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at , or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132 or by e-mail at .

    This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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. Forward-looking statements contained in this press release include statements relating to Five Prime's expectations regarding the completion of the proposed public offering, the net proceeds of the offering and Five Prime's planned use of the proceeds from the proposed public offering. These forward-looking statements are based on Five Prime's expectations and assumptions as of the date of this press release. Actual results may differ materially from these forward-looking statements. Each of these forward-looking statements involves risks and uncertainties. These risks and uncertainties include, without limitation, risks and uncertainties related to market conditions and satisfaction of customary closing conditions related to the proposed public offering. There can be no assurance that Five Prime will be able to complete the offering on the anticipated terms, or at all. 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 under the heading "Risk Factors" contained therein, as well as the risks identified in the registration statement and the preliminary prospectus supplement relating to the offering. 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.

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    • Preclinical data support evaluation of FPA157 as a novel immunomodulator with the potential to remove Treg-mediated immune suppression in solid tumors
    • FPA157 is an anti-CCR8 antibody engineered to enhance antibody-dependent cell-mediated cytotoxicity to preferentially eliminate CCR8+ Treg cells in the tumor microenvironment
    • Data presented today at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting & Pre-Conference Programs (SITC 2020) show investigational immunotherapy FPA157 elicits anti-tumor activity in multiple preclinical models
    • FPT157 is undergoing IND-enabling studies

    Five Prime Therapeutics, Inc. (NASDAQ:FPRX) today presented the first preclinical data from its anti-CCR8 FPA157 program at The Society…

    • Preclinical data support evaluation of FPA157 as a novel immunomodulator with the potential to remove Treg-mediated immune suppression in solid tumors
    • FPA157 is an anti-CCR8 antibody engineered to enhance antibody-dependent cell-mediated cytotoxicity to preferentially eliminate CCR8+ Treg cells in the tumor microenvironment
    • Data presented today at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting & Pre-Conference Programs (SITC 2020) show investigational immunotherapy FPA157 elicits anti-tumor activity in multiple preclinical models
    • FPT157 is undergoing IND-enabling studies

    Five Prime Therapeutics, Inc. (NASDAQ:FPRX) today presented the first preclinical data from its anti-CCR8 FPA157 program at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting & Pre-Conference Programs (SITC 2020).

    The poster, "Development of FPA157, an anti-CCR8 depleting antibody engineered to preferentially eliminate tumor-infiltrating T regulatory cells," was presented in a late-breaker live Q&A session and is available here.

    Key highlights from the poster included:

    • CCR8 expression is highly restricted to T regulatory (Treg) cells within the tumor
    • Preclinical efficacy studies demonstrate that anti-CCR8 antibody treatment depletes CCR8+ Tregs in the tumor microenvironment while sparing peripheral Treg subsets
    • Anti-CCR8 treatment elicits the development of robust anti-tumor memory responses
    • FPA157 leads to potent natural killer (NK) cell-dependent killing of CCR8+ target cells

    "Preclinical data for FPA157 suggest that selective depletion of regulatory T cells within the tumor— without affecting peripheral Tregs—is a promising and exciting therapeutic pathway to pursue," said Andrew Rankin, PhD, Vice President of Research. "This is the first time we are publicly sharing information about the CCR8 inhibitor antibody in the Five Prime immuno-oncology pipeline and to do so at SITC is very rewarding. We are eager to further investigate the potential of FPA157 in the clinic."

    There will be two live Q&A sessions with poster author Edwina Naik, PhD, Associate Director, Immuno-Oncology Research. The first is today, November 11, 2020 from 5:15-5:45pm EST and the second is on November 13, 2020 from 4:40-5:10pm EST.

    About FPA157

    FPA157 is a monoclonal antibody targeting CCR8 that is designed to enhance antibody-dependent cell-mediated cytotoxicity (ADCC) and deplete the T regulatory cell (Treg) population in the tumor microenvironment. Tregs inhibit anti-tumoral immune responses and act through multiple suppressive mechanisms.1,2 FPA157 is part of the Five Prime immuno-oncology antibody pipeline and is undergoing IND-enabling studies.

    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) Five Prime's expectations regarding the potential safety, efficacy or clinical utility of FPA157; and (ii) the potential use of FPA157 to treat certain patients. 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.

    References

    1. Teng MW, Ngiow SF, von Scheidt B, McLaughlin N, Sparwasser T, Smyth MJ. Conditional regulatory T-cell depletion releases adaptive immunity preventing carcinogenesis and suppressing established tumor growth [published correction appears in Cancer Res. 2010; 70(23):10014]. Cancer Res. 2010; 70(20):7800-7809. doi:10.1158/0008-5472.CAN-10-1681
    2. Simpson TR, Li F, Montalvo-Ortiz W, et al. Fc-dependent depletion of tumor-infiltrating regulatory T cells co-defines the efficacy of anti-CTLA-4 therapy against melanoma. J Exp Med. 2013; 210(9):1695-710. doi:10.1084/jem.20130579

    Source: Five Prime Therapeutics, Inc.

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  5. Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, announced today that it plans to offer and sell, subject to market and other conditions, 5,000,000 shares of its common stock in an underwritten public offering. In connection with the offering, Five Prime intends to grant the underwriters in the offering a 30-day option to purchase up to an additional 750,000 shares of common stock offered in the public offering.

    Five Prime plans to use the net proceeds of the offering, together with other available funds, to fund ongoing clinical development of bemarituzumab and FPT155, to advance FPA157 through preclinical and into clinical…

    Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, announced today that it plans to offer and sell, subject to market and other conditions, 5,000,000 shares of its common stock in an underwritten public offering. In connection with the offering, Five Prime intends to grant the underwriters in the offering a 30-day option to purchase up to an additional 750,000 shares of common stock offered in the public offering.

    Five Prime plans to use the net proceeds of the offering, together with other available funds, to fund ongoing clinical development of bemarituzumab and FPT155, to advance FPA157 through preclinical and into clinical development, to advance its late-stage research programs and for working capital and general corporate purposes.

    Cowen and SVB Leerink are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as co-manager for the offering.

    The shares of common stock are being offered pursuant to a "shelf" registration statement previously filed with and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the website of the SEC at www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at , or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132 or by e-mail at .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of a prospectus supplement and accompanying prospectus, which are a part of the effective registration statement.

    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. Forward-looking statements contained in this press release include statements relating to Five Prime's expectations regarding the completion, timing and size of the proposed public offering and Five Prime's planned use of the proceeds from the proposed public offering. These forward-looking statements are based on Five Prime's expectations and assumptions as of the date of this press release. Actual results may differ materially from these forward-looking statements. Each of these forward-looking statements involves risks and uncertainties. These risks and uncertainties include, without limitation, risks and uncertainties related to market conditions and satisfaction of customary closing conditions related to the proposed public offering. There can be no assurance that Five Prime will be able to complete the offering on the anticipated terms, or at all. 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 under the heading "Risk Factors" contained therein, as well as the risks identified in the registration statement and the preliminary prospectus supplement relating to the offering. 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.

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    • All three efficacy endpoints in the global Phase 2 FIGHT trial met pre-specified statistical significance

      • Median progression-free survival (PFS) improved from 7.4 months in the placebo arm to 9.5 months in the bemarituzumab arm. Hazard ratio (HR) 0.68 (95% CI: 0.44-1.04) p=0.073

      • Median overall survival (OS) improved from 12.9 months to not reached. HR 0.58 (95% CI: 0.35-0.95) p=0.027

      • Overall response rate (ORR) improved by 13% (p=0.106)
    • Bemarituzumab is a potential first-in-class therapeutic antibody targeting FGFR2b+ tumors found in approximately 30 percent of HER2- gastric cancers worldwide

    • Trial results support FGFR2b as a novel target for the third most common cause of cancer mortality worldwide and highlight development opportunities in…
    • All three efficacy endpoints in the global Phase 2 FIGHT trial met pre-specified statistical significance



      • Median progression-free survival (PFS) improved from 7.4 months in the placebo arm to 9.5 months in the bemarituzumab arm. Hazard ratio (HR) 0.68 (95% CI: 0.44-1.04) p=0.073



      • Median overall survival (OS) improved from 12.9 months to not reached. HR 0.58 (95% CI: 0.35-0.95) p=0.027



      • Overall response rate (ORR) improved by 13% (p=0.106)
    • Bemarituzumab is a potential first-in-class therapeutic antibody targeting FGFR2b+ tumors found in approximately 30 percent of HER2- gastric cancers worldwide



    • Trial results support FGFR2b as a novel target for the third most common cause of cancer mortality worldwide and highlight development opportunities in other tumors that overexpress FGFR2b

    SHANGHAI and SAN FRANCISCO, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Zai Lab Limited's (NASDAQ:ZLAB, HKEX: 9688))) partner 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 positive topline results from the global, randomized, double-blind, placebo-controlled Phase 2 FIGHT trial. The trial compared bemarituzumab (FPA144), a potential first-in-class targeted therapy, in combination with mFOLFOX6 chemotherapy to placebo in combination with mFOLFOX6 in patients with fibroblast growth factor receptor 2b-positive (FGFR2b+), HER2-negative front-line advanced gastric or gastroesophageal junction (GEJ) cancer.

    All three efficacy endpoints in the FIGHT trial – PFS, OS and ORR – achieved pre-specified statistical significance in the bemarituzumab arm compared to the placebo arm. The Phase 2 FIGHT trial results validate the importance of the novel target FGFR2b, which is overexpressed in approximately 30 percent of HER2- gastric cancers worldwide. The incidence of all-grade adverse events was comparable in the treatment and control arms of the study (100% vs. 98.7%, respectively), as were serious adverse events (31.6% vs. 36.4%) and deaths due to adverse events (6.6% vs. 5.2%). Adverse events ≥ Grade 3 were reported more frequently in the treatment arm (82.9% vs. 74.0%). Corneal and stomatitis adverse events were reported more frequently in the bemarituzumab arm. No adverse events of retinal detachment or hyperphosphatemia were reported in the bemarituzumab arm. More patients discontinued bemarituzumab (34.2%) compared to placebo (5.2%) due to an adverse event.

    "These results bring us one step closer to the first potential targeted therapy for advanced gastric cancer in over a decade," said Helen Collins, M.D., Five Prime's Executive Vice President and Chief Medical Officer. "Benefit was observed in patients whose tumors overexpressed FGFR2b, even without evidence of amplification, and that may broaden the therapeutic potential of bemarituzumab in more cancer types. We are excited about the results of the FIGHT trial and the opportunity to advance bemarituzumab, the first and only investigational treatment for patients with FGFR2b+ tumors, to the next phase of development. Five Prime is grateful to the patients and investigators who participated in our clinical trials, and we look forward to discussing next steps with health authorities worldwide."

    Five Prime will complete a full evaluation of the available FIGHT Phase 2 data and work with investigators to share the results at an upcoming medical conference.

    "We have known for some time that FGFR is a viable target in gastric cancer and many other malignancies," said Zev A. Wainberg, M.D., Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research Support at the Jonsson Comprehensive Cancer Center. "This is the first data to signal that a targeted therapy directed to FGFR2b may reduce the risk of disease progression and improve overall survival in gastric cancer. This study result showing bemarituzumab's potential benefit is an important and exciting development."

