FPRX Five Prime Therapeutics Inc.

13.81
-1.01  -7%
Previous Close 14.82
Open 14.71
52 Week Low 1.75
52 Week High 24.7
Market Cap $639,646,967
Shares 46,317,666
Float 37,608,086
Enterprise Value $646,834,526
Volume 2,834,916
Av. Daily Volume 3,149,214
Stock charts supplied by TradingView

Drug Pipeline

Drug Stage Notes
FPA144 + chemo (FIGHT)
Gastric and gastro-esophageal junction cancer
Phase 2
Phase 2
Phase 2 data released November 10, 2020. All three efficacy endpoints met. Data presented at ASCO GI January 15, 2021.
FPT155
Solid tumors
Phase 1
Phase 1
Phase 1 second cohort is open for enrollment.
FPA150
Solid tumors
Phase 1
Phase 1
No plans to independently advance the clinical development.
Cabiralizumab (FPA008)
Pigmented Villonodular Synovitis (PVNS)
Phase 1/2
Phase 1/2
Phase 2 complete. Phase 3 development will not be pursued.
Cabiralizumab (FPA008) and Opdivo (nivolumab)
Pancreatic cancer
Phase 2
Phase 2
Phase 2 trial did not meet primary endpoint - February 18, 2020.

Latest News

    • 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.

    View Full Article Hide Full Article
    • 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.

    View Full Article Hide Full Article
  1. 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.

    View Full Article Hide Full Article
  2. 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.

    View Full Article Hide Full Article
    • 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.

    View Full Article Hide Full Article
View All Five Prime Therapeutics Inc. News