CAMBRIDGE, Mass., Dec. 4, 2015 (GLOBE NEWSWIRE) -- Dimension Therapeutics, Inc. (NASDAQ:DMTX), a leading gene therapy company advancing novel, liver-directed treatments for diverse rare diseases, today reported financial results for the third quarter ended September 30, 2015, and provided an update on the company's recent corporate progress.
"With the proceeds from our IPO, we are well-capitalized to maintain the momentum of our gene therapy product portfolio, particularly DTX101, our lead product candidate for hemophilia B which we expect will enter phase 1/2 clinical development by the end of this year," said Annalisa Jenkins, MBBS, MRCP, Chief Executive Officer of Dimension. "Additionally, we are in a strong position to rapidly advance multiple development programs addressing significant unmet medical needs for patients living with rare genetic disorders associated with the liver."
Recent Highlights and Upcoming Milestones
Corporate
- Completed an initial public offering (IPO), raising approximately $64.7 million in net proceeds.
- Expanded leadership team in August 2015 with the appointment of Jean M. Franchi to the newly created position of Chief Financial Officer and Treasurer.
- Expanded Board of Directors with the elections of industry leaders: Georges Gemayel, Ph.D., former Executive Vice President of Genzyme Corporation; Arlene M. Morris, former CEO of Syndax Pharmaceuticals, and Alan B. Colowick, M.D., M.P.H., Executive Vice President of Celgene Corporation.
- Broadened internal research and process development capabilities in November 2015 by signing a lease agreement for state-of-the-art laboratory and office space in Woburn, Massachusetts, with occupancy expected in April 2016.
Hemophilia B
- Prepared to commence multi-center Phase 1/2 study by end of 2015 to evaluate DTX101, a Factor IX (FIX) gene therapy product, in adult patients with moderate/severe to severe hemophilia B.
- Announced FDA's acceptance of the company's investigational new drug (IND) application in September 2015.
- Received Fast Track designation for DTX101 in September 2015 and was granted orphan drug designation for DTX101 in August 2015.
Pipeline
- Further advanced the company's product development pipeline, including DTX201 for hemophilia A via our collaboration with Bayer, DTX301 for OTC deficiency and DTX401 for GSDIa.
Third Quarter 2015 Financial Results
Cash and cash equivalents as of September 30, 2015 were $69.2 million, compared with $80.7 million on June 30, 2015. Cash and cash equivalents as of September 30, 2015 did not include total net proceeds of approximately $64.7 million from the company's initial public offering of common stock in October 2015 and the underwriters' exercise of their over-allotment option in November 2015.
For the quarter ended September 30, 2015, Dimension reported a net loss of $(10.7) million, or $(2.73) per share, compared to a net loss of $(2.5) million, or $(0.70) per share, for the same period in 2014.
- For the quarter ended September 30, 2015, Dimension recognized $2.1 million of revenue associated with our collaboration agreement with Bayer, compared to $1.2 million for the same period in 2014.
- Research and development (R&D) expenses for the quarter ended September 30, 2015, were approximately $10.4 million, compared to $3.2 million for the same period in 2014. The increase was largely due to expenditures in advancing preclinical development of Dimension's pipeline and R&D personnel costs associated with the growth of the company.
- General and administrative (G&A) expenses were $2.3 million for the quarter ended September 30, 2015, compared to $0.5 million for the same period in 2014. The increase was largely due to expenditures in G&A personnel associated with the growth of the company and increased professional fees.
About Dimension Therapeutics
Dimension Therapeutics, Inc. (NASDAQ:DMTX) is a leading gene therapy company focused on discovering and developing new therapeutic products for people living with devastating rare diseases associated with the liver and based on the most advanced adeno-associated virus (AAV) delivery technology. The company is advancing multiple programs toward clinical development, including: programs addressing unmet needs for patients suffering from OTC deficiency and GSDIa, a collaboration with Bayer in hemophilia A, and a wholly owned program in hemophilia B. The company targets diseases with readily identifiable patient populations, highly predictive preclinical models, and well-described, and often clinically validated, biomarkers. Founded in 2013, Dimension maintains headquarters in Cambridge, Massachusetts.