    Five Prime and Roche Tissue Diagnostics (formerly Ventana Medical Systems) have also found that FGFR2b is overexpressed in numerous other cancers, including squamous non-small-cell lung cancer (NSCLC), triple negative breast cancer (TNBC), ovarian cancer, pancreatic cancer and intrahepatic cholangiocarcinoma. This finding points to additional potential areas for development of bemarituzumab beyond gastric and GEJ cancer.

    About the FIGHT Trial

    The FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment (FIGHT) trial (NCT03694522) was designed to evaluate the efficacy and safety of bemarituzumab in combination with modified FOLFOX6 (mFOLFOX6; leucovorin calcium, fluorouracil, and oxaliplatin) vs. mFOLFOX6 plus placebo in the front-line setting of patients with newly diagnosed FGFR2b positive, locally advanced or metastatic gastric and GEJ cancer.

    Patients' tumors were identified to be FGFR2b+ by immunohistochemistry and by FGFR2 gene amplification using a blood-based circulating tumor DNA assay. Testing was performed at a central laboratory.

    The trial enrolled 155 patients in 15 countries across Asia, the European Union, and the United States. Today's announcement contains the initial top-line results from the primary analysis based on a prespecified number of events.

    About FGFR2b

    The fibroblast growth factor (FGF) / fibroblast growth factor receptor (FGFR) pathway is implicated in the development and growth of cancer cells. FGFR2b is a form of FGFR found in epithelial cells, such as those in the stomach and skin. Data from the FIGHT trial suggests that approximately 30% of patients with HER2- gastroesophageal cancers overexpress FGFR2b.1

    About Bemarituzumab 

    Bemarituzumab (anti-FGFR2b, FPA144) is a first-in-class targeted antibody that blocks fibroblast growth factors (FGFs) from binding and activating FGFR2b, inhibiting several downstream pathways. Blocking FGFR2b activation is thought to slow cancer progression. Bemarituzumab is being developed in gastric and GEJ cancer as a targeted therapy for tumors that overexpress FGFR2b.

    Five Prime granted an exclusive license to Zai Lab to develop and commercialize bemarituzumab in Greater China, and Zai Lab collaborated with Five Prime on the Phase 2 FIGHT trial in Greater China.  

    About Gastric Cancer and GEJ Cancer

    Gastric cancer, also known as stomach cancer, is the third most common cause of cancer death and, excluding non-melanoma skin cancer, the fifth most common cancer worldwide, with over 1,000,000 new cases diagnosed each year.2 In countries where routine screening is not readily available, up to 90 percent of patients are diagnosed with advanced disease that is inoperable.3 For HER2- patients, front-line therapy available today is the same systemic chemotherapy available since the 1990s.3,4

    Gastric cancer is the second most common cancer type (679,100 new cases in 2015) and the second leading cause of death (498,000 deaths in 2015) in China. Both gastric cancer and GEJ cancer are often diagnosed at an advanced stage and therefore have very poor prognosis, with a five-year survival of only 35.9%.

    About Zai Lab

    Zai Lab (NASDAQ:ZLAB, HKEX: 9688))) is an innovative commercial stage biopharmaceutical company focused on bringing transformative medicines for cancer, infectious diseases and autoimmune diseases to patients in China and around the world. To quickly target the large, fast-growing segments of China's pharmaceutical market and address unmet medical needs, Zai Lab's experienced team has secured partnerships with leading global biopharma companies, generating a broad pipeline of innovative drug candidates. Zai Lab has also built an in-house team with strong drug discovery and translational research capabilities, aiming to establish a global pipeline of proprietary drug candidates against targets in our focus areas. Zai Lab's vision is to become a fully integrated global biopharmaceutical company, discovering, developing, manufacturing and commercializing its portfolio in order to impact human health worldwide.

    For additional information about the company, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.

    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.



    Zai Lab Forward-Looking Statements

    This press release contains statements about future expectations, plans and prospects for Zai Lab, including, without limitation, statements regarding business strategy, plans and objectives for future operations. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact nor are they guarantees or assurances of future performance. Forward-looking statements are based on Zai Lab's expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) Zai Lab's ability to obtain additional future funding, (2) Zai Lab's results of clinical and pre-clinical development of its drug candidates, (3) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of Zai Lab's drug candidates, (4) Zai Lab's ability to generate revenue from its drug candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on general economic, regulatory and political conditions and (6) other factors discussed in Zai Lab's Annual Report on Form 20-F for the fiscal year ended December 31, 2019, filed on April 29, 2020, and its other filings with the Securities and Exchange Commission. Zai Lab anticipates that subsequent events and developments will cause Zai Lab's expectations and assumptions to change and undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing Zai Lab's views as of any date subsequent to the date of this press release. 

    References

    1. Data on file. Five Prime Therapeutics; 2020.

    2. Bray F, Ferlay J, Soerjomataram I, et al: Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394-424. doi:10.3322/caac.21492

    3. Wagner AD, Syn NL, Moehler M, et al. Chemotherapy for advanced gastric cancer. Cochrane Database Syst Rev. 2017;8(8):CD004064. doi:10.1002/14651858.CD004064.pub4

    4. Drugs approved for stomach (gastric) cancer. Food and Drug Administration. Updated April 21, 2020. Accessed October 14, 2020. https://www.cancer.gov/about-cancer/treatment/drugs/stomach#1

    Source: Five Prime Therapeutics, Inc.

    For more information, please contact:

    Billy Cho, CFO

    +86 137 6151 2501

    Media: Ryo Imai / Robert Flamm, Ph.D.

    Burns McClellan, on behalf of Zai Lab

    212-213-0006 ext. 315 / 364

    /

    Investors: Pete Rahmer / Mike Zanoni

    Endurance Advisors, on behalf of Zai Lab

    415-515-9763 / 610-442-8570

    /

    Zai Lab Limited

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    • All 3 efficacy endpoints in the Global Phase 2 FIGHT trial met pre-specified statistical significance
      • Median progression-free survival (PFS) improved from 7.4 months to 9.5 months. Hazard ratio (HR) 0.68 (95% CI: 0.44-1.04) p=0.073
      • Median overall survival (OS) improved from 12.9 months to not reached. HR 0.58 (95% CI: 0.35-0.95) p=0.027
      • Overall response rate (ORR) improved by 13.1% (p=0.106)
    • Bemarituzumab is a first-in-class therapeutic antibody targeting FGFR2b+ tumors found in approximately 30 percent of HER2- gastric cancers worldwide
    • Trial results validate FGFR2b as a novel target for the third most common cause of cancer mortality worldwide and highlight development opportunities for other tumors that overexpress FGFR2b
    • Webcast…
    • All 3 efficacy endpoints in the Global Phase 2 FIGHT trial met pre-specified statistical significance
      • Median progression-free survival (PFS) improved from 7.4 months to 9.5 months. Hazard ratio (HR) 0.68 (95% CI: 0.44-1.04) p=0.073
      • Median overall survival (OS) improved from 12.9 months to not reached. HR 0.58 (95% CI: 0.35-0.95) p=0.027
      • Overall response rate (ORR) improved by 13.1% (p=0.106)
    • Bemarituzumab is a first-in-class therapeutic antibody targeting FGFR2b+ tumors found in approximately 30 percent of HER2- gastric cancers worldwide
    • Trial results validate FGFR2b as a novel target for the third most common cause of cancer mortality worldwide and highlight development opportunities for other tumors that overexpress FGFR2b
    • Webcast and conference call today at 1:30pm PST / 4:30pm EST

    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 positive topline results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial. The trial compared mFOLFOX6 chemotherapy in combination with bemarituzumab (bema, FPA144), a first-in-class targeted therapy, in patients with fibroblast growth factor receptor 2b-positive (FGFR2b+), non HER2 positive (non HER2+) front-line advanced gastric or gastroesophageal junction (GEJ) cancer.

    "These results bring us one step closer to the first potential targeted therapy for advanced gastric cancer in over a decade," said Helen Collins, M.D., Five Prime's Executive Vice President and Chief Medical Officer. "Benefit was observed in patients whose tumors overexpressed FGFR2b, even without evidence of amplification, and that may broaden the therapeutic potential of bemarituzumab in more cancer types. We are excited about the results of the FIGHT trial and the opportunity to advance the development of bemarituzumab, the first and only investigational treatment targeting FGFR2b+. Five Prime is grateful to the patients and investigators who participated in our clinical trials, and we look forward to discussing next steps with health authorities worldwide."

    All three efficacy endpoints in the FIGHT trial – PFS, OS and ORR – achieved pre-specified statistical significance at a 2-sided alpha of 0.20. The incidence of all grade adverse events was comparable in the treatment and control arms of the study (100% vs 98.7%, respectively) as were serious adverse events (31.6% vs 36.4%) and deaths due to adverse events (6.6% vs 5.2%). Adverse events ≥ Grade 3 were reported more frequently in the treatment arm than in the placebo arm (82.9% vs 74.0%). Corneal and stomatitis adverse events were reported more frequently in the bemarituzumab arm, and more patients discontinued bemarituzumab (34.2%) compared to placebo (5.2%) due to an adverse event. Importantly, no adverse events of retinal detachment or hyperphosphatemia were reported in the bemarituzumab arm. Despite the higher frequency of discontinuation of bemarituzumab compared to placebo, all efficacy endpoints favored bemarituzumab. Overall, the Phase 2 FIGHT trial results validate the importance of the novel target, FGFR2b, which is overexpressed in approximately 30 percent of HER2- gastric cancers worldwide.

    The company will complete a full evaluation of the available FIGHT Phase 2 data and work with investigators to share the results at an upcoming medical conference.

    "We have known for some time that FGFR is a viable target in gastric cancer and many other malignancies," said Zev A. Wainberg, M.D., Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center. "This is the first data to signal that a targeted therapy directed to FGFR2b may reduce the risk of disease progression and improve overall survival in gastric cancer. This study result showing bemarituzumab's potential benefit is an important and exciting development."

    Five Prime and Roche Tissue Diagnostics (formerly Ventana Medical Systems) have also found that FGFR2b is overexpressed in numerous other cancers, including squamous non-small cell lung cancer, triple negative breast cancer, ovarian cancer, pancreatic cancer and intrahepatic cholangiocarcinoma. This represents additional potential areas for development of bemarituzumab beyond gastric and GEJ cancer.

    Conference Call Information

    Five Prime will host a conference call and live audio webcast today at 4:30pm (EST) / 1:30 (PST) to discuss topline results from the Phase 2 FIGHT trial. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 9977806. To access the live webcast please visit https://investor.fiveprime.com/events-presentations.

    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 the FIGHT Trial

    The FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment (FIGHT) trial (NCT03694522) was designed to evaluate the efficacy and safety of bemarituzumab in combination with modified FOLFOX6 (mFOLFOX6; leucovorin calcium, fluorouracil, and oxaliplatin) vs. mFOLFOX6 plus placebo in the front-line setting of patients with newly diagnosed FGFR2b positive, locally advanced or metastatic gastric and GEJ cancer.

