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 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 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer reported that it will host today a financial community call to discuss recent findings from the investigator sponsored trial (IST) at The University of Texas MD Anderson Cancer Center investigating the treatment of CD30-positive lymphoma patients with its innate cell engager (ICE) AFM13, pre-complexed with cord blood-derived natural killer (cbNK) cells (AFM13-104) (Press release, Affimed, DEC 9, 2021, View Source [SID1234596651]).

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A treatment cycle consists of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed two days later by a single infusion of cytokine-preactivated and expanded cbNK cells that are pre-complexed with AFM13, followed by three weekly infusions of AFM13 (200 mg) monotherapy. Responses are assessed on day 28 by FDG-PET and patients can receive up to two cycles. Three patients were treated with 1×106, three patients with 1×107 and 13 patients with 1×108 AFM13-pre-complexed cbNK cells per kg body weight.

Response Assessment

A total of 19 patients with CD30-positive relapsed or refractory Hodgkin and non-Hodgkin lymphomas (17 and 2 patients, respectively) have been treated to date across three dose cohorts. According to investigator assessment, 17 of 19 patients had achieved an objective response (ORR 89.5%) to the treatment, with seven complete responses (CR 36.8%) and ten partial responses (PR 52.6%).

In patients treated at the RP2D level of 1×108 cbNK cells per kg, 12 of 13 had classical Hodgkin lymphoma and 1 patient had CD30-positive NHL. In this cohort, 100% of patients responded after the first cycle of treatment with five CRs (38.5%) and seven PRs (61.5%). All patients treated at the RP2D have now received a second cycle of therapy. Response evaluation after cycle 2 will be reported at a future scientific conference.

Initial Durability of Response Observations

Nine patients treated in the dose escalation phase of the study had follow-up at 6 months. Of note, the three patients treated at the RP2D remain in remission at 6 months after start of treatment, two without additional treatment and one on anti-PD-1 antibody maintenance.

In the four responders out of six treated at the two lower dose levels, one patient, who started treatment in September 2020, remains in remission after consolidation autologous stem cell transplant, and three relapsed at 3.4, 4.8 and 6.3 months after start of therapy.

Safety

Five reported cases of transient infusion related reactions were reported after the monotherapy infusions of AFM13. Of note, there were no instances of serious adverse events such as cytokine release syndrome, immune cell-associated neurotoxicity syndrome or graft-versus-host disease.

Conference Call/Webcast Information

The event today will include a review of Affimed’s approach to activating the innate immune system in the fight against cancer, preclinical data supporting the combination of Affimed’s ICE molecules with adoptive NK cell transfer, a review of the treatment challenges and clinical opportunities for CD30+ lymphomas, and review of the interim data from AFM13-104 by the study’s principal investigator, Yago L. Nieto, M.D., Ph.D., professor of Stem Cell Transplantation and Cellular Therapy at of The University of Texas MD Anderson Cancer Center.

Affimed will host a conference call and webcast today, December 9th, 2021, at 8:30 a.m. EST. To access the call, please dial +1 (409) 220-9054 for U.S. callers, or +44 (0) 8000 323836 for international callers, and reference passcode 3065475 approximately 15 minutes prior to the call.

A live audio webcast of the conference call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source or View Source A replay of the webcast will be accessible at the same link for 30 days following the call.

About the Phase 1-2 Study

The University of Texas MD Anderson Cancer Center is studying AFM13 in an investigator-initiated phase 1-2 trial in combination with cord blood-derived allogeneic NK cells in patients with recurrent or refractory CD30-positive lymphomas. The first phase of this study involves dose escalation of pre-complexed NK cells, with patients receiving lymphodepleting chemotherapy followed by 1×106 NK cells/kg in Cohort 1; 1×107 NK cells/kg in Cohort 2; and 1×108 NK cells/kg in Cohort 3. The trial is designed to explore safety and to determine the recommended phase 2 dose and evaluate its activity. The recommended phase 2 dose was determined as 1×108 NK cells/kg. In each cohort, the dose of the pre-complexed NK cells with AFM13 is followed by weekly doses of 200 mg AFM13 monotherapy for three weeks, with each patient evaluated for dose-limiting toxicities and responses on day 28. MD Anderson has an institutional financial conflict of interest with Affimed related to this research and has therefore implemented an Institutional Conflict of Interest Management and Monitoring Plan. Additional information about the study can be found at www.clinicaltrials.gov (NCT04074746).

About AFM13

AFM13 is a first-in-class innate cell engager (ICE) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is Affimed’s most advanced ICE clinical program and is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma or transformed mycosis fungoides (REDIRECT). The study is actively recruiting. Additional details can be found at www.clinicaltrials.gov (NCT04101331).

On December 9, 2021 Redx (AIM: REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported that a milestone payment from Jazz Pharmaceuticals (NASDAQ: JAZZ) has been triggered as a result of entering the second year of the oncology research collaboration with the Company (Press release, Redx Pharma, DEC 9, 2021, View Source [SID1234596649]).

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The milestone payment of $10 million arises in accordance with the terms of the research collaboration agreement announced on 9 September 2020. Under the agreement to discover and develop drug candidates for two cancer targets in the Ras/Raf/MAP kinase (MAPK) pathway, Redx is responsible for research and preclinical development activities up to Investigational New Drug (IND) submission. In addition to the $20 million in payments that have now been realised, Redx may receive up to a further $200 million from Jazz in development, regulatory and commercial milestone payments for each programme. The next milestone is payable upon successful IND submission and all subsequent milestones are contingent on successful completion of the relevant stages of development. In addition, Redx is eligible for tiered royalties in mid-single digit percentages, based on any future net sales.

Lisa Anson, Chief Executive Officer of Redx, commented: "We are extremely pleased to extend our productive oncology research collaboration with Jazz into its second year. This is based on advancing our programmes in this key signalling pathway and reflects Redx’s core strength in discovering highly targeted potential drug candidates. We look forward to further progress in partnership with Jazz."

Redx continues to execute on its strategy, progressing its lead oncology and fibrosis programmes. These include the oral Porcupine inhibitor, RXC004, targeting Wnt-ligand driven tumours, which has recently entered a Phase 2 trial in genetically selected patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) and the oral selective ROCK2 inhibitor, RXC007, being developed for idiopathic pulmonary fibrosis, where first in human studies commenced in June 2021.

On December 9, 2021 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and Denovo Biopharma LLC reported a collaboration to develop a blood-based companion diagnostic (CDx) test to identify patients expressing Denovo Genomic Marker 1 (DGM1TM) who are likely to respond to Denovo’s investigational cancer drug DB102TM for treatment of diffuse large B-cell lymphoma (DLBCL), one of the most common lymphoid cancers (Press release, Qiagen, DEC 9, 2021, View Source [SID1234596648]).

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Under the agreement, QIAGEN will develop a diagnostic assay that can detect the Denovo Genomic Marker 1 (DGM1TM) in DLBCL patients, a biomarker discovered by Denovo that predicts the responsiveness to DB102. Also known as enzastaurin, Denovo’s drug is a first-in-class investigational small molecule inhibitor of PKC-beta, a protein whose presence has been compellingly linked to DLBCL cases.

"We are proud to be at the cutting edge of precision medicine, a quantum leap from traditional one-drug-fits all medicine," said Jonathan Arnold, Vice President, Head of Oncology and Precision Diagnostics at QIAGEN. "Our molecular testing expertise will help Denovo to develop the use of the DGM1 marker with the DB102 drug for patients with DLBCL."

QIAGEN will develop a real-time qualitative PCR companion diagnostic for the QIAGEN Rotor-Gene Q MDx instrument and apply for premarket approval (PMA) with the US-based Food and Drug Administration (FDA). The goal is to get the PMA for the test contemporaneously with Denovo receiving new drug application (NDA) approval for its DB102. The drug and the DGM1 marker are currently in a phase III trial, called ENGINE, on newly diagