On March 8, 2021 Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases, reported recent business progress and year-end financial results for 2020 (Press release, Cerecor, MAR 8, 2021, View Source [SID1234576208]).

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

Business Updates:

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

•CERC-002: Anti-LIGHT monoclonal antibody in clinical development for COVID-19 ARDS and severe pediatric onset Crohn’s disease.
°Completed double-blinded, placebo-controlled Phase 2 proof-of-concept study of CERC-002 in cytokine storm-induced COVID-19 ARDS.
°Final analysis inclusive of the 60-day safety update in the randomized placebo-controlled study demonstrated CERC-002 was statistically significant in reducing respiratory failure and mortality at Day 28 in patients hospitalized with COVID-19-associated pneumonia and mild to moderate acute respiratory distress syndrome (ARDS), the primary endpoint, (n=62, p=0.044)
°At both the 28-day and the 60-day final timepoints, an approximately 50% trend in mortality reduction (22.5% vs 10.8%) was observed. CERC-002 appeared safe and well-tolerated on top of standard of care including high dose steroids (>90%) and remdesivir (>65%).
°Cerecor has submitted applications to the FDA for Breakthrough Therapy and Fast Track Designations and plans to meet with FDA to discuss the path to Emergency Use Authorization (EUA) and full approval.
°The company is continuing to enroll patients in its Phase 1b trial in severe pediatric-onset Crohn’s disease with initial data expected in the second quarter and is exploring the applicability of CERC-002 in non-COVID-19 ARDS.

•CERC-007: Anti-IL-18 monoclonal antibody for the treatment of multiple myeloma (MM) and Still’s disease (AOSD and sJIA).
°In December 2020, announced FDA Acceptance of two Investigational New Drug Applications for CERC-007 for the treatment of Still’s disease and for the treatment of relapsed or refractory multiple myeloma (MM).
°Following the first patient dosed in the Phase 1b clinical trial in patients with relapsed or refractory MM in December, the Company has successfully completed enrollment of the first patient cohort and looks to begin dosing cohort two.
°Initial data anticipated from Phase 1b clinical trial in adult onset Still’s disease in the second quarter of 2021.

•CERC-006: Dual mTORC1 and mTORC2 small molecule inhibitor for complex lymphatic malformations.
°Initial data anticipated from proof-of-concept study in the second quarter of 2021.

•CERC-800 programs (CERC-801, CERC-802, and CERC-803): Therapeutic doses of monosaccharide therapies for congenital disorders of glycosylation (CDGs).
°CERC-801 – In collaboration with the Frontiers in Congenital Disorders of Glycosylation Consortium clinical program, data are anticipated from the pivotal trial evaluating the safety and efficacy of D-galactose in patients suffering from Phosphoglucomutase-1 deficiency related congenital disorders of glycosylation (PGM1-CDG) in second half of 2021.
°CERC-802 – Data anticipated from the pivotal trial evaluating the safety and efficacy of D-mannose in patients suffering from Mannose phosphate isomerase deficiency related CDG (MPI-CDG) in second half of 2021.
°CERC-803 – Clearance to proceed on the Investigational New Drug Application and received Fast Track Designation from the FDA in the fourth quarter 2020. Data anticipated from the pivotal trial evaluating the safety and efficacy of L-fucose in patients suffering from Leukocyte Adhesion Deficiency II (LAD II) in second half of 2021.
2020 Financial Update:

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

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

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

On March 8, 2021 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported financial results for the third quarter and first nine months of fiscal 2021, ended January 31, 2021 (Press release, Avid Bioservices, MAR 8, 2021, View Source [SID1234576207]).

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Highlights Since October 31, 2020

"The third quarter was exceptional on all fronts," stated Nicholas Green, president and chief executive officer of Avid Bioservices. "Top line revenues were strong, contributing to a significant improvement in margins and other key financial metrics, and we continued to generate cash from operations during the quarter.

"Avid’s business development team signed $74 million in new business during the quarter, resulting in a backlog of $120 million, the largest in our history. As a result, we are raising our revenue guidance for the second time in fiscal 2021 to between $88 million and $91 million.