    Patients' tumors were identified to be FGFR2b+ by immunohistochemistry and by FGFR2 gene amplification using a blood-based circulating tumor DNA assay. Testing was performed at a central laboratory.

    The trial enrolled 155 patients in 15 countries across Asia, the European Union, and the United States. Today's announcement contains the initial top-line results from the primary analysis based on a prespecified number of events.

    About FGFR2b

    The fibroblast growth factor (FGF)/fibroblast growth factor receptor (FGFR) pathway is implicated in the development and growth of cancer cells. FGFR2b is a form of FGFR found in epithelial cells, such as those in the stomach and skin. Data from the FIGHT trial suggests that approximately 30% of patients with non HER2+ gastroesophageal cancers overexpress FGFR2b.1 Five Prime and Roche Tissue Diagnostics have also found that FGFR2b is overexpressed in numerous other cancers, including squamous non-small cell lung cancer (NSCLC), triple negative breast (TNBC), ovarian, pancreatic and intrahepatic cholangiocarcinoma.

    About Bemarituzumab

    Bemarituzumab (anti-FGFR2b, FPA144) is a first-in-class targeted antibody that blocks fibroblast growth factors (FGFs) from binding and activating FGFR2b, inhibiting several downstream pathways. Blocking FGFR2b activation is thought to slow cancer progression. Bemarituzumab is being developed in gastric and GEJ cancer as a targeted therapy for tumors that overexpress FGFR2b.

    Five Prime granted an exclusive license to Zai Lab to develop and commercialize bemarituzumab in Greater China, and Zai Lab collaborated with Five Prime on the Phase 2 FIGHT trial in Greater China.

    About Gastric Cancer and GEJ Cancer

    Gastric cancer, also known as stomach cancer, is the third most common cause of cancer death worldwide and, excluding non-melanoma skin cancer, the fifth most common cancer worldwide, with over 1,000,000 new cases diagnosed each year.2 In countries where routine screening is not readily available, up to 90 percent of patients are diagnosed with advanced disease that is inoperable.3 For HER2- patients, frontline therapy available today is the same systemic chemotherapy available since the 1990s.3,4

    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 potential advancement of the development of bemarituzumab; (ii) the potential use of bemarituzumab, including in combination with other products, to treat patients; (iii) the potential development of bemarituzumab in indications in addition to gastric and GEJ cancer; (iv) the timing of the presentation of data for bemarituzumab; and (v) the extent of FGFR2b protein overexpression in certain patient populations. 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 preclinical development and business and corporate development and other objectives 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.

    References

    1. Data on file. Five Prime Therapeutics; 2020.

    2. Bray F, Ferlay J, Soerjomataram I, et al: Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394-424. doi:10.3322/caac.21492

    3. Wagner AD, Syn NL, Moehler M, et al. Chemotherapy for advanced gastric cancer. Cochrane Database Syst Rev. 2017;8(8):CD004064. doi:10.1002/14651858.CD004064.pub4

    4. Drugs approved for stomach (gastric) cancer. Food and Drug Administration. Updated April 21, 2020. Accessed October 14, 2020. https://www.cancer.gov/about-cancer/treatment/drugs/stomach#1

    Source: Five Prime Therapeutics, Inc.

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    • Top-Line Phase 2 FIGHT data on track to be announced in 2020
    • FPT155 advancing to year-end goal of informing next steps for the program
      • Enrollment in the monotherapy exploratory cohort continues at the 560mg dose
      • Enrollment in the dose escalation of FPT155 in combination with pembrolizumab has advanced to the second cohort in patients with non-small cell lung cancer
    • Novel antibody targeting CCR8 moves into IND-enabling studies
    • Year-end cash guidance raised to $100 to $105 million

    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 third quarter of 2020 in addition to providing an…

    • Top-Line Phase 2 FIGHT data on track to be announced in 2020
    • FPT155 advancing to year-end goal of informing next steps for the program
      • Enrollment in the monotherapy exploratory cohort continues at the 560mg dose
      • Enrollment in the dose escalation of FPT155 in combination with pembrolizumab has advanced to the second cohort in patients with non-small cell lung cancer
    • Novel antibody targeting CCR8 moves into IND-enabling studies
    • Year-end cash guidance raised to $100 to $105 million

    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 third quarter of 2020 in addition to providing an update on the company's recent activities.

    "We look forward to achieving three milestones before the end of the year that will inform future development of our pipeline," said Tom Civik, Chief Executive Officer of Five Prime Therapeutics. "Before year end, we expect to report top-line data from the FIGHT Phase 2 trial in front-line gastric cancer. We also expect to have enough FPT155 monotherapy data to inform next steps for the program, and we will present the first data set from our anti-CCR8 program at the upcoming SITC annual meeting. The Five Prime team has done an excellent job advancing our clinical and research programs despite the many challenges we have all confronted this year."

    Third 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 front-line FGFR2b+/HER2- gastric and gastroesophageal junction (GEJ) cancer.

    • The company expects to report top-line data before year end from the double-blind Phase 2 FIGHT study where all 155 patients receive standard mFOLFOX6 chemotherapy and are randomized to receive bemarituzumab or placebo.
    • The primary endpoint of the Phase 2 FIGHT trial is progression-free survival (PFS), and a secondary endpoint is overall survival (OS).

    FPT155 (CD80-Fc) is a first-in-class CD80-Fc fusion protein that directly engages CD28 and binds to CTLA-4, promoting CD8 T cell activation in the tumor microenvironment.

    • Patients with warm/hot tumor types continue to be enrolled at the 560mg dose in the ongoing Phase 1a/1b trial, with the aim of generating early clinical data at a potentially active dose to determine next steps for this program.
    • The first cohort has been cleared and the second cohort is open for enrollment in a dose escalation of FPT155 and pembrolizumab in patients with non-small cell lung cancer.

    FPA157 (anti-CCR8) is a novel antibody directed to CCR8, a promising immuno-oncology target that is expressed by a highly immunosuppressive population of T regulatory cells within tumors. Eliminating CCR8-expressing T regulatory cells is anticipated to reduce immunosuppression in the tumor microenvironment and promote development of anti-tumor responses.

    • The company's FPA157 late-breaking abstract has been accepted for a poster presentation at the 2020 Society of Immunotherapy of Cancer (SITC) Annual Meeting.
    • The company expects to submit an IND application for this program in the first half of 2022.

    Summary of Third Quarter 2020 Financial Results and Cash Guidance:

    Cash Position: Cash, cash equivalents and marketable securities totaled $112.9 million as of September 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 third quarter of 2020 decreased by $0.9 million, or 31%, to $2.0 million from $2.9 million for the third quarter of 2019. The decrease was primarily the result of a reduction in revenue pursuant to progress achieved toward satisfying performance obligations under the company's November 2014 cabiralizumab collaboration agreement with BMS. The decrease was partially offset by higher collaboration revenue from Zai Lab that resulted from the company's decision to amend the FIGHT trial to a Phase 2 design.

    R&D Expenses: Research and development expenses for the third quarter of 2020 decreased by $5.5 million, or 20%, to $21.4 million from $26.9 million for the third quarter of 2019. The decrease was primarily due to lower compensation costs resulting from the October 2019 restructuring, lower clinical trial expense and manufacturing costs, along with lower allocated costs, bioanalytics and central lab costs, and a decrease in costs related to preclinical programs. These reductions were partially offset by an impairment charge on right-of-use assets and other fixed assets related to the sublease of a portion of the company's facility, as well as an increase in companion diagnostics costs related to bemarituzumab.

    G&A Expenses: General and administrative expenses for the third quarter of 2020 increased by $0.5 million, or 4%, to $13.7 million from $13.2 million for the third quarter of 2019. The increase was primarily due to an impairment charge taken in the third quarter on the right-of-use asset and other fixed assets related to the sublease of a portion of the company's facility, as well as higher allocated costs that were offset by lower compensation, depreciation, and other miscellaneous general and administrative costs.

    Net Loss: Net loss for the third quarter of 2020 was $26.4 million, or $0.74 per basic and diluted share, compared to a net loss of $36.1 million, or $1.03 per basic and diluted share, for the third quarter of 2019.

    Shares Outstanding: Total shares outstanding were 35,620,167 as of September 30, 2020.

    Cash Guidance: Five Prime expects full-year 2020 net cash used in operating activities to be between $70 and $75 million and has raised guidance to end 2020 with cash, cash equivalents and marketable securities between $100 and $105 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 7757227. 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) the timing of the IND submission for Five Prime's FPA157 program; (v) Five Prime's estimated full-year 2020 net cash used in operating activities; and (vi) 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.

    Selected Balance Sheets Data

    (In Thousands)

     
     
    Balance Sheet Data:

    September 30,

    December 31

    2020

    2019

    Cash, cash equivalents and marketable securities

    $ 112,912

    $ 157,923

    Total assets

    160,381

    224,142

    Total current liabilities (excluding deferred revenue)

    21,796

    21,728

    Deferred revenue (in total, including short term portion)

    1,251

    6,409

    Total stockholders' equity

    95,231

    150,473

    Five Prime Therapeutics, Inc.

    Consolidated Statements of Operations

    ( (In Thousands Except Per Share Amounts)

     

    Three Months Ended

    Nine Months Ended

    September 30,

    September 30,

    2020

    2019

    2020

    2019

    License revenue

    $

     

    $

     

    $

    5,000

     

    $

     

    Collaboration revenue

     

    2,048

     

     

    2,984

     

     

    8,886

     

     

    11,663

     

    Total revenues

     

    2,048

     

     

    2,984

     

     

    13,886

     

     

    11,663

     

    Operating expenses:
    Research and development

     

    21,446

     

     

    26,948

     

     

    52,575

     

     

    88,126

     

    General and administrative

     

    13,712

     

     

    13,206

     

     

    32,198

     

     

    33,377

     

    Total operating expenses

     

    35,158

     

     

    40,154

     

     

    84,773

     

     

    121,503

     

    Loss from operations

     

    (33,110

    )

     

    (37,170

    )

     

    (70,887

    )

     

    (109,840

    )

    Interest income

     

    59

     

     

    1,100

     

     

    783

     

     

    3,996

     

    Other loss, net

     

    (2

    )

     

    1

     

     

    (2

    )

     

    (2

    )

    Loss before income tax

     

    (33,053

    )

     

    (36,069

    )

     

    (70,106

    )

     

    (105,846

    )

    Income tax (provision) benefit

     

    6,630

     

     

     

     

    6,630

     

     

     

    Net loss

    $

    (26,423

    )

    $

    (36,069

    )

    $

    (63,476

    )

    $

    (105,846

    )

    Basic and diluted net loss per common share

    $

    (0.74

    )

    $

    (1.03

    )

    $

    (1.79

    )

    $

    (3.03

    )

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

     

    35,521

     

     

    34,996

     

     

    35,404

     

     

    34,901

     

     

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    • Data will be presented during the late-breaker virtual poster sessions on November 11 and November 13, 2020

    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 the upcoming virtual poster presentation of the first preclinical data from its anti-CCR8 antibody, FPA157 program, at the Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting being held from November 9-14, 2020.

