CERC Cerecor Inc.

2.6
+0.03  (+1%)
Previous Close 2.57
Open 2.6
52 Week Low 1.52
52 Week High 6.19
Market Cap $197,423,255
Shares 76,043,161
Float 44,902,371
Enterprise Value $175,064,028
Volume 142,717
Av. Daily Volume 538,363
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Upcoming Catalysts

Drug Stage Catalyst Date
CERC-802
Healthy volunteers
Phase 1
Phase 1
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CERC-002
COVID-19 induced Acute Respiratory Distress Syndrome (ARDS)
Phase 2
Phase 2
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CERC-007
Adult Onset Still's Disease (AOSD) and Multiple Myeloma (MM)
Phase 1/2
Phase 1/2
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CERC-002 (AEVI-002)
Pediatric onset Crohn'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
NDA Filing
NDA Filing
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Drug Pipeline

Drug Stage Notes
CERC-301
Diabetic Orthostatic Hypotension
Phase 1
Phase 1
Phase 1 commencement of enrolment announced November 11, 2019.
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

  1. ROCKVILLE, Md., June 11, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases, announced today the closing of the previously announced underwritten offering of 15,180,000 shares of its common stock (inclusive of 1,980,000 shares that were sold pursuant to the underwriter's full exercise of its option to purchase additional shares of Cerecor's common stock), at a public offering price of $2.50 per share. Certain insiders, including certain of the Company's officers, purchased shares of Cerecor common stock in the offering.

    Oppenheimer & Co. Inc. acted as the sole book-running manager for the offering…

    ROCKVILLE, Md., June 11, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases, announced today the closing of the previously announced underwritten offering of 15,180,000 shares of its common stock (inclusive of 1,980,000 shares that were sold pursuant to the underwriter's full exercise of its option to purchase additional shares of Cerecor's common stock), at a public offering price of $2.50 per share. Certain insiders, including certain of the Company's officers, purchased shares of Cerecor common stock in the offering.

    Oppenheimer & Co. Inc. acted as the sole book-running manager for the offering.

    The net proceeds to Cerecor from the offering are expected to be approximately $35.4 million, after deducting underwriting discounts and commissions and estimated offering expenses. Cerecor intends to use the net proceeds of the offering for working capital and general corporate purposes, which include the funding of development of its product candidates, and general and administrative expenses.

    The shares of common stock described above were offered by Cerecor pursuant to an effective shelf registration statement on Form S-3 (File No. 333-233978), previously filed with the U.S. Securities and Exchange Commission (the "SEC") on September 27, 2019 and declared effective on October 24, 2019, and the accompanying prospectus contained therein.  The offering of the shares of common stock was made by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus relating to and describing the terms of the offering has been filed with the SEC. Copies of the final prospectus relating to the offering may be obtained on the SEC's website at http://www.sec.gov or by contacting Oppenheimer & Co. Inc. at 85 Broad Street, 26th Floor, New York, NY 10004, Attention: Equity Syndicate Prospectus Department, by e-mail at or by calling (212) 667-8055.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Cerecor Inc.

    Cerecor is a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases. The Company is advancing an emerging clinical-stage pipeline of innovative therapies. The Company's pediatric rare disease pipeline is led by CERC-801, CERC-802 and CERC-803 ("CERC-800 programs"), which are therapies for inborn errors of metabolism, specifically disorders known as Congenital Disorders of Glycosylation ("CDGs"). The FDA granted Rare Pediatric Disease Designation and Orphan Drug Designation ("ODD") to all three CERC-800 programs, thus potentially qualifying the Company to receive a Priority Review Voucher ("PRV") upon approval of a 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 ARDS and Pediatric-onset Crohn's Disease. CERC-006 is a dual mTOR inhibitor being developed for the treatment of complex Lymphatic Malformations.  CERC-007 is an anti-IL-18 monoclonal antibody being developed for the treatment of autoimmune inflammatory diseases such as Adult Onset Stills Disease ("AOSD") and Multiple Myeloma ("MM").

    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

    James Harrell

    Investor Relations

    Chief Commercial Officer

    Cerecor Inc.



