CERC Cerecor Inc.

2.66
-0.03  -1%
Previous Close 2.69
Open 2.68
52 Week Low 1.98
52 Week High 4.5
Market Cap $253,955,102
Shares 95,471,843
Float 55,469,640
Enterprise Value $222,266,971
Volume 351,724
Av. Daily Volume 803,197
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Upcoming Catalysts

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

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

Latest News

    • Positive results for low-dose cohort of CERC-002 (1.0 mg/kg) in moderate to severe Crohn's disease patients who had previously failed three or more lines of biologic therapies, including anti-TNF alpha treatments
    • Mean reduction in LIGHT levels of approximately 80% compared to baseline signify a dramatic and rapid reduction of LIGHT levels correlating to the pharmacodynamic effect of CERC-002
    • Clinically meaningful endoscopic improvement in 75% (3/4) of subjects, as determined by colonoscopy (SES-CD score)
    • CERC-002 was well tolerated with no drug-related severe adverse events
    • Cohort 2 (3.0 mg/kg dose) fully enrolled; complete data anticipated in 2H21
    • Promising initial results support expansion to patients with moderate to severe ulcerative colitis
    • Positive results for low-dose cohort of CERC-002 (1.0 mg/kg) in moderate to severe Crohn's disease patients who had previously failed three or more lines of biologic therapies, including anti-TNF alpha treatments

    • Mean reduction in LIGHT levels of approximately 80% compared to baseline signify a dramatic and rapid reduction of LIGHT levels correlating to the pharmacodynamic effect of CERC-002
    • Clinically meaningful endoscopic improvement in 75% (3/4) of subjects, as determined by colonoscopy (SES-CD score)
    • CERC-002 was well tolerated with no drug-related severe adverse events
    • Cohort 2 (3.0 mg/kg dose) fully enrolled; complete data anticipated in 2H21
    • Promising initial results support expansion to patients with moderate to severe ulcerative colitis refractory to anti-TNF alpha therapies
    • The Company believes this second positive proof-of-concept study with CERC-002 further validates the LIGHT mechanism of action in inflammatory diseases

    ROCKVILLE, Md. and CHESTERBROOK, Pa., July 26, 2021 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for immunologic, immuno-oncologic and rare genetic disorders, today announced positive initial results from a Phase 1b proof-of-concept study evaluating CERC-002, an investigational first-in-class fully human anti-LIGHT (tumor necrosis factor superfamily member 14 (TNFSF14)) monoclonal antibody, in adult patients with moderate to severe Crohn's disease (CD). Crohn's disease is a disorder affecting as many as 780,000 people in the United States.

    Initial Phase 1b Proof-of-Concept Clinical Trial Results

    This is a Phase 1b, open-label, dose-escalation, signal-finding, multi-center study. The ongoing study is evaluating the safety, tolerability, pharmacokinetics, and short-term efficacy of CERC-002 in adults with moderate to severe, active Crohn's disease who have previously failed anti-tumor necrosis factor alpha (anti-TNFα) treatment. The study is a pilot study using a dose-escalation design to characterize the safety and tolerability of two different doses of CERC-002 (1.0 mg/kg and 3.0 mg/kg). All subjects receive a total of four doses of CERC-002 by subcutaneous (SQ) injection at 14-day intervals. The trial is designed to initially evaluate two doses of CERC-002 – 1 mg/kg SQ every two weeks and 3 mg/kg SQ every two weeks. The treatment period of the study is eight weeks – when enrolled subjects are evaluated for safety throughout and colonoscopies are performed at baseline and then again at eight weeks. Subjects enrolled in the study must have moderate to severe disease based on simple endoscopic score for Crohn's disease (SES-CD) of at least seven and must have failed at least one anti-TNF alpha therapy.