    Late-breaker Virtual Poster Presentation and Q&A Details:
    Title:
    Development of FPA157, an anti-CCR8 depleting antibody engineered to preferentially eliminate tumor-infiltrating T regulatory cells
    Poster Number: 861…

    • Data will be presented during the late-breaker virtual poster sessions on November 11 and November 13, 2020

    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 the upcoming virtual poster presentation of the first preclinical data from its anti-CCR8 antibody, FPA157 program, at the Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting being held from November 9-14, 2020.

    Late-breaker Virtual Poster Presentation and Q&A Details:

    Title:
    Development of FPA157, an anti-CCR8 depleting antibody engineered to preferentially eliminate tumor-infiltrating T regulatory cells

    Poster Number: 861

    Live Q&A Sessions: November 11, 2020 from 5:15-5:45 pm EST and November 13, 2020 from 4:40-5:10 EST

    Author and Q&A Presenter: Edwina Naik, PhD, Associate Director, Immuno-Oncology Research

    About FPA157

    FPA157 is an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced monoclonal antibody targeting CCR8 that is designed to deplete the T regulatory cell (Treg) population in the tumor microenvironment. Tregs inhibit anti-tumoral immune responses and act through multiple suppressive mechanisms.1,2 FPA157 is part of the Five Prime immuno-oncology antibody pipeline and is undergoing IND-enabling studies.

    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 the timing of the presentation of data for Five Prime's product candidates. 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 preclinical development and business and corporate development and other objectives 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.

    References

    1. Teng MW, Ngiow SF, von Scheidt B, McLaughlin N, Sparwasser T, Smyth MJ. Conditional regulatory T-cell depletion releases adaptive immunity preventing carcinogenesis and suppressing established tumor growth [published correction appears in Cancer Res. 2010; 70(23):10014]. Cancer Res. 2010; 70(20):7800-7809. doi:10.1158/0008-5472.CAN-10-1681
    2. Simpson TR, Li F, Montalvo-Ortiz W, et al. Fc-dependent depletion of tumor-infiltrating regulatory T cells co-defines the efficacy of anti-CTLA-4 therapy against melanoma. J Exp Med. 2013; 210(9):1695-710. doi:10.1084/jem.20130579

    Source: Five Prime Therapeutics, Inc.

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  6. 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 third quarter 2020 operational and financial results on Tuesday, November 3, 2020 after the U.S. financial markets close. Five Prime will also host a conference call and live audio webcast on Tuesday, November 3, 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 third quarter 2020 operational and financial results on Tuesday, November 3, 2020 after the U.S. financial markets close. Five Prime will also host a conference call and live audio webcast on Tuesday, November 3, 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: 7757227

    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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  7. 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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  8. 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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  9. 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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  10. 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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    • FIGHT trial converted to a randomized Phase 2 study with data in late 2020 or early 2021
    • New leadership, financial strength and discipline equip the company to progress toward important near-term data milestones
    • Transition to a remote-work environment in response to coronavirus pandemic results in minimal impact to operations and clinical 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 first quarter of 2020 in addition to providing an update on the company's recent activities.

    "Five Prime is in a solid position with near-term data readouts for our two lead programs and…

    • FIGHT trial converted to a randomized Phase 2 study with data in late 2020 or early 2021
    • New leadership, financial strength and discipline equip the company to progress toward important near-term data milestones
    • Transition to a remote-work environment in response to coronavirus pandemic results in minimal impact to operations and clinical 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 first quarter of 2020 in addition to providing an update on the company's recent activities.

    "Five Prime is in a solid position with near-term data readouts for our two lead programs and a strong cash runway, which is a result of our financial discipline," said Tom Civik, Chief Executive Officer of Five Prime Therapeutics. "I am immensely proud of our employees who continue to show resolve and agility during this challenging time of the coronavirus pandemic. The team has kept our clinical trials on track bringing us closer to potentially having a significant impact on some of the most devastating cancers."

    First 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 cancer therapy for tumors that overexpress FGFR2b.

    • The FIGHT trial is being converted to a Phase 2 randomized, double-blind trial, based on the approximately 150 patients enrolled.
    • The Phase 2 FIGHT study is expected to have a sufficient number of PFS and OS events to generate clinically meaningful and actionable data by the end of the year or early 2021.
    • Converting to a Phase 2 trial is the fastest path to generating informative data about bemarituzumab: the first agent to target FGFR2b overexpressing gastric and gastroesophageal junction cancer (GEJ).

    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 expansion of memory T-cells has been identified, consistent with the mechanism of action of FPT155 observed in preclinical studies.
    • In parallel with continued dose escalation, patients with warm/hot tumor types are being enrolled with the aim to generate early clinical evidence of FPT155 single-agent activity by the end of 2020.
    • An arm has been added to the ongoing trial to test the combination of escalating doses of FPT155 and pembrolizumab in patients with PD-1 treated non-small cell lung cancer. Five Prime expects to begin enrolling patients in this cohort in the third quarter of 2020.

    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), the first clinical candidate from the discovery collaboration between Five Prime and Bristol-Myers Squibb (BMS) that includes targets in three immune checkpoint pathways. In light of the coronavirus pandemic, Five Prime is withdrawing its guidance that this trial may advance from Phase 1 to Phase 2 in 2020.

    2020 Corporate Highlights

    • In April 2020, Five Prime announced the appointment of Thomas Civik as President and Chief Executive Officer and a member of the Board of Directors of the company. Mr. Civik joins Five Prime from Foundation Medicine, where he served as Chief Commercial Officer. Prior to that, Mr. Civik most recently served as Vice President and Oncology Franchise Head at Genentech.
    • In February 2020, the company announced a global license agreement with Seattle Genetics, Inc. to develop and commercialize novel ADC therapies using monoclonal antibodies, developed by Five Prime, that are directed to a single target. Under the terms of the agreement, the company received a $5 million upfront payment and is eligible to receive progress-dependent development and regulatory milestone payments as well as cumulative commercial milestone payments. Cumulative milestone payments may reach up to $525 million for the first two ADC product candidates.

    Summary of First Quarter 2020 Financial Results and Cash Guidance:

    Cash Position: Cash, cash equivalents and marketable securities totaled $142.7 million as of March 31, 2020, compared to $157.9 million as of December 31, 2019. The decrease in cash, cash equivalents and marketable securities was primarily attributed to quarterly operating expenses that exceeded quarterly revenues.

    Revenue: Collaboration and license revenue for the first quarter of 2020 increased by $3.1 million, or 58%, to $8.4 million from $5.3 million for the first quarter of 2019. The increase was primarily related to license revenues earned from the Seattle Genetics license agreement, signed in February 2020, and revenue from the collaboration with Zai Lab. These increases were partially offset by the completion of the immuno-oncology research collaboration with BMS and progress pursuant to the company's performance obligation under the original cabiralizumab collaboration with BMS.

    R&D Expenses: Research and development expenses for the first quarter of 2020 decreased by $13.2 million, or 42%, to $18.6 million from $31.8 million for first quarter of 2019. The decrease was primarily related to lower compensation costs resulting from the October 2019 restructuring, lower manufacturing directed towards our FPA 150 program, lower pre-clinical and allocated costs, lower clinical services and specialty lab services related to our cabiralizumab and FPA 150 clinical studies, reduced companion diagnostics expenses directed towards our bemarituzumab development program and decrease in miscellaneous research and development expenses. These decreases were partially offset by increased clinical trial expenses primarily related to bemarituzumab.

    G&A Expenses: General and administrative expenses for both the first quarter of 2020 and the first quarter of 2019 were $10.5 million.

    Net Loss: Net loss for the first quarter of 2020 was $20.1 million, or $0.57 per basic and diluted share, compared to a net loss of $35.4 million, or $1.02 per basic and diluted share, for the first quarter of 2019.

    Shares Outstanding: Total shares outstanding were 35,324,056 as of March 31, 2020.

    Cash Guidance: Five Prime expects full-year 2020 net cash used in operating activities to be between $77 and $82 million and affirms previously issued guidance to end 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 (253) 237-1188 (domestic) or (877) 878-2269 (international) and refer to conference ID 5376706. 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, 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) Five Prime's estimated full-year 2020 net cash used in operating activities; and (vii) 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.  
    Selected Balance Sheets Data  
    (in thousands)  
      March 31, December 31,
     

    2020

    2019

    Balance Sheet Data:  
    Cash, cash equivalents and marketable securities  

    $

    142,671

    $

    157,923

    Total assets  

     

    202,971

     

    224,142

    Total current liabilities (excluding deferred revenue)  

     

    19,091

     

    21,728

    Deferred revenue (in total, including short term portion)  

     

    4,929

     

    6,409

    Total stockholders' equity  

     

    134,543

     

    150,473

    Five Prime Therapeutics, Inc  
    Condensed Statement of Operations  
    (in thousands, except per share data)  
      For The Three Months Ended
      March 31
     

    2020

    2019

    Revenue from contracts with customers  

    $

    5,000

     

    $

    -

     

    Collaboration revenue  

     

    3,414

     

     

    5,347

     

    Total revenues  

     

    8,414

     

     

    5,347

     

       
    Operating expenses:  
    Research and development  

     

    18,556

     

     

    31,753

     

    General and administrative  

     

    10,491

     

     

    10,510

     

    Total operating expenses  

     

    29,047

     

     

    42,263

     

    Loss from operations  

     

    (20,633

    )

     

    (36,916

    )

    Interest income and other loss, net  

     

    517

     

     

    1,533

     

    Other (loss)/gain), net  

     

    -

     

     

    (2

    )

    Loss before income tax  

     

    (20,116

    )

     

    (35,385

    )

    Income tax provision  

     

    -

     

     

    -

     

    Net loss  

    $

    (20,116

    )

    $

    (35,385

    )

    Basic and diluted net loss per common share  

    $

    (0.57

    )

    $

    (1.02

    )

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

     

    35,263

     

     

    34,794

     

     

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  11. 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 first quarter 2020 operational and financial results on Thursday, May 7, 2020 after the U.S. financial markets close. Five Prime will also host a conference call and live audio webcast on Thursday, May 7, 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 (253) 237-1188 (domestic) or (877) 878-2269…

    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 first quarter 2020 operational and financial results on Thursday, May 7, 2020 after the U.S. financial markets close. Five Prime will also host a conference call and live audio webcast on Thursday, May 7, 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 (253) 237-1188 (domestic) or (877) 878-2269 (international) and refer to conference ID: 5376706.

    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 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. 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.

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  12. 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 its 2020 Annual Meeting of Stockholders will take place virtually and will be available as a live audio webcast. The company is making this change to comply with the directives of federal and California authorities and to support the health and well-being of its stockholders, employees and the general public during the COVID-19 pandemic.

    As previously announced, the Annual Meeting will be held on Thursday, May 14, 2020 at 8:30 A.M., Pacific Time and online access to the live audio webcast of the Annual Meeting will begin at approximately 8:15 A.M…

    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 its 2020 Annual Meeting of Stockholders will take place virtually and will be available as a live audio webcast. The company is making this change to comply with the directives of federal and California authorities and to support the health and well-being of its stockholders, employees and the general public during the COVID-19 pandemic.

