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09/06/13 11:06 AM

#166104 RE: DewDiligence #164598

Five Prime Therapuetics (FPRX): roadshow presentation...
http://www.retailroadshow.com/sys/launch.asp?qv=26699688588269055&k=82709304652


Prospectus...
http://www.retailroadshow.com/sys/pdf.asp?d=/shows/FPRX100u_rr/DHHB4ZU/prosp.pdf


Our Company
We are a clinical-stage biotechnology company focused on discovering and developing novel protein
therapeutics. Protein therapeutics are antibodies or drugs developed from extracellular proteins or protein
fragments that block disease processes, including cancer and inflammatory diseases. We have developed a
library of more than 5,600 human extracellular proteins, which we believe represent substantially all of the
body’s medically important targets for protein therapeutics. We screen this comprehensive library with our
proprietary high-throughput protein screening technologies to identify new targets for protein therapeutics. This
platform has allowed us to develop a pipeline of novel product candidates for cancer and inflammatory
diseases and to generate over $220 million under our collaboration arrangements.

Each of our product candidates has an innovative mechanism of action and addresses patient populations for
which better therapies are still needed. In addition, we are pursuing companion diagnostics for each of our
lead programs to allow us to select patients most likely to benefit from treatment and therefore accelerate
clinical development and improve patient care. Our most advanced product candidates are as follows:

FP-1039/GSK3052230, or FP-1039, is a protein therapeutic that “traps” and neutralizes cancerpromoting
fibroblast growth factors, or FGFs, involved in cancer cell proliferation and new blood vessel formation.
FGFs are a family of related extracellular proteins that normally regulate cell proliferation
and survival in humans. They act by binding to and activating FGF receptors, or FGFRs, which are cell
surface proteins that transmit growth signals to cells. Certain FGFs promote growth of multiple solid
tumors by binding and activating FGFRs. Unlike other therapies that indiscriminately block all FGFs,
FP-1039 is designed to only block cancer-promoting FGFs and therefore may be associated with
better tolerability than other known drug candidates targeting the FGF pathway. We have completed a
Phase 1 clinical trial, and our partner, GlaxoSmithKline, or GSK, commenced a multi-arm Phase 1b
clinical trial in July 2013 in patients with abnormally high levels of FGFR1. We expect preliminary
data from this trial in the second half of 2014. GSK is responsible for the development and
commercialization of FP-1039 in the United States, the European Union and Canada. Under our
agreement, we received a $50 million license fee and are eligible to receive up to $435 million in
contingent payments. We have an option to co-promote FP-1039 in the United States.

FPA008 is an antibody that inhibits colony stimulating factor-1 receptor, or CSF1R, and is being
developed to treat patients with inflammatory diseases, including rheumatoid arthritis, or RA. CSF1R
is a cell surface protein that controls the survival and function of certain inflammatory cells called
monocytes and macrophages. By inhibiting CSF1R activation, FPA008 prevents the production of
multiple inflammatory factors, such as tumor necrosis factor, interleukin-6 and interleukin-1, that are
individually targeted by approved therapeutics such as Humira® (adalimumab), Actemra®
(tocilizumab) and Kineret® (anakinra), respectively. As a result, we believe FPA008 has the potential
to have better efficacy than each of these approved drugs. In addition, unlike currently marketed RA drugs, FPA008 directly inhibits bone-destroying cells called osteoclasts. We plan to begin a Phase 1
clinical trial for FPA008 by the end of 2013 and expect preliminary data by the end of 2014.

FPA144 is an antibody that inhibits FGF receptor 2b, or FGFR2b, and is being developed to treat
patients with gastric cancer and potentially other solid tumors. In preclinical studies, FPA144 was
highly effective in blocking the growth of gastric tumors that had abnormally high levels of FGFR2b.
We plan to begin a Phase 1 clinical trial for FPA144 in the second half of 2014 in patients with
tumors expressing high levels of FGFR2b and expect preliminary data by the end of 2015.

Our Platform
The process of discovering targets for protein therapeutics has historically proven to be difficult and slow.
There are more than 5,600 proteins in the body that represent potential protein therapeutic targets, but only
about 30 are targeted by currently marketed protein drugs in cancer and inflammatory diseases. We spent
seven years successfully developing a platform to improve and accelerate the protein therapeutic discovery
process. Our platform is based on two components:
¦ a proprietary library of more than 5,600 human extracellular proteins that we believe is the most
comprehensive collection of fully functional extracellular proteins available and is an abundant source
of medically relevant novel targets for protein therapeutics; and
¦ proprietary and new technologies for producing and testing thousands of proteins at a time.

