On December 9, 2021 Alloy Therapeutics, a biotechnology ecosystem company, reported it has acquired deepCDR Biologics, a Basel, Switzerland-based developer of deep learning technology for antibody discovery and optimization (Press release, Alloy Therapeutics, DEC 9, 2021, View Source [SID1234596652]). The team and technology stack will form new bioinformatics and machine learning (ML) capabilities for Alloy and will be fully integrated into Alloy Discovery Services complementary workflow and processes. Alloy will expand the Basel deepCDR site as a permanent Alloy research facility and will hire additional computational scientists and developers as it grows with the Alloy network.

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The deepCDR engine combines deep sequencing and deep learning methods with a proprietary mammalian display process to select from a wide range of antibodies and rapidly identify candidates with the highest possible affinity and developability profiles. The company was a spinoff of ETH Zurich and Department of Biosystems Science and Engineering and was founded by Sai Reddy, an Associate Professor of Systems and Synthetic Immunology at ETH Zurich and an expert in immunogenomics and machine learning-guided protein engineering.

"Uniting deepCDR and Alloy reflects our conviction in the power of network effects and scientific collaboration—together our companies’ capabilities are amplified to better serve the global scientific community in its pursuit of finding the best medicines for patients," said Alloy Therapeutics CEO and Founder Errik Anderson. "Our network of partners will be able to work with deepCDR’s machine learning engine in a way that otherwise would have been cost prohibitive or inaccessible. The ongoing technology improvements will enhance the output of Alloy platforms and Alloy Discovery Services for the benefit of all of our drug discovery partners."

DeepCDR’s technology will strengthen Alloy Discovery Services capabilities with patent-pending machine learning-powered antibody repertoire screening, in silico library screening, and mammalian display. DeepCDR thoughtfully integrates wet lab antibody screening and characterization with the computational tools to enable a powerful learning loop generating real world results. The deepCDR team will form Alloy’s new Basel, Switzerland operations and comprises expertise in antibody engineering and optimization, bioinformatics, and in silico library screening.

"We are thrilled to join Alloy on its mission of empowering scientific entrepreneurs and democratizing foundational drug discovery capabilities," said deepCDR founder Sai Reddy. "The data sets and infrastructure within Alloy unlock powerful new opportunities for the deepCDR technology and team that will in turn enable us to help drug discovery teams more effectively and efficiently find the best antibody candidates. We envision a future where Alloy will be a leader in unifying real-world patient, genomic, and protein sequence data to empower integrated AI and ML drug discovery and engineering."

On December 9, 2021 SUNY Upstate reported that Selected as one of just 30 recipients from a field of 1400 applicants nationally, the Upstate Foundation was awarded a $25,000 grant from AstraZeneca’s inaugural ACT on Health Equity: Community Solutions Challenge for the Upstate Cancer Center’s She Matters program (Press release, SUNY Upstate, DEC 9, 2021, View Source [SID1234596679]).

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This award stems from AstraZeneca’s commitment to advance health equity through collaboration with non-profit organizations positively impacting the health of underserved populations through regional and local community-based programming.

She Matters is a peer-to-peer community outreach program of the Upstate Cancer Center to reduce breast cancer disparities in low income, primarily Black and Latinx women living in public housing in Syracuse. Working in partnership with the Syracuse Housing Authority, residents are recruited to serve as community health workers (CHWs). CHWs receive training and ongoing support from the Upstate Cancer Center while working as peer health advocates. CHWs provide breast health education, offer support from navigation to screening mammography, and improve access to necessary diagnostic and treatment services. The goal is to eliminate health care barriers, change behavior and make annual breast cancer screening a priority.

Since its establishment in 2014, She Matters has reached over 3,500 women of all ages and facilitated screening in over 650 women ages 40 and above, the majority of whom are low-income, women of color who experience lapses in routine health care services. At the same time, She Matters serves as a work readiness, skill development opportunity for women who serve as CHWs.

The grant will be used to expand She Matters into additional Syracuse Housing Authority residential communities to increase access to breast cancer education, screening and navigation services.

"We are so pleased that AstraZeneca recognizes the value of the She Matters program and the important work that the team does in the community to get underserved women screened for breast cancer," explained Linda Veit, assistant vice president of community relations and interim chief of staff at Upstate. "Due to this grant, we will be able to expand the program into other public housing communities in Central New York, educate more women on screening and find more breast cancers earlier, when treatment can be most effective."

"It’s exciting to receive this funding from AstraZeneca," said Eileen Pezzi, Upstate vice president for development. "To be selected from such a large field of applicants is a testament to the importance of the work Upstate carries out every day in our community."

According to the American Cancer Society, breast cancer is the most common cancer among American women and the second leading cause of cancer death. Black women are more likely than all other women to die from breast cancer. Their tumors are often found at a later, more advanced stage when there are fewer treatment options. In order to improve health and well-being in underserved communities, especially women of color, it is critical that outreach is provided to those most at risk of early death.

About AstraZeneca’s ACT on Health Equity: Community Solutions Challenge

Through its ACT on Health Equity: Community Solutions Challenge, AstraZeneca has awarded 30 nonprofit organizations across the country support for programs focused on community health and well-being and youth STEM education and career readiness. The organizations awarded represent a variety of innovative programs providing a wide range of services that support underserved communities to improve health outcomes. Click here for a complete list of programs awarded.

On December 9, 2021 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that its collaborator, BeiGene, Ltd., has dosed the first patient in South Korea in the HERIZON‑GEA‑01 trial (Press release, Zymeworks, DEC 9, 2021, View Source [SID1234596706]). As a result of this development milestone, Zymeworks will receive a US$8 million payment under its zanidatamab collaboration agreement with BeiGene.

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Zymeworks and BeiGene continue to work to expedite the opening of approximately 300 clinical trial sites across 38 countries in support of the global Phase 3 pivotal trial. With a 24-month projected enrollment period, this study may enable the submission of a supplemental Biologics License Application by Zymeworks in the United States as early as 2024.

About the HERIZON-GEA-01 Clinical Trial

HERIZON-GEA-01 is a global, randomized, Phase 3 clinical trial [NCT05152147] designed to evaluate the efficacy and safety of zanidatamab in combination with physician’s choice chemotherapy [CAPOX (capecitabine/oxaliplatin) or FP (5FU/cisplatin)] with or without the PD-1 inhibitor, tislelizumab, compared to trastuzumab plus physician’s choice chemotherapy for first-line treatment in subjects with advanced or metastatic HER2-positive gastroesophageal adenocarcinomas. Primary endpoints are progression-free survival per RECIST 1.1 criteria, as assessed by blinded independent central review, and overall survival. The trial is expected to enroll approximately 700 patients at approximately 300 sites across 38 countries. Zymeworks’ collaborator, BeiGene, will oversee trial sites in Asia (excluding Japan), Australia and New Zealand, and Zymeworks will oversee trial sites in the rest of the world, including North and South America, Japan, Europe, Middle East and Africa.

About the Zymeworks-BeiGene Collaboration

In November 2018, Zymeworks and BeiGene entered into license and collaboration agreements in which BeiGene was granted an exclusive license for the research, development, and commercialization of zanidatamab and ZW49 in Asia (excluding Japan), Australia, and New Zealand. The companies are collaborating on joint global development for selected indications, with the goal of developing zanidatamab and ZW49 worldwide across multiple HER2-expressing cancers and lines of therapy.

About Zanidatamab

Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. Zanidatamab’s unique binding properties result in multiple mechanisms of action including HER2-receptor clustering, internalization, and downregulation; inhibition of growth factor-dependent and -independent tumor cell proliferation; antibody-dependent cellular cytotoxicity and phagocytosis; and complement-dependent cytotoxicity. Zanidatamab is currently being evaluated in two pivotal clinical trials, one for the first-line treatment of advanced or metastatic HER2-positive gastroesophageal adenocarcinoma (HERIZON-GEA-01) and one for previously treated HER2-amplified biliary tract cancer (HERIZON-BTC-01). Zanidatamab is also being evaluated in several Phase 2 clinical trials for HER2‑expressing gastroesophageal, colorectal, and breast cancers. The FDA has granted zanidatamab with Breakthrough Therapy designation for patients with previously treated HER2 gene-amplified biliary tract cancer, as well as two Fast Track designations, one as monotherapy for refractory biliary tract cancer and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma. These designations mean zanidatamab is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as intensive FDA guidance on an efficient drug development program. Zanidatamab has also received Orphan Drug designations from the FDA as well as the European Medicines Agency for the treatment of biliary tract and gastric cancers.

On December 9, 2021 Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, reported consolidated financial results for the full fiscal year and quarter ended September 30, 2021 (Press release, Applied DNA Sciences, DEC 9, 2021, View Source [SID1234596653]).

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"We are pleased to report a fourth consecutive quarter of year-over-year revenue growth in the fourth quarter and record revenues for the fiscal year, both of which are the result of our decision to enter the COVID-19 testing and assay manufacturing markets and leverage our expertise in PCR refined in our Industrial DNA and LinearDNA businesses," said Dr. James A. Hayward, president and CEO of Applied DNA. "COVID-19-related revenues in the fiscal year were driven by the establishment of ADCL, our clinical laboratory subsidiary, to meet the need for population-scale COVID-19 testing, as well as from sales of our Linea 1.0 COVID-19 Assay Kit and testing consumables. Momentum in COVID-19 testing client acquisition, especially in the second half of the fiscal year, supported our continued investment in ADCL that is now largely complete. We recorded strong year-over-year quarterly revenue comparisons that nevertheless fell short of a key client’s projections due to the combination of increased vaccination rates and vaccine mandates. Average weekly testing levels remain in flux but are on an uptrend: new clients are onboarding in FQ1; the key client’s testing needs have increased since Thanksgiving to include the random testing of vaccinated individuals.

"We were also pleased to see the re-emergence of demand for Industrial DNA from the textile industry and repeat and new orders for LinearDNA in the second half of the fiscal year," continued Dr. Hayward. "The pandemic has impacted demand trends; nevertheless, we believe our textiles practice has gained the attention of global apparel and footwear brands seeking to reprioritize their post-pandemic supply chains towards sustainability, brand protection, and traceability. At LineaRx, vaccine development against COVID-19 has put a large spotlight on nucleic acid therapies, so much so that plasmid manufacturers are projecting long lead times with growing capital and labor costs that are incenting developers to seek an alternative to plasmid DNA-based manufacture. With both factors playing to LinearDNA’s strengths, we believe a window is opening for a disruptive force in the market for therapeutic DNA and particularly as we believe we will generate compelling data from our clinical veterinary trials."

Concluded Dr. Hayward, "In fiscal 2022, the emergence of a new SARS-CoV-2 variant of concern, the unpredictable trajectory of the virus’ mutations, asymmetric vaccine distribution, and potentially waning effectiveness of vaccines, we believe, keep testing on the front lines of the global battle against the virus. Our COVID-19 diagnostic development plan and go-to-market strategy are aligned with our capacity to conduct population-scale testing to meet the evolving demands of current and prospective customers. We are progressing a dual-COVID-19/influenza test and an at-home sample collection system, advancing our Linea SARS-CoV-2 Mutation Panel EUA request, and recently submitted our Linea 2.0 COVID-19 Assay Kit, a new N and E gene-based test for COVID-19 that we believe is well suited to serve our future testing needs as new variants continue to emerge, to the New York State Department of Health for its review as a laboratory developed test. In the non-COVID-19 arena, we are leveraging our deep scientific bench to explore new areas of cutting edge molecular testing that will further leverage our investment in ADCL.

"We are also prepared to capitalize on opportunities cultivated in fiscal 2021 in Industrial DNA and the therapeutic application of LinearDNA. In fiscal 2022 our textiles practice is focused on commercial-scale trials and certain scale-up programs. With LinearDNA, we believe our roadmap to an initial cGMP production capacity is ideally timed given the biotech industry’s increasing investments in cell and gene therapies and nucleic acid vaccines and through valuable third-party validation of the benefits of LinearDNA. We intend to continue to pursue the use of LinearDNA for veterinary therapeutics. In addition, we are closing in on a potentially first-in-human clinical trial opportunity with one of our international customers.""

Fiscal Fourth Quarter 2021 Financial Highlights:

Revenues increased 868% for the fourth quarter of fiscal 2021 to $3.0 million, compared with $314 thousand reported in the same period of the prior fiscal year and increased 79% from $1.7 million for the third quarter of fiscal 2021. The increase in revenues year-over-year was due primarily to an increase in clinical laboratory service revenues of $1.6 million and an increase of $1.0 million in product revenues. Clinical laboratory service revenues represent the revenue from our safeCircle COVID-19 testing and is now presented as a separate revenue line item on the statement of operations. The increase in product revenue was mainly attributable to an increase in sales of DNA concentrate of approximately $810 thousand to protect a textile supply chain.
Total operating expenses increased to $5.6 million for the fourth fiscal quarter of 2021, compared with $4.2 million in the prior fiscal year’s fourth fiscal quarter The year-over-year increase is primarily attributable to an impairment charge of $822 thousand for the write-off of goodwill and the remaining net book value of intangible assets. To a lesser extent the increase was attributable to an accrued bonus, which was subsequently paid by the issuance of stock options, as well as an increase in depreciation and amortization expense of $218 thousand.
Net loss applicable to common stockholders for the quarter ended September 30, 2021, was $4.5 million, or $0.60 per share, compared with a net loss of $4.1 million, or $0.82 per share, for the quarter ended September 30, 2020.
Excluding non-cash expenses, Adjusted EBITDA was negative $3.3 million and a negative $3.8 million for the quarters ended September 30, 2021, and 2020, respectively. See below for information regarding non-GAAP measures.
Cash and cash equivalents stood at $6.6 million on September 30, 2021, compared to $7.8 million as of September 30, 2020.
Fiscal Year 2021 Financial Highlights:

Revenues increased 367% for the fiscal year ended September 30, 2021, to $9.0 million, compared with $1.9 million reported in the prior fiscal year. The increase in revenues year over year was due primarily to an increase in clinical laboratory service revenues of approximately $4.7 million and an increase of $2.7 million in product revenues. The increase in clinical laboratory service revenue was from revenues derived from safeCircle. The increase in product revenue was mainly attributable to an increase in sales of our Linea 1.0 assay. Further increases include approximately $810 thousand in Textiles related to the shipment of DNA concentrate to protect a textile supply chain.
Total operating expenses increased to $18.0 million for fiscal 2021, compared with $13.6 million in the prior fiscal year. The increase is primarily related to an increase in stock-based compensation expense of $667 thousand relating to officer and employee stock option grants that vested immediately and an increase in payroll of approximately $1.1 million. The increase also relates to increases in research and development expenses of $444 thousand and depreciation and amortization of $559 thousand.
Net loss applicable to common stockholders for the fiscal year ended September 30, 2021, was $14.3 million, or $2.07 per share, compared with a net loss of $13.0 million, or $3.32 per share, for fiscal 2020.
Excluding non-cash expenses, Adjusted EBITDA was negative $10.0 million for the fiscal year ended September 30, 2021, compared to negative $11.6 million for the prior fiscal year. See below for information regarding non-GAAP measures.
Fourth Quarter and Full Year Fiscal 2021 Conference Call Information
The Company will hold a conference call and webcast to discuss its fourth quarter and fiscal full year 2021 financial results on Thursday, December 9, 2021, at 4:30 PM ET. To participate on the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, not all questions may be answered.

Telephonic replay (available 1 hour following the conclusion of the live call through December 19, 2021):

Participant Toll Free: 1-877-344-7529
Participant Toll: 1-412-317-0088
Participant Passcode: 10161912
The webcast and accompanying PowerPoint presentation will be archived on the ‘Company Events’ sub-page of the Company’s Investor Relations website

Information about Non-GAAP Financial Measures
As used herein, "GAAP" refers to accounting principles generally accepted in the United States of America. To supplement our condensed consolidated financial statements prepared and presented in accordance with GAAP, this earnings release includes Adjusted EBITDA, which is a non-GAAP financial measure as defined in Rule 101 of Regulation G promulgated by the Securities and Exchange Commission. Generally, a non-GAAP financial measure is a numerical measure of a company’s historical or future performance, financial position, or cash flows that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with GAAP. The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information presented in accordance with GAAP. We use this non-GAAP financial measure for internal financial and operational decision-making purposes and as a means to evaluate period-to-period comparisons of the performance and results of operations of our core business. Our management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the performance of our business by excluding non-cash expenses that may not be indicative of our recurring operating results. We believe this non-GAAP financial measure is useful to investors as they allow for greater transparency with respect to key metrics used by management in its financial and operational decision making.

"EBITDA"- is defined as earnings (loss) before interest expense, income tax expense and depreciation and amortization expense.

"Adjusted EBITDA"- is defined as EBITDA adjusted to exclude (i) stock-based compensation and (ii) other non-cash expenses.

On December 9, 2021 Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX) reported that the Hart-Scott-Rodino (HSR) antitrust waiting period had expired and that the parties closed the exclusive worldwide collaboration and license agreement between Syndax and Incyte to develop and commercialize axatilimab, Syndax’s anti-CSF-1R monoclonal antibody (Press release, Syndax, DEC 9, 2021, View Source [SID1234596680]).

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In connection with closing, Incyte paid Syndax the $117 million upfront initial license fee, and Syndax closed on Incyte’s $35 million equity investment in the company.

Additional information about the collaboration can be found in the press release announcements dated September 27, 2021, as well as in Syndax’s Form 8-K filed with the Securities and Exchange Commission (SEC) on September 27, 2021.

About Axatilimab

Axatilimab is an investigational monoclonal antibody that targets colony stimulating factor-1 receptor, or CSF-1R, a cell surface protein thought to control the survival and function of monocytes and macrophages. In pre-clinical models, inhibition of signaling through the CSF-1 receptor has been shown to reduce the number of disease-mediating macrophages along with their monocyte precursors, which has been shown to play a key role in the fibrotic disease process underlying diseases, such as chronic graft-versus-host disease (cGVHD) and idiopathic pulmonary fibrosis (IPF). Axatilimab data has demonstrated deep, durable responses and multi-organ clinical benefit in patients with cGVHD refractory to multiple therapeutic agents, and is currently being evaluated in the global pivotal Phase 2 AGAVE-201 trial in patients with cGVHD. Axatilimab was granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of patients with cGVHD and IPF. Axatilimab is being developed under an exclusive worldwide license from UCB entered into between Syndax and UCB in 2016.