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Delaware
(State or other jurisdiction of
incorporation or organization)
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27-0072226
(I.R.S. Employer
Identification No.)
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128 Sidney Street
Cambridge, Massachusetts
(Address of principal executive offices)
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02139
(Zip Code)
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Title of Class:
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Name of Each Exchange on Which Registered
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Common Stock, $0.001 par value
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NASDAQ Global Market
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Large accelerated filer
ý
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Accelerated filer
o
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Non-accelerated filer
o
(Do not check if a
smaller reporting company)
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Smaller reporting company
o
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Page
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our ongoing and planned preclinical studies and clinical trials;
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clinical trial data and the timing of results of our ongoing clinical trials;
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our plans to develop and commercialize dalantercept and ACE-083, and our and Celgene's plans to develop and commercialize luspatercept and sotatercept;
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the potential benefits of strategic partnership agreements and our ability to enter into selective strategic partnership arrangements;
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the timing of, and our and Celgene's ability to, obtain and maintain regulatory approvals for our therapeutic candidates;
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the rate and degree of market acceptance and clinical utility of any approved therapeutic candidate, particularly in specific patient populations;
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our ability to quickly and efficiently identify and develop therapeutic candidates;
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our commercialization, marketing and manufacturing capabilities and strategy;
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our intellectual property position; and
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our estimates regarding our results of operations, financial condition, liquidity, capital requirements, prospects, growth and strategies.
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Sotatercept and Luspatercept in Rare Blood Disorders - Celgene collaboration
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Complete Phase 2 clinical trials of luspatercept and sotatercept in MDS and ß-thalassemia
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Finalize Phase 3 clinical development plans with health authorities for MDS and ß-thalassemia
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Initiate a Phase 3 clinical trial in MDS
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Initiate a Phase 3 clinical trial in ß-thalassemia
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Sotatercept in End-Stage Renal Disease - Celgene collaboration
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Initiate randomized, controlled part of Phase 2b clinical trial of sotatercept in end-stage renal disease patients
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Dalantercept in Advanced Cancers
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Announce top line data from the ascending dose part of the Phase 2 trial of dalantercept with axitinib in renal cell carcinoma
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Demonstrate an acceptable safety profile for the combination of dalantercept and sorafenib in hepatocellular carcinoma
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ACE-083 in Muscle Disorders
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Initiate a Phase 2 trial with novel muscle agent ACE-083
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Pipeline Expansion
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Conduct IND-enabling work to advance at least one new therapeutic candidate to the clinic in 2016
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Advance and expand our clinical programs to achieve regulatory approvals in five different indications.
Luspatercept is expected to enter Phase 3 development in 2015, in collaboration with Celgene, and our ongoing clinical development programs with sotatercept, luspatercept, dalantercept and ACE-083 are expected to give rise to additional approvals by 2020.
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Leverage our discovery platform to generate at least four additional novel therapeutic candidates and advance these molecules into clinical development.
We intend to continue to discover and develop new therapeutic candidates that target and regulate various pathways in the TGF-ß superfamily. We plan to bring an additional therapeutic candidate into the clinic in 2016, with further candidates to follow. We expect to focus in the areas of muscle and metabolic disorders, cancer, diseases of the eye and diseases involving fibrosis.
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Build a sales and marketing organization in the United States.
We have retained co-promotion rights in North America for luspatercept and sotatercept, which will be entirely funded by Celgene. We intend to build specialty sales and marketing capabilities to commercialize our other therapeutic candidates that receive regulatory approval.
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Become cash flow positive.
Utilizing a combination of collaborations, and milestone and royalty payments, we intend to have revenues that meet or exceed our expenses by the year 2020.
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Strategically leverage collaborations to advance our therapeutic candidates.
Our two collaborations with Celgene for sotatercept and luspatercept provide us with significant funding and access to Celgene's considerable scientific, development, regulatory and commercial capabilities. We will continue to strategically evaluate possible collaborations where doing so could enhance the development or commercialization of other therapeutic candidates in our pipeline.
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Non-Small Cell Lung Cancer (NSCLC).
The National Cancer Institute estimates there were 224,210 new cases of lung cancer in the United States in 2014 with 159,260 deaths. In 2014, sales of Avastin® in NSCLC were an estimated $1.2 billion in the United States and $1.8 billion worldwide.
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Colorectal Cancer.
The National Cancer Institute estimates there were 136,830 new cases of colon cancer or rectal cancer in the United States in 2014 with 50,310 deaths. In 2014, sales of Avastin® for colorectal cancer were an estimated $1.3 billion in the United States and $3.9 billion worldwide.
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Renal Cell Carcinoma.
The National Cancer Institute estimates there were 63,920 new cases of kidney and renal pelvis cancer in the United States in 2014 with 13,860 deaths. In 2014, U.S. sales of drugs for renal cell carcinoma were $1.6 billion, of which $1.1 billion were anti-angiogenesis drugs that target the VEGF pathway, principally Sutent®, Inlyta®, Votrient® and Avastin®. Worldwide sales in 2014 of drugs for renal cell carcinoma were $3.8 billion, of which $2.8 billion were drugs that target the VEGF pathway.
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Liver Cancer.
The National Cancer Institute estimates there were 33,190 new cases of liver cancer in the United States in 2014 with 23,000 deaths. The only drug approved in the United States for the treatment of liver cancer is the VEGF pathway inhibitor Nexavar®. In 2014, sales of Nexavar® for liver cancer were an estimated $215 million in the United States and $771 million worldwide.
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Other Tumors.
One or more anti-angiogenesis agents are also approved as treatments for ovarian cancer, neuroendocrine tumors, soft tissue sarcoma, gastric cancer, thyroid cancer and glioblastoma.
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Dalantercept/Sunitinib Combination
Exceeds Activity of Either Alone
(Mouse Model of Renal Cell Carcinoma (A498))
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Dalantercept/Sunitinib Combination
Slows Tumor Growth in a Sunitinib Resistant Model
(Mouse Model of Renal Cell Carcinoma (786O))
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increase in systemic muscle mass;
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inhibition of liver fibrosis in mouse models of this condition;
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improvement of cardiovascular function in a mouse model of a fibrotic disorder of the lungs; and
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improvement in diseases of the eye such as in a mouse laser-induced neovascularization model of age-related macular degeneration (AMD).
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Red blood cell transfusions and iron chelation therapy, such as Novartis's oral iron chelating agent, Exjade®. We are also aware that Shire is studying a new oral iron chelator, SHP602, in clinical trials, and is currently on clinical hold. Sideris Pharmaceuticals is developing an oral iron chelator, SP-420, that is currently in Phase 1 clinical trials. Novartis has been granted an exclusive right to acquire Sideris and its lead asset, SP-420.
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Fetal hemoglobin stimulating agents, such as hydroxyurea, which are primarily used to treat patients with anemia from sickle cell disease, are sometimes used to treat patients with ß-thalassemia. In addition, HQK-1001, a fetal hemoglobin stimulating agent being developed by HemaQuest Pharmaceuticals, Inc., has completed a Phase 1/2 clinical trial and an investigator sponsored Phase 2 clinical trial in patients with ß-thalassemia.
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Hematopoietic stem cell transplant treatment is given to a small percentage of patients with ß-thalassemia, since it requires a sufficiently well-matched source of donor cells. Certain academic centers around the world are seeking to develop improvements to this approach.
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Other therapies in development, including gene therapy and genome editing are being developed by several different groups, including bluebird bio, Inc., Memorial Sloan Kettering Cancer Center, GlaxoSmithKline plc, and Sangamo BioSciences Inc. in collaboration with Biogen Idec.
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Recombinant erythropoietin and other erythropoiesis stimulating agents. Although these agents are not approved to treat anemia in MDS, current practice guidelines include the use of erythropoiesis stimulating agents and granulocyte colony stimulating factor agents (G-CSF) to treat patients with MDS. Additionally, Amgen is currently studying erythropoiesis stimulating agent, Aranesp® and Janssen Pharmaceuticals is studying erythropoiesis stimulating agent Eprex® in Phase 3 clinical trials in Europe for treatment of anemia in patients with lower risk MDS.
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Red blood cell transfusion and iron chelation therapy, including Exjade®, which is used to treat anemia in patients with MDS.
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Immunomodulators, including Celgene's approved product, Revlimid® (lenalidomide), for the treatment of anemia of certain MDS patients.
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Eli Lilly and Company is studying TGF-ß receptor I kinase inhibitor, LY2157299 in a phase 2 study in lower risk MDS patients with anemia.
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Other therapies in development, including: an oral form of the hypomethylating agent azacitidine, known as CC-486, being developed by Celgene to treat patients with transfusion dependent anemia and thrombocytopenia due to lower risk MDS, which is currently in Phase 3 clinical trials in the United States and Europe; an anti-cancer therapy being developed by Onconova to treat patients with MDS; and a CD95 ligand inhibitor, APG101, being studied by Apogenix in a phase 1 study in transfusion dependent, lower risk MDS patients.
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Tracon is developing TRC105, an antibody to endoglin, which is a protein in the TGF-ß superfamily that is overexpressed on endothelial cells and plays a role in angiogenesis. TRC105 is currently being studied in Phase 1 and Phase 2 clinical trials for the treatment of multiple solid tumor types, including soft tissue sarcoma, renal cell carcinoma, glioblastoma, hepatocellular carcinoma and colorectal cancer, in combination with approved VEGF inhibitors.
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Pfizer's fully human monoclonal antibody against the ALK1 receptor is currently being studied in a Phase 1 investigator-sponsored trial in patients with colorectal cancer, in combination with Stivarga® (regorafenib).
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Other non-VEGF angiogenesis inhibitors in development, which also have the potential to be combined with VEGF pathway inhibitors or used independently of VEGF pathway inhibitors to inhibit angiogenesis. Amgen, Regeneron, MedImmune, and OncoMed Pharmaceuticals are each developing non-VEGF angiogenesis inhibitors.
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completion of preclinical laboratory tests, animal studies and formulation studies conducted according to Good Laboratory Practices, or GLPs, and other applicable regulations;
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submission to the FDA of an Investigational New Drug application or IND, which must become effective before human clinical trials may commence;
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completion of adequate and well-controlled human clinical trials in accordance with Good Clinical Practices, or GCPs, to establish that the biological product is "safe, pure and potent", which is analogous to the safety and efficacy approval standard for a chemical drug product for its intended use;
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submission to the FDA of a BLA;
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satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with applicable current Good Manufacturing Practice requirements, or cGMPs; and
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FDA review of the BLA and issuance of a biologics license which is the approval necessary to market a therapeutic candidate.
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the scope, progress, results and costs of researching and developing our other therapeutic candidates, and conducting preclinical studies and clinical trials;
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the timing of, and the costs involved in, obtaining regulatory approvals for our other therapeutic candidates if clinical trials are successful;
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the cost of commercialization activities for our other therapeutic candidates, if any of these therapeutic candidates is approved for sale, including marketing, sales and distribution costs;
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the cost of manufacturing our other therapeutic candidates for clinical trials in preparation for regulatory approval and in preparation for commercialization;
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our ability to establish and maintain strategic partnerships, licensing or other arrangements and the financial terms of such agreements;
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the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; and
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the timing, receipt, and amount of sales of, or royalties on, our future products, if any.