    623.439.2220 office

    Primary Logo

    View Full Article Hide Full Article
  2. ROCKVILLE, Md., June 09, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases, announced today that it has entered into an underwriting agreement with Oppenheimer & Co. Inc. under which the underwriter agreed to purchase, on a firm commitment basis, 13,200,000 shares of common stock of the Company, at a public offering price of $2.50 per share (the "Public Offering Price"). The offering is expected to close on or about June 11, 2020, subject to customary closing conditions.

    Oppenheimer & Co. Inc. is acting as the sole book-running manager for the offering.

    The Company also has granted to the…

    ROCKVILLE, Md., June 09, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases, announced today that it has entered into an underwriting agreement with Oppenheimer & Co. Inc. under which the underwriter agreed to purchase, on a firm commitment basis, 13,200,000 shares of common stock of the Company, at a public offering price of $2.50 per share (the "Public Offering Price"). The offering is expected to close on or about June 11, 2020, subject to customary closing conditions.

    Oppenheimer & Co. Inc. is acting as the sole book-running manager for the offering.

    The Company also has granted to the underwriter a 30-day option to purchase up to an additional 1,980,000 shares of common stock at the Public Offering Price to cover over-allotments in the sales of the shares, if any. The gross proceeds to Cerecor from this offering, before deducting underwriting discounts and commissions and estimated offering expenses and excluding any exercise of the underwriter's option to purchase additional shares of common stock, are expected to be approximately $33.0 million. Assuming the full exercise of the over-allotment option, total gross proceeds to Cerecor would be $37.95 million. Cerecor intends to use the net proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses.

    The shares of common stock described above are being offered by Cerecor pursuant to an effective shelf registration statement on Form S-3 (File No. 333-233978), previously filed with the U.S. Securities and Exchange Commission (the "SEC") on September 27, 2019 and declared effective on October 24, 2019, and the accompanying prospectus contained therein. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained on the SEC's website at http://www.sec.gov or by contacting Oppenheimer & Co. Inc. at 85 Broad Street, 26th Floor, New York, NY 10004, Attention: Equity Syndicate Prospectus Department, by e-mail at or by calling (212) 667-8055.

    Before investing in the offering, you should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Cerecor has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus, which provide more information about Cerecor and the offering.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Cerecor Inc.

    Cerecor is a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases. The Company is advancing an emerging clinical-stage pipeline of innovative therapies. The Company's pediatric rare disease pipeline is led by CERC-801, CERC-802 and CERC-803 ("CERC-800 programs"), which are therapies for inborn errors of metabolism, specifically disorders known as Congenital Disorders of Glycosylation ("CDGs"). The FDA granted Rare Pediatric Disease Designation and Orphan Drug Designation ("ODD") to all three CERC-800 programs, thus potentially qualifying the Company to receive a Priority Review Voucher ("PRV") upon approval of a 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 ARDS and Pediatric-onset Crohn's Disease. CERC-006 is a dual mTOR inhibitor being developed for the treatment of complex Lymphatic Malformations. CERC-007 is an anti-IL-18 monoclonal antibody being developed for the treatment of autoimmune inflammatory diseases such as Adult Onset Stills Disease ("AOSD") and Multiple Myeloma ("MM").

    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 completion of the public offering, 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

    James Harrell

    Investor Relations

    Chief Commercial Officer

    Cerecor Inc.



    623.439.2220 office

    Primary Logo

    View Full Article Hide Full Article
  3. ROCKVILLE, Md., June 08, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases, announced today that it intends to offer for sale shares of its common stock in an underwritten public offering. Cerecor intends to grant the underwriters a 30-day option to purchase additional shares of its common stock sold in the offering, to cover over-allotments in the sales of the shares, if any. All of the shares of common stock will be offered by Cerecor. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual…

    ROCKVILLE, Md., June 08, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases, announced today that it intends to offer for sale shares of its common stock in an underwritten public offering. Cerecor intends to grant the underwriters a 30-day option to purchase additional shares of its common stock sold in the offering, to cover over-allotments in the sales of the shares, if any. All of the shares of common stock will be offered by Cerecor. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    Oppenheimer & Co. Inc. is acting as the sole book-running manager for the offering.

    Cerecor intends to use the net proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses.

    This offering by Cerecor is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-233978), previously filed with the U.S. Securities and Exchange Commission (the "SEC") on September 27, 2019 and declared effective on October 24, 2019, and the accompanying prospectus contained therein. The offering of the shares of common stock will be made by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC, and will be available on the SEC's website at http://www.sec.gov or by contacting Oppenheimer & Co. Inc. at 85 Broad Street, 26th Floor, New York, NY 10004, Attention: Equity Syndicate Prospectus Department, by e-mail at or by calling (212) 667-8055.

