• 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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  1. ROCKVILLE, Md. and CHESTERBROOK, Pa., March 01, 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 the appointment of Schond L. Greenway as Chief Financial Officer, effective March 1, 2021. Mr. Greenway comes to Cerecor with over 20 years' experience in investment banking, finance and corporate advisory and investment analysis in the life sciences and financial services industries. Chris Sullivan, who has served as the Company's Interim Chief Financial Officer for the past year, will continue with the Company as its Chief Accounting Officer.

    "We are excited to have recruited such talent

    ROCKVILLE, Md. and CHESTERBROOK, Pa., March 01, 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 the appointment of Schond L. Greenway as Chief Financial Officer, effective March 1, 2021. Mr. Greenway comes to Cerecor with over 20 years' experience in investment banking, finance and corporate advisory and investment analysis in the life sciences and financial services industries. Chris Sullivan, who has served as the Company's Interim Chief Financial Officer for the past year, will continue with the Company as its Chief Accounting Officer.

    "We are excited to have recruited such talent and experience at this exciting point in our progress. We have several significant near-term milestones on the horizon. Schond's strategic and financial experience will be invaluable as we advance our portfolio of assets," said Mike Cola, Chief Executive Officer of Cerecor. "Additionally, we would like to thank Chris Sullivan for his service as our Interim Chief Financial Officer over the past year and we look forward to Chris remaining an essential part of our finance team as our Chief Accounting Officer."

    "Cerecor is a dynamic company and I'm excited to join its outstanding and experienced leadership team," said Mr. Greenway. "I look forward to working with Cerecor's Board of Directors and management team to advance the Company's robust pipeline of innovative therapies that address unmet patient needs within rare and orphan diseases."

    Mr. Greenway joins Cerecor from Mesoblast Ltd., an allogeneic cellular medicines company, where he served as Vice President, Investor Relations. At Mesoblast, Mr. Greenway led the Company's investor relations activities and successfully concluded several strategic corporate finance transactions and capital markets initiatives. Prior to Mesoblast, from 2013 to 2016, he served in a similar role at Halozyme Therapeutics, Inc. Prior to that, Mr. Greenway has served in positions of increasing responsibility at investment banking firms and healthcare companies such as Morgan Stanley, Barclays Capital and DURECT Corporation, predominantly focused on healthcare and technology.

    In his career, Mr. Greenway has participated in and advised on transactions valued at over $30 billion during his tenure in investment banking and capital markets. During his tenure at Mesoblast, Halozyme Therapeutics and DURECT Corporation, Mr. Greenway assisted with securing more than $1 billion in cumulative growth capital through a variety of equity and debt instruments in the public and private markets, as well as through funding from significant collaboration arrangements with therapeutics companies.

    Mr. Greenway received a B.S. from Florida A&M University and an M.B.A. from the Darden Graduate School of Business – University of Virginia.

    In connection with the appointment of Mr. Greenway and in accordance with the terms of his employment agreement with the Company, Cerecor's Board of Directors approved the grant to Mr. Greenway of a non-qualified stock option awarded to purchase 500,000 shares of its common stock, vesting over four (4) years, with a twelve-month cliff, such that the first 25% will vest on the first anniversary following Mr. Greenway's start date with the Company, and the remainder will vest in equal monthly installments over the following three (3) years, in each case, subject to continued employment with the Company through the applicable vesting date. In the event that Mr. Greenway's employment by the Company is terminated without cause or Mr. Greenway terminates his employment for Good Reason, then the portion of the option equal to what would have vested had he remained employed for twelve (12) additional months following the termination date will automatically vest. The stock option was granted on March 1, 2021 as an inducement material to Mr. Greenway becoming an employee of Cerecor in accordance with Nasdaq Listing Rule 5635(c)(4). The option will have an exercise price equal to the closing price of Cerecor's common stock on The Nasdaq Capital Market on March 1, 2021. The option is subject to the terms and conditions of the stock option agreement covering the grant.

    About Cerecor Inc.

    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

     



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  2. ROCKVILLE, Md., Feb. 02, 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 that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CERC-803 for the treatment of Leukocyte Adhesion Deficiency Type II (LAD-II, also known as SLC35C1-CDG). The company remains on track to initiate a pivotal trial of CERC-803 in LAD-II in the first half of 2021 and anticipates topline data in the second half of 2021.

    "We are excited to receive Fast Track Designation for CERC-803 to treat LAD-II," said H. Jeffrey Wilkins, MD, Chief Medical Officer of Cerecor. "LAD-II is a serious

    ROCKVILLE, Md., Feb. 02, 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 that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CERC-803 for the treatment of Leukocyte Adhesion Deficiency Type II (LAD-II, also known as SLC35C1-CDG). The company remains on track to initiate a pivotal trial of CERC-803 in LAD-II in the first half of 2021 and anticipates topline data in the second half of 2021.

    "We are excited to receive Fast Track Designation for CERC-803 to treat LAD-II," said H. Jeffrey Wilkins, MD, Chief Medical Officer of Cerecor. "LAD-II is a serious and life-threatening ultra-rare disease caused by genetic mutations resulting in hypotonia, failure to thrive, and increased susceptibility to developing recurrent bacterial and fungal infections. Many patients also have significant life-threatening bleeding disorders. There are currently no FDA-approved therapies for patients suffering from LAD-II. Fast Track Designation offers us broader access to the FDA and an expedited review process, giving us the potential for accelerated approval to bring a much-needed therapy for patients with LAD-II."

    Fast Track Designation is granted to drugs being developed for the treatment of serious or life-threatening diseases or conditions where there is an unmet medical need. The purpose of the provision is to help facilitate development and expedite the review of drugs to treat serious or life-threatening conditions so that an approved product can reach the market expeditiously. Sponsors of drugs that receive Fast Track Designation have the opportunity for more frequent interactions with the FDA review team throughout the development program.

    About CERC-800s

    CERC-801, CERC-802 and CERC-803 are monosaccharide therapies with known therapeutic utility for the treatment of select congenital disorders of glycosylation (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, 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

    James Harrell

    Investor Relations

    Chief Commercial Officer

    Cerecor Inc.



    623.439.2220 office



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  3. ROCKVILLE, Md. and CHESTERBROOK, Pa., Jan. 20, 2021 (GLOBE NEWSWIRE) -- Cerecor Inc. (("Cerecor", 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 exercise by the underwriters of their option to purchase an additional 1,648,812 shares of Cerecor's common stock, $0.001 par value (the "Common Stock") at a price to the public of $2.60 per share, increasing the total offered through the previously announced underwritten public offering to 13,971,819 of Common Stock and 1,676,923 of prefunded warrants. The gross proceeds to Cerecor from this exercise were approximately $4.3 million, resulting in approximately $40.7…

    ROCKVILLE, Md. and CHESTERBROOK, Pa., Jan. 20, 2021 (GLOBE NEWSWIRE) -- Cerecor Inc. (("Cerecor", 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 exercise by the underwriters of their option to purchase an additional 1,648,812 shares of Cerecor's common stock, $0.001 par value (the "Common Stock") at a price to the public of $2.60 per share, increasing the total offered through the previously announced underwritten public offering to 13,971,819 of Common Stock and 1,676,923 of prefunded warrants. The gross proceeds to Cerecor from this exercise were approximately $4.3 million, resulting in approximately $40.7 million total gross proceeds from the offering. Cerecor intends to use the 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 securities 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 securities 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 Jefferies LLC at 520 Madison Avenue, 2nd Floor, New York, NY 10022, Attention: Equity Syndicate Prospectus Department, by e-mail at  or by calling (877) 547-6340.

    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

    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

    James Harrell

    Investor Relations

    Chief Commercial Officer

    Cerecor Inc.



    623.439.2220 office



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  4. ROCKVILLE, Md. and CHESTERBROOK, Pa., Jan. 12, 2021 (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 12,323,077 shares of its common stock at a public offering price of $2.60 per share (the "Public Offering Price"). In addition, and in lieu of common stock, the Company offered to a certain existing investor pre-funded warrants to purchase up to an aggregate of 1,676,923 shares of common stock at a purchase price of $2.599 per pre-funded warrant, which represents the Public Offering Price for the common stock less the…

    ROCKVILLE, Md. and CHESTERBROOK, Pa., Jan. 12, 2021 (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 12,323,077 shares of its common stock at a public offering price of $2.60 per share (the "Public Offering Price"). In addition, and in lieu of common stock, the Company offered to a certain existing investor pre-funded warrants to purchase up to an aggregate of 1,676,923 shares of common stock at a purchase price of $2.599 per pre-funded warrant, which represents the Public Offering Price for the common stock less the $0.001 per share exercise price for each pre-funded warrant. Certain related parties purchased shares of Cerecor common stock in the offering.

    Jefferies acted as the sole book-running manager for the offering and Oppenheimer & Co. acted as lead manager for the offering.

    The Company also has granted to the underwriters a 30-day option to purchase up to an additional 2,100,000 shares of common stock at the Public Offering Price. The net proceeds to Cerecor from the offering are expected to be approximately $33.6 million (or $38.7 million if the underwriters exercise their option to purchase additional shares of common stock in full), after deducting the underwriting discounts and commissions and estimated offering expenses payable by Cerecor. 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 securities 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 securities 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 Jefferies LLC at 520 Madison Avenue, 2nd Floor, New York, NY 10022, Attention: Equity Syndicate Prospectus Department, by e-mail at or by calling (877) 547-6340.

    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 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

    James Harrell

    Investor Relations

    Chief Commercial Officer

    Cerecor Inc.

     

    623.439.2220 office



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  5. ROCKVILLE, Md. and CHESTERBROOK, Pa., Jan. 07, 2021 (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 Jefferies LLC under which the underwriters agreed to purchase, on a firm commitment basis, 12,323,077 shares of common stock of the Company, at a public offering price of $2.60 per share (the "Public Offering Price"). In addition, and in lieu of common stock, the Company is offering to a certain existing investor pre-funded warrants to purchase up to an aggregate of 1,676,923 shares of common stock at a purchase price of $2.599…

    ROCKVILLE, Md. and CHESTERBROOK, Pa., Jan. 07, 2021 (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 Jefferies LLC under which the underwriters agreed to purchase, on a firm commitment basis, 12,323,077 shares of common stock of the Company, at a public offering price of $2.60 per share (the "Public Offering Price"). In addition, and in lieu of common stock, the Company is offering to a certain existing investor pre-funded warrants to purchase up to an aggregate of 1,676,923 shares of common stock at a purchase price of $2.599 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.001 per share exercise price for each pre-funded warrant. The offering is expected to close on or about January 12, 2021, subject to customary closing conditions.

    Jefferies is acting as the sole book-running manager for the offering and Oppenheimer & Co. is acting as lead manager for the offering.

    The Company also has granted to the underwriters a 30-day option to purchase up to an additional 2,100,000 shares of common stock at the Public Offering Price to cover over-allotments in the sales of the securities, 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 underwriters' option to purchase additional shares of common stock, are expected to be approximately $36.4 million. Assuming the full exercise of the over-allotment option, total gross proceeds to Cerecor would be approximately $41.9 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 securities 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 securities 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 Jefferies LLC at 520 Madison Avenue, 2nd Floor, New York, NY 10022, Attention: Equity Syndicate Prospectus Department, by e-mail at or by calling (877) 547-6340.

    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 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 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 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

    James Harrell

    Investor Relations

    Chief Commercial Officer

    Cerecor Inc.



    623.439.2220 office



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  6. ROCKVILLE, Md. and CHESTERBROOK, Pa., Jan. 07, 2021 (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 and, to a certain investor in lieu thereof, pre-funded warrants to purchase shares of 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 proposed offering of up to 15% of the aggregate number of shares of common stock plus the shares of common stock underlying the pre-funded warrants being offered in the…

    ROCKVILLE, Md. and CHESTERBROOK, Pa., Jan. 07, 2021 (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 and, to a certain investor in lieu thereof, pre-funded warrants to purchase shares of 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 proposed offering of up to 15% of the aggregate number of shares of common stock plus the shares of common stock underlying the pre-funded warrants being offered in the offering. All of the securities 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.

    Jefferies is acting as the sole book-running manager for the offering and Oppenheimer is acting as lead 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 securities 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 Jefferies LLC at 520 Madison Avenue, 2nd Floor, New York, NY 10022, Attention: Equity Syndicate Prospectus Department, by e-mail at  or by calling (877) 547-6340.

    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 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 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 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

    James Harrell

    Investor Relations

    Chief Commercial Officer

    Cerecor Inc.



    623.439.2220 office



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    • COVID-19 ARDS patients treated with a single dose of the anti-LIGHT monoclonal antibody CERC-002 demonstrated robust improvement in the primary endpoint (proportion of patients alive and free of respiratory failure over the 28-day study period) compared to placebo (n=62, odds ratio [OR] = 2.62, p=0.059)
    • A prespecified subgroup analysis of patients 60 years of age showed that CERC-002 treatment led to a greater than 3-fold increase in likelihood of avoiding respiratory failure and death compared to placebo (n=33, OR = 3.38, p=0.054)
    • 28-day mortality was reduced by approximately 50% in patients treated with CERC-002 (3 patients) vs. placebo (6 patients). There were a total of 4 COVID-19 related deaths in patients on CERC-002 vs. 9 on placebo as
    • COVID-19 ARDS patients treated with a single dose of the anti-LIGHT monoclonal antibody CERC-002 demonstrated robust improvement in the primary endpoint (proportion of patients alive and free of respiratory failure over the 28-day study period) compared to placebo (n=62, odds ratio [OR] = 2.62, p=0.059)
    • A prespecified subgroup analysis of patients 60 years of age showed that CERC-002 treatment led to a greater than 3-fold increase in likelihood of avoiding respiratory failure and death compared to placebo (n=33, OR = 3.38, p=0.054)
    • 28-day mortality was reduced by approximately 50% in patients treated with CERC-002 (3 patients) vs. placebo (6 patients). There were a total of 4 COVID-19 related deaths in patients on CERC-002 vs. 9 on placebo as of December 2020. These data will be updated and analyzed at the 60-day timepoint
    • Importantly, CERC-002 showed activity on top of corticosteroids in COVID-19 ARDS (>90% of patients in the trial received corticosteroids and >60% received remdesivir)
    • CERC-002 dramatically and rapidly reduced serum free-LIGHT levels
    • CERC-002 was well tolerated with no drug related SAEs and no clinically meaningful differences in immunosuppression or other SAEs between CERC-002 and placebo
    • The company intends to meet with the FDA and believes that these data support the initiation of a registration trial and filing for Breakthrough Therapy Designation. Additionally, the company is continuing its program in severe pediatric-onset Crohn's disease and is exploring the applicability of CERC-002 in non-COVID-19 ARDS

    ROCKVILLE, Md. and CHESTERBROOK, Pa., Jan. 05, 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 results from its exploratory Phase 2 US-based randomized, double-blind, placebo-controlled proof of concept trial (NCT04412057) of the human anti-LIGHT (TNFSF14) monoclonal antibody CERC-002. 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 (82 treated) 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 trial demonstrated robust improvement in the primary 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, OR = 2.62, p=0.059; these data trended towards statistical significance, p≤0.05). A prespecified subpopulation of patients 60 years of age showed similar improvement in the primary endpoint (n=33, OR = 3.38, p=0.054).   CERC-002-treated patients in the subpopulation of patients 60 years of age also had a shorter average hospital stay compared with placebo-treated patients.

    These data further showed a numerical mortality benefit favoring CERC-002 with 4 patients dying on active drug and 9 on placebo as of December 31, 2020. These data will be updated and analyzed at the 60-day timepoint.

    Importantly, >90% of patients received concomitant systemic corticosteroids and >60% received remdesivir. Thus CERC-002 showed activity on top of corticosteroids in COVID-19 ARDS.

    No drug-related serious adverse effects (SAEs) were reported in the trial, and there was no increase in infections in CERC-002 treated patients. The large majority of hospitalized COVID-19 patients had elevated LIGHT (TNFSF14) levels in their serum upon admission. Consistent with its targeted mechanism of action, CERC-002 dramatically and rapidly reduced LIGHT levels in nearly all treated patients, while patients on placebo saw a rise in LIGHT levels through Day 5. LIGHT levels were higher in the older patients who have a higher risk of death and respiratory failure. Moreover, these data demonstrate that corticosteroid therapy does not seem to affect serum LIGHT levels and that CERC-002 provides additional benefit on top of corticosteroid therapy.

    "I would first like to thank the patients, their families, and the investigators for their participation in this important study," said Jeff Wilkins, Chief Medical Officer of Cerecor. "We are very excited about these results as they demonstrate the therapeutic potential of CERC-002. In spite of recent advances in the treatment of COVID-19 ARDS patients, COVID-19 remains a global health threat, and this study demonstrates the potential for significant improvement for patients most at risk."

    Garry Neil, Chief Scientific Officer added, "Cytokine release syndrome remains a major cause of death and morbidity in COVID-19 ARDS.  We and others have shown that the important immunoregulatory cytokine, LIGHT, plays a critical role in this syndrome – and that such patients have elevated LIGHT levels in their serum, roughly correlating with disease activity.1 The data from this proof-of-concept study clearly demonstrate that neutralizing LIGHT with CERC-002 can improve clinical outcomes for COVID-19 ARDS patients, even when given to patients on concomitant steroids and remdesivir. In this study, CERC-002 was safe and well tolerated in sick, older, steroid-treated patients in the ICU. These data greatly increase our confidence in the mechanism of action and clinical utility of CERC-002, in COVID-19 ARDS and in other immune diseases.  We believe we now have sufficient information to work with the FDA to design a registration trial for COVID-19 ARDS patients.  We believe that these data also provide valuable insights that we can apply to other programs including our Crohn's disease program."

    A presentation of these data updates can be found on the "Company Information" page of the "Investors" section on 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 IL1, IL6, IL-8, IL-10, TNF and GM-CSF. It thus 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

    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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  7. ROCKVILLE, Md. and CHESTERBROOK, Pa., Dec. 22, 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 that its Investigational New Drug Application (IND) to study the use of CERC-007 to treat Still's disease has been accepted by the United States Food and Drug Administration (FDA) and is now open. CERC-007 is a high affinity, fully human anti-IL-18 monoclonal antibody (mAb). The first study will be a global multicenter Phase 1b clinical trial in adult onset Still's disease and is planned to start in the first quarter of 2021. Initial data is expected in the second quarter of 2021.

    "Adult

    ROCKVILLE, Md. and CHESTERBROOK, Pa., Dec. 22, 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 that its Investigational New Drug Application (IND) to study the use of CERC-007 to treat Still's disease has been accepted by the United States Food and Drug Administration (FDA) and is now open. CERC-007 is a high affinity, fully human anti-IL-18 monoclonal antibody (mAb). The first study will be a global multicenter Phase 1b clinical trial in adult onset Still's disease and is planned to start in the first quarter of 2021. Initial data is expected in the second quarter of 2021.

    "Adult onset Still's disease (AOSD) is a rare inflammatory disease resulting in joint damage, high fever and rashes," said H. Jeffrey Wilkins, MD, Chief Medical Officer of Cerecor. "The hallmark of AOSD is elevated IL-18 levels. Targeting IL-18 using CERC-007 is a novel therapeutic approach for the treatment of AOSD."

    The planned Phase 1b clinical trial will be a global multi-center, open-label trial of CERC-007 that will enroll approximately 12 subjects with active AOSD. The primary objectives of the study will be to determine the safety and tolerability of CERC-007, and assess preliminary efficacy as measured by reductions in systemic clinical manifestations and markers of inflammation in subjects with AOSD.

    About Still's disease

    Still's disease is a serious and rare auto-inflammatory disorder that affects the entire body. There are two major forms of the disease: adult onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (sJIA). AOSD and sJIA share common clinical manifestations, including episodes of high, spiking fevers, rash, joint pain, muscle pain, sore throat, multiorgan involvement and elevated levels of IL-18.

    About CERC-007

    CERC-007 is a high affinity, fully human monoclonal antibody targeting the proinflammatory cytokine IL-18. It is in development for multiple auto-immune diseases, including Still's disease (adult onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (sJIA)), and multiple myeloma (MM).

    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

    James Harrell

    Investor Relations

    Chief Commercial Officer

    Cerecor Inc.



    623.439.2220 office

     



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  8. ROCKVILLE, Md. and CHESTERBROOK, Pa., Dec. 16, 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 that it has dosed its first patient in a Phase 1b clinical trial of CERC-007. CERC-007 is a high affinity, fully human anti-IL-18 monoclonal antibody (mAb) being developed for patients with relapsed or refractory multiple myeloma (MM). The study will determine the recommended Phase 2 dose, safety and preliminary efficacy of CERC-007. The Company anticipates initial data to be reported in the first quarter of 2021.

    "We are very excited to have dosed our first patient. We are on track for initial

    ROCKVILLE, Md. and CHESTERBROOK, Pa., Dec. 16, 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 that it has dosed its first patient in a Phase 1b clinical trial of CERC-007. CERC-007 is a high affinity, fully human anti-IL-18 monoclonal antibody (mAb) being developed for patients with relapsed or refractory multiple myeloma (MM). The study will determine the recommended Phase 2 dose, safety and preliminary efficacy of CERC-007. The Company anticipates initial data to be reported in the first quarter of 2021.

    "We are very excited to have dosed our first patient. We are on track for initial data during the first quarter of 2021," said H. Jeffrey Wilkins, MD, Chief Medical Officer of Cerecor. "Multiple myeloma is the second most common form of blood cancer and is characterized by anemia, bone pain and fatigue with the majority of patients relapsing or becoming refractory on current treatments. Elevated levels of IL-18 are correlated with poor survival in patients with multiple myeloma.1 The approximately 50% mortality rate at five years reinforces the need for novel and targeted therapies, such as CERC-007, as another treatment option."



    The Phase 1b clinical trial is a U.S. multicenter, open-label, dose-escalation, sequential group study of CERC-007 as a monotherapy in approximately 30 patients with relapsed or refractory MM. The primary objectives of the study will be to determine the safety and tolerability of CERC-007, the recommended Phase 2 dose, and preliminary efficacy as measured by response rate in accordance with International Myeloma Working Group (IMWG) criteria.

    About Multiple Myeloma

    Multiple myeloma is the second most common blood cancer, with approximately 140,000 patients in the United States.2 Multiple myeloma is characterized by an excess proliferation of plasma cells. Despite increased availability of new agents, the disease is characterized by a pattern of recurrent relapses and remains incurable for the majority of patients, with a 5-year survival rate of approximately 50%.2

    About CERC-007

    CERC-007 is a high affinity, fully human monoclonal antibody targeting the proinflammatory cytokine IL-18. It is in development for multiple auto-immune diseases, including Still's disease (adult onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (sJIA)), and multiple myeloma (MM).

    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

    James Harrell

    Investor Relations

    Chief Commercial Officer

    Cerecor Inc.



    623.439.2220 office

    1Nakamura K, Kassem S, Cleynen A et al. Cancer Cell. 2018. 33(4):634-648.e5. 2National Cancer Institute, Cancer Stat Facts: Myeloma (https://seer.cancer.gov/statfacts/html/mulmy.html)

     



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  9. ROCKVILLE, Md. and CHESTERBROOK, Pa., Dec. 08, 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 that its Investigational New Drug Application (IND) to study the use of CERC-007 to treat relapsed or refractory multiple myeloma (MM) has been accepted by the United States Food and Drug Administration (FDA) and is now open. The first study will be a U.S. multicenter Phase 1b clinical trial. Initial data is expected in the first quarter of 2021.

    "Elevated levels of IL-18 are correlated with poor survival in patients with multiple myeloma1," said H. Jeffrey Wilkins, MD, Chief Medical Officer…

    ROCKVILLE, Md. and CHESTERBROOK, Pa., Dec. 08, 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 that its Investigational New Drug Application (IND) to study the use of CERC-007 to treat relapsed or refractory multiple myeloma (MM) has been accepted by the United States Food and Drug Administration (FDA) and is now open. The first study will be a U.S. multicenter Phase 1b clinical trial. Initial data is expected in the first quarter of 2021.

    "Elevated levels of IL-18 are correlated with poor survival in patients with multiple myeloma1," said H. Jeffrey Wilkins, MD, Chief Medical Officer of Cerecor. "Targeting and reducing IL-18 using CERC-007 may substantially benefit relapsed or refractory multiple myeloma patients. Our first study under this new IND will give us important information about the pharmacokinetics, pharmacodynamics, dose, safety and preliminary efficacy that should illuminate the path forward. We look forward to sharing the data with the scientific and medical communities in the first quarter of 2021."

    The planned Phase 1b clinical trial is a U.S. multicenter, open-label, dose-escalation, sequential group study of CERC-007 as a monotherapy in approximately 30 patients with relapsed or refractory MM. The primary objectives of the study will be to determine the safety and tolerability of CERC-007, the recommended Phase 2 dose, and preliminary efficacy as measured by response rate in accordance with International Myeloma Working Group (IMWG) criteria.

    About Multiple Myeloma

    Multiple myeloma is the second most common blood cancer, with approximately 140,000 patients in the United States.2 Multiple myeloma is characterized by an excess proliferation of plasma cells. Despite increased availability of new agents, the disease is characterized by a pattern of recurrent relapses and remains incurable for the majority of patients, with a 5-year survival rate of approximately 50%.2

    About CERC-007

    CERC-007 is a fully human monoclonal antibody targeting the proinflammatory cytokine IL-18. It is in development for multiple auto-immune diseases, including Still's disease (adult onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (sJIA)), and multiple myeloma (MM).

    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

    James Harrell

    Investor Relations

    Chief Commercial Officer

    Cerecor Inc.



    623.439.2220 office

    1Nakamura K, Kassem S, Cleynen A et al. Cancer Cell. 2018. 33(4):634-648.e5. 2National Cancer Institute, Cancer Stat Facts: Myeloma (https://seer.cancer.gov/statfacts/html/mulmy.html)

     



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  10. ROCKVILLE, Md. and CHESTERBROOK, Pa., Dec. 01, 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 that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) to study the use of CERC-803 to treat Leukocyte Adhesion Deficiency Type II (LAD II). The company plans to initiate a pivotal trial of CERC-803 in LAD-II (SLC35C1-CDG) by the first half of 2021 and anticipates topline data in the second half of 2021.

    "There are currently no FDA-approved therapies for patients suffering from LAD-II" said H. Jeffrey Wilkins, MD, Chief Medical Officer…

    ROCKVILLE, Md. and CHESTERBROOK, Pa., Dec. 01, 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 that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) to study the use of CERC-803 to treat Leukocyte Adhesion Deficiency Type II (LAD II). The company plans to initiate a pivotal trial of CERC-803 in LAD-II (SLC35C1-CDG) by the first half of 2021 and anticipates topline data in the second half of 2021.

    "There are currently no FDA-approved therapies for patients suffering from LAD-II" said H. Jeffrey Wilkins, MD, Chief Medical Officer of Cerecor. "LAD-II is caused by genetic mutations that result in deficiency in expression of surface adhesion molecule selectin, leading to defective leukocyte functions. This is a pediatric disease with the first symptoms appearing in infancy with recurrent bacterial infections, growth retardation, facial dysmorphism, and severe intellectual deficit as they continue to grow. We are excited to advance this program into the clinic."

    The FDA granted Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) to CERC-803, thus potentially qualifying the Company to receive a Priority Review Voucher (PRV) upon approval of a new drug application (NDA).

    About CERC-800s

    CERC-801, CERC-802 and CERC-803 are monosaccharide therapies with known therapeutic utility for the treatment of select congenital disorders of glycosylation (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 FDA granted RPDD and ODD to all three CERC-800 compounds, thus potentially qualifying the Company to receive a PRV upon approval of each 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 inquiries

    James Harrell

    Investor Relations

    Chief Commercial Officer

    Cerecor Inc.



    623.439.2220 office



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  11. 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…

    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-CDG

    CDGs 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 FCDGC

    The 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-800s

    CERC-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 inquiries

    James Harrell

    Investor Relations

    Chief Commercial Officer

    Cerecor Inc.



    623.439.2220 office



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  12. 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

    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 Update

    Cerecor 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.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

    James Harrell

    Investor Relations

    Chief Commercial Officer

    Cerecor Inc.



    623.439.2220 office

    Primary Logo

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  13. ROCKVILLE, Md. and CHESTERBROOK, Pa., Oct. 12, 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 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.

    "We are pleased to welcome Dr. Kaplan to our Board," said Dr. Sol J. Barer Ph.D., Chairman of the Board. "Dr. Kaplan brings with her decades of both academic and industry experience making her a natural fit for Cerecor as we advance our pipeline targeting rare diseases and immune-meditated disorders. We look forward to having her on the Board at this

    ROCKVILLE, Md. and CHESTERBROOK, Pa., Oct. 12, 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 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.

    "We are pleased to welcome Dr. Kaplan to our Board," said Dr. Sol J. Barer Ph.D., Chairman of the Board. "Dr. Kaplan brings with her decades of both academic and industry experience making her a natural fit for Cerecor as we advance our pipeline targeting rare diseases and immune-meditated disorders. We look forward to having her on the Board at this exciting time for Cerecor."  

    Dr. Kaplan is recognized as an authority on various aspects of the host immune response to mycobacterial pathogens, including the causative agents of leprosy and tuberculosis (TB). She was the Director of the Global Health Program, Tuberculosis, at the Bill and Melinda Gates Foundation (BMGF) from January 2014 until April 2018. Her work has encompassed developing a deep understanding of the cellular immune response and how to harness it for host adjunctive therapies. She spent her career as an academic research scientist leading her laboratory in investigations focusing on human disease, exploring novel experimental medicine approaches that modulate the immune response for disease control. Building on her research experience at Rockefeller University in New York City (for 20 years) and then at the Public Health Research Institute Center at UMDNJ (for 10 years), she led the reshaping of the tuberculosis program at BMGF. Dr. Kaplan is the recipient of multiple grants from the NIH-NIAID and other funding organizations for her research. Dr. Kaplan served on the Board of Directors at Celgene from 1998 to 2018 and is currently a member of Tyra Bioscience, Inc. Board of Directors.

    "I am very excited about the work Cerecor is doing," said Dr. Kaplan. "Their pipeline focused on rare diseases and immune-inflammatory disorders is especially exciting to me because of my background in immunology and immune modulation. Cerecor has made great progress with their pipeline to date and I am happy to join at a time when the Company is making great strides in advancing their programs into clinical trials."

    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 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," "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; regulatory risks; impacts of the COVID-19 pandemic on clinical trials, the Company and the economy in general; Cerecor's cash position and the need for it to raise additional capital; 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
  14. ROCKVILLE, Md. and CHESTERBROOK, Pa., Sept. 10, 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 that Michael F. Cola, President and Chief Executive Officer, will present at two upcoming virtual conferences.

    H.C. Wainwright 22nd Annual Global Investment Conference
    Date: Monday, September 14, 2020
    Time: 3:00 PM ET

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
    Date: Monday, September 21, 2020
    Time: 1:40 PM 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…

    ROCKVILLE, Md. and CHESTERBROOK, Pa., Sept. 10, 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 that Michael F. Cola, President and Chief Executive Officer, will present at two upcoming virtual conferences.

    H.C. Wainwright 22nd Annual Global Investment Conference

    Date: Monday, September 14, 2020

    Time: 3:00 PM ET

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

    Date: Monday, September 21, 2020

    Time: 1:40 PM 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 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 in a clinical trial 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 RPDD and ODD 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 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

    James Harrell

    Investor Relations

    Chief Commercial Officer

    Cerecor Inc.



    623.439.2220 office

    Primary Logo

    View Full Article Hide Full Article
  15. ROCKVILLE, Md. and CHESTERBROOK, Pa., Aug. 26, 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 it has resumed the Phase 1b clinical study of CERC-002 in anti-TNF refractory adult Crohn's patients with the lifting of the moratorium on elective endoscopy resulting from the COVID-19 pandemic. CERC-002 is a first-in-class fully human anti-LIGHT (TNFSF14) monoclonal antibody currently being developed as a treatment for severe pediatric onset Crohn's disease as well as in a placebo-controlled proof-of-concept trial evaluating the safety and efficacy in patients with COVID-19 cytokine storm-induced…

    ROCKVILLE, Md. and CHESTERBROOK, Pa., Aug. 26, 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 it has resumed the Phase 1b clinical study of CERC-002 in anti-TNF refractory adult Crohn's patients with the lifting of the moratorium on elective endoscopy resulting from the COVID-19 pandemic. CERC-002 is a first-in-class fully human anti-LIGHT (TNFSF14) monoclonal antibody currently being developed as a treatment for severe pediatric onset Crohn's disease as well as in a placebo-controlled proof-of-concept trial evaluating the safety and efficacy in patients with COVID-19 cytokine storm-induced Acute Respiratory Distress Syndrome (ARDS).

    The open-label, dose-escalating, signal-finding Phase 1b clinical study is designed to assess the safety, tolerability, and short-term efficacy of CERC-002 in adult subjects with moderate-to-severe Crohn's disease who have previously failed treatment with anti-TNF agents. The Company expects to announce topline data in the first quarter of 2021.

    "We are excited to now have two active clinical studies evaluating the safety and efficacy of the anti-LIGHT monoclonal antibody, CERC-002," stated Dr. H. Jeffery Wilkins, chief medical officer at Cerecor. "There has been an increasing level of scientific evidence supporting the rationale behind LIGHT being a key target for immune conditions of the mucosa of the lung and gut.  We believe CERC-002 may have the potential to treat both patients with Crohn's disease refractory to biologics and patients with COVID-19 ARDS, both of which lack effective treatment options."

    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 lymphocytes) is a cytokine with inflammatory actions encoded by the Tumor Necrosis Factor Super Family 14 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 and gut. 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, TNFs and GM-CSF.

    CERC-002 (anti-LIGHT monoclonal antibody)

    CERC-002 is a first in class fully human anti-LIGHT (TNFSF14) monoclonal antibody licensed from Kyowa Kirin Co., Ltd. It offers the potential to treat cytokine release syndrome-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 release syndrome 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.

    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 severe pediatric-onset Crohn's disease, and is also in clinical trial 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 adult onset Stills 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 inquiries

    James Harrell

    Investor Relations

    Chief Commercial Officer

    Cerecor Inc.



    623.439.2220 office

    Primary Logo

    View Full Article Hide Full Article
  16. ROCKVILLE, Md. and CHESTERBROOK, Pa., Aug. 13, 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 the publication of a peer-reviewed paper demonstrating significantly elevated free LIGHT levels in the serum of hospitalized patients with severe COVID-19 infection. The publication, entitled Levels of the TNF related cytokine, LIGHT, increased in hospitalized COVID-19 patients with Cytokine Release Syndrome and ARDS in the Journal mSphere by David S. Perlin et al, highlights the potential role of the inflammatory cytokine, LIGHT in the development of COVID-19 ARDS. Cerecor believes…

    ROCKVILLE, Md. and CHESTERBROOK, Pa., Aug. 13, 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 the publication of a peer-reviewed paper demonstrating significantly elevated free LIGHT levels in the serum of hospitalized patients with severe COVID-19 infection. The publication, entitled Levels of the TNF related cytokine, LIGHT, increased in hospitalized COVID-19 patients with Cytokine Release Syndrome and ARDS in the Journal mSphere by David S. Perlin et al, highlights the potential role of the inflammatory cytokine, LIGHT in the development of COVID-19 ARDS. Cerecor believes that the publication supports its clinical program evaluating CERC-002, the only clinical stage anti-LIGHT monoclonal antibody, as a potential treatment for patients with severe COVID-19 acute respiratory distress syndrome ("ARDS"). A link to the publication can be accessed here.

    Dr. Perlin, chief scientific officer, senior vice president of the Center for Discovery and Innovation, and Professor of Medical Sciences at the Hackensack Meridian School of Medicine, said, "Identifying the role of LIGHT in patients infected with SARS-CoV-2 ("COVID-19") is a seminal finding pointing to understanding the potential mechanism by which COVID-19 infection leads to ARDS and suggests a promising new strategy to treat these patients." 

    "We believe these compelling results strongly support our hypothesis that LIGHT plays an important role in COVID-19 ARDS and indicated that a clinical trial of CERC-002 in COVID-19 ARDS was a logical next step," said Dr. Garry Neil, chief scientific officer at Cerecor. "This study is now well underway, and we expect topline results in the fourth quarter of 2020. We are further exploring the potential role of LIGHT as a driver of and biomarker for ARDS in additional studies of both COVID-19 infected patients as well as in a broader patient population of non-COVID-19 associated ARDS patients. From these studies we hope to learn more about the role of LIGHT in ARDS in general, while potentially opening a path for treatment of a broader population of ARDS patients who have high mortality and, in many cases, lack effective treatment options."

    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 Tumor Necrosis Factor Super Family 14 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.

    CERC-002 (anti-LIGHT monoclonal antibody)

    CERC-002 is a first in class fully human anti-LIGHT (TNFSF14) monoclonal antibody licensed from Kyowa Kirin Co., Ltd. It offers the potential to treat cytokine release syndrome-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 release syndrome 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.

    About the CERC-002 COVID-19 ARDS Trial

    Cerecor is sponsoring a randomized, multicenter U.S., double-blind, placebo-controlled clinical study that 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 intensive care unit length of stay, hospital length of stay, and oxygen saturation at the end of the study. The trial is currently underway and enrolling patients in the U.S. with topline data expected in the fourth quarter of 2020.

    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 its clinical-stage pipeline of innovative therapies that address unmet patient needs within rare pediatric and orphan diseases. The company's pediatric 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 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 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

    James Harrell

    Investor Relations

    Chief Commercial Officer

    Cerecor Inc.



    623.439.2220 office

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  17. -Generated net proceeds of $48 million from equity offering and disposition of Aytu shares to support pipeline advancement

    -Enrolled first patient in CERC-002 (anti-LIGHT mAb) clinical trial for the prevention of COVID-19 induced ARDS

    ROCKVILLE, Md. and CHESTERBROOK, Pa., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a leading biopharmaceutical company focused on development and commercialization of treatments for rare pediatric and orphan diseases, today announced recent business progress and second quarter results for 2020.

    "We're pleased with our progress as we have continued to advance our pipeline, including investigating the use of our novel anti-inflammatory candidate, CERC-002, for the potential treatment of COVID-19

    -Generated net proceeds of $48 million from equity offering and disposition of Aytu shares to support pipeline advancement

    -Enrolled first patient in CERC-002 (anti-LIGHT mAb) clinical trial for the prevention of COVID-19 induced ARDS

    ROCKVILLE, Md. and CHESTERBROOK, Pa., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a leading biopharmaceutical company focused on development and commercialization of treatments for rare pediatric and orphan diseases, today announced recent business progress and second quarter results for 2020.