For more information, please visit www.dimensiontx.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the anticipated advantages of the new facility, increased production and scale capacity, development of manufacturing processes and growth in Dimension's portfolio. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include the risks that Dimension's product candidates, including its lead candidate, DTX101, will not successfully be developed or commercialized; and the risks described under the caption "Risk Factors" in Dimension Therapeutics' Registration Statement on Form S-1 (File No. 333-206911), which is on file with the Securities and Exchange Commission, as well as other risks detailed in Dimension Therapeutics' subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Dimension Therapeutics undertakes no duty to update this information unless required by law.
| DIMENSION THERAPEUTICS, INC. | ||||
| CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||
| (In thousands, except share and per share amounts) | ||||
| (Unaudited) | ||||
| Three Months Ended | Nine Months Ended | |||
| September 30, | September 30, | |||
| 2015 | 2014 | 2015 | 2014 | |
| Revenue | $ 2,061 | $ 1,184 | $ 5,397 | $ 1,343 |
| Operating expenses: | ||||
| Research and development | 10,372 | 3,217 | 25,238 | 8,157 |
| General and administrative | 2,334 | 451 | 6,115 | 1,536 |
| Total operating expenses | 12,706 | 3,668 | 31,353 | 9,693 |
| Loss from operations | (10,645) | (2,484) | (25,956) | (8,350) |
| Interest income (expense), net | (22) | — | (72) | — |
| Net loss and comprehensive loss | (10,667) | (2,484) | (26,028) | (8,350) |
| Accretion of convertible preferred stock to redemption value | — | (18) | (23) | (52) |
| Net loss attributable to common stockholders | $ (10,667) | $ (2,502) | $ (26,051) | $ (8,402) |
| Net loss per share attributable to common stockholders — basic and diluted | $ (2.73) | $ (0.70) | $ (6.71) | $ (2.35) |
| Weighted average common shares outstanding — basic and diluted | 3,907,196 | 3,585,603 | 3,880,779 | 3,582,213 |
| DIMENSION THERAPEUTICS, INC. | ||
| CONDENSED BALANCE SHEETS | ||
| (In thousands, except share and per share amounts) | ||
| (Unaudited) | ||
| September 30, | December 31, | |
| 2015 | 2014 | |
| Assets | ||
| Current assets: | ||
| Cash and cash equivalents | $ 69,245 | $ 17,913 |
| Accounts receivable | 2,092 | 1,974 |
| Prepaid expenses and other current assets | 1,694 | 404 |
| Total current assets | 73,031 | 20,291 |
| Property and equipment, net | 3,506 | 1,780 |
| Deferred offering costs | 2,508 | — |
| Other assets | — | 62 |
| Total assets | $ 79,045 | $ 22,133 |
| Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit) | ||
| Current liabilities: | ||
| Accounts payable | $ 775 | $ 675 |
| Accrued expenses and other current liabilities | 4,449 | 1,080 |
| Amounts due to related parties | 21 | 750 |
| Deferred revenue | 6,335 | 5,129 |
| Notes payable | 574 | 358 |
| Total current liabilities | 12,154 | 7,992 |
| Deferred revenue, net of current portion | 16,380 | 17,513 |
| Notes payable, net of discount and current portion | 903 | 1,166 |
| Other liabilities | 64 | — |
| Total liabilities | 29,501 | 26,671 |
| Commitments and contingencies | ||
| Convertible preferred stock (Series A and B), $0.0001 par value; 44,683,824 shares authorized as of September 30, 2015 and 45,000,000 shares authorized as of December 31, 2014; 44,683,824 and 10,000,000 shares issued and outstanding as of September 30, 2015 and December 31, 2014, respectively; liquidation preference of $89,500 and $10,000 as of September 30, 2015 and December 31, 2014 | 88,895 | 9,653 |
| Stockholders' deficit: | ||
| Common stock, $0.0001 par value; 68,000,000 shares authorized as of September 30, 2015 and 65,700,000 shares authorized as of December 31, 2014; 4,105,178 and 4,056,818 shares issued and outstanding as of September 30, 2015 and December 31, 2014, respectively | — | — |
| Additional paid-in capital | 2,815 | 1,947 |
| Accumulated deficit | (42,166) | (16,138) |
| Total stockholders' deficit | (39,351) | (14,191) |
| Total liabilities, convertible preferred stock and stockholders' deficit | $ 79,045 | $ 22,133 |