AGTC Announces Financial Results and Business Update for the Quarter Ended September 30, 2018
“Advancing our diversified pipeline of differentiated product candidates continues to be a key priority, and I am pleased with the progress we are making toward that goal,” said
- AGTC received a milestone payment of
$10.0 millionfrom Biogen following the successful enrollment of the first patient of the second dose group in the company’s Phase 1/2 clinical trial evaluating the safety and efficacy of an investigational AAV-based gene therapy for the treatment of X-linked retinitis pigmentosa (XLRP).
- AGTC enhanced its Board with the appointment of
William Aliski. Mr. Aliski has extensive leadership and management experience in the life sciences industry and has contributed to the commercialization of several rare disease products and will add insight in advancing commercialization strategies for the Company’s four clinical-stage programs.
AGTC Clinical Program Update
AGTC continues to enhance its clinical infrastructure resulting in the acceleration of clinical enrollment in all of the company’s ongoing clinical trials. These resources have allowed AGTC to expand patient recruitment efforts, introduce new clinical trial sites, conduct surgical training and enhance clinical site support.
XLRP Phase 1/2 Clinical Trial
AGTC has enrolled eight patients in the Phase 1/2 clinical trial of its product candidate for XLRP and expects to complete the dose escalation portion of the XLRP trial in the first quarter of 2019.
ACHM Phase 1/2 Clinical Trials
The company is presently enrolling patients in two parallel Phase 1/2 clinical trials of its product candidates for achromatopsia (ACHM) caused by mutations in the two most common ACHM genes, CNGB3 and CNGA3. In the ACHM CNGB3 trial, AGTC has enrolled a total of ten patients. The company expects to complete the dose escalation portion of the CNGB3 trial in the first quarter of 2019. In the ACHM CNGA3 trial, the company has enrolled four patients.
XLRS Phase 1/2 Clinical Trial
In April, AGTC completed its target enrollment of 27 patients in the Phase 1/2 clinical trial for its x-linked retinoschisis (XLRS) product candidate as part of the company’s collaboration with Biogen. The primary endpoint of this clinical trial is safety, and available data to date have shown that the XLRS product candidate is generally safe and well tolerated. In addition to safety, this trial will measure biologic activity by analyzing changes in a wide number of visual function, retinal structure, and quality of life assessments. The company expects to provide topline interim six-month data across both safety and biologic activity endpoints by the end of
AGTC-Bionic Sight Collaboration
Through the AGTC-Bionic Sight collaboration, the companies are pursuing the development of an innovative optogenetic therapy to treat patients with advanced retinal disease that utilizes AGTC's broad experience in gene therapy and ophthalmology, and Bionic Sight's neuro-prosthetic device and novel algorithm for retinal coding. Bionic Sight expects to file the IND for this product candidate in the first half of 2019.
Financial Results for the Quarter Ended
Revenue: Total revenue for the three months ended
R&D Expenses: Research and development expenses for the three months ended
G&A Expenses: General and administrative expenses for the three months ended
Net Income or Loss: Net income was $1.2 million for the three months ended
Financial Guidance: As of
Conference Call and Webcast
AGTC will host a conference call and webcast to discuss financial results for the first fiscal quarter ended
The archived webcast will be available in the Events and Presentations section of the company's website.
AGTC is a clinical-stage biotechnology company that uses a proprietary gene therapy platform to develop transformational genetic therapies for patients suffering from rare and debilitating diseases. Its initial focus is in the field of ophthalmology, where it has active clinical trials in X-linked retinitis pigmentosa (XLRP), achromatopsia (ACHM CNGB3 & ACHM CNGA3), and X-linked retinoschisis (XLRS). In addition to its clinical trials, AGTC has preclinical programs in optogenetics, adrenoleukodystrophy (ALD), which is a disease of the central nervous system (CNS), and otology. The clinical-stage XLRS and XLRP programs, the discovery program in ALD and two additional ophthalmology programs are being developed in collaboration with Biogen, and the optogenetics program is being developed in collaboration with Bionic Sight. In addition to its product pipeline, AGTC has a significant intellectual property portfolio and extensive expertise in the design of gene therapy products including capsids, promoters and expression cassettes, as well as expertise in the formulation, manufacture and physical delivery of gene therapy products.
About Achromatopsia (ACHM)
Achromatopsia 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, extreme light sensitivity causing day blindness, and complete loss of color discrimination. Best-corrected visual acuity in persons affected by achromatopsia, 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 condition that causes progressive vision loss in boys and young men. Characteristics of the disease include night blindness in early childhood and progressive constriction of the visual field. In general, XLRP patients experience a gradual decline in visual acuity over the disease course, which results in legal blindness around the 4th decade of life. AGTC was granted U.S. Food and Drug (
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.
Forward Looking Statements
This release contains forward-looking statements that reflect AGTC's plans, estimates, assumptions and beliefs. 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, 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. Actual results could differ materially from those discussed in the forward-looking statements, due to a number of important factors. Risks and uncertainties that may cause actual results to differ materially include, among others: gene therapy is still novel with only a few approved treatments so far; AGTC cannot predict when or if it will obtain regulatory approval to commercialize a product candidate or receive reasonable reimbursement; uncertainty inherent in clinical trials and the regulatory review process; risks and uncertainties associated with drug development and commercialization; factors that could cause actual results to differ materially from those described in the forward-looking statements are set forth under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the fiscal year ended
Financial tables follow
|In thousands, except per share data||Sept 30, 2018||June 30, 2018|
|Cash and cash equivalents||$||26,472||$||31,065|
|Prepaid and other current assets||2,527||4,009|
|Total current assets||108,186||109,124|
|Investments, net of current portion||-||-|
|Property and equipment, net||5,016||5,254|
|Intangible assets, net||949||968|
|Investment in Bionic Sight||1,972||1,980|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued and other liabilities||5,677||7,155|
|Total current liabilities||25,025||14,395|
|Deferred revenue, net of current portion||9,106||610|
|Common stock, par value $.001 per share, 150,000 shares authorized;
18,143 and 18,137 shares issued; 18,130 and 18,126 shares outstanding
at September 30, 2018 and June 30, 2018, respectively
|Additional paid-in capital||211,320||210,139|
|Shares held in treasury of: 13 and 11 at September 30, 2018 and June 30,
|Total stockholders' equity||78,939||99,182|
|Total liabilities and stockholders' equity||$||117,328||$||118,532|
STATEMENTS OF OPERATIONS
|For the three months ended Sept 30,|
|In thousands, except per share amounts||2018||2017|
|Grant and other revenue||9||7|
|Research and development||10,065||8,276|
|General and administrative and other||3,213||3,706|
|Total operating expenses||13,278||11,982|
|Income (loss) from operations||756||(1,667||)|
|Investment income, net||471||270|
|Total other income, net||471||270|
|Income (loss) before provision for income taxes||1,227||(1,397||)|
|Provision for income taxes||19||-|
|Income (loss) before equity in net losses of affiliate||1,208||(1,397||)|
|Equity in net losses of affiliate||(8||)||-|
|Net income (loss)||$||1,200||$||(1,397||)|
|Net income (loss) per share, basic||$||0.07||$||(0.08||)|
|Net income (loss) per share, diluted||$||0.07||$||(0.08||)|
|Weighted average shares outstanding, basic||18,128||18,088|
|Weighted average shares outstanding, diluted||18,158||18,088|
Chief Financial Officer
T: (617) 843-5728
Chief Business Officer
T: (617) 413-2754
Source: Applied Genetic Technologies Corporation