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Cerecor Inc. (CERC)

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2.4200+0.0400 (+1.68%)
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Neutralpattern detected
Previous Close2.3800
Open2.3800
Bid2.5600 x 900
Ask2.6800 x 1400
Day's Range2.3400 - 2.4500
52 Week Range1.5200 - 6.1900
Volume121,305
Avg. Volume277,466
Market Cap184.325M
Beta (5Y Monthly)1.70
PE Ratio (TTM)N/A
EPS (TTM)-0.8210
Earnings DateNov 09, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est9.33
  • Cerecor to Collaborate with Frontiers CDG Consortium on Pivotal Trial of CERC-801 for the Treatment of PGM1-CDG
    GlobeNewswire

    Cerecor to Collaborate with Frontiers CDG Consortium on Pivotal Trial of CERC-801 for the Treatment of PGM1-CDG

    ROCKVILLE, Md., Nov. 17, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare and orphan diseases, today announced a collaboration with The Frontiers in Congenital Disorders of Glycosylation Consortium (FCDGC) led by Eva Morava-Kozicz, M.D. Ph.D., Principal Investigator of the trial, Professor of Medical Genetics, Senior Associate Consultant, Department of Clinical Genomics, Mayo Clinic and Editor in Chief of the Journal of Inherited Metabolic Disease on a prospective pivotal trial evaluating the safety and efficacy of CERC-801 in patients suffering from Phosphoglucomutase-1 deficiency related congenital disorders of glycosylation (PGM1-CDG). Dr. H. Jeffrey Wilkins, M.D., Chief Medical Officer for Cerecor, stated, “We are delighted to be working with the premier group of thought leaders from The FCDGC to study CERC-801 in patients suffering from PGM1-CDG. We intend to use the data generated from this prospective trial to support our submission package to the FDA for CERC-801 as the first approved product for the treatment and management of PGM1-CDG.”This trial will study the safety, tolerability, and efficacy of CERC-801 in patients with PGM1-CDG using daily therapeutic doses of CERC-801 in approximately ten patients. Outcome measures will include evaluation of clinical symptoms and clinically meaningful biomarkers.Andrea Miller, JD, MHA, President & Founder of CDG CARE, stated, “We are truly excited to see the collaboration between FCDGC and Cerecor and this prospective trial in PGM1-CDG. CDG is an area of high unmet need where there are no approved therapies today. The possibility for there to be an approved therapy for PGM1-CDG is exciting and has the potential to improve the quality of life of patients suffering from this ultra rare form of CDG.”About PGM1-CDGCDGs are a group of rare, inherited, metabolic disorders caused by glycosylation defects that present as a broad range of clinical symptoms, including coagulopathy, hepatopathy, myopathy, hypoglycemia, protein-losing enteropathy and reduced cell counts. CDG patients are born with a genetic defect that hinders their ability to utilize certain monosaccharides in the production of glycoproteins. A deletion or misplacement of a sugar subunit produces a dysfunctional glycoprotein, resulting in a myriad of medical issues.While there are no U.S. Food and Drug Administration-approved treatments for the treatment of CDGs, dietary monosaccharide formulations have been shown to alleviate several of the clinical manifestations in CDG patients. These restorative monosaccharide therapies work by increasing the availability of metabolic intermediates for glycoprotein synthesis. PGM1-CDG is caused by mutation in the PGM1 gene encoding an enzyme responsible for the interconversion of glucose-6-phosphate to glucose-1-phosphate. Glucose-1-phosphate can be utilized to supply UDP-galactose, a substrate that donates galactose subunits for glycoprotein synthesis. CERC-801 uses therapeutic doses of D-galactose to restore glycosylation in patients with PGM1 deficiency.About FCDGCThe Frontiers in CDG Consortium leverages cross-disciplinary, team-based clinical science to address decades of unresolved questions, increase clinical trial readiness, advance and share knowledge, develop treatments, and address current unmet patient needs. The Consortium establishes a nation-wide network of ten regional academic centers, the Sanford Burnham Presbyterian