GAINESVILLE, Fla., May 14, 2014 (GLOBE NEWSWIRE) -- Applied Genetic Technologies Corporation (Nasdaq:AGTC), a clinical stage biotechnology company developing adeno-associated virus (AAV)-based gene therapies for the treatment of rare eye diseases, today announced financial results for the three and nine months YTD ended March 31, 2014.
"We successfully completed our initial public offering in early April, which provides us with the financial resources to support our strategy of developing a portfolio of gene therapy-based products for orphan eye diseases," said Sue Washer, President and CEO. "We are pleased to report that we remain on track to meet the timelines for each of our product candidates that we outlined in the final prospectus for our initial public offering."
Select Financial Results for the Quarter Ended March 31, 2014
Total revenue for the three months ended March 31, 2014 was $232,000 compared with $116,000 in the same period in 2013. The increase was primarily due to the inception of new grant-funded projects related to the Company's ACHM product candidate.
Research and development expense was $2.1 million in the three months ended March 31, 2014 compared with $744,000 in the same period in 2013. The increase was due to activities needed to advance the company's XLRS and ACHM product candidates, including increased facilities costs relating to new laboratory expansion, and new hires.
General and administrative expense increased by $1.0 million from $323,000 for the three months ended March 31, 2013 to $1.4 million for the three months ended March 31, 2014. The increase was the result of increased personnel costs relating to new hires, as well as increased legal and accounting costs.
The Company reported a net loss of $3.6 million in the quarter ended March 31, 2014 compared with $1.6 million for the same period in 2013.
As of March 31, 2014, the Company had cash and cash equivalents and short-term investments of $24.5 million. This amount does not include the net proceeds from the Company's initial public offering, which closed on April 1 and April 3, 2014. The aggregate net proceeds to AGTC, after underwriting discounts and commissions and estimated offering expenses, were $51.8 million.
About AGTC
AGTC is a clinical-stage biotechnology company that uses its proprietary gene therapy platform to develop products designed to transform the lives of patients with severe inherited orphan diseases in ophthalmology. AGTC's lead product candidates, which are each in the preclinical stage, focus on X-linked retinoschisis, achromatopsia and X-linked retinitis pigmentosa, which are rare diseases of the eye, caused by mutations in single genes, that significantly affect visual function and currently lack effective medical treatments.
About X-linked Retinoschisis (XLRS)
XLRS is an inherited retinal disease caused by mutations in the RS1 gene, which encodes the retinoschisin protein. It is characterized by abnormal splitting of the layers of the retina, resulting in poor visual acuity in young boys, which can progress to legal blindness in adult men.
About Achromatopsia (ACHM)
ACHM is an inherited retinal disease, which is present from birth and is characterized by the lack of cone photoreceptor function. The condition results in markedly reduced visual acuity light sensitivity causing day blindness, and complete loss of color discrimination. Best-corrected visual acuity in persons affected by ACHM, even under subdued light conditions, is usually about 20/200, a level at which people are considered legally blind.
About X-linked Retinitis Pigmentosa (XLRP)
XLRP is an inherited retinal dystrophy characterized by the progressive loss of vision, one form of which is caused by mutations in the RPGR gene, which encodes a protein essential for normal vision. It is commonly first observed in young men, who notice problems with vision under low light conditions, or night blindness, followed by tunnel vision, leading to poor central vision and eventual total blindness.
