Ovid Therapeutics Reports Second Quarter 2020 Financial Results and Provides Corporate Update
- Announces completion of enrollment in the pivotal Phase 3 NEPTUNE trial with OV101 in Angelman syndrome; topline results expected in Q4 2020
- Multiple data readouts for soticlestat expected in Q3 2020, including from the randomized Phase 2 ELEKTRA trial in Dravet syndrome and Lennox-Gastaut syndrome, the Phase 2 ARCADE trial in CDKL5 deficiency disorder and Dup15q syndrome and the ENDYMION open-label extension study
- Receipt of Rare Pediatric Disease Designation by the FDA for OV101 for the treatment of Angelman syndrome, which if approved by the FDA can result in a priority review voucher
- Entered into an exclusive license agreement with Angelini Pharma to develop, manufacture and commercialize OV101 for the treatment of Angelman syndrome in
- Expanded early-stage pipeline research activities through a license agreement with
University of Connecticut School of Medicineand a strategic research collaboration with Columbia University Irving Medical Center
"Ovid is in an exciting and transformational period. We expect a number of important late-stage data readouts across our pipeline this quarter and over the remainder of the year,” said
Pipeline Updates and Recent Highlights
OV101 (gaboxadol) for Angelman Syndrome
- Ovid has completed enrollment in the pivotal Phase 3 NEPTUNE trial of OV101 in Angelman syndrome. Topline results from the trial are expected in the fourth quarter of 2020. NEPTUNE, if positive, will be part of a broad data set intended to support registrational filings for OV101 in the
U.S.and the rest of the world.
- Ovid entered into an exclusive license agreement with Angelini Pharma to develop, manufacture and commercialize OV101 for the treatment of Angelman syndrome in
Europe. Terms of the agreement include an upfront payment of $20 millionfrom Angelini with Ovid eligible to receive up to an additional $212.5 millionin payments upon the achievement of development, manufacturing and sales milestones for the initial indication (Angelman syndrome), as well as double-digit royalties, above the teens, on net sales if OV101 is successfully commercialized. Ovid retains all U.S.and rest-of-world commercial rights to OV101.
June 2020, the U.S. Food and Drug Administration(FDA) granted Rare Pediatric Disease Designation to OV101 for the treatment of Angelman syndrome. If a new drug application (NDA) for OV101 in Angelman syndrome is approved, Ovid may be eligible to receive a priority review voucher from the FDA, which can be redeemed to obtain priority review for any subsequent marketing application or may be transferred and/or sold to other companies.
OV101 for Fragile X Syndrome
- Ovid announced positive topline results from the Phase 2 ROCKET trial with OV101 in Fragile X syndrome in
May 2020, and the Company plans to meet with regulatory authorities to discuss the future development path and registration pathway.
OV935 (soticlestat) for Rare Developmental and Epileptic Encephalopathies (DEE)
- Results from the Phase 2 ARCADE trial in CDKL5 deficiency disorder (CDD) and Dup15q syndrome are expected in the third quarter of 2020.
- Results from the randomized Phase 2 ELEKTRA trial in patients with Dravet syndrome and Lennox-Gastaut syndrome (LGS) are expected in the third quarter of 2020.
- To date, all patients who have completed the Phase 2 ARCADE and ELEKTRA trials have rolled over into the ENDYMION open-label extension study. Ovid plans to report updated data from ENDYMION in the third quarter of 2020.
Summary of Anticipated Clinical Data Readouts
|Product Candidate||Trial||Condition or Disease||Phase of Clinical Trial||Expected Timing of Data Release|
|Soticlestat||ARCADE||CDD or Dup15q syndrome||Phase 2||3Q 2020|
|Soticlestat||ELEKTRA||Dravet syndrome or LGS||Phase 2||3Q 2020|
|Soticlestat||ENDYMION||CDD, Dup15q syndrome, Dravet syndrome, LGS, other DEEs||Open-label Extension
|OV101||NEPTUNE||Angelman syndrome||Phase 3||4Q 2020|
Expansion of Early-Stage Pipeline Research Activities
- Ovid and the
University of Connecticut School of Medicine(UConn) announced a license agreement to accelerate the development of a next-generation short hairpin RNA (shRNA)-based therapeutic for Angelman syndrome and potentially other indications. Ovid will work closely with UConn’s Stormy J. Chamberlain, Ph.D., and gain exclusive access to identified genetic sequences for a shRNA-based therapeutic for potential future use alone or in combination with OV101 in Angelman syndrome.
- Ovid entered into a research collaboration with
Columbia University Irving Medical Centerresearchers to focus on development of potential medicines using genetic-based therapies and create a therapeutic platform for a range of rare neurological conditions such as KIF1A-associated neurological disorder (KAND).
Pipeline Teach-In Webinar Series
June 2020, Ovid hosted a webinar to review the Company’s soticlestat development program for rare developmental and epileptic encephalopathies (DEE).
- Ovid is planning to hold a second educational webinar early in the fourth quarter of 2020 to review the Company’s OV101 development program for Angelman syndrome and Fragile X syndrome.
Second Quarter 2020 Financial Results
- As of
June 30, 2020, cash and cash equivalents totaled $41.3 million. Additionally, the Company received an upfront net payment from Angelini Pharma of $19.6 millionin July 2020.
- Research and development expenses were
$16.0 millionfor the second quarter ended June 30, 2020, as compared to $9.1 millionfor the same period in 2019. The increase of $6.9 millionwas primarily due to an increase in clinical activities related to Ovid’s ongoing development programs.
- General and administrative expenses were
$7.1 millionfor the second quarter ended June 30, 2020, as compared to $4.2 millionfor the same period in 2019. The increase of $2.9 millionwas primarily due to an increase in legal fees, compliance and pre-commercialization expenses and professional fees, payroll and payroll-related expenses and general office expenses.
- The Company reported a net loss of
$22.6 million, or basic and diluted net loss per share attributable to common stockholders of $0.41, for the second quarter of 2020, as compared to a net loss of $13.1 million, or net loss per share attributable to common stockholders of $0.34, for the same period in 2019.
This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding: development and commercialization of our programs, development of combination therapies, potential benefits of OV101, OV935 and our other research programs, anticipated reporting schedule of clinical data and the potential benefits and value of certain licenses and collaborations and the potential benefits of the Rare Pediatric Disease Designation. You can identify forward-looking statements because they contain words such as “will,” “appears,” “believes” and “expects.” Forward-looking statements are based on Ovid’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include uncertainties in the development and regulatory approval processes, and the fact that initial data from clinical trials may not be indicative, and are not guarantees, of the final results of the clinical trials and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and/or more patient data become available. Additional risks that could cause actual results to differ materially from those in the forward-looking statements are set forth in Ovid’s filings with the
Condensed Consolidated Statements of Operations
|For the Three Months Ended
||For the Three Months Ended
||For the Six Months Ended
||For the Six Months Ended
|Research and development||$||16,032,945||$||9,117,495||$||30,658,313||$||18,454,804|
|General and administrative||7,108,742||4,204,771||12,777,759||8,920,999|
|Total operating expenses||23,141,687||13,322,266||43,436,072||27,375,803|
|Loss from operations||(23,141,687||)||(13,322,266||)||(43,436,072||)||(27,375,803||)|
|Net loss attributable to common stockholders||$||(22,551,196||)||$||(13,057,267||)||$||(42,581,286||)||$||(26,857,462||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.41||)||$||(0.34||)||$||(0.77||)||$||(0.78||)|
|Weighted-average common shares outstanding basic and diluted||55,607,110||38,693,018||55,161,360||34,534,432|
Selected Condensed Balance Sheet Data
|Cash, cash equivalents and short-term investments||$||41,253,898||$||76,739,113|
|Total stockholders' equity||$||30,482,914||$||70,023,561|
|1Working capital defined as current assets less current liabilities|
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Source: Ovid Therapeutics Inc.