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delays by us or our partners in reaching a consensus with regulatory agencies on trial design;
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delays in reaching agreement on acceptable terms with prospective clinical research organizations, or CROs, and clinical trial sites;
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delays in obtaining required Institutional Review Board, or IRB, approval at each clinical trial site;
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delays in recruiting suitable patients to participate in clinical trials;
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imposition of a clinical hold by regulatory agencies for any reason, including safety or manufacturing concerns or after an inspection of clinical operations or trial sites;
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failure by CROs, other third parties or us or our partners to adhere to clinical trial requirements;
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failure to perform in accordance with the FDA's good clinical practices, or GCP, or applicable regulatory guidelines in other countries;
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delays in the testing, validation, manufacturing and delivery of the therapeutic candidates to the clinical sites;
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delays caused by patients not completing participation in a trial or not returning for post-treatment follow-up;
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clinical trial sites or patients dropping out of a trial;
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occurrence of serious adverse events in clinical trials that are associated with the therapeutic candidates that are viewed to outweigh its potential benefits; or
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changes in regulatory requirements and guidance that require amending or submitting new clinical protocols.
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restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, or voluntary or mandatory product recalls;
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fines, warning letters, or holds on clinical trials;
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refusal by the FDA to approve pending applications or supplements to approved applications filed by us or our partners, or suspension or revocation of product license approvals;
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product seizure or detention, or refusal to permit the import or export of products; and
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injunctions or the imposition of civil or criminal penalties.
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Celgene has wide discretion in determining the efforts and resources that it will apply to its partnership with us. The timing and amount of any development milestones, and downstream commercial milestones and royalties that we may receive under such partnership will depend on, among other things, the efforts, allocation of resources and successful development and commercialization of these therapeutic candidates by Celgene.
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Celgene may develop and commercialize, either alone or with others, products that are similar to or competitive with the therapeutic candidates that are the subject of its partnerships with us. For example, Celgene is currently commercializing and/or developing certain of its existing products, lenalidomide and azacitidine, for certain MDS patients for which sotatercept and luspatercept are also being developed.
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Celgene may terminate its partnership with us without cause and for circumstances outside of our control, which could make it difficult for us to attract new strategic partners or adversely affect how we are perceived in scientific and financial communities.
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Celgene may develop or commercialize our therapeutic candidates in such a way as to elicit litigation that could jeopardize or invalidate our intellectual property rights or expose us to potential liability.
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Celgene may not comply with all applicable regulatory requirements, or may fail to report safety data in accordance with all applicable regulatory requirements.
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If Celgene were to breach its arrangements with us, we may need to enforce our right to terminate the agreement in legal proceedings, which could be costly and cause delay in our ability to receive rights back to the relevant therapeutic candidates. If we were to terminate an agreement with Celgene due to Celgene's breach or Celgene terminated the agreement without cause, the development and commercialization of sotatercept and luspatercept could be delayed, curtailed or terminated because we may not have sufficient financial resources or capabilities to continue development and commercialization of these candidates on our own if we choose not to, or are unable to, enter into a new collaboration for these candidates.
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Celgene may enter into one or more transactions with third parties, including a merger, consolidation, reorganization, sale of substantial assets, sale of substantial stock or other change in control, which could divert the attention of its management and adversely affect Celgene's ability to retain and motivate key personnel who are important to the continued development of the programs under the strategic partnership with us. In addition, the third-party to any such transaction could determine to reprioritize Celgene's development programs such that Celgene ceases to diligently pursue the development of our programs and/or cause the respective partnership with us to terminate.
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the efficacy and safety of the product, as demonstrated in clinical trials;
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the clinical indications for which the product is approved and the label approved by regulatory authorities for use with the product, including any warnings that may be required on the label;
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acceptance by physicians and patients of the product as a safe and effective treatment;
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decisions by healthcare organizations to utilize the product;
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the cost, safety and efficacy of treatment in relation to alternative treatments;
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the availability of adequate reimbursement and pricing by third party payers and government authorities;
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the continued projected growth of drug markets in our various indications;
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relative convenience and ease of administration;
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the prevalence and severity of adverse side effects; and
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the effectiveness of our, and our partners' sales and marketing efforts.
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a covered benefit under its health plan;
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safe, effective and medically necessary;
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appropriate for the specific patient;
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cost-effective; and
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neither experimental nor investigational.
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the demand for any drug products for which we may obtain regulatory approval;
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our ability to set a price that we believe is fair for our products;
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our ability to obtain coverage and reimbursement approval for a product;
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our ability to generate revenues and achieve or maintain profitability; and
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the level of taxes that we are required to pay.
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regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
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we may have delays in reaching or fail to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;
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clinical trials of our therapeutic candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;
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the number of patients required for clinical trials of our therapeutic candidates may be larger than we anticipate; enrollment in these clinical trials may be slower than we anticipate; or participants may drop out of these clinical trials at a higher rate than we anticipate;
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third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;
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we might have to suspend or terminate clinical trials of our therapeutic candidates for various reasons, including a finding that the participants are being exposed to unacceptable health risks;
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regulators, institutional review boards, or the data safety monitoring board for such trials may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;
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the cost of clinical trials of our therapeutic candidates may be greater than we anticipate;
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the supply or quality of our therapeutic candidates or other materials necessary to conduct clinical trials of our therapeutic candidates may be insufficient or inadequate; and
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our therapeutic candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators or institutional review boards to suspend or terminate the trials.
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be delayed in obtaining or be unable to obtain marketing approval for our therapeutic candidates;
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obtain approval for indications or patient populations that are not as broad as intended or desired;
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be required to provide a medication guide outlining the risks of such side effects for distribution to patients;
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obtain approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings;
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suffer reputational harm;
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be sued and held liable for harm caused to patients;
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be subject to additional post-marketing testing requirements; or
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have the product removed from the market after obtaining marketing approval.
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injury to our reputation;
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withdrawal of clinical trial participants;
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costs to defend the related litigations;
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a diversion of management's time and our resources;
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substantial monetary awards to trial participants or patients;
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product recalls, withdrawals, or labeling, marketing or promotional restrictions;
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loss of revenue;
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the inability to commercialize our therapeutic candidates; and
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a decline in our stock price.
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results of clinical trials of our therapeutic candidates, including sotatercept, luspatercept, dalantercept and ACE-083;
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the timing of the release of results of our clinical trials that are being conducted by Celgene;
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results of clinical trials of our competitors' products;
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regulatory actions with respect to our products or our competitors' products;
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actual or anticipated fluctuations in our financial condition and operating results;
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publication of research reports by securities analysts about us or our competitors or our industry;
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our failure or the failure of our competitors to meet analysts' projections or guidance that we or our competitors may give to the market;
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additions and departures of key personnel;
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strategic decisions by us or our competitors, such as acquisitions, divestitures, spin-offs, joint ventures, strategic investments or changes in business strategy;
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the passage of legislation or other regulatory developments affecting us or our industry;
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fluctuations in the valuation of companies perceived by investors to be comparable to us;
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sales of our common stock by us, our insiders or our other stockholders;
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speculation in the press or investment community;
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announcement or expectation of additional financing efforts;
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changes in accounting principles;
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terrorist acts, acts of war or periods of widespread civil unrest;
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natural disasters and other calamities;
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changes in market conditions for biopharmaceutical stocks; and
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changes in general market and economic conditions.
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authorize "blank check" preferred stock, which could be issued by our board of directors without stockholder approval and may contain voting, liquidation, dividend and other rights superior to our common stock;
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create a classified board of directors whose members serve staggered three-year terms;
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specify that special meetings of our stockholders can be called only by our board of directors;
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prohibit stockholder action by written consent;
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establish an advance notice procedure for stockholder approvals to be brought before an annual meeting of our stockholders, including proposed nominations of persons for election to our board of directors;
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provide that our directors may be removed only for cause;
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provide that vacancies on our board of directors may be filled only by a majority of directors then in office, even though less than a quorum;
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specify that no stockholder is permitted to cumulate votes at any election of directors;
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expressly authorize our board of directors to modify, alter or repeal our amended and restated by-laws; and
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require supermajority votes of the holders of our common stock to amend specified provisions of our restated certificate of incorporation and amended and restated by-laws
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Common Stock Price
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||||||||||||||
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2014
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2013
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||||||||||||
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High
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Low
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High
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Low
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||||||||
First Quarter
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$
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57.89
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$
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33.81
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—
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—
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Second Quarter
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$
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42.24
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$
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28.53
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—
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—
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Third Quarter(1)
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$
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35.00
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$
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23.61
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$
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23.41
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$
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18.50
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Fourth Quarter
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$
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48.50
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$
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27.64
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$
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40.02
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$
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16.78
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(1)
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For 2013, represents the period from September 19, 2013, the date on which our common stock first began to trade on The NASDAQ Global Market after the pricing of our initial public offering, through September 30, 2013, the end of our third fiscal quarter.
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(1)
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This performance graph shall not be deemed "soliciting material" or to be "filed" with the SEC for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities under that Section, and shall not be deemed incorporated by reference into any filing of Acceleron Pharma, Inc. under the Securities Act of 1933, as amended.
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(2)
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$100 invested on September 19, 2013 in stock, or on August 31, 2013 in each index, including reinvestment of dividends.
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•
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In October 2014, we issued
124,135
shares of common stock upon the cashless exercise of warrants to purchase
155,171
shares of common stock.
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•
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In December 2014, we issued
10,284
shares of common stock upon the cashless exercise of warrants to purchase
13,736
shares of common stock, and
13,585
shares of common stock upon the cashless exercise of warrants to purchase
19,108
shares of common stock.
