CERC Cerecor Inc.

2.81
-0.16  -5%
Previous Close 2.97
Open 2.95
52 Week Low 1.97
52 Week High 4.5
Market Cap $253,917,105
Shares 90,361,959
Float 59,221,169
Enterprise Value $249,883,172
Volume 330,771
Av. Daily Volume 714,410
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Upcoming Catalysts

Drug Stage Catalyst Date
CERC-002
Crohn’s disease (adults)
Phase 1b
Phase 1b
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CERC-007
Still’s disease
Phase 1b
Phase 1b
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CERC-006
Lymphatic Malformations
Phase 1/2
Phase 1/2
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CERC 801
Phosphoglucomutase 1 (PGM1) deficiency
Phase 3
Phase 3
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CERC-802
Mannose phosphate isomerase deficiency related CDG (MPI-CDG)
Phase 3
Phase 3
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CERC-803
Leukocyte Adhesion Deficiency Type II (LAD II)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
CERC-007
Multiple Myeloma (MM)
Phase 1b
Phase 1b
Phase 1b trial enrolling.
CERC-002
COVID-19 induced Acute Respiratory Distress Syndrome (ARDS)
Phase 2
Phase 2
Phase 2 data released March 2, 2021. At both the 28-day and the 60-day final timepoints, an approximately 50% trend in mortality reduction (22.5% vs 10.8% - placebo) was observed.
CERC-501
Smoking cessation
Phase 2
Phase 2
Phase 2 top-line data released December 5, 2016 - endpoint not met.
CERC-301
Major depressive disorder (MDD)
Phase 2
Phase 2
Phase 2 top-line data released November 29, 2016 failed to meet primary endpoint.

Latest News

    • Expanded agreement for exclusive, world-wide rights to develop, manufacture and commercialize CERC-002 for all indications including severe pediatric onset inflammatory bowel disease and ARDS (including COVID-19 ARDS)
    • Kyowa Kirin Co. has an option to retain the rights for all indications in Japan

    ROCKVILLE, Md., March 29, 2021 (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 that its wholly-owned subsidiary, Aevi Genomic Medicine, LLC ("Cerecor"), has entered into an expanded agreement with Kyowa Kirin Co., for exclusive worldwide rights to develop, manufacture and commercialize CERC-002…

    • Expanded agreement for exclusive, world-wide rights to develop, manufacture and commercialize CERC-002 for all indications including severe pediatric onset inflammatory bowel disease and ARDS (including COVID-19 ARDS)

    • Kyowa Kirin Co. has an option to retain the rights for all indications in Japan

    ROCKVILLE, Md., March 29, 2021 (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 that its wholly-owned subsidiary, Aevi Genomic Medicine, LLC ("Cerecor"), has entered into an expanded agreement with Kyowa Kirin Co., for exclusive worldwide rights to develop, manufacture and commercialize CERC-002, Kyowa Kirin's first-in-class fully human anti-LIGHT (tumor necrosis factor superfamily member 14, TNFSF14) monoclonal antibody for all indications.

    "We are pleased to expand our agreement for this promising first-in-class asset with Kyowa Kirin, a global leader in innovative antibody engineering technology," said Mike Cola, Chief Executive Officer of Cerecor. "We have recently demonstrated clinically meaningful and statistically significant results with CERC-002 in patients with COVID-19 ARDS and will continue to explore the role of LIGHT in additional inflammatory disorders. We believe the expansion of this agreement enables us to potentially develop this innovative therapy to fill a significant unmet medical need for a growing number of patients worldwide."

    Under the terms of the agreement, Cerecor will receive exclusive rights for the development, manufacturing and commercialization of the antibody for all indications worldwide including the United States, Europe and Japan. Kyowa Kirin has an option to retain the rights in Japan. Kyowa Kirin will receive an up-front payment from Cerecor and is also eligible to receive additional payments based on achievement of regulatory and commercial milestones, as well as sales-based royalties and a share of sublicensing income.

