Full Press Release Details
REGENXBIO Reports Third Quarter 2017 Financial Results and Recent Operational Highlights
ROCKVILLE, Md., November 8, 2017 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV Technology Platform, today announced financial results for the third quarter ended September 30, 2017 and recent operational highlights.
"We continue to make meaningful progress in the clinical development of our lead product candidates, most notably with the recent completion of dosing of the second cohort in our Phase I clinical trial evaluating RGX-314 for the treatment of wet AMD and completion of dosing in the first cohort in our Phase I/II clinical trial evaluating RGX-501 for the treatment of HoFH," said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. "We remain committed to advancing our internal and partnered gene therapy product candidates, leveraging our proprietary NAV Technology Platform to evaluate the curative potential of one-time administrations of gene therapy for patients with significant unmet need. We look forward to providing additional trial details on our lead product candidates, including interim updates from the RGX-314 Phase I clinical trial and the RGX-501 Phase I/II clinical trial, as part of our year-end 2017 corporate update."
Recent Operational Highlights
Cash, cash equivalents and marketable securities were $191.1 million as of September 30, 2017, compared to $159.0 million as of December 31, 2016.
Revenues were $1.3 million for the three months ended September 30, 2017, compared to $0.1 million for the three months ended September 30, 2016.
Total operating expenses were $22.6 million for the three months ended September 30, 2017, compared to $18.8 million for the three months ended September 30, 2016.
Net loss was $20.7 million, or $0.67 net loss per basic and diluted common share, for the three months ended September 30, 2017, compared to $18.2 million, or $0.69 net loss per basic and diluted share, for the three months ended September 30, 2016.
REGENXBIO continues to expect full-year 2017 cash burn to be between $75 million and $80 million, which will support the continued development of its lead product candidate programs. Full-year 2017 cash burn guidance excludes the effect of REGENXBIO's previously announced underwritten public offering of common stock in March 2017, which resulted in aggregate net proceeds to REGENXBIO of approximately $81.5 million, after deducting underwriting discounts and commissions and offering expenses.
Conference Call Information
In connection with the earnings release, REGENXBIO will host a conference call today at 4:30 p.m. ET. To access the live call by phone, dial (855) 422-8964 (domestic) or (210) 229-8819 (international), and enter the passcode 96009722. To access a live or recorded webcast of the call, please visit the "Investors" section of the REGENXBIO website at www.regenxbio.com. The recorded webcast will be available for approximately 30 days following the call.
About REGENXBIO Inc.
REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. REGENXBIO's NAV Technology Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates in multiple therapeutic areas.
Forward Looking Statements
This press release includes "forward-looking statements," within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements express a belief, expectation or intention and are generally accompanied by words that convey projected future events or outcomes such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would" or by variations of such words or by similar expressions. The forward-looking statements include statements relating to, among other things, statements about REGENXBIO's future operations, costs and cash flow. REGENXBIO has based these forward-looking statements on its current expectations and assumptions and analyses made by REGENXBIO in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors REGENXBIO believes are appropriate under the circumstances. However, whether actual results and developments will conform with REGENXBIO's expectations and predictions is subject to a number of risks and uncertainties, including the timing of enrollment, commencement and completion of REGENXBIO's clinical trials; the timing and success of preclinical studies and clinical trials conducted by REGENXBIO and its development partners, the timely development and launch of new products, the ability to obtain and maintain regulatory approval of product candidates, the ability to obtain and maintain intellectual property protection for product candidates and technology, trends and challenges in the business and markets in which REGENXBIO operates, the size and growth of potential markets for product candidates and the ability to serve those markets, the rate and degree of acceptance of product candidates, and other factors, many of which are beyond the control of REGENXBIO. Refer to the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of REGENXBIO's Annual Report on Form 10-K for the year ended December 31, 2016 and comparable "risk factors" sections of REGENXBIO's Quarterly Reports on Form 10-Q and other filings, which have been filed with the U.S. Securities and Exchange Commission (SEC) and are available on the SEC's website at www.sec.gov. All of the forward-looking statements made in this press release are expressly qualified by the cautionary statements contained or referred to herein. The actual results or developments anticipated may not be realized or, even if substantially realized, they may not have the expected consequences to or effects on REGENXBIO or its businesses or operations. Such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Readers are cautioned not to rely too heavily on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this press release. REGENXBIO does not undertake any obligation, and specifically declines any obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
CONSOLIDATED BALANCE SHEETS
(in thousands, except per share data)
| September 30, 2017 | December 31, 2016 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 59,884 | $ | 24,840 | ||||
| Marketable securities | 106,778 | 64,714 | ||||||
| Accounts receivable | 884 | 1,032 | ||||||
| Prepaid expenses | 3,225 | 1,775 | ||||||
| Other current assets | 1,390 | 1,010 | ||||||
| Total current assets | 172,161 | 93,371 | ||||||
| Marketable securities | 24,485 | 69,412 | ||||||
| Property and equipment, net | 11,548 | 9,324 | ||||||
| Restricted cash | 225 | 225 | ||||||
| Other assets | 836 | 400 | ||||||
| Total assets | $ | 209,255 | $ | 172,732 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 2,594 | $ | 1,543 | ||||
| Accrued expenses and other current liabilities | 10,805 | 8,126 | ||||||
| Total current liabilities | 13,399 | 9,669 | ||||||
| Deferred rent, net of current portion | 1,205 | 1,326 | ||||||
| Total liabilities | 14,604 | 10,995 | ||||||
| Stockholders' equity | ||||||||
| Preferred stock; $0.0001 par value; 10,000 shares authorized, and no shares issued and outstanding at September 30, 2017 and December 31, 2016 | - | - | ||||||
| Common stock; $0.0001 par value; 100,000 shares authorized at September 30, 2017 and December 31, 2016; 31,109 and 26,477 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively | 3 | 3 | ||||||
| Additional paid-in capital | 366,960 | 276,354 | ||||||
| Accumulated other comprehensive loss | (553 | ) | (33 | ) | ||||
| Accumulated deficit | (171,759 | ) | (114,587 | ) | ||||
| Total stockholders' equity | 194,651 | 161,737 | ||||||
| Total liabilities and stockholders' equity | $ | 209,255 | $ | 172,732 |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Revenues | ||||||||||||||||
| License revenue | $ | 1,335 | $ | 65 | $ | 8,345 | $ | 2,638 | ||||||||
| Reagent sales | - | 47 | - | 213 | ||||||||||||
| Grant revenue | 1 | 13 | 8 | 42 | ||||||||||||
| Total revenues | 1,336 | 125 | 8,353 | 2,893 | ||||||||||||
| Expenses | ||||||||||||||||
| Costs of revenues | ||||||||||||||||
| Licensing costs | 683 | 13 | 2,085 | 528 | ||||||||||||
| Costs of reagent sales | - | 22 | 6 | 101 | ||||||||||||
| Research and development | 12,518 | 12,560 | 43,054 | 29,423 | ||||||||||||
| General and administrative | 9,444 | 6,200 | 22,421 | 17,848 | ||||||||||||
| Other operating expenses (income) | - | (2 | ) | 74 | (136 | ) | ||||||||||
| Total operating expenses | 22,645 | 18,793 | 67,640 | 47,764 | ||||||||||||
| Loss from operations | (21,309 | ) | (18,668 | ) | (59,287 | ) | (44,871 | ) | ||||||||
| Other Income | ||||||||||||||||
| Investment income | 603 | 514 | 2,115 | 1,512 | ||||||||||||
| Total other income | 603 | 514 | 2,115 | 1,512 | ||||||||||||
| Net loss | $ | (20,706 | ) | $ | (18,154 | ) | $ | (57,172 | ) | $ | (43,359 | ) | ||||
| Other Comprehensive Income (Loss) | ||||||||||||||||
| Unrealized gain (loss) on available-for-sale securities, net of reclassifications of $479 and $20 for the nine months ended September 30, 2017 and 2016, respectively | 93 | 332 | (521 | ) | 1,572 | |||||||||||
| Total other comprehensive income (loss) | 93 | 332 | (521 | ) | 1,572 | |||||||||||
| Comprehensive loss | $ | (20,613 | ) | $ | (17,822 | ) | $ | (57,693 | ) | $ | (41,787 | ) | ||||
| Basic and diluted net loss per common share | $ | (0.67 | ) | $ | (0.69 | ) | $ | (1.94 | ) | $ | (1.64 | ) | ||||
| Weighted-average basic and diluted common shares | 30,940 | 26,469 | 29,440 | 26,386 |
Natalie Wildenradt, 646-681-8192
Adam Pawluk, 202-591-4063