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 Wugen Inc., a clinical-stage biotechnology company developing novel universal natural killer (NK) and T-cell therapies for the treatment of cancer, reported that it has entered into an exclusive license and collaboration agreement with Shanghai-based Alpha Biopharma Inc. to manufacture, develop, and commercialize its allogeneic cell products in Asia, including mainland China, Hong Kong, Macao, Taiwan region and Singapore (Press release, Wugen, MAR 8, 2021, View Source [SID1234576256]). The products included in the agreement incorporate Wugen’s proprietary technology to manufacture universal "off-the-shelf" Memory NK and CAR-T cells for the treatment of solid tumors, T-cell malignancies, Acute Myeloid Leukemia, and Multiple Myeloma.

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"We are looking forward to collaborating with the experienced and accomplished team at Alpha Biopharma, a company committed to the clinical development of innovative drugs in China," said John McKearn, Ph.D., CEO of Wugen. "This agreement represents a significant milestone for Wugen’s clinical progress as it allows us to extend our pipeline of novel cell therapies to geographies with substantial unmet needs and position our clinical programs for expedited global approvals."

"This collaboration will generate significant synergies in both clinical development and future commercialization. We will bring Wugen’s leading next-generation cell therapies to China to fulfill the tremendous unmet medical need in combating cancer," said Eric Zhang, CEO of Alpha Biopharma. "We will leverage our strength to accelerate clinical development, manufacturing, and regulatory activities in China now and commercialization upon approval."

Per the agreement, Alpha Biopharma will be responsible for the development and commercialization of the products in the defined territory, including manufacturing, clinical, regulatory, marketing and sales activities. Alpha Biopharma and Wugen will equally share profits and losses related to the development and commercialization of products in the territory, as well as sharing data to support territory and global approvals.

Currently approved cellular therapies have been shown to effectively treat B-cell cancers, but there remains a significant unmet need for treating other cancers. Wugen is using its proprietary platform to manufacture "off-the-shelf" Memory NK and CAR-T therapies, providing several advantages over current autologous therapies, including robust manufacturing, lower cost of goods, and enhanced safety profile.

On March 8, 2021 Immodulon, the immuno-oncology company, reported that it has received Notices of Allowance from the U.S. Patent and Trademark Office and the Japanese Patent Office; and a Notice of Intention to Grant from the European Patent Office for Immodulon’s patent applications No’s. 16/820,058 (US), 16/820,132 (US), 2016-541474 (Japan) and EP3319635 (Europe) (Press release, Immodulon Therapeutics, MAR 8, 2021, View Source [SID1234576188]). These patent applicationsrelate to combining IMM-101, the Company’s investigational treatment comprising heat-killed Mycobacterium obuense, with various immune checkpoint inhibitors (CPIs) for the treatment of various tumour types.

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The allowed claims in the two US patent applications relate to Immodulon’s first CPI combination patent family, and cover methods of treating sarcoma with IMM-101 in combination with anti-PD1, anti-PD-L1 or anti-CTLA4 antibodies, in addition to methods of treating colorectal cancer with IMM-101 in combination with anti-PD-L1, anti-PD-L1 or anti-CTLA4 antibodies. Upon grant, both patents are expected to expire in 2034. This allowance followed earlier allowances for two other US patent applications with similar claims related to pancreatic cancer and melanoma. The company intends to conduct further clinical studies related to the allowed claim scope and advance IMM-101 into other such cancers with high unmet need.

In addition, Immodulon also received a Notice of Allowance in Japan for a patent application related to its first CPI combination patent family. The allowed claims cover IMM-101 in combination with anti-PD1 or anti-PD-L1 antibodies for the treatment of any cancer. Upon grant, this Japanese patent is expected to expire in 2034.

Furthermore, Immodulon received a Notice of Intention to Grant from the European Patent Office for a patent application related to its second CPI combination patent family. The allowed claims cover IMM-101 in combination with pembrolizumab, atezolizumab or tremelimumab for the treatment of any cancer. Upon grant, this European patent is expected to expire in 2036.

Dr Jaap Kampinga, Chief Executive Officer of Immodulon, commented:
"We are pleased to have received these Notices of Allowance and Intention to Grant which cover methods of treating cancers with IMM-101 in combination with immune checkpoint inhibitors. Immodulon has 11 patent families with 30 patents granted globally and it is pursuing multiple avenues for securing and enhancing additional intellectual property protection for IMM-101. These new patents support ongoing discussions with third parties as well as clinical studies in several stages of preparation. These include the treatment of various stages of pancreatic cancer, the key focus of the company; soft tissue sarcoma, for which we have an Investigational New Drug (IND) Application; and colorectal cancer."

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 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported that Ron Cohen, M.D., President and Chief Executive Officer, will present during the March 9th & 10th H.C. Wainwright Global Life Sciences Virtual Conference (Press release, Acorda Therapeutics, MAR 8, 2021, View Source [SID1234576258]). For more information about the conference, please visit the event website at View Source

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