Last update 01 Nov 2024
MIN-301
Last update 01 Nov 2024
Overview
Basic Info
Drug Type Recombinant protein |
Synonyms |
Target- |
Mechanism- |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhasePreclinical |
First Approval Date- |
Regulation- |
Related
100 Clinical Results associated with MIN-301
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100 Patents (Medical) associated with MIN-301
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22
News (Medical) associated with MIN-30106 Aug 2024
BURLINGTON, Mass., Aug. 06, 2024 (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 business updates and financial results for the second quarter of 2024 ending June 30, 2024. Roluperidone NDA Update During the first quarter of this year, the Company announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to its New Drug Application (NDA) for roluperidone (f/k/a MIN-101) for the treatment of negative symptoms in patients with schizophrenia. Since receiving the CRL, the Company has continued to have interactions with the FDA with the goal of addressing questions raised in the CRL. Second Quarter 2024 Financial Results Research and development (R&D) expense: For the three months ended June 30, 2024 and 2023, R&D expense was $3.9 million and $1.9 million, respectively. R&D expense was higher versus the prior year period primarily due to higher subcontractor fees related to costs associated with our drug substance validation campaign, partially offset by lower compensation expenses. For the six months ended June 30, 2024 and 2023, R&D expense was $8.0 million and $4.5 million, respectively. R&D expense was higher versus the prior year period primarily due to costs associated with our drug substance validation campaign and the conduct of the MIN-101C18 study. General and administrative (G&A) expense: For the three months ended June 30, 2024 and 2023, G&A expense was $2.4 million and $2.6 million, respectively. G&A expense was lower versus the prior year period primarily due to lower compensation expenses. For the six months ended June 30, 2024 and 2023, G&A expense was $4.9 million and $5.3 million, respectively. G&A expense was lower versus the prior year period primarily due to lower compensation expenses and professional service fees. Non-cash interest expense: For the three and six months ended June 30, 2024, non-cash interest expense for the sale of future royalties was $2.3 million and $4.6 million, respectively, as compared to $2.0 million and $4.0 million for the three and six months ended June 30, 2023, respectively. The increase versus the prior year period was primarily due to the amortization of non-cash interest expense for the difference between the balance of the liability related to the sale of future royalties and the estimated amount of future royalties to be received over the royalty period. Net loss: Net loss for the three and six months ended June 30, 2024 was $8.2 million and $16.8 million, or a basic and diluted net loss per share of $1.09 and $2.22, respectively, as compared to a net loss for the three and six months ended June 30, 2023 of $6.2 million and $13.2 million or a basic and diluted net loss per share of $1.12 and $2.43, respectively. Cash Position: Cash, cash equivalents and restricted cash at June 30, 2024 were approximately $31.0 million, as compared to $41.0 million at December 31, 2023. About Minerva Neurosciences Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing product candidates to treat CNS diseases. Minerva’s goal is to transform the lives of patients with improved therapeutic options, including roluperidone for negative symptoms of schizophrenia and MIN-301 for Parkinson’s disease. For more information, please visit the Company’s website. 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 are not limited to, statements herein with respect to expectations concerning Minerva’s ability to remediate or otherwise resolve issues and deficiencies identified in the CRL and the timing and outcome of its interactions with the FDA. 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, Minerva’s ability to address FDA’s feedback and timing thereof; uncertainties associated with regulatory processes, including the content and timing of decisions by the FDA; general risks associated with developing biopharmaceutical product candidates; management’s ability to successfully achieve its goals; our ability to raise additional capital to fund its operations and corporate objectives on terms acceptable to Minerva; general economic conditions; and other factors that are described under the caption “Risk Factors” in Minerva’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on February 22, 2024, as updated by its Quarterly Report on Form 10-Q for the quarter ended June 30, 3024. Copies of reports filed with the SEC are posted on Minerva’s website at http://ir.minervaneurosciences.com/. The forward-looking statements in this press release are based on information available to the Company as of the date hereof, and the Company disclaims any obligation to update any forward-looking statements, except as required by law. Contact: Investor inquiries:Frederick AhlholmChief Financial OfficerMinerva Neurosciences, Inc.info@minervaneurosciences.com Media inquiries: Helen ShikPrincipalShik Communications LLChelen@shikcommunications.com CONDENSED CONSOLIDATED BALANCE SHEET DATA(Unaudited) June 30, 2024December 31, 2023 (in thousands)ASSETSCurrent assets: Cash and cash equivalents$30,881 $40,913 Restricted cash 100 100 Prepaid expenses and other current assets 428 989 Total current assets 31,409 42,002 Equipment and capitalized software, net 13 29 Goodwill 14,869 14,869 Total assets$46,291 $56,900 LIABILITIES AND STOCKHOLDERS' DEFICITCurrent liabilities: Accounts payable$829 $1,805 Accrued expenses and other current liabilities 3,375 1,535 Total current liabilities 4,204 3,340 Long-term liabilities: Liability related to the sale of future royalties 86,579 82,017 Total liabilities 90,783 85,357 Stockholders' deficit: Common stock 1 1 Additional paid-in capital 369,125 368,357 Accumulated deficit (413,618) (396,815)Total stockholders' deficit (44,492) (28,457)Total liabilities and stockholders' deficit$46,291 $56,900
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) 2024 2023 2024 2023 Operating expenses:
Research and development $3,860 $1,887 $8,028 $4,541 General and administrative 2,417 2,633 4,932 5,327 Total operating expenses 6,277 4,520 12,960 9,868 Loss from operations (6,277) (4,520) (12,960) (9,868)
Foreign exchange (losses) gains (5) (7) 1 (16)Investment income 361 365 719 730 Non-cash interest expense for the sale of future royalties (2,312) (2,030) (4,562) (4,008)Net loss $(8,233) $(6,192) $(16,802) $(13,162)
Net loss per share, basic and diluted $(1.09) $(1.12) $(2.22) $(2.43)Weighted average shares outstanding, basic and diluted 7,569 5,511 7,569 5,426
Financial StatementNDA
01 May 2024
BURLINGTON, Mass., May 01, 2024 (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 business updates and financial results for the first quarter of 2024 ending March 31, 2024.
Roluperidone NDA Update
On February 27, 2024, the Company announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to its New Drug Application (NDA) for roluperidone (f/k/a MIN-101) for the treatment of negative symptoms in patients with schizophrenia. The Company is in discussions with the FDA regarding the issues and clinical deficiencies raised in the CRL.
Phase 1b Clinical Trial (MIN-101C18)
In the first quarter of 2024, the Company completed a clinical trial initiated in October 2023 to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of the co-administration of roluperidone and olanzapine in adult subjects with moderate to severe negative symptoms of schizophrenia. This clinical trial (NCT06107803) was designed to investigate the pharmacodynamic and pharmacokinetic effects and safety of the concomitant therapy of roluperidone with an established and widely used antipsychotic. Of the 17 patients enrolled, 13 completed all 17 days of daily dosing of roluperidone at 64 mg. No new safety signals were observed during the study with few treatment-emergent adverse events (TEAEs), most of which were mild and all resolved without sequelae. No emergent clinically significant electrocardiogram or laboratory abnormalities were observed during the study. There was no symptomatic worsening during the administration of roluperidone alone (7 days) or when administered in combination with olanzapine at 10 mg (10 days).
The study demonstrated that pharmacokinetic interactions between the two drugs were not relevant.
First Quarter 2024 Financial Results
Research and development (R&D) expense: For the three months ended March 31, 2024 and 2023, R&D expense was $4.2 million and $2.7 million, respectively. R&D expense was higher versus the prior year period primarily due to costs associated with the FDA’s review of the Company’s NDA and the conduct of the MIN-101C18 study.
General and administrative (G&A) expense: For the three months ended March 31, 2024 and 2023, G&A expense was $2.5 million and $2.7 million, respectively. G&A expense was lower versus the prior year period primarily due to lower professional service fees.
Non-cash interest expense: For the three months ended March 31, 2024 and 2023, non-cash interest expense for the sale of future royalties was $2.3 million and $2.0 million, respectively. The increase versus the prior year period was primarily due to the amortization of non-cash interest expense for the difference between the balance of the liability related to the sale of future royalties and the estimated amount of future royalties to be received over the royalty period.
Net loss: Net loss was $8.6 million for the three months ended March 31, 2024, or net loss per share of $1.13 basic and diluted, as compared to net loss of $7.0 million for the three months ended March 31, 2023, or net loss per share of $1.31 basic and diluted.
Cash Position: Cash, cash equivalents and restricted cash at March 31, 2024 were approximately $34.9 million, as compared to $41.0 million at December 31, 2023.
About Minerva Neurosciences
Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing product candidates to treat CNS diseases. Minerva’s goal is to transform the lives of patients with improved therapeutic options, including roluperidone for negative symptoms of schizophrenia and MIN-301 for Parkinson’s disease. For more information, please visit the Company’s website.
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 are not limited to, statements herein with respect to expectations concerning Minerva’s ability to remediate or otherwise resolve issues and deficiencies identified in the CRL. 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, Minerva’s ability to address FDA’s feedback and timing thereof; uncertainties associated with regulatory processes, including the content and timing of decisions by the FDA; general risks associated with developing biopharmaceutical product candidates; management’s ability to successfully achieve its goals; our ability to raise additional capital to fund its operations and corporate objectives on terms acceptable to Minerva; general economic conditions; and other factors that are described under the caption “Risk Factors” in Minerva’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on February 22, 2024, as updated by its Quarterly Report on Form 10-Q for the quarter ended March 31, 2024. Copies of reports filed with the SEC are posted on Minerva’s website at . The forward-looking statements in this press release are based on information available to the Company as of the date hereof, and the Company disclaims any obligation to update any forward-looking statements, except as required by law.
Contact:
Investor inquiries:
Frederick Ahlholm
Chief Financial Officer
Minerva Neurosciences, Inc.
info@minervaneurosciences.com
Media inquiries:
Helen Shik
Principal
Shik Communications LLC
helen@shikcommunications.com
CONDENSED CONSOLIDATED BALANCE SHEET DATA
(Unaudited)
March 31, 2024
December 31, 2023
(in thousands)
ASSETS
Current assets:
Cash and cash equivalents
$
34,818
$
40,913
Restricted cash
100
100
Refundable regulatory fee
-
-
Prepaid expenses and other current assets
703
989
Total current assets
35,621
42,002
Equipment and capitalized software, net
20
29
Goodwill
14,869
14,869
Total assets
$
50,510
$
56,900
LIABILITIES AND STOCKHOLDERS' DEFICIT
Current liabilities:
Accounts payable
$
1,435
$
1,805
Accrued expenses and other current liabilities
1,395
1,535
Total current liabilities
2,830
3,340
Long-term liabilities:
Liability related to the sale of future royalties
84,267
82,017
Total liabilities
87,097
85,357
Stockholders' deficit:
Common stock
1
1
Additional paid-in capital
368,796
368,357
Accumulated deficit
(405,384
)
(396,815
)
Total stockholders' deficit
(36,587
)
(28,457
)
Total liabilities and stockholders' deficit
$
50,510
$
56,900
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended March 31,
(in thousands, except per share amounts)
2024
2023
Operating expenses:
Research and development
$
4,167
$
2,653
General and administrative
2,515
2,695
Total operating expenses
6,682
5,348
Loss from operations
(6,682
)
(5,348
)
Foreign exchange gains (losses)
5
(9
)
Investment income
358
364
Non-cash interest expense for the sale of future royalties
(2,250
)
(1,977
)
Net loss
$
(8,569
)
$
(6,970
)
Net loss per share, basic and diluted
$
(1.13
)
$
(1.31
)
Weighted average shares outstanding, basic and diluted
7,569
5,340
Financial StatementPhase 1NDA
27 Feb 2024
To fix the many issues, the FDA is asking for at least one more positive, adequate and well-controlled study of roluperidone to support its use for the negative symptoms of schizophrenia.
Perhaps Minerva Neurosciences should have taken a page from the tale of Arachne: Never boast that you know better than the goddess of knowledge. Or in this case, the FDA.
The central nervous system-focused biotech’s schizophrenia drug has been roundly rejected by the agency, which said the studies submitted to support an approval did not establish evidence of effectiveness, lacked data and not enough patients were exposed to the proposed dose. The writing had been on the wall for years, and yet Minerva pushed on to have its application reviewed despite numerous warnings from the agency.
Minerva’s shares plunged by 58% as the markets opened Tuesday, falling to $2.72 compared to $6.80 at close Monday.
The company had been seeking an approval for roluperidone, also known as MIN-101, to treat the negative symptoms associated with schizophrenia. This is not the first time the FDA has said no. The agency issued a refusal to file letter for the application in October 2022, a rejection used when an application is not complete. The company appealed the refusal to file.
The FDA eventually agreed to take up review of the drug in May 2023 on appeal to consider the issues in the original refusal to file. The review was to be conducted on a standard timeline with a due date of February 26, bringing the story to today, when the application was officially rejected with a complete response letter.
“We are disappointed that the FDA has not approved roluperidone and will request a meeting to discuss the issues raised and attempt to address FDA’s feedback,” said Remy Luthringer, Ph.D., Minerva CEO.
The FDA flagged a number of clinical deficiencies in the application. While one study showed statistical significance on the primary endpoint, the agency said it was insufficient to establish substantial evidence of effectiveness. The submission did not have enough data to support concomitant antipsychotic administration, which is the use of two or more antipsychotic agents and is often standard treatment for patients with schizophrenia.
The submission also lacked data to establish that the changes in negative symptoms—social withdrawal, lack of interest, lack of motivation—were clinically meaningful. And finally, the FDA said the submission did not have adequate data from patients exposed to the proposed 64 mg dose for at least 12 months.
To fix these issues, the FDA is asking for at least one more positive, adequate and well-controlled study of roluperidone to support its use for the negative symptoms of schizophrenia. Minerva will also have to provide additional safety and efficacy data to support co-administration of the therapy with antipsychotic medicines, show a clinically meaningful observed effect on negative symptoms and to support long-term safety of the 64 mg dose.
The FDA also had notes on clinical pharmacology, product quality, biopharmaceutics and nonclinical issues.
“We believe that roluperidone is a safe and effective therapy for negative symptoms of schizophrenia and we will review FDA’s feedback and consider our potential paths forward, including continuing to work closely with the FDA and providing any additional information as needed, with the goal of bringing this much-needed therapy to patients and physicians,” Luthringer said.
In 2019, Minerva suffered a clinical failure of the major depressive disorder drug MIN-117. The only other therapy in the biotech's pipeline now besides roluperidone is MIN-301, which is in preclinical testing for Parkinson's disease.
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Parkinson Disease | Preclinical | CH | - |
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