Company Continues to Prepare for Potential Submission of an NDA for Roluperidone in the Third Quarter of 2022
WALTHAM, Mass., Aug. 09, 2022(Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today reported key business updates and financial results for the quarter ended June 30, 2022.
Roluperidone Update
Following the March 2, 2022 Type C Meeting with the Food and Drug Administrationon April 7, 2022, providing an update and an outline of next steps in preparation for the anticipated submission of a New Drug Applicationon April 13, 2022, which is archived and can be accessed under "Events and Presentations" in the Investors and Media section of the Company's website.
Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva Neurosciences said, "Following the Type C meeting last quarter, we continue to be encouraged by our interactions with the FDA and we are preparing our NDA, which is on track for potential submission during the third quarter of 2022. With no treatments currently approved in the US for negative symptoms of schizophrenia, we are committed to addressing this critical need and believe that roluperidone has the potential to improve the lives of people impacted by negative symptoms."
Minerva has conducted two adequate and well controlled studies for the intended indication and is of the opinion that the data from these studies are sufficient to support a marketing application. Following the Type C meeting, the Company submitted additional data to the FDA to address certain matters discussed at the meeting.
Second Quarter 2022 Financial Results
At the annual meeting of shareholders held on June 10, 2022 shareholders approved a 1 for 8 reverse stock split of the Company's common stock. The per share numbers below reflect the reverse stock split for both current and comparable prior periods.
- Net Loss: Net loss was $8.7 million for the three months ended June 30, 2022, or net loss per share of $1.63 (basic and diluted), as compared to net loss for the three months ended June 30, 2021 of $10.6 million, or net loss per share of $1.98 (basic and diluted).
Net loss was $18.5 million for the six months ended June 30, 2022, or net loss per share of $3.46 (basic and diluted), as compared to net loss for the six months ended June 30, 2021 of $19.4 million, or net loss per share of $3.63 (basic and diluted). - R&D Expense: For the three months ended June 30, 2022 and 2021, research and development (R&D) expense was $4.1 million and $5.5 million, respectively, a decrease of approximately $1.4 million. For the three months ended June 30, 2022 and 2021, non-cash stock compensation expense included in R&D was $0.5 million and $0.6 million, respectively. The decrease in R&D expense for the three months ended June 30, 2022 versus the prior year period was primarily due to lower costs for the Phase 3 clinical trial of roluperidone as a result of the completion of the 40-Week Open-Label Extension in May 2021.
For the six months ended June 30, 2022 and 2021, research and development (R&D) expense was $9.1 million and $8.8 million, respectively, an increase of approximately $0.3 million. For the six months ended June 30, 2022 and 2021, non-cash stock compensation expense included in R&D was $1.0 million and $1.3 million, respectively. The increase in R&D expense for the six months ended June 30, 2022 versus the prior year period was primarily due to lower costs for the Phase 3 clinical trial of roluperidone as a result of the completion of the 40-Week Open-Label Extension in May 2021, offset by higher consulting fees related to NDA support activities. - G&A Expense: For the three months ended June 30, 2022 and 2021, general and administrative (G&A) expense was $2.8 million and $3.4 million, respectively, a decrease of approximately $0.6 million. For the three months ended June 30, 2022 and 2021, non-cash stock compensation expense included in G&A was $0.6 million and $0.7 million, respectively.
For the six months ended June 30, 2022 and 2021, general and administrative (G&A) expense was $5.9 million and $7.7 million, respectively, a decrease of approximately $1.8 million. For the six months ended June 30, 2022 and 2021, non-cash stock compensation expense included in G&A was $1.1 million and $1.6 million, respectively.
The decrease in G&A expense for both the three and six months ended June 30, 2022 versus the prior year periods was primarily due to lower staffing related expenses, non-cash stock compensation expense, and lower legal and insurance costs. - Non-cash Interest Expense for the Sale of Future Royalties: For the three months ended June 30, 2022 and 2021, non-cash interest expense for the sale of future royalties was $1.8 million and $1.6 million, respectively, an increase of approximately $0.2 million. For the six months ended June 30, 2022 and 2021, non-cash interest expense for the sale of future royalties was $3.6 million and $2.9 million, respectively, an increase of approximately $0.7 million. The increase in non-cash interest expense for both the three and six months ended June 30, 2022 versus the prior year periods was primarily due to interest accruing with effect from January 19, 2021, the date at which the Company entered into an agreement to sell our royalty interest in seltorexant to Royalty Pharma, as well as an increase in the underlying balance of the liability, which totaled $69.9 million at June 30, 2022. The effective interest rate is based upon estimates which contain significant assumptions regarding the timing and amount of expected royalty and milestone payments to be recognized over the royalty period.