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Year Ended December 31,
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||||||||||||||
(in thousands, except per share data)
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2014
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2013
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2012
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2011
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Consolidated Statements of Operations Data:
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||||||||
Revenue:
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|
|
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|||||
Collaboration revenue:
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|
|
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|
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|||||
License and milestone
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$
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1,673
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$
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43,948
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$
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9,696
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|
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$
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74,406
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Cost-sharing, net
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12,959
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13,282
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5,558
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|
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4,760
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||||
Contract manufacturing
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—
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|
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—
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|
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—
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|
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1,745
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|
||||
Total revenue
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14,632
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|
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57,230
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|
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15,254
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|
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80,911
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||||
Costs and expenses:
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|
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|
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|
|
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||||
Research and development
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50,897
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36,051
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|
|
35,319
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|
|
32,713
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|
||||
Litigation Settlement
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5,000
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|
|
—
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|
|
—
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|
|
—
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|
||||
General and administrative
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14,199
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|
|
14,227
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|
|
8,824
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|
|
8,142
|
|
||||
Cost of contract manufacturing revenue
|
—
|
|
|
—
|
|
|
—
|
|
|
1,500
|
|
||||
Total costs and expenses
|
70,096
|
|
|
50,278
|
|
|
44,143
|
|
|
42,355
|
|
||||
(Loss) income from operations
|
(55,464
|
)
|
|
6,952
|
|
|
(28,889
|
)
|
|
38,556
|
|
||||
Total other expense, net
|
4,205
|
|
|
(28,850
|
)
|
|
(3,693
|
)
|
|
(2,290
|
)
|
||||
Net (loss) income
|
$
|
(51,259
|
)
|
|
$
|
(21,898
|
)
|
|
$
|
(32,582
|
)
|
|
$
|
36,266
|
|
Net (loss) income per share applicable to common stockholders(1)
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic
|
$
|
(1.63
|
)
|
|
$
|
(4.15
|
)
|
|
$
|
(24.84
|
)
|
|
$
|
0.80
|
|
Diluted
|
$
|
(1.63
|
)
|
|
$
|
(4.15
|
)
|
|
$
|
(24.84
|
)
|
|
$
|
0.78
|
|
Weighted-average number of common shares used in computing net (loss) income per share applicable to common stockholders
|
|
|
|
|
|
|
|
|
|
|
|||||
Basic
|
31,515
|
|
|
9,407
|
|
|
2,401
|
|
|
2,328
|
|
||||
Diluted
|
31,515
|
|
|
9,407
|
|
|
2,401
|
|
|
2,716
|
|
|
As of December 31,
|
||||||||||||||
(in thousands)
|
2014
|
|
2013
|
|
2012
|
|
2011
|
||||||||
Consolidated Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|||||
Cash and cash equivalents
|
$
|
176,460
|
|
|
$
|
113,163
|
|
|
$
|
39,611
|
|
|
$
|
65,037
|
|
Total assets
|
186,296
|
|
|
123,732
|
|
|
49,212
|
|
|
73,789
|
|
||||
Total current liabilities
|
9,253
|
|
|
18,162
|
|
|
38,802
|
|
|
23,853
|
|
||||
Long-term deferred revenue
|
4,816
|
|
|
5,620
|
|
|
6,760
|
|
|
33,350
|
|
||||
Long-term deferred rent
|
1,818
|
|
|
2,337
|
|
|
2,837
|
|
|
3,335
|
|
||||
Long-term notes payable
|
—
|
|
|
9,048
|
|
|
16,525
|
|
|
—
|
|
||||
Warrants to purchase redeemable convertible preferred stock
|
—
|
|
|
—
|
|
|
1,422
|
|
|
1,046
|
|
||||
Warrants to purchase common stock
|
14,124
|
|
|
30,753
|
|
|
5,229
|
|
|
3,347
|
|
||||
Redeemable convertible preferred stock
|
—
|
|
|
—
|
|
|
268,610
|
|
|
241,549
|
|
||||
Total stockholder's equity (deficit)
|
156,285
|
|
|
57,812
|
|
|
(290,973
|
)
|
|
(232,691
|
)
|
(1)
|
See Note 2 within the notes to our consolidated financial statements appearing elsewhere in this Annual Report on Form 10-K for a description of the method used to calculate basic and diluted net (loss) income per common share.
|
•
|
conduct clinical trials for dalantercept and ACE-083;
|
•
|
continue our preclinical studies and potential clinical development efforts of our existing preclinical therapeutic candidates;
|
•
|
continue research activities for the discovery of new therapeutic candidates;
|
•
|
manufacture therapeutic candidates for our preclinical studies and clinical trials;
|
•
|
seek regulatory approval for our therapeutic candidates; and
|
•
|
operate as a public company.
|
•
|
direct employee-related expenses, including salaries, benefits, travel and stock-based compensation expense of our research and development personnel;
|
•
|
expenses incurred under agreements with clinical research organizations, or CROs, and investigative sites that will conduct our clinical trials;
|
•
|
the cost of acquiring and manufacturing preclinical and clinical study materials and developing manufacturing processes;
|
•
|
allocated facilities, depreciation, and other expenses, which include rent and maintenance of facilities, insurance and other supplies;
|
•
|
expenses associated with obtaining and maintaining patents; and
|
•
|
costs associated with preclinical activities and regulatory compliance.
|
•
|
the scope, rate of progress, and expense of our ongoing, as well as any additional, clinical trials and other research and development activities;
|
•
|
future clinical trial results;
|
•
|
potential changes in government regulation; and
|
•
|
the timing and receipt of any regulatory approvals.
|
|
Year ended December 31,
|
||||||||||
(in thousands)
|
2014
|
|
2013
|
|
2012
|
||||||
Sotatercept(1)
|
$
|
—
|
|
|
$
|
2
|
|
|
$
|
6
|
|
Luspatercept(1)
|
7,944
|
|
|
5,081
|
|
|
2,885
|
|
|||
Dalantercept
|
7,526
|
|
|
4,636
|
|
|
3,422
|
|
|||
ACE-083
|
5,111
|
|
|
105
|
|
|
—
|
|
|||
ACE-031(2)
|
8
|
|
|
1,023
|
|
|
3,453
|
|
|||
Total direct research and development expenses
|
20,589
|
|
|
10,847
|
|
|
9,766
|
|
|||
Other expenses(3)
|
30,308
|
|
|
25,204
|
|
|
25,553
|
|
|||
Total research and development expenses
|
$
|
50,897
|
|
|
$
|
36,051
|
|
|
$
|
35,319
|
|
(1)
|
As of January 1, 2013, expenses associated with sotatercept and luspatercept are reimbursed 100% by Celgene. These reimbursements are recorded as revenue and are presented as cost-sharing, net. In the periods presented, Celgene conducted most of the development activities for sotatercept, and we do not incur and are not reimbursed for expenses related to development activities directly conducted by Celgene.
|
(2)
|
In April 2013, we and Shire AG, or Shire, determined not to further advance the development of ACE-031, and Shire terminated our collaboration agreement, effective as of June 30, 2013.
|
(3)
|
Other expenses include unallocated employee and contractor-related expenses, facility expenses, lab supplies and miscellaneous expenses.
|
|
Year Ended
December 31,
|
|
|
||||||||
|
Increase
(Decrease)
|
||||||||||
(in thousands)
|
2014
|
|
2013
|
|
|||||||
Revenue:
|
|
|
|
|
|
|
|
|
|||
Collaboration revenue:
|
|
|
|
|
|
|
|
|
|||
License and milestone
|
$
|
1,673
|
|
|
$
|
43,948
|
|
|
$
|
(42,275
|
)
|
Cost-sharing, net
|
12,959
|
|
|
13,282
|
|
|
(323
|
)
|
|||
Total revenue
|
14,632
|
|
|
57,230
|
|
|
(42,598
|
)
|
|||
Costs and expenses:
|
|
|
|
|
|
|
|||||
Research and development
|
50,897
|
|
|
36,051
|
|
|
14,846
|
|
|||
Litigation settlement
|
5,000
|
|
|
—
|
|
|
5,000
|
|
|||
General and administrative
|
14,199
|
|
|
14,227
|
|
|
(28
|
)
|
|||
Total costs and expenses
|
70,096
|
|
|
50,278
|
|
|
19,818
|
|
|||
(Loss) income from operations
|
(55,464
|
)
|
|
6,952
|
|
|
(62,416
|
)
|
|||
Other income (expense), net
|
4,205
|
|
|
(28,850
|
)
|
|
33,055
|
|
|||
Net loss
|
$
|
(51,259
|
)
|
|
$
|
(21,898
|
)
|
|
$
|
(29,361
|
)
|
|
Year Ended
December 31, |
|
|
||||||||
|
Increase
(Decrease) |
||||||||||
(in thousands)
|
2014
|
|
2013
|
|
|||||||
Collaboration revenue:
|
|
|
|
|
|
|
|
|
|||
Celgene:
|
|
|
|
|
|
|
|
|
|||
License and milestone
|
$
|
1,673
|
|
|
$
|
19,626
|
|
|
$
|
(17,953
|
)
|
Cost-sharing, net
|
12,959
|
|
|
12,658
|
|
|
301
|
|
|||
Total Celgene
|
14,632
|
|
|
32,284
|
|
|
(17,652
|
)
|
|||
Shire:
|
|
|
|
|
|
|
|
||||
License and milestone
|
—
|
|
|
24,322
|
|
|
(24,322
|
)
|
|||
Cost-sharing, net
|
—
|
|
|
624
|
|
|
(624
|
)
|
|||
Total Shire
|
—
|
|
|
24,946
|
|
|
(24,946
|
)
|
|||
Total collaboration revenue
|
14,632
|
|
|
57,230
|
|
|
(42,598
|
)
|
|||
Total revenue
|
$
|
14,632
|
|
|
$
|
57,230
|
|
|
$
|
(42,598
|
)
|
|
Year Ended
December 31,
|
|
|
||||||||
|
Increase
(Decrease)
|
||||||||||
(in thousands)
|
2013
|
|
2012
|
|
|||||||
Revenue:
|
|
|
|
|
|
|
|
|
|||
Collaboration revenue:
|
|
|
|
|
|
|
|
|
|||
License and milestone
|
$
|
43,948
|
|
|
$
|
9,696
|
|
|
$
|
34,252
|
|
Cost-sharing, net
|
13,282
|
|
|
5,558
|
|
|
7,724
|
|
|||
Total revenue
|
57,230
|
|
|
15,254
|
|
|
41,976
|
|
|||
Costs and expenses:
|
|
|
|
|
|
|
|
|
|||
Research and development
|
36,051
|
|
|
35,319
|
|
|
732
|
|
|||
General and administrative
|
14,227
|
|
|
8,824
|
|
|
5,403
|
|
|||
Total costs and expenses
|
50,278
|
|
|
44,143
|
|
|
6,135
|
|
|||
Income (loss) from operations
|
6,952
|
|
|
(28,889
|
)
|
|
35,841
|
|
|||
Other expense, net
|
(28,850
|
)
|
|
(3,693
|
)
|
|
(25,157
|
)
|
|||
Net loss
|
$
|
(21,898
|
)
|
|
$
|
(32,582
|
)
|
|
$
|
10,684
|
|
|
Year Ended
December 31,
|
|
|
||||||||
|
Increase
(Decrease)
|
||||||||||
(in thousands)
|
2013
|
|
2012
|
|
|||||||
Collaboration revenue:
|
|
|
|
|
|
|
|
|
|||
Celgene:
|
|
|
|
|
|
|
|
|
|||
License and milestone
|
$
|
19,626
|
|
|
$
|
2,035
|
|
|
$
|
17,591
|
|
Cost-sharing, net
|
12,658
|
|
|
2,879
|
|
|
9,779
|
|
|||
Total Celgene
|
32,284
|
|
|
4,914
|
|
|
27,370
|
|
|||
Shire:
|
|
|
|
|
|
|
|
|
|||
License and milestone
|
24,322
|
|
|
7,661
|
|
|
16,661
|
|
|||
Cost-sharing, net
|
624
|
|
|
2,679
|
|
|
(2,055
|
)
|
|||
Total Shire
|
24,946
|
|
|
10,340
|
|
|
14,606
|
|
|||
Total collaboration revenue
|
57,230
|
|
|
15,254
|
|
|
41,976
|
|
|||
Total revenue
|
$
|
57,230
|
|
|
$
|
15,254
|
|
|
$
|
41,976
|
|
|
Year Ended December 31,
|
||||||||||
(in thousands)
|
2014
|
|
2013
|
|
2012
|
||||||
Net cash provided by (used in):
|
|
|
|
|
|
|
|
|
|||
Operating activities
|
$
|
(53,220
|
)
|
|
$
|
(19,650
|
)
|
|
$
|
(38,884
|
)
|
Investing activities
|
(514
|
)
|
|
(307
|
)
|
|
(441
|
)
|
|||
Financing activities
|
117,031
|
|
|
93,509
|
|
|
13,899
|
|
|||
Net increase (decrease) in cash and cash equivalents
|
$
|
63,297
|
|
|
$
|
73,552
|
|
|
$
|
(25,426
|
)
|
•
|
the achievement of milestones under our agreement with Celgene;
|
•
|
the terms and timing of any other collaborative, licensing and other arrangements that we may establish;
|
•
|
the initiation, progress, timing and completion of preclinical studies and clinical trials for our therapeutic candidates and potential therapeutic candidates;
|
•
|
the number and characteristics of therapeutic candidates that we pursue;
|
•
|
the progress, costs and results of our clinical trials;
|
•
|
the outcome, timing and cost of regulatory approvals;
|
•
|
delays that may be caused by changing regulatory requirements;
|
•
|
the cost and timing of hiring new employees to support our continued growth;
|
•
|
the costs involved in filing and prosecuting patent applications and enforcing and defending patent claims;
|
•
|
the costs and timing of procuring clinical and commercial supplies of our therapeutic candidates;
|
•
|
the extent to which we acquire or invest in businesses, products or technologies; and
|
•
|
the costs involved in defending and prosecuting litigation regarding in-licensed intellectual property.
|
(in thousands)
|
Total
|
|
1 year
|
|
2 - 3 years
|
|
4 - 5 years
|
||||||||
Operating lease obligations(1)
|
$
|
14,936
|
|
|
$
|
4,106
|
|
|
$
|
7,876
|
|
|
$
|
2,954
|
|
Less: sublease income(2)
|
(241
|
)
|
|
(241
|
)
|
|
—
|
|
|
—
|
|
||||
Total
|
$
|
14,695
|
|
|
$
|
3,865
|
|
|
$
|
7,876
|
|
|
$
|
2,954
|
|
(1)
|
We lease office and lab space at 128 Sidney Street and 149 Sidney Street in Cambridge, Massachusetts under noncancelable operating leases that expire in September 2018, and at 12 Emily Street in Cambridge, Massachusetts under a noncancelable operating lease that expires in May 2015. Our leasehold improvements are being amortized over 3-10 years which represent the shorter of their useful life or remaining lease term.
|
(2)
|
In February 2011, we entered into a sublease for 14,214 square feet of office space at 12 Emily Street in Cambridge, Massachusetts, that expires in May 2015. On December 31, 2013 the sublease was expanded to the remaining space in that facility. The expansion portion sublease expired in December 2014.
|
•
|
Under our license agreement with the Beth Israel Deaconess Medical Center, or BIDMC, in respect of BIDMC's joint interest in patent rights related to the treatment of renal cell cancer by combination therapy with dalantercept and VEGF-receptor tyrosine kinase inhibitors, we agreed to pay BIDMC specified development and sales milestone payments aggregating up to $1.0 million. In addition, we are required to pay BIDMC royalties in the low single digits on worldwide net product sales of drug labeled for treatment regimens that are claimed in the licensed patents.
|
•
|
Under our license agreement with the Ludwig Institute for Cancer Research, or LICR, in respect of patent rights relating to the first cloning of the type I activin receptors, as well as the treatment of pancreatic tumors with dalantercept, we agreed to pay LICR specified development and sales milestone payments aggregating up to $1.6 million relating to the development and commercialization of dalantercept. In addition, we are required to pay LICR royalties in the low single-digits on worldwide net product sales of dalantercept, with royalty obligations continuing at a 50% reduced rate for a period of time after patent expiration. If we sublicense the LICR patent rights, we will owe LICR a percentage of sublicensing revenue, excluding payments based on the level of sales, profits or other levels of commercialization.
|
•
|
Under our two license agreements with the Salk Institute for Biological Studies, or Salk, relating to the first cloning of the type II activin receptors, if we sublicense the Salk patent rights, we will owe Salk a percentage of sublicensing revenue, excluding payments based on sales. Under one agreement, we agreed to pay Salk specified development milestone payments totaling up to $2.0 million for sotatercept. Under the other agreement, we agreed to pay Salk specified development milestone payments of up to $0.7 million for luspatercept. In addition, under both agreements, we are required to pay Salk royalties in the low single-digits on worldwide net product sales by us or our sublicensees under the licensed patent rights of products claimed in the licensed patents, or products derived from use of the licensed patent rights, with royalty obligations for sotatercept continuing at a reduced rate for a period of time after patent expiration.
|
•
|
In May 2014, we executed a collaboration agreement with a research technology company. We paid an upfront and research fee of
$0.3 million
upon execution of the agreement and we are obligated to pay additional research fees of approximately $0.6 million within the next year, depending on the success of the research program. We also received
|
|
|
/s/ Ernst & Young LLP
|
(a)
|
The following documents are filed as part of this report:
|
(2)
|
Financial Statement Schedules
|
(3)
|
Exhibits
|
(b)
|
The list of Exhibits filed as a part of this Annual Report on Form 10-K is set forth on the Exhibit Index immediately preceding such Exhibits and is incorporated herein by this reference.
|
(c)
|
None.
|
|
|
/s/ Ernst & Young LLP
|
|
December 31,
|
||||||
|
2014
|
|
2013
|
||||
Assets
|
|
|
|
|
|||
Current assets:
|
|
|
|
|
|||
Cash and cash equivalents
|
$
|
176,460
|
|
|
$
|
113,163
|
|
Collaboration receivables (all amounts are with a related party)
|
3,367
|
|
|
3,616
|
|
||
Prepaid expenses and other current assets
|
2,480
|
|
|
2,243
|
|
||
Total current assets
|
182,307
|
|
|
119,022
|
|
||
Property and equipment, net
|
3,087
|
|
|
3,705
|
|
||
Restricted cash
|
902
|
|
|
913
|
|
||
Other assets
|
—
|
|
|
92
|
|
||
Total assets
|
$
|
186,296
|
|
|
$
|
123,732
|
|
Liabilities and stockholders' equity
|
|
|
|
|
|||
Current liabilities:
|
|
|
|
|
|||
Accounts payable
|
$
|
724
|
|
|
$
|
885
|
|
Accrued expenses
|
6,848
|
|
|
6,927
|
|
||
Deferred revenue
|
1,162
|
|
|
2,031
|
|
||
Deferred rent
|
519
|
|
|
499
|
|
||
Notes payable, net of discount
|
—
|
|
|
16,868
|
|
||
Total current liabilities
|
9,253
|
|
|
27,210
|
|
||
Deferred revenue, net of current portion
|
4,816
|
|
|
5,620
|
|
||
Deferred rent, net of current portion
|
1,818
|
|
|
2,337
|
|
||
Warrants to purchase common stock
|
14,124
|
|
|
30,753
|
|
||
Total liabilities
|
30,011
|
|
|
65,920
|
|
||
Commitments and contingencies (Note 7)
|
—
|
|
|
—
|
|
||
Stockholders' equity:
|
|
|
|
||||
Undesignated preferred stock, $0.001 par value: 25,000,000 shares authorized and no shares issued or outstanding
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value: 175,000,000 shares authorized; 32,432,025 and 28,348,630, shares issued and outstanding at December 31, 2014 and 2013, respectively
|
33
|
|
|
29
|
|
||
Additional paid-in capital
|
399,835
|
|
|
250,107
|
|
||
Accumulated deficit
|
(243,583
|
)
|
|
(192,324
|
)
|
||
Total stockholders' equity
|
156,285
|
|
|
57,812
|
|
||
Total liabilities and stockholders' equity
|
$
|
186,296
|
|
|
$
|
123,732
|
|
|
Year Ended December 31,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Revenue:
|
|
|
|
|
|
|
|
||||
Collaboration revenue:
|
|
|
|
|
|
|
|
||||
License and milestone
|
$
|
1,673
|
|
|
$
|
43,948
|
|
|
$
|
9,696
|
|
Cost-sharing, net
|
12,959
|
|
|
13,282
|
|
|
5,558
|
|
|||
Total revenue(1)
|
14,632
|
|
|
57,230
|
|
|
15,254
|
|
|||
Costs and expenses:
|
|
|
|
|
|
|
|
|
|||
Research and development
|
50,897
|
|
|
36,051
|
|
|
35,319
|
|
|||
Litigation settlement
|
5,000
|
|
|
—
|
|
|
—
|
|
|||
General and administrative
|
14,199
|
|
|
14,227
|
|
|
8,824
|
|
|||
Total costs and expenses
|
70,096
|
|
|
50,278
|
|
|
44,143
|
|
|||
(Loss) income from operations
|
(55,464
|
)
|
|
6,952
|
|
|
(28,889
|
)
|
|||
Other income (expense):
|
|
|
|
|
|
|
|
|
|||
Other income (expense), net
|
5,044
|
|
|
(26,797
|
)
|
|
(2,255
|
)
|
|||
Interest income
|
83
|
|
|
39
|
|
|
91
|
|
|||
Interest expense
|
(922
|
)
|
|
(2,092
|
)
|
|
(1,529
|
)
|
|||
Total other income (expense), net
|
4,205
|
|
|
(28,850
|
)
|
|
(3,693
|
)
|
|||
Net loss
|
$
|
(51,259
|
)
|
|
$
|
(21,898
|
)
|
|
$
|
(32,582
|
)
|
Comprehensive loss
|
$
|
(51,259
|
)
|
|
$
|
(21,898
|
)
|
|
$
|
(32,582
|
)
|
Reconciliation of net loss to net loss applicable to common stockholders:
|
|
|
|
|
|
|
|
|
|||
Net loss
|
$
|
(51,259
|
)
|
|
$
|
(21,898
|
)
|
|
$
|
(32,582
|
)
|
Accretion of dividends, interest, redemption value and issuance costs on redeemable convertible preferred stock
|
—
|
|
|
(19,870
|
)
|
|
(27,061
|
)
|
|||
Gain on extinguishment of redeemable convertible preferred stock
|
—
|
|
|
2,765
|
|
|
—
|
|
|||
Net loss applicable to common stockholders—basic and diluted
|
$
|
(51,259
|
)
|
|
$
|
(39,003
|
)
|
|
$
|
(59,643
|
)
|
|
|
|
|
|
|
|
|
|
|||
Net loss per share applicable to common stockholders-basic and diluted
|
$
|
(1.63
|
)
|
|
$
|
(4.15
|
)
|
|
$
|
(24.84
|
)
|
|
|
|
|
|
|
||||||
Weighted-average number of common shares used in computing net loss per share applicable to common stockholders-basic and diluted
|
31,515
|
|
|
9,407
|
|
|
2,401
|
|
___________________________________________________________
|
|
|
|
|
|
||||||
(1) Includes related party revenue (Note 14)
|
$
|
14,632
|
|
|
$
|
32,284
|
|
|
$
|
4,914
|
|
|
Series A Redeemable
Convertible
Preferred Stock
|
|
Series B Redeemable
Convertible
Preferred Stock
|
|
Series C Redeemable
Convertible
Preferred Stock
|
|
Series C-1
Redeemable
Convertible
Preferred Stock
|
|
Series D
Redeemable
Convertible
Preferred Stock
|
|
Series D-1
Redeemable
Convertible
Preferred Stock
|
||||||||||||||||||||||||||||||
|
Number
of
Shares
|
|
Value
|
|
Number
of
Shares
|
|
Value
|
|
Number
of
Shares
|
|
Value
|
|
Number
of
Shares
|
|
Value
|
|
Number
of
Shares
|
|
Value
|
|
Number
of
Shares
|
|
Value
|
||||||||||||||||||
Balance at December 31, 2011
|
6,410,976
|
|
|
$
|
62,049
|
|
|
4,204,185
|
|
|
$
|
61,464
|
|
|
2,978,062
|
|
|
$
|
54,320
|
|
|
457,875
|
|
|
$
|
8,479
|
|
|
234,940
|
|
|
$
|
3,657
|
|
|
636,942
|
|
|
$
|
10,128
|
|
Accretion of dividends, interest, redemption value and issuance costs related to redeemable convertible preferred stock
|
—
|
|
|
4,616
|
|
|
—
|
|
|
5,580
|
|
|
—
|
|
|
5,589
|
|
|
—
|
|
|
908
|
|
|
—
|
|
|
668
|
|
|
—
|
|
|
1,736
|
|
||||||
Compensation expense associated with stock options
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Exercise of stock options
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Balance at December 31, 2012
|
6,410,976
|
|
|
66,665
|
|
|
4,204,185
|
|
|
67,044
|
|
|
2,978,062
|
|
|
59,909
|
|
|
457,875
|
|
|
9,387
|
|
|
234,940
|
|
|
4,325
|
|
|
636,942
|
|
|
11,864
|
|
||||||
Accretion of dividends, interest, redemption value and issuance costs related to redeemable convertible preferred stock
|
—
|
|
|
3,408
|
|
|
—
|
|
|
4,138
|
|
|
—
|
|
|
4,068
|
|
|
—
|
|
|
661
|
|
|
—
|
|
|
487
|
|
|
—
|
|
|
1,273
|
|
||||||
Repurchase and retirement of redeemable convertible preferred stock
|
—
|
|
|
—
|
|
|
(139,741
|
)
|
|
(2,267
|
)
|
|
(21,744
|
)
|
|
(445
|
)
|
|
—
|
|
|
—
|
|
|
(2,906
|
)
|
|
(54
|
)
|
|
—
|
|
|
—
|
|
||||||
Exercise of warrants to purchase convertible preferred stock
|
46,668
|
|
|
678
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Exercise of warrants to purchase common stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Compensation expense associated with stock options
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Exercise of stock options
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Conversion of redeemable convertible preferred stock into common stock
|
(6,457,644
|
)
|
|
(70,751
|
)
|
|
(4,064,444
|
)
|
|
(68,915
|
)
|
|
(2,956,318
|
)
|
|
(63,532
|
)
|
|
(457,875
|
)
|
|
(10,048
|
)
|
|
(232,034
|
)
|
|
(4,758
|
)
|
|
(636,942
|
)
|
|
(13,137
|
)
|
||||||
Reclassification of warrants to purchase shares of redeemable convertible preferred stock into warrants to purchase common stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Issuance of common stock in connection with initial public offering and private placement, net of issuance costs of $2,692
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Balance at December 31, 2013
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Issuance of common stock net of expenses of $554
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Exercise of stock options
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Net exercise of warrants to purchase common stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Exercise of warrants to purchase common stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Balance at December 31, 2014
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
Series E Redeemable
Convertible
Preferred Stock
|
|
Series F Redeemable
Convertible
Preferred Stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Total
Redeemable
Convertible
Preferred
Stock
|
|
Common Stock
|
|
|
|
|
|
|
|||||||||||||||||||||||||||
|
Number
of
Shares
|
|
Value
|
|
Number
of
Shares
|
|
Value
|
|
Number
of
Shares
|
|
$0.001 Par
Value
|
|
Additional
Paid-In
Capital
|
|
Accumulated
Deficit
|
|
Total
Stockholders'
Equity (Deficit)
|
|||||||||||||||||||
Balance at December 31, 2011
|
816,060
|
|
|
$
|
10,934
|
|
|
2,426,171
|
|
|
$
|
30,518
|
|
|
$
|
241,549
|
|
|
2,393,458
|
|
|
$
|
3
|
|
|
$
|
—
|
|
|
$
|
(232,694
|
)
|
|
$
|
(232,691
|
)
|
Accretion of dividends, interest, redemption value and issuance costs related to redeemable convertible preferred stock
|
—
|
|
|
2,459
|
|
|
—
|
|
|
5,505
|
|
|
27,061
|
|
|
—
|
|
|
—
|
|
|
(1,361
|
)
|
|
(25,700
|
)
|
|
(27,061
|
)
|
|||||||
Compensation expense associated with stock options
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,206
|
|
|
—
|
|
|
1,206
|
|
|||||||
Exercise of stock options
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
38,697
|
|
|
—
|
|
|
155
|
|
|
—
|
|
|
155
|
|
|||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(32,582
|
)
|
|
(32,582
|
)
|
|||||||
Balance at December 31, 2012
|
816,060
|
|
|
13,393
|
|
|
2,426,171
|
|
|
36,023
|
|
|
268,610
|
|
|
2,432,155
|
|
|
3
|
|
|
—
|
|
|
(290,976
|
)
|
|
(290,973
|
)
|
|||||||
Accretion of dividends, interest, redemption value and issuance costs related to redeemable convertible preferred stock
|
—
|
|
|
1,802
|
|
|
—
|
|
|
4,033
|
|
|
19,870
|
|
|
—
|
|
|
—
|
|
|
(4,230
|
)
|
|
(15,640
|
)
|
|
(19,870
|
)
|
|||||||
Repurchase and retirement of redeemable convertible preferred stock
|
(13,103
|
)
|
|
(224
|
)
|
|
(4,825
|
)
|
|
(74
|
)
|
|
(3,064
|
)
|
|
(722
|
)
|
|
—
|
|
|
2,773
|
|
|
—
|
|
|
2,773
|
|
|||||||
Exercise of warrants to purchase convertible preferred stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
678
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Exercise of warrants to purchase common stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
23,735
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Compensation expense associated with stock options
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,196
|
|
|
—
|
|
|
2,196
|
|
|||||||
Exercise of stock options
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
292,802
|
|
|
—
|
|
|
653
|
|
|
—
|
|
|
653
|
|
|||||||
Conversion of redeemable convertible preferred stock into common stock
|
(802,957
|
)
|
|
(14,971
|
)
|
|
(2,421,346
|
)
|
|
(39,982
|
)
|
|
(286,094
|
)
|
|
18,516,993
|
|
|
19
|
|
|
149,885
|
|
|
136,190
|
|
|
286,094
|
|
|||||||
Reclassification of warrants to purchase shares of redeemable convertible preferred stock into warrants to purchase common stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,012
|
|
|
—
|
|
|
2,012
|
|
|||||||
Issuance of common stock in connection with initial public offering and private placement, net of issuance costs of $2,692
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,083,667
|
|
|
7
|
|
|
96,818
|
|
|
—
|
|
|
96,825
|
|
|||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(21,898
|
)
|
|
(21,898
|
)
|
|||||||
Balance at December 31, 2013
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
28,348,630
|
|
|
29
|
|
|
250,107
|
|
|
(192,324
|
)
|
|
57,812
|
|
|||||||
Issuance of common stock net of expenses of $554
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,760,000
|
|
|
3
|
|
|
129,171
|
|
|
—
|
|
|
129,174
|
|
|||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,778
|
|
|
—
|
|
|
4,778
|
|
|||||||
Exercise of stock options
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
853,507
|
|
|
1
|
|
|
3,207
|
|
|
—
|
|
|
3,208
|
|
|||||||
Net exercise of warrants to purchase common stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
303,204
|
|
|
—
|
|
|
7,422
|
|
|
—
|
|
|
7,422
|
|
|||||||
Exercise of warrants to purchase common stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
166,684
|
|
|
—
|
|
|
5,150
|
|
|
—
|
|
|
5,150
|
|
|||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(51,259
|
)
|
|
(51,259
|
)
|
|||||||
Balance at December 31, 2014
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
32,432,025
|
|
|
$
|
33
|
|
|
$
|
399,835
|
|
|
$
|
(243,583
|
)
|
|
$
|
156,285
|
|
|
Year Ended December 31,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Operating Activities
|
|
|
|
|
|
|
|
||||
Net loss
|
$
|
(51,259
|
)
|
|
$
|
(21,898
|
)
|
|
$
|
(32,582
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|||
Depreciation and amortization
|
1,118
|
|
|
915
|
|
|
1,293
|
|
|||
Loss on disposition of property and equipment
|
25
|
|
|
32
|
|
|
—
|
|
|||
Stock-based compensation
|
4,778
|
|
|
2,196
|
|
|
1,206
|
|
|||
Amortization of debt discount
|
—
|
|
|
—
|
|
|
51
|
|
|||
Accretion of deferred interest
|
(536
|
)
|
|
342
|
|
|
335
|
|
|||
Amortization of deferred debt issuance costs
|
36
|
|
|
186
|
|
|
84
|
|
|||
Change in fair value of warrants
|
(5,037
|
)
|
|
26,875
|
|
|
2,258
|
|
|||
Gain on retirement of warrants
|
—
|
|
|
(76
|
)
|
|
—
|
|
|||
Forgiveness of related party receivable
|
—
|
|
|
237
|
|
|
—
|
|
|||
Changes in assets and liabilities:
|
|
|
|
|
|
|
|
|
|||
Prepaid expenses and other current assets
|
(255
|
)
|
|
(823
|
)
|
|
(594
|
)
|
|||
Collaboration receivables
|
249
|
|
|
(840
|
)
|
|
(1,116
|
)
|
|||
Related party receivable
|
—
|
|
|
(4
|
)
|
|
(8
|
)
|
|||
Accounts payable
|
(161
|
)
|
|
(53
|
)
|
|
(1,272
|
)
|
|||
Accrued expenses
|
(17
|
)
|
|
709
|
|
|
1,640
|
|
|||
Deferred revenue
|
(1,673
|
)
|
|
(26,949
|
)
|
|
(9,696
|
)
|
|||
Deferred rent
|
(499
|
)
|
|
(499
|
)
|
|
(482
|
)
|
|||
Restricted cash
|
11
|
|
|
—
|
|
|
(1
|
)
|
|||
Net cash used in operating activities
|
(53,220
|
)
|
|
(19,650
|
)
|
|
(38,884
|
)
|
|||
Investing Activities
|
|
|
|
|
|
|
|
|
|||
Purchases of property and equipment
|
(514
|
)
|
|
(307
|
)
|
|
(441
|
)
|
|||
Net cash used in investing activities
|
(514
|
)
|
|
(307
|
)
|
|
(441
|
)
|
|||
Financing Activities
|
|
|
|
|
|
|
|
||||
Proceeds from long-term debt, net of issuance costs
|
—
|
|
|
—
|
|
|
19,935
|
|
|||
Proceeds from issuance of common stock from public offering, net of issuance costs
|
129,174
|
|
|
86,825
|
|
|
—
|
|
|||
Proceeds from issuance of common stock from private placements
|
—
|
|
|
10,000
|
|
|
—
|
|
|||
Payments of long-term debt
|
(16,331
|
)
|
|
(3,669
|
)
|
|
(6,191
|
)
|
|||
Payments made to repurchase redeemable convertible preferred stock, common stock and warrants to purchase common stock
|
—
|
|
|
(300
|
)
|
|
—
|
|
|||
Proceeds from exercise of stock options and warrants to purchase common stock
|
4,188
|
|
|
653
|
|
|
155
|
|
|||
Net cash provided by financing activities
|
117,031
|
|
|
93,509
|
|
|
13,899
|
|
|||
Net increase (decrease) in cash and cash equivalents
|
63,297
|
|
|
73,552
|
|
|
(25,426
|
)
|
|||
Cash and cash equivalents at beginning of period
|
113,163
|
|
|
39,611
|
|
|
65,037
|
|
|||
Cash and cash equivalents at end of period
|
$
|
176,460
|
|
|
$
|
113,163
|
|
|
$
|
39,611
|
|
Supplemental Disclosure of Cash Flow Information:
|
|
|
|
|
|
|
|
|
|||
Cash paid for interest
|
$
|
1,574
|
|
|
$
|
1,657
|
|
|
$
|
1,065
|
|
Supplemental Disclosure of Non-Cash Investing and Financing Activities:
|
|
|
|
|
|
|
|
|
|||
Accretion of dividends, interest, redemption value, and issuance costs on preferred stock
|
$
|
—
|
|
|
$
|
19,870
|
|
|
$
|
27,061
|
|
Conversion of preferred stock into common stock
|
$
|
—
|
|
|
$
|
286,094
|
|
|
$
|
—
|
|
Conversion of preferred stock warrants into common stock warrants
|
$
|
—
|
|
|
$
|
2,012
|
|
|
$
|
—
|
|
Reclassification of warrant liability to additional paid-in capital
|
$
|
11,592
|
|
|
$
|
678
|
|
|
$
|
—
|
|
Capitalized follow-on public offering costs included in accrued expenses
|
$
|
—
|
|
|
$
|
74
|
|
|
$
|
—
|
|
Purchase of property and equipment included in accounts payable and accrued expenses
|
$
|
11
|
|
|
$
|
297
|
|
|
$
|
—
|
|
•
|
Level 1—Quoted market prices in active markets for identical assets or liabilities.