We believe our platform improves and accelerates the discovery of new protein targets and protein therapeutics
because it can:

identify novel medically relevant protein targets and protein therapeutics that have little or no
previously known biological function or are not in the public domain and cannot easily be discovered
by other methods;

determine the best protein target among many alternatives for a particular disease by screening and
comparing nearly all possible medically important targets simultaneously; and

identify new targets more quickly and efficiently than previously possible because it can produce and
test thousands of proteins at a time, rather than one or just a few at a time.

In the past several years we have used this platform to identify dozens of targets validated in rodent models
and to build a growing pipeline of drug candidates. We have attracted numerous partnerships with leading
biopharmaceutical companies, which have generated over $220 million in funding for our business since
2006. In addition to our FP-1039 license and collaboration agreement, under which we are eligible to receive
up to $435 million in contingent payments, we have ongoing discovery collaborations with GSK and UCB
Pharma, S.A., or UCB. We are eligible to receive potential option exercise fees and contingent payments up to
$124.3 million per target under the GSK muscle diseases collaboration, $193.8 million per target under the
GSK respiratory diseases collaboration and $92.2 million per target under the UCB fibrosis and CNS
collaboration. We believe our platform will continue to provide funding opportunities through product and
discovery collaborations.

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09/18/13 10:15 AM

#166611 RE: DewDiligence #164598

IPO Preview: Five Prime Therapeutics
Sep 17 2013, 16:34 | about: FPRX, includes: GSK BOOKMARK / READ

Based in South San Francisco, CA, Five Prime Therapeutics (FPRX) scheduled a $52 million IPO with a market capitalization of $198 million at a price range mid-point of $13, for Wednesday, September 18, 2013.

Nine IPOs are scheduled for this week, 11 for next week. The full IPO calendar can be found at IPOpremium.

S-1 filed September 5, 2013

Manager, Joint Managers: Jefferies; BMO Capital; Wells Fargo Securities
Co-Managers: Guggenheim Securities

Summary

FPRX is a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics. Only one of its product candidates is in clinical development. The others are in pre-clinical development.

In the past several years FPRX has used its proprietary platform to identify dozens of targets validated in rodent models and to build a growing pipeline of drug candidates

This platform has allowed FPRX to develop a pipeline of novel product candidates for cancer and inflammatory diseases and to generate over $220 million under collaboration arrangements.

(However, as one skeptical doctor said, "You can do almost anything with mice.")

FPRX is 80% owned by VC firms & strategic partners, pre-IPO

Conclusion

The rating is buy FPRX, because it has a proven development platform, with one product candidate is in Phase 1 clinical trials. The price-to-book value of 3.7 appears reasonable to low in the current IPO stock market for stocks in FPRX's sector.

Note: Existing stockholders, including affiliates of directors, have indicated a non-binding interest in purchasing up to an aggregate of approximately $10.0 million of shares of common stock in this offering at the initial offering price.

To put the conclusions and observations in context, the following is reorganized, edited and summarized from the full S-1 referenced above:

Business

FPRX is a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics. Protein therapeutics are antibodies or drugs developed from extracellular proteins or protein fragments that block disease processes, including cancer and inflammatory diseases.

FPRX has developed a library of more than 5,600 human extracellular proteins, which FPRX believes represent substantially all of the body's medically important targets for protein therapeutics.

FPRX screens this comprehensive library with proprietary high-throughput protein screening technologies to identify new targets for protein therapeutics.

This platform has allowed FPRX to develop a pipeline of novel product candidates for cancer and inflammatory diseases and to generate over $220 million under collaboration arrangements.

In the past several years FPRX has used this platform to identify dozens of targets validated in rodent models and to build a growing pipeline of drug candidates. FPRX has attracted numerous partnerships with leading biopharmaceutical companies, which have generated over $220 million in funding for our business since 2006.

In addition to the FP-1039 license and collaboration agreement, under which FPRX is eligible to receive up to $435 million in contingent payments, FPRX has ongoing discovery collaborations with GlaxoSmithKline ($124 billion market cap) and UCB Pharma, S.A., or UCB.

