Last week, BioNews Texas reported on The Woodlands’ Opexa Therapeutics Inc.‘s announcement that they had closed on a public stock offering worth $18 million. The crux of the 12 million shares sold in the public offering was to continue development of Tcelna, the company’s patient-specific T-cell immunotherapy for the treatment of multiple sclerosis (MS). Now, Opexa has followed up its announcement with a Q2 financial report, which puts the company’s financial moves into better perspective.
In the company’s recent financial report, Opexa revisited their public stock offering news, adding that net proceeds from the sale totaled $16.2 million after underwriting discounts and commissions and estimated offering expenses for the offering. On the clinical side of the report, Opexa had several interesting remarks:
The company enrolled 68 patients as of August 8, 2013 in the Phase IIb ‘Abili-T’ clinical study of Tcelna (imilecleucel-T) in patients with Secondary Progressive Multiple Sclerosis (SPMS). The Abili-T clinical trial is a randomized, double-blind, placebo-controlled study and will enroll 180 patients through approximately 30 leading clinical sites in the U.S. and Canada;
Furthered the accumulation of comprehensive subject data to support Opexa’s Immune Monitoring Program initiative in conjunction with the Abili-T trial, including the potential identification of biomarkers for SPMS and further understanding of the immunopathology of SPMS; and
Presented baseline data from Opexa’s Immune Monitoring Program in a poster session at the 2013 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) and the Fifth Cooperative Meeting with the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).
This is the first recent news for continued clinical study efforts for Tcelna, which reveals that the drug has now reached Phase IIb testing via the Abili-T study. The company also appears to continue to make presentations on their emerging technology, such as the one they presented at the Vatican on adult stem cells back in early April.
Operationally, Opexa contributed to the continued steady biotech hiring trend that has been observed throughout Texas, with the company hiring several new team members to advance their Precision Immunotherapy™ in SPMS and further development initiatives. The hirings also contributed to increasing the company’s manufacturing and delivery capabilities for Tcelna to patients enrolled in the Abili-T study. Neil K. Warma, Opexa’s President and Chief Executive Officer, commented, “We are coming off a productive quarter with demonstrated progress in the Abili-T clinical trial and the announcement of our recent public offering of $18 million in shares of our common stock,” adding, “We are pleased with the positive response from the investment community and the proceeds raised from this offering will allow us to focus on patient enrollment and trial execution. Top-line data from the trial is expected in the first half of 2016.” Mr. Warma’s full comments can be reviewed on the company’s press release.
Other financial details include:
- Opexa reported revenue of $348,837 and $568,937 for the three and six months ended June 30, 2013, respectively. The revenue is related to the recognized portion of the $5 million upfront payment received from Merck Serono in conjunction with the February 2013 Option and License Agreement between Opexa and Merck Serono. The unearned revenue will be recognized over the expected term of Merck’s period to exercise its option to license Tcelna for multiple sclerosis. No revenues were recognized during the three and six months ended June 30, 2012.
- Research and development expenses were $2,223,030 and $3,844,396 for the three and six months ended June 30, 2013, respectively, compared with $1,558,208 and $3,048,305 for the three and six months ended June 30, 2012, respectively. The increase for the three and six months ended June 30, 2013 compared to the three and six months ended June 30, 2012 was primarily due to an increase in the procurement and use of supplies for product manufacturing and development, the initiation of clinical sites and increasing enrollment of patients for the ongoing clinical trial of Tcelna in SPMS and an increase in the number of employees to support the ongoing clinical trial, and was partially offset by costs associated with the training and qualification activities preceding the commencement of the clinical trial in the second half of 2012.
- Cash and cash equivalents were $5,028,280 as of June 30, 2013 compared to $592,004 as of December 31, 2012. Inclusive of the $5 million upfront payment received from Merck Serono in conjunction with the License and Option Agreement, our financing activities generated approximately $9.5 million in gross proceeds for the six months ended June 30, 2013.
- Opexa reported a net loss for the three and six months ended June 30, 2013 of $3.0 million, or $0.37 per share, and $7.17 million, or $0.94 per share, respectively. For the same three and six month period ended June 30, 2012, Opexa reported a net loss of $2.16 million, or $0.38, and $4.54 million, or $0.79, respectively.
Photo from http://www.opexatherapeutics.com.