AGTC Announces Financial Results and Business Update for the Quarter Ended March 31, 2020
- Company on track to provide multiple data readouts for XLRP and ACHM clinical programs in 2H 2020 -
- Company on track for End of Phase 2 meeting in Q2 2020 -
- Company sees minimal COVID-19 impact to date -
- Company to host conference call and webcast today at
“AGTC started 2020 with significant momentum, announcing sustained improvements in visual function for four of eight centrally dosed patients in our XLRP trial and encouraging preliminary signs of biologic activity in our ACHM trials. The company also completed enrollment in the XLRP trial, completed adult enrollment in both ACHM trials, and strengthened our balance sheet with a successful financing in February,” said
X-linked Retinitis Pigmentosa (XLRP)
- In January, AGTC announced positive interim six-month data from its ongoing Phase 1/2 clinical program in XLRP. The results show that four of eight evaluable patients treated centrally with the company’s product candidate demonstrated durable improvement in visual sensitivity six months after dosing. All patients demonstrated a favorable safety profile for the XLRP candidate, with no dose-limiting inflammatory responses observed and no secondary inflammatory responses requiring re-administration of any steroids in any patients. Preliminary data also showed that all nine centrally dosed patients had stable or improving visual acuity at the six-month time point, a result that has not been reported by others.
- In February, AGTC completed enrollment in the two highest dose groups of its XLRP trial, bringing the total number of patients dosed to 28.
- An End of Phase 2 meeting with the FDA is planned for the second quarter of 2020.
- The company plans to release additional data in the second half of 2020 and initiate a pivotal trial by the end of 2020.
- In January, AGTC announced encouraging interim data from the dose-escalation cohorts of its ongoing Phase 1/2 clinical programs in patients with ACHM due to mutations in the ACHM CNGB3 or ACHM CNGA3 genes. The interim three-month results from both studies demonstrated encouraging signs of biologic activity based on improvements in light discomfort. Interim six-month data from both trials continue to demonstrate a favorable safety profile with no dose-limiting inflammatory responses.
- In March, AGTC completed the planned enrollment in all dose groups for adult patients (age 18 years or older), including the two higher dose groups, of both ACHM trials, bringing the total number of adults dosed to 15 in the ACHM A3 trial and 22 in the ACHM B3 trial. Pediatric dosing is ongoing with three pediatric patients dosed in each trial to date. The company expects that pediatric enrollment will continue to be challenging.
- The company plans to release additional data for the adult dose groups in the second half of 2020, which will be used to inform decision-making regarding readiness to move the product candidates to pivotal trials.
As previously announced at AGTC’s R&D Day on
COVID-19 Business Update
Despite the worldwide impact of the COVID-19 pandemic, AGTC remains on track and expects to report data from its XLRP program and both ACHM programs in the second half of 2020. The company already completed enrollment in the XLRP Phase 1/2 clinical trial and enrollment in all dose groups for adult patients of both ACHM trials. The company also closed a
AGTC is taking appropriate measures to ensure that the health and safety of its employees and patients are protected. The majority of the company’s personnel have been working from home and those corporate facilities and clinical testing sites that are open are operating with the utmost caution and in-line with government guidelines. These precautions and pandemic-related travel restrictions have created challenges for new patients to meet with clinicians and receive proper evaluations.
Financial Results for the Three and Nine Months Ended
Revenue: Total revenue for the three and nine months ended
R&D Expenses: Research and development expenses for the three and nine months ended
G&A Expenses: General and administrative expenses for the three and nine months ended
Net Income (Loss): Net loss for the three and nine months ended
Financial Guidance: As of
Conference Call and Webcast
AGTC will host a conference call and webcast to discuss financial results for the third 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 developing genetic therapies for people with rare and debilitating ophthalmic, otologic and central nervous system (CNS) diseases. AGTC is a leader in designing and constructing all critical gene therapy elements and bringing them together to develop customized therapies that address real patient needs. Initially focusing on ophthalmology, our goal is to preserve or, hopefully, be able to improve vision in some cases. AGTC has active clinical trials in X-linked retinitis pigmentosa and achromatopsia (ACHM CNGB3 & ACHM CNGA3). Our pre-clinical programs build on our industry leading AAV manufacturing technology and expertise. AGTC is advancing multiple important pipeline candidates to address substantial unmet clinical need in optogenetics, otology and CNS disorders.
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
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.
This release contains forward-looking statements that reflect AGTC's plans, estimates, assumptions and beliefs, including statements regarding the timing for reporting data and the commencement of pivotal clinical trials. Forward-looking statements include information concerning possible or assumed future results of operations, financial guidance, business strategies and operations, preclinical and clinical product development and regulatory progress, potential growth opportunities, potential market opportunities, the effects of competition and the impact of the COVID-19 pandemic. 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; the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations, and financial condition; 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 our most recent annual or quarterly report and in other reports we have filed with the
|In thousands, except per share data||
|Cash and cash equivalents||$||58,491||$||26,703|
|Prepaid and other current assets||2,942||2,276|
|Total current assets||87,459||84,284|
|Property and equipment, net||4,216||4,430|
|Intangible assets, net||1,176||1,013|
|Investment in Bionic Sight||8,115||1,945|
|Right-of-use assets – operating leases||3,503||—|
|Right-of-use asset – finance lease||91||—|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued and other liabilities||9,434||8,024|
|Lease liabilities – operating||1,054||—|
|Lease liability – finance||47||—|
|Total current liabilities||13,548||9,355|
|Lease liabilities – operating, net of current portion||4,329||—|
|Lease liability – finance, net of current portion||51||—|
|Preferred stock, par value
|Common stock, par value
|Additional paid-in capital||251,819||214,324|
|Shares held in treasury of 20 and 19 at
|Total stockholders’ equity||84,819||78,709|
|Total liabilities and stockholders’ equity||$||105,104||$||92,216|
STATEMENTS OF OPERATIONS
|In thousands, except per share amounts||2020||2019||2020||2019|
|Grant and other revenue||—||111||156||158|
|Research and development||8,308||7,203||25,325||24,851|
|General and administrative and other||3,134||3,110||9,490||9,345|
|Total operating expenses||11,442||10,313||34,815||34,196|
|Income (loss) from operations||(11,442||)||11,005||(32,362||)||7,090|
|Investment income, net||281||512||1,063||1,504|
|Total other income, net||285||512||1,063||1,504|
|Income (loss) before provision for income taxes||(11,157||)||11,517||(31,299||)||8,594|
|Provision for income taxes||21||19||63||57|
|Income (loss) before equity in net losses of an affiliate||(11,178||)||11,498||(31,362||)||8,537|
|Equity in net losses of an affiliate||(11||)||(9||)||(27||)||(29||)|
|Net income (loss)||$||(11,189||)||$||11,489||$||(31,389||)||$||8,508|
|Weighted Average Shares Outstanding|
|Net income (loss) per common share|
Chief Financial Officer
T: (617) 843-5728
Chief Business Officer
T: (617) 413-2754
Source: Applied Genetic Technologies Corporation