FPRX is eligible to receive potential option exercise fees and contingent payments up to $124.3 million per target under the GSK muscle diseases collaboration, $193.8 million per target under the GSK respiratory diseases collaboration and $92.2 million per target under the UCB fibrosis and CNS collaboration. FPRX believes its platform will continue to provide funding opportunities through product and discovery collaborations.

Management

FPRX's executive management team has extensive experience in leading the discovery and development of innovative protein therapeutics and significant expertise in operational and business development functions.

The founder, President and Chief Executive Officer, Lewis T. "Rusty" Williams is a member of the National Academy of Sciences and was a co-founder and a member of the board of directors of COR Therapeutics, Inc., which was sold to Millennium Pharmaceuticals, Inc. for approximately $2.0 billion, and the Chief Scientific Officer and a member of the board of directors of Chiron Corporation.

The Senior Vice President and Chief Medical Officer, Julie Hambleton, led clinical development programs across all phases, including regulatory approvals, at Genentech, Inc. and Clovis Oncology, Inc.

The Senior Vice President and Chief Business Officer, Aron M. Knickerbocker, led oncology business development at Genentech, Inc.

Senior Vice President and Chief Scientific Officer, W. Michael Kavanaugh, led protein therapeutic programs at Novartis Institutes for Biomedical Research and Chiron Corporation.

Product candidates

FPRX's lead candidates are still in preclinical or early clinical development.

FPRX's most advanced product candidates are as follows:

FP-1039/GSK3052230, or FP-1039, is a protein therapeutic that "traps" and neutralizes cancer-promoting fibroblast growth factors, or FGFs, involved in cancer cell proliferation and new blood vessel formation.

FPRX has completed a Phase 1 clinical trial, and its partner, GlaxoSmithKline (GSK), commenced a multi-arm Phase 1b clinical trial in July 2013 in patients with abnormally high levels of FGFR1. FPRX expects preliminary data from this trial in the second half of 2014. GSK is responsible for the development and commercialization of FP-1039 in the United States, the European Union and Canada. Under an agreement, FPRX received a $50 million license fee and is eligible to receive up to $435 million in contingent payments. FPRX has an option to co-promote FP-1039 in the United States.

License Agreements

License Agreement with Galaxy

In December 2011, FPRX entered into a license agreement with Galaxy Biotech LLC, pursuant to which Galaxy granted to us an exclusive worldwide license to develop and commercialize FGFR2b antibodies, including FPA144. Under the license agreement, FPRX is obligated to use commercially reasonable efforts to develop and commercialize at least one licensed product in at least one tumor indication. FPRX paid Galaxy an upfront license fee of $3.0 million in connection with entering into the license agreement, which was paid in two equal installments in January 2012 and July 2012.

FPRX is obligated to pay Galaxy milestone payments of up to $92.5 million comprising aggregate preclinical and intellectual property-related milestone payments of up to $3.0 million, development-related milestone payments of up to $18.0 million for development in two indications, aggregate regulatory-related milestone payments of up to $41.5 million for two indications and aggregate commercial-related milestone payments of up to $30.0 million. FPRX is also obligated to pay tiered royalties on net sales of FPA144 from the high-single digits to the low-double digits

License Agreement with The Regents of the University of California

In September 2006, FPRX entered into a license agreement with The Regents of the University of California, or the UC Regents, pursuant to which the UC Regents granted to FPRX an exclusive license under certain patents to develop and commercialize products, including FP-1039, and practice certain methods covered by the patents. Under the license agreement, FPRX is obligated to use commercially reasonable efforts to develop and commercialize at least one licensed product.

FPRX is obligated to pay the UC Regents milestone payments of up to $0.8 million for the development and marketing approval of FP-1039 in cancer. FPRX is also obligated to pay the UC Regents a low single-digit royalty on net sales of FP-1039 for the life of the relevant licensed patents

Non-exclusive License with BioWa-Lonza

In February 2012, FPRX entered into a license agreement with BioWa, Inc. and Lonza Sales AG, or BioWa-Lonza, pursuant to which BioWa-Lonza granted us a non-exclusive license to use their Potelligent® CHOK1SV technology, including the CHOK1SV cell line, and a non-exclusive license to related know-how and patents. This license is necessary to produce FPRX's FPA144 antibody.

FPRX is obligated to pay BioWa-Lonza aggregate milestone payments of up to $25.7 million for development, regulatory and commercialization milestones achieved in the FPA144 antibody program. FPRX is also obligated to pay BioWa-Lonza tiered royalties on net sales of FPA144 up to mid-single digit percentages of the proceeds of such sales.

Patent Portfolio

FP-1039

The patent portfolio for FP-1039 includes patents and patent applications wholly owned by FPRX, as well as patents exclusively licensed from UC Regents.

The FP-1039 patent portfolio also includes issued U.S. and foreign patents FPRX exclusively licenses from the UC Regents that cover composition of matter and methods of producing FP-1039. These exclusively licensed patents include issued U.S. patents covering composition of matter and methods of producing FP-1039 that expire between 2019 and 2020 and an issued patent in Korea covering composition of matter and methods of producing FP-1039 that expires in 2014.

FPA008

The FPA008 patent portfolio is wholly owned by us and includes an issued U.S. patent as well as pending U.S. and foreign patent applications covering compositions of matter, methods of use and biomarkers relating to FPA008. The issued U.S. composition of matter patent expires in 2031. Patents that may issue from these pending U.S. and foreign applications would expire between 2031 and 2033.

FPA144

The patent portfolio for FPA144 includes patents and patent applications FPRX exclusively licensed from Galaxy, as well as a pending U.S. patent application wholly owned by us. The patent portfolio FPRX exclusively licensed from Galaxy includes an issued U.S. patent as well as pending U.S. and foreign patent applications covering compositions of matter and methods of use of FPA144. The issued U.S. composition of matter patent expires in 2029. Patents that may issue from these pending U.S. and foreign applications would expire in 2029. Patents that may issue from the pending U.S. patent application wholly owned by us would expire in 2034.

Competition

If FP-1039, the lead product candidate, were approved for the treatment of squamous non-small cell lung cancer, it could face competition from currently approved and marketed products, including carboplatin, cisplatin, paclitaxel, docetaxel, gemcitabine and Tarceva® (erlotinib). Further competition could arise from products currently in development, including several small molecules that act in the same pathway as FP-1039, including Novartis AG's BGJ-398, AstraZeneca plc's AZD-4547, Eli Lilly and Company's LY-2874455, ArQule Inc.'s ARQ-087, Les Laboratoires Servier/EOS S.p.A.'s E-3810 and Janssen Pharmaceuticals, Inc.'s JNJ-42756493. Some of these programs have been advanced further in clinical development than FP-1039 and could receive approval before FP-1039 is approved, if it is approved at all.

If FPA008 were approved for the treatment of rheumatoid arthritis, it could face competition from currently approved and marketed products, including Humira®, Remicade® (infliximab) and Enbrel® (etanercept). Further competition could arise from products currently in development, including Daiichi Sankyo Co., Ltd./Plexxikon Inc.'s PLX5622 product, which acts in the same pathway as FPA008.

If FPA144 were approved for the treatment of gastric cancer, it could face competition from currently approved and marketed products, including 5-fluorouracil, capecitabine, doxorubicin, cisplatin and docetaxel, all of which are available as generics. Further competition could arise from products currently in development, including AstraZeneca plc's AZD-4547.

5% stockholders pre-IPO

80% owned by VC firms & strategic partners, pre-IPO
Advanced Technology Ventures, 9%
Domain Associates, LLC, 9%
Entities affiliated with GlaxoSmithKline, 6.3%
Entities affiliated with HealthCap, 9%
Johnson and Johnson Development Corporation, 5.2%
Kleiner Perkins Caufield & Byers, 9%
Pfizer International LLC, 13.7%
Texas Pacific Group, 9%
Versant Ventures, 9%

Use of Proceeds

FPRX expects to net $46 million from its IPO.

Proceeds are allocated as follows:

$10.0 million to fund a Phase 1 clinical trial of FPA008;
$20.0 million to fund a Phase 1 clinical trial of FPA144; and
the remainder for working capital and general corporate purposes.

Disclaimer: This FPRX IPO report is based on a reading and analysis of FPRX's S-1 filing, which can be found here, and a separate, independent analysis by IPOdesktop.com. There are no unattributed direct quotes in this article.
http://seekingalpha.com/article/1699562-ipo-preview-five-prime-therapeutics