VANCOUVER, Nov. 5, 2015 /PRNewswire/ - ProNAi Therapeutics, Inc. (NASDAQ: DNAI), a clinical-stage oncology company pioneering a novel class of therapeutics based on its proprietary DNAi technology platform, today reported its financial and operational results for the third quarter of 2015.
“We recently announced the initiation of Brighton, a Phase 2 monotherapy trial evaluating our lead DNAi-based product candidate PNT2258 in approximately 50 patients with Richter’s transformation, a rare form of lymphoma with no approved treatments. We also continue to enroll patients in Wolverine, our Phase 2 monotherapy trial of PNT2258 in patients with relapsed or refractory diffuse large B-cell lymphoma, DLBCL, and we remain on track to report initial data from this trial in the second quarter of 2016,” said Dr. Nick Glover, President and CEO of ProNAi Therapeutics. “With these trials underway, we are now preparing planned Phase 2 trials of PNT2258 in combinations with other therapeutics in patients with earlier lines of DLBCL and anticipate initiating the first of these trials in the first half of 2016.”
Third Quarter 2015 Financial Results (all amounts reported in U.S. currency)
Total operating expenses for the three months ended September 30, 2015 were $11.0 million compared to $3.5 million for the three months ended September 30, 2014. Total operating expenses for the nine months ended September 30, 2015 were $24.4 million compared to $19.3 million for the nine months ended September 30, 2014. Total operating expenses include non-cash stock based compensation of $1.3 million and $1.9 million for three and nine months ended September 30, 2015 and of $0.1 million and $0.2 million for the three and nine months ended September 30, 2014.
For the three months ended September 30, 2015, ProNAi incurred a net loss of approximately $18.5 million, compared to a net loss of $4.0 million for the quarter ended September 30, 2014. For the nine months ended September 30, 2015, ProNAi incurred a net loss of $41.8 million compared to a net loss of $20.3 million for the nine months ended September 30, 2014. The net loss includes a non-cash charge related to the change in fair value of preferred stock warrants of $7.5 million and $17.4 million for the three and nine months ended September 30, 2015 and of $0.5 million and $1.0 million for the three and nine months ended September 30, 2014.
Research and development expenses increased to $8.3 million for the three months ended September 30, 2015 from $2.4 million for the three months ended September 30, 2014. Research and development expenses increased to $18.3 million for the nine months ended September 30, 2015 from $17.0 million for the nine months ended September 30, 2014. These increases were primarily due to expenses related to the continuation of our PNT2258 clinical trials, the manufacture of PNT2258 and an increase in personnel-related costs. Expenses for the nine months ended September 30, 2014 include a one-time $11.0 million milestone payment that was made to Novosom AG during the second quarter of 2014.
General and administrative expenses increased to $2.7 million for the three months ended September 30, 2015 from $1.0 million for the three months ended September 30, 2014. General and administrative expenses increased to $6.1 million for the nine months ended September 30, 2015 from $2.3 million for the nine months ended September 30, 2014. These increases were primarily due to increased personnel-related costs and professional fees incurred in support of activities as a public company and corporate growth.
At September 30, 2015, ProNAi had $157.3 million in cash and cash equivalents compared to $39.2 million in cash, cash equivalents and short-term investments at December 31, 2014.
At September 30, 2015, there were approximately 30,058,105 shares of common stock issued and outstanding and 3,314,159 options issued and outstanding.
About ProNAi Therapeutics
ProNAi Therapeutics is a clinical-stage oncology company pioneering a novel class of therapeutics based on its proprietary DNAi technology platform for patients with cancer and hematological diseases. ProNAi’s lead DNAi product candidate, PNT2258, is designed to treat cancers that overexpress BCL2, an important and validated oncogene known to be dysregulated in many types of cancer. ProNAi is pursuing a multi-faceted clinical development strategy designed to efficiently achieve regulatory approval and maximize the commercial opportunity of PNT2258. ProNAi is enrolling patients in “Wolverine”, a Phase 2 trial evaluating PNT2258 for the treatment of relapsed or refractory diffuse large B-cell lymphoma, and in “Brighton”, a Phase 2 trial evaluating PNT2258 for the treatment of Richter’s transformation. For more information, please visit www.pronai.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding ProNAi’s anticipated clinical development activities, including the design, timing and outcome of such activities. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements.
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