    CERC-002 (anti-LIGHT monoclonal antibody)

    CERC-002 is a fully human anti-LIGHT or tumor necrosis factor superfamily member 14 (TNFSF14) monoclonal antibody licensed from Kyowa Kirin Co., Ltd. It is the only clinical stage anti-LIGHT therapy and has the potential to treat a number of LIGHT-associated immune diseases including cytokine storm-induced COVID-19 ARDS. It is currently in development for pediatric onset Crohn's disease and cytokine storm induced COVID-19 ARDS. Cerecor has also developed a validated, high sensitivity serum/plasma free LIGHT assay in collaboration with Myriad RBM.

    Role of LIGHT in Acute Inflammatory Response

    LIGHT (homologous to Lymphotoxin, exhibits inducible expression and competes with HSV glycoprotein D for binding to herpesvirus entry mediator, a receptor expressed on T lymphocytes) is a cytokine with inflammatory actions encoded by the TNFSF14 gene. LIGHT plays an important role in regulating immune responses in the lung, gut and skin. It stimulates T Cell and B Cell response as well as induces the release of other cytokines such as IL-1, IL-6, IL-8, IL-10, TNF and GM-CSF. Therefore, LIGHT potentially plays a key role in immune responses to viral pneumonia and other diseases.

    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, which are in development for congenital disorders of glycosylation and CERC-006, an oral mTORc1/c2 inhibitor in development for the treatment of complex lymphatic malformations. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007.  CERC-002 targets the cytokine LIGHT (TNFSF14) and is in clinical development for treatment of severe pediatric-onset Crohn's disease, and COVID-19 acute respiratory distress syndrome.  CERC-007 targets the cytokine IL-18 and is in clinical development for the treatment of Still's disease (adult onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (sJIA)), and multiple myeloma (MM). CERC-006, 801, 802 and 803 have all received Orphan Drug Designation and Rare Pediatric Disease Designation, which makes all four eligible for a priority review voucher upon FDA approval.

    For more information about Cerecor, please visit www.cerecor.com.

    About Kyowa Kirin

    Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company with over 70-year heritage, they apply cutting-edge science including an expertise in antibody research and engineering, to address the needs of patients and society across multiple therapeutic areas including Nephrology, Oncology, Immunology/Allergy and Neurology. Across their four regions – Japan, Asia Pacific, North America and EMEA/International – they focus on their purpose, to make people smile, and are united by their shared values of commitment to life, teamwork, innovation, and integrity. You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.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 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 inquiries

    Chris Brinzey

    Westwicke, an ICR Company



    339-970-2843

    or

    Schond L. Greenway

    Investor Relations

    Chief Financial Officer

    Cerecor Inc.



    610-522-6200 office



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  1. MINNEAPOLIS, March 15, 2021 (GLOBE NEWSWIRE) --  Panbela Therapeutics, Inc. (NASDAQ:PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, today announced the appointment of Garry A. Weems, PharmD, as its Vice President of Clinical Development and Medical Affairs. Dr. Weems joins Panbela from Cerecor, Inc. (NASDAQ:CERC) where he was Senior Director of Clinical Development.

    "Panbela has made considerable progress in the last 12-months and is now at a critical juncture as we begin to plan more expansive development of SBP-101," said Jennifer Simpson, Chief Executive Officer at Panbela. "Garry's substantial background of success and extensive experience in executing clinical…

    MINNEAPOLIS, March 15, 2021 (GLOBE NEWSWIRE) --  Panbela Therapeutics, Inc. (NASDAQ:PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, today announced the appointment of Garry A. Weems, PharmD, as its Vice President of Clinical Development and Medical Affairs. Dr. Weems joins Panbela from Cerecor, Inc. (NASDAQ:CERC) where he was Senior Director of Clinical Development.

    "Panbela has made considerable progress in the last 12-months and is now at a critical juncture as we begin to plan more expansive development of SBP-101," said Jennifer Simpson, Chief Executive Officer at Panbela. "Garry's substantial background of success and extensive experience in executing clinical programs in oncology, including immunotherapy, will bring tremendous value to Panbela. With key milestones expected during this year, as well as communications with the U.S. Food and Drug Administration that will help shape our lead program in pancreatic cancer, his expertise will be an asset straightaway."

    "I'm excited to join Panbela at such a critical time to continue the development of SBP-101. I look forward to exploring applications for this technology across a number of tumor types beyond pancreatic cancer," said Dr. Weems. "I am genuinely excited about developing SPB-101, leading our clinical research efforts, and building a pipeline for patients with unmet medical needs."

    Dr. Weems brings 25 years of industry experience in clinical research and medical affairs, primarily focused in solid tumor oncology drug development. In his role at Cerecor, he led clinical development of an anti-IL18 mAb (CERC-007) in relapsed/refractory multiple myeloma and an mTORC1/2 inhibitor (CERC-006) targeting complex lymphatic malformations (rare pediatric disease).  Prior to Cerecor, Dr. Weems was Executive Director of Clinical Development at Lycera Corp, where he was clinical program lead for investigational immunotherapy agent LYC-55716 (cintirorgon), an agonist of nuclear transcription factor, RORgamma.  Prior to joining Lycera, he led Medical Affairs activities for Gliadel (carmustine wafer) in patients with high-grade glioma (brain tumor) at Arbor Pharmaceuticals.  Prior to Arbor, Dr. Weems led the pralatrexate (FOLOTYN) solid tumor development program at Allos Therapeutics and was Sr. Director, Medical Development for MGI Pharma, where he led clinical development of a novel cytotoxic chemotherapy agent, a PARP inhibitor, and a plasmid DNA immunotherapeutic.  Dr. Weems received his undergraduate degree from Bethel University in St. Paul, MN, and completed his Doctorate in Pharmacy, at University of Minnesota, in Minneapolis, MN.

    About SBP-101

    SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Recently observed serious visual adverse evets are being evaluated and the FDA has issued a partial clinical hold for the impacted study, pending Panbela's evaluation and response. The safety data and PMI profile observed in the current Panbela sponsored current clinical trial generally provides potential support for continued evaluation of the compound in a randomized clinical trial, subject to Panbela's submission of a complete response and the FDA's removal of the partial clinical hold.  For more information, please visit https://clinicaltrials.gov/ct2/show/NCT03412799 .

    About Panbela

     Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing disruptive therapeutics for patients with urgent unmet medical needs. The company's initial product candidate, SBP-101, is for the treatment of patients with metastatic pancreatic ductal adenocarcinoma, the most common type of pancreatic cancer. Panbela Therapeutics, Inc. is dedicated to treating patients with pancreatic cancer and exploring SBP-101's potential for efficacy in combination with other agents and in treating other types of cancer. Further information can be found at www.panbela.com. Panbela Therapeutics, Inc. common stock is listed on The Nasdaq Stock Market LLC under the symbol PBLA.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains "forward-looking statements," including within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "believes," "continue," "dedicated," "expect," "intend," "may," "plan," and "seek." Examples of forward-looking statements include, among others, statements we make regarding future determinations of the characteristics of SBP-101 and its effectiveness, removal of the partial clinical hold, other trial activities and the timing of the same. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially and adversely from the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: (i) our ability to obtain additional funding to complete a randomized clinical trial; (ii) progress and success of our Phase 1 clinical trial; (iii) the impact of the COVID-19 pandemic on our ability to complete monitoring and reporting in our current clinical trial; (iv) our ability to demonstrate the safety and effectiveness of our SBP-101 product candidate (v) our ability to obtain regulatory approvals for our SBP-101 product candidate in the United States, the European Union or other international markets; (vi) the market acceptance and level of future sales of our SBP-101 product candidate; (vii) the cost and delays in product development that may result from changes in regulatory oversight applicable to our SBP-101 product candidate; (viii) the rate of progress in establishing reimbursement arrangements with third-party payors; (ix) the effect of competing technological and market developments; (x) the costs involved in filing and prosecuting patent applications and enforcing or defending patent claims; and (xi) such other factors as discussed in Part I, Item 1A under the caption "Risk Factors" in our most recent Annual Report on Form 10-K, any additional risks presented in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Any forward-looking statement made by us in this press release is based on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement or reasons why actual results would differ from those anticipated in any such forward-looking statement, whether written or oral, whether as a result of new information, future developments or otherwise.



    Contact Information:
    
    Investors: 
    James Carbonara 
    Hayden IR 
    (646) 755-7412 
    
    
    Media: 
    Tammy Groene 
    Panbela Therapeutics, Inc. 
    (952) 479-1196 
    

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  2.  Announced CERC-002 significantly reduced respiratory failure and mortality in Phase 2 clinical trial in patients hospitalized with COVID-19 ARDS
     Improved financial position with $18.9M of cash on hand as of December 31, 2020 and $37.6M of net proceeds raised in January 2021
     Poised to deliver significant number of clinical and regulatory catalysts in 2021

    ROCKVILLE, Md. and CHESTERBROOK, Pa., March 08, 2021 (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 year-end financial results for 2020.

    "Looking back, 2020 was a very productive and transformative year for

     Announced CERC-002 significantly reduced respiratory failure and mortality in Phase 2 clinical trial in patients hospitalized with COVID-19 ARDS
     Improved financial position with $18.9M of cash on hand as of December 31, 2020 and $37.6M of net proceeds raised in January 2021
     Poised to deliver significant number of clinical and regulatory catalysts in 2021

    ROCKVILLE, Md. and CHESTERBROOK, Pa., March 08, 2021 (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 year-end financial results for 2020.

    "Looking back, 2020 was a very productive and transformative year for Cerecor highlighted by swift transition post the merger with Aevi Genomic Medicine, improving the financial position of the company and initiating clinical trials across our pipeline," said Mike Cola, Chief Executive Officer of Cerecor. "2021 started strong with positive Phase 2 data from CERC-002, our novel anti-LIGHT drug candidate in development for the treatment of COVID-19 ARDS. We have recently filed both Breakthrough Therapy and Fast Track Designations and anticipate meeting with the FDA to discuss next steps in this program soon. Overall, we believe 2021 will be a breakout year for Cerecor and look forward to building on early momentum with important pipeline updates across our immunology, oncology, and rare disease assets."

    Business Updates:

     Cerecor announced CERC-002 significantly reduced respiratory failure and mortality in Phase 2 clinical trial in Patients hospitalized with COVID-19 ARDS.
     The Company closed an underwritten public offering for net proceeds of approximately $37.6 million in January.
     Dr. Gilla Kaplan was appointed to the Board of Directors in October of 2020 bringing decades of experience in rare diseases and immune-inflammatory disorders.
     Schond Greenway was appointed as Chief Financial Officer, with an established focus on investor relations to further help capitalize the company.

    Program Updates:

     CERC-002: Anti-LIGHT monoclonal antibody in clinical development for COVID-19 ARDS and severe pediatric onset Crohn's disease.
       °Completed double-blinded, placebo-controlled Phase 2 proof-of-concept study of CERC-002 in cytokine storm-induced COVID-19 ARDS.
       °Final analysis inclusive of the 60-day safety update in the randomized placebo-controlled study demonstrated CERC-002 was statistically significant in reducing respiratory failure and mortality at Day 28 in patients hospitalized with COVID-19-associated pneumonia and mild to moderate acute respiratory distress syndrome (ARDS), the primary endpoint, (n=62, p=0.044)
       °At both the 28-day and the 60-day final timepoints, an approximately 50% trend in mortality reduction (22.5% vs 10.8%) was observed. CERC-002 appeared safe and well-tolerated on top of standard of care including high dose steroids (>90%) and remdesivir (>65%).
       °Cerecor has submitted applications to the FDA for Breakthrough Therapy and Fast Track Designations and plans to meet with FDA to discuss the path to Emergency Use Authorization (EUA) and full approval.
       °The company is continuing to enroll patients in its Phase 1b trial in severe pediatric-onset Crohn's disease with initial data expected in the second quarter and is exploring the applicability of CERC-002 in non-COVID-19 ARDS.
         
      •CERC-007: Anti-IL-18 monoclonal antibody for the treatment of multiple myeloma (MM) and Still's disease (AOSD and sJIA).
       °In December 2020, announced FDA Acceptance of two Investigational New Drug Applications for CERC-007 for the treatment of Still's disease and for the treatment of relapsed or refractory multiple myeloma (MM).
       °Following the first patient dosed in the Phase 1b clinical trial in patients with relapsed or refractory MM in December, the Company has successfully completed enrollment of the first patient cohort and looks to begin dosing cohort two.
       °Initial data anticipated from Phase 1b clinical trial 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 second quarter of 2021.
         
