GlobeNewswire Inc | Aug 2, 2021 07:30AM EDT

August 02, 2021

WALTHAM, Mass., Aug. 02, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (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, 2021.

Roluperidone Update

Following the completion of the open-label portion of the Phase 3 trial with roluperidone in schizophrenia and the Type C meeting with the U.S. Food and Drug Administration (FDA), the Company continues to work towards the submission of a New Drug Application (NDA) in the first half of 2022. On June 29, 2021, the Company completed the enrollment of 48 subjects in a pivotal bioequivalence study with roluperidone in healthy volunteers. The objective of this study is to compare the formulations employed in the Phase 2b and Phase 3 trials with roluperidone, as well as at least one new formulation designed in conjunction with the Companys commercial supplier to facilitate large scale manufacturing. Top line results from this study are expected in the third quarter of 2021. Demonstration of bioequivalence between the formulations used in our late-stage studies with roluperidone will be an important step toward advancing our NDA package, said Dr. Luthringer. We are working in parallel on additional activities to support the submission of the NDA that were informed by interactions we have had since the Type C meeting with the FDA. We continue to view roluperidone as a significant innovative agent for the treatment of negative symptoms of schizophrenia, a key unmet need among patients with this disease.

Second Quarter 2021 Financial Results

-- Net Income/Loss: Net loss was $10.6 million for the second quarter of 2021, or net loss per share of $0.25 basic and diluted, as compared to net income of $29.5 million, or net income per share of $0.75 basic and $0.73 diluted, for the second quarter of 2020. Net loss was $19.4 million for the six months ended June 30, 2021, or net loss per share of $0.45 basic and diluted, as compared to net income of $17.4 million, or net income per share of $0.44 basic and $0.43 diluted for the six months ended June 30, 2020.

The decreases in net income for both the three and six month periods ended June 30, 2021 were primarily due to the Companys opting out of its joint development agreement with Janssen Pharmaceutica for seltorexant during the second quarter of 2020. As a result of opting out of the agreement, the Company immediately recognized $41.2 million in collaborative revenue which had previously been included on the balance sheet under deferred revenue.

Net loss during the three and six month periods ended June 30, 2021 included non-cash interest expense of $1.6 million and $2.9 million, respectively, versus zero expense for both periods during 2020. The non-cash interest is incurred in connection with the Liability related to the sale of future royalties to Royalty Pharma in January of this year, which is included on the Companys balance sheet.

-- R&D Expense: For the three months ended June 30, 2021 and 2020, research and development (R&D) expense was $5.5 million and $5.8 million, respectively, a decrease of approximately $0.3 million. For the three months ended June 30, 2021 and 2020, non-cash stock compensation expense included in R&D was $0.6 million and $0.7 million, respectively.

For the six months ended June 30, 2021 and 2020, R&D expense was $8.8 million and $13.8 million, respectively, a decrease of approximately $5.0 million. For the six months ended June 30, 2021 and 2020, non-cash stock compensation expense included in R&D was $1.3 million and $1.4 million, respectively.

The decrease in R&D expense for both the three and six month periods ended June 30, 2021 versus the same periods in 2020 was primarily due to lower costs for the Phase 3 clinical trial of roluperidone, for which the three-month core study portion of the trial was completed in May 2020.

-- G&A Expense: For the three months ended June 30, 2021 and 2020, general and administrative (G&A) expense was $3.4 million and $5.9 million, respectively, a decrease of approximately $2.5 million. For the three months ended June 30, 2021 and 2020, non-cash stock compensation expense included in G&A was $0.7 million and $2.8 million, respectively.

For the six months ended June 30, 2021 and 2020, G&A expense was $7.7 million and $10.1million, respectively, a decrease of approximately $2.4million. For the six months ended June 30, 2021 and June 30, 2020, non-cash stock compensation expense included in G&A was $1.6 million and $4.3 million, respectively.

The decrease in G&A expense for both the three and six month periods ended June 30, 2021 was primarily due to a decrease in non-cash stock-based compensation. Stock-based compensation charges were higher in 2020 primarily due to the approval of certain stock option grants and certain severance related benefits.

-- Cash Position: Cash, cash equivalents, restricted cash and marketable securities as of June 30, 2021 were approximately $74.3 million, compared to $25.5 million as of December 31, 2020.

Conference Call Information:

Minerva Neurosciences will host a conference call and live audio webcast today at 8:30 a.m. Eastern Time to discuss the quarter and recent business activities. To participate, please dial (877) 312-5845 (domestic) or (765) 507-2618 (international) and refer to conference ID 4327209.

The live webcast can be accessed under Events and Presentations in the Investors and Media section of Minervas website at ir.minervaneurosciences.com. The archived webcast will be available on the website beginning approximately two hours after the event for 90 days.

About Minerva Neurosciences

Minervas portfolio of compounds includes: roluperidone (MIN-101), in clinical development for schizophrenia, and MIN-301, in pre-clinical development for Parkinsons disease. Minervas common stock is listed on the Nasdaq Global Market under the symbol NERV.For more information, please visit www.minervaneurosciences.com.

Forward-Looking Safe Harbor Statement

This press release contains forward-looking statements. Forward-looking statements are statements that are not historical facts, reflect managements expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include, but are not limited to, statements herein with respect to the timing and scope of clinical trials and regulatory review and results and outcomes of such clinical trials and regulatory review with roluperidone (MIN-101); the clinical and therapeutic potential of this compound; the likelihood of successful clinical trials, regulatory review, commercialization, and future sales of and potential royalty stream from seltorexant; the timing and outcomes of future interactions with U.S. and foreign regulatory bodies, including the U.S. Food and Drug Administration; our ability to successfully develop and commercialize our therapeutic products; the sufficiency of our current cash position to fund our operations; and managements ability to successfully achieve its goals. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, whether roluperidone will advance further in the clinical trials process and whether and when, if at all, it will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether any of our therapeutic products or seltorexant will be successfully marketed if approved; whether any of our therapeutic product discovery and development efforts will be successful; managements ability to successfully achieve its goals; our ability to raise additional capital to fund our operations on terms acceptable to us; changes in expected or existing competition; unexpected litigation or other disputes; the impacts of the COVID-19 pandemic on our business; and general economic conditions. These and other potential risks and uncertainties that could cause actual results to differ from the results predicted are more fully detailed under the caption Risk Factors in our filings with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter endedJune 30, 2021, filed with theSecurities and Exchange Commission on August 2, 2021. Copies of reports filed with theSECare posted on our website at www.minervaneurosciences.com. The forward-looking statements in this press release are based on information available to us as of the date hereof, and we disclaim any obligation to update any forward-looking statements, except as required by law.

CONDENSED CONSOLIDATED BALANCE SHEET DATA(Unaudited) June 31, December31, 2021 2020 (in thousands)ASSETSCurrent Assets: Cash and cash equivalents $ 74,215 $ 25,357 Marketable securities - - Restricted cash 100 100 Prepaid expenses and other current assets 910 1,983 Total current assets 75,225 27,440 Equipment, net - - Other noncurrent assets 15 15 Operating lease right-of-use assets 15 102 In-process research and development 15,200 15,200 Goodwill 14,869 14,869 Total Assets $ 105,324 $ 57,626 LIABILITIES AND STOCKHOLDERS' EQUITYCurrent Liabilities: Accounts payable $ 1,594 $ 996 Accrued expenses and other current liabilities 2,834 2,053 Operating leases 16 111 Total current liabilities 4,444 3,160 Long-Term Liabilities: Deferred taxes 1,803 1,803 Deferred revenue - - Liability related to the sale of future royalties 62,908 - Noncurrent operating leases - - Total liabilities 69,155 4,963 Stockholders' Equity: Common stock 4 4 Additional paid-in capital 340,354 337,454 Accumulated deficit (304,189 ) (284,795 )Total stockholders' equity 36,169 52,663 Total Liabilities and Stockholders' Equity $ 105,324 $ 57,626

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(Unaudited) Three Months Ended June Six Months Ended June 30 30, (in thousands, except per (in thousands, except per share amounts) share amounts) 2021 2020 2021 2020 Collaborative $ - $ 41,176 $ - $ 41,176 revenueOperating expenses: Research and 5,521 5,767 8,780 13,849 developmentGeneral and 3,442 5,901 7,691 10,090 administrativeTotal operating 8,963 11,668 16,471 23,939 expensesLoss from (8,963 ) 29,508 (16,471 ) 17,237 operations Foreign exchange (19 ) (4 ) (24 ) (13 )lossesInvestment income 5 25 9 154 Non-cash interestexpense for the (1,612 ) - (2,908 ) - sale of futureroyaltiesLoss before income (10,589 ) 29,529 (19,394 ) 17,378 taxes Net income (loss) $ (0.25 ) $ 0.75 $ (0.45 ) $ 0.44 per share, basicWeighted averageshares outstanding, 42,722 39,483 42,722 39,330 basicNet income (loss) $ (0.25 ) $ 0.73 $ (0.45 ) $ 0.43 per share, dilutedWeighted averageshares outstanding, 42,722 40,278 42,722 40,145 diluted

ContactWilliam B. BoniVP, Investor Relations/Corp. CommunicationsMinerva Neurosciences, Inc.(617) 600-7376