    Before investing in the offering, you should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that Cerecor has filed with the SEC that are incorporated by reference in the preliminary prospectus supplement and the accompanying prospectus, which provide more information about Cerecor and the offering.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Cerecor Inc.

    Cerecor is a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases. The Company is advancing an emerging clinical-stage pipeline of innovative therapies. The Company's pediatric rare disease pipeline is led by CERC-801, CERC-802 and CERC-803 ("CERC-800 programs"), which are therapies for inborn errors of metabolism, specifically disorders known as Congenital Disorders of Glycosylation ("CDGs"). The FDA granted Rare Pediatric Disease Designation and Orphan Drug Designation ("ODD") to all three CERC-800 programs, thus potentially qualifying the Company to receive a Priority Review Voucher ("PRV") upon approval of a 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 ARDS and Pediatric-onset Crohn's Disease. CERC-006 is a dual mTOR inhibitor being developed for the treatment of complex Lymphatic Malformations. CERC-007 is an anti-IL-18 monoclonal antibody being developed for the treatment of autoimmune inflammatory diseases such as Adult Onset Stills Disease ("AOSD") and Multiple Myeloma ("MM").

    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 completion of the public offering, 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

    James Harrell

    Investor Relations

    Chief Commercial Officer

    Cerecor Inc.

     

    623.439.2220 office

    Primary Logo

    View Full Article Hide Full Article
  4. ROCKVILLE, Md., May 29, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC) today announced that Michael F. Cola, President and Chief Executive Officer, will present at the Jefferies Virtual Healthcare Conference on Tuesday, June 2, 2020 at 2:30 p.m. EDT.

    A live webcast of the presentation 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 development and commercialization of treatments for rare pediatric and orphan diseases. The Company is advancing an emerging clinical-stage pipeline of innovative therapies. The Company's pediatric rare disease pipeline is led by CERC-801, CERC-802 and CERC-803…

    ROCKVILLE, Md., May 29, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC) today announced that Michael F. Cola, President and Chief Executive Officer, will present at the Jefferies Virtual Healthcare Conference on Tuesday, June 2, 2020 at 2:30 p.m. EDT.

    A live webcast of the presentation 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 development and commercialization of treatments for rare pediatric and orphan diseases. The Company is advancing an emerging clinical-stage pipeline of innovative therapies. The Company's pediatric rare disease pipeline is led by CERC-801, CERC-802 and CERC-803 ("CERC-800 programs"), which are therapies for inborn errors of metabolism, specifically disorders known as Congenital Disorders of Glycosylation ("CDGs"). The FDA granted Rare Pediatric Disease Designation and Orphan Drug Designation ("ODD") to all three CERC-800 programs, thus potentially qualifying the Company to receive a Priority Review Voucher ("PRV") upon approval of a new drug application ("NDA"). The Company is also developing CERC-002, CERC-006 and CERC-007. CERC-007 is an anti-IL-18 monoclonal antibody being developed for the treatment of autoimmune inflammatory diseases such as Adult Onset Stills Disease ("AOSD") and Multiple Myeloma ("MM"). CERC-006 is a dual mTOR inhibitor being developed for the treatment of complex Lymphatic Malformations. CERC-002 is an anti-LIGHT monoclonal antibody being developed for the treatment of COVID-19 ARDS and Pediatric-onset Crohn's Disease. 

    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

    James Harrell,
    Investor Relations
    Chief Commercial Officer
    Cerecor Inc.

    623.439.2220 office

    Primary Logo

    View Full Article Hide Full Article
  5. Company to Initiate Multicenter, Placebo-controlled, Randomized Study in June
    Top-line Data Anticipated in Fourth Quarter 2020

    ROCKVILLE, Md., May 28, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a proof-of-concept clinical trial of its anti-LIGHT monoclonal antibody CERC-002 in patients with COVID-19 cytokine storm induced Acute Respiratory Distress Syndrome (ARDS). The study will assess the efficacy and safety of CERC-002. The first patient is expected to enroll in June and top-line…

    Company to Initiate Multicenter, Placebo-controlled, Randomized Study in June
    Top-line Data Anticipated in Fourth Quarter 2020

    ROCKVILLE, Md., May 28, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a proof-of-concept clinical trial of its anti-LIGHT monoclonal antibody CERC-002 in patients with COVID-19 cytokine storm induced Acute Respiratory Distress Syndrome (ARDS). The study will assess the efficacy and safety of CERC-002. The first patient is expected to enroll in June and top-line data are expected in the fourth quarter of 2020.