    As previously announced, the Annual Meeting will be held on Thursday, May 14, 2020 at 8:30 A.M., Pacific Time and online access to the live audio webcast of the Annual Meeting will begin at approximately 8:15 A.M. Pacific Time. Stockholders will not be able to attend the Annual Meeting in person.

    Attending the Virtual Annual Meeting

    As described in the proxy materials for the Annual Meeting, stockholders of record and beneficial owners as of the close of business on March 16, 2020 are entitled to attend and vote at the Annual Meeting. To attend the Annual Meeting, stockholders must register at www.proxydocs.com/FPRX before the deadline of 2:00 P.M., Pacific Time, on May 12, 2020.

    As part of the registration process, you will be required to enter the control number that appears on your proxy card, voter instruction form, notice of internet availability of proxy materials, or previously received email. If you are a beneficial owner, you must obtain a legally valid proxy from your broker, bank or other agent and provide this proxy during the registration process. After completing your registration, you will receive further instructions via email, including unique links to the website where you can access the Annual Meeting and vote online during the Annual Meeting.

    If you encounter difficulties accessing the Annual Meeting during check-in or during the Annual Meeting, please contact technical support as provided in the email instructions received after registration. You will be permitted to submit questions relating to matters properly before the Annual Meeting as part of the registration process and during the Annual Meeting through the Annual Meeting website. The Annual Meeting will not include a presentation on the company's accomplishments and operations. The Annual Meeting agenda and rules of conduct will be available on the Annual Meeting website.

    Voting Shares

    We urge you to vote and submit your proxy in advance of the Annual Meeting by one of the methods described in the proxy materials even if you do not plan on attending the Annual Meeting. If you have already voted, you do not need to take any action unless you wish to change your vote. Proxies that have already been returned by stockholders will remain valid and will be voted at the Annual Meeting unless revoked.

    If you have not already voted your shares in advance, you will be able to vote your shares electronically during the Annual Meeting by following the email instructions received after registration. You are not required to attend the Annual Meeting to vote your shares by proxy.

    The proxy card or voter instruction form included with the proxy materials previously distributed will not be updated to reflect the change to a virtual-only Annual Meeting and may continue to be used to vote your shares in connection with the Annual Meeting.

    List of Stockholders

    A list of stockholders entitled to vote will be available for inspection by stockholders of record for any legally valid purpose related to the Annual Meeting during the Annual Meeting by following the email instructions received after registration, and for a period of 10 days prior to the Annual Meeting by sending a request to .

    The proxy statement and annual report are available at www.proxydocs.com/FPRX, on the Annual Meeting website when you join the Annual Meeting and on our Investor Relations website at investor.fiveprime.com. Additionally, you may access our proxy materials at www.sec.gov.

    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.

    Source: Five Prime Therapeutics, Inc.

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  13. Phase 1 data illustrates the therapeutic potential of bemarituzumab as a novel approach to treating patients with FGFR2b-overexpressing gastric and gastroesophageal junction adenocarcinoma (GEA)

    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 the publication of results from the phase 1 escalation and expansion study of bemarituzumab in patients with advanced solid tumors and FGFR2b-selected gastroesophageal adenocarcinoma in the digital edition of the Journal of Clinical Oncology.

    The purpose of the phase 1 trial was to evaluate the safety, pharmacokinetics, and preliminary activity of single-agent…

    Phase 1 data illustrates the therapeutic potential of bemarituzumab as a novel approach to treating patients with FGFR2b-overexpressing gastric and gastroesophageal junction adenocarcinoma (GEA)

    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 the publication of results from the phase 1 escalation and expansion study of bemarituzumab in patients with advanced solid tumors and FGFR2b-selected gastroesophageal adenocarcinoma in the digital edition of the Journal of Clinical Oncology.

    The purpose of the phase 1 trial was to evaluate the safety, pharmacokinetics, and preliminary activity of single-agent bemarituzumab in patients with FGFR2b-overexpressing GEA. Seventy-nine patients were enrolled in the trial and no dose-limiting toxicities were reported. Bemarituzumab was well tolerated and the most frequent treatment-related adverse events (TRAEs) were fatigue, nausea, and dry eye. The overall response rate observed in this study of advanced-stage patients with high FGFR2b-overexpressing GEA was 17.9% (95% CI 6.1% to 36.9%) with five of 28 patients achieving a confirmed partial response.

    "Gastroesophageal adenocarcinoma is the third most common cause of cancer death worldwide and the median overall survival of patients who present with advanced disease remains dismal at only 11 months," said Helen Collins, M.D., Executive Vice President and Chief Medical Officer of Five Prime Therapeutics. "The results of this study underscore the potential of bemarituzumab evaluation as a novel treatment option for patients with advanced gastric and gastroesophageal junction cancer."

    "Monotherapy activity of bemarituzumab and its lack of significant overlapping toxicities with standard chemotherapeutic agents suggest that combining bemarituzumab with chemotherapy may potentially benefit patients in the front-line setting whose GEA tumors overexpress FGFR2b," said Daniel Catenacci, M.D. and Associate Professor, the University of Chicago Medical Center and Biological Sciences.

    Bemarituzumab is being evaluated in combination with mFOLFOX6 in the Phase 3 FIGHT (FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) trial in the front-line treatment setting.

    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.

    About Bemarituzumab and the FIGHT Trial

    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.

    In December 2017, Five Prime initiated the Phase 1 portion (NCT03343301) of the Phase 1/3 FIGHT (FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) global registrational trial. The Phase 1 safety lead-in portion of the trial was designed to identify a recommended dose of bemarituzumab in combination with the modified FOLFOX6 standard-of-care chemotherapy regimen (mFOLFOX6) to support the initiation of the Phase 3 portion of the trial.

    The Phase 3 portion of the FIGHT trial is evaluating bemarituzumab in combination with mFOLFOX6 versus placebo plus mFOLFOX6 in approximately 550 patients with gastric cancer or gastroesophageal junction cancer whose tumors overexpress FGFR2b. The Phase 3 portion of the trial began in September 2018 and the primary endpoint of the FIGHT trial is overall survival (OS) with secondary endpoints of progression-free survival (PFS), objective response rate (ORR), safety and pharmacokinetic (PK) parameters.

    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. 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.

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  14. 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…

    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.

    • The company has paused enrollment in the FIGHT trial pending the occurrence of a sufficient number of events to trigger a futility analysis that is expected to occur in mid-2020.
    • Approximately 150 patients with newly diagnosed advanced stage gastric cancer were enrolled into the FIGHT trial before the company paused enrollment in the fourth quarter of 2019.
    • The company expects that it will only resume enrollment in the FIGHT trial if the trial passes the futility analysis and the company will look to enter into a collaboration or license agreement that will pay for all or substantially all of any future development and commercialization costs for bemarituzumab.
    • In the event that the company is unable to secure a partner, it will consider alternatives that would allow for the advancement of the bemarituzumab program, including converting the FIGHT trial to a Phase 2 or Phase 2/3 clinical 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.

    • The company remains on track to generate data by mid-2020 from the Phase 1 combination of FPA150 plus pembrolizumab in a cohort of ovarian cancer patients with B7-H4 overexpression.
    • The company presented safety and preliminary FPA150 efficacy results from the Phase 1a/1b clinical trial at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and the 2019 European Society for Medical Oncology (ESMO) Congress.
    • Data from the Phase 1a/1b trial of FPA150 showed that the drug was well tolerated in monotherapy and in combination at a recommended dose of 20mg/kg every three weeks. While an efficacy signal for FPA150 as monotherapy was observed, the response was not sufficient for the company to move forward in developing the compound as a single agent.
    • The company continues to evaluate FPA150 in combination with Keytruda in a Phase 1b cohort of patients with ovarian cancer that overexpresses B7-H4, but does not plan to advance the clinical development of the combination independently in the near term given the cost of advancing this combination in clinical development when compared to current resources and priorities.
    • The company believes B7-H4 may be a potential target to treat tumors that overexpress B7-H4 using antibody drug candidates (ADCs), bi-specific antibodies, or CAR-T therapies that incorporate FPA150 or one of the company's other B7-H4 antibodies.

    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.

    • The company remains on track to generate early monotherapy efficacy data in 2020.
    • The company has completed nine monotherapy dose escalation cohorts and is currently dosing patients in the 280mg dose level in the Phase 1a portion of the study. The company has not observed evidence of superagonism in the trial. Dose escalation continues and the company has initiated screening of patients for enrollment in an exploratory cohort evaluating FPT155 in patients with tumors more likely to have T cell infiltration.
    • The company has observed pharmacodynamic (PD) biomarker data in the Phase 1a dose escalation portion of the trial that show expansion of central memory T cells in blood. This expansion of central memory T cells is consistent with the mechanism of action of FPT155 observed in preclinical studies.
    • Based on this early clinical PD data and the safety data to date, the company plans to add a cohort to the ongoing Phase 1a/1b trial to test the combination of escalating doses of FPT155 and an anti-PD(L)-1 therapy in patients with non-small cell lung cancer followed by an expansion in this same patient population at a selected dose of FPT155 in combination with an anti-PD(L)-1 therapy.
    • The company presented initial safety results from dose escalation in the FPT155 Phase 1 study at the 2019 Society for Immunotherapy of Cancer (SITC) Annual Meeting. This study is designed to characterize the safety and pharmacokinetic (PK)/pharmacodynamic (PD) profile of FPT155 and identify a recommended dose for ongoing clinical development.

    Cabiralizumab (FPA008) is an antibody that inhibits CSF1R and has been shown to block the activation and survival of tumor-associated macrophages.

    • In February 2020, the company announced that the Phase 2 trial of cabiralizumab plus Opdivo® (nivolumab) with and without chemotherapy in advanced pancreatic cancer being conducted by Bristol-Myers Squibb Company (BMS) did not meet its primary endpoint.
    • BMS informed the company that while BMS has no near-term plans for additional sponsored development of cabiralizumab, it will continue to support the evaluation of cabiralizumab in select, ongoing investigator-sponsored trials and may continue to assess future development opportunities for the investigational asset. In addition, BMS informed the company that no new safety signals were observed in the Phase 2 clinical trial.

    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.

    • BMS continues to conduct the Phase 1/2 clinical trial testing the combination of BMS-986258 with Opdivo or hyaluronidase, with the objective of evaluating the safety and tolerability of the combination.
    • The next anticipated event from this trial is BMS's potential transition of the trial from the Phase 1 portion of the trial to the Phase 2 portion of the trial.

    2020 and 2019 Corporate Highlights

    • In February 2020, the company announced a global license agreement with Seattle Genetics, Inc. to develop and commercialize novel ADC therapies using monoclonal antibodies developed by Five Prime that are directed to a single target. Under the terms of the agreement, the company received a $5 million upfront payment and is eligible to receive progress-dependent development and regulatory milestone payments as well as cumulative commercial milestone payments. Cumulative milestone payments may reach up to $525 million for the first two ADC product candidates.
    • In October 2019, the company announced a corporate restructuring to extend its cash runway without impacting or delaying the data timelines of its clinical programs while still advancing its three wholly-owned, late-stage research programs. This followed a restructuring in January 2019 to focus on clinical development and later-stage research priorities.
    • In September 2019, the company announced a management transition and the appointment of William Ringo as interim Chief Executive Officer in addition to his position as Chairman of the Board of Directors.
    • During 2019, the company announced the appointment of Lori Lyons-Williams and Carol Schafer to its board of directors and the resignation of Dr. Lewis T. "Rusty" Williams and Dr. Sheila Gujrathi from the Board.

    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 31

    2019

    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

     

     

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  15. 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 Helen Collins, M.D., Executive Vice President and Chief Medical Officer, is scheduled to present at the following investor conference:

    • The Cowen 40th Annual Healthcare Conference on Wednesday, March 4th at 8:00am ET / 5:00am PT

    The presentations will be webcast and may be accessed at 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 30 days after the conference.

    About Five Prime

    Five Prime Therapeutics, Inc…

    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 Helen Collins, M.D., Executive Vice President and Chief Medical Officer, is scheduled to present at the following investor conference:

    • The Cowen 40th Annual Healthcare Conference on Wednesday, March 4th at 8:00am ET / 5:00am PT

    The presentations will be webcast and may be accessed at 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 30 days after the conference.

    About Five Prime

    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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  16. Five Prime receives $5 million upfront payment and is eligible to receive up to a combined total of $525 million in future milestone payments for the first two ADC product candidates

    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 a global license agreement with Seattle Genetics, Inc. to develop and commercialize novel antibody-drug conjugate (ADC) therapies using monoclonal antibodies developed by Five Prime. ADCs harness the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells.

    Under the terms of the agreement, Five Prime granted Seattle Genetics an exclusive worldwide…

    Five Prime receives $5 million upfront payment and is eligible to receive up to a combined total of $525 million in future milestone payments for the first two ADC product candidates

    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 a global license agreement with Seattle Genetics, Inc. to develop and commercialize novel antibody-drug conjugate (ADC) therapies using monoclonal antibodies developed by Five Prime. ADCs harness the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells.

    Under the terms of the agreement, Five Prime granted Seattle Genetics an exclusive worldwide license to a family of monoclonal antibodies that are directed to a single target and Seattle Genetics will be responsible for research, development, manufacturing and commercialization of ADC products based on these antibodies. For the multi-product deal, Five Prime will receive a $5 million upfront payment and is eligible to receive progress-dependent development and regulatory milestone payments as well as cumulative commercial milestone payments. Cumulative milestones may reach up to $295 million for the first ADC product that is developed and commercialized. Five Prime will additionally receive tiered mid-single digit royalties on net product sales.

    "We are pleased to enter into this license agreement with Seattle Genetics, a global leader that develops and commercializes transformative targeted cancer therapies that utilize its industry-leading ADC technology," said William Ringo, Chairman and interim Chief Executive Officer of Five Prime Therapeutics. "This agreement allows Five Prime to realize value from our pre-clinical pipeline while prioritizing our clinical investments based on upcoming data readouts for our programs. Looking to the future, we will continue to seek strategic partnerships that allow us to maximize the value of our assets and the long-term potential of the company."

    About Five Prime Therapeutics

    Five Prime Therapeutics, Inc. develops innovative protein therapeutics to improve the lives of patients with cancer. The company focuses on developing immune modulators and precision therapies for solid tumor cancers paired with companion diagnostics to identify patients who are most likely to benefit from treatment with Five Prime's product candidates. The company's product candidates have innovative mechanisms of action and address patient populations in need of better therapies. 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 Five Prime's potential receipt of upfront and milestone payments and royalties under the license agreement. 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 preclinical or clinical studies, changes in expected or existing competition, changes in the regulatory, pricing or reimbursement environment, and unexpected litigation or other disputes. 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.

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  17. Phase 2 Trial of Cabiralizumab plus Opdivo (nivolumab) with and without Chemotherapy in Advanced Pancreatic Cancer Did not Meet Primary Endpoint

    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 Bristol-Myers Squibb informed the company that the randomized Phase 2 trial testing the combination of cabiralizumab with Opdivo® (nivolumab) with and without chemotherapy in patients with advanced pancreatic cancer did not meet its primary endpoint. While Bristol-Myers Squibb has no near term plans for additional sponsored development of cabiralizumab, Bristol-Myers Squibb will continue to support the evaluation…

    Phase 2 Trial of Cabiralizumab plus Opdivo (nivolumab) with and without Chemotherapy in Advanced Pancreatic Cancer Did not Meet Primary Endpoint

    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 Bristol-Myers Squibb informed the company that the randomized Phase 2 trial testing the combination of cabiralizumab with Opdivo® (nivolumab) with and without chemotherapy in patients with advanced pancreatic cancer did not meet its primary endpoint. While Bristol-Myers Squibb has no near term plans for additional sponsored development of cabiralizumab, Bristol-Myers Squibb will continue to support the evaluation of cabiralizumab in select, ongoing investigator-sponsored trials and may continue to assess future development opportunities for the investigational asset. Bristol-Myers Squibb also informed the company that no new safety signals were observed in the Phase 2 trial.

    "Pancreatic cancer is a difficult disease to treat, and unfortunately the combination of cabiralizumab and Opdivo with and without chemotherapy did not show any meaningful benefit over standard of care chemotherapy in this randomized, controlled Phase 2 trial," said Helen Collins, M.D., Executive Vice President and Chief Medical Officer of Five Prime Therapeutics. "We are disappointed by this outcome and appreciate the participation of the investigators, staff, patients, caregivers, and our development partner who all contributed to the conduct and completion of this Phase 2 clinical trial."

    The multi-arm, randomized, controlled Phase 2 clinical trial (NCT03336216) enrolled approximately 160 patients with locally advanced or metastatic pancreatic cancer that has progressed during or after one line of chemotherapy.

    About Five Prime Therapeutics

    Five Prime Therapeutics, Inc. develops innovative protein therapeutics to improve the lives of patients with cancer. The company focuses on developing immune modulators and precision therapies for solid tumor cancers paired with companion diagnostics to identify patients who are most likely to benefit from treatment with Five Prime's product candidates. The company's product candidates have innovative mechanisms of action and address patient populations in need of better therapies. 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.

    About Cabiralizumab (FPA008)

    Cabiralizumab is an investigational antibody that inhibits the CSF-1 receptor and has been shown in preclinical models and clinical studies to block the activation and survival of monocytes and macrophages. Inhibition of CSF1R in preclinical models of several cancers reduces the number of immunosuppressive tumor-associated macrophages (TAMs) in the tumor microenvironment, thereby facilitating an immune response against tumors. Bristol-Myers Squibb acquired rights in October 2015 to cabiralizumab under an exclusive worldwide license and collaboration agreement.

    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. 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 preclinical or clinical studies, changes in expected or existing competition, changes in the regulatory, pricing or reimbursement environment, and unexpected litigation or other disputes. 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.

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  18. 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 fourth quarter and full year 2019 operational and financial results on Thursday, February 27, 2020 after the U.S. financial markets close. Five Prime will also host a conference call and live audio webcast on Thursday, February 27, 2020 at 4:30 p.m. (ET) / 1:30 p.m. (PT) to provide a general business update and dicuss 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…

    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 fourth quarter and full year 2019 operational and financial results on Thursday, February 27, 2020 after the U.S. financial markets close. Five Prime will also host a conference call and live audio webcast on Thursday, February 27, 2020 at 4:30 p.m. (ET) / 1:30 p.m. (PT) to provide a general business update and dicuss 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: 3872638.

    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 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. 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.

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  19. Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, will participate in the 38th Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2020. William Ringo, who is Five Prime's Chairman and interim Chief Executive Officer, will represent the company and respond to questions from investors. He is scheduled to present at 7:30 a.m. PT (10:30 a.m. ET).

    Investors and other interested parties will be able to access a live audio webcast of the presentation by visiting http://investor.fiveprime.com/events-presentations. A replay of the presentation will also be available on the Five Prime website for 30 days after the…

    Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, will participate in the 38th Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2020. William Ringo, who is Five Prime's Chairman and interim Chief Executive Officer, will represent the company and respond to questions from investors. He is scheduled to present at 7:30 a.m. PT (10:30 a.m. ET).

    Investors and other interested parties will be able to access a live audio webcast of the presentation by visiting http://investor.fiveprime.com/events-presentations. A replay of the presentation will also be available on the Five Prime website for 30 days after the conference.

    About Five Prime

    Five Prime Therapeutics, Inc. develops innovative protein therapeutics to improve the lives of patients with cancer. The company focuses on developing immune modulators and precision therapies for solid tumor cancers paired with companion diagnostics to identify patients who are most likely to benefit from treatment with Five Prime's product candidates. The company's product candidates have innovative mechanisms of action and address patient populations in need of better therapies. 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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  20. 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 the company's founder, Lewis T. "Rusty" Williams, M.D., Ph.D., has resigned as a member of the Five Prime Board of Directors to focus on his role as Chief Executive Officer of Walking Fish Therapeutics, a start-up company that he co-founded, and other activities supporting life science start-up companies.

    "On behalf of the Executive Team and the company, we thank Rusty for the integral role he played in founding and building Five Prime," said William Ringo, Chairman and interim Chief Executive Officer of Five Prime Therapeutics. "He made countless…

    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 the company's founder, Lewis T. "Rusty" Williams, M.D., Ph.D., has resigned as a member of the Five Prime Board of Directors to focus on his role as Chief Executive Officer of Walking Fish Therapeutics, a start-up company that he co-founded, and other activities supporting life science start-up companies.

    "On behalf of the Executive Team and the company, we thank Rusty for the integral role he played in founding and building Five Prime," said William Ringo, Chairman and interim Chief Executive Officer of Five Prime Therapeutics. "He made countless contributions to the company, establishing our reputation for world class innovative research and leading to a strong pipeline with five programs in the clinic. We wish him continued success in his future endeavors."

    In addition to establishing Five Prime, Dr. Williams served in a variety of leadership roles, including as President and Chief Executive Officer, Executive Chairman of the Board, and member of the Board. Under his leadership, Five Prime transitioned from being a private company to a publicly traded company with multiple global pharmaceutical partnerships.

    Following Dr. Williams' departure, the Five Prime Board will be comprised of seven members, including six independent directors. In mid-2019, the company appointed two new independent directors to its Board, Carol Schafer and Lori Lyons-Williams. Ms. Schafer has more than 25 years of investment banking and equity capital markets experience in the biotechnology sector and Ms. Lyons-Williams has 20 years of experience launching and commercializing innovative pharmaceutical products.

    About Five Prime Therapeutics

    Five Prime Therapeutics, Inc. develops innovative protein therapeutics to improve the lives of patients with cancer. The company focuses on developing immune modulators and precision therapies for solid tumor cancers paired with companion diagnostics to identify patients who are most likely to benefit from treatment with Five Prime's product candidates. The company's product candidates have innovative mechanisms of action and address patient populations in need of better therapies. 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.

    Five Prime Therapeutics 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. 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.

