8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 13, 2015

Five Prime Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-36070	26-0038620
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)
Two Corporate Drive South San Francisco, California		94080
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (415) 365-5600

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 1.01 Entry into a Material Definitive Agreement

On July 13, 2015, Five Prime Therapeutics, Inc. (“FivePrime”) entered into a Research Collaboration and License Agreement (the “Agreement”) with INBRX 110 LP (“Inhibrx”).

Under the terms of the Agreement, FivePrime obtained (a) an exclusive, worldwide license to antibodies to glucocorticoid-induced tumor necrosis factor receptor (GITR) for therapeutic and diagnostic uses (respectively, “Licensed Therapeutic Products” and “Licensed Diagnostic Products” and collectively, the “Licensed Products”), and (b) an exclusive option (the “Option”) to obtain exclusive, worldwide licenses to multi-specific antibodies developed by Inhibrx that bind to both GITR and other targets (each, a “Multi-Specific Product”), which option FivePrime can exercise with respect to a Multi-Specific Product within a limited period of time after (i) certain activities related to initiating clinical manufacturing of such Multi-Specific Compound (the “Manufacturing Initiation”) or (ii) if not earlier exercised, the dosing of the first patient in a Phase 2 clinical trial of such Multi-Specific Product (“Phase 2 Dosing”).

Pursuant to the Agreement, FivePrime will make an upfront payment of $10 million to Inhibrx. Additionally, with respect to each Licensed Therapeutic Product, FivePrime will be obligated to pay up to $62.5 million in specified development milestone payments and (i) if such Licensed Therapeutic Product does not receive a Breakthrough Therapy Designation from the U.S. Food and Drug Administration (the “FDA”), up to $280 million in specified regulatory and commercial milestone payments, or (ii) if such Licensed Therapeutic Product receives a Breakthrough Therapy Designation from the FDA, up to $380 million in specified regulatory and commercial milestone payments.

If FivePrime exercises the Option with respect to a Multi-Specific Product at Manufacturing Initiation, FivePrime would pay Inhibrx $15 million for such Option exercise. If FivePrime exercises the Option with respect to a Multi-Specific Product at Phase 2 Dosing, FivePrime would pay Inhibrx $30 million for such Option exercise. After such Option exercise, such Multi-Specific Product would be treated as a Licensed Therapeutic Product under the Agreement and FivePrime would be obligated to pay the milestone payments specified in the preceding paragraph with respect to such Multi-Specific Product.

FivePrime may pay all or a portion of milestone payments for development and regulatory events in shares of common stock of FivePrime, subject to certain limitations and conditions. FivePrime would be obligated to register for resale under the Securities Act of 1933, as amended, any such shares of common stock of FivePrime.

FivePrime is also obligated to pay Inhibrx (a) with respect to each Licensed Therapeutic Product, tiered low double-digit percentage royalties on net sales of such Licensed Therapeutic Product, subject to reduction in certain circumstances, and (b) with respect to each Licensed Diagnostic Product, low single-digit percentage royalties on net sales of such Licensed Diagnostic Product, in each case, for the longer of (i) 12 years after the first commercial sale of such Licensed Product or (ii) the life of certain patents licensed covering such Licensed Product. FivePrime cannot determine the date on which FivePrime’s potential royalty payment obligations to Inhibrx would expire because FivePrime has not yet commercialized any Licensed Products under the Agreement and therefore FivePrime cannot identify the date of the first commercial sale or the expiration dates of any related patents covering such Licensed Products.

Unless earlier terminated by either party, the Agreement will expire on a product-by-product and country-by-country basis upon the expiration of all of FivePrime’s payment obligations under the Agreement. FivePrime may terminate the Agreement in its entirety at any time with advance written notice. Either party may terminate the Agreement in its entirety with written notice for the other party’s material breach if such party fails to cure the breach. Either party also may terminate the Agreement in its entirety upon certain insolvency events involving the other party.

The foregoing description of the Agreement is only a summary and is qualified in its entirety by reference to the Agreement, a copy of which FivePrime plans to file as an exhibit in a subsequently filed Quarterly Report on Form 10-Q.

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FivePrime issued a press release on July 15, 2015 announcing the Agreement, a copy of which is attached to this Current Report on Form 8-K as Exhibit 99.1.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
99.1	Press Release, dated July 15, 2015

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Five Prime Therapeutics, Inc.
By:	/s/ Francis Sarena
	Francis Sarena
	Senior Vice President, General Counsel and Secretary

Dated: July 15, 2015

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EXHIBIT INDEX

Exhibit No.	Description
99.1	Press Release, dated July 15, 2015

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EX-99.1

Exhibit 99.1

Five Prime Therapeutics Establishes Strategic Research Collaboration and License Agreement with Inhibrx for Novel GITR Antibodies

• Inhibrx’s technology may offer best-in-class approach for agonist antibodies

• New program further expands Five Prime’s immuno-oncology pipeline and potential for combination therapies

SOUTH SAN FRANCISCO, Calif., and LA JOLLA, Calif., July 15, 2015 (GLOBE NEWSWIRE) — Five Prime Therapeutics, Inc. (Nasdaq: FPRX) (Five Prime), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today announced a strategic research collaboration and license agreement with Inhibrx for Inhibrx’s novel glucocorticoid-induced tumor necrosis factor receptor (GITR) antibody program, which is currently at lead selection stage.

Leveraging its comprehensive protein library and proprietary in vivo screening technologies, Five Prime identified GITR as one of the most potent inhibitors of tumor growth. GITR is an immune checkpoint protein that is selectively expressed on effector T cells and T regulatory cells (Tregs), and is believed to activate an immune response against tumor cells. In preclinical studies, agonist antibodies have demonstrated the ability to induce tumor regressions, particularly when administered in combination with other immuno-oncology therapies.

Inhibrx’s technology offers a novel, potentially best-in-class approach for engineering a GITR antibody with the desired properties aimed at maximizing safety, efficacy and combinability with other therapies. Inhibrx’s multivalent antibody scaffolds are designed to multimerize and activate GITR independent of Fc binding. This is in contrast to conventional GITR antibodies, where efficacy is dependent upon binding and the presence of Fc-receptor bearing cells and may vary due to Fc receptor polymorphisms and be dampened by competing serum IgG.

Under the terms of the agreement, Five Prime will pay Inhibrx a $10 million license fee in return for exclusive, worldwide therapeutic and diagnostic rights to antibodies provided by Inhibrx that bind to GITR, as well as an option to license multi-specific antibodies that bind to GITR and other targets. Inhibrx is eligible to receive up to $342.5 million in development, regulatory and commercial milestone payments per therapeutic product, or up to $442.5 million in development, regulatory and commercial milestone payments if the U.S. Food and Drug Administration grants a Breakthrough Therapy Designation to such therapeutic product. Milestone payments for development, regulatory and first commercial sale events may be paid in cash or in Five Prime common stock at Five Prime’s discretion. Inhibrx is also eligible for low double-digit tiered royalties on future product sales.

“Five Prime is actively pursuing a comprehensive approach to immuno-oncology by identifying pipeline candidates with the potential to work independently or in combination to target macrophages, immune check points, T cell agonist pathways and Treg cells. Comparing across many potential targets, our platform pointed to GITR as an ideal agonist to expand our portfolio,” said Lewis “Rusty” T. Williams, M.D., Ph.D., chief executive officer & president of Five Prime. “Inhibrx’s antibody technology is uniquely suited to activate GITR and enhance the immune response against the tumor. We believe this program has the potential to create a differentiated, next-generation GITR agonist that may have broad therapeutic application as a monotherapy or in combination with approved checkpoint inhibitors or other therapies, including products in our pipeline.”

“We believe Five Prime’s insights into GITR biology and their scientific and clinical translation capabilities make them the optimal partner for our GITR program,” said Mark Lappe, CEO of Inhibrx. “They share our commitment to bring therapeutics to patients in need as quickly as possible and we are excited to be collaborating with them.”

Five Prime intends to provide updated cash guidance when it reports its second quarter 2015 financial results.

About Five Prime

Five Prime Therapeutics, Inc. discovers and develops innovative therapeutics to improve the lives of patients with serious diseases. Five Prime’s comprehensive discovery platform, which encompasses virtually every medically relevant extracellular protein, positions it to explore pathways in cancer, inflammation and their intersection in immuno-oncology, an area with significant therapeutic potential and a growing focus of the company’s R&D activities. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and late preclinical development. For more information, please visit www.fiveprime.com.

About Inhibrx

Inhibrx is a biologic immunotherapeutic company focused on the treatment of high unmet medical needs in oncology, infectious disease and inflammatory conditions. Inhibrx’s proprietary platforms enable fit-for-function biotherapeutics that optimally interface with the biology of each target antigen, focus immune activation and mediate enhanced signaling. Inhibrx’s programs are based on comprehensive target discovery and selection expertise coupled with the creative implementation of multiple antibody and biologic development strategies. Inhibrx has numerous immuno-oncology therapeutics in development including a highly differentiated CD47 antibody, licensed by Celgene, which entered clinical studies in early 2015. For more information visit www.inhibrx.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. Forward-looking statements contained in this press release include statements regarding Five Prime’s potential receipt of upfront and milestone payments and royalties. 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.

CONTACT:

Five Prime Therapeutics, Inc.

Amy Kendall, Corporate Communications

415-365-5776

amy.kendall@fiveprime.com

Inhibrx

Mark Lappe, President & CEO

858-759-1499

mark@inhibrx.com