Investors & Media
Axovant Announces First Fiscal Quarter 2018 Financial Results and Corporate Update
- Pipeline expanded with gene therapy technologies including AXO-Lenti-PD for treatment of Parkinson’s Disease and AXO-AAV-OPMD for treatment of oculopharyngeal muscular dystrophy
Ilise Lombardo, MD, promoted to Chief Medical Officer
- Leadership and advisory team broadened with experts in gene therapy and neurological disorders
“Axovant is methodically rebuilding its clinical pipeline with the goal of becoming a leader in neurological gene therapies. We are focused on transformative approaches that can have a significant impact on the lives of patients suffering from debilitating or potentially life-threatening conditions. With the promotion of
“We also continue to identify opportunities to further strengthen our pipeline, focusing on programs that will be in the clinic in the next 12 to 18 months and that have genetically-identifiable targets in indications with well-characterized biology. I look forward to providing additional updates as these efforts progress.”
Key Highlights since
- Announced global licensing agreement for AXO-Lenti-PD, an investigational gene therapy for Parkinson’s disease, from
Oxford BioMedica. Axovant expects to initiate a Phase 1/2 dose escalation study of AXO-Lenti-PD in patients with advanced Parkinson’s disease by the end of 2018, with initial clinical data from the study available in 2019.
- Announced global licensing agreement with
Benitec Biopharmafor AXO-AAV-OPMD, a potential one-time treatment for oculopharyngeal muscular dystrophy, and a broader platform collaboration for development of five additional gene therapy products in neurological disorders. Axovant plans to initiate a placebo-controlled clinical study of AXO-AAV-OPMD in 2019.
$25.0 millionnet proceeds from private placement of common stock to Roivant Sciences Ltd.
- Additional leadership hires included Dr.
Gavin Corcoranas Executive Vice President of Research & Development and Dr. Fraser Wrightas Chief Technology Officer overseeing the Company’s gene therapy initiatives.
- Announced the formation of
Scientific Advisory Boardto be led by Dr. Michael Hayden, who was also named as a senior scientific advisor to the Company.
Today, Axovant announced the promotion of
“I am excited about our new gene therapy pipeline that will leverage our expertise in the clinical development of treatments for debilitating neurological diseases,” commented Dr. Lombardo. “We have the opportunity to drive the growth of the Company based on transformative science, and I am honored to take on the role of CMO at this time.”
Top-line data from the Phase 2 study evaluating nelotanserin for treatment of REM Sleep Behavior Disorder in subjects with Lewy body dementia are expected in the second half of 2018. We plan to determine the overall development strategy for nelotanserin once we have reviewed the final data from this study and have completed our ongoing comprehensive clinical, regulatory and commercial review.
For the first fiscal quarter ended
Net cash used in operating activities was
Axovant is a clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of novel therapeutics in the fields of neurology and psychiatry. We are developing a pipeline of clinical and nonclinical product candidates that focuses on the various aspects of debilitating neurodegenerative diseases such as Parkinson's disease, oculopharyngeal muscular dystrophy, Lewy body dementia and other indications in the fields of neurology and psychiatry. Our goal is to be the leading biopharmaceutical company focused on the fields of neurology and psychiatry.
For more information, visit www.axovant.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,” “plan,” “goal,” “anticipate,” “believe,” “estimate,” “undoubtedly,” “project,” “intend,” “future,” “potential,” “continue,” or “well-positioned” 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 and clinical trials and its research and development programs, its ability to advance its small molecule and gene therapies into, and successfully initiate, enroll and complete, clinical trials, the potential clinical utility of its product candidates, its ability to continue to develop its small molecule and 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,
|AXOVANT SCIENCES LTD.
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share amounts)
|Three Months Ended
June 30, 2018
|Three Months Ended
June 30, 2017
|Research and development expenses(1)|
|(includes share-based compensation expense of $2,517 and $6,256 for the three months ended June 30, 2018 and 2017, respectively)||$||37,418||$||43,712|
|General and administrative expenses(2)|
|(includes share-based compensation expense of $3,342 and $9,344 for the three months ended June 30, 2018 and 2017, respectively)||11,754||21,518|
|Total operating expenses||49,172||65,230|
|Other expense (income)||668||(357||)|
|Loss before income tax expense||(51,810||)||(66,747||)|
|Income tax expense||78||2,519|
|Net loss per common share — basic and diluted||$||(0.48||)||$||(0.65||)|
|Weighted average common shares outstanding — basic and diluted||107,789,920||106,400,912|
|AXOVANT SCIENCES LTD.
Condensed Consolidated Balance Sheets
(Unaudited, in thousands)
|June 30, 2018||March 31, 2018|
|Prepaid expenses and other current assets||7,448||2,174|
|Income tax receivable||1,616||1,751|
|Total current assets||101,998||158,262|
|Other non-current assets||3,784||—|
|Property and equipment, net||1,802||2,524|
|Liabilities and Shareholders’ Equity|
|Due to RSL, RSI and RSG||2,156||1,011|
|Current portion of long term debt||14,791||9,753|
|Total current liabilities||43,511||46,575|
|Long term debt||38,247||42,925|
|Total shareholders’ equity||25,826||71,286|
|Total liabilities and shareholders’ equity||$||107,584||$||160,786|
Source: Axovant Sciences Ltd.