Investors & Media Press Releases
Axovant Announces Financial Results and Corporate Updates for Fourth Quarter and Fiscal Year Ended March 31, 2019
- Established diversified pipeline of three clinical-stage gene therapy programs for serious neurological disorders including Parkinson’s disease, GM1 gangliosidosis, and Tay-Sachs
- SUNRISE-PD Phase 2 trial of AXO-Lenti-PD for Parkinson's disease continues to enroll patients in second dose cohort with data expected in the fourth quarter of 2019
- Reported initial data from Tay-Sachs patient dosed with AXO-AAV-GM2 in
March 2019; additional data from patients dosed with AXO-AAV-GM1 and AXO-AAV-GM2 expected in second half of 2019
$94.5 millionin net equity capital from healthcare-dedicated investors in fiscal year ended March 31, 2019
- Net loss for the quarter ended
March 31, 2019was $9.0 million, or $0.45per share, compared to a net loss of $25.3 million, or $1.88per share, for the prior-year quarter
“The past year has been transformational as Axovant has been rebuilt around a singular mission of becoming an industry leader in the clinical development of gene therapies for neurological diseases,” said Pavan Cheruvu, Chief Executive Officer of Axovant. “We have assembled a world-class team with decades of experience in gene therapy development and built a diversified pipeline of clinical-stage programs in collaboration with leading gene therapy institutions. Two of these programs, AXO-Lenti-PD and AXO-AAV-GM2, have already generated encouraging data readouts and continue to enroll patients. Additionally, in historic moments for the field of neurological gene therapies, children with GM1 gangliosidosis and Tay-Sachs disease were dosed with gene therapy for the first time at our partner institutions.”
“We expect a data-rich second half of the year with key clinical readouts across all three of our gene therapy programs. Over the last year, we have taken steps to direct our focus and resources towards the clinical programs that will drive long-term value for our shareholders. I’m incredibly proud of the new direction that Axovant is taking, and we look forward to continuing to drive innovative science to transform the lives of patients and their families.”
Key Highlights and Development Updates
- Reported six-month data from the first cohort of the dose escalation portion of the SUNRISE-PD study of AXO-Lenti-PD in Parkinson’s disease patients. AXO-Lenti-PD was observed to be generally well tolerated at six months and continued to demonstrate benefits in both patients across multiple measures after a single administration. Enrollment in the second dose cohort has begun, with initial data from up to six patients in this cohort expected in the fourth quarter of 2019.
- Reported initial data from the AXO-AAV-GM2 study in
March 2019, which suggested that the gene therapy was generally well-tolerated and no serious adverse events in a patient with advanced Tay-Sachs disease. An apparent increase in β-Hexosaminidase A enzyme activity at three months was reported, and the patient’s clinical condition was stable from baseline. Axovant expects to enroll patients in a multi-subject clinical trial in the second half of 2019.
- AXO-AAV-GM1 is currently being evaluated for the potential treatment of GM1 gangliosidosis, with the first patient dosed in
May 2019by collaborators at the National Institutes of Health. Axovant expects initial data from this clinical program in the second half of 2019 with continued enrollment of patients throughout 2019.
- Terminated the license and collaboration agreement with
Benitec Biopharma Limitedfollowing the decision to no longer pursue development of AXO-AAV-OPMD and related gene therapy products.
$94.5 millionin net equity in fiscal year ended March 31, 2019, including $37.9 millionof net equity financing in March 2019led by existing shareholders and several new healthcare-dedicated investors.
- Announced the formation of Arvelle Therapeutics and the strategic transition of the legacy small molecule team with Axovant receiving an approximate 5% preferred equity stake in Arvelle.
- Hosted first R&D Day for investors and analysts in
March 2019to highlight development updates, scientific and clinical insights from prominent physicians and researchers, and patient perspectives across Axovant’s gene therapy pipeline.
- Effected a reverse share split of common shares on a 1-for-8 basis in
May 2019, reducing the shares outstanding from approximately 182.2 million common shares to approximately 22.8 million, and completed name change to Axovant Gene Therapiesand ticker change to AXGT.