Forward Looking Statements
Statements in this press release should be read in conjunction with the Company's financial statements and related notes and Management's Discussion and Analysis of Financial Condition and Result of Operations appearing in the Company's registration statement on Form S-1 (File No. 333-193309), as amended, filed with the SEC. In addition to historical financial information, the following discussion contains forward-looking statements that reflect the Company's plans, estimates, assumptions and beliefs. Actual results could differ materially from those discussed in the forward-looking statements. Forward-looking statements include information concerning possible or assumed future results of operations, business strategies and operations, preclinical and clinical product development and regulatory progress, financing plans, potential growth opportunities, potential market opportunities and the effects of competition. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as "anticipates," "believes," "could," "seeks," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" or similar expressions and the negatives of those terms. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent management's plans, estimates, assumptions and beliefs only as of the date of this release. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
Financial tables follow
| APPLIED GENETIC TECHNOLOGIES CORPORATION | |||
| BALANCE SHEETS | |||
| (UNAUDITED) | |||
|
(in thousands, except per share data) |
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|
March 31, 2014 |
Pro forma March 31, 2014 |
June 30, 2013 |
|
| ASSETS | |||
| Current assets | |||
| Cash and cash equivalents | $ 8,030 | $ 8,030 | $ 8,893 |
| Short-term investments | 16,500 | 16,500 | 14,000 |
| Grants receivable | 363 | 363 | 143 |
| Other current assets | 690 | 690 | 475 |
| Total current assets | 25,583 | 25,583 | 23,511 |
| Property and equipment, net | 362 | 362 | 341 |
| Intangible assets, net | 1,573 | 1,573 | 1,630 |
| Other assets | 1,752 | 1,752 | 8 |
| Total assets | $ 29,270 | $ 29,270 | $ 25,490 |
| LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS' (DEFICIT) EQUITY | |||
| Current liabilities | |||
| Accounts payable | $ 1,253 | $ 1,253 | $ 792 |
| Accrued expenses | 921 | 921 | 359 |
| Deferred revenue | — | — | 212 |
| Current portion of debt and capital lease | — | — | 1 |
| Series B purchase rights | — | — | 2,096 |
| Total current liabilities | 2,174 | 2,174 | 3,460 |
| Long-term liabilities | |||
| Warrant liabilities | 551 | — | 110 |
| Total liabilities | 2,725 | 2,174 | 3,570 |
| Commitments and contingencies | |||
| Series A-1 convertible preferred stock, par value $0.001 per share, 29,737 shares authorized at June 30, 2013 and March 31, 2014, 22,466 and 22,467 shares issued and outstanding at June 30, 2013 and March 31, 2014, respectively, and no shares issued and outstanding pro forma (aggregate liquidation preference of $21,699) | 21,527 | — | 21,526 |
| Series A-1A convertible preferred stock, par value $0.001 per share, 11,572 shares authorized, 11,479 shares issued and outstanding at June 30, 2013 and March 31, 2014, and no shares issued and outstanding pro forma (aggregate liquidation preference of $11,086) | 10,998 | — | 10,998 |
| Series B-1 convertible preferred stock, par value $0.001 per share, 67,570 shares authorized, 66,147 shares issued and outstanding at June 30, 2013 and March 31, 2014, and no shares issued and outstanding pro forma (aggregate liquidation preference of $8,579) | 6,539 | — | 6,539 |
| Series B-2 convertible preferred stock, par value $0.001 per share, 140,542 shares authorized, 122,750 shares issued and outstanding at June 30, 2013 and March 31, 2014, and no shares issued and outstanding pro forma (aggregate liquidation preference of $18,228) | 19,040 | — | 19,040 |
| Series B-3 convertible preferred stock, par value $0.001 per share, 82,670 shares authorized, no shares issued and outstanding at June 30, 2013 and pro forma, 58,817 shares issued and outstanding March 31, 2014 (aggregate liquidation preference of $10,722) | 15,617 | — | — |
| Stockholders' (deficit) equity | |||
| Common stock, par value $.001 per share, 150,000 shares authorized, 166 shares issued and outstanding at June 30, 2013 and March 31, 2014, and 9,286 shares issued and outstanding pro forma | — | 9 | — |
| Additional paid-in capital | 12,637 | 86,900 | 12,243 |
| Accumulated deficit | (59,813) | (59,813) | (48,426) |
| Total stockholders' (deficit) equity | (47,176) | 27,096 | (36,183) |
| Total liabilities, convertible preferred stock and stockholders' (deficit) equity | $ 29,270 | $ 29,270 | $ 25,490 |
| APPLIED GENETIC TECHNOLOGIES CORPORATION | ||||
| STATEMENTS OF OPERATIONS | ||||
| (UNAUDITED) | ||||
| (in thousands, except per share data) | ||||
|
Three Months Ended March 31, |
Nine Months Ended March 31, |
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| 2014 | 2013 | 2014 | 2013 | |
| Revenue | ||||
| Grant revenue | $ 182 | $ 33 | $ 648 | $ 326 |
| Sponsored research revenue | 50 | 83 | 357 | 239 |
| Total revenue | 232 | 116 | 1,005 | 565 |
| Operating expenses | ||||
| Research and development | 2,128 | 744 | 5,801 | 1,900 |
| General and administrative | 1,364 | 323 | 3,335 | 972 |
| Total operating expenses | 3,492 | 1,067 | 9,136 | 2,872 |
| Loss from operations | (3,260) | (951) | (8,131) | (2,307) |
| Other income (expense) | ||||
| Interest income | 8 | 1 | 23 | 1 |
| Interest expense | — | (20) | — | (172) |
| Fair value adjustments to warrant liabilities | (336) | 3 | (441) | 8 |
| Fair value adjustments to Series B purchase rights | — | (655) | (2,838) | (1,092) |
| Total other income (expense) | (328) | (671) | (3,256) | (1,255) |
| Net loss | $ (3,588) | $ (1,622) | $ (11,387) | $ (3,562) |
| Net loss per share, basic and diluted | $ (25.45) | $ (14.88) | $ (95.69) | $ (32.68) |
| Weighted-average shares outstanding, basic and diluted | 141 | 109 | 119 | 109 |