    "We're pleased with our progress as we have continued to advance our pipeline, including investigating the use of our novel anti-inflammatory candidate, CERC-002, for the potential treatment of COVID-19 induced ARDS, while also significantly strengthening our balance sheet," said Mike Cola, Chief Executive Officer of Cerecor. "Building on our work with Myriad Genetics demonstrating that levels of the cytokine LIGHT were highly correlated with disease severity and mortality in COVID-19 induced ARDS, we were pleased to enroll our first patient in a proof-of-concept trial evaluating CERC-002 in this patient population. As we look to the second half of the year, we believe we are well-positioned to advance our programs given progress to date and our improved cash position."

    Second Quarter Highlights and Business Update

    • Reported results from a biomarker study in partnership with Myriad Genetics and Hackensack Meridian Health Network that highlighted the correlation of a novel cytokine, LIGHT, with disease severity and mortality in patients with COVID-19 induced ARDS. These data establish the rationale for the proof-of-concept clinical trial
    • Enrolled the first patient in the CERC-002 proof-of-concept trial evaluating the safety and efficacy in patients with COVID-19 induced acute respiratory distress syndrome (ARDS)
    • Completed CDG FIRST (a retrospective trial evaluating the use of monosaccharide replacement therapy in PGMI-CDG, MPI-CDG and LADII-CDG); initial findings are informing prospective trial design and study sites for anticipated pivotal trials for CERC-800 series

    Second Quarter Financial Update

    Cerecor reported a cash balance of $45.4 million as of June 30, 2020, representing a $39.7 million increase as compared to March 31, 2020. The increase was primarily due to an underwritten public offering that resulted in net proceeds of $35.4 million and the sale of an investment for net proceeds of $12.8 million, partially offset by operating activities, including increased research and development expenses.

    Cerecor recognized $5.9 million of research and development expenses and $6.1 million of general and administrative expenses during the quarter, which were the primary drivers of the increase in operating expenses, net loss and net loss per share as compared to the same period in 2019. General and administrative expenses increased $3.8 million primarily due to increased stock-based compensation and severance expenses as a result of leadership changes during the quarter, while research and development expenses increased $2.2 million due to the Company continuing to advance its expanded pipeline assets.





    Condensed Consolidated Balance Sheets

        
     June 30, 2020 (a)   December 31, 2019 (a)
      (unaudited)   
        
    Assets(in thousands)
    Current assets:   
    Cash and cash equivalents$45,391  $3,609 
    Accounts receivable, net 2,032   1,002 
    Other receivables 1,953   4,241 
    Inventory, net 12   21 
    Prepaid expenses and other current assets 824   707 
    Restricted cash, current portion 33   17 
    Investment in Aytu -   7,629 
    Current assets of discontinued operations -   498 
    Total current assets 50,245   17,724 
    Property and equipment, net 1,741   1,448 
    Intangible assets, net 2,292   2,426 
    Goodwill 14,409   14,409 
    Restricted cash, net of current portion 180   102 
    Deferred tax asset, net 338   - 
    Total assets$69,205  $36,109 
    Liabilities and stockholders' equity   
    Current liabilities:   
    Accounts payable$2,558  $2,078 
    Accrued expenses and other current liabilities 6,487   5,640 
    Income taxes payable -   552 
    Current liabilities of discontinued operations 5,550   3,891 
    Total current liabilities 14,595   12,161 
    Royalty Obligation 2,000   - 
    Deferred tax liability, net -   86 
    Other long-term liabilities 2,032   1,112 
    Long-term liabilities of discontinued operations -   1,755 
    Total liabilities 18,627   15,114 
    Stockholders' equity:   
    Common stock—$0.001 par value; 200,000,000 shares authorized at June 30, 2020 and December 31, 2019; 74,900,047 and 44,384,222 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively 75   44 
    Preferred stock—$0.001 par value; 5,000,000 shares authorized at June 30, 2020 and December 31, 2019; 1,257,143 and 2,857,143 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively 1   3 
    Additional paid-in capital 199,191   135,239 
    Accumulated deficit (148,689)  (114,291)
    Total stockholders' equity 50,578   20,995 
    Total liabilities and stockholders' equity$69,205  $36,109 
        
    (a) The condensed consolidated balance sheets as of June 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 June 30,  Six Months Ended June 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$1,338  $1,392  $4,092  $3,968  
    Total revenues, net 1,338   1,392   4,092   3,968  
             
    Operating expenses:        
    Cost of product sales 78   (1,497)  144   (744) 
    Research and development 5,917   3,712   10,685   7,114  
    Acquired in-process research and development -   -   25,549   -  
    General and administrative 6,101   2,341   8,777   5,016  
    Sales and marketing 653   326   1,330   722  
    Amortization expense 404   335   834   669  
    Change in fair value of contingent consideration -   (1,277)  -   (1,256) 
    Total operating expenses 13,153   3,940   47,319   11,521  
    Loss from continuing operations (11,815)  (2,548)  (43,227)  (7,553) 
    Other income (expense):        
    Change in fair value of Investment in Aytu (1,872)  -   5,208   -  
    Change in fair value of warrant liability and unit purchase option liability 2   19   14   (29) 
    Other income (expense), net 396   -   396   (9) 
    Interest income, net 9   38   18   69  
    Total other (expense) income, net from continuing operations (1,465)  57   5,636   31  
    Loss from continuing operations before taxes (13,280)  (2,491)  (37,591)  (7,522) 
    Income tax (benefit) expense (454)  53   (2,611)  184  
    Loss from continuing operations$(12,826) $(2,544) $(34,980) $(7,706) 
    (Loss) income from discontinued operations, net of tax (455)  (3,679)  582   (5,971) 
    Net loss$(13,281) $(6,223) $(34,398) $(13,677) 
             
    Net (loss) income per share of common stock, basic and diluted:        
    Continuing operations$(0.18) $(0.05) $(0.53) $(0.14) 
    Discontinued operations (0.01)  (0.06)  0.01   (0.10) 
    Net loss per share of common stock, basic and diluted$(0.19) $(0.11) $(0.52) $(0.24) 
             
    Net (loss) income per share of preferred stock, basic and diluted:        
    Continuing operations$(0.93) $(0.23) $(2.66) $(0.68) 
    Discontinued operations (0.03)  (0.32)  0.04   (0.53) 
    Net loss per share of preferred stock, basic and diluted$(0.96) $(0.55) $(2.62) $(1.21) 
             
    (a) The unaudited condensed consolidated statements of operations for the three and six months ended June 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 pediatric and orphan diseases. The Company is advancing an emerging clinical-stage pipeline of innovative therapies that address unmet patient needs within rare pediatric and orphan diseases. The Company's pediatric 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 ("CDGs"). 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 ("ARDS") and 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 PRV upon approval of a 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 ("AOSD") 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 inquiries

    James Harrell

    Investor Relations

    Chief Commercial Officer

    Cerecor Inc.



    623.439.2220 office

     

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  18. ROCKVILLE, Md., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a leading biopharmaceutical company focused on the development and commercialization of treatments for rare pediatric and orphan diseases, today announced that Michael F. Cola, President and Chief Executive Officer, will present at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Tuesday, August 11, 2020 at 8:00 a.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…

    ROCKVILLE, Md., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a leading biopharmaceutical company focused on the development and commercialization of treatments for rare pediatric and orphan diseases, today announced that Michael F. Cola, President and Chief Executive Officer, will present at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Tuesday, August 11, 2020 at 8:00 a.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
  19. ROCKVILLE, Md. and CHESTERBROOK, Pa., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a leading biopharmaceutical company in the development and commercialization of treatments for rare pediatric and orphan diseases, today announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation (RPDD) to CERC-006, a dual inhibitor of mTOR complexes 1 and 2 for the treatment of lymphatic malformations (LM).

    Lymphatic malformations are rare, non-malignant masses consisting of fluid-filled channels or spaces thought to be caused by the abnormal development of the lymphatic system. LM occurs mostly in infancy or early childhood and can persist throughout life. It is estimated that 30,000 to 60,000 Americans…

    ROCKVILLE, Md. and CHESTERBROOK, Pa., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a leading biopharmaceutical company in the development and commercialization of treatments for rare pediatric and orphan diseases, today announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation (RPDD) to CERC-006, a dual inhibitor of mTOR complexes 1 and 2 for the treatment of lymphatic malformations (LM).

    Lymphatic malformations are rare, non-malignant masses consisting of fluid-filled channels or spaces thought to be caused by the abnormal development of the lymphatic system. LM occurs mostly in infancy or early childhood and can persist throughout life. It is estimated that 30,000 to 60,000 Americans have this condition in the United States.1

    "We are very pleased to receive FDA Rare Pediatric Disease Designation for CERC-006. This designation underscores the high unmet need in this family of serious and rare diseases of infants and children that so often lead to disability and in some cases, death," said Mike Cola, Chief Executive Officer, Cerecor

    The FDA grants RPDD to programs addressing rare diseases or conditions that are serious or life-threatening in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years.  The term "rare disease or condition" means any disease or conditions affecting less than 200,000 people in the United States. If a new drug application (NDA) for CERC-006 is approved, Cerecor would be eligible to receive a priority review voucher for another compound, which it could use itself, or sell to another company.

    About CERC-006

    CERC-006 is an orally available blocker of mTOR complex 1 and 2 that is being developed for the treatment of serious lymphatic malformations (LM) not treatable with surgery or sclerotherapy. Because a large majority of LM patients have activating mutations in the PK/AKT/mTOR pathway, we believe CERC-006 has the potential to specifically reduce proliferation of the abnormal cells that cause LM, reduce the size of neoplastic lesions and restore lymphatic function; ultimately improving and prolonging the lives of many affected children. A Phase 1b/2a proof-of-concept trial to test the safety and efficacy of CERC-006 in LM is planned to begin in 2021.

    About Cerecor

    Cerecor is a leading biopharmaceutical company focused on 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 ("RPDD") 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") of a drug that is a part of such program. 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.

    1. Perkins et al. 2010

    For media and investor inquiries for Cerecor, Inc.

    James Harrell,

    Investor Relations

    Chief Commercial Officer

    Cerecor Inc.



    623.439.2220 office

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  20. ROCKVILLE, Md. and CHESTERBROOK, Pa., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a leading biopharmaceutical company in the development and commercialization of treatments for rare pediatric and orphan diseases, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to CERC-006, a dual inhibitor of mTOR complexes 1 and 2 for the treatment of lymphatic malformations (LM).

    Lymphatic malformations are a family of rare, congenital neoplastic diseases caused by mutations in certain genes that regulate cell growth in the lymphatic system. Children who suffer from this condition often have life-altering and in severe cases, life-threatening accumulation of fluid or growth affecting…

    ROCKVILLE, Md. and CHESTERBROOK, Pa., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a leading biopharmaceutical company in the development and commercialization of treatments for rare pediatric and orphan diseases, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to CERC-006, a dual inhibitor of mTOR complexes 1 and 2 for the treatment of lymphatic malformations (LM).

    Lymphatic malformations are a family of rare, congenital neoplastic diseases caused by mutations in certain genes that regulate cell growth in the lymphatic system. Children who suffer from this condition often have life-altering and in severe cases, life-threatening accumulation of fluid or growth affecting the head, neck and vital organs. LM appears at birth or in infancy and may persist throughout life.   It is estimated that 30,000 to 60,000 Americans have this condition.1 Currently, there are no approved medicines for LM and affected children must often endure painful and potentially disfiguring surgery or sclerosis. As many as 20% of afflicted children die within 7 years.2

    "We are very pleased to receive FDA Orphan Drug Designation for CERC-006, as this moves us one step closer to bringing a novel, targeted  therapy to infants, children and adults living with this serious disease. We are working closely with expert thought leaders at key academic medical centers, to initiate a clinical trial of CERC-006 in LM as soon as possible," said Dr. Garry Neil, Chief Scientific Officer, Cerecor.

    The FDA's Office of Orphan Drug Products grants ODD to medicines intended to treat underserved patient populations or rare disorders that affect fewer than 200,000 people in the United States. The designation provides sponsors certain benefits, including seven years of market exclusivity upon FDA approval, exemption of FDA application fees and tax credits for qualified clinical trials.

    About CERC-006

    CERC-006 is an orally available blocker of mTOR complex 1 and 2 that is being developed for the treatment of serious lymphatic malformations (LM) not treatable with surgery or sclerotherapy. Because a large majority of LM patients have activating mutations in the PK/AKT/mTOR pathway, we believe CERC-006 has the potential to specifically reduce proliferation of the abnormal cells that cause LM, reduce the size of neoplastic lesions and restore lymphatic function; ultimately improving and prolonging the lives of many affected children. A Phase 1b/2a proof-of-concept trial to test the safety and efficacy of CERC-006 in LM is planned to begin in 2021.

    About Cerecor

    Cerecor is a leading biopharmaceutical company focused on 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 ("RPDD") and 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") of a drug that is a part of such program. 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.

    1. Perkins et al. 2010; 2. Ozeki et al. 2016

    For media and investor inquiries for Cerecor, Inc.

    James Harrell,

    Investor Relations

    Chief Commercial Officer

    Cerecor Inc.



    623.439.2220 office

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  21. ROCKVILLE, Md., July 21, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare pediatric and orphan diseases, today announced the first patient has been enrolled in a proof-of-concept trial evaluating the safety and efficacy of the anti-LIGHT monoclonal antibody, CERC-002, in patients with COVID-19 cytokine storm-induced Acute Respiratory Distress Syndrome (ARDS).

    The proof-of-concept, randomized, multicenter, 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…

    ROCKVILLE, Md., July 21, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare pediatric and orphan diseases, today announced the first patient has been enrolled in a proof-of-concept trial evaluating the safety and efficacy of the anti-LIGHT monoclonal antibody, CERC-002, in patients with COVID-19 cytokine storm-induced Acute Respiratory Distress Syndrome (ARDS).

    The proof-of-concept, randomized, multicenter, 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 intensive care unit (ICU) length of stay, hospital length of stay, and oxygen saturation at the end of the study. Top-line data are expected in the fourth quarter of 2020.

    "We believe that suppressing levels of the inflammatory cytokine LIGHT, which is associated with increased morbidity and mortality in ventilated COVID-19 patients, might dampen the cytokine storm and prevent severe ARDS in this population," said H. Jeffrey Wilkins, MD, Chief Medical Officer of Cerecor. "As the first and only fully human anti-LIGHT monoclonal antibody, we believe CERC-002 has the potential to treat patients hospitalized with COVID-19 ARDS. Our collaboration with PRA Health Sciences – a contract research organization and healthcare intelligence partner – has helped us to rapidly identify, recruit and initiate key centers to expedite the study.  Both organizations look forward to advancing this program, as we strive to provide an effective therapeutic option for hospitalized COVID-19 patients to keep them from progressing to ARDS."

    The scientific rationale for the study is supported by positive results from Cerecor's and Myriad Genetics' recent biomarker study, conducted with Hackensack Meridian Health Network, which demonstrated 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 might 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.

    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.

    About PRA Health Sciences

    PRA Health Sciences is one of the world's leading global contract research organizations by revenue, providing outsourced clinical development and data solution services to the biotechnology and pharmaceutical industries. PRA's global clinical development platform includes more than 75 offices across North America, Europe, Asia, Latin America, South Africa, Australia, and the Middle East and more than 17,500 employees worldwide. Since 2000, PRA has participated in approximately 4,000 clinical trials worldwide. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 95 drugs. To learn more about PRA, please visit www.prahs.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

    Laurie Hurst

    Director, Communications and Public Relations

    PRA Health Sciences

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    919.786.8435 office

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  22. 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

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  23. 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
  24. 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

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  25. 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

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  26. 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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  27. - Patients hospitalized with COVID-19 had significantly elevated levels of the inflammatory cytokine LIGHT

    - LIGHT was strongly linked with mortality (82%) in patients over 60 years of age

    - Decreasing LIGHT levels using CERC-002 (anti-LIGHT mAb) may prevent cytokine storm induced severe ARDS and thereby reduce mortality and the need for ventilation

    ROCKVILLE, Md., May 26, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC) and Myriad Genetics Inc. (NASDAQ:MYGN) today announced that levels of novel cytokine, LIGHT, were highly correlated with disease severity and mortality in a COVID-19 acute respiratory distress syndrome (ARDS) biomarker study. The biomarker study was conducted using the serum samples of 47 hospitalized COVID-19 patients…

    - Patients hospitalized with COVID-19 had significantly elevated levels of the inflammatory cytokine LIGHT

    - LIGHT was strongly linked with mortality (82%) in patients over 60 years of age

    - Decreasing LIGHT levels using CERC-002 (anti-LIGHT mAb) may prevent cytokine storm induced severe ARDS and thereby reduce mortality and the need for ventilation

    ROCKVILLE, Md., May 26, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC) and Myriad Genetics Inc. (NASDAQ:MYGN) today announced that levels of novel cytokine, LIGHT, were highly correlated with disease severity and mortality in a COVID-19 acute respiratory distress syndrome (ARDS) biomarker study. The biomarker study was conducted using the serum samples of 47 hospitalized COVID-19 patients and 30 healthy controls from Hackensack Meridian Health Network.

    In April 2020, approximately 1,500 people in the United States died each day from COVID-19. The viral infection triggers a hyperactive immune response leading to cytokine storm and Acute Respiratory Distress Syndrome (ARDS), which is a leading cause of death in patients who die of COVID-19. Although this hyperinflammatory process is poorly understood, the data from this study implicates the inflammatory cytokine, LIGHT, as a potential key driver of cytokine storm leading to ARDS and death.

    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. Importantly, the data demonstrated elevated LIGHT levels were also strongly linked with mortality (p=0.02).

    Dr. David Perlin, Ph.D., chief scientific officer, senior vice president of the Center for Discovery and Innovation, and Professor of Medical Sciences at the Hackensack Meridian School of Medicine at Seton Hall University, commented "These data are compelling and demonstrate that the inflammatory cytokine LIGHT may play a key role in cytokine storm associated with COVID-19 ARDS that leads to increased morbidity and mortality. Reducing LIGHT levels might be a key to dampening the cytokine storm in these patients, preventing the need for ventilator support and reducing mortality."

    Dr. Garry Neil, M.D. chief scientific officer, Cerecor commented, "As a company, we recognized the impact of cytokine storm-induced ARDS and the need for treatment options for patients in this area of high unmet need. We remain focused on the CERC-002 clinical program and rapidly moving it forward for the treatment of cytokine storm induced 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.

    CERC-002 (anti-LIGHT monoclonal antibody)

    CERC-002 is a fully human monoclonal antibody with neutralizing action against LIGHT (TNFSF14), for treatment of children with Pediatric Crohn's Disease. Cerecor holds an open IND with FDA and the drug is currently being studied in a Phase I clinical trial for patients with refractory severe Crohn's disease, currently not recruiting due to COVID-19.

    Free LIGHT Assay from Myriad RBM

    Myriad RBM, a subsidiary of Myriad Genetics, Inc.,  in collaboration with Cerecor has developed an ultrasensitive assay for the detection of free LIGHT. The assay is validated for serum or plasma samples and has sufficient sensitivity to reliably measure LIGHT from normal and disease subjects.