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  21. - Results Demonstrate FPT155 was Well Tolerated in all Patients through Seven Cohorts, Allowing for Continuation of Dose Escalation and Dose Finding -

    Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, today presented initial safety data from the Phase 1 clinical trial of FPT155 in patients with advanced solid tumors in a poster presentation at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting in National Harbor, Maryland. The poster can be found on the Publications Page of the Five Prime Therapeutics website.

    "FPT155 is a first-in-class CD80 fusion protein with potential dual mechanisms to activate…

    - Results Demonstrate FPT155 was Well Tolerated in all Patients through Seven Cohorts, Allowing for Continuation of Dose Escalation and Dose Finding -

    Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, today presented initial safety data from the Phase 1 clinical trial of FPT155 in patients with advanced solid tumors in a poster presentation at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting in National Harbor, Maryland. The poster can be found on the Publications Page of the Five Prime Therapeutics website.

    "FPT155 is a first-in-class CD80 fusion protein with potential dual mechanisms to activate T cells," said Helen Collins, M.D., Executive Vice President and Chief Medical Officer of Five Prime Therapeutics. "Importantly, the initial safety results for FPT155 suggest that it may not cause the same safety issues seen with a prior molecule targeting CD28. This allows us to continue enrolling patients to study additional dose escalation cohorts and identify a dose for future studies."

    The FPT155 data presented at SITC included initial safety results from the Phase 1a dose escalation portion of the trial, which is designed to characterize the safety and pharmacokinetic (PK)/pharmacodynamic (PD) profile of FPT155 and identify a recommended dose for the Phase 1b portion of the trial. This included data from 15 patients with solid tumors that were treated with FPT155 at doses of 0.07 mg, 0.21 mg, 0.7 mg, 2.1 mg, 7 mg, 21 mg, and 42 mg. The key highlights from the presentation include:

    • FPT155 was well tolerated at all dose levels, with no dose-limiting toxicities and no grade 4 or higher adverse events.
    • There is no evidence of clinical or laboratory cytokine release syndrome, an adverse event associated with a prior therapy targeting CD28.
    • Dose escalation with FPT155 is ongoing with the study currently enrolling patients at the 70 mg dose level.

    The Phase 1a/1b open-label, multicenter, dose escalation, dose exploration and dose expansion study will evaluate the safety and tolerability of FPT155 in patients with advanced solid tumors. The Phase 1a dose escalation portion of the trial will characterize the safety and PK/PD profile of FPT155 and will identify a recommended dose for the Phase 1b portion of the trial. The Phase 1b portion of the trial is intended to further characterize the safety, PK/PD profile, and preliminary efficacy of FPT155.

    About FPT155

    FPT155 is a first-in-class CD80 fusion protein that (i) directly engages CD28 to enhance its co-stimulatory T-cell activation activity without inducing super agonism, and (ii) blocks CTLA-4 from competing for endogenous CD80, allowing CD28 signaling to prevail in T-cell activation in the tumor microenvironment. FPT155 has also demonstrated its ability to retain anti-tumor activity independent of its engagement with CTLA-4, suggesting a differentiated mechanism of action from CTLA-4-blocking antibodies. Studies in preclinical models suggest FPT155 has the potential to be a potent T-cell co-stimulator with strong monotherapy anti-tumor activity.

    About Five Prime Therapeutics

    Five Prime Therapeutics, Inc. develops innovative protein therapeutics to improve the lives of patients with cancer. The company focuses on developing immune modulators and precision therapies for solid tumor cancers paired with companion diagnostics to identify patients who are most likely to benefit from treatment with Five Prime's product candidates. The company's product candidates have innovative mechanisms of action and address patient populations in need of better therapies. 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. 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.

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  22. 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 its results for the third quarter and provided an update on the company's recent activities.

    "We have advanced all of our wholly-owned programs according to our plan for 2019," said William Ringo, Chairman and interim Chief Executive Officer of Five Prime Therapeutics. "As we approach 2020, we have repositioned Five Prime with a focus on prioritizing our pipeline based on upcoming data readouts, while also extending our cash runway, in order to maximize the long-term potential of the company."

    Third Quarter 2019 Business Highlights and Milestones

    Clinical

    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 its results for the third quarter and provided an update on the company's recent activities.

    "We have advanced all of our wholly-owned programs according to our plan for 2019," said William Ringo, Chairman and interim Chief Executive Officer of Five Prime Therapeutics. "As we approach 2020, we have repositioned Five Prime with a focus on prioritizing our pipeline based on upcoming data readouts, while also extending our cash runway, in order to maximize the long-term potential of the company."

    Third Quarter 2019 Business Highlights and Milestones

    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.

    • The company has enrolled approximately 140 patients with newly diagnosed advanced stage gastric cancer into the FIGHT trial, representing approximately 25% of projected total trial enrollment, and has paused pre-screening of patients for enrollment in the trial.
    • The prevalence of FGFR2b overexpression in this patient population is approximately 30% based on global pre-screening data.
    • The company expects to conduct a planned futility analysis for the FIGHT trial in mid-2020. The purpose of the futility analysis is to ensure the trial is adequately powered to detect an overall survival benefit at full enrollment.

    FPA150 (anti-B7-H4) is a first-in-class B7-H4 antibody designed to target tumor cells by enhancing killing of B7-H4 overexpressing tumors through ADCC and by blocking B7-H4 from sending an inhibitory signal to CD8 T cells. B7-H4 is frequently overexpressed in breast, ovarian and endometrial cancers.

    • The company presented a poster at the European Society for Medical Oncology (ESMO) Congress with preliminary FPA150 efficacy results from the monotherapy Phase 1b expansion cohorts at the 20mg/kg dose in patients with breast, ovarian or endometrial cancers that overexpress B7-H4.
    • As of the August 9, 2019 data cut-off date, one patient in the ovarian cohort had a confirmed response; 11 patients had stable disease and remained on therapy. As of the data cut-off date, 31 patients across the ovarian, endometrial and breast cohorts were evaluable for response.
    • The company also presented safety data for four patients in the combination arm of FPA150 with Keytruda® (pembrolizumab) suggesting that FPA150 could be combined at a full dose of 20 mg/kg every three weeks with the standard dose of pembrolizumab.

    FPT155 (CD80-Fc) is a first-in-class CD80-Fc fusion protein that uses the binding interactions of soluble CD80 to directly engage CD28 to enhance its co-stimulatory T cell activity without inducing super agonism and to block CTLA-4 from competing for endogenous CD80, allowing CD28 signaling to prevail in T cell activation in the tumor microenvironment.

    • On November 9, the company will present initial safety data from the Phase 1 clinical trial of FPT155 in patients with advanced solid tumors in a poster presentation at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting in National Harbor, Maryland.
    • FPT155 data presented at SITC will include initial safety results from the Phase 1a dose escalation portion of the trial, which is designed to characterize the safety and pharmacokinetic (PK)/pharmacodynamic (PD) profile of FPT155 and identify a recommended dose for the Phase 1b portion of the trial.

    Cabiralizumab (anti-CSF1R) is an antibody that inhibits CSF1R and has been shown to block the activation and survival of tumor-associated macrophages. Pursuant to a worldwide collaboration agreement, Bristol-Myers Squibb (BMS) has an exclusive worldwide license for the development and commercialization of cabiralizumab, and Five Prime retains the rights to a U.S. co-promotion option.

    • Bristol-Myers Squibb has completed enrollment in the randomized Phase 2 trial testing the combination of cabiralizumab with Opdivo® (nivolumab) with and without chemotherapy in approximately 160 patients with locally advanced or metastatic pancreatic cancer that has progressed during or after one line of chemotherapy.
    • The next anticipated event from the Phase 2 trial is the announcement of actionable data from BMS in 2020.

    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.

    • The Phase 1/2 clinical trial continues to progress, with the expected size of the trial increased to 383 patients in July 2019.

    Corporate Highlights

    • In October, the company announced a corporate restructuring to extend its cash runway without impacting or delaying the data timelines of its clinical programs. The company will retain a small research group focused on advancing three wholly-owned, late-stage research programs.
    • In September, the company's board of directors appointed William Ringo as interim Chief Executive Officer in addition to his position as Chairman of the Board of Directors.

    Summary of Financial Results and Guidance:

    Cash Position: Cash, cash equivalents and marketable securities totaled $186.0 million as of September 30, 2019, compared to $214.1 million as of June 30, 2019. The decrease in cash, cash equivalents and marketable securities was primarily attributable to quarterly operating expenses that exceeded quarterly revenues.

    Revenue: Collaboration and license revenue for the third quarter of 2019 decreased by $2.8 million, or 48.3%, to $3.0 million from $5.8 million for the third quarter of 2018. This decrease was primarily related to the completion of the research term under the immuno-oncology research collaboration with BMS in March 2019 and from progress made towards the company's performance obligation under the original collaboration agreement.

    R&D Expenses: Research and development expenses for the third quarter of 2019 decreased by $17.8 million, or 39.8%, to $26.9 million from $44.7 million for the third quarter of 2018. This decrease was primarily due a one-time milestone payment triggered by the dosing of the first patient in the Phase 3 FIGHT trial in the third quarter of 2018. Lower compensation costs, pre-clinical and research activities, manufacturing and diagnostic expenses and the reduction in the use of temporary resources contributed to the decrease and were partially offset by increased clinical trial expense to advance the company's bemarituzumab, FPA150, and FPT155 clinical programs.

    G&A Expenses: General and administrative expenses for the third quarter of 2019 increased by $3.4 million, or 34.7%, to $13.2 million from $9.8 million for the third quarter of 2018. The increase was primarily due to increased compensation costs offset by a reduction in the use of temporary resources.

    Net Loss: Net loss for the third quarter of 2019 was $36.1 million, or $1.03 per basic and diluted share, compared to a net loss of $47.2 million, or $1.37 per basic and diluted share, for the third quarter of 2018.

    Shares Outstanding: Weighted average shares outstanding for the third quarter of 2019 was 34,996,298 as of September 30, 2019.