"Finally, to support this increase in demand, we are currently executing a two-phased expansion plan of our Myford facility that, when complete, is expected to provide a total revenue capacity of up to $270 million annually. During the quarter we also raised funds to support this expansion. The expansions represent critical developments in the business as we continue to provide capacity to onboard new clients as well as capacity to accommodate the successful clinical development and commercial growth of our existing clients. Furthermore, we look forward to incorporating a higher level of automation and digitization into the second phase as we add further focus on commercial manufacture.

"The team’s strong performance across all areas of the business is not only driving growth today, but also establishing the foundation necessary for continued growth in the future."

Financial Highlights and Guidance

The company is increasing revenue guidance for the full fiscal year 2021 from between $84 million and $88 million to between $88 million and $91 million.

Revenues for the third quarter of fiscal 2021 were $21.8 million, a 61% increase compared to revenues of $13.6 million recorded during the third quarter of fiscal 2020. For the first nine months of fiscal 2021, revenues were $68.3 million, a 45% increase as compared to revenues of $47.2 million in the prior year period. The increases in revenue for both the third quarter and first nine months of fiscal 2021 were primarily attributable to the growth in the number and scope of in-process and/or completed manufacturing runs, as well as an increase in process development projects. Additionally, as previously disclosed, prior year manufacturing revenue for the third quarter and first nine months was impacted by a production interruption.

As of January 31, 2021, revenue backlog was $120 million, an increase of 78% compared to $67 million at the end of the second quarter of fiscal 2021, and an increase of 85% compared to $65 million at the end of the prior fiscal year. The company expects to recognize most of this backlog by the end of the next fiscal year.

Gross margin for the third quarter of fiscal 2021 was 28%, a significant increase compared to a gross margin of 6% for the third quarter of fiscal 2020. Gross margin for the first nine months of fiscal 2021 was 31%, a significant increase compared to 11% in the prior year period. The increase in the third quarter and first nine months of fiscal 2021 was primarily due to the growth in manufacturing and process development revenues. Additionally, the prior year period gross profit was impacted by certain costs associated with the production interruption noted above, which costs were not incurred during the current year period.

Selling, general and administrative expenses ("SG&A") for the third quarter of fiscal 2021 were $4.0 million, an increase compared to $3.0 million recorded for the third quarter of fiscal 2020. For the first nine months of fiscal 2021, SG&A expenses were $12.0 million, an increase compared to $11.0 million recorded for the prior year period. The increases during both the third quarter and first nine months of 2021 were due primarily to increases in payroll related costs, including stock-based compensation.

For the third quarter of fiscal 2021, the company recorded a consolidated net income attributable to common stockholders of $0.8 million or $0.01 per basic and diluted share, as compared to a consolidated net loss attributable to common stockholders of $3.5 million or $0.06 per basic and diluted share, for the third quarter of fiscal 2020. For the first nine months of fiscal 2021, the company recorded a consolidated net income attributable to common stockholders of $5.6 million or $0.10 per basic and diluted share, compared to a consolidated net loss attributable to common stockholders of $9.3 million or $0.17 per basic and diluted share, for fiscal 2020.

Avid reported $70.9 million in cash and cash equivalents as of January 31, 2021. This balance includes approximately $32.1 million in net proceeds raised in the third quarter follow-on underwritten equity offering. This balance represents an increase of $35.2 million from the end of the second quarter and an increase of $34.6 million compared to $36.3 million as of the end of the prior fiscal year. The company also generated cash flows from operating activities of $5.2 million during the third quarter and $13.3 million during the nine months ended January 31, 2021.
More detailed financial information and analysis may be found in Avid Bioservices’ Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.

Recent Corporate Developments

Signed orders for $74 million during the quarter with new and existing customers, driving Avid’s backlog to an all-time high.

Completed a follow-on underwritten public offering resulting in net proceeds of approximately $32.1 million, after deducting underwriting discounts and commissions and other offering related expenses. The company intends to use the net proceeds from the offering for the expansion of its manufacturing capabilities.