|
•
|
Level 2—Inputs other than Level 1 inputs that are either directly or indirectly observable, such as quoted market prices, interest rates, and yield curves.
|
•
|
Level 3—Unobservable inputs developed using estimates of assumptions developed by the Company, which reflect those that a market participant would use.
|
|
December 31, 2014
|
||||||||||||||
|
Quoted Prices
in Active Markets for Identical Items (Level 1) |
|
Significant Other
Observable Inputs (Level 2) |
|
Significant
Unobservable Inputs (Level 3) |
|
Total
|
||||||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds
|
$
|
169,679
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
169,679
|
|
Restricted cash
|
902
|
|
|
—
|
|
|
—
|
|
|
902
|
|
||||
Total assets
|
$
|
170,581
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
170,581
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Warrants to purchase common stock
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
14,124
|
|
|
$
|
14,124
|
|
Total liabilities
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
14,124
|
|
|
$
|
14,124
|
|
|
December 31, 2013
|
||||||||||||||
|
Quoted Prices
in Active Markets for Identical Items (Level 1) |
|
Significant Other
Observable Inputs (Level 2) |
|
Significant
Unobservable Inputs (Level 3) |
|
Total
|
||||||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds
|
$
|
101,394
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
101,394
|
|
Restricted cash
|
913
|
|
|
—
|
|
|
—
|
|
|
913
|
|
||||
Total assets
|
$
|
102,307
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
102,307
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Warrants to purchase common stock
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
30,753
|
|
|
$
|
30,753
|
|
Total liabilities
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
30,753
|
|
|
$
|
30,753
|
|
|
Year Ended
December 31,
|
||||||
|
2014
|
|
2013
|
||||
Beginning balance
|
$
|
30,753
|
|
|
$
|
6,651
|
|
Change in fair value
|
(5,037
|
)
|
|
26,875
|
|
||
Exercises
|
(11,592
|
)
|
|
(678
|
)
|
||
Repurchases
|
—
|
|
|
(83
|
)
|
||
Conversions
|
—
|
|
|
(2,012
|
)
|
||
Ending balance
|
$
|
14,124
|
|
|
$
|
30,753
|
|
Asset
|
Estimated Useful Life
|
Computer equipment and software
|
3 years
|
Office and laboratory equipment
|
3 years
|
Leasehold improvements
|
Shorter of the useful life or remaining lease term
|
|
Year Ended December 31,
|
|||||||
|
2014
|
|
2013
|
|
2012
|
|||
Outstanding stock options
|
3,210
|
|
|
3,709
|
|
|
3,730
|
|
Common stock warrants
|
422
|
|
|
908
|
|
|
884
|
|
Shares issuable under employee stock purchase plan
|
14
|
|
|
—
|
|
|
—
|
|
Preferred stock
|
—
|
|
|
13,218
|
|
|
18,166
|
|
Preferred stock warrants
|
—
|
|
|
114
|
|
|
248
|
|
|
3,646
|
|
|
17,949
|
|
|
23,028
|
|
|
December 31,
|
||||||
|
2014
|
|
2013
|
||||
Computer equipment and software
|
$
|
956
|
|
|
$
|
921
|
|
Office equipment
|
213
|
|
|
205
|
|
||
Laboratory equipment
|
11,311
|
|
|
12,334
|
|
||
Leasehold improvements
|
9,930
|
|
|
9,930
|
|
||
Construction in progress
|
11
|
|
|
—
|
|
||
Total property and equipment
|
22,421
|
|
|
23,390
|
|
||
Accumulated depreciation and amortization
|
(19,334
|
)
|
|
(19,685
|
)
|
||
Property and equipment, net
|
$
|
3,087
|
|
|
$
|
3,705
|
|
|
December 31,
|
||||||
|
2014
|
|
2013
|
||||
Research and development related
|
2,291
|
|
|
1,330
|
|
||
Employee compensation
|
3,050
|
|
|
2,930
|
|
||
Professional services
|
426
|
|
|
1,017
|
|
||
Other
|
1,081
|
|
|
1,650
|
|
||
|
$
|
6,848
|
|
|
$
|
6,927
|
|
|
Warrants as of
|
|
|
|
|
|
|
||||||
|
|
|
|
|
2014 Weighted-
Average Exercise Price Per Share |
|
|
|
Balance Sheet
Classification |
||||
|
|
|
|
|
|
|
|
|
|
||||
|
December 31,
|
|
|
December 31, 2014
|
|
December 31, 2013
|
|||||||
|
2014
|
|
2013
|
|
Expiration
|
|
|||||||
Warrants to purchase Common Stock
|
—
|
|
|
46
|
|
|
$10.92
|
|
June 25, 2019
|
|
Equity(1) (2)
|
|
Equity(1) (2)
|
Warrants to purchase Common Stock
|
—
|
|
|
64
|
|
|
12.56
|
|
March 18, 2020
|
|
Equity(3) (4) (5)
|
|
Equity(3) (4) (5)
|
Warrants to purchase Common Stock
|
409
|
|
|
857
|
|
|
5.88
|
|
June 10, 2020 - July 9, 2020
|
|
Liability(6) (7) (8) (9) (10) (11) (12)
|
|
Liability(6) (7) (8) (9) (10) (11) (12)
|
Warrants to purchase Common Stock
|
13
|
|
|
13
|
|
|
4.00 - 7.40
|
|
March 31, 2015 - December 31, 2017
|
|
Equity(13)
|
|
Equity(13)
|
All warrants
|
422
|
|
|
980
|
|
|
$5.85
|
|
|
|
|
|
|
(1)
|
In March 2014, the warrant holders exercised warrants to purchase
32,050
shares of Common Stock on a net basis, resulting in the issuance of
22,955
shares of Common Stock.
|
(2)
|
In December 2014, the warrant holders exercised warrants to purchase
13,736
shares of Common Stock on a net basis, resulting in the issuance of
10,284
shares of Common Stock.
|
(3)
|
In March 2014, the warrant holders exercised warrants to purchase
12,738
shares of Common Stock on a net basis, resulting in the issuance of
9,202
shares of Common Stock.
|
(4)
|
In April 2014, the warrant holders exercised warrants to purchase
31,847
shares of common stock on a net basis, resulting in the issuance of
21,082
shares of Common Stock.
|
(5)
|
In December 2014, the warrant holders exercised warrants to purchase
19,108
shares of Common Stock on a net basis, resulting in the issuance of
13,585
shares of Common Stock.
|
(6)
|
In March 2014, the warrant holders exercised warrants to purchase
543
shares of Common Stock on a net basis, resulting in the issuance of
456
shares of Common Stock.
|
(7)
|
In March 2014, the warrant holders exercised warrants to purchase
23,445
shares of Common Stock on a cash basis, resulting in the issuance of
23,445
shares of Common Stock.
|
(8)
|
In May and June 2014, the warrant holders exercised warrants to purchase
114,103
shares of common stock on a net basis, resulting in the issuance of
92,173
shares of Common Stock.
|
(9)
|
In April 2014, the warrant holders exercised warrants to purchase
16,956
shares of common stock on a cash basis, resulting in the issuance of
16,956
shares of Common Stock.
|
(10)
|
In August 2014, the warrant holders exercised warrants to purchase
11,611
shares of common stock on a net basis, resulting in the issuance of
9,332
shares of Common Stock.
|
(11)
|
In September 2014, the warrant holders exercised warrants to purchase
126,283
shares of common stock on a cash basis, resulting in the issuance of
126,283
shares of Common Stock.
|
(12)
|
In October 2014, the warrant holders exercised warrants to purchase
155,171
shares of Common Stock on a net basis, resulting in the issuance of
124,135
shares of Common Stock.
|
(13)
|
Warrants to purchase common stock were issued in connection with various debt financing transactions that were consummated in periods prior to December 31, 2012. See discussion below for further details.
|
|
Year Ended December 31,
|
||||||
|
2014
|
|
2013(2)
|
|
2012(1)
|
||
Fair value of underlying instrument
|
n/a
|
|
n/a
|
|
$
|
9.24
|
|
Expected volatility
|
n/a
|
|
n/a
|
|
69.1
|
%
|
|
Expected term (in years)
|
n/a
|
|
n/a
|
|
0.16
|
|
|
Risk-free interest rate
|
n/a
|
|
n/a
|
|
0.04
|
%
|
|
Expected dividend yield
|
n/a
|
|
n/a
|
|
—
|
%
|
(1)
|
During December 2012, the expiration date of the warrant to purchase Series A Preferred Stock was extended from December 21, 2012 to February 28, 2013.
|
(2)
|
The warrant to purchase Series A Preferred Stock was exercised during the three months ended March 31, 2013.
|
|
Year Ended December 31,
|
||||||||
|
2014
|
|
2013(1)
|
|
2012
|
||||
Fair value of underlying instrument
|
n/a
|
|
$
|
20.03
|
|
|
$
|
9.96
|
|
Expected volatility
|
n/a
|
|
71.2
|
%
|
|
69.1
|
%
|
||
Expected term (in years)
|
n/a
|
|
0.24
|
|
|
0.97
|
|
||
Risk-free interest rate
|
n/a
|
|
0.04
|
%
|
|
0.16
|
%
|
||
Expected dividend yield
|
n/a
|
|
—
|
%
|
|
—
|
%
|
(1)
|
Warrants to purchase Series B Preferred Stock were converted to warrants to purchase common stock at the closing of the IPO on September 24, 2013.
|
|
Year Ended December 31,
|
||||||||
|
2014
|
|
2013(1)
|
|
2012
|
||||
Fair value of underlying instrument
|
n/a
|
|
$
|
20.03
|
|
|
$
|
11.04
|
|
Expected volatility
|
n/a
|
|
71.2
|
%
|
|
69.1
|
%
|
||
Expected term (in years)
|
n/a
|
|
5.73
|
|
|
6.46
|
|
||
Risk-free interest rate
|
n/a
|
|
1.75
|
%
|
|
0.95
|
%
|
||
Expected dividend yield
|
n/a
|
|
—
|
%
|
|
—
|
%
|
(1)
|
Warrants to purchase Series C-1 Preferred Stock were converted to warrants to purchase common stock at the closing of the IPO on September 24, 2013.
|
|
Year Ended December 31,
|
||||||||
|
2014
|
|
2013(1)
|
|
2012
|
||||
Fair value of underlying instrument
|
n/a
|
|
$
|
20.03
|
|
|
$
|
10.52
|
|
Expected volatility
|
n/a
|
|
71.2
|
%
|
|
69.1
|
%
|
||
Expected term (in years)
|
n/a
|
|
6.48
|
|
|
7.22
|
|
||
Risk-free interest rate
|
n/a
|
|
1.75
|
%
|
|
1.18
|
%
|
||
Expected dividend yield
|
n/a
|
|
—
|
%
|
|
—
|
%
|
(1)
|
Warrants to purchase Series D-1 Preferred Stock were converted to warrants to purchase common stock at the closing of the IPO on September 24, 2013.
|
2015
|
4,106
|
|
|
2016
|
3,938
|
|
|
2017
|
3,938
|
|
|
2018
|
2,954
|
|
|
Total
|
$
|
14,936
|
|
2015
|
241
|
|
|
Total
|
$
|
241
|
|
|
December 31, 2012
|
||
Series A Preferred Stock, $0.001 par value: 26,069,980 shares authorized, 6,410,976 shares issued and outstanding at December 31, 2012, at redemption value
|
$
|
66,665
|
|
Series B Preferred Stock, $0.001 par value: 16,944,378 shares authorized, 4,204,185 shares issued and outstanding at December 31, 2012, at redemption value
|
67,044
|
|
|
Series C Preferred Stock, $0.001 par value: 11,923,077 shares authorized, 2,978,062 shares issued, and outstanding at December 31, 2012, at redemption value
|
59,909
|
|
|
Series C-1 Preferred Stock, $0.001 par value: 2,014,652 shares authorized, 457,875 issued, and outstanding at December 31, 2012, at redemption value
|
9,387
|
|
|
Series D Preferred Stock, $0.001 par value: 955,414 shares authorized, 234,940 shares issued, and outstanding at December 31, 2012, at redemption value
|
4,325
|
|
|
Series D-1 Preferred Stock, $0.001 par value: 2,802,548 shares authorized, 636,942 issued and outstanding at December 31, 2012, at redemption value
|
11,864
|
|
|
Series E Preferred Stock, $0.001 par value: 3,662,422 shares authorized, 816,060 shares issued and outstanding at December 31, 2012, at redemption value
|
13,393
|
|
|
Series F Preferred Stock, $0.001 par value: 9,704,756 shares authorized, 2,426,171 issued and outstanding at December 31, 2012, at redemption value
|
36,023
|
|
|
Total redeemable convertible preferred stock
|
$
|
268,610
|
|
|
December 31, 2014
|
|
Outstanding stock options to purchase common stock
|
3,210
|
|
Shares available for future issuance under stock option plan
|
1,943
|
|
Warrants to purchase common stock
|
422
|
|
Shares available for future issuance under the employee stock purchase plan
|
275
|
|
Additional shares reserved for unissued, but designated, Preferred Stock
|
25,000
|
|
Total shares of authorized common stock reserved for future issuance
|
30,850
|
|
•
|
$18.8 million
for research and development services
|
•
|
$2.9 million
for the sotatercept joint development committee
|
•
|
$3.7 million
for the ACE 536 joint development committee
|
•
|
$2.8 million
for the manufacturing services
|
|
Year Ended December 31,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Research and development
|
$
|
2,065
|
|
|
$
|
659
|
|
|
$
|
514
|
|
General and administrative
|
2,713
|
|
|
1,537
|
|
|
692
|
|
|||
|
$
|
4,778
|
|
|
$
|
2,196
|
|
|
$
|
1,206
|
|
|
Year Ended December 31,
|
|||||||
|
2014
|
|
2013
|
|
2012
|
|||
Expected volatility
|
70.9
|
%
|
|
71.5
|
%
|
|
69.0
|
%
|
Expected term (in years)
|
6.0
|
|
|
6.0
|
|
|
6.0
|
|
Risk-free interest rate
|
1.82
|
%
|
|
1.85
|
%
|
|
0.90
|
%
|
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
Number
of Grants |
|
Weighted-
Average Exercise Price Per Share |
|
Weighted-
Average Contractual Life
(in years)
|
|
Aggregate
Intrinsic Value(1) |
|||||
Outstanding at December 31, 2013
|
3,942
|
|
|
$
|
7.05
|
|
|
|
|
|
|
|
Granted
|
204
|
|
|
$
|
38.35
|
|
|
|
|
|
|
|
Exercised
|
(854
|
)
|
|
$
|
3.76
|
|
|
|
|
|
|
|
Canceled or forfeited
|
(82
|
)
|
|
$
|
19.99
|
|
|
|
|
|
|
|
Outstanding at December 31, 2014
|
3,210
|
|
|
$
|
9.57
|
|
|
5.96
|
|
$
|
95,007
|
|
Exercisable at December 31, 2014
|
2,292
|
|
|
$
|
5.90
|
|
|
4.95
|
|
$
|
75,880,284
|
|
Vested and expected to vest at December 31, 2014(2)
|
3,164
|
|
|
$
|
9.40
|
|
|
5.92
|
|
$
|
94,160,194
|
|
(1)
|
The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the estimated fair value of the common stock for the options that were in the money at
December 31, 2014
and
2013
.
|
(2)
|
This represents the number of vested options at
December 31, 2014
, plus the number of unvested options expected to vest at
December 31, 2014
, based on the unvested options outstanding at
December 31, 2014
, adjusted for the estimated forfeiture rate.
|
|
Year Ended December 31,
|
||||||
|
2014
|
|
2013
|
||||
Deferred tax assets:
|
|
|
|
|
|
||
U.S. and state net operating loss carryforwards
|
$
|
75,334
|
|
|
$
|
51,886
|
|
Research and development credits
|
6,704
|
|
|
5,519
|
|
||
Deferred revenue
|
2,348
|
|
|
3,005
|
|
||
Accruals and other temporary differences
|
5,416
|
|
|
5,675
|
|
||
Total deferred tax assets
|
89,802
|
|
|
66,085
|
|
||
Less valuation allowance
|
(89,802
|
)
|
|
(66,085
|
)
|
||
Net deferred tax assets
|
$
|
—
|
|
|
$
|
—
|
|
|
Year Ended December 31,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
License and milestone
|
$
|
1,673
|
|
|
$
|
19,626
|
|
|
$
|
2,035
|
|
Cost sharing, net
|
12,959
|
|
|
12,658
|
|
|
2,879
|
|
|||
|
$
|
14,632
|
|
|
$
|
32,284
|
|
|
$
|
4,914
|
|
|
For the Three Months Ended(1)
|
||||||||||||||
|
March 31
|
|
June 30
|
|
September 30
|
|
December 31
|
||||||||
|
(in thousands except per share data)
|
||||||||||||||
2014:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total revenue
|
$
|
3,307
|
|
|
$
|
4,078
|
|
|
$
|
3,508
|
|
|
$
|
3,739
|
|
Total costs and expenses
|
15,515
|
|
|
21,389
|
|
|
14,899
|
|
|
18,293
|
|
||||
Loss from operations
|
(12,208
|
)
|
|
(17,311
|
)
|
|
(11,391
|
)
|
|
(14,554
|
)
|
||||
Net loss
|
(9,120
|
)
|
|
(16,550
|
)
|
|
(7,972
|
)
|
|
(17,617
|
)
|
||||
Basic net loss per share*
|
$
|
(0.30
|
)
|
|
$
|
(0.52
|
)
|
|
$
|
(0.25
|
)
|
|
$
|
(0.55
|
)
|
Diluted net loss per share*
|
$
|
(0.30
|
)
|
|
$
|
(0.52
|
)
|
|
$
|
(0.25
|
)
|
|
$
|
(0.55
|
)
|
2013:
|
|
|
|
|
|
|
|
||||||||
Total revenue
|
$
|
15,012
|
|
|
$
|
26,427
|
|
|
$
|
4,270
|
|
|
$
|
11,521
|
|
Total costs and expenses
|
(11,876
|
)
|
|
(12,276
|
)
|
|
(11,154
|
)
|
|
(14,972
|
)
|
||||
Income (loss) from operations
|
3,136
|
|
|
14,151
|
|
|
(6,884
|
)
|
|
(3,451
|
)
|
||||
Net income (loss)
|
1,647
|
|
|
13,078
|
|
|
(18,513
|
)
|
|
(18,110
|
)
|
||||
Basic net income (loss) per share*
|
$
|
(0.24
|
)
|
|
$
|
0.30
|
|
|
$
|
(5.62
|
)
|
|
$
|
(0.64
|
)
|
Diluted net income (loss) per share*
|
$
|
(0.24
|
)
|
|
$
|
0.28
|
|
|
$
|
(5.62
|
)
|
|
$
|
(0.64
|
)
|
(1)
|
The amounts were computed independently for each quarter, and the sum of the quarters may not total the annual amounts.
|
*
|
Applicable to common stockholders
|
Exhibit
Number
|
|
Exhibit Description
|
|
Filed
with this
Report
|
|
Incorporated by
Reference
herein from
Form or
Schedule
|
|
Filing Date
|
|
SEC File/Reg.
Number
|
3.1
|
|
Restated Certificate of Incorporation
|
|
|
|
Form 8-K (Exhibit 3.1)
|
|
9/24/2013
|
|
001-36065
|
3.2
|
|
Amended and Restated By-laws
|
|
|
|
Form 8-K (Exhibit 3.2)
|
|
9/24/2013
|
|
001-36065
|
4.1
|
|
Form of Common Stock Certificate
|
|
|
|
Form S-1 (Exhibit 4.1)
|
|
8/7/2013
|
|
333-190417
|
4.2
|
|
Form of Amended and Restated Registration Rights Agreement
|
|
|
|
Form S-1 (Exhibit 4.2)
|
|
8/7/2013
|
|
333-190417
|
4.3
|
|
Form of Warrant to Purchase Stock, issued to Series E Investors as of June 10, 2010 and July 9, 2010
|
|
|
|
Form S-1 (Exhibit 4.3)
|
|
8/7/2013
|
|
333-190417
|
4.4
|
|
Form of Common Stock Warrant Certificate, issued to General Electric Capital Corporation as of March 28, 2007
|
|
|
|
Form S-1 (Exhibit 4.4)
|
|
8/7/2013
|
|
333-190417
|
10.1*
|
|
Form of Director Indemnification Agreement
|
|
|
|
Form S-1 (Exhibit 10.1)
|
|
8/7/2013
|
|
333-190417
|
10.2+
|
|
Collaboration, License and Option Agreement between Acceleron Pharma Inc. and Celgene Corporation, dated as of February 20, 2008, and amended as of August 2, 2011
|
|
|
|
Form S-1/A (Exhibit 10.6)
|
|
9/6/2013
|
|
333-190417
|
10.3
|
|
Amended and Restated License Agreement between Acceleron Pharma Inc. and Ludwig Institute for Cancer Research Ltd., dated as of August 6, 2010
|
|
|
|
Form S-1 (Exhibit 10.7)
|
|
8/7/2013
|
|
333-190417
|
10.4+
|
|
Exclusive License Agreement between Beth Israel Deaconess Medical Center and Acceleron Pharma Inc., dated as of June 21, 2012
|
|
|
|
Form S-1 (Exhibit 10.8)
|
|
8/7/2013
|
|
333-190417
|
10.5+
|
|
Collaboration, License and Option Agreement between Acceleron Pharma Inc. and Celgene Corporation, dated as of August 2, 2011
|
|
|
|
Form S-1/A (Exhibit 10.9)
|
|
9/6/2013
|
|
333-190417
|
10.6
|
|
Exclusive License Agreement between Salk Institute for Biological Studies and Acceleron Pharma Inc., dated as of August 10, 2010
|
|
|
|
Form S-1 (Exhibit 10.10)
|
|
8/7/2013
|
|
333-190417
|
10.7
|
|
Amended and Restated License Agreement between Salk Institute for Biological Studies and Acceleron Pharma Inc., dated as of August 11, 2010
|
|
|
|
Form S-1 (Exhibit 10.11)
|
|
8/7/2013
|
|
333-190417
|
10.8
|
|
Amendment, dated as of July 25, 2014, to Amended and Restated License Agreement between Salk Institute for Biological Studies and Acceleron Pharma Inc. dated as of August 11, 2010
|
|
|
|
Form 10-Q (Exhibit 10.1)
|
|
8/12/2014
|
|
001-36065
|
10.9
|
|
Indenture of Lease between Massachusetts Institute of Technology and Acceleron Pharma Inc., dated as of May 20, 2008
|
|
|
|
Form S-1 (Exhibit 10.12)
|
|
8/7/2013
|
|
333-190417
|
10.10*
|
|
Acceleron Pharma Inc. 2013 Equity Incentive Plan
|
|
|
|
Form S-8 (Exhibit 4.4)
|
|
12/12/2013
|
|
333-192789
|
10.11*
|
|
Form of Acceleron Pharma Inc. Cash Incentive Plan
|
|
|
|
Form S-1/A (Exhibit 10.14)
|
|
8/19/2013
|
|
333-190417
|
10.12*
|
|
Acceleron Pharma Inc. 2003 Stock Option and Restricted Stock Plan
|
|
|
|
Form S-1 (Exhibit 10.15)
|
|
8/7/2013
|
|
333-190417
|
10.13*
|
|
Amended and Restated Employment Agreement between John Knopf and Acceleron Pharma Inc., dated as of August 26, 2013
|
|
X
|
|
|
|
|
|
|
10.14*
|
|
Amended and Restated Employment Agreement between Matthew L. Sherman and Acceleron Pharma Inc., dated as of August 26, 2013
|
|
X
|
|
|
|
|
|
|
Exhibit
Number
|
|
Exhibit Description
|
|
Filed
with this
Report
|
|
Incorporated by
Reference
herein from
Form or
Schedule
|
|
Filing Date
|
|
SEC File/Reg.
Number
|
10.15*
|
|
Amended and Restated Employment Agreement between John D. Quisel and Acceleron Pharma Inc., dated as of August 26, 2013
|
|
X
|
|
|
|
|
|
|
10.16*
|
|
Amended and Restated Employment Agreement between Kevin F. McLaughlin and Acceleron Pharma Inc. dated as of January 31, 2014
|
|
X
|
|
|
|
|
|
|
10.17*
|
|
Amended and Restated Employment Agreement between Steven D. Ertel and Acceleron Pharma Inc. dated as of January 31, 2014
|
|
X
|
|
|
|
|
|
|
10.18*
|
|
Employee Stock Purchase Plan
|
|
|
|
Form S-1/A (Exhibit 10.20)
|
|
9/6/2013
|
|
333-190417
|
10.19*
|
|
Form of Non-Statutory Stock Option Agreement under the 2013 Equity Incentive Plan
|
|
|
|
Form S-1 (Exhibit 10.21)
|
|
1/9/2014
|
|
333-193252
|
10.20*
|
|
Form of Incentive Stock Option Agreement under the 2013 Equity Incentive Plan
|
|
|
|
Form S-1 (Exhibit 10.22)
|
|
1/9/2014
|
|
333-193252
|
10.21*
|
|
Form of Restricted Stock Unit Award Agreement under the 2013 Equity Incentive Plan
|
|
X
|
|
|
|
|
|
|
21.1
|
|
List of Subsidiaries
|
|
|
|
Form 10-K (Exhibit 21.1)
|
|
3/17/2014
|
|
001-36065
|
23.1
|
|
Consent of Ernst & Young LLP, Independent Registered Public Accounting Firm
|
|
X
|
|
|
|
|
|
|
31.1
|
|
Certification of Principal Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
X
|
|
|
|
|
|
|
31.2
|
|
Certification of Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
X
|
|
|
|
|
|
|
32.1
|
|
Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
X
|
|
|
|
|
|
|
101
|
|
The following financial information from the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2014 formatted in XBRL (eXtensible Business Reporting Language): (i) Consolidated Balance Sheets as of December 31, 2014 and December 31, 2013, (ii) Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2014, 2013 and 2012, (iii) Consolidated Statements of Comprehensive Income for the years ended December 31, 2014, 2013 and 2012, (iv) Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) for the years ended December 31, 2014, 2013 and 2012, (v) Consolidated Statements of Cash Flows for the years ended December 31, 2014, 2013 and 2012, and (vi) Notes to Consolidated Financial Statements
|
|
X
|
|
|
|
|
|
|
+
|
Confidential treatment has been granted by, or is being requested from, the Securities and Exchange Commission as to certain portions of this Exhibit, which portions have been omitted and filed separately with the Securities and Exchange Commission as part of an application for confidential treatment pursuant to the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, as applicable.
|
*
|
Management contract or compensatory plan or arrangement.
|
|
ACCELERON PHARMA INC.
|
||
Date: March 2, 2015
|
By:
|
|
/s/ JOHN L. KNOPF, PH.D.
|
|
|
|
John L. Knopf, Ph.D.
Chief Executive Officer, President and Director
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ JOHN KNOPF, PH.D.
|
|
Chief Executive Officer, President and Director (Principal Executive Officer)
|
|
March 2, 2015
|
John L. Knopf, Ph.D.
|
|
|
||
|
|
|
|
|
/s/ KEVIN F. MCLAUGHLIN
|
|
Senior Vice President, Chief Financial Officer and Treasurer (Principal Financial Officer and Principal Accounting Officer)
|
|
March 2, 2015
|
Kevin F. McLaughlin
|
|
|
||
|
|
|
|
|
/s/ JEAN M. GEORGE
|
|
Director
|
|
March 2, 2015
|
Jean M. George
|
|
|
||
|
|
|
|
|
/s/ GEORGE GOLUMBESKI, PH.D.
|
|
Director
|
|
March 2, 2015
|
George Golumbeski, Ph.D.
|
|
|
||
|
|
|
|
|
/s/ EDWIN M. KANIA, JR.
|
|
Director
|
|
March 2, 2015
|
Edwin M. Kania, Jr.
|
|
|
||
|
|
|
|
|
/s/ TERRENCE C. KEARNEY
|
|
Director
|
|
March 2, 2015
|
Terrence C. Kearney
|
|
|
||
|
|
|
|
|
/s/ TOM MANIATIS, PH.D.
|
|
Director
|
|
March 2, 2015
|
Tom Maniatis, Ph.D.
|
|
|
||
|
|
|
|
|
/s/ TERRANCE G. MCGUIRE
|
|
Director
|
|
March 2, 2015
|
Terrance G. McGuire
|
|
|
||
|
|
|
|
|
/s/ FRANCOIS NADER, M.D.
|
|
Director
|
|
March 2, 2015
|
Francois Nader, M.D.
|
|
|
||
|
|
|
|
|
/s/ RICHARD F. POPS
|
|
Director
|
|
March 2, 2015
|
Richard F. Pops
|
|
|
||
|
|
|
|
|
/s/ JOSEPH S. ZAKRZEWSKI
|
|
Director
|
|
March 2, 2015
|
Joseph S. Zakrzewski
|
|
|
Name:
|
[●]
|
Number of Restricted Stock Units subject to Award:
|
[●]
|
Date of Grant:
|
[●]
|
1.
|
Restricted Stock Unit Award
.
|
2.
|
Vesting; Termination of Employment
.
|
3.
|
Delivery of Shares
.
|
4.
|
Forfeiture; Recovery of Compensation
.
|
5.
|
Dividends; Other Rights
.
|
6.
|
Certain Tax Matters
.
|
7.
|
Covered Transaction
.
|
8.
|
Withholding
.
|
9.
|
Transfer of Award
.
|
10.
|
Effect on Employment
.
|
11.
|
Provisions of the Plan
.
|
12.
|
Acknowledgements
.
|
(1)
|
Registration Statement (Form S-8 No. 333-192789) pertaining to the Acceleron Pharma Inc. 2003 Stock Option and Restricted Stock Plan and the Acceleron Pharma Inc. 2013 Equity Incentive Plan, and
|
(2)
|
Registration Statement (Form S-8 No. 333-198259) pertaining to the Acceleron Pharma Inc. 2013 Employee Stock Purchase Plan and the Acceleron Pharma Inc. 2013 Equity Incentive Plan;
|
|
|
/s/ Ernst & Young LLP
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
March 2, 2015
|
|
/s/ John L. Knopf, Ph.D.
|
Date
|
John L. Knopf, Ph.D.
|
|
|
Chief Executive Officer and President
(Principal Executive Officer)
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
March 2, 2015
|
|
/s/ Kevin F. McLaughlin
|
Date
|
Kevin F. McLaughlin
|
|
|
Senior Vice President, Chief Financial Officer and Treasurer (Principal Financial Officer)
|
Date: March 2, 2015
|
By:
|
/s/ John L. Knopf, Ph.D.
|
|
|
John L. Knopf Ph.D.
|
|
|
President and Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
|
|
|
Date: March 2, 2015
|
By:
|
/s/ Kevin F. McLaughlin
|
|
|
Kevin F. McLaughlin
|
|
|
Senior Vice President, Chief Financial Officer and Treasurer (Principal Financial Officer)
|
|
|
|