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CERC – Cerecor Inc. (NASDAQ: CERC)

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Wednesday, February 03 2021 6:11 AM, EST


Cerecor Announces Fast Track Designation for CERC-803 for the Treatment of Leukocyte Adhesion Deficiency Type II

M2 Communications   “ENP Newswire”

ROCKVILLE – 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.

Cerecor Announces Proceeds from Option to Purchase Additional Shares of Common Stock Bringing Public Offering Proceeds to $40.7 Million M2 Communications   “ENP 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.

Cerecor Inc. Announces Closing of $36.4 Million Public Offering of Common Stock and Pre-Funded Warrants GlobeNewswire   “Press Releases”

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.

Cerecor Inc. Announces Pricing of $36.4 Million Public Offering of Common Stock and Pre-Funded Warrants GlobeNewswire   “Press Releases”

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.

Cerecor Announces Successful Proof of Concept Data for CERC-002, a Unique LIGHT-Neutralizing Antibody, in Patients Hospitalized with COVID-19 ARDS M2 Communications   “ENP Newswire”

ROCKVILLE – 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, p0.05). 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. 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.

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