     CERC-800 programs (CERC-801, CERC-802, and CERC-803): Therapeutic doses of monosaccharide therapies for congenital disorders of glycosylation (CDGs).
       °CERC-801 – In collaboration with the Frontiers in Congenital Disorders of Glycosylation Consortium clinical program, data are anticipated from the pivotal trial evaluating the safety and efficacy of D-galactose in patients suffering from Phosphoglucomutase-1 deficiency related congenital disorders of glycosylation (PGM1-CDG) in second half of 2021.
       °CERC-802 – Data anticipated from the pivotal trial evaluating the safety and efficacy of D-mannose in patients suffering from Mannose phosphate isomerase deficiency related CDG (MPI-CDG) in second half of 2021.
       °CERC-803 – Clearance to proceed on the Investigational New Drug Application and received Fast Track Designation from the FDA in the fourth quarter 2020. Data anticipated from the pivotal trial evaluating the safety and efficacy of L-fucose in patients suffering from Leukocyte Adhesion Deficiency II (LAD II) in second half of 2021.

    2020 Financial Update:

    As of December 31, 2020, Cerecor had $18.9 million in cash and cash equivalents which is a significant increase over the prior year balance of $3.6 million. Furthermore, in January 2021, the Company closed an underwritten public offering for net proceeds of approximately $37.6 million.

    There were significant increases to most operating expenses, net loss and net loss per share related to the merger with Aevi Genomic Medicine that occurred in February 2020 (the Aevi Merger). Notably, research and development expense for the year ended December 31, 2020 significantly increased to $32.2 million, which was driven by activities to advance the Company's expanded pipeline as a result of the Aevi Merger. There was a $25.5 million acquired in-process research and development (IPR&D) charge in 2020 directly related to the Aevi Merger. General and administrative expense increased to $17.4 million; the largest driver of such increase was stock-based compensation and other expenses related to leadership changes as a result of the Aevi Merger.

    We believe these significant investments in our expanded pipeline and leadership team will lead to value driving milestones as our pipeline progresses toward commercialization.



    Condensed Consolidated Balance Sheets

     December 31,
      2020  2019
        
    Assets(in thousands)
    Current assets:   
    Cash and cash equivalents$18,919  $3,609 
    Accounts receivable, net 2,177   1,002 
    Other receivables 2,208   4,241 
    Inventory, net 3   21 
    Prepaid expenses and other current assets 2,660   707 
    Restricted cash, current portion 38   17 
    Investment in Aytu -   7,629 
    Current assets of discontinued operations -   498 
    Total current assets 26,005   17,724 
    Property and equipment, net 1,607   1,448 
    Intangible assets, net 1,585   2,426 
    Goodwill 14,409   14,409 
    Restricted cash, net of current portion 149   102 
    Total assets$43,755  $36,109 
    Liabilities and stockholders' equity   
    Current liabilities:   
    Accounts payable$2,574  $2,078 
    Accrued expenses and other current liabilities 11,310   5,640 
    Income taxes payable -   552 
    Current liabilities of discontinued operations 1,341   3,891 
    Total current liabilities 15,225   12,161 
    Royalty obligation 2,000   - 
    Deferred tax liability, net 90   86 
    Other long-term liabilities 1,878   1,112 
    Long-term liabilities of discontinued operations -   1,755 
    Total liabilities 19,193   15,114 
    Stockholders' equity:   
    Common stock—$0.001 par value; 200,000,000 shares authorized at December 31, 2020 and 2019; 75,004,127 and 44,384,222 shares issued and outstanding at December 31, 2020 and 2019, respectively 75   44 
    Preferred stock—$0.001 par value; 5,000,000 shares authorized at December 31, 2020 and 2019; 1,257,143 and 2,857,143 shares issued and outstanding at December 31, 2020 and 2019, respectively 1   3 
    Additional paid-in capital 202,276   135,239 
    Accumulated deficit (177,790)  (114,291)
    Total stockholders' equity 24,562   20,995 
    Total liabilities and stockholders' equity$43,755  $36,109 
        
