Business description of MADRIGAL-PHARMACEUTICALS-INC from last 10-k form

Washington, D.C. 20549

FORM 10-K

Commission file number: 001-33277

SYNTA PHARMACEUTICALS CORP.
(Exact name of registrant as specified in its charter)

Registrant's telephone number, including area code (781) 274-8200

         Securities registered pursuant to Section 12(b) of the Exchange Act:

         Securities registered pursuant to Section 12(g) of the Exchange Act: None.

         Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes o    No ý

         Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes o    No ý

         Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ý    No o

         Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ý    No o

         Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. o

         Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of "large accelerated filer," "accelerated filer," and "smaller reporting company" in Rule 12b-2 of the Exchange Act.

         Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o    No ý

         The aggregate market value of the registrant's common stock held by non-affiliates of the registrant (without admitting that any person whose shares are not included in such calculation is an affiliate), computed by reference to the price at which the common stock was last sold on June 30, 2011, the last business day of the registrant's most recently completed second fiscal quarter, was $144,500,004.

         As of February 17, 2012 the registrant had 57,624,866 shares of common stock outstanding.

DOCUMENTS INCORPORATED BY REFERENCE

         The following documents (or parts thereof) are incorporated by reference into the following parts of this Annual Report on Form 10-K: Certain information required in Part III of this Annual Report on Form 10-K is incorporated from the registrant's Proxy Statement for the 2012 Annual Meeting of Stockholders.

   

PART I

Item 1.    BUSINESS

The Company

        Synta Pharmaceuticals Corp. is a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to extend and enhance the lives of patients with severe medical conditions, including cancer and chronic inflammatory diseases. We have two drug candidates in clinical trials for treating multiple types of cancer and several drug candidates in the preclinical stage of development. Each of our drug candidates was discovered and developed internally using our proprietary, unique chemical compound library and integrated discovery engine. We retain full ownership of all of our drug candidates.

        In 2011, we made significant progress in advancing our drug candidates. Our lead drug candidate, ganetespib, is currently being evaluated in a broad range of clinical trials, including trials in non-small cell lung, breast, colon, gastric, prostate, pancreatic, melanoma and hematologic cancers. In total, over 20 clinical trials with ganetespib are ongoing, recently completed, or currently initiating.

        Milestones achieved with the ganetespib program in 2011 include:

•

Initiated a multinational, randomized Phase 2b/3 clinical trial (GALAXY) of ganetespib in combination with docetaxel in non-small cell lung cancer (NSCLC). Results from the first-stage, 240-patient, Phase 2b portion of this trial are expected in 2012.



•

Presented clinical results identifying certain targeted patient populations, with specific tumor genetic profiles, for which ganetespib has shown particularly encouraging anti-cancer activity. Patients with these profiles, whose tumors did not respond to or progressed following treatment with multiple prior standard-of-care or experimental therapies, exhibited durable objective responses, significant tumor shrinkage, or sustained disease control following monotherapy treatment with ganetespib. These profiles include: NSCLC patients whose tumors exhibit the anaplastic lymphoma kinase gene rearrangement (ALK+); NSCLC patients whose tumors exhibit a KRAS gene mutation; breast cancer patients whose tumors exhibit amplified HER2 expression (HER2+); and breast cancer patients with a tumor gene profile known as triple-negative (TNBC).



•

Initiated plans for global clinical trials in ALK+ lung cancer, HER2+ breast cancer, and triple-negative breast cancer, which are expected to begin in the first half of 2012.



•

Demonstrated a favorable clinical safety profile, with no evidence of the common ocular toxicities and serious liver toxicities seen with other Hsp90 inhibitors, or the neurotoxicity, bone marrow toxicities, and alopecia characteristic of many chemotherapies. The most common side effect from ganetespib administration has been transient, low- or moderate-grade diarrhea, which has been manageable with standard supportive care.



•

Published preclinical results supportive of the safety profile achieved with ganetespib, in particular physicochemical properties that compare favorably with both first-generation, ansamycin-family Hsp90 inhibitors and certain other, synthetic, second-generation Hsp90 inhibitors.



•

Built awareness in the scientific and medical communities of recent scientific and clinical results with ganetespib, which has generated support for over fifteen investigator-sponsored, foundation-sponsored, and cooperative-group sponsored trials recently initiated or expected to initiate in 2012, in indications including prostate cancer, multiple myeloma, pancreatic cancer, colon cancer, hematologic cancers, and others.

        In addition to progress with our ganetespib program, we also made significant progress with our elesclomol and CRAC programs. For our elesclomol program we published preclinical results demonstrating that elesclomol triggers cancer cell apoptosis by disrupting mitochondrial energy metabolism, which potentially establishes elesclomol as a leading compound in the emerging field of anti-cancer therapies targeting cancer cell metabolism; continued development of elesclomol in patients with advanced ovarian cancer, a trial being conducted by the Gynecologic Oncology Group (GOG) and supported by the National Cancer Institute; and continued development of elesclomol in acute myeloid leukemia (AML). For our CRAC program, our scientists developed a number of distinct families of preclinical stage compounds that exhibited a favorable safety and activity profile in inflammatory disease models.

        We believe that the broad clinical and commercial potential of our drug candidates, together with our operational capabilities and additional competitive advantages, provide us with multiple, sustainable growth opportunities. Our capabilities and advantages include: our intellectual property portfolio, consisting of over 700 issued and pending patents; the full ownership of all commercial rights in all geographic regions to our programs; our ability to integrate discovery, translational, and clinical research to optimize our development programs and further strengthen our intellectual property position; our operational experience in effectively managing large-scale, global clinical programs; our strong network of relationships with leading investigators and medical centers; our proprietary chemical compound library and the strength of our drug discovery platform; and the skills, talent, and level of industry experience of our employees.

Company Strategy

        Our strategy is to discover, develop, and commercialize novel small molecule drug candidates for treating severe medical conditions, including cancer and chronic inflammatory diseases, using our unique collection of assets, technologies, and capabilities in drug discovery and development. Important elements of our long-term strategy include: