Geron’s (GERN) Good and Bad News, Q4/09 Results
GERN reported a Q4/09 net loss of $18.4 M, or $0.20 a share based on higher operating expenses. FY09’s loss was $70.4 M, or $0.80 a share.
Q4/09 revenue was $605 K, with $1.7 M in revenue for FY09. Revenues in 2009 reflected royalty and license fee revenue and collaboration funding from various agreements. GERN in Q4 had operating expenses of $19 M, with R&D expenses of $15.3 M which increased primarily due to higher non-cash compensation expense for equity-based awards. Q4 G&A expenses were $3.6 M with FY09 operating expenses finishing at $72 M. Shares of Geron fell $0.25, or 4.3 % to $5.55 in Friday’s trading. Shares have traded between $3.67 and $9.24 over the last 52 weeks. Don’t count GERN down and out with $178.62 M in cash!
The biggest issue in Q4/09 … was the FDA placing Geron’s IND for GRNOPC1 (a cell therapy for neurologically complete, sub-acute spinal cord injury) on clinical hold after GERN notified the agency of additional preclinical animal study data.
- The data showed a higher frequency of cysts than had been seen in numerous foregoing preclinical studies with clinical grade GRNOPC1, including the IND-enabling studies. The characteristics of the cysts were similar to what was observed in previous studies: non-proliferative, confined to the injury site and smaller than the injury cavity but not associated with adverse clinical outcomes,
- But … the FDA has advised that it concurs with GERN … that positive data from this study can be used to support both the release of the clinical hold related to the pending IND and expansion of the clinical trial to cervical patients,
- A confirmatory preclinical study using GRNOPC1 will be completed that … has been characterized by new markers and assays (as agreed upon in discussions with the FDA).
Interim data was presented from the ongoing trial of GRN163L, a telomerase inhibitor drug, in patients with refractory, advanced solid cancers at the 2009 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.
- The data showed that current patient exposures to GRN163 are exceeding the levels that have been associated with efficacy in several models of human cancers and that telomerase inhibition has been observed in tissue samples from patients, while minimizing hematological toxicities through an alternative dosing schedule.
Interim data was also presented from the Phase II trial of GRNVAC1, an autologous dendritic cell vaccine targeting telomerase, in patients with acute myelogenous leukemia (AML) at the 51st Annual Meeting of the American Society of Hematology.
- The data showed that the endpoints of safety and tolerability have been met. In addition, in the study a number of high risk patients have entered the extended boost phase of the vaccination regimen,
- These patients have been in remission for a period ranging from four months to nearly two years. Analyses of minimal residual disease by qPCR of WT-1, a tumor gene associated with differentiation and proliferation of AML, showed that the 14 patients who remain in complete remission are negative for WT-1.
Reiterating from our 2/2/10 blog about a Very Adroit Move; GERN completed (2/19/09) a public offering of 7.25 M shares of common stock at a price of $6.60 per share; total net proceeds were $45.9 M. In 1/10, GERN exchanged outstanding warrants held by certain institutional investors for shares of common stock. In connection with the exchange, they then … sold additional shares of common stock to the investors at a premium to market for gross proceeds of $10 M, and issued warrants to the investors to purchase an additional $5 M of common stock at the premium price.
- GERN sold shares of its common stock and warrants to purchase common stock to institutional investors for proceeds of $3.6 M to fund an equity contribution to ViaGen to maintain Geron’s ownership interest and were in part, used to repay a $1.5 M loan extended by Geron to ViaGen.