    The condensed consolidated balance sheets at December 31, 2020 and 2019 have been derived from the 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

     Year Ended December 31,
      2020  2019
        
     (in thousands, except per share data)
    Revenues:   
    Product revenue, net$6,699  $6,650 
    License and other revenue -   100 
    Total revenues, net 6,699   6,750 
        
    Operating expenses:   
    Cost of product sales 300   (567)
    Research and development 32,193   11,764 
    Acquired in-process research and development 25,549   - 
    General and administrative 17,418   10,124 
    Sales and marketing 2,341   1,484 
    Amortization expense 1,741   1,339 
    Change in fair value of contingent consideration -   (1,256)
    Total operating expenses 79,542   22,888 
      (72,843)  (16,138)
    Other income:   
    Change in fair value of Investment in Aytu 5,208   54 
    Other income (expense), net 409   (28)
    Interest income, net 49   121 
    Total other income, net from continuing operations 5,666   147 
    Loss from continuing operations before taxes (67,177)  (15,991)
    Income tax (benefit) expense (2,793)  280 
    Loss from continuing operations$(64,384) $(16,271)
    Income from discontinued operations, net of tax 884   198 
    Net loss$(63,500) $(16,073)
        
    Net (loss) income per share of common stock, basic and diluted:   
    Continuing operations$(0.87) $(0.28)
    Discontinued operations 0.01   0.00 
    Net loss per share of common stock, basic and diluted$(0.86) $(0.28)
        
    Net (loss) income per share of preferred stock, basic and diluted:   
    Continuing operations$(4.38) $(1.42)
    Discontinued operations 0.06   0.01 
    Net loss per share of preferred stock, basic and diluted$(4.32) $(1.41)
        
    The condensed consolidated statements of operations for the years ended December 31, 2020 and 2019 have been derived from the 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 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, which are in development for congenital disorders of glycosylation and CERC-006, an oral mTORc1/c2 inhibitor in development for the treatment of complex lymphatic malformations. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007. CERC-002 targets the cytokine LIGHT (TNFSF14) and is in clinical development for treatment of severe pediatric-onset Crohn's disease, and COVID-19 acute respiratory distress syndrome. CERC-007 targets the cytokine IL-18 and is in clinical development for the treatment of Still's disease (adult onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (sJIA)), and multiple myeloma (MM). CERC-006, 801, 802 and 803 have all received Orphan Drug Designation and Rare Pediatric Disease Designation, which makes all four eligible for a priority review voucher upon FDA approval.

    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 inquiries

    Chris Brinzey

    Westwicke, an ICR Company



    339-970-2843

    or

    Schond L. Greenway

    Investor Relations

    Chief Financial Officer

    Cerecor Inc.



    610-522-6200 office



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  3. ROCKVILLE, Md. and CHESTERBROOK, Pa., March 04, 2021 (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 that Michael F. Cola, President and Chief Executive Officer, will present at two upcoming virtual conferences.

    H.C. Wainwright Global Life Sciences Conference
    Date: March 9-10, 2021
    Pre-Recorded Formal Presentation will be made available on Tuesday, March 9, 2021 at 7:00 AM ET

    Oppenheimer's 31st Annual Healthcare Conference
    Date: Wednesday, March 17, 2021
    Time: 8:00 AM ET

    A live webcast of the presentations can be accessed under "News/Events" page in the Investors section of the Company's…

    ROCKVILLE, Md. and CHESTERBROOK, Pa., March 04, 2021 (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 that Michael F. Cola, President and Chief Executive Officer, will present at two upcoming virtual conferences.

    H.C. Wainwright Global Life Sciences Conference

    Date: March 9-10, 2021

    Pre-Recorded Formal Presentation will be made available on Tuesday, March 9, 2021 at 7:00 AM ET

    Oppenheimer's 31st Annual Healthcare Conference

    Date: Wednesday, March 17, 2021

    Time: 8:00 AM ET

    A live webcast of the presentations can be accessed under "News/Events" page in the Investors section of the Company's website at www.cerecor.com.