    Following eight weeks of treatment, the key preliminary efficacy and safety findings from CERC-002 subjects in the first cohort (n=4) include the following:

    Subject #

    Age

    Prior Therapy /

    # of Prior Lines

    SES-CDLIGHT pg/mLResponse

    Baseline8 WeeksBaseline8 Weeks
    Subject #142Remicade, Entyvio,

    Stelara
    11445524Significant mucosal healing:
    • 64% reduction in SES-CD score (moderate to mild)
    • Patient relapsed post treatment and needed surgery

    Subject #263Remicade, Humira, Entyvio,

    Stelara

    181919329No evidence of improvement

    Subject #328Remicade, Humira,

    Stelara, Methotrexate
    21157527Significant mucosal healing:
    • 29% reduction in SES-CD score (severe to moderate)
    • Exploring single-patient IND

    Subject #449Remicade, Stelara,

    Humira, Entyvio, Methotrexate, Mercaptopurine

    12316245Significant mucosal healing:
    • 75% reduction in SES-CD score (moderate to mild)
    • Exploring single-patient IND

    Disease severity according to SES-CD score1:

    Remission: 0-2

    Mild: 3-6

    Moderate: 7-15

    Severe: >15

    1 Italian Group for the Study of Inflammatory Bowel Disease. https://www.igibdscores.it/en/info-sescd.html. Accessed July 19, 2021.

    Clinical Activity and Preliminary Efficacy Results

    • Rapid response within eight weeks of treatment;
    • Mean reduction in LIGHT levels of approximately 80% as compared to baseline;
    • Clinically meaningful endoscopic improvement in 75% (3/4) of subjects, as determined by colonoscopy (SES-CD score);
    • Three subjects that demonstrated endoscopic healing have explored single-patient investigational new drug (IND) applications; and
    • One subject (1/4) relapsed post treatment and required surgery.

    Preliminary Safety Results

    • The adverse events observed in study subjects were mild to moderate with the most common adverse events associated with the gastrointestinal track and the underlying Crohn's disease;
    • There were no treatment emergent serious adverse events attributed to CERC-002;
    • No evidence of increased infections or adverse events related to immunosuppression; and
    • The favorable safety profile is consistent with that which was seen in the CERC-002 COVID19 ARDS trial that studied a 16 mg/kg single dose.

    Based on results of the first cohort of data, the independent safety review committee of the Phase 1b clinical trial endorsed continued dose exploration by proceeding to the next planned cohort (n=4) without protocol modification. The trial is ongoing, and the total duration of participation is approximately 26 weeks. More information can be found on clinicaltrials.gov (NCT03169894).

    "Crohn's disease is a serious, chronic disease with symptoms and complications that can have a major impact on patients' daily lives, and additional therapies are needed to improve the prognosis for many living with this inflammatory bowel disease," said Gerald W. Dryden, M.D., Ph.D., M.S., MSPH, study investigator and Professor of Medicine and Director of the Inflammatory Bowel Disease Program, Department of Medicine, Gastroenterology, Hepatology and Nutrition at the University of Louisville. "This proof-of-concept study included patients with moderate to severe Crohn's disease who failed more than three biologic treatment alternatives with multiple mechanisms of actions and had very resistant disease. These positive results support further advancement as a potential new treatment option that may address the unmet needs of patients living with this challenging disease."

    "We are delighted with the therapeutic response and favorable safety and tolerability profile observed in this initial cohort of our Phase 1b study for CERC-002 in moderate to severe Crohn's disease subjects refractory to biologics, and we plan to proceed into further clinical development. Later this year, we expect to report additional efficacy and safety data from the high dose cohort for this ongoing open-label study and intend to use those data as an important component of the design of the next clinical study," said H. Jeffrey Wilkins, M.D., Chief Medical Officer of Cerecor. "These encouraging results are our second positive proof-of-concept with this novel first-in-class monoclonal antibody, and we believe further validate the LIGHT mechanism of action in both acute and chronic inflammatory diseases. Our goal is to develop promising therapeutics driven by our biomarker approach which elucidates novel targets for combating specific auto-immune disorders which still have a significant unmet need."

    Investor Conference Call and Webcast

    Cerecor management will host an investor webcast and conference call today at 4:30 p.m. ET to discuss the initial Phase 1b proof-of-concept Crohn's disease results of CERC-002, as well the next steps for the CERC-002 clinical program. The conference call may be accessed by dialing +1 (833) 693-0535 for participants based in the United States or +1 (661) 407-1574 for participants based outside of the United States and entering conference ID 1979467. The accompanying slide presentation and live webcast may be accessed by visiting the investor relations section of the Cerecor website at www.cerecor.com. Following the webcast, a replay will be available on the website.

    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 Crohn's disease and cytokine storm-induced COVID-19 ARDS. Cerecor has also developed a validated, high sensitivity serum/plasma 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 immunologic, immuno-oncologic and rare genetic disorders. 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; the risk that preliminary findings from our clinical studies may not be indicative of subsequent study results; and those other risks detailed in Cerecor's filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Except as required by applicable law, Cerecor expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Cerecor's expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

    For media and investor inquiries

    Chris Brinzey

    Westwicke, an ICR Company



    339-970-2843

    or

    Schond L. Greenway

    Investor Relations

    Chief Financial Officer

    Cerecor Inc.



    610-522-6200



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  1. ROCKVILLE, Md., June 23, 2021 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for immunology, immuno-oncology and rare genetic disorders, today announced that it has entered into an exclusive license agreement with Sanford Burnham Prebys for the worldwide development and commercialization of an immune checkpoint program. The acquisition further enhances the Company's development pipeline of novel biologics that address immunology and immuno-oncology targets.

    "We are delighted to enter into this license agreement with Sanford Burnham Prebys," said Garry Neil, Chief Scientific Officer of Cerecor. "Our goal is to identify and develop

    ROCKVILLE, Md., June 23, 2021 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for immunology, immuno-oncology and rare genetic disorders, today announced that it has entered into an exclusive license agreement with Sanford Burnham Prebys for the worldwide development and commercialization of an immune checkpoint program. The acquisition further enhances the Company's development pipeline of novel biologics that address immunology and immuno-oncology targets.

    "We are delighted to enter into this license agreement with Sanford Burnham Prebys," said Garry Neil, Chief Scientific Officer of Cerecor. "Our goal is to identify and develop programs with a promising novel target for combating specific auto-immune disorders which still have significant unmet need, and this transaction helps us achieve this goal."

    "I am excited that Cerecor will develop this much needed therapeutic," said Carl F. Ware, the Director of the Infectious and Inflammatory Diseases Center at Sanford Burnham Prebys, a leading center in immunology research located in La Jolla, California. "This program reflects the increasing importance of novel immune checkpoints in health and disease.   I look forward to Cerecor rapidly advancing this program to the clinic."

    Under the terms of the agreement, Sanford Burnham Prebys will receive an up-front payment from Cerecor and is also eligible to receive additional payments based on achievement of development, regulatory and commercial milestones, sales-based royalties and a share of sublicensing income.

    Cerecor also announces that it has divested its non-core neurology pipeline assets (compounds used in CERC-301 and the COMTi platform, including CERC-406) to Alto Neuroscience and ES Therapeutics, respectively. The Company previously disclosed its intentions to explore strategic alternatives for these neurology pipeline assets, which are non-core to the Company's business, and focus on developing innovative therapies in areas of high unmet need within the fields of immunology, immuno-oncology, and rare genetic disorders. As part of the divestitures, Cerecor will receive undisclosed initial payments and is eligible to receive additional payments upon achievement of specified development, regulatory and sales-based milestones. Cerecor is also entitled to royalty payments based on net sales of CERC-301.

    About Sanford Burnham Prebys Medical Discovery Institute

    Sanford Burnham Prebys is a preeminent, independent biomedical research institute dedicated to understanding human biology and disease and advancing scientific discoveries to profoundly impact human health. For over 45 years, our research has produced breakthroughs in cancer, neuroscience, immunology and children's diseases, and is anchored by our NCI-designated cancer center and advanced drug discovery capabilities. For more information, visit us at SBPdiscovery.org or on Facebook at facebook.com/SBPdiscovery and on Twitter @SBPdiscovery.

    About Cerecor

    Cerecor is a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for immunology, immuno-oncology and rare genetic disorders.   The company is advancing its clinical-stage pipeline of innovative therapies that address unmet patient needs within rare and orphan diseases.   The company's rare disease pipeline includes CERC-801, CERC-802 and CERC-803, which are in development for congenital disorders of glycosylation and CERC-006, an oral mTORc1/c2 inhibitor in development for the treatment of complex lymphatic malformations.   The company is also developing two monoclonal antibodies, CERC-002, and CERC-007.   CERC-002 targets the cytokine LIGHT (TNFSF14) and is in clinical development for treatment of severe pediatric-onset Crohn's disease and COVID-19 acute respiratory distress syndrome.   CERC-007 targets the cytokine IL-18 and is in clinical development for the treatment of Still's disease (adult onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (sJIA)) and multiple myeloma (MM).    CERC-006, 801, 802 and 803 have all received Orphan Drug Designation and Rare Pediatric Disease Designation, which makes all four eligible for a priority review voucher upon FDA approval.

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

    Forward-Looking Statements

    This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and uncertainties that are subject to change based on various factors (many of which are beyond Cerecor's control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Cerecor's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "might," "will," "could," "would," "should," "continue," "seeks," "aims," "predicts," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential," or similar expressions (including their use in the negative), or by discussions of future matters such as: the development of product candidates or products; timing and success of trial results and regulatory review; potential attributes and benefits of product candidates; and other statements that are not historical. These statements are based upon the current beliefs and expectations of Cerecor's management but are subject to significant risks and uncertainties, including: drug development costs, timing and other risks, including reliance on investigators and enrollment of patients in clinical trials, which might be slowed by the COVID-19 pandemic; regulatory risks; Cerecor's cash position and the potential need for it to raise additional capital; general economic and market risks and uncertainties, including those caused by the COVID-19 pandemic; and those other risks detailed in Cerecor's filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Except as required by applicable law, Cerecor expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Cerecor's expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

    For media and investor inquiries

    Chris Brinzey

    Westwicke, an ICR Company



    339-970-2843

    or

    Schond L. Greenway

    Investor Relations

    Chief Financial Officer

    Cerecor Inc.



    610-522-6200 



    Primary Logo

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    • An initial tranche of $20 million drawn at the loan closing
    • Funds ongoing clinical development of key investigational product candidates
    • Financing provides flexibility and extends runway through multiple clinical catalysts expected in 2021

    ROCKVILLE, Md. and CHESTERBROOK, Pa., June 07, 2021 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare and orphan diseases, today announced that it has entered into a debt financing agreement led by Horizon Technology Finance Corporation (NASDAQ:HRZN) ("Horizon") to provide up to $35.0 million in term loans.

    "We are pleased to partner with Horizon, a leading specialty finance company that has

    • An initial tranche of $20 million drawn at the loan closing

    • Funds ongoing clinical development of key investigational product candidates
    • Financing provides flexibility and extends runway through multiple clinical catalysts expected in 2021

    ROCKVILLE, Md. and CHESTERBROOK, Pa., June 07, 2021 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare and orphan diseases, today announced that it has entered into a debt financing agreement led by Horizon Technology Finance Corporation (NASDAQ:HRZN) ("Horizon") to provide up to $35.0 million in term loans.

    "We are pleased to partner with Horizon, a leading specialty finance company that has an extensive history of supporting innovative life science companies," said Michael Cola, Chief Executive Officer of Cerecor. "Over the course of 2021, we anticipate a number of important data readouts across our immunology, oncology, and rare genetic disorders product candidates. This transaction immediately strengthens and extends our financial resources to advance our clinical pipeline towards these key development milestones."

    Gerald A. Michaud, President of Horizon stated, "We are delighted to provide this financing to Cerecor and have confidence in the Company's business strategy. We look forward to watching the Company reach its critical development milestones for its orphan and rare disease therapies in the pipeline. This investment in Cerecor provides another example of our ability to finance life sciences companies through multiple stages of development and through various value inflection points."

    $20 million of the $35 million loan was funded upon closing. The remaining $15 million may be funded upon Cerecor achieving certain predetermined milestones. Each advance of the loan will be repaid in 42 monthly payments consisting of 18 monthly payments of interest only, followed by 24 monthly payments of principal and accrued interest, and will be payable monthly in arrears. The interest-only period may be extended to 24 months contingent upon Cerecor achieving certain milestones. In connection with the financing, Cerecor issued Horizon warrants to purchase up to 403,844 of its common shares at an exercise price of $2.60 per share. Proceeds will be used to support the ongoing clinical development of key investigational product candidates within its pipeline and for general working capital purposes.

    Jefferies acted as exclusive arranger and financial advisor to Cerecor in this transaction.

    Further information with respect to the debt financing agreement with Horizon will be contained in a Current Report to be filed on Form 8-K by Cerecor with the Securities and Exchange Commission.

    About Cerecor

    Cerecor is a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare and orphan diseases. The company is advancing its clinical-stage pipeline of innovative therapies that address unmet patient needs within rare and orphan diseases. The company's rare disease pipeline includes CERC-801, CERC-802 and CERC-803, which are in development for congenital disorders of glycosylation and CERC-006, an oral mTORc1/c2 inhibitor in development for the treatment of complex lymphatic malformations. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007. CERC-002 targets the cytokine LIGHT (TNFSF14) and is in clinical development for treatment of severe pediatric-onset Crohn's disease, and COVID-19 acute respiratory distress syndrome. CERC-007 targets the cytokine IL-18 and is in clinical development for the treatment of Still's disease (adult onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (sJIA)), and multiple myeloma (MM). CERC-006, 801, 802 and 803 have all received Orphan Drug Designation and Rare Pediatric Disease Designation, which makes all four eligible for a priority review voucher upon FDA approval.

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

    About Horizon Technology Finance

    Horizon Technology Finance Corporation (NASDAQ:HRZN) is a leading specialty finance company that provides capital in the form of secured loans to venture capital backed companies in the technology, life science, healthcare information and services, and sustainability industries. The investment objective of Horizon is to maximize its investment portfolio's return by generating current income from the debt investments it makes and capital appreciation from the warrants it receives when making such debt investments. Horizon is headquartered in Farmington, Connecticut, with a regional office in Pleasanton, California, and investment professionals located in Portland, Maine, Austin, Texas, and Reston, Virginia. To learn more, please visit www.horizontechfinance.com.

    Forward-Looking Statements

    This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and uncertainties that are subject to change based on various factors (many of which are beyond Cerecor's control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Cerecor's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "might," "will," "could," "would," "should," "continue," "seeks," "aims," "predicts," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential," or similar expressions (including their use in the negative), or by discussions of future matters such as: the development of product candidates or products; timing and success of trial results and regulatory review; potential attributes and benefits of product candidates; and other statements that are not historical. These statements are based upon the current beliefs and expectations of Cerecor's management but are subject to significant risks and uncertainties, including: drug development costs, timing and other risks, including reliance on investigators and enrollment of patients in clinical trials, which might be slowed by the COVID-19 pandemic; regulatory risks; Cerecor's cash position and the potential need for it to raise additional capital; general economic and market risks and uncertainties, including those caused by the COVID-19 pandemic; and those other risks detailed in Cerecor's filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Except as required by applicable law, Cerecor expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Cerecor's expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

    For media and investor inquiries

    Chris Brinzey

    Westwicke, an ICR Company



    339-970-2843

    or

    Schond L. Greenway

    Investor Relations

    Chief Financial Officer

    Cerecor Inc.



    610-522-6200



    Primary Logo

    View Full Article Hide Full Article
  2. ROCKVILLE, Md. and CHESTERBROOK, Pa., May 17, 2021 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare and orphan diseases, today announced that members of its senior management team will participate in three upcoming virtual investor conferences.

    2021 RBC Capital Markets Global Healthcare Virtual Conference
    Date: Tuesday, May 18, 2021
    Time: 8:35 AM ET

    Oppenheimer Rare & Orphan Disease Summit
    Date: Friday, May 21, 2021
    1x1 meetings only

    Jefferies Virtual Healthcare Conference
    Date: Wednesday, June 2, 2021
    Time: 1:00 PM ET

    A live webcast of the presentation at the 2021 RBC Capital Markets Global Healthcare Virtual Conference and…

    ROCKVILLE, Md. and CHESTERBROOK, Pa., May 17, 2021 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ:CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare and orphan diseases, today announced that members of its senior management team will participate in three upcoming virtual investor conferences.

    2021 RBC Capital Markets Global Healthcare Virtual Conference

    Date: Tuesday, May 18, 2021

    Time: 8:35 AM ET

    Oppenheimer Rare & Orphan Disease Summit

    Date: Friday, May 21, 2021

    1x1 meetings only

    Jefferies Virtual Healthcare Conference

    Date: Wednesday, June 2, 2021

    Time: 1:00 PM ET

    A live webcast of the presentation at the 2021 RBC Capital Markets Global Healthcare Virtual Conference and the Jefferies Virtual Healthcare Conference can be accessed under the "News/Events" page in the Investors section of the Company's website at www.cerecor.com.

    About Cerecor

    Cerecor is a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare and orphan diseases. The company is advancing its clinical-stage pipeline of innovative therapies that address unmet patient needs within rare and orphan diseases. The company's rare disease pipeline includes CERC-801, CERC-802 and CERC-803, which are in development for congenital disorders of glycosylation and CERC-006, an oral mTORc1/c2 inhibitor in development for the treatment of complex lymphatic malformations. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007. CERC-002 targets the cytokine LIGHT (TNFSF14) and is in clinical development for treatment of severe pediatric-onset Crohn's disease, and COVID-19 acute respiratory distress syndrome. CERC-007 targets the cytokine IL-18 and is in clinical development for the treatment of Still's disease (adult onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (sJIA)), and multiple myeloma (MM). CERC-006, 801, 802 and 803 have all received Orphan Drug Designation and Rare Pediatric Disease Designation, which makes all four eligible for a priority review voucher upon FDA approval.

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

    Forward-Looking Statements

    This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and uncertainties that are subject to change based on various factors (many of which are beyond Cerecor's control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Cerecor's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "might," "will," "could," "would," "should," "continue," "seeks," "aims," "predicts," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential," or similar expressions (including their use in the negative), or by discussions of future matters such as: the development of product candidates or products; timing and success of trial results and regulatory review; potential attributes and benefits of product candidates; and other statements that are not historical. These statements are based upon the current beliefs and expectations of Cerecor's management but are subject to significant risks and uncertainties, including: drug development costs, timing and other risks, including reliance on investigators and enrollment of patients in clinical trials, which might be slowed by the COVID-19 pandemic; regulatory risks; Cerecor's cash position and the potential need for it to raise additional capital; general economic and market risks and uncertainties, including those caused by the COVID-19 pandemic; and those other risks detailed in Cerecor's filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Except as required by applicable law, Cerecor expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Cerecor's expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

    For media and investor inquiries

    Chris Brinzey

    Westwicke, an ICR Company



    339-970-2843

    or

    Schond L. Greenway

    Investor Relations

    Chief Financial Officer

    Cerecor Inc.



    610-522-6200



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    • Announced CERC-002 received Fast Track Designation from the U.S. Food and Drug Administration, following positive Phase 2 clinical trial for the treatment of patients hospitalized with COVID-19 ARDS
    • Secured exclusive, world-wide rights to develop, manufacture and commercialize CERC-002 for all indications
    • Poised to deliver significant number of clinical and regulatory catalysts in 2021

    ROCKVILLE, Md. and CHESTERBROOK, Pa., May 13, 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 recent business progress and first quarter 2021 financial results.

    "It has been a productive start to the

    • Announced CERC-002 received Fast Track Designation from the U.S. Food and Drug Administration, following positive Phase 2 clinical trial for the treatment of patients hospitalized with COVID-19 ARDS

    • Secured exclusive, world-wide rights to develop, manufacture and commercialize CERC-002 for all indications
    • Poised to deliver significant number of clinical and regulatory catalysts in 2021

    ROCKVILLE, Md. and CHESTERBROOK, Pa., May 13, 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 recent business progress and first quarter 2021 financial results.

    "It has been a productive start to the year," said Mike Cola, Chief Executive Officer of Cerecor. "Over the course of 2021, we anticipate multiple data readouts, including CERC-007 in multiple myeloma and adult onset Still's disease and CERC-006 in complex lymphatic malformations, that will demonstrate significant progress in developing treatments for immunology, oncology, and rare genetic disorders."

    Business Updates:

    • Cerecor announced an expanded agreement with Kyowa Kirin for the world-wide rights to develop, manufacture and commercialize the anti-LIGHT antibody CERC-002 for all indications, including severe pediatric onset inflammatory bowel disease and acute respiratory distress syndrome (ARDS) including COVID-19 ARDS. Kyowa Kirin has an option to retain the rights in Japan.
    • The U.S. Food and Drug Administration (FDA) granted Fast Track designation to CERC-002 for the treatment of hospitalized COVID-19 patients.
    • Cerecor announced that it has dosed its first patient in a Phase 1b proof-of-concept, multi-center, open-label dose-escalation, clinical trial of CERC-007, a fully human anti-IL-18 monoclonal antibody, in patients with adult onset Still's disease (AOSD).

    Program Updates:

    • CERC-002: Anti-LIGHT monoclonal antibody in clinical development for COVID-19 ARDS and severe pediatric onset Crohn's disease.
      • Completed double-blinded, placebo-controlled Phase 2 proof-of-concept study of CERC-002 in hospitalized COVID-19 patients with mild-to-moderate ARDS.
      • Final analysis inclusive of the 60-day safety update in the randomized placebo-controlled study demonstrated a single dose of CERC-002 led to a statistically significant reduction in respiratory failure and mortality at Day 28 in patients hospitalized with COVID-19-associated pneumonia and mild to moderate ARDS, the primary endpoint, (n=62, p=0.044).
      • At both the 28-day and the 60-day final timepoints, an approximately 50% trend in mortality reduction (22.5% vs 10.8%) was observed. CERC-002 was safe and well-tolerated on top of standard of care including high dose steroids (>90%) and remdesivir (>65%).
      • CERC-002 was granted FDA Fast Track designation for the treatment of hospitalized patients with COVID-19.
      • The Company is continuing to enroll patients in its Phase 1b trial in severe pediatric-onset Crohn's disease with initial data expected in the second quarter and is exploring the applicability of CERC-002 in non-COVID-19 ARDS.
    • CERC-007: Anti-IL-18 monoclonal antibody for the treatment of multiple myeloma (MM) and Still's disease (AOSD and systemic juvenile idiopathic arthritis (sJIA)).
      • The Company has successfully completed enrollment of the first cohort, and has begun to enroll patients in the second of the three cohorts, in the Phase 1b clinical trial in patients with relapsed or refractory MM.
      • The Company anticipates top-line data from the Phase 1b MM trial in the second half of 2021.
      • Initial data anticipated from Phase 1b clinical trial in AOSD in the third quarter of 2021.
    • CERC-006: Dual mTORc1/c2 small molecule inhibitor for complex lymphatic malformations.
      • Initial data anticipated from a Phase 1b proof-of-concept clinical study in the third quarter of 2021.
    • CERC-800 programs (CERC-801, CERC-802, and CERC-803): Therapeutic doses of monosaccharide therapies for congenital disorders of glycosylation (CDGs).
      • CERC-801 – In collaboration with the Frontiers in Congenital Disorders of Glycosylation Consortium clinical program, data are anticipated from the pivotal trial evaluating the safety and efficacy of D-galactose in patients suffering from Phosphoglucomutase-1 deficiency related congenital disorders of glycosylation (PGM1-CDG) in the second half of 2021.
      • CERC-802 – Data anticipated from the pivotal trial evaluating the safety and efficacy of D-mannose in patients suffering from Mannose phosphate isomerase deficiency related CDG (MPI-CDG) in the second half of 2021.
      • CERC-803 – Data anticipated from the pivotal trial evaluating the safety and efficacy of L-fucose in patients suffering from Leukocyte Adhesion Deficiency II (LAD II) in the second half of 2021.

    First Quarter 2021 Financial Update:

    As of March 31, 2021, Cerecor had $38.3 million in cash and cash equivalents, which was a significant increase over the $18.9 million balance as of December 31, 2020. The increase was driven by net proceeds of $37.7 million from an underwritten public offering completed in January 2021, partially offset by operating expenditures, the majority of which related to pipeline development.

    Net product revenue of the Company's commercialized product, which the Company considers non-core and for which strategic alternatives are being explored, decreased $2.3 million for the three months ended March 31, 2021. The decrease was due to a full sales return allowance recorded on sales of product that became short-dated in February 2021 due to manufacturing delays. The Company received the delayed inventory lot in April 2021 and it therefore expects revenues to normalize over the remainder of the year.

    Total operating expenses decreased $3.1 million for the three months ended March 31, 2021 as compared to the three months ended March 31, 2020. In 2020, there was a $25.5 million acquired in-process research and development (IPR&D) charge directly related to the Company's merger with Aevi Genomic Medicine, Inc. (the Aevi Merger), which led to the decrease compared to the prior period. This decrease was largely offset by a significant increase in research and development expenses. This increase was due partially to a full quarter of the expanded pipeline from the Aevi Merger as opposed to a partial quarter in the prior year and partially as a result of the focus on integration as opposed to pipeline development. Additionally, the increase in research and development expenses for the quarter includes the $10 million upfront license fee related to the expanded license agreement for CERC-002 entered into and expensed in March 2021. While the IPR&D charge in 2020 largely offset the increased research and development expenses in 2021, the net loss increased as compared to the prior year due to a $7.1 million increase in the fair value of an investment of the Company in the prior year that did not repeat in the current quarter. Loss per share was largely consistent with the prior year with an increase in shares, due to financings, offsetting the larger net loss.



    Condensed Consolidated Balance Sheets

    (In thousands, except share and per share data)

     March 31,

    2021
     December

    31, 2020
     (unaudited)

    (a)
     (a)
    Assets   
    Current assets:   
    Cash and cash equivalents$38,292  $18,919 
    Accounts receivable, net3,130  2,177 
    Other receivables2,056  2,208 
    Inventory, net  3 
    Prepaid expenses and other current assets2,465  2,660 
    Restricted cash, current portion153  38 
    Total current assets46,096  26,005 
    Property and equipment, net1,530  1,607 
    Intangible assets, net1,161  1,585 
    Goodwill14,409  14,409 
    Restricted cash, net of current portion149  149 
    Total assets$63,345  $43,755 
    Liabilities and stockholders' equity   
    Current liabilities:   
    Accounts payable$11,913  $2,574 
    Accrued expenses and other current liabilities14,238  11,310 
    Current liabilities of discontinued operations209  1,341 
    Total current liabilities26,360  15,225 
    Royalty obligation2,000  2,000 
    Deferred tax liability, net111  90 
    Other long-term liabilities1,719  1,878 
    Total liabilities30,190  19,193 
    Stockholders' equity:   
    Common stock—$0.001 par value; 200,000,000 shares authorized at March 31,

    2021 and December 31, 2020; 89,104,816 and 75,004,127 shares issued and

    outstanding at March 31, 2021 and December 31, 2020, respectively
    89  75 
    Preferred stock—$0.001 par value; 5,000,000 shares authorized at March 31,

    2021 and December 31, 2020; 1,257,143 shares issued and outstanding at March

    31, 2021 and December 31, 2020
    1  1 
    Additional paid-in capital241,535  202,276 
    Accumulated deficit(208,470) (177,790)
    Total stockholders' equity33,155  24,562 
    Total liabilities and stockholders' equity$63,345  $43,755 

    (a) The condensed consolidated balance sheets as of March 31, 2021 and December 31, 2020 have been derived from the reviewed and audited financial statements, respectively, but do not include all of the information and footnotes required by accounting principles accepted in the United States for complete financial statements.



    Condensed Consolidated Statements of Operations

    (In thousands, except per share data)

     Three Months Ended
     March 31,
     2021 (a) 2020 (a)
    Revenues:   
    Product revenue, net$473  $2,754 
        Total revenues, net473  2,754 
        
    Operating expenses:   
    Cost of product sales77  66 
    Research and development25,206  4,768 
    Acquired in-process research and development  25,549 
    General and administrative4,911  2,676 
    Sales and marketing435  677 
    Amortization expense424  431 
        Total operating expenses31,053  34,167 
     (30,580) (31,413)
    Other income:   
    Change in fair value of Investment in Aytu  7,080 
    Other income  11 
    Interest income17  10 
    Total other income, net from continuing operations17  7,101 
    Loss from continuing operations before taxes(30,563) (24,312)
    Income tax expense (benefit)11  (2,157)
    Loss from continuing operations$(30,574) $(22,155)
    (Loss) Income from discontinued operations, net of tax(106) 1,038 
    Net loss$(30,680) $(21,117)
        
    Net (loss) income per share of common stock, basic and diluted:   
    Continuing operations$(0.32) $(0.36)
    Discontinued operations(0.00) 0.02 
    Net loss per share of common stock, basic and diluted$(0.32) $(0.34)
        
    Net (loss) income per share of preferred stock, basic and diluted:   
    Continuing operations$(1.61) $(1.78)
    Discontinued operations(0.01) 0.08 
    Net loss per share of preferred stock, basic and diluted$(1.62) $(1.70)

    (a) The unaudited condensed consolidated statements of operations for the three months ended March 31, 2021 and 2020 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 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

    Schond L. Greenway

    Investor Relations

    Chief Financial Officer

    Cerecor Inc.



    610-522-6200



    Primary Logo

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