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Verastem (VSTM) Q1/13 Results – HOLD – Just Trugs Along

Net loss of $9 million or $0.44 per share

Net loss of $9 million or $0.44 per share compared to a net loss of $6.9 M or $0.47 per share for Q1/12. The decrease in net loss for the 2013 is primarily due to non-cash stock-based compensation expense of $2.5 million as compared to $1.5 million for the 2012 Quarter.

R&D expenses were $5.3 M compared to $4.8 M for Q1/12. The increase in R&D expenses was primarily attributable to an increase of $650 K in CRO expenses for outsourced biology, chemistry and development services and an increase of $309 K for personnel costs primarily due to increased headcount. These increases are partially offset by a decrease of $367 K in license fee expense primarily related to the revaluation of the obligation to issue the warrant to Poniard Pharmaceuticals in the 2012 Quarter.

G&A expense increased to $3.8 million as compared to $2.1 million for Q1/12. The $1.7 million increase from Q1/12 to Q1/13 primarily resulted from an increase of $1 million for personnel costs primarily due to stock-based compensation expense associated with restricted stock units and restricted stock units with performance-based vesting provisions, an increase of $437 K in professional fees and an increase of $111 K in consulting fees. The number of shares used to compute the net loss was 20.48 million versus 14.69 million in Q1/12.

  • VSTM had a total of $84.4 million in cash, cash equivalents and investments compared to $91.5 million in cash and cash equivalents at 12/31/12.

Q1/13 Highlights

  • Advanced the FAK inhibition program and defined a potential registration pathway;
  • Met with the regulatory agencies in the US and UK and, based on these discussions, VSTM believes that positive results from its anticipated trial of VS-6063 in mesothelioma will enable the company seek regulatory approval;
  • Advanced diagnostic strategy through an agreement with LabCorp to develop a companion diagnostic for VS-6063 to stratify patients in the mesothelioma trial;
  • Filed for orphan drug designation for VS-6063 in mesothelioma within the EU and US;
  • Initiated a P1/1b study of VS-6063 in combination with paclitaxel for patients with ovarian cancer, which is open and enrolling at all sites;
  • Presented data at the 2013 AACR Annual Meeting showing that treatment with FAK inhibitor VS-4718 results in an approximate 200-fold reduction in the tumor-initiating capability of cells extracted from tumors as compared to paclitaxel in a xenograft model of triple negative breast cancer;
  • Received IND allowance from the FDA for the VS-4718 P1 trial to proceed in advanced solid tumors;
  • Progressed the dual PI3K/mTOR inhibition program;
  • Conducted IND-enabling studies of VS-5584 with a goal of initiating P1 clinical development in H2 2013
  • Presented data at the 2013 AACR Annual Meeting demonstrating the ability of VS-5584 treatment to induce tumor regression intaxane-resistant patient-derived xenograft models;
  • Published data on PI3K/mTOR inhibitor VS-5584 in Molecular Cancer Therapeutics
  • Presented research results widely at scientific conferences including AACR, Keystone PI3 Kinase Symposium and the Molecular Medicine Tri-Conference Symposium on Targeting Cancer Stem Cells.

Bottom Line: VSTM just "trugs" along in the preliminary stages of clinical development with twists and turns but nothing that upsets the apple cart - but great cash position!

VSTM closed at $9.68 on 5/9 DOWN from $9.74 on 5/8 on minimal 2700 shares. The combination trial of VS-6063 plus paclitaxel for ovarian cancer is open and enrolling patients at all sites. In addition, VSTM has met with the regulatory agencies in the US and UK and are on track to initiate midyear the potentially pivotal trial of VS-6063 in mesothelioma. 2013 milestones include the following: Complete the dose finding portion of the P1/1b trial of VS-6063 plus paclitaxel in ovarian cancer; Initiate P1 clinical development of VS-4718 H1 2013 and Initiate P1 clinical development of VS-5584 H2 2013. A …HOLD as I don't see any great expectation in a Q or 2!

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.