Medical Discovery Institute and the patient advocacy group CDG CARE.CDG CARE (Community Alliance and Resource Exchange) is the Patient Advocacy Group representing all Congenital Disorders of Glycosylation (CDG) and Deglycosylation (CDDG) for the FCDGC. CDG CARE is a nonprofit 501(c)(3) organization founded by parents seeking information and support for a group of disorders known as CDG. Their mission is to promote greater awareness and understanding of CDG, to provide information and support to families affected by CDG, and to advocate for and fund scientific research to advance the diagnosis and treatment of all CDGs.About CERC-800sCERC-801, CERC-802 and CERC-803 are restorative monosaccharide therapies with known therapeutic utility for the treatment of select CDGs. Oral administration at therapeutic doses of CERC-801, CERC-802, and CERC-803 replenishes critical metabolic intermediates that are reduced or absent due to genetic mutation, overcoming single enzyme defects in respective CDGs to support glycoprotein synthesis, maintenance and function.About Cerecor Cerecor is a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare and orphan diseases.  The company is advancing its clinical-stage pipeline of innovative therapies that address unmet patient needs within rare and orphan diseases.  The company's rare disease pipeline includes CERC-801, CERC-802 and CERC-803 ("CERC-800 compounds"), which are therapies for inherited metabolic disorders known as congenital disorders of glycosylation.  The U.S. Food and Drug Administration ("FDA") granted Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) to all three CERC-800 compounds, thus potentially qualifying the Company to receive a Priority Review Voucher (PRV) upon approval of each new drug application (NDA).  The company is also developing CERC-002, CERC-006 and CERC-007.  CERC-002 is an anti-LIGHT monoclonal antibody being developed for the treatment of severe pediatric-onset Crohn's disease, and is also being studied for COVID-19 acute respiratory distress syndrome.  CERC-006 is a dual mTOR inhibitor being developed for the treatment of complex lymphatic malformations and has been granted ODD and RPDD by the FDA, thus potentially qualifying the company to receive a fourth PRV upon approval of an NDA.  CERC-007 is an anti-IL-18 monoclonal antibody being developed for the treatment of autoimmune inflammatory diseases such as Still’s disease and multiple myeloma. For more information about Cerecor, please visit www.cerecor.com.Forward-Looking Statements This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and uncertainties that are subject to change based on various factors (many of which are beyond Cerecor’s control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Cerecor’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “might,” “will,” “could,” “would,” “should,” “continue,” “seeks,” “aims,” “predicts,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” or similar expressions (including their use in the negative), or by discussions of future matters such as: the development of product candidates or products; timing and success of trial results and regulatory review; potential attributes and benefits of product candidates; and other statements that are not historical. These statements are based upon the current beliefs and expectations of Cerecor’s management but are subject to significant risks and uncertainties, including: drug development costs, timing and other risks, including reliance on investigators and enrollment of patients in clinical trials, which might be slowed by the COVID-19 pandemic; regulatory risks; Cerecor's cash position and the potential need for it to raise additional capital; general economic and market risks and uncertainties, including those caused by the COVID-19 pandemic; and those other risks detailed in Cerecor’s filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Except as required by applicable law, Cerecor expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Cerecor’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.For media and investor inquiriesJames Harrell Investor Relations Chief Commercial Officer Cerecor Inc. jharrell@cerecor.com 623.439.2220 office

  • CERC: Multiple Catalysts Over the Next 6-12 Months…
    Zacks Small Cap Research

    CERC: Multiple Catalysts Over the Next 6-12 Months…

    By David Bautz, PhD NASDAQ:CERC READ THE FULL CERC RESEARCH REPORT Business Update Proof-of-Concept Data for CERC-002 in ARDS in 4Q20 Cerecor, Inc. (NASDAQ:CERC) is currently conducting a proof-of-concept clinical trial of CERC-002 (anti-LIGHT monoclonal antibody) in patients suffering from cytokine storm as a result of COVID-19. It is a randomized, double blind, placebo controlled trial in

  • Cerecor Reports Third Quarter 2020 Financial Results and Provides Business Update
    GlobeNewswire

    Cerecor Reports Third Quarter 2020 Financial Results and Provides Business Update

    On track to complete clinical trial for CERC-002 in cytokine storm-induced COVID-19 ARDS by year end Strengthened leadership team with the appointment of Gilla Kaplan, Ph.D., to the Board of Directors ROCKVILLE, Md. and CHESTERBROOK, Pa., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ : CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases, today announced recent business progress and third quarter results for 2020.“We are very pleased with the progress we have made in the third quarter,” said Mike Cola, Chief Executive Officer of Cerecor. “We anticipate completion of the trial of our novel anti-LIGHT mAb, CERC-002, for the treatment of COVID-19 induced acute respiratory distress syndrome, by year end. We are excited to welcome Dr. Gilla Kaplan to our Board, who brings with her a strong track record and expertise in immunology and rare diseases. The timing of her involvement is ideal as we prepare for multiple clinical data readouts in 2021 that we believe represent key inflection points for Cerecor.” Third Quarter Highlights and Program Updates * Strengthened leadership team with the appointment of Gilla Kaplan, Ph.D., to the Board of Directors. Dr. Kaplan brings with her over 30 years of academic and industry experience specializing in various aspects of the host immune response to mycobacterial pathogens, including the causative agents of leprosy and tuberculosis. * The Company’s pipeline of novel, first-in-class compounds remains on track with all clinical development timelines and anticipates the following milestones: \- CERC-002: Anti-LIGHT monoclonal antibody in clinical studies for COVID-19 ARDS and severe pediatric onset Crohn’s disease.    - Completion of the multi-center, randomized, double-blinded, placebo-controlled Phase 1 proof-of-concept study of CERC-002 in cytokine storm-induced COVID-19 ARDS is anticipated by year end 2020.    - Initial data from the open-label Phase 1b clinical study designed to assess the safety, tolerability and short-term efficacy of CERC-002 in anti-TNF refractory adult subjects with moderate-to-severe Crohn’s disease is anticipated in the first quarter of 2021. * CERC-007: Anti-IL-18 monoclonal antibody for the treatment of multiple myeloma (MM) and Adult-onset Still's Disease (AOSD). \- Initial data anticipated from proof-of-concept studies for multiple myeloma in the first quarter of 2021 and in Adult-onset Still’s disease in the second quarter of 2021. * CERC-006: Dual mTORC1 and mTORC2 small molecule inhibitor for complex lymphatic malformations. \- Initial data anticipated from proof-of-concept study in the first half of 2021. * CERC-800 programs (CERC-801, CERC-802, and CERC-803): Restorative monosaccharide therapies for congenital disorders of glycosylation (CDGs). \- CERC-801 – data anticipated from the pivotal trial evaluating the safety and efficacy of CERC-801 in patients suffering from Phosphoglucomutase-1 deficiency related congenital disorders of glycosylation (PGM1-CDG) in 2021. \- CERC-802 – data anticipated from the pivotal trial evaluating the safety and efficacy of CERC-802 in patients suffering from Mannose phosphate isomerase deficiency related CDG (MPI-CDG) in 2021. \- CERC-803 – clearance to proceed on the Investigational New Drug Application from the FDA anticipated in the fourth quarter 2020.Third Quarter Financial UpdateCerecor reported a cash balance of $33.4 million as of September 30, 2020, representing a $12 million decrease as compared to June 30, 2020. The decrease was primarily due to operational spend.Cerecor recognized $8.9 million of research and development expenses and $4.6 million of general and administrative expenses during the quarter, which were the primary reasons for the increase in operating expenses, net loss and net loss per share as compared to the same period in 2019. The $7.1 million increase in research and development expenses as compared to the same period in 2019 primarily resulted from Cerecor’s continuing advancement of its expanded pipeline, including costs related to the ongoing clinical trial for COVID-19 ARDS and other programs acquired in the merger with Aevi Genomic Medicine, Inc.Condensed Consolidated Balance Sheets               September 30, 2020 (a) December 31, 2019 (a)      (unaudited)           Assets  (in thousands)  Current assets:         Cash and cash equivalents    $33,391  $3,609   Accounts receivable, net     1,671   1,002   Other receivables     4,285   4,241   Inventory, net     9   21   Prepaid expenses and other current assets     1,544   707   Restricted cash, current portion     132   17   Investment in Aytu     -   7,629   Current assets of discontinued operations     -   498   Total current assets     41,032   17,724   Property and equipment, net     1,708   1,448   Intangible assets, net     1,889   2,426   Goodwill     14,409   14,409   Restricted cash, net of current portion     149   102   Total assets    $59,187  $36,109   Liabilities and stockholders’ equity         Current liabilities:         Accounts payable    $1,927  $2,078   Accrued expenses and other current liabilities     8,811   5,640   Income taxes payable     -   552   Current liabilities of discontinued operations     5,833   3,891   Total current liabilities     16,571   12,161   Royalty obligation     2,000   -   Deferred tax liability, net     115   86   Other long-term liabilities     1,934   1,112   Long-term liabilities of discontinued operations     -   1,755   Total liabilities     20,620   15,114   Stockholders’ equity:         Common stock—$0.001 par value; 200,000,000 shares authorized at September 30, 2020 and December 31, 2019; 74,900,047 and 44,384,222 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively     75   44   Preferred stock—$0.001 par value; 5,000,000 shares authorized at September 30, 2020 and December 31, 2019; 1,257,143 and 2,857,143 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively     1   3   Additional paid-in capital     200,639   135,239   Accumulated deficit     (162,148)  (114,291)  Total stockholders’ equity     38,567   20,995   Total liabilities and stockholders’ equity    $59,187  $36,109             (a) The condensed consolidated balance sheets as of September 30, 2020 and December 31, 2019 have been derived from the reviewed and audited financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.  