Continued to advance the two-phased expansion of the Myford facility. The first phase of our expansion plan, which was initiated during the second quarter of fiscal 2021, expands the production capacity of the company’s existing Myford North facility by adding a second downstream processing suite. The second phase, which was initiated during February, will further expand capacity through the build out of a second manufacturing train, including both upstream and downstream processing suites within Myford South.

The company estimates the first phase will take approximately 12 to 15 months to complete at an estimated cost of approximately $15 million and may increase the company’s annual revenue generating capacity by up to $50 million, bringing the combined annual revenue generating capacity of our Franklin and Myford North facilities to up to $170 million. The company estimates that the Myford South expansion will take approximately 18 to 24 months to complete at a cost of approximately $45 to $55 million and may increase the company’s annual revenue generating capacity by an additional $100 million for a total revenue generating capacity of up to $270 million annually.
Conference Call

Avid will host a conference call and webcast this afternoon, March 8, 2021, at 4:30 PM EST (1:30 PM PST).

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices conference call. To listen to the live webcast, or access the archived webcast, please visit: View Source

On March 8, 2021 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported its financial results for the fourth quarter ended December 31, 2020 (Press release, Syndax, MAR 8, 2021, View Source [SID1234576206]). In addition, the Company provided a clinical and business update.

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"We expect 2021 will be a year of immense progress across our two highly promising programs aimed at addressing key areas of unmet need, coupled with a sharp focus on pipeline expansion," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "Notably, we plan to present data from the Phase 1 portion of our ongoing AUGMENT-101 trial of SNDX-5613, our selective menin inhibitor, in patients with acute leukemias. We presented promising initial clinical data at the 2020 AACR (Free AACR Whitepaper) Annual Meeting that provided the first clinical evidence that disrupting the interaction between menin and MLL1 can induce rapid responses in difficult to treat acute leukemias. We look forward to sharing updated results which further expand on SNDX-5613’s potential to meaningfully alter the treatment paradigm in genetically-defined acute leukemias."

"Additionally, on the heels of positive data presented at the ASH (Free ASH Whitepaper) Annual Meeting in December from our Phase 1 trial of axatilimab, our anti-CSF-1R monoclonal antibody, in patients with cGVHD, we are pleased to announce that our pivotal Phase 2 AGAVE-101 trial is now underway. Through inhibition of monocyte derived macrophages, axatilimab has demonstrated important clinical benefits in multiple organ systems. We believe axatilimab could represent a meaningful therapeutic option for additional fibrotic diseases where macrophages have been shown to play a significant role, and we are actively exploring additional indications."

Recent Progress and Anticipated Milestones

SNDX-5613

Syndax plans to share data from the Phase 1 AUGMENT-101 trial of SNDX-5613, its highly selective, oral menin inhibitor, in patients with mixed lineage leukemia rearranged (MLL-r) and nucleophosmin (NPM1) mutant acute leukemias late in the first quarter or early in the second quarter of 2021. Additional details regarding the presentation, which will feature the trial’s principal investigator, Eytan M. Stein, M.D. Assistant Attending Physician and Director, Program for Drug Development in Leukemia, Department of Medicine at Memorial Sloan Kettering Cancer Center, will be announced in the coming weeks. The Company remains on track to initiate the Phase 2 portion of the trial in the second quarter of 2021, which could potentially serve as the basis for a regulatory filing.

Axatilimab

At the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2020, Syndax reported updated data from its Phase 1 trial of axatilimab, its anti-CSF-1R monoclonal antibody, in patients with chronic graft versus host disease (cGVHD). Data demonstrated deep, durable responses and multiorgan clinical benefit in patients refractory to multiple therapeutic agents.

The Company announced today that the pivotal Phase 2 AGAVE-201 trial, which will evaluate the safety and efficacy of three doses and schedules of axatilimab in patients with cGVHD, began enrolling patients earlier this quarter. The primary endpoint will assess objective response rate based on the 2014 NIH consensus criteria for GVHD, with key secondary endpoints including duration of response and improvement in modified Lee Symptom Scale score. The Company expects to report topline data in 2023.