Fiscal Fourth Quarter Financial Summary
For the fiscal fourth quarter ended
General and administrative expenses for the fiscal fourth quarter ended
Net loss for the fiscal fourth quarter ended
Fiscal Year Financial Summary
For the fiscal year ended
General and administrative expenses for the fiscal year ended
Net loss for the year ended
Axovant, part of the Roivant family of companies, is a clinical-stage gene therapy company focused on developing a pipeline of innovative product candidates for debilitating neurological and neuromuscular diseases. Our current pipeline of gene therapy candidates targets GM1 gangliosidosis, GM2 gangliosidosis (including Tay-Sachs disease and Sandhoff disease), and Parkinson’s disease. Axovant is focused on accelerating product candidates into and through clinical trials with a team of experts in gene therapy development and through external partnerships with leading gene therapy organizations. For more information, visit www.axovant.com.
Roivant Sciences aims to improve health by rapidly delivering innovative medicines and technologies to patients. It does this by building Vants – nimble, entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives, and deploying technology to drive greater efficiency in R&D and commercialization. For more information, please visit www.roivant.com.
This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” and other similar expressions are intended to identify forward-looking statements. For example, all statements Axovant makes regarding the initiation, timing, progress, and reporting of results of its preclinical programs, clinical trials, and research and development programs; cash to be used in operating activities; its ability to advance its gene therapy product candidates into and successfully initiate, enroll, and complete clinical trials; the potential clinical utility of its product candidates; its ability to continue to develop its gene therapy platforms; its ability to develop and manufacture its products and successfully transition manufacturing processes; its ability to perform under existing collaborations with, among others,
Media and Investors
|AXOVANT GENE THERAPIES LTD.|
|Consolidated Statements of Operations|
|(in thousands, except share and per share amounts)|
|Three Months Ended March 31,||Years Ended March 31,|
|Research and development expenses(1)|
|(includes total share-based compensation expense of $1,459 and $1,972 for the three months ended March 31, 2019 and 2018 and $4,758 and $16,597 for the years ended March 31, 2019 and 2018, respectively)||$||7,149||$||21,799||$||87,552||$||141,412|
|General and administrative expenses(2)|
|(includes total share-based compensation expense of $2,096 and $(11,673) for the three months ended March 31, 2019 and 2018 and $11,671 and $15,281 for the years ended March 31, 2019 and 2018, respectively)||6,157||2,244||39,466||71,906|
|Total operating expenses||13,306||24,043||127,018||213,318|
|Loss before income tax expense (benefit)||(9,137||)||(25,351||)||(128,932||)||(220,652||)|
|Income tax expense (benefit)||(91||)||(32||)||133||921|
|Net loss per common share — basic and diluted||$||(0.45||)||$||(1.88||)||$||(8.02||)||$||(16.51||)|
|Weighted average common shares outstanding — basic and diluted||19,962,170||13,473,509||16,100,686||13,421,984|
(1) Includes total costs allocated from
(2) Includes total costs allocated from
|AXOVANT GENE THERAPIES LTD.|
|Consolidated Balance Sheets|
|(in thousands, except share and per share amounts)|
March 31, 2019
|March 31, 2018|
|Cash and cash equivalents||$||106,999||$||154,337|
|Prepaid expenses and other current assets||5,859||2,174|
|Income tax receivable||1,726||1,751|
|Total current assets||114,584||158,262|
|Other non-current assets||973||—|
|Property and equipment, net||1,278||2,524|
|Liabilities and Shareholders’ Equity|
|Due to Roivant Sciences Ltd., Roivant Sciences, Inc. and Roivant Sciences GmbH||—||1,011|
|Current portion of long-term debt||21,182||9,753|
|Total current liabilities||43,499||46,575|
|Common shares, par value $0.00001 per share, 1,000,000,000 shares authorized, 22,779,891 and 13,473,512 issued and outstanding at March 31, 2019 and March 31, 2018, respectively||—||—|
|Accumulated other comprehensive income||911||126|
|Additional paid-in capital||741,318||628,111|
|Total shareholders’ equity||56,213||71,286|
|Total liabilities and shareholders’ equity||$||122,706||$||160,786|
Source: Axovant Sciences Ltd.