    Cash Guidance: Five Prime expects full-year 2019 net cash used in operating activities to be between $117 and $122 million and estimates ending 2019 with cash, cash equivalents and marketable securities between $148 and $153 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 5769473. 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. develops innovative protein therapeutics to improve the lives of patients with cancer. The company focuses on developing immune modulators and precision therapies for solid tumor cancers paired with companion diagnostics to identify patients who are most likely to benefit from treatment with Five Prime's product candidates. The company's product candidates have innovative mechanisms of action and address patient populations in need of better therapies. 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 extent of protein overexpression in certain patient populations; (iv) the timing of the presentation of data for Five Prime's product candidates; (v) the impact of the restructuring on the data timelines of Five Prime's clinical trials; (vi) Five Prime's full-year 2019 net cash used in operating activities; and (vii) the amount of Five Prime's cash, cash equivalents and marketable securities at the end of 2019. 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)
    September 30 December 31,

     

    2019

     

    2018

    Balance Sheet Data:
    Cash, cash equivalents and marketable securities

    $

    185,987

    $

    270,138

    Total assets

     

    258,540

     

    321,534

    Total current liabilities (excluding deferred revenue)

     

    26,356

     

    26,059

    Deferred revenue (in total, including short term portion)

     

    7,176

     

    11,893

    Total stockholders' equity

     

    178,434

     

    265,139

     
    Five Prime Therapeutics, Inc
    Condensed Statement of Operations
    (in thousands, except per share data)
    For The Three Months Ended For The Six Months Ended
    September 30 September 30

     

    2019

     

     

    2018

     

     

    2019

     

     

    2018

     

    Collaboration and license revenue

    $

     

    2,984

     

    $

     

    5,771

     

    $

     

    11,664

     

    $

     

    45,837

     

    Operating expenses:
    Research and development

     

    26,948

     

     

    44,687

     

     

    88,126

     

     

    121,619

     

    General and administrative

     

    13,206

     

     

    9,832

     

     

    33,377

     

     

    30,092

     

    Total operating expenses

     

    40,154

     

     

    54,519

     

     

    121,503

     

     

    151,711

     

    Loss from operations

     

    (37,170

    )

     

    (48,748

    )

     

    (109,839

    )

     

    (105,874

    )

    Interest income and other loss, net

     

    1,100

     

     

    1,531

     

     

    3,996

     

     

    4,212

     

    Other (lss)/gain), net

     

    1

     

     

    (27

    )

     

    (2

    )

     

    (32

    )

    Loss before income tax

     

    (36,069

    )

     

    (47,244

    )

     

    (105,845

    )

     

    (101,694

    )

    Income tax provision

     

    -

     

     

    -

     

     

    -

     

     

    -

     

    Net loss

    $

     

    (36,069

    )

    $

     

    (47,244

    )

    $

     

    (105,845

    )

    $

     

    (101,694

    )

    Basic and diluted net loss per common share

    $

     

    (1.03

    )

    $

     

    (1.37

    )

    $

     

    (3.03

    )

    $

     

    (3.01

    )

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

     

    34,996

     

     

    34,482

     

     

    34,901

     

     

    33,740

     

    Five Prime Therapeutics, Inc.
    Shares outstanding      
    9/30/2019      
           
    Total shares outstanding as of:
    September 30, 2019      

    35,099,100

           

     

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  23. 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 third quarter 2019 financial results on Wednesday, November 6, 2019 after the U.S. financial markets close. Five Prime will also host a conference call and live audio webcast on Wednesday, November 6, 2019 at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss the company's financial results and provide a general business update.

    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…

    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 third quarter 2019 financial results on Wednesday, November 6, 2019 after the U.S. financial markets close. Five Prime will also host a conference call and live audio webcast on Wednesday, November 6, 2019 at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss the company's financial results and provide a general business update.

    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: 5769473.

    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 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. 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.

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  24. Clinical Timelines Not Impacted and $20 Million of Annualized Savings Expected

    Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on discovering and developing immune modulators and precision therapies for solid tumor cancers, announced today a corporate restructuring to extend the company's cash runway without impacting or delaying the data timelines of its clinical programs. The company will retain a small research group focused on advancing three wholly-owned, late-stage research assets and will increasingly rely on outsourcing and contracted capabilities.

    "My immediate focus as CEO has been to conduct a review of Five Prime's operations with the goal of ensuring long-term sustainability and value…

    Clinical Timelines Not Impacted and $20 Million of Annualized Savings Expected

    Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on discovering and developing immune modulators and precision therapies for solid tumor cancers, announced today a corporate restructuring to extend the company's cash runway without impacting or delaying the data timelines of its clinical programs. The company will retain a small research group focused on advancing three wholly-owned, late-stage research assets and will increasingly rely on outsourcing and contracted capabilities.

    "My immediate focus as CEO has been to conduct a review of Five Prime's operations with the goal of ensuring long-term sustainability and value creation," said William Ringo, Chairman and Interim Chief Executive Officer of Five Prime Therapeutics. "This restructuring provides the cash runway to prioritize future pipeline investments based on clinical data readouts in 2020. It also allows us to evaluate long-term strategies to grow our pipeline. We acknowledge this decision impacts many talented employees who helped build Five Prime into a clinical-stage company. We are grateful for their contributions and hold them in high regard."

    Corporate Restructuring

    The company will eliminate approximately 70 positions across all functions. Seventy percent of these positions will be eliminated by the end of 2019, with the remainder occurring in 2020. The company is also initiating activities to reduce its corporate facilities footprint by either subletting a significant portion of its leased space or subletting the entirety of its building and relocating to smaller facilities. The company believes these actions will improve its potential to bring value to patients, employees and shareholders.

    The company expects that the restructuring, planned facility expense reduction and other cost-saving efforts will result in approximately $20 million in annualized cost savings, extending the company's cash runway. Five Prime estimates that it will incur approximately $3 million of pre-tax charges for severance and other costs related to the restructuring, primarily in 2019.

    The company is reaffirming its financial guidance and anticipates ending 2019 with $148 to $153 million in cash, cash equivalents and marketable securities.

    About Five Prime

    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. Five Prime has five programs in various stages of clinical development, two of which are partnered with Bristol-Myers Squibb. 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 effect the restructuring will have on Five Prime's expected cash runway; (ii) the timing of the presentation of data for Five Prime's product candidates; (iii) the timing of progress and scope of clinical trials for Five Prime's product candidates; (iv) the scope and timing of the restructuring; (v) plans to reduce Five Prime's corporate facilities footprint; (vi) the expected annual cost savings associated with the restructuring, planned facility expense reductions and the company's other cost-saving efforts; (vii) the timing and scope of expected pre-tax charges for severance and other costs related to the restructuring; and (viii) the amount of Five Prime's cash, cash equivalents and marketable securities at the end of 2019. 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.

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  25. - Results Provide First Clinical Demonstration of B7-H4 as a Potential Therapeutic Target and Continue to Support FPA150's Greatest Potential in Combination Therapy -

    Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on discovering and developing immune modulators and precision therapies for solid tumor cancers, today presented updated data from the Phase 1a/1b clinical trial of FPA150 in patients with advanced solid tumors in a poster presentation at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain. The poster can be found on the Scientific Publications Page of the Five Prime Therapeutics website.

    The FPA150 data presented at ESMO included preliminary efficacy…

    - Results Provide First Clinical Demonstration of B7-H4 as a Potential Therapeutic Target and Continue to Support FPA150's Greatest Potential in Combination Therapy -

    Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on discovering and developing immune modulators and precision therapies for solid tumor cancers, today presented updated data from the Phase 1a/1b clinical trial of FPA150 in patients with advanced solid tumors in a poster presentation at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain. The poster can be found on the Scientific Publications Page of the Five Prime Therapeutics website.

    The FPA150 data presented at ESMO included preliminary efficacy results from the Phase 1b monotherapy expansion portion of the study in patients preselected for B7-H4 tumor overexpression across breast, endometrial and ovarian cancers, and early safety results from the Phase 1a Keytruda® (pembrolizumab, a PD1 antibody) combination portion of the study in patients preselected for B7-H4 tumor overexpression in ovarian cancer.

    "B7-H4 is a novel T cell immune checkpoint and the early results from the phase 1b monotherapy portion of our FPA150 study provide the first clinical demonstration of B7-H4 as a potential therapeutic target," said Helen Collins, Executive Vice President and Chief Medical Officer of Five Prime Therapeutics. "Based on the study results to-date, we continue to believe that the most promising opportunity for FPA150 is in combination with other therapeutic agents."

    Key highlights from the presentation include:

    Phase 1 FPA150 Monotherapy:

    • Two patients with B7-H4 positive ovarian cancer experienced a confirmed partial response (one in the dose escalation and one at the recommended dose of 20mg/kg)
    • 10 patients with stable disease remain on therapy as of August 9, 2019
    • Increased tumor infiltration of T cells and NK cells observed in patients with a partial response or stable disease
    • Recommended dose of 20 mg/kg was well tolerated in all patients

    Phase 1 Safety Lead-in Combination of FPA150 + Pembrolizumab :

    • Combination was well tolerated in the first four patients treated with FPA150 (20 mg/kg) and pembrolizumab (200 mg)
    • Expansion initiated in August 2019 in a cohort of ovarian cancer patients with B7-H4 overexpression

    About FPA150

    FPA150 is a novel, fully human, afucosylated monoclonal antibody targeting B7-H4. B7-H4 overexpression is observed in multiple solid tumors, including breast and gynecologic cancers. FPA150 is designed with a dual mechanism of action: blocking the T cell checkpoint activity of B7-H4 as well as promoting enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) against tumor cells expressing B7-H4.

    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. Five Prime has five programs in various stages of clinical development with two of these programs partnered with Bristol-Myers Squibb. 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. 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.

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  26. Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on discovering and developing immune modulators and precision therapies for solid tumor cancers, announced today that its Board of Directors has appointed William "Bill" Ringo as Interim Chief Executive Officer, effective immediately. Mr. Ringo will succeed Chief Executive Officer and Board Member Aron Knickerbocker, who has resigned from the company to pursue new challenges and opportunities. Mr. Ringo will continue to serve as Chairman of Five Prime's Board of Directors.

    "I look forward to working with the talented executive team at Five Prime as interim CEO to ensure that all clinical programs remain on track as we enter a period where upcoming…

    Five Prime Therapeutics, Inc. (NASDAQ:FPRX), a clinical-stage biotechnology company focused on discovering and developing immune modulators and precision therapies for solid tumor cancers, announced today that its Board of Directors has appointed William "Bill" Ringo as Interim Chief Executive Officer, effective immediately. Mr. Ringo will succeed Chief Executive Officer and Board Member Aron Knickerbocker, who has resigned from the company to pursue new challenges and opportunities. Mr. Ringo will continue to serve as Chairman of Five Prime's Board of Directors.

    "I look forward to working with the talented executive team at Five Prime as interim CEO to ensure that all clinical programs remain on track as we enter a period where upcoming data events will provide insights to enable prioritization of clinical investments and pipeline programs," said Mr. Ringo. "The Board is initiating a search process to recruit a permanent Chief Executive Officer."

    Mr. Ringo has served as the Chairman of the Five Prime Board of Directors since January 2019 and as a Board Member since October 2014. He is an industry leader who has served in numerous executive and board roles across the pharmaceutical, biotech and venture capital sectors. Mr. Ringo served as President and Chief Executive Officer of Abgenix and as Senior Vice President of Business Development, Strategy and Innovation at Pfizer. He also served for 28 years at Eli Lilly and Company in numerous executive roles, including Product Group President for Oncology and Critical Care, President of Internal Medicine Products, President of the Infectious Diseases Business Unit and Vice President of Sales and Marketing for U.S. Pharmaceuticals.

    "On behalf of the Board, I thank Aron for his dedication and numerous contributions during ten years of service as Five Prime evolved from a research-oriented private company to a public one with multiple programs advancing in clinical development," Mr. Ringo continued. "As Chief Executive Officer, Aron provided leadership for the expansion of our clinical portfolio and we wish him well in his future endeavors."

    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. Five Prime has five programs in various stages of clinical development with two of these programs partnered with Bristol-Myers Squibb. 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. 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.

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