On December 2, 2020 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 second quarter and first six months of fiscal 2021, ended October 31, 2020 (Press release, Avid Bioservices, DEC 2, 2020, View Source [SID1234572083]).

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Highlights Since July 31, 2020

"During the second quarter, we recorded strong revenues, expanded our customer base and project pipeline, and advanced the company’s expansion plans," stated Nicholas Green, president and chief executive officer of Avid Bioservices. "Driven by growth in customer demand, the company achieved higher-than-expected revenues and margins, and generated operating cash flow and income from operations during the period. In consideration of these results combined with our substantial backlog and our visibility into customer demand, we are raising revenue guidance for fiscal 2021 from between $76 and $81 million to between $84 and $88 million.

"On the business development front, our team continues to execute, signing new business orders and project expansion orders with existing customers for $28 million during the quarter and increasing backlog to $67 million, our highest level since becoming a pure-play CDMO.

"With respect to operations, we have completed a comprehensive review of our options and have initiated a phased approach plan for expansion. Phase 1, which is currently underway, is focused on the streamlining of existing facilities. We are confident that this work will allow us to optimize capacity, increase revenue, minimize near-term expense, and best align our expansion with growth in customer demand.

"And finally, it is important to note that we continue to execute our business and achieve growth without interruption to our operations as a result of the COVID-19 pandemic. This resilience is due largely to the diligence and dedication of our employees. Despite these challenging times, Avid’s incredible workforce remains committed to excellence to ensure the highest quality product for our clients."

Financial Highlights and Guidance

The company is increasing revenue guidance for the full fiscal year 2021 from between $76 million and $81 million to between $84 million and $88 million.

Revenues for the second quarter of fiscal 2021 were $21.1 million, a 15% increase compared to revenues of $18.3 million recorded during the second quarter of fiscal 2020. The year-over-year increase in revenue was primarily attributable to the growth in the number and scope of in-process and/or completed manufacturing runs during the quarter. In addition, the increase in manufacturing revenues included the recognition of $1.7 million from changes in estimated variable revenue consideration as a result of completing performance obligations for certain projects during the quarter, therefore increasing revenue recognized for those projects during the period. For the first six months of fiscal 2021, revenues were $46.5 million, a 38% increase as compared to revenues of $33.6 million in the prior year period. The increase in revenues can be attributed to a $13.6 million increase in manufacturing revenues primarily due to an increase in the number and scope of in-process and/or completed manufacturing runs during the first six months of fiscal 2021, partially offset by a $0.7 million decrease in process development revenues.

As of October 31, 2020, revenue backlog was $67 million, an increase of 12% compared to $60 million at the end of the first quarter of fiscal 2021, and an increase of 3% compare to $65 million at the end of last fiscal year. The company expects to recognize the majority of this backlog over the next twelve months.

Gross margin for the second quarter of fiscal 2021 was 30%, a significant increase compared to a gross margin of 18% for the second quarter of fiscal 2020. The increase in gross margin for the 2021 quarter was primarily attributable to the growth in manufacturing revenues, including the $1.7 million in additional manufacturing revenue recognized, as previously discussed. Excluding the $1.7 million in additional variable revenue consideration, gross margin for the second quarter was approximately 24%. Gross margin for the first six months of fiscal 2021 was 32%, a significant increase compared to 13% in the prior year period. This increase was also primarily due to the growth in manufacturing revenues.

Selling, general and administrative expenses ("SG&A") for the second quarter of fiscal 2021 were $4.2 million, an increase compared to $3.5 million recorded for the second quarter of fiscal 2020. The increase during the 2021 quarter was due primarily to increases in payroll related costs, including stock-based compensation. For the first six months of fiscal 2021, SG&A expenses were $8 million, consistent with $8 million for the prior year period.

For the second 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 $1.9 million or $0.03 per basic and diluted share, for the second quarter of fiscal 2020. For the first six months of fiscal 2021, the company recorded a consolidated net income attributable to common stockholders of $4.5 million or $0.08 per basic and diluted share, compared to a consolidated net loss attributable to common stockholders of $6.1 million or $0.11 per basic and diluted share, for fiscal 2020.

Avid reported $35.7 million in cash and cash equivalents as of October 31, 2020, an increase of $7.5 million compared to cash of $28.2 million at the end of the first quarter of fiscal 2021, and consistent with $36.3 million in cash as of the prior fiscal year ended April 30, 2020. The company also generated cash flows from operating activities of $8.1 million during the six months ended October 31. 2020.
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 $28 million during the quarter with new and existing customers, driving Avid’s backlog to its highest level since transitioning to a dedicated CDMO.
Developed plans for a two-phased expansion of our Myford facility. The first phase, which has commenced, expands the production capacity of our existing Myford North facility by adding a second downstream processing suite. The second phase, the timing of which will be dictated by revenue growth and projected customer demand, 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.
Conference Call

Avid will host a conference call and webcast this afternoon, December 2, 2020, 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 December 2, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that it will host a virtual KOL event on Tuesday, December 8, 2020, at 8:00 am ET (Press release, Curis, DEC 2, 2020, View Source [SID1234572081]).

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The event will discuss progress to date for first-in-class IRAK4 kinase inhibitor, CA-4948, including data presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition from the Phase 1 study in patients with non-Hodgkin lymphoma and new clinical data from the Phase 1 study in patients with acute myeloid leukemia and myelodysplastic syndromes.

The event will be led by James Dentzer, President and CEO, and will include a presentation by Dr. Amit Verma, Professor of Medicine-Oncology at Albert Einstein College of Medicine, and Director of the MDS Program at Montefiore Medical Center in Bronx, NY. Dr Verma and members of Curis leadership will be available to answer questions at the end of the event.

A live webcast of the presentation will be available under "Events & Presentations" in the Investors section of the Company’s website at www.curis.com. A replay of the webcast will be available on the Curis website for 90 days following the event.

On December 2, 2020 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, and Frontier Medicines, Corp., a precision medicine company drugging challenging protein targets to develop breakthrough medicines that change the course of human diseases, reported a global strategic collaboration to discover, develop and commercialize a pipeline of innovative small molecule therapeutics against high-interest, difficult-to-drug protein targets (Press release, AbbVie, DEC 2, 2020, View Source [SID1234572080]).

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Under the multi-year collaboration, AbbVie and Frontier will utilize Frontier’s proprietary chemoproteomics platform to identify small molecules for programs directed to novel E3 ligases and certain oncology and immunology targets. Whereas conventional drug discovery methodologies have been primarily successful against a relatively discrete set of target classes, chemoproteomics-based screening in relevant cellular contexts has the potential to enable targeting of a significantly broader range of proteins. By selecting certain immunology and oncology targets for the collaboration that are considered well validated but to date, inaccessible, the collaboration has the potential to develop highly differentiated and efficacious therapeutics.

Under the terms of the agreement, AbbVie will pay Frontier an upfront cash payment of $55 million, and Frontier is eligible to receive additional milestone payments. In addition, AbbVie will reimburse Frontier’s R&D costs through defined stages of pre-clinical development. The companies will collaborate on the research and pre-clinical development of programs directed against E3 ligase, immunology and oncology targets. Upon successful completion of defined stages of pre-clinical development, AbbVie will assume full responsibility for global development and commercialization activities and costs for the programs. Frontier will retain an option to share development activities and expenses for certain oncology programs through the completion of Phase 2. Frontier will be eligible to receive success-based development and commercial milestone payments that could potentially exceed $1 billion, in addition to royalty payments on commercialized products. AbbVie retains the right to expand the collaboration in the future by exercising options to a defined number of additional targets. The collaboration excludes all of Frontier’s internal programs for which Frontier retains exclusive global rights.

"AbbVie is focused on making investments in promising new technologies that assist us in our mission to develop innovative medicines," said Jose-Carlos Gutiérrez-Ramos, Ph.D., vice president, Discovery, AbbVie. "One of our key strategic focus areas is targeted protein degradation and chemoproteomics, and this collaboration with Frontier Medicines will be highly synergistic and complementary to our ongoing efforts."

"AbbVie’s commitment to innovative therapies makes them an ideal partner in the development and commercialization of new medicines for cancer and immunological diseases," said Chris Varma, Ph.D., Frontier’s co-founder, chairman, and CEO. "With our powerful chemoproteomics platform, we are greatly expanding the universe of therapeutic targets that can be accessed with small molecule drugs. This partnership enables us to build a shared pipeline of novel therapeutics with AbbVie, while Frontier continues to independently advance our internal programs into the clinic."

On December 2, 2020 Tubulis, WuXi STA and WuXi Biologics reported a strategic collaboration to manufacture and advance Tubulis’ next generation antibody-drug conjugates (ADCs) towards IND-enabling studies (Press release, Tubulis, DEC 2, 2020, View Source [SID1234572079]). Tubulis has developed a dual platform approach to generate uniquely matched and disease-specific ADCs that combine selective antibodies with effective payloads. This approach has demonstrated superior stability and efficacy in preclinical studies. The partnership with WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms and STA Pharmaceutical, a WuXi AppTec Company, (WuXi STA), will support the scale-up of the manufacturing process to a global clinical standard. The first program from Tubulis’ pipeline the companies will collaborate on is TUB-010, a uniquely matched, highly stable and efficient protein-drug conjugate designed to treat patients with lymphoma.

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Under the terms of the agreement, WuXi Biologics and WuXi STA will become the Contract Development and Manufacturing Organization (CDMO) partners for Tubulis. WuXi Biologics and WuXi STA will perform scale-up, process development and GMP manufacturing for the ADC product intermediates, with WuXi STA focused on the linker and payload and WuXi Biologics on the monoclonal antibody (mAb) and the enzyme used in Tubulis´ proprietary Tub-tag technology. WuXi Biologics subsequently will conduct process development and GMP bioconjugation to produce the drug substance and the final drug product formulation and fill for final preclinical toxicology studies. WuXi Biologics will also supply product batches for clinical evaluation. Financial details of the collaboration were not disclosed.

"As leaders in manufacturing for innovative technology platforms, WuXi Biologics and WuXi STA provide world-class capabilities for the development and production of our ADCs," said Dr. Dominik Schumacher, CEO of Tubulis. "For our uniquely versatile and customizable ADC technology portfolio, it was important to partner with CDMOs that have extensive experience with ADCs and offer the opportunity for a long-term partnership at the highest quality level. We are rapidly moving towards the clinic with our first ADC candidate and are excited to have entered this partnership, which will enable the further maturation of our pipeline."

"Tubulis requires single-source technology platforms, scientific expertise and state-of-the-art facilities set to the highest global quality standards. This is why we are thrilled to be selected for this project," remarked Dr. Chris Chen, CEO of WuXi Biologics. "This collaboration is a perfect illustration of the value that WuXi Biologics provides to innovative companies worldwide. Bioconjugates like TUB-010 are highly complex and require high levels of expertise and integration across the entire supply chain. We will leverage our advanced development platforms, large scientific teams dedicated to ADCs and industry-leading development timelines to bring TUB-010 towards the clinic."

"We are honored that Tubulis selected our organization to help bring this novel therapeutic towards the clinic with the goal of benefiting patients worldwide," commented Dr. Minzhang Chen, CEO of WuXi STA. "I am confident that WuXi STA’s leading capability and capacity for high potency API, along with our high quality standards in meeting global regulatory requirements, will provide the strongest support for ADC linker and payload development and manufacturing. Our strong connection and past experience working with WuXi Biologics on ADC therapeutics, and our shared commitment to providing seamless project management and one-stop services, will ensure that together we can develop and manufacture TUB-010 efficiently."

Tubulis recently completed a €10.7 million Series A to expand the therapeutic potential of ADCs and to advance its uniquely versatile and customizable ADC technology portfolio. The company utilizes two proprietary technologies to tackle limitations of currently approved ADCs, which include stability and payload-driven toxicity. With the P5 conjugation, Tubulis employs a cysteine-selective conjugation that enables the generation of ultra-stable ADCs with unprecedented linker stability and chemical flexibility, enabling rapid lead identification. The second technology, the human-derived Tub-tag platform, modulates the antibody to provide a highly beneficial microenvironment for the payload, thereby adding a significant amount of stability to the ADC. By tailoring the ADCs to the respective indication, Tubulis develops innovative compounds to treat cancer and beyond.

On December 3, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX) reported the publication of data from a Phase 2 study evaluating umbralisib, the Company’s investigational once daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, in patients with chronic lymphocytic leukemia (CLL) who are intolerant to prior BTK or PI3K-delta inhibitor therapy, in Blood, the Journal of the American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, TG Therapeutics, DEC 2, 2020, View Source [SID1234572077]).

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, "We are extremely encouraged by the data published today demonstrating that umbralisib monotherapy induced durable responses and enhanced progression-free survival in patients who were unable to tolerate their prior BTKi or PI3K delta therapy. Despite many advances in the treatment of CLL in recent years, early termination of kinase inhibitors due to tolerability is an emerging issue leaving too many CLL patients without adequate therapy." Mr. Weiss continued, "With our rolling BLA submission recently initiated for ublituximab in combination with umbralisib for patients with CLL, and our ongoing clinical studies evaluating triplet regimens in this disease, we remain committed to addressing unmet needs in CLL."

The manuscript includes data from 51 chronic lymphocytic leukemia (CLL) patients who were previously treated with and became intolerant to prior BTK or PI3K inhibitor therapy (44 BTK intolerant and 7 PI3K intolerant patients). Patients were treated with 800 mg of umbralisib once daily. The primary endpoint was progression-free survival (PFS). Safety data was available from all patients enrolled (n=51). Key highlights from this manuscript include:

The most common (≥5%) grade ≥3 AEs were neutropenia (18%), leukocytosis (14%), thrombocytopenia (12%), pneumonia (12%), and diarrhea (8%).
Six patients (12%) discontinued umbralisib due to an AE. Eight patients (16%) had dose reductions and were successfully re‐challenged allowing them to continue on umbralisib.
Median progression free survival (PFS) was 23.5 months (95% CI 13.1‐not estimable).
As of the data cut off, 58% of patients had been on umbralisib for a longer duration than their prior kinase inhibitor.
These data are described further in the manuscript entitled, "Phase 2 Study of the Safety and Efficacy of Umbralisib in Patients with CLL Who Are Intolerant to BTK or PI3Kδ Inhibitor Therapy," which was published online in the First Edition section of Blood, the Journal of the American Society of Hematology (ASH) (Free ASH Whitepaper). The online version of the article can be accessed at www.bloodjournal.org.