    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, which are in development for congenital disorders of glycosylation and CERC-006, an oral mTORc1/c2 inhibitor in development for the treatment of complex lymphatic malformations. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007. CERC-002 targets the cytokine LIGHT (TNFSF14) and is in clinical development for treatment of severe pediatric-onset Crohn's disease, and COVID-19 acute respiratory distress syndrome. CERC-007 targets the cytokine IL-18 and is in clinical development for the treatment of Still's disease (adult onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (sJIA)), and multiple myeloma (MM). CERC-006, 801, 802 and 803 have all received Orphan Drug Designation and Rare Pediatric Disease Designation, which makes all four eligible for a priority review voucher upon FDA approval.

    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 inquiries

    Chris Brinzey

    Westwicke, an ICR Company



    339-970-2843

    or

    Schond L. Greenway

    Investor Relations

    Chief Financial Officer

    Cerecor Inc.



    610-522-6200 office



    Primary Logo

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    • Final analysis inclusive of the 60-day safety update in the randomized placebo-controlled study demonstrated CERC-002 was statistically significant in reducing respiratory failure and mortality at Day 28 in patients hospitalized with COVID-19 associated pneumonia and mild to moderate acute respiratory distress syndrome (ARDS), the primary endpoint, (p=0.044)
    • Efficacy was highest in patients over the age of 60, the population most vulnerable to severe complications and death with COVID-19 infection
    • At both the 28-day and the 60-day final timepoints, an approximately 50% trend in mortality reduction (22.5% vs 10.8%) was observed
    • Results were observed on top of standard of care including high dose steroids (>90%) and remdesivir (>65%)
    • Cerecor has applied
    • Final analysis inclusive of the 60-day safety update in the randomized placebo-controlled study demonstrated CERC-002 was statistically significant in reducing respiratory failure and mortality at Day 28 in patients hospitalized with COVID-19 associated pneumonia and mild to moderate acute respiratory distress syndrome (ARDS), the primary endpoint, (p=0.044)

    • Efficacy was highest in patients over the age of 60, the population most vulnerable to severe complications and death with COVID-19 infection
    • At both the 28-day and the 60-day final timepoints, an approximately 50% trend in mortality reduction (22.5% vs 10.8%) was observed
    • Results were observed on top of standard of care including high dose steroids (>90%) and remdesivir (>65%)
    • Cerecor has applied for FDA Breakthrough Therapy and Fast Track Designations, and plans to meet with FDA to discuss potential path to Emergency Use Authorization

    ROCKVILLE, Md. and CHESTERBROOK, Pa., March 02, 2021 (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 final efficacy data including 60-day mortality from their recently completed US-based, multi-center (10 sites), Phase 2 trial (NCT04412057) of the human anti-LIGHT (TNFSF14) monoclonal antibody CERC-002. This analysis updates the preliminary topline data reported on January 5, 2021. All patients in this trial were hospitalized with COVID-19 associated pneumonia and mild-to-moderate acute respiratory distress syndrome ("ARDS"). A total of 83 patients were randomized 1:1 to receive standard of care at the sites plus either a single dose of 1,200 mg of CERC-002 or placebo subcutaneously. Due to the protocol allowing patients to receive high flow oxygen prior to randomization, 62 patients were included in the intention-to-treat (ITT) analysis of the primary endpoint.

    The final analysis inclusive of the 60-day safety update demonstrated the trial met its primary efficacy endpoint (proportion of patients alive and free of respiratory failure over the 28-day study period) compared to placebo in COVID-19 patients with ARDS treated with a single dose of the anti-LIGHT monoclonal antibody CERC-002 (n=62, p=0.044). Efficacy was highest in a prespecified subpopulation of patients over the age of 60 (n=34, p=0.042), the population most vulnerable to severe complications and death with COVID-19 infection.

    At both the 28-day and the 60-day final timepoints, an approximately 50% trend in mortality reduction (22.5% vs 10.8%) was observed.