    About Myriad

    Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics.  Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs.  Myriad is focused on three strategic imperatives:  transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets.  For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com.

    About Hackensack Meridian Health

    Hackensack Meridian Health is a leading not-for-profit health care organization that is the largest, most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care. Hackensack Meridian Health comprises 17 hospitals from Bergen to Ocean counties, which includes three academic medical centers – Hackensack University Medical Center in Hackensack, Jersey Shore University Medical Center in Neptune, JFK Medical Center in Edison; two children's hospitals - Joseph M. Sanzari Children's Hospital in Hackensack, K. Hovnanian Children's Hospital in Neptune; nine community hospitals – Bayshore Medical Center in Holmdel, Mountainside Medical Center in Montclair, Ocean Medical Center in Brick, Palisades Medical Center in North Bergen, Pascack Valley Medical Center in Westwood, Raritan Bay Medical Center in Old Bridge, Raritan Bay Medical Center in Perth Amboy, Riverview Medical Center in Red Bank, and Southern Ocean Medical Center in Manahawkin; a behavioral health hospital – Carrier Clinic in Belle Mead; and two rehabilitation hospitals – JFK Johnson Rehabilitation Institute in Edison and Shore Rehabilitation Institute in Brick. Additionally, the network has more than 500 patient care locations throughout the state which include ambulatory care centers, surgery centers, home health services, long-term care and assisted living communities, ambulance services, lifesaving air medical transportation, fitness and wellness centers, rehabilitation centers, urgent care centers and physician practice locations. Hackensack Meridian Health has more than 34,100 team members, and 6,500 physicians and is a distinguished leader in health care philanthropy, committed to the health and well-being of the communities it serves.

    About the Center for Discovery and Innovation

    The Center for Discovery and Innovation (CDI), a newly established member of Hackensack Meridian Health, seeks to translate current innovations in science to improve clinical outcomes for patients with cancer, infectious diseases and other life-threatening and disabling conditions. The CDI, housed in a fully renovated state-of-the-art facility, offers world-class researchers a support infrastructure and culture of discovery that promotes science innovation and rapid translation to the clinic.

    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 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 for Cerecor, Inc.

    James Harrell,
    Investor Relations
    Chief Commercial Officer
    Cerecor Inc.

    623.439.2220 office

    For media and investor inquiries for Myriad Genetics, Inc.

    Scott Gleason
    SVP of Investor Relations and Corporate Strategy
    Myriad Genetics, Inc.

    801.584.1143 office

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    • Significantly Improved Cash Position and Balance Sheet
    • Closed Aevi Merger; Transformed into Orphan and Rare Disease Biotech

    ROCKVILLE, Md., May 07, 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 first quarter results for 2020. The Company significantly improved its balance sheet as a result of an appreciation in an investment and as a result of an income tax receivable from the Coronavirus Aid, Relief, and Economic Security ("CARES") Act which are expected to generate cash proceeds of $15 million in the second quarter ($12.8 million of which has already been realized). 

    "I

    • Significantly Improved Cash Position and Balance Sheet
    • Closed Aevi Merger; Transformed into Orphan and Rare Disease Biotech

    ROCKVILLE, Md., May 07, 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 first quarter results for 2020. The Company significantly improved its balance sheet as a result of an appreciation in an investment and as a result of an income tax receivable from the Coronavirus Aid, Relief, and Economic Security ("CARES") Act which are expected to generate cash proceeds of $15 million in the second quarter ($12.8 million of which has already been realized). 

    "I am extremely proud of the team as we have merged seamlessly across the business.  We are poised to deliver on numerous milestones from our clinical programs and have strengthened our balance sheet with significant non-dilutive financing. I firmly believe we continue to do all the right things to put us in a good position, especially with our clinical programs, heading into the second quarter," said Mike Cola, Chief Executive Officer of Cerecor.

    Q1 Highlights and Business Update

    • Initiated biomarker study to evaluate the role of LIGHT in the development of Acute Respiratory Distress Syndrome ("ARDS") and Acute Lung Injury ("ALI") in hospitalized COVID-19 patients
    • Dr. Sol Barer joined Board of Directors and was appointed Chairman of the Board
    • Appointed Dr. Suzanne Bruhn and Mr. Joseph Miller to the Board
    • Closed merger with Aevi Genomic Medicine, increasing pipeline to six clinical assets

    Q1 Financial Update

    The Company increased its cash as of March 31, 2020 by $2.1 million as compared to December 31, 2019, largely as a result of a registered direct offering in February 2020 and a private placement with Armistice in March 2020, partially offset by transaction costs and other operating expenses. 

    Cerecor recognized $25.5 million of acquired in-process research and development ("IPR&D") expense during the quarter related to the clinical assets acquired as part of the Aevi merger, which was the primary driver of the increase in operating expenses, net loss and net loss per share.  The IPR&D expense was partially offset by a $7 million increase in the change in fair value of an investment driven by a significant increase in its stock price.  A $2.2 million discrete tax benefit recorded in the quarter, as a result of the CARES Act, will allow the Company to recover taxes paid on income generated in 2017 through net operating losses incurred subsequent to that date.  

    Condensed Consolidated Balance Sheets

             
        March 31, 2020 (a)   December 31, 2019 (a)
        (unaudited)    
      Assets (in thousands)
      Current assets:      
      Cash and cash equivalents $ 5,659     $ 3,609  
      Accounts receivable, net   2,195       1,002  
      Other receivables   2,064       4,241  
      Inventory, net   16       21  
      Prepaid expenses and other current assets   777       707  
      Restricted cash, current portion   65       17  
      Investment in Aytu   14,709       7,629  
      Current assets of discontinued operations   -       498  
      Total current assets   25,485       17,724  
      Property and equipment, net   1,417       1,448  
      Intangible assets, net   2,696       2,426  
      Goodwill   14,409       14,409  
      Restricted cash, net of current portion   113       102  
      Total assets $ 44,120     $ 36,109  
      Liabilities and stockholders' equity      
      Current liabilities:      
      Accounts payable $ 2,726     $ 2,078  
      Accrued expenses and other current liabilities   6,194       5,640  
      Income taxes payable   -       552  
      Current liabilities of discontinued operations   6,410       3,891  
      Total current liabilities   15,330       12,161  
      Royalty Obligation   2,000       -  
      Deferred tax liability, net   107       86  
      Other long-term liabilities   1,094       1,112  
      Long-term liabilities of discontinued operations   -       1,755  
      Total liabilities   18,531       15,114  
      Stockholders' equity:      
      Common stock—$0.001 par value; 200,000,000 shares authorized at March 31, 2020 and December 31, 2019; 59,560,252 and 44,384,222 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively   60       44  
      Preferred stock—$0.001 par value; 5,000,000 shares authorized at March 31, 2020 and December 31, 2019; 1,257,143 and 2,857,143 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively   1       3  
      Additional paid-in capital   160,936       135,239  
      Accumulated deficit   (135,408 )     (114,291 )
      Total stockholders' equity   25,589       20,995  
      Total liabilities and stockholders' equity $ 44,120     $ 36,109  
             
      (a) The condensed consolidated balance sheets as of March 31, 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 March 31,
        2020 (a)   2019 (a)
        (in thousands, except per share data)
      Revenues:      
      Product revenue, net $ 2,754     $ 2,576  
      Total revenues, net   2,754       2,576  
             
      Operating expenses:      
      Cost of product sales   66       752  
      Research and development   4,768       3,401  
      Acquired in-process research and development   25,549       -  
      General and administrative   2,676       2,676  
      Sales and marketing   677       396  
      Amortization expense   431       335  
      Change in fair value of contingent consideration   -       21  
      Total operating expenses   34,167       7,581  
      Loss from continuing operations   (31,413 )     (5,005 )
      Other income (expense):      
      Change in fair value of Investment in Aytu   7,080       -  
      Change in fair value of warrant liability and unit purchase option liability   11       (48 )
      Other expense, net   -       (9 )
      Interest income, net   10       30  
      Total other income (expense), net from continuing operations   7,101       (27 )
      Loss from continuing operations before taxes   (24,312 )     (5,032 )
      Income tax (benefit) expense   (2,157 )     130  
      Loss from continuing operations $ (22,155 )   $ (5,162 )
      Income (loss) from discontinued operations, net of tax   1,038       (2,292 )
      Net loss $ (21,117 )   $ (7,454 )
             
      Net (loss) income per share of common stock, basic and diluted:      
      Continuing operations $ (0.36 )   $ (0.09 )
      Discontinued operations   0.02       (0.04 )
      Net loss per share of common stock, basic and diluted $ (0.34 )   $ (0.13 )
             
      Net (loss) income per share of preferred stock, basic and diluted:      
      Continuing operations $ (1.78 )   $ (0.46 )
      Discontinued operations   0.08       (0.21 )
      Net loss per share of preferred stock, basic and diluted $ (1.70 )   $ (0.67 )
             
      (a) The unaudited condensed consolidated statements of operations for the three months ended March 31, 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.
             

    2020 Outlook

    The 2020 organizational focus is driving clinical development programs towards key milestones:

    • CERC-800s (CERC-801, CERC-802 and CERC-803) anticipate initial data readout from the CDG-FIRST Trial within the 1st Half of 2020
    • CERC-002 (anti-LIGHT mAb) being developed for Pediatric-onset Crohn's Disease expects initial data readout in Q1 2021 with the moratorium placed on endoscopy from the AGA
    • CERC-007 (anti-IL-18 mAb) being developed for auto-inflammatory diseases (AOSD, MM) expects initial data readout in Q4 2020 to Q1 2021
    • CERC-006 (dual mTOR inhibitor) being developed for complex Lymphatic Malformations anticipates initial data readout within the 1st Half 2021

    Actual results might vary materially, whether as a result of market conditions, or other factors, including those described in the "Risk Factors" sections of our SEC filings.

    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 Pediatric-onset Crohn's Disease. Cerecor is also exploring the role of LIGHT in patients with COVID-19 induced Acute Respiratory Distress Syndrome ("ARDS") to determine if CERC-002 can treat patients infected by COVID-19 who progress to ARDS.

    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;  strategic alternatives for the neurological assets and Millipred; 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: reliance on and integration of key personnel; 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; risks related to potential strategic alternatives for the Company's neurology assets and Millipred; 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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  28. -Appoints Sol J. Barer, Ph.D. as Chairman of the Board
    - Appoints Suzanne Bruhn, Ph.D. and Joseph Miller as Directors to the Board

    ROCKVILLE, Md., April 24, 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 Dr. Sol J. Barer has been appointed as the Chairman of the Board as Dr. Simon Pedder steps down as Executive Chairman.  Additionally, Dr. Suzanne Bruhn and Mr. Joseph Miller have been appointed as Directors to the Company's Board.

    "We are extremely pleased to welcome Dr. Barer as our Chairman of the Board. Sol is an icon in the biopharmaceutical industry with decades of

    -Appoints Sol J. Barer, Ph.D. as Chairman of the Board
    - Appoints Suzanne Bruhn, Ph.D. and Joseph Miller as Directors to the Board

    ROCKVILLE, Md., April 24, 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 Dr. Sol J. Barer has been appointed as the Chairman of the Board as Dr. Simon Pedder steps down as Executive Chairman.  Additionally, Dr. Suzanne Bruhn and Mr. Joseph Miller have been appointed as Directors to the Company's Board.

    "We are extremely pleased to welcome Dr. Barer as our Chairman of the Board. Sol is an icon in the biopharmaceutical industry with decades of hands-on experience building, leading and financing companies based on innovative science and technologies that have potential to address significant unmet patient needs.  The additions of Dr. Bruhn and Mr. Miller further strengthen our Board with their deep insights from years of successful biopharmaceutical experience.  We look forward to their leadership, insights and experience to help guide our organization and the development of our near-term clinical pipeline in rare pediatric and orphan diseases," stated Mike Cola, CEO of Cerecor.  "Additionally, we would like to thank Dr. Pedder for his service as Executive Chairman, who will stay on the Board until our shareholders meeting, and his willingness afterwards, to stay on in an advisory role to the Board."

    Dr. Barer has served on the Company's Board since February 2020.  Dr. Barer spent most of his professional career with the Celgene Corporation where he was the Founder, CEO and Chairman.  Dr. Barer serves as Chairman of the Board of Teva Pharmaceuticals, Centrexion Therapeutics Corporation, and NexImmune and is the Lead Director of ContraFect. Dr. Barer received his Ph.D. in organic and physical chemistry from Rutgers University and his B.S. in chemistry from Brooklyn College of the City University of New York. 

    "I am thrilled to take on the role as Chairman of the Board," said Dr. Barer.  "I look forward to applying my expertise and detailed knowledge of the business to help guide the organization.  It is an exciting time for Cerecor as the Company works to accelerate its pipeline of six near-term, novel clinical assets to help the patients and families associated with rare pediatric and orphan diseases."

    Dr. Bruhn brings to the Company her extensive experience in the biopharmaceutical industry, including her expertise in the development, commercialization and partnering of products for the treatments of serious and rare diseases.  Dr. Bruhn currently serves as the President, CEO and as a director of Tiaki Therapeutics. Prior to that, she has served as the President and CEO, and as a director of Proclara Biosciences and previously at Promedior.  Dr. Bruhn currently serves on the board of directors of Aeglea BioTherapeutics, Retrophin and Pliant Therapeutics.  Dr. Bruhn received her B.S. degree in Chemistry from Iowa State University and her Ph.D. in Chemistry from Massachusetts Institute of Technology.

    Mr. Miller, who recently resigned from Cerecor to pursue other interests, will be joining the Board to continue his support of the Company while it advances its emerging clinical stage pipeline of innovative therapies.  Mr. Miller served for the past two years as the Company's Chief Financial Officer, Principal Executive Officer, and Corporate Secretary. He has over two decades of experience as a senior executive managing financial operations and supporting enterprise growth in companies across the health sciences, biotech and pharmaceutical sectors. He started his career with KPMG in Philadelphia. Mr. Miller received his B.S. in accounting from Villanova University and is a Certified Public Accountant. 

    Chris Sullivan, Vice President of Finance, will assume the role as interim Chief Financial Officer for Cerecor while a retained search is undertaken.

    Mr. Sullivan brings to the Company his strong technical accounting and SEC reporting background, along with his wealth of financial knowledge, including experience with multiple forms of capital raises, knowledge from leading accounting and finance functions at various health sciences and biopharmaceutical companies.  Prior to being named the Company's Interim Chief Financial Officer, Mr. Sullivan was the Vice President of Finance and served in various other escalating roles since April 2018.  Prior to joining Cerecor, Mr. Sullivan was the Corporate Controller for Sucampo Pharmaceuticals when it was merged with Mallinckrodt in a $1.2 billion transaction.  He also served as the Corporate Controller for OpGen and prior to that was an Auditor and Senior Manager at Ernst & Young.  Mr. Sullivan received his B.S. degrees in Accounting and Finance from the University of Maryland, College Park and is a Certified Public Accountant.

    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 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," "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: reliance on and integration of key personnel; drug development costs, timing and other risks, including reliance on investigators and enrollment of patients in clinical trials; regulatory risks; Cerecor's cash position and the need for it to raise additional capital; 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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  29. ROCKVILLE, Md., March 26, 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 announces that it will explore the role of an inflammatory cytokine, LIGHT, in patients with COVID-19 induced Acute Respiratory Distress. The Company will use its proprietary free LIGHT assay as well as a multiplex assay to determine whether there are differences in LIGHT levels and other inflammatory markers including IL-18 and IFN-g in patients with mild to moderate vs severe disease with Acute Lung Injury / Acute Respiratory Distress Syndrome ("ARDS").

    Dr. Garry Neil, Chief Medical Officer for Cerecor, commented…

    ROCKVILLE, Md., March 26, 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 announces that it will explore the role of an inflammatory cytokine, LIGHT, in patients with COVID-19 induced Acute Respiratory Distress. The Company will use its proprietary free LIGHT assay as well as a multiplex assay to determine whether there are differences in LIGHT levels and other inflammatory markers including IL-18 and IFN-g in patients with mild to moderate vs severe disease with Acute Lung Injury / Acute Respiratory Distress Syndrome ("ARDS").

    Dr. Garry Neil, Chief Medical Officer for Cerecor, commented, "We know there is accumulating evidence that suggest that the main cause for morbidity and mortality from COVID-19 is a dysregulated immune response causing a "cytokine storm" that can exacerbate lung injury and in some patients cause Acute Respiratory Distress Syndrome (ARDS) and even fatal respiratory failure. We believe there is a strong mechanistic rationale for anti-LIGHT therapy in patients infected by COVID-19 who progress to ARDS."

    COVID-19 and Auto-Inflammatory Response
    Dysregulated inflammatory response and cytokine storm in patients with acute infection leading to respiratory distress and failure is well documented. Many of these patients require intensive care and ventilation owing to emergence of acute respiratory distress syndrome (ARDS) which is a well-described and potentially fatal complication of other viral respiratory syndromes (i.e., SARS, MERS, and H1N1).

    In COVID-19 and other human corona respiratory virus (hCoV) infections, ARDS appears to result from a dysregulated hyperinflammatory response manifested by the release of excessive pro‐inflammatory cytokines and chemokines, coined a "cytokine storm". This cytokine storm can drive acute lung injury and multiple system organ failure.

    In addition, reports indicate that pulmonary fibrosis, which is known to be a result of ARDS, is a known COVID-19 infection complication. The cytokine storm that drives tissue injury and vascular permeability in the lungs is likely mediated, in part by T cell, monocytes and macrophages activation with increased expression of cytokines.

    Role of LIGHT in Acute Inflammatory Response 
    An important immunoregulatory cytokine, LIGHT (homologous to lymphotoxin, exhibits inducible expression and competes with HSV glycoprotein D for binding to herpesvirus entry mediator, a receptor expressed on T lymphocyte) is secreted in high levels during viral infection. Early in infection, LIGHT is released from neutrophils and macrophages, bind its cellular receptors, which causes inflammatory cell infiltration and the release of high levels of TNF and additional pro-inflammatory cytokines. LIGHT also has a co-stimulatory role in T cell activation driving proinflammatory and tissue damaging effects. Neutrophils and macrophages express high levels of LIGHT and TNF and are a major source of these inflammatory cytokines. Moreover, LIGHT has a key role in driving pulmonary fibrosis via well characterized mechanisms. Therefore, neutralizing LIGHT may be beneficial for severe COVID-19 infection who are at high risk of ARDS and respiratory failure.

    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 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," "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; regulatory risks; Cerecor's cash position and the need for it to raise additional capital; 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

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  30. -Company Transformed Into Orphan and Rare Disease Biotech
    -Clear Corporate Strategy with New Leadership
    -Significant Advancement in Pipeline and Regulatory Milestones

    ROCKVILLE, Md., March 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, today announced full-year results for 2019.  The Company achieved significant research, development and regulatory milestones while transforming the organization through significant business development activities.

    "We believe the Company made aggressive steps to transform itself over the second half of 2019.  The first being the divestiture of the commercial

    -Company Transformed Into Orphan and Rare Disease Biotech
    -Clear Corporate Strategy with New Leadership
    -Significant Advancement in Pipeline and Regulatory Milestones

    ROCKVILLE, Md., March 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, today announced full-year results for 2019.  The Company achieved significant research, development and regulatory milestones while transforming the organization through significant business development activities.

    "We believe the Company made aggressive steps to transform itself over the second half of 2019.  The first being the divestiture of the commercial pediatric portfolio to AYTU, providing near term cash flow, eliminating the debt overhang and improving the Company's balance sheet.  The second being the merger with Aevi Genomic Medicine, which more than doubled the Company's pipeline and refined the focus of the organization as a rare pediatric and orphan disease biotech," said Mike Cola, Chief Executive Officer of Cerecor. "At the same time, we continued to advance our pipeline achieving numerous clinical and regulatory milestones."

    2019 Highlights

    Clinical and Regulatory Highlights

    • The FDA granted Orphan Drug Designation to CERC-801, CERC-802 and CERC-803 as therapies in development for Congenital Disorders of Glycosylation ("CDGs")
    • Received Fast Track Designation from the FDA for CERC-801 for the treatment of PGM1 Deficiency and for CERC-802 for the treatment of Mannose-Phosphate Isomerase Deficiency
    • The FDA accepted the IND application for Cerecor's investigational drugs CERC-801 for the treatment of PGM1 Deficiency and CERC-802 for the treatment of MPI-CDG
    • Announced positive Phase I data for CERC-801 and CERC-802 in Healthy Volunteers
    • First patient enrolled into the CDG FIRST Trial; a retrospective trial looking at the natural history of the disease and the current treatment paradigm of patients with specific CDGs

    Corporate and Financial Highlights

    • Announced Company headquarters move to the pharmaceutical corridor of Rockville, Maryland
    • Closed a $10 million Common Stock offering
    • The Company was added to the Russell 3000 Index®
    • Sold the pediatric portfolio and underlying commercial infrastructure to AYTU BioScience, Inc. ("AYTU") in a deal valued in excess of $43 million and removed debt associated with Deerfield agreement on commercial assets ("Aytu Divestiture")
    • Signed, then subsequently closed deal in February 2020, to merge with Aevi Genomic Medicine
    • Mike Cola announced as Chief Executive Officer and Garry Neil announced as Chief Medical Officer effective upon closing of the Aevi Merger 
    • Merger doubled the number of near-term clinical assets from the three CERC-800s programs to six total programs; honing the organizational strategy as a rare pediatric and orphan disease biotech
       
      • CERC-002 an anti-LIGHT MAb for Pediatric-onset Crohn's Disease 
      • CERC-006 a dual mTor inhibitor for complex Lymphatic Malformations
      • CERC-007 an anti-IL 18 MAb for Adult-onset Still's Disease and Multiple Myeloma
      • CERC-801 D Galactose substrate replacement therapy for PGMI-CDG
      • CERC-802 D Mannose substrate replacement therapy for MPI-CDG
      • CERC-803 L Fucose substrate replacement therapy for (LADII), also known as SLC35C1-CDG

    Dr. Garry Neil, Chief Medical Officer for Cerecor commented, "We have a rich pipeline with near-term approvals possible in 2022 and/or 2023.  All of our assets have novel mechanisms of action and have the potential to be high value,  first-in-class medicines for patient populations suffering from orphan and rare diseases.  At Cerecor we are committed to developing and delivering medicines to help these underserved patient populations."

    2019 Financial Update

    Cerecor significantly improved its working capital from a negative $4.3 million as of December 31, 2018 to a positive $5.6 million as of December 31, 2019, largely as a result of the Aytu Divestiture.  Additionally, the Company avoided future cash outflows by eliminating long-term debt and contingent consideration, also as a result of the  Aytu Divestiture.  Operating expenses declined largely as a result of acquired in-process research and development expense of $18.7 million recognized as part of the Ichorion acquisition in 2018, which did not repeat in 2019.  Net loss and net loss per share improved largely as a result of the decrease in operating expenses. 

    Condensed Consolidated Balance Sheets

               
        December 31,  
         2019     2018   
               
      Assets (in thousands)  
      Current assets:        
      Cash and cash equivalents $ 3,609     $ 10,646    
      Accounts receivable, net   1,002       822    
      Other receivables   4,241       5,262    
      Inventory, net   21       318    
      Prepaid expenses and other current assets   707       732    
      Restricted cash, current portion   17       19    
      Investment in Aytu   7,629       -    
      Current assets of discontinued operations   498       4,133    
      Total current assets   17,724       21,932    
      Property and equipment, net   1,448       587    
      Intangibles assets, net   2,426       3,765    
      Goodwill   14,409       14,409    
      Restricted cash, net of current portion   102       82    
      Long-term assets of discontinued operations   -       29,476    
      Total assets $ 36,109     $ 70,251    
      Liabilities and stockholders' equity        
      Current liabilities:        
      Accounts payable $ 2,078     $ 1,446    
      Accrued expenses and other current liabilities   5,640       14,329    
      Income taxes payable   552       2,032    
      Contingent consideration, current portion   -       860    
      Current liabilities of discontinued operations   3,891       7,550    
      Total current liabilities   12,161       26,217    
      Contingent consideration, net of current portion   -       397    
      Deferred tax liability, net   86       69    
      License obligations   -       1,250    
      Other long-term liabilities   1,112       385    
      Long-term liabilities of discontinued operations   1,755       21,025    
      Total liabilities   15,114       49,343    
      Stockholders' equity:        
      Common Stock—$0.001 par value; 200,000,000 shares authorized at December 31, 2019 and 2018; 44,384,222 and 40,804,189 shares issued and outstanding at December 31, 2019 and 2018, respectively   44       41    
      Preferred Stock—$0.001 par value; 5,000,000 shares authorized at December 31, 2019 and 2018; 2,857,143 shares issued and outstanding at December 31, 2019 and 2018, respectively   3       3    
      Additional paid-in capital   135,239       119,082    
      Accumulated deficit   (114,291 )     (98,218 )  
      Total stockholders' equity   20,995       20,908    
      Total liabilities and stockholders' equity $ 36,109     $ 70,251    
               
      The condensed consolidated balance sheets at December 31, 2019 and 2018 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,    
         2019     2018     
                 
        (in thousands, except per share data)    
      Revenues          
      Product revenue, net $ 6,650     $ 6,572      
      Sales force revenue   -       456      
      License and other revenue   100       -      
      Total revenues, net   6,750       7,028      
                 
      Operating expenses:          
      Cost of product sales   (567 )     3,261      
      Research and development   11,764       5,786      
      Acquired in-process research and development   -       18,724      
      General and administrative   10,124       10,511      
      Sales and marketing   1,484       545      
      Amortization expense   1,339       1,828      
      Impairment of intangible assets   -       1,862      
      Change in fair value of contingent consideration   (1,256 )     (111 )    
      Total operating expenses   22,888       42,406      
      Loss from continuing operations   (16,138 )     (35,378 )    
      Other (expense) income:          
      Change in fair value of Investment in Aytu   54       -      
      Change in fair value of warrant liability and unit purchase option liability   (4 )     25      
      Other (expense) income, net   (24 )     13      
      Interest income, net   121       16      
      Total other income, net from continuing operations   147       54      
      Loss from continuing operations before taxes   (15,991 )     (35,324 )    
      Income tax expense (benefit)   280       (49 )    
      Loss from continuing operations $ (16,271 )   $ (35,275 )    
      Income (loss) from discontinued operations, net of tax (inclusive of gain on sale)   198       (4,778 )    
      Net loss $ (16,073 )   $ (40,053 )    
                 
      Net (loss) income per share of common stock, basic and diluted:          
      Continuing operations $ (0.28 )   $ (1.06 )    
      Discontinued operations   0.00       (0.14 )    
      Net loss per share of common stock, basic and diluted $ (0.28 )   $ (1.20 )    
                 
      Net (loss) income per share of preferred stock, basic and diluted:          
      Continuing operations $ (1.42 )        
      Discontinued operations   0.01          
      Net loss per share of preferred stock, basic and diluted $ (1.41 )        
                 
      The condensed consolidated statements of operations for the years ended December 31, 2019 and 2018 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.  
                 

    2020 Outlook

    The 2020 organizational focus is driving clinical development programs towards key milestones:

    • CERC-800s (CERC-801, CERC-802 and CERC-803) anticipate initial data readout from the CDG-FIRST Trial within the 1 Half 2020
    • CERC-002 (anti-LIGHT mAb) being developed for Pediatric-onset Crohn's Disease expects initial data readout 2 Half 2020
    • CERC-007 (anti-IL-18 mAb) being developed for auto-inflammatory diseases (AOSD, MM) is expecting initial data readout Q4 2020 to Q1 2021
    • CERC-006 (dual mTOR inhibitor) being developed for complex Lymphatic Malformations anticipates initial data readout 1 Half 2021

    Actual results might vary materially, whether as a result of market conditions, or other factors, including those described in the "Risk Factors" sections of our SEC filings.

    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 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," "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 integration of the companies and their personnel; the development of product candidates or products; timing and success of trial results and regulatory review; potential attributes and benefits of product candidates; the expansion of Cerecor's drug portfolio; strategic alternatives for the neurological assets and Millipred; 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: risks related to integration of the combined company; drug development costs, timing and other risks, including reliance on investigators and enrollment of patients in clinical trials; regulatory risks; reliance on and the need to attract, integrate and retain key personnel; Cerecor's cash position and the need for it to raise additional capital; risks related to potential strategic alternatives for the Company's neurology assets and Millipred; 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

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  31. ROCKVILLE, Md., March 06, 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 Jeff Wilkins, MD  has joined the Company as its Chief Development Officer, with a specific focus on CERC-002, CERC-006 and CERC-007 clinical development programs.

    "We are delighted to welcome Dr. Wilkins to the organization," said Mike Cola, Chief Executive Officer. "With his experience in discovery, leading new product development programs and bringing products to market, Dr. Wilkins is a key addition for the Company. We believe he will provide valuable patient insights and clinical guidance as

    ROCKVILLE, Md., March 06, 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 Jeff Wilkins, MD  has joined the Company as its Chief Development Officer, with a specific focus on CERC-002, CERC-006 and CERC-007 clinical development programs.

    "We are delighted to welcome Dr. Wilkins to the organization," said Mike Cola, Chief Executive Officer. "With his experience in discovery, leading new product development programs and bringing products to market, Dr. Wilkins is a key addition for the Company. We believe he will provide valuable patient insights and clinical guidance as we continue to progress our programs in auto-immune/ inflammatory diseases and complex lymphatic malformations."

    Dr. Wilkins brings over 19 years of clinical research experience to the Company, most recently serving as Chief Medical Officer of Zyla Life Sciences. Previously, he held position of Chief Medical Officer at Onspira Therapeutics, Lycera, and Ceptaris Therapeutics, Inc., where he led clinical programs from IND Phase I trials to regulatory approval (including Valchlor®).   Prior to this, Dr. Wilkins was Vice President, Worldwide Clinical Research, Inflammation/Oncology at Cephalon Inc., where he led clinical development, medical affairs and business development efforts in both therapy areas. Previously, he was Senior Vice President of Clinical Development with Ception Therapeutics, where he headed a successful program in eosinophilic asthma prior to the company's acquisition by Cephalon. Dr. Wilkins entered the pharmaceutical industry with GlaxoSmithKline, where he rose to become Vice President of Discovery Medicine for GSK's Center of Excellence in External Drug Discovery. He also served as Group Director of GSK's urology franchise, responsible for Levitra® and the launch of VESIcare®. Earlier in his career as a practicing primary care physician, Dr. Wilkins was Co-Founder and Chief Executive Officer of TriValley Primary Care, a large multi-center primary care group in Southeastern Pennsylvania.

    Dr. Wilkins received his M.D. from Temple University School of Medicine and his B.S. from Bucknell University.

    "I am excited for the opportunity to be part of the Cerecor management team and to lead the development programs across three of our clinical assets," said Dr. Wilkins. "I look forward to applying my program management and clinical development  skills to guide the development of CERC-002 in Pediatric-onset Crohn's Disease, CERC-006 for complex Lymphatic Malformations and CERC-007 for Adult Onset Still's Disease (AOSD) and Multiple Myeloma (MM)."

    About CERC-002

    CERC-002 (formerly AEVI-002) is an anti-LIGHT (Lymphotoxin-like, exhibits Inducible expression, and competes with HSV Glycoprotein D for HVEM, a receptor expressed by Tlymphocytes (part of the Tumor Necrosis Super Family 14)), fully human, monoclonal antibody being developed as a treatment for Pediatric Crohn's Disease.

    About CERC-006

    CERC-006 (formerly AEVI-006) is a dual mTOR inhibitor (a class of drugs that inhibit the mammalian target of rapamycin) being developed as a treatment for complex Lymphatic Malformations (LM). LM patients often have activating mutations along the PI3K/AKT/mTOR pathway; sirolimus, an mTORC1 inhibitor, has demonstrated clinical utility in LM. CERC-006 has the potential to improve upon both the safety and efficacy of mTOR inhibition in LM.

    About CERC-007

    CERC-007 (formerly AEVI-007) is a fully human, anti-IL-18 monoclonal antibody with the potential to address multiple auto-inflammatory diseases, including Adult Onset Stills Disease (AOSD) and Multiple Myeloma (MM). IL-18 is a pro-inflammatory cytokine that stimulates the production of interferon gamma; patients with ASOD and MM show elevated serum levels of IL-18.

    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 autoimmune inflammatory diseases such as Adult Onset Stills Disease (AOSD) and Multiple Myeloma.  CERC-006 is a dual mTOR inhibitor targeted towards complex Lymphatic Malformations, also with initial proof-of-concept in patients expected in 2021. CERC-002 is an anti-LIGHT monoclonal antibody currently in a Phase 1 clinical trial. 

    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," "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 integration of new personnel; 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: risks related to reliance on and integration and retention of key personnel, including Dr. Wilkins and staff generally subsequent to the recent merger with Aevi Genomics; drug development costs, timing and other risks, including reliance on investigators and enrollment of patients in clinical trials; regulatory risks; Cerecor's cash position and the need for it to raise additional capital; 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

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  32. -Cerecor Emerges as a Leading Biopharmaceutical Company in Rare Pediatric and Orphan Diseases 
    -Mike Cola Named Chief Executive Officer and Dr. Garry Neil Named Chief Medical Officer

    ROCKVILLE, Md., Feb. 03, 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 it has completed the previously announced acquisition of Aevi Genomic Medicine (NASDAQ:GNMX) in an all-stock transaction valued at approximately $15.6 million at close, plus contingent value rights (CVRs) for up to an additional $6.5 million in subsequent payments based on clinical and/or regulatory milestones. Cerecor's pipeline…

    -Cerecor Emerges as a Leading Biopharmaceutical Company in Rare Pediatric and Orphan Diseases 
    -Mike Cola Named Chief Executive Officer and Dr. Garry Neil Named Chief Medical Officer

    ROCKVILLE, Md., Feb. 03, 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 it has completed the previously announced acquisition of Aevi Genomic Medicine (NASDAQ:GNMX) in an all-stock transaction valued at approximately $15.6 million at close, plus contingent value rights (CVRs) for up to an additional $6.5 million in subsequent payments based on clinical and/or regulatory milestones. Cerecor's pipeline now includes six clinical-stage assets, accelerating the Company's transformation into a research and development organization focused on developing new medicines for unmet needs in rare diseases, particularly for pediatric patients. The Company continues to explore strategic alternatives for its non-core neurological assets, including CERC-301, as well as its sole commercialized product, Millipred®.

    Mike Cola, Chief Executive Officer, Cerecor, stated, "Cerecor began this transformation roughly 15 months ago with the acquisition of the CERC-800s, which have the potential to be the first-ever approved treatments for Congenital Disorders of Glycosylation (CDGs). Following the more recent divestiture of the majority of the commercial pediatric portfolio and the acquisition of Aevi, today the Company is proud to advance a robust pipeline of six clinical-stage rare disease programs with the potential to be first-in-class medicines addressing high unmet needs of patients and families.   Four of these programs are potentially Priority Review Voucher (PRV) eligible, with three already granted Rare Pediatric Disease Designation (RPDD) by the FDA.  Cerecor is focused on achieving several critical inflection points throughout 2020, including initiation of pivotal studies for one or more CERC-800 program(s) and clinical proof-of-concept studies in patients with the recently integrated Aevi assets: CERC-002, CERC-006 and CERC-007. We believe this combination of assets present a unique opportunity to efficiently deliver high impact medicines by leveraging biomarker-driven approaches in clinical development".

    Pipeline Assets Accelerate Company Transformation

    • Commitment to Rare Pediatric and Orphan Diseases:  Cerecor continues its commitment to becoming an R&D-focused biopharmaceutical company with a robust pipeline of rare pediatric and orphan disease programs. This transaction expands the number of clinical programs in development at Cerecor while creating depth of focus in rare pediatric and orphan diseases.
    • Pipeline Assets:  The emerging clinical-stage pipeline consists of six medicines with compelling biological rationale in orphan autoimmune, metabolic and oncology indications, with the potential for multiple product launches through 2023:
      • CERC-002 (formerly AEVI-002), a fully-human, anti-LIGHT monoclonal antibody for Pediatric Onset Crohn's Disease
      • CERC-006 (formerly AEVI-006), a potent, orally-available mTORC1/2 inhibitor for complex Lymphatic Malformations
      • CERC-007 (formerly AEVI-007), a fully-human, anti-IL-18 monoclonal antibody for auto-inflammatory diseases, including Adult Onset Still's Disease (AOSD) and Multiple Myeloma) 
      • CERC-801, an ultra-pure, D-Galactose substrate replacement therapy for PGM1-CDG
      • CERC-802, an ultra-pure, D-Mannose substrate replacement therapy for MPI-CDG
      • CERC-803, an ultra-pure, L-Fucose substrate replacement therapy for SLC35C1-CDG 

    Details of the Transaction

    For details of the transaction please see the Investor Relations section of Cerecor.com.
    www.cerecor.com

    New Officers Appointed

    Michael Cola has been appointed as the Chief Executive Officer and Dr. Garry Neil has been appointed as the Chief Medical Officer of Cerecor.

    Mr. Cola  brings a wealth of leadership experience in the biopharmaceutical industry.  Prior to joining Cerecor, Mr. Cola served as President and CEO of Aevi Genomic Medicine since September 2013. Prior to joining Aevi Genomic Medicine, Mr. Cola served as President of Specialty Pharmaceuticals at Shire plc, a global specialty pharmaceutical company, from 2007 until April 2012. He joined Shire in 2005 as EVP of Global Therapeutic Business Units and Portfolio Management. Prior to joining Shire, he was with Safeguard Scientifics, Inc., a growth capital provider to life sciences and technology companies, where he served as President of the Life Sciences Group. While at Safeguard, Mr. Cola served as Chairman and CEO of Clarient, Inc., a cancer diagnostics company subsequently acquired by GE Healthcare, and as Chairman of Laureate Pharma, Inc., Prior to Safeguard Scientifics, Mr. Cola held senior positions in product development and commercialization at Astra Merck, a top 20 U.S. pharmaceutical company, and at Astra Zeneca, a global biopharmaceutical company.  Mr. Cola received a B.A. in biology and physics from Ursinus College and an M.S. in biomedical science from Drexel University. He serves on the Board of Directors of Vanda Pharmaceuticals Inc., Sage Therapeutics and Phathom Pharmaceuticals, and currently serves as Chairman of the Board of Governors of the Boys & Girls Clubs of Philadelphia.

    Prior to becoming the Chief Medical Officer at Cerecor, Dr. Garry Neil served as Chief Scientific Officer of Aevi Genomic Medicine since September 2013. Prior to joining Aevi Genomic Medicine, Dr. Neil held a number of senior positions in the pharmaceutical industry, academia and venture capital. These include Corporate VP of Science & Technology at Johnson & Johnson, and Group President at Johnson & Johnson Pharmaceutical Research and Development, VP of R&D at Merck KGaA/EMD Pharmaceuticals, VP of Clinical Research at Astra Zeneca and Astra Merck. Dr. Neil holds a B.S. from the University of Saskatchewan and an M.D. from the University of Saskatchewan College of Medicine. He completed his postdoctoral clinical training in internal medicine and gastroenterology at the University of Toronto. Dr. Neil also completed a postdoctoral research fellowship at the Research Institute of Scripps Clinic. He is the Founding Chairman of the Pharmaceutical Industry R&D Consortium, TransCelerate Biopharmaceuticals Inc.  He also serves on the Boards of Arena Pharmaceuticals, the Reagan Udall Foundation and the Center for Discovery and Innovation at Hackensack Meridian Health.  He is past Chairman of the Pharmaceutical Research and Manufacturers Association (PhRMA) Science and Regulatory Executive Committee and the PhRMA Foundation Board.  He is a past member of the Boards of GTx Pharmaceuticals, the Foundation for the National Institutes of Health (FNIH), and the Science Management Review Board of the NIH.

    Additionally, Mr. Cola and Dr. Sol J. Barer will be joining the Board of Directors during the first quarter of 2020.  Dr. Barer's long career as a senior pharmaceutical executive with leadership roles in various biopharmaceutical companies, coupled with his experience and knowledge of the global pharmaceutical industry and extensive scientific expertise will be a valuable addition to the Cerecor Board of Directors.

    The independent directors of the Board approved, pursuant to NASDAQ Listing Rule 5635(c)(4), the grant of inducement equity awards in the form of stock options to Mr. Cola to purchase 1.2 million shares of common stock, to Dr. Neil to purchase 800,000 shares of common stock and to Dr. Jeffery Wilkins, our new Chief Development Officer, to purchase 375,000 shares of common stock.  Each inducement option grant will vest over four years, with the first 25% of such option vesting on the first anniversary of the date of grant, and the remainder vesting in equal monthly installments, subject to the continued service of Mr. Cola, Dr. Neil, or Dr. Wilkins respectively, through the applicable vesting date.  

    Dr. Simon Pedder, Cerecor's Executive Chairman of the Board, added, "We are extremely pleased to complete this acquisition.  We welcome Mike and Garry to Cerecor's management team and Dr. Barer to our Board of Directors.  The combined pipeline and leadership team create an exciting platform for the Company to solidify itself as a leader in rare pediatric and orphan drug development.  The team is focused on executing and advancing the pipeline to near-term inflection points throughout 2020 that can set the stage for multiple drug approvals in the years to come, starting as soon as 2021."

    About CERC-002

    CERC-002 (formerly AEVI-002) is an anti-LIGHT (Lymphotoxin-like, exhibits Inducible expression, and competes with HSV Glycoprotein D for HVEM, a receptor expressed by T lymphocytes (part of the Tumor Necrosis Super Family 14)), fully human, monoclonal antibody being developed as a treatment for Pediatric Onset Crohn's Disease. CERC-002 is currently in a Phase I trial in adult Crohn's patients and has recently dosed the first patient, we anticipate initial data in the first half of 2020.

    About CERC-006

    CERC-006 (formerly AEVI-006) is an mTORC1/2 inhibitor (a class of drugs that inhibit the mammalian target of rapamycin) being developed as a treatment for complex Lymphatic Malformations (LM). LM patients often have activating mutations along the PI3K/AKT/mTOR pathway; sirolimus, an mTORC1 inhibitor, has demonstrated clinical utility in LM. CERC-006 has the potential to improve upon both the safety and efficacy of mTOR inhibition in LM. Cerecor seeks to initiate a Phase 1b/2a proof-of-concept study of CERC-006 in LM patients by the end of 2020. 

    About CERC-007

    CERC-007 (formerly AEVI-007) is a fully human, anti-IL-18 monoclonal antibody with the potential to address multiple auto-inflammatory diseases, including Adult Onset Stills Disease (AOSD) and Multiple Myeloma (MM). IL-18 is a pro-inflammatory cytokine that stimulates the production of interferon gamma; patients with ASOD and MM show elevated serum levels of IL-18. Cerecor seeks to initiate two separate Phase 1b/2a proof-of-concept studies in ASOD and MM patients in the second half of 2020.

    About CERC-800s

    CERC-801, CERC-802 and CERC-803 are monosaccharide substrate replacement therapies with known therapeutic utility for the treatment of Congenital Disorders of Glycosylation. Oral administration of these substrates replenishes critical metabolic intermediates that are reduced or absent due to genetic mutation, overcoming single enzyme defects to support glycoprotein synthesis, maintenance and function. The FDA has granted RPDD and Orphan Drug Designation (ODD) to all three CERC-800 programs. CERC-801 and CERC-802 have completed phase 1 studies and the IND filing for CERC-803 is anticipated in the first half of 2020. The Company has an ongoing retrospective study, CDG FIRST, which seeks to collect natural history and treatment-related data for patients diagnosed with PGM1-CDG, MPI-CDG or SLC35C1-CDG who are either treated with or without D-galactose, D-mannose and L-fucose, respectively, as well as patients with other CDGs who are treated with one of the three monosaccharides. Cerecor seeks to initiate a pivotal study for one or more CERC-800 program(s) in 2020, with the first anticipated NDA filing in 2021.

    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 compounds, thus qualifying the Company to receive a Priority Review Voucher ("PRV") upon approval of a new drug application ("NDA"). The Company plans to leverage the 505(b)(2) NDA pathway for all three compounds to accelerate development and approval.  The Company is also developing CERC-002, CERC-006 and CERC-007. CERC-007 is an anti-IL-18 monoclonal antibody being developed for autoimmune inflammatory diseases such as Adult Onset Stills Disease (AOSD) and Multiple Myeloma, with initial proof-of-concept in patients expected in 2021.  CERC-006 is an mTORC1/2 inhibitor targeted towards complex Lymphatic Malformations, also with initial proof-of-concept in patients expected in 2021. CERC-002 is an anti-LIGHT monoclonal antibody currently in a Phase 1 clinical trial; initial proof-of-concept data is expected in the first half of 2020 in Adult Crohn's Disease, an FDA requirement before proceeding into Pediatric Onset Crohn's.  The Company is also developing one other preclinical pediatric orphan rare disease compound, CERC-913, for the treatment of mitochondrial DNA Depletion Syndrome.

    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 Aevi's or Cerecor's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "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 integration of the companies and their personnel; the development of product candidates or products; timing and success of trial results and regulatory review; potential attributes and benefits of product candidates; the expansion of Cerecor's drug portfolio; strategic alternatives for the neurological assets and Millipred; 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:  risks related to integration of the combined company; drug development costs, timing and other risks, including reliance on investigators and enrollment of patients in clinical trials; regulatory risks; reliance on and the need to attract, integrate and retain key personnel, including Mr. Cola and Dr. Neil; Cerecor's cash position and the need for it to raise additional capital; risks related to potential strategic alternatives for the Company's neurology assets and Millipred; and those other risks detailed in Aevi's and 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,
    Chief Commercial Officer
    Cerecor Inc.

    623.439.2220 office

     

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  33. -Expands Clinical-stage Pipeline, Further Positioning Cerecor as a Leader in Rare and Orphan Diseases
    -Enhances Leadership Team with the Addition of Chief Executive Officer and Chief Medical Officer
    -Strategic Alternatives Being Explored for Neurological Assets and Millipred®

    ROCKVILLE, Md., Dec. 05, 2019 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for orphan and rare diseases, as well as neurology announced today it has entered into a definitive merger agreement to acquire Aevi Genomic Medicine (NASDAQ:GNMX) in an all-stock transaction valued at approximately $16.1 million at closing, plus contingent value rights, or CVRs, for up…

    -Expands Clinical-stage Pipeline, Further Positioning Cerecor as a Leader in Rare and Orphan Diseases
    -Enhances Leadership Team with the Addition of Chief Executive Officer and Chief Medical Officer
    -Strategic Alternatives Being Explored for Neurological Assets and Millipred®

    ROCKVILLE, Md., Dec. 05, 2019 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for orphan and rare diseases, as well as neurology announced today it has entered into a definitive merger agreement to acquire Aevi Genomic Medicine (NASDAQ:GNMX) in an all-stock transaction valued at approximately $16.1 million at closing, plus contingent value rights, or CVRs, for up to an additional $6.5 million in subsequent milestone payments on clinical or regulatory successes, or both.  Additionally, the Company is exploring strategic alternatives for its neurological assets as well as its one commercialized product Millipred®.

    "This deal is transformative for both organizations and solidifies Cerecor's commitment to developing new medicines for rare and orphan diseases," said Dr. Simon Pedder, Executive Chairman of the Board, Cerecor.  "This acquisition expands our rare disease pipeline with the addition of three clinical-stage programs in areas of high unmet need.  Additionally, the merger of Aevi into Cerecor will enhance our leadership team with the appointment of Mike Cola as Chief Executive Officer and Dr. Garry Neil as Chief Medical Officer upon closing."

    Deal Components

    • The transaction is structured as a merger and is anticipated to be tax-deferred to the Aevi stockholders, with Cerecor retaining its public reporting and current NASDAQ listing status.
    • Cerecor will acquire all outstanding shares of Aevi stock at an aggregate purchase price of $16.1 million less an amount by which Aevi's net assets at closing are less than negative $1.3 million, but in no event will such adjustment be more than $500,000.  The per share price will be based on the number of Aevi shares outstanding immediately prior to closing, which, including the shares of Aevi stock to be issued to Children's Hospital of Philadelphia Foundation upon conversion of its outstanding secured promissory note and to AstraZeneca in connection with the exercise by Aevi of its license option for MEDI2338, is anticipated to result in an approximate per share value of $0.134 to Aevi stockholders, assuming the maximum net asset related adjustment. 
    • Cerecor will issue contingent value rights to former Aevi stockholders, which would entitle them to an additional $2 million in cash or stock (at Cerecor's discretion) upon the enrollment of a patient in a Phase II study related to the AEVI-002, AEVI-006 or AEVI-007 within 24 months.
    • The contingent value rights also entitle former Aevi stockholders to an additional $4.5 million in cash or stock (at Cerecor's discretion) upon FDA approval of a New Drug Application (NDA) for AEVI-007 (MEDI2338) or AEVI-006 (OSI-027) within 60 months.
    • Closing is targeted during the first quarter of 2020, subject to effectiveness of a Cerecor registration statement on Form S-4, Aevi shareholder approval and other standard closing conditions.

    Benefits of the Transaction

    • Commitment to Rare and Orphan Diseases:  Cerecor continues its commitment to becoming an R&D-focused biopharmaceutical company with a robust pipeline of rare and orphan disease programs. This transaction expands the number of clinical programs in development at Cerecor while creating depth of focus in rare and orphan and pediatric diseases. To that end, the Company looks forward to continuing Aevi's work with Children's Hospital of Philadelphia in the field of rare and orphan diseases. 

    • Value creation through pipeline assets:  The integration of Aevi's pipeline programs should enhance the Cerecor pipeline and broaden an already rich set of near-term inflection points for Cerecor's rare and orphan disease portfolio, which includes the CERC-800s. Aevi's clinical-stage programs have the potential to benefit a variety of patient populations with significant unmet needs.  Additionally, one or more of Aevi's programs may be eligible for a Priority Review Voucher (PRV) granted by the Food and Drug Administration (FDA) associated with Rare Pediatric Disease (RPD) Designation.  FDA will award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. Under this program, a sponsor who receives an approval for a drug or biologic for a "rare pediatric disease" (RPD) may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product.
      • AEVI-007 is a fully human anti-IL-18 monoclonal antibody with the potential to address multiple auto-inflammatory diseases, including Adult Onset Stills Disease (AOSD) and Multiple Myeloma (MM). IL-18 is a pro-inflammatory cytokine; patients with AOSD and MM show elevated levels of IL-18. Cerecor seeks to initiate a Phase 1b/2a proof-of-concept study of AEVI-007 in AOSD and MM patients in 2020.
      • AEVI-006 is an mTORC1/2 inhibitor (a class of drugs that inhibit the mammalian target of rapamycin) targeted towards Complex Lymphatic Malformations (LM).  LM patients often have activating mutations along the PI3K/AKT/mTOR pathway and sirolimus is an mTORC1 inhibitor that has demonstrated clinical utility in LM. AEVI-006 has the potential to improve on both the safety and efficacy of mTOR inhibition in LM. Cerecor seeks to initiate a Phase 1b/2a proof-of-concept study of AEVI-006 in LM patients in 2020. 
      • AEVI-002 is an anti-LIGHT (Lymphotoxin-like, exhibits Inducible expression, and competes with HSV Glycoprotein D for HVEM, a receptor expressed by T lymphocytes (part of the Tumor Necrosis Super Family 14)), fully human, monoclonal antibody being developed as a treatment for Pediatric Crohn's Disease. AEVI-002 is currently in a Phase I study in adult Crohn's patients and has recently dosed the first patient. We anticipate initial data in the first half of 2020.
    • Aligns with Cerecor's transformation and innovation strategy: Cerecor's pipeline strategy is focused on developing new medicines for rare and orphan diseases.  Aevi's pipeline programs complement Cerecor's existing pediatric rare disease pipeline 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. The FDA has granted RPD Designation and Orphan Drug Designation ("ODD") to all three CERC-800 compounds, thus qualifying the Company to receive a PRV upon approval of an NDA. 
    • Organizational fit: Upon closing of the merger, it is expected that Mike Cola, current Chief Executive Officer of Aevi, will become Chief Executive Officer of Cerecor and Dr. Garry Neil, current Chief Scientific Officer of Aevi, will become Chief Medical Officer of Cerecor.  Both of these individuals bring a wealth of clinical development and commercialization experience in the biopharmaceutical industry and should complement and enhance the executive leadership team at Cerecor.

    Mike Cola, Chief Executive Officer of Aevi, stated, "We at Aevi Genomics are extremely excited about joining the Cerecor organization. The combined pipeline of both organizations is an immediate transformation of Cerecor into a leading biopharmaceutical company focused in the Rare and Orphan Disease space.  The pipeline of six near-term assets are focused in areas of significant unmet need where there are no or few approved therapies. While there is a lot of work to do in our ongoing clinical programs, I feel confident that the combined team will be able to submit numerous NDAs and gain FDA approvals over the next several years to bring new therapies to patients and families in need."  

    About the Transaction

    Wedbush PacGrow is acting as the exclusive strategic advisor to Aevi and Pepper Hamilton LLP is serving as its legal counsel. Wyrick Robbins Yates & Ponton LLP is serving as Cerecor's legal counsel.

    Strategic Optionality for Two Neurological Assets and Millipred® (oral prednisolone)

    The addition of three clinical programs in the rare disease space solidifies Cerecor's strategic focus as a biopharmaceutical company focused on the treatment of rare and orphan diseases.  The Company plans to concentrate resources toward advancing those assets to critical clinical and regulatory milestones.  As a result, and based on multiple inbound expressions of interest, the Company is evaluating strategic options for its neurological assets, CERC-301, a clinical-stage program being evaluated in diseases characterized by orthostatic hypotension, CERC-406, a next-generation, CNS-penetrant COMT inhibitor for Parkinson's disease, and for Millipred® (5mg oral prednisolone), Cerecor's sole remaining commercial asset.

    About Aevi Genomic Medicine

    Aevi Genomic Medicine, Inc. is dedicated to unlocking the potential of genomic medicine to translate genetic discoveries into novel therapies. Driven by a commitment to patients with pediatric onset life-altering diseases, Aevi's research and development efforts include working with the Center for Applied Genomics (CAG) at Children's Hospital of Philadelphia to leverage novel genetic discoveries to progress its genomic medicine strategy.

    About CERC-800's

    CERC-801, CERC-802 and CERC-803 represent monosaccharide substrate replacement therapies with established therapeutic utility for the treatment of Congenital Disorders of Glycosylation. Oral administration of these substrates replenishes critical metabolic intermediates that are reduced or absent due to genetic mutation, overcoming single enzyme defects to support glycoprotein synthesis, maintenance and function.

    About CERC-301  

    CERC-301 is an orally available, NR2B-specific, NMDA receptor antagonist being developed for the treatment of symptomatic orthostatic hypotension (OH), specifically being investigated in neurogenic Orthostatic Hypotension, (nOH) Diabetic Orthostatic Hypotension (DOH) and Intradialytic Hypotension (IDH) associated with End Stage Renal Disease (ESRD) and hemodialysis.

    About CERC-406

    CERC-406 is a small molecule, selective, catechol-O-methyltransferase (or COMT) inhibitor being developed as an oral neuro-selective adjunctive medication to levodopa / carbidopa in patients experiencing the "off-periods" of symptom management with Parkinson's Disease.

    About Millipred®

    Millipred is an oral prednisolone that is commercially available and is being actively marketed in the United States.  Millipred is indicated across a wide variety of inflammatory conditions:  Endocrine disorders, rheumatic disorders, collagen diseases, dermatologic diseases, allergic states, ophthalmic diseases, respiratory diseases, hematologic disorders, neoplastic diseases, edematous states, gastrointestinal diseases, nervous system, and certain miscellaneous indications. (Please see Full Package Insert at www.cerecor.com)

    • Prednisolone is rapidly absorbed following an oral dose
    • Peak effects following oral administration occur within 1—2 hours.
    • Rapid onset of action with intermediate duration of action
    • Prednisolone is preferred to prednisone in significant hepatic disease because prednisolone does not require hepatic activation
    • No dosage adjustments are needed in renally impaired

    About Cerecor

    Cerecor is a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases, as well as neurological conditions. The Company is building a robust 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.  The FDA granted Rare Pediatric Disease Designation and Orphan Drug Designation ("ODD") to all three CERC-800 compounds, thus qualifying the Company to receive a Priority Review Voucher ("PRV") upon approval of a new drug application ("NDA"). The PRV may be sold or transferred an unlimited number of times.  The Company plans to leverage the 505(b)(2) NDA pathway for all three compounds to accelerate development and approval.  The Company is also developing one other preclinical pediatric orphan rare disease compound, CERC-913, for the treatment of mitochondrial DNA Depletion Syndrome.  The Company's neurology pipeline is led by CERC-301, a Glutamate NR2B selective, NMDA Receptor antagonist, which Cerecor is currently exploring as a novel treatment for orthostatic hypotension.  The Company is also developing CERC-406, a CNS-targeted COMT inhibitor for Parkinson's Disease.  The Company also has one marketed product, Millipred®, an oral prednisolone indicated across a wide variety of inflammatory conditions and indications.
    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 Aevi's or 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 Aevi's or Cerecor's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "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 timing of closing of the merger with Aevi; the development of product candidates or products; timing and success of trial results and regulatory review; potential attributes and benefits of product candidates; the expansion of Cerecor's drug portfolio; 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:  risks that the merger might not close as soon as expected or at all; risks related to integration of the combined company; drug development costs, timing and other risks, including reliance on investigators and enrollment of patients in clinical trials; regulatory risks; reliance on and the need to attract, integrate and retain key personnel, including Mr. Cola and Dr. Neill; Cerecor's cash position and the need for it to raise additional capital; risks related to potential strategic alternatives for the Company's neurology assets and Millipred; and those other risks detailed in Aevi's and 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.

    Important Information and Where to Find It

    This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities of Aevi or Cerecor or the solicitation of any vote or approval. In connection with the proposed transaction, Cerecor will file with the SEC a Registration Statement on Form S-4 containing a proxy statement/prospectus. The proxy statement/prospectus will contain important information about Aevi, Cerecor, the transaction and related matters. Aevi will mail or otherwise deliver the proxy statement/prospectus to its stockholders when it becomes available. Investors and security holders of Aevi and Cerecor are urged to read carefully the proxy statement/prospectus relating to the merger (including any amendments or supplements thereto) in its entirety when it is available, because it will contain important information about the proposed transaction.

    Investors and security holders of Aevi and Cerecor will be able to obtain free copies of the proxy statement/prospectus for the proposed merger (when it is available) and other documents filed with the SEC by Aevi and Cerecor through the website maintained by the SEC at www.sec.gov. In addition, investors and security holders of Aevi will be able to obtain free copies of the proxy statement/prospectus for the proposed merger (when it is available) by contacting Aevi, Attn: Mike McInaw, . Investors and security holders of Cerecor will be able to obtain free copies of the proxy statement/prospectus for the merger by contacting Cerecor, Attn:  James Harrell, .

    Aevi and Cerecor, and their respective directors and certain of their executive officers, may be deemed to be participants in the solicitation of proxies in respect of the transactions contemplated by the agreement between Aevi and Cerecor. Information regarding Aevi's directors and executive officers is contained in Aevi's Annual Report on Form 10-K for the fiscal year ended December 31, 2018, which was filed with the SEC on March 29, 2019, and will also be available in the proxy statement/prospectus that will be filed by Cerecor with the SEC in connection with the proposed transaction. Information regarding Cerecor's directors and executive officers is contained in Cerecor's Annual Report on Form 10-K for the fiscal year ended December 31, 2018, which was filed with the SEC on March 18, 2019, and will also be available in the proxy statement/prospectus that will be filed by Cerecor with the SEC in connection with the proposed transaction.

    For Media and Investor Inquiries
    James Harrell,
    Chief Commercial Officer
    Cerecor Inc.

    623.439.2220 office

    Primary Logo

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  34. PHILADELPHIA, Dec. 5, 2019 /PRNewswire/ -- Aevi Genomic Medicine, Inc. ("Aevi") (NASDAQ:GNMX) today announced that it entered into a definitive merger agreement with Cerecor, Inc. ("Cerecor") (NASDAQ:CERC) pursuant to which Aevi will merge with a wholly owned subsidiary of Cerecor in an all-stock transaction (the "Merger") valued at approximately $16.1 million at closing, plus contingent value rights, or CVRs, for up to an additional $6.5 million in subsequent milestone payments on clinical or regulatory successes, or both. Following closing, the combined bio-pharmaceutical company will continue to be focused on pediatric orphan diseases and operate under the name Cerecor.  Michael F. Cola will become Chief Executive Officer and Garry Neil will…

    PHILADELPHIA, Dec. 5, 2019 /PRNewswire/ -- Aevi Genomic Medicine, Inc. ("Aevi") (NASDAQ:GNMX) today announced that it entered into a definitive merger agreement with Cerecor, Inc. ("Cerecor") (NASDAQ:CERC) pursuant to which Aevi will merge with a wholly owned subsidiary of Cerecor in an all-stock transaction (the "Merger") valued at approximately $16.1 million at closing, plus contingent value rights, or CVRs, for up to an additional $6.5 million in subsequent milestone payments on clinical or regulatory successes, or both. Following closing, the combined bio-pharmaceutical company will continue to be focused on pediatric orphan diseases and operate under the name Cerecor.  Michael F. Cola will become Chief Executive Officer and Garry Neil will become Chief Medical Officer, of the combined company.  

    Deal Components

    • Cerecor will acquire all outstanding shares of Aevi stock at an aggregate purchase price of $16.1 million less an amount by which Aevi's net assets at closing are less than negative $1.3 million, but in no event will such adjustment be more than $500,000.  The per share price will be based on the number of Aevi shares outstanding immediately prior to closing, including the shares of Aevi stock to be issued to Children's Hospital of Philadelphia Foundation upon conversion of its outstanding secured promissory note and to AstraZeneca in connection with the exercise by Aevi of its license option for MEDI2338, which, is anticipated to result in an approximate per share value of $0.134 to Aevi stockholders, assuming the maximum net asset related adjustment. 
    • Cerecor will issue contingent value rights to former Aevi stockholders, which would entitle them to an additional $2 million in cash or stock (at Cerecor's discretion) upon the enrollment of a patient in a Phase II study related to the AEVI-002, AEVI-006 or AEVI-007 within 24 months of closing.  
    • The contingent value rights also entitle former Aevi stockholders to an additional $4.5 million in cash or stock (at Cerecor's discretion) upon Food and Drug Administration (FDA) approval of a New Drug Application (NDA) for AEVI-007 (MEDI2338) or AEVI-006 (OSI-027) within 60 months of closing.

    Benefits of the Transaction

    • Value creation through pipeline assets:   The integration of Aevi's pipeline programs should enhance the Cerecor pipeline and broaden an already rich set of near-term inflection points for Cerecor's rare disease portfolio, which includes the CERC-800s. Aevi's clinical-stage  programs have the potential to benefit a variety of patient populations with significant unmet needs.  Additionally, one or more of Aevi's programs may have the potential to be eligible for a Priority Review Voucher (PRV) granted by the FDA associated with Rare Pediatric Disease (RPD) Designation.  FDA will award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. Under this program, a sponsor who receives an approval for a drug or biologic for a "rare pediatric disease" (RPD) may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product.
      • AEVI-007 is a fully human anti-IL-18 monoclonal antibody with the potential to address multiple auto-inflammatory diseases, including Adult Onset Stills Disease (AOSD) and Multiple Myeloma (MM). IL-18 is a pro-inflammatory cytokine; patients with AOSD and MM show elevated levels of IL-18. Cerecor seeks to initiate a Phase 1b/2a proof-of-concept study of AEVI-007 in ASOD and MM patients in 2020.
      • AEVI-006 is an mTORC1/2 inhibitor (a class of drugs that inhibit the mammalian target of rapamycin) targeted towards Complex Lymphatic Malformations (LM).  LM patients often have activating mutations along the PI3K/AKT/mTOR pathway and sirolimus is an mTORC1 inhibitor that has demonstrated clinical utility in LM. AEVI-006 has the potential to improve on both the safety and efficacy of mTOR inhibition in LM. Cerecor seeks to initiate a Phase 1b/2a proof-of-concept study of AEVI-006 in LM patients in 2020. 
      • AEVI-002 is an anti-LIGHT (Lymphotoxin-like, exhibits Inducible expression, and competes with HSV Glycoprotein D for HVEM, a receptor expressed by T lymphocytes (part of the Tumor Necrosis Super Family 14)), fully-human, monoclonal antibody being developed as a treatment for Pediatric Crohn's Disease. AEVI-002 is currently in a Phase I study in adult Crohn's patients and has recently dosed the first patient. Cerecor anticipates initial data in the first half of 2020.
    • Aligns with Cerecor's and Aevi's transformation and innovation strategies: Cerecor's pipeline strategy is focused on developing new medicines for rare and orphan diseases and Aevi is focused on developing novel therapies primarily for pediatric onset, life-altering diseases, including rare and orphan diseases.  Aevi's pipeline programs complement Cerecor's existing pediatric rare disease pipeline 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. The FDA has granted RPD Designation and Orphan Drug Designation ("ODD") to all three CERC-800 compounds, thus qualifying Cerecor to receive a PRV upon approval of an NDA. 

    About the Transaction

    The boards of directors of both Aevi and Cerecor have approved the proposed transaction.  The consummation of the Merger is subject to customary closing conditions, including the stockholders of Aevi approving the Merger and the Securities and Exchange Commission declaring effective the registration statement on which the shares of Cerecor common stock issued in the merger will be registered.  The merger is expected to close during the first quarter of 2020.

    Wedbush PacGrow is acting as the exclusive strategic advisor to Aevi and Pepper Hamilton LLP is serving as its legal counsel. Wyrick Robbins Yates & Ponton LLP is serving as Cerecor's legal counsel.

    About Aevi:

    Aevi Genomic Medicine, Inc. is dedicated to unlocking the potential of genomic medicine to translate genetic discoveries into novel therapies. Driven by a commitment to patients with pediatric onset life-altering diseases, Aevi's research and development efforts include working with the Center for Applied Genomics (CAG) at Children's Hospital of Philadelphia to leverage novel genetic discoveries to progress its genomic medicine strategy.

    About Cerecor:

    Cerecor is a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases and neurological conditions. Cerecor is building a robust pipeline of innovative therapies in orphan diseases and neurology.  Cerecor'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.  The FDA granted Rare Pediatric Disease Designation and Orphan Drug Designation ("ODD") to all three CERC-800 compounds, thus qualifying Cerecor to receive a Priority Review Voucher ("PRV") upon approval of a new drug application ("NDA"). The PRV may be sold or transferred an unlimited number of times. Cerecor plans to leverage the 505(b)(2) NDA pathway for all three compounds to accelerate development and approval. Cerecor is also developing one other preclinical pediatric orphan rare disease compound, CERC-913, for the treatment of mitochondrial DNA Depletion Syndrome.  Cerecor's neurology pipeline is led by CERC-301, a Glutamate NR2B selective, NMDA Receptor antagonist, which Cerecor is currently exploring as a novel treatment for orthostatic hypotension.  Cerecor is also developing CERC-406, a CNS-targeted COMT inhibitor for Parkinson's Disease. Cerecor also has one marketed product, Millipred®, an oral prednisolone indicated across a wide variety of inflammatory conditions and indications.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, including, but not limited to, Aevi's and Cerecor's expectations or predictions of future financial or business performance or conditions. Forward-looking statements are sometimes identified by their use of the terms and phrases such as "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning, "expect," "believe," "will," "will likely," "should," "could," "would," "may" or the negative of such terms and other comparable terminology. These forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time, are difficult to predict and are generally beyond the control of either company. Actual results may differ materially from current projections.

    Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the timing and completion of the Merger, the parties' ability to satisfy the closing conditions of the merger agreement, the failure by Aevi or Cerecor to secure and maintain relationships with collaborators and/or investors; risks relating to clinical trials; risks relating to the commercialization, if any, of Aevi's or Cerecor's proposed product candidates (such as marketing, regulatory, product liability, supply, competition, and other risks); dependence on the efforts of third parties; dependence on intellectual property; and risks that Aevi or Cerecor may lack the financial resources and access to capital to fund proposed operations. Further information on the factors and risks that could affect Aevi's and Cerecor's respective businesses, financial conditions and results of operations are contained in Aevi's and Cerecor's filings with the U.S. Securities and Exchange Commission, or SEC, which are available at www.sec.gov. The forward-looking statements represent Aevi's and Cerecor's estimate as of the date hereof only, and Aevi and Cerecor specifically disclaim any duty or obligation to update forward-looking statements.

    Important Information and Where to Find It

    This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities of Aevi or Cerecor or the solicitation of any vote or approval. In connection with the proposed transaction, Cerecor will file with the SEC a Registration Statement on Form S-4 containing a proxy statement/prospectus. The proxy statement/prospectus will contain important information about Aevi, Cerecor, the transaction and related matters. Aevi will mail or otherwise deliver the proxy statement/prospectus to its stockholders when it becomes available. Investors and security holders of Aevi and Cerecor are urged to read carefully the proxy statement/prospectus relating to the merger (including any amendments or supplements thereto) in its entirety when it is available, because it will contain important information about the proposed transaction.

    Investors and security holders of Aevi and Cerecor will be able to obtain free copies of the proxy statement/prospectus for the proposed merger (when it is available) and other documents filed with the SEC by Aevi and Cerecor through the website maintained by the SEC at www.sec.gov. In addition, investors and security holders of Aevi will be able to obtain free copies of the proxy statement/prospectus for the proposed merger (when it is available) by contacting Aevi, Attn: Mike McInaw, . Investors and security holders of Cerecor will be able to obtain free copies of the proxy statement/prospectus for the merger by contacting Cerecor, Attn: James Harrell, .

    Aevi and Cerecor, and their respective directors and certain of their executive officers, may be deemed to be participants in the solicitation of proxies in respect of the transactions contemplated by the agreement between Aevi and Cerecor. Information regarding Aevi's directors and executive officers is contained in Aevi's Annual Report on Form 10-K for the fiscal year ended December 31, 2018, which was filed with the SEC on March 29, 2019, and will also be available in the proxy statement/prospectus that will be filed by Cerecor with the SEC in connection with the proposed transaction. Information regarding Cerecor's directors and executive officers is contained in Cerecor's Annual Report on Form 10-K for the fiscal year ended December 31, 2018, which was filed with the SEC on March 18, 2019, and will also be available in the proxy statement/prospectus that will be filed by Cerecor with the SEC in connection with the proposed transaction.

    CONTACTS:

    For Aevi Genomic Medicine, Inc.
    Mike Cola

    Westwicke Partners
    Chris Brinzey
    +1-339-970-2843

    MEDIA INQUIRIES:
    FTI Consulting
    Irma Gomez-Dib
    +1-212-850-5761
    +1-415-706-9155

    For Cerecor Inc.
    For Media and Investor Inquiries
    James Harrell,
    Chief Commercial Officer
    Cerecor Inc.

    623.439.2220 office

    Cision View original content:http://www.prnewswire.com/news-releases/cerecor-to-acquire-aevi-genomic-medicine-300969870.html

    SOURCE Aevi Genomic Medicine, Inc.

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    • Sale of Pediatric Portfolio in a Deal Valued in Excess of $43 Million
    • First Patient Enrolled in Diabetic OH Trial with CERC-301
    • Completed Phase 1 Healthy Volunteer Study with CERC-802
    • CERC-802 IND Accepted by FDA and Received Fast Track Designation

    ROCKVILLE, Md., Nov. 14, 2019 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for orphan diseases  and neurology, announced today its financial results for the third quarter ended September 30, 2019 and provided additional corporate highlights.

    "It's been a transformational start to the back-half of the year for Cerecor.  We continue to execute on our plan to increase shareholder value by

    • Sale of Pediatric Portfolio in a Deal Valued in Excess of $43 Million
    • First Patient Enrolled in Diabetic OH Trial with CERC-301
    • Completed Phase 1 Healthy Volunteer Study with CERC-802
    • CERC-802 IND Accepted by FDA and Received Fast Track Designation

    ROCKVILLE, Md., Nov. 14, 2019 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for orphan diseases  and neurology, announced today its financial results for the third quarter ended September 30, 2019 and provided additional corporate highlights.

    "It's been a transformational start to the back-half of the year for Cerecor.  We continue to execute on our plan to increase shareholder value by advancing our clinical pipeline and executing transformative business development deals.  CERC-802 achieved several regulatory milestones and had encouraging results from its Phase I Safety Study in Healthy Volunteers. CERC-301 final results were reported from its neurogenic Orthostatic Hypotension (nOH) trial in patients with Parkinson's disease and is preparing to advance into a proof-of-concept trial investigating its use in Orthostatic Hypotension (OH) associated with Diabetes.  Diabetic OH is a significantly larger patient population (15-fold greater than nOH with ~3 million U.S. patients) ; and there are no approved therapies. Additionally, the sale of the Pediatric Portfolio strengthens our balance sheet by providing non-dilutive capital for R&D helping us to advance CERC-801 towards NDA approval, allowing us to obtain a PRV for potential monetization.,"  said Dr. Simon Pedder, Executive Chairman of the Board.

    Corporate Update

    • On October 10, 2019, the Company entered into, and subsequently closed on, an asset purchase agreement with Aytu BioScience, Inc. (Aytu) to sell its Pediatric Portfolio with the overall deal valued in excess of $43 million
      º The Pediatric Portfolio includes the following five product lines: Aciphex® Sprinkle™, Cefaclor for Oral Suspension, Karbinal® ER, Flexichamber™, Poly-Vi-Flor® and
      Tri-Vi-Flor™
      º  Composite of $17 million in cash and preferred stock ($4.5  in cash & 12.5 million of Aytu stock)
      º  Assumption of Cerecor's outstanding payment obligations payable to Deerfield CSF, LLC ("Deerfield Note") and other liabilities in excess of $15 million
      º  Elimination of existing royalty obligations & various commercial accruals of $11 million
      º  Estimated annual expense reduction of $7 to $9 million associated with Commercial Sales organization transfer to Aytu
      º  The Company retained all rights to Millipred®, which is the Company's most profitable product.  Millipred® profits will assist the Company in funding its pipeline assets and may provide future optionality towards monetization and further pipeline funding
    • James Harrell, EVP of Marketing and Investor Relations, was promoted to Chief Commercial Officer
    • Private Placement of ~$3.7 million from Armistice Capital in September 2019

    Research and Development Update

    Orphan Pipeline

    • The CDG FIRST trial enrolled its first patient in July 2019.  The purpose of the trial is to investigate the natural course of disease and current treatment approaches for Congenital Disorders of Glycosylation (CDGs). The data acquired through the CDG FIRST study is expected to be used to support regulatory filings for the CERC-800s series (CERC-801, CERC-802 and CERC-803), and may help to expedite the first approved treatment(s) for CDGs
    • The U.S. Food and Drug Administration ("FDA") communicated that the Company may proceed under   the IND for CERC-802 in MPI-CDG (Mannose-Phosphate Isomerase)
    • CERC-802 obtained fast-track designation (FTD) from the FDA.  Both CERC-801 and CERC-802 now have fast-track designation from the FDA   
    • CERC-802 completed its Phase I Safety Study in healthy volunteers.  The single-center, US-based safety, tolerability and pharmacokinetic study was an open-label, randomized, single-dose, 4-way crossover study in 16 healthy adult volunteers. Pharmacokinetic (PK) data is expected in early 2020

    Neurological Pipeline

    • CERC-301 completed and reported its final results from its Phase I trial in nOH
      º  The 20mg dose group (the highest dose tested) demonstrated rapid, robust and sustained increases in blood pressure over baseline and placebo with a maximum improvement of 29.1 mmHg throughout the study 
      º  Additionally, there was strong dose-related consistency of plasma concentrations across all doses studied.  We believe this data may support a single daily dose and has the potential to be used in a broader Orthostatic Hypotension patient population
    • Initiated a Phase I Proof-of-Concept trial in diabetic orthostatic hypotension (DOH)
      º  The purpose of this study is to assess the single dose effects of CERC-301 in patients with symptomatic DOH
      º  This study is a randomized, double-blind, placebo-controlled, two-way cross-over trial over two 24-hour in-clinic visits. At each visit, subjects will receive a single 20 mg dose of CERC-301 or placebo then undergo a series of orthostatic challenge tests over the 24 hour in-clinic period
      º  Patients will also complete an OH symptomatic assessment following each orthostatic challenge. Safety, tolerability, PK data will also be collected. As part of the routine laboratory tests, particular interest will be paid to the patient's plasma glucose levels  over the course of the study

    Third Quarter 2019 Financial Results

    Net product revenue increased  $1.4 million to $5.5 million for the three months ended September 30, 2019 as compared to the same period in 2018. The increase was due to improved product mix and higher sales volume during the current period.

    Total operating expenses were $9.3 million for the three months ended September 30, 2019, compared to operating expenses of $28.4 million for the three months ended September 30, 2018.  The significant decrease was due to $18.7 million of in-process research and development costs as a result of the Ichorion acquisition in 2018. 

    Net loss for the three months ended September 30, 2019 was $4.0 million compared to net loss of $24.6 million for the three months ended September 30, 2018.  The significant decrease was largely a result of the 2018 in-process research and development costs highlighted above.

    The cash balance was $5.3 million for the quarter ended September 30, 2019.  The company received $4.5 million in cash from Aytu from the sale of the pediatric portfolio in the fourth quarter of 2019.

    Unaudited Condensed Consolidated Statements of Operations

                               
        Three Months Ended   Nine Months Ended  
        September 30,   September 30,  
        2019 (a), (b)   2018 (a)   2019 (a), (b)   2018 (a)  
        (in thousands, except per share data)   (in thousands, except per share data)  
    Revenues                          
    Product revenue, net   $ 5,513     $ 4,075     $ 15,374     $ 13,046    
    License and other revenue     100             100          
    Sales force revenue                       297    
    Total revenues, net     5,613       4,075       15,474       13,343    
    Operating expenses:                          
    Cost of product sales     1,435       3,111       3,241       5,398    
    Research and development     1,743       1,048       8,857       3,780    
    Acquired in-process research and development           18,724             18,724    
    General and administrative     2,679       1,884       7,779       7,834    
    Sales and marketing     2,631       2,311       8,676       5,889    
    Amortization expense     1,037       1,065       3,195       3,316    
    Impairment of intangible assets           160       1,449       1,861    
    Change in fair value of contingent consideration     (197 )     85       (1,009 )     361    
    Total operating expenses     9,328       28,388       32,188       47,163    
    Loss from operations     (3,715 )     (24,313 )     (16,714 )     (33,820 )  
    Other (expense) income:                          
    Change in fair value of warrant liability and unit purchase option liability     35       (3 )     7       (23 )  
    Other (expense) income, net     (15 )           (24 )     19    
    Interest expense, net     (206 )     (235 )     (614 )     (578 )  
    Total other expense, net     (186 )     (238 )     (631 )     (582 )  
    Net loss before taxes     (3,901 )     (24,551 )     (17,345 )     (34,402 )  
    Income tax expense     115       52       349       92    
    Net loss   $ (4,016 )   $ (24,603 )   $ (17,694 )   $ (34,494 )  
    Net loss per share of common stock, basic and diluted   $ (0.07 )   $ (0.71 )   $ (0.31 )   $ (1.05 )  
    Net loss per share of preferred stock, basic and diluted   $ (0.35 )   $     $ (1.56 )   $    
                               
    (a) The unaudited condensed consolidated statements of operations for the three and nine months ended September 30, 2019 and 2018 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.  
    (b) The unaudited condensed consolidated statements of operations for the three and nine months ended September 30, 2019 do not include the impact of the Aytu transaction because the transaction was entered into and subsequently closed in the fourth quarter of 2019.  
                               

    Condensed Consolidated Balance Sheets

                   
        September 30   December 31,  
        2019 (a), (b)   2018 (a)  
        (unaudited)        
        (in thousands)  
    Assets              
    Current assets:              
    Cash and cash equivalents   $ 5,251     $ 10,646    
    Accounts receivable, net     4,956       3,158    
    Other receivables     208       5,469    
    Inventory, net     402       1,111    
    Prepaid expenses and other current assets     1,670       1,529    
    Restricted cash, current portion     102       19    
    Total current assets     12,589       21,932    
    Property and equipment, net     1,497       587    
    Intangible assets, net     26,595       31,239    
    Goodwill     16,411       16,411    
    Restricted cash, net of current portion     102       82    
    Total assets   $ 57,194     $ 70,251    
    Liabilities and stockholders' equity              
    Current liabilities:              
    Accounts payable   $ 826     $ 1,446    
    Accrued expenses and other current liabilities     13,134       19,731    
    Income taxes payable     1,015       2,032    
    Long-term debt, current portion     1,050       1,050    
    Contingent consideration, current portion     1,237       1,957    
    Total current liabilities     17,262       26,216    
    Long-term debt, net of current portion     14,255       14,328    
    Contingent consideration, net of current portion     6,236       7,094    
    Deferred tax liability, net     98       69    
    License obligations           1,250    
    Other long-term liabilities     1,122       386    
    Total liabilities     38,973       49,343    
    Stockholders' equity:              
    Common stock—$0.001 par value; 200,000,000 shares authorized at September 30, 2019 and December 31, 2018; 44,106,794 and 40,804,189 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively     44       41    
    Preferred stock—$0.001 par value; 5,000,000 shares authorized at September 30, 2019 and December 31, 2018; 2,857,143 shares issued and outstanding at September 30, 2019 and December 31, 2018     3       3    
    Additional paid-in capital     134,086       119,082    
    Accumulated deficit     (115,912 )     (98,218 )  
    Total stockholders' equity     18,221       20,908    
    Total liabilities and stockholders' equity   $ 57,194     $ 70,251    
                   
    (a) The condensed consolidated balance sheets as of September 30, 2019 and December 31, 2018 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.  
    (b) The condensed consolidated balance sheets as of September 30, 2019 do not include the impact of the Aytu transaction because the transaction was entered into and subsequently closed in the fourth quarter of 2019.  
                   

    Outlook

    Cerecor was on track to achieve its 2019 revenue guidance in a range of $20 to $22 million.  However, as a result of the sale of the Pediatric Portfolio to Aytu, Cerecor will no longer be providing revenue guidance.

    About Cerecor
    Cerecor is a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for orphan diseases and neurological conditions. The Company is building a robust pipeline of innovative therapies in orphan diseases and neurology.  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.  The FDA granted Rare Pediatric Disease Designation and Orphan Drug Designation ("ODD") to all three CERC-800 compounds, thus qualifying the Company to receive a Priority Review Voucher ("PRV") upon approval of a new drug application ("NDA"). The PRV may be sold or transferred an unlimited number of times.  The Company plans to leverage the 505(b)(2) NDA pathway for all three compounds to accelerate development and approval.  The Company is also developing one other preclinical pediatric orphan rare disease compound, CERC-913, for the treatment of mitochondrial DNA Depletion Syndrome.  The Company's neurology pipeline is led by CERC-301, a Glutamate NR2B selective, NMDA Receptor antagonist, which Cerecor is currently exploring as a novel treatment for orthostatic hypotension.  The Company is also developing CERC-406, a CNS-targeted COMT inhibitor for Parkinson's Disease.  The Company also has one marketed product, Millipred®, an oral prednisolone indicated across a wide variety of inflammatory conditions and indications.

    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," "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; the expansion of Cerecor's drug portfolio; 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; regulatory risks; reliance on and the need to attract, integrate and retain key personnel; Cerecor's cash position and the potential need for it to raise additional capital; 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,
    Chief Commercial Officer
    Cerecor Inc.

    623.439.2220 office

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  35. - CERC-301 Enrolls First Patient in Diabetic Orthostatic Hypotension Trial
    -CERC-802 Completes Phase I Safety Study in Healthy Volunteers

    ROCKVILLE, Md., Nov. 11, 2019 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for orphan diseases and neurology, announced today that it has achieved significant milestones in its clinical development programs.  The first patient has been enrolled in a Phase I Proof-of-Concept Trial investigating the safety, tolerability and effects on blood pressure in patients with orthostatic hypotension associated with diabetes ("DOH").  In addition, in October 2019, the Company completed dosing healthy volunteers…

    - CERC-301 Enrolls First Patient in Diabetic Orthostatic Hypotension Trial
    -CERC-802 Completes Phase I Safety Study in Healthy Volunteers

    ROCKVILLE, Md., Nov. 11, 2019 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for orphan diseases and neurology, announced today that it has achieved significant milestones in its clinical development programs.  The first patient has been enrolled in a Phase I Proof-of-Concept Trial investigating the safety, tolerability and effects on blood pressure in patients with orthostatic hypotension associated with diabetes ("DOH").  In addition, in October 2019, the Company completed dosing healthy volunteers in a Phase I Safety Study of CERC-802, an ultra-pure, oral, crystalline formulation of D-mannose currently in development for the treatment of MPI Deficiency ("MPI-CDG").

    Dr. Simon Pedder, Executive Chairman of the Board, commented, "We are very enthusiastic about our continued progress from our research and development team.  It's very exciting to see the advancement and expansion of the CERC-301 development program into a substantially broader patient population namely the millions of diabetic patients suffering from the untoward effects of  Orthostatic Hypotension."         

    "Likewise, the completion of the CERC-802 Phase I Safety Study allows us to advance our second asset for the treatment of Congenital Disorders of Glycosylation (CDGs) getting us another step closer to helping the hundreds of patients and families world-wide.  We continue to stay on track against our R&D milestones which could deliver our first product approval as early as 2021 with an associated Priority Review Voucher." 

    About the CERC-301 Proof-of-Concept Study in DOH
    The purpose of this study is to assess the single dose effects of CERC-301 in patients with symptomatic Orthostatic Hypotension ("OH") associated with diabetes.  This study is a randomized, double-blind, placebo-controlled, two-way cross-over trial, over two, 24-hour, in-clinic visits. At each visit, patients will receive a single 20 mg dose of CERC-301 or placebo and then undergo a series of orthostatic challenge tests over the 24-hour, in-clinic period. Patients will also complete an OH symptomatic assessment following each orthostatic challenge. Safety, tolerability and pharmacokinetic ("PK") data will also be collected. As part of the routine laboratory tests, particular interest will be paid to the patient's plasma glucose levels over the course of the study.

    Clin301-101 was a study in patients with nOH associated with Parkinson's disease. In the Clin301-101 study, a single 20 mg dose of CERC-301 achieved clinically meaningful improvements over baseline and placebo with a maximum improvement of 29.1 mmHg upon standing throughout the 6-hour study period. All doses tested were  safe and well tolerated with no serious adverse event reported.

    Of note, in previous clinical studies conducted by Cerecor, 20 mg doses of CERC-301 were safe and well tolerated for up to 28 days.

    About CERC-301
    CERC-301 is an orally available, NR2B-specific, NMDA receptor antagonist being developed for the treatment of symptomatic OH.

    About Orthostatic Hypotension ("OH")
    Orthostatic hypotension is a sudden fall in blood pressure that occurs when a person assumes a standing position. It can be due to a lesion of the baroreflex loop, which senses a change in blood pressure and adjusts heart rate and activates sympathetic nerve system fibers to cause the blood vessels to narrow and correct blood pressure. It may also be caused by hypovolemia (a decreased amount of blood in the body), resulting from the excessive use of diuretics, vasodilators, or other types of drugs, dehydration, or prolonged bed rest. The disorder may be associated with Addison's Disease, diabetes, spinal cord injuries, dialysis, advanced age and certain neurological disorders including Multiple System Atrophy with Orthostatic Hypotension (formerly known as Shy-Drager syndrome), autonomic system neuropathies, and other dysautonomias. Symptoms, which generally occur after sudden standing, include dizziness, lightheadedness, blurred vision, and syncope (temporary loss of consciousness).

    Current treatment options for OH target symptom burden reductions to increase quality of life such as correcting aggravating factors (i.e. discontinuation of hypotension drugs and correction of anemia and vitamin deficiencies); nonpharmacologic measures such as intravascular volume expansion, increased physical activity, reduction of meal size, compression stocking/abdominal binder, and sleeping arrangement; and drug therapies (i.e. droxidopa, midrodrine). 

    Orthostatic Hypotension affects numerous comorbid disease conditions with significant underserved patient populations (see chart) in the United States and in the rest of the world.

    Comorbid Disease % with OH U.S. Based Estimated Population Estimated # of Patients
    Advanced Age 30%1,2 46,000,000 > 65 Years of Age8 13,800,000
    Diabetes 16 to 25%2,3,4 30,000,0009 6,000,000
    Parkinson's Disease 15 to 58%4 1,200,000 Patients10 420,000
    ESRD Dialysis 15 to 50%5 660,000 Patients / 1,980,000 Procedures11 216,450
    Spinal Cord Injury 35 to 60%6,7 288,000 Patients12 136,800

    Professor Christopher Mathias MBBS DPhil DSc FRCP FMedSci, a world-renowned thought leader in  Autonomic and Neurovascular Disorders from the Imperial College and University College London Hospitals stated, "The unique mechanism of action of CERC-301 and its demonstrated effect on blood pressure clearly warrants further investigation for the treatment of conditions associated with hypotension. Its potential to be, perhaps, safer and more effective in a much broader patient population than our current therapeutic options provide is promising.  It's exciting to think of a compound being developed for Orthostatic Hypotension in patients suffering from Parkinson's disease and diabetes that may also have clinical utility for other conditions exacerbated by hypotension such as advanced age, intradialytic hypotension and patients with spinal cord injury."

    About the CERC-802 Phase I Study (Clin802-101)
    The single-center, US-based safety, tolerability and PK study was an open-label, randomized, single-dose, 4-way crossover study in 16 healthy adult volunteers, of which 14 completed. CERC-802 had no serious adverse events.  All CERC‑802 related adverse events were transient and resolved with no sequalae. PK data is expected in early 2020.

    "The doses were generally well tolerated by the majority of healthy volunteers and anticipated PK data should provide a solid foundation for the ongoing development of CERC-802," said Dr. Perry Calias, PhD, Chief Scientific Officer at Cerecor.  "We are also very excited about the progress being made with the CDG FIRST Trial our retrospective study seeking to collect natural history, efficacy and safety data from CDG patients treated with monosaccharide substrate replacement therapy for, PGM1-CDG, MPI-CDG and Leukocyte Adhesion Deficiency Type II (LADII) also known as SLC35C1-CDG.  We believe the information gathered through this study will be instrumental in facilitating regulatory approval of all three CERC-800 programs through the 505(b)(2) pathway."      

    About CERC-802                                           
    CERC-802 is an ultra-pure formulation of D-mannose, a naturally occurring monosaccharide commonly found in animals, microorganisms, and plants, including edible fruits and herbs. D-mannose is consumed by the body to provide substrates for protein glycosylation, the process by which carbohydrates are utilized to modify certain proteins as it relates to protein structure and function. CERC-802 has been granted Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) by the FDA, making the Company eligible to receive a Priority Review Voucher (PRV) upon approval of an NDA.

    About MPI-CDG
    CDGs 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. CDGs have high infant morbidity and mortality with no FDA-approved treatments.  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.

    Dietary monosaccharide formulations have been shown to alleviate several of the clinical manifestations in CDG patients. These substrate replacement therapies work by increasing the availability of metabolic intermediates for glycoprotein synthesis. Biallelic pathogenic variants of the MPI gene lead to enzymatic deficiencies of mannose-6-phosphate isomerase (MPI enzyme) associated with the clinical syndrome MPI-CDG. The overall estimated occurrence of MPI-CDG worldwide is less than 50 cases, although MPI-CDG is suspected to be under-diagnosed.

    About the CDG First Trial
    The CDG FIRST (Congenital Disorders of Glycosylation Formative Retrospective Study) trial is a multi-center, international, non-interventional, retrospective study that follows general principles of periodic assessment of CDG patients in routine practice.  The objectives of the study are to collect natural history and treatment-related data of patients diagnosed with PGM1-CDG, MPI-CDG or SLC35C1-CDG who are either treated with or without D-galactose, D-mannose and L-fucose, respectively, as well as patients with other CDGs who are treated with one of the sugars.

    About Cerecor
    Cerecor is a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for orphan diseases and neurological conditions. The Company is building a robust pipeline of innovative therapies in orphan diseases and neurology.  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.  The FDA granted Rare Pediatric Disease Designation and Orphan Drug Designation ("ODD") to all three CERC-800 compounds, thus qualifying the Company to receive a Priority Review Voucher ("PRV") upon approval of a new drug application ("NDA"). The PRV may be sold or transferred an unlimited number of times.  The Company plans to leverage the 505(b)(2) NDA pathway for all three compounds to accelerate development and approval.  The Company is also in the process of developing one other preclinical pediatric orphan rare disease compound, CERC-913, for the treatment of mitochondrial DNA Depletion Syndrome.  The Company's neurology pipeline is led by CERC-301, a Glutamate NR2B selective, NMDA Receptor antagonist, which Cerecor is currently exploring as a novel treatment for orthostatic hypotension.  The Company is also developing CERC-406, a CNS-targeted COMT inhibitor for Parkinson's Disease.  The Company also has one marketed product, Millipred®, an oral prednisolone indicated across a wide variety of inflammatory conditions and indications.

    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," "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; the expansion of Cerecor's drug portfolio; 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; regulatory risks; reliance on and the need to attract, integrate and retain key personnel; Cerecor's cash position and the potential need for it to raise additional capital; 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,
    Chief Commercial Officer
    Cerecor Inc.

    623.439.2220 office

    1. Ricci F, De Caterina R, Federowski A. Orthostatic hypotension: epidemiology, prognosis and treatment. JACC 2015;66:848-60.
    2. Frith J, Parry SW. New horizons in orthostatic hypotension. Age Ageing 2017;46:168-174.
    3. Zhou Y, Ke SJ, Qiu XP, et al. Prevalence, risk factors, and prognosis of orthostatic hypotension in diabetic patients. Medicine 2017; 96:36 (e8004).
    4. Low P. Neurogenic orthostatic hypotension: pathophysiology and diagnosis. AJMC 2015;21:S248-257.
    5. Sulowicz W, Radziszewski A. Pathogenesis and treatment of dialysis hypotension. Kidney International 2006; 70:S36-39.
    6. Illman A, Stiller K, Williams M. The prevalence of orthostatic hypotension during physiotherapy treatment in patients with an acute spinal cord injury. Spinal Cord 2000; 38:741-747.
    7. Claydon VE, Steeves JD, Krassioukov A. Orthostatic hypotension following spinal cord injury: understanding clinical pathophysiology. Spinal Cord 2006;44:341-351. 
    8. Colby, Sandra L. and Jennifer M. Ortman, Projections of the Size and Composition of the U.S. Population: 2014 to 2060, Current Population Reports, P25-1143, U.S. Census Bureau, Washington, DC, 2014X
    9. Centers for Disease Control and Prevention. New  CDC report: more than 100 million Americans have diabetes or prediabetes. https://www.cdc.gov/media/releases/2017/p0718-diabetes-report.html. Accessed June 21, 2019.
    10. Parkinson's Foundation. Statistics. https://parkinson.org/Understanding-Parkinsons/Statistics. Accessed June 21, 2019.
    11. National Kidney Foundation. Kidney Disease: The Basics. https://www.kidney.org/news/newsroom/factsheets/KidneyDiseaseBasics. Accessed June 21, 2019
    12. National Spinal Cord Injury Statistical Center. Spinal Cord Injury Facts and Figures at a Glance. Birmingham, AL: University of Alabama at Birmingham, 2018.

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  36. ENGLEWOOD, CO / ACCESSWIRE / November 11, 2019 / Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company focused on global commercialization of novel products addressing significant medical needs, today announced the hiring of Matthew Phillips as the company's Executive Vice President of Commercial Operations. Mr. Phillips' hiring became effective November 8, 2019 following the recently announced ac