    The randomized, multi-center, double-blind, placebo-controlled trial will enroll approximately 82 subjects hospitalized with COVID-19 ARDS. The primary objective of the study is to demonstrate that treatment with CERC-002 results in fewer instances of respiratory failure and death versus the standard of care. Patients in the CERC-002 arm will receive a single dose of drug and be followed for 28 days. Key secondary endpoints include ICU length of stay, hospital length of stay and oxygen saturation at the end of study.

    The scientific rationale for the study was driven by positive results from a recent biomarker study conducted with Hackensack Meridian Health Network demonstrating elevated levels of the inflammatory cytokine LIGHT in patients hospitalized with COVID-19 cytokine storm-induced ARDS. In the patients studied, LIGHT levels were significantly elevated in the serum of hospitalized patients with COVID-19 versus healthy controls (p value < 0.0001). The highest LIGHT levels were found in patients who required ventilator support, particularly in patients over 60 years of age. Importantly, the data demonstrated elevated LIGHT levels were also strongly linked with mortality (p=0.02). The data suggest that LIGHT may play a key role in cytokine storm that leads to ARDS. CERC-002 is a first in class monoclonal antibody targeted against the inflammatory cytokine LIGHT. It is the only anti-LIGHT therapy in clinical development and has the potential to be a treatment option for this patient population in critical need.

    Cerecor's chief medical officer, Dr. H. Jeffrey Wilkins stated, "There is an urgent need for therapies to help patients with COVID-19 ARDS given the ongoing spread of the SARS-CoV-2 and limited therapeutic options. With FDA clearance, we plan to initiate a clinical trial to evaluate anti-LIGHT antibody therapy in patients with COVID-19 cytokine storm-induced ARDS. The trial is designed to generate rapid and definitive results in the fourth quarter of 2020."

    CERC-002 (anti-LIGHT monoclonal antibody)

    CERC-002 is an anti-LIGHT (part of the Tumor Necrosis Super Family 14) fully human monoclonal antibody licensed from Kyowa Kirin Co., Ltd. in the clinic. It offers the potential to treat cytokine storm-induced COVID-19 ARDS in the near-term and broader ARDS indication beyond. It is currently being developed as a treatment for Pediatric Crohn's Disease and now cytokine storm induced COVID-19 ARDS. Cerecor has also developed a validated serum/plasma free LIGHT assay in collaboration with Myriad RBM. This assay has shown to have high sensitivity and specificity for free LIGHT which has been shown to be elevated in patients with active Crohn's disease and with COVID-19 related ARDS.

    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 has been shown to play a key role in the immune response to viral pneumonia. 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 IL1, IL6, IL-8, IL-10, TNF and GM-CSF.

    About Cerecor

    Cerecor is a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases. The Company is advancing an emerging clinical-stage pipeline of innovative therapies. The Company's pediatric rare disease pipeline is led by CERC-801, CERC-802 and CERC-803 ("CERC-800 programs"), which are therapies for inborn errors of metabolism, specifically disorders known as Congenital Disorders of Glycosylation ("CDGs"). The FDA granted Rare Pediatric Disease Designation and Orphan Drug Designation ("ODD") to all three CERC-800 programs, thus potentially qualifying the Company to receive a Priority Review Voucher ("PRV") upon approval of a new drug application ("NDA"). The Company is also developing CERC-002, CERC-006 and CERC-007. CERC-007 is an anti-IL-18 monoclonal antibody being developed for the treatment of autoimmune inflammatory diseases such as Adult Onset Stills Disease ("AOSD") and Multiple Myeloma ("MM"). CERC-006 is a dual mTOR inhibitor being developed for the treatment of complex Lymphatic Malformations. CERC-002 is an anti-LIGHT monoclonal antibody being developed for the treatment of COVID-19 ARDS and Pediatric-onset Crohn's Disease.

    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

    James Harrell
    Investor Relations
    Chief Commercial Officer
    Cerecor Inc.

    623.439.2220 office

     

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