- Cash Position: Cash, cash equivalents and restricted cash as of June 30, 2022 and December 31, 2021 were approximately $49.9 million and $60.9 million, respectively.
About Minerva Neurosciences
Minerva Neurosciences, Inc..
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management's expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include, but not limited to, statements herein with respect to the clinical development of roluperidone as monotherapy for the treatment of negative symptoms of schizophrenia; the potential benefits of roluperidone; the adequacy and efficacy of our clinical trials and studies with roluperidone, and the sufficiency of the data from such trials and studies to support marketing application; our interpretation of the feedback from the U.S. Food and Drug Administration. The forward-looking statements in this press release are based on information available to us as of the date hereof, and we expressly disclaim any obligation to update any forward-looking statements, except as required by law.
| For more information: | |
| Investor inquiries: | Media Inquiries: |
| Fred Ahlholm | Helen Shik |
| CFO, Minerva Neurosciences | Principal, Shik Communications LLC |
| info@minervaneurosciences.com (mailto:info@minervaneurosciences.com) | helen@shikcommunications.com (mailto:helen@shikcommunications.com) |
| CONDENSED CONSOLIDATED BALANCE SHEET DATA | ||||||||
| (Unaudited) | ||||||||
| June 30, 2022 | December 31, 2021 | |||||||
| (in thousands) | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 49,754 | $ | 60,755 | ||||
| Restricted cash | 100 | 100 | ||||||
| Prepaid expenses and other current assets | 184 | 1,346 | ||||||
| Total current assets | 50,038 | 62,201 | ||||||
| Capitalized software, net | 52 | 52 | ||||||
| Goodwill | 14,869 | 14,869 | ||||||
| Total Assets | $ | 64,959 | $ | 77,122 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 1,520 | $ | 1,853 | ||||
| Accrued expenses and other current liabilities | 1,889 | 966 | ||||||
| Total current liabilities | 3,409 | 2,819 | ||||||
| Long-Term Liabilities: | ||||||||
| Liability related to the sale of future royalties | 69,932 | 66,327 | ||||||
| Total liabilities | 73,341 | 69,146 | ||||||
| Stockholders' Equity: | ||||||||
| Common stock | 1 | 1 | ||||||
| Additional paid-in capital | 344,801 | 342,676 | ||||||
| Accumulated deficit | (353,184) | (334,701) | ||||||
| Total stockholders' equity | (8,382) | 7,976 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 64,959 | $ | 77,122 | ||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended June 30, (in thousands, except per share amounts) | Six Months Ended June 30, (in thousands, except per share amounts) | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 4,132 | $ | 5,521 | $ | 9,092 | $ | 8,780 | ||||||||
| General and administrative | 2,833 | 3,442 | 5,862 | 7,691 | ||||||||||||
| Total operating expenses | 6,965 | 8,963 | 14,954 | 16,471 | ||||||||||||
| Loss from operations | (6,965) | (8,963) | (14,954) | (16,471) | ||||||||||||
| Foreign exchange losses | 2 | (19) | (2) | (24) | ||||||||||||
| Investment income | 72 | 5 | 80 | 9 | ||||||||||||
| Non-cash interest expense for the sale of future royalties | (1,827) | (1,612 ) | (3,606) | (2,908) | ||||||||||||
| Net loss | (8,718) | (10,589) | (18,482) | (19,394) | ||||||||||||
| Net loss per share, basic | $ | (1.63) | $ | (1.98) | $ | (3.46) | $ | (3.63) | ||||||||
| Weighted average shares outstanding, basic and diluted | 5,340 | 5,340 | 5,340 | 5,340 | ||||||||||||