Fourth Quarter 2020 Financial Results

As of December 31, 2020, Syndax had cash, cash equivalents and short-term investments of $293.1 million and 51.4 million shares and share equivalents issued and outstanding. This includes 3.6 million pre-funded warrants.

Fourth quarter 2020 research and development expenses increased to $15.5 million from $9.5 million, and for the full year increased to $50.4 million compared to $43.0 million for 2019. The fourth quarter and full year increases were primarily due to increased clinical trial activities, increased CMC activities and professional fees.

General and administrative expenses for the fourth quarter 2020 decreased to $4.7 million from $5.1 million, and, for the year ended December 31, 2020, increased to $22.5 million compared to $16.1 million for the prior year. The fourth quarter decrease is primarily due to decreased pre-commercialization expenses. The increase for the full year was primarily due to increased professional fees and employee related expenses.

For the three months ended December 31, 2020, Syndax reported a net loss attributable to common stockholders of $20.4 million or $0.44 per share compared to $14.0 million or $0.44 per share for the prior year period. For the year ended December 31, 2020, Syndax reported a net loss attributable to common stockholders of $77.8 million or $1.88 per share, compared to $56.0 million or $1.84 per share for the prior year. For the year ended December 31, 2020, this includes a deemed dividend of $3.9 million.

Financial Update and Guidance

In December 2020, Syndax issued 6,250,000 shares of its common stock at $23.00 per share. As a result of the offering, Syndax received gross proceeds of approximately $143.8 million.

For the first quarter of 2021, research and development expenses are expected to be $25 to $30 million, and total operating expenses are expected to be $30 to $35 million. For the full year of 2021, research and development expenses are expected to be $90 to $100 million, and total operating expenses are expected to be $110 to $120 million.

Conference Call and Webcast

In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Monday, March 8, 2021.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the followin

On March 8, 2021 Cleave Therapeutics, Inc. ("Cleave"), a clinical-stage biopharmaceutical company focused on valosin-containing protein (VCP)/p97 as a novel target in protein homeostasis, DNA damage response and other cellular stress pathways for therapeutic use in cancer, and CASI Pharmaceuticals, Inc (NASDAQ: CASI), a U.S. biopharmaceutical company with an established clinical development and commercial infrastructure in China, reported they have entered an exclusive licensing agreement for the development and commercialization of CB-5339, a novel VCP/p97 inhibitor, in mainland China, Taiwan, Hong Kong and Macau (Press release, CASI Pharmaceuticals, MAR 8, 2021, View Source [SID1234576205]).

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Under the terms of the agreement, Cleave and CASI will develop CB-5339 in both hematological malignancies and solid tumors, with CASI responsible for development and commercialization in China and associated markets. Cleave will receive a $5.5 million upfront payment and is eligible to receive up to $74 million in development and commercial milestone payments plus tiered royalties in the high-single to mid-double-digit range on net sales of CB-5339. In addition to the upfront cash payment, CASI will make a $5.5 million investment in Cleave through a convertible note.

CB-5339, an oral second-generation, small molecule VCP/p97 inhibitor, is being evaluated in a Phase 1 clinical trial in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), while the National Cancer Institute (NCI) is sponsoring and evaluating CB-5339 in a Phase 1 clinical trial of patients with solid tumors and lymphomas.

"Our collaboration with CASI is a strategic step to accelerate the development of CB-5339 globally by initiating trials for additional indications such as multiple myeloma in Greater China," said Amy Burroughs, President and CEO of Cleave Therapeutics. "CASI’s development and commercial capabilities in hematology oncology and long-term commitment as an investor make them an ideal partner at this exciting time in the development of our first-in-class drug candidate."

Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, said: "Cleave’s novel approach to inhibiting VCP/p97 in hematological malignancies such as AML and MDS is supported by extensive preclinical research and early clinical data. CB-5339 represents a promising new agent for selectively targeting VCP/p97 in cancers and is a complementary addition to our growing portfolio of approved and investigational therapies for hematology oncology. We are thrilled to partner with Cleave as CB-5339 advances through clinical development."

On March 8, 2021 Axial Therapeutics Inc., a clinical-stage biopharmaceutical company focused on leveraging the gut-brain axis for the discovery and development of small molecule therapeutics with an initial focus on autism spectrum disorder (ASD) and Parkinson’s disease (PD), reported the appointment of A. Stewart Campbell, Ph.D. as Chief Executive Officer (CEO) (Press release, Axial Biotherapeutics, MAR 8, 2021, View Source [SID1234576204]). Dr. Campbell will also serve as a member on the Axial Board of Directors.

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"Stew is a proven executive leader with extensive experience in R&D innovation. His expertise across the drug development lifecycle, combined with his experience building results-focused teams makes him the right leader to take Axial forward," said Ronald C. Renaud, Axial Board Chair and Chief Executive Officer, Translate BIO. "His focus on bringing new therapies to patients will be critically important as he spearheads Axial’s efforts to advance new gut-targeted small molecule treatments for serious central nervous system (CNS) diseases and conditions."

Dr. Campbell is an accomplished executive with more than 25 years of experience building and leading teams that have strong track records of discovering and developing novel therapeutics, including numerous innovative product candidates that have progressed to the clinic. He is co-inventor on 20 issued patents.

He joined Axial in 2016 and has led the company’s research and development efforts, most recently serving as Senior Vice President, R&D. Prior to joining Axial, Dr. Campbell held various leadership roles at biopharmaceutical and chemical manufacturing companies including Ancora/CordenPharma, Surface Logix and Insmed Inc. He led the acquisition of Ancora by CordenPharma and subsequently served as Head of Product Management and Business Development for Carbohydrates and Lipids at CordenPharma. While at Surface Logix and Insmed, Dr. Campbell played an integral role in the discovery or development of five clinical stage drug candidates, including belumosudil and TAK-607. He holds a Ph.D. in Organic Chemistry from Queen’s University (Canada) and did post-doctoral research at Duke University.

"Axial is well-positioned for future growth with deep expertise in the gut-brain axis and cutting-edge science leading to the discovery of new drug targets and the development of safe and effective first-in-class therapies for CNS diseases and conditions, as well as oncology," said Dr. Campbell. "I look forward to working together with the leadership, the Board, and the dedicated Axial team to expand our pioneering drug discovery approach and advance our product candidates through the clinic."

Dr. Campbell succeeds David H. Donabedian, Ph.D., who served as CEO of Axial since co-founding the company in 2016. "We thank David for his commitment and tireless effort over the past four years, taking Axial from an idea to a company poised to enter Phase 2B in autism and with a robust pipeline of innovative programs in Parkinson’s disease and oncology," said Dr. Campbell.

Axial’s unique focus on targeting the gut as a means to treat CNS diseases and conditions is rooted in the groundbreaking research of its co-founder Dr. Sarkis Mazmanian at the California Institute of Technology establishing the biological link between the gut-brain axis and neurological disease.

The foundation of Axial’s approach is its innovative platform that leverages its proprietary in vivo models and "omics" capabilities as the scientific underpinning for the identification and validation of new disease targets followed by the design and delivery of gut-restricted, small molecule therapeutics. The company’s platform has significant potential for the development of novel therapies that mitigate underlying disease pathology, resulting symptoms, and disease progression in neurological diseases as well as oncology.

Axial’s lead product candidate is AB-2004, an oral compound poised to redefine the treatment of irritability in children with ASD, improving the lives of affected children and their families. In a Phase 1B/2A study, AB-2004 was shown to reduce metabolites implicated in ASD and improve key behaviors including irritability and anxiety. AB-2004 had no drug-related adverse events consistent with the large body of existing human safety data.

The company’s pipeline also includes small molecule, microbiome-inspired therapies in preclinical development for treatment of the underlying disease burden in PD.