Condensed Consolidated Statements of Operations           Three Months Ended September 30,  Nine Months Ended September 30,   2020 (a) 2019 (a) 2020 (a) 2019 (a)               (in thousands, except per share data) (in thousands, except per share data)  Revenues:         Product revenue, net$1,111  $2,101  $5,202  $6,070   License and other revenue -   100   -   100   Total revenues, net 1,111   2,201   5,202   6,170             Operating expenses:         Cost of product sales 77   132   221   (612)  Research and development 8,872   1,744   19,556   8,858   Acquired in-process research and development -   -   25,549   -   General and administrative 4,573   2,638   13,350   7,654   Sales and marketing 462   214   1,792   936   Amortization expense 404   335   1,238   1,004   Change in fair value of contingent consideration -   -   -   (1,256)  Total operating expenses 14,388   5,063   61,706   16,584   Loss from continuing operations (13,277)  (2,862)  (56,504)  (10,414)  Other income:         Change in fair value of Investment in Aytu -   -   5,208   -   Other income, net 19   53   447   83   Total other income, net from continuing operations 19   53   5,655   83   Loss from continuing operations before taxes (13,258)  (2,809)  (50,849)  (10,331)  Income tax expense (benefit) 3   121   (2,607)  306   Loss from continuing operations$(13,261) $(2,930) $(48,242) $(10,637)  (Loss) income from discontinued operations, net of tax (198)  (1,086)  385   (7,057)  Net loss$(13,459) $(4,016) $(47,857) $(17,694)            Net (loss) income per share of common stock, basic and diluted:         Continuing operations$(0.16) $(0.05) $(0.68) $(0.19)  Discontinued operations (0.01)  (0.02)  0.00   (0.12)  Net loss per share of common stock, basic and diluted$(0.17) $(0.07) $(0.68) $(0.31)            Net (loss) income per share of preferred stock, basic and diluted:         Continuing operations$(0.82) $(0.26) $(3.40) $(0.94)  Discontinued operations (0.01)  (0.09)  0.02   (0.62)  Net loss per share of preferred stock, basic and diluted$(0.83) $(0.35) $(3.38) $(1.56)            (a) The unaudited condensed consolidated statements of operations for the three and nine months ended September 30, 2020 and 2019 have been derived from the reviewed financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.  About Cerecor Cerecor is a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases.  The company is advancing its clinical-stage pipeline of innovative therapies that address unmet patient needs within rare and orphan diseases.  The company's rare disease pipeline includes CERC-801, CERC-802 and CERC-803 ("CERC-800 compounds"), which are therapies for inherited metabolic disorders known as congenital disorders of glycosylation.  The U.S. Food and Drug Administration ("FDA") granted Rare Pediatric Disease Designation (“RPDD”) and Orphan Drug Designation ("ODD") to all three CERC-800 compounds, thus potentially qualifying the Company to receive a Priority Review Voucher ("PRV") upon approval of each new drug application ("NDA").  The company is also developing CERC-002, CERC-006 and CERC-007.  CERC-002 is an anti-LIGHT monoclonal antibody being developed for the treatment of COVID-19 acute respiratory distress syndrome and for severe pediatric-onset Crohn's disease. CERC-006 is a dual mTOR inhibitor being developed for the treatment of complex lymphatic malformations and has been granted ODD and RPDD by the FDA, thus potentially qualifying the company to receive a fourth PRV upon approval of an NDA.  CERC-007 is an anti-IL-18 monoclonal antibody being developed for the treatment of autoimmune inflammatory diseases such as adult onset Stills disease, and multiple myeloma. For more information about Cerecor, please visit Cerecor.comForward-Looking Statements This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and uncertainties that are subject to change based on various factors (many of which are beyond Cerecor’s control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Cerecor’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “might,” “will,” “could,” “would,” “should,” “continue,” “seeks,” “aims,” “predicts,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” or similar expressions (including their use in the negative), or by discussions of future matters such as: the development of product candidates or products; timing and success of trial results and regulatory review; potential attributes and benefits of product candidates; and other statements that are not historical. These statements are based upon the current beliefs and expectations of Cerecor’s management but are subject to significant risks and uncertainties, including: drug development costs, timing and other risks, including reliance on investigators and enrollment of patients in clinical trials, which might be slowed by the COVID-19 pandemic; regulatory risks; Cerecor's cash position and the potential need for it to raise additional capital; general economic and market risks and uncertainties, including those caused by the COVID-19 pandemic; and those other risks detailed in Cerecor’s filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Except as required by applicable law, Cerecor expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Cerecor’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.For media and investor inquiriesJames Harrell Investor Relations Chief Commercial Officer Cerecor Inc. jharrell@cerecor.com 623.439.2220 office