    CERC-002 showed statistically significant efficacy on top of corticosteroids and standard of care treatments in COVID-19 ARDS: over 90% of patients received concomitant systemic corticosteroids and over 65% received remdesivir. CERC-002 was well-tolerated. No drug-related serious adverse effects (SAEs) were reported in the trial, and there was no increase in infections in CERC-002 treated patients.

    Cerecor has submitted applications to the U.S. Food and Drug Administration (FDA) for Breakthrough Therapy and Fast Track Designations. The Company plans to meet with FDA to discuss the potential path to Emergency Use Authorization (EUA) and approval.

    "We would like to thank the patients who participated in this landmark study. These results not only validate our hypothesis that elevated LIGHT is a key driver of morbidity and mortality in COVID-19 ARDS1, but also provide strong initial evidence that LIGHT neutralization with CERC-002 in this setting may be able to save lives and can spare patients from the need for ventilatory support," said H. Jeffrey Wilkins, MD, Chief Medical Officer of Cerecor. "These results are all the more encouraging given that this novel targeted therapy demonstrated efficacy and excellent tolerability despite being administered over and above standard of care including high dose systemic corticosteroids."

    "Despite progress with vaccinations, thousands of people in the US and around the world continue to die of COVID-19 related cytokine release syndrome and ARDS every day. There is an urgent need for new safe and effective therapies to treat these patients," said Dr. David Perlin, Ph.D., Chief Scientific Officer and Senior Vice President of the Center for Discovery and Innovation at the Hackensack Meridian School of Medicine. "The need is all the greater given the increasing levels of COVID-19 mutation and resistance emerging in variants. Even with widespread vaccination such therapies will be required for many years to come."

    A presentation of these data updates can be found on the Investors section of the Cerecor website linked here.

    CERC-002 (anti-LIGHT monoclonal antibody)

    CERC-002 is a fully human anti-LIGHT or tumor necrosis factor superfamily member 14 (TNFSF14) monoclonal antibody licensed from Kyowa Kirin Co., Ltd. It is the only clinical stage anti-LIGHT therapy and has the potential to treat a number of LIGHT-associated immune diseases including cytokine storm-induced COVID-19 ARDS. It is currently in development for pediatric onset Crohn's disease and cytokine storm induced COVID-19 ARDS. Cerecor has also developed a validated, high sensitivity serum/plasma free LIGHT assay in collaboration with Myriad RBM.

    Role of LIGHT in Acute Inflammatory Response

    LIGHT (homologous to Lymphotoxin, exhibits inducible expression and competes with HSV glycoprotein D for binding to herpesvirus entry mediator, a receptor expressed on T lymphocytes) is a cytokine with inflammatory actions encoded by the TNFSF14 gene. LIGHT plays an important role in regulating immune responses in the lung, gut and skin. It stimulates T Cell and B Cell response as well as induces the release of other cytokines such as IL-1, IL-6, IL-8, IL-10, TNF and GM-CSF. Therefore, LIGHT potentially plays a key role in immune responses to viral pneumonia and other diseases.

    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, which are in development for congenital disorders of glycosylation and CERC-006, an oral mTORc1/c2 inhibitor in development for the treatment of complex lymphatic malformations. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007. CERC-002 targets the cytokine LIGHT (TNFSF14) and is in clinical development for treatment of severe pediatric-onset Crohn's disease, and COVID-19 acute respiratory distress syndrome. CERC-007 targets the cytokine IL-18 and is in clinical development for the treatment of Still's disease (adult onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (sJIA)), and multiple myeloma (MM). CERC-006, 801, 802 and 803 have all received Orphan Drug Designation and Rare Pediatric Disease Designation, which makes all four eligible for a priority review voucher upon FDA approval.

    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 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 inquiries

    Chris Brinzey

    Westwicke, an ICR Company



    339-970-2843

    or

    James Harrell

    Investor Relations

    Chief Commercial Officer

    Cerecor Inc.



    623.439.2220 office

    1 Perlin DS, Zafir-Lavie I, Roadcap L, et al Levels of the TNF-Related Cytokine LIGHT Increase in Hospitalized COVID-19 Patients with Cytokine Release Syndrome and ARDS. mSphere. 2020 Aug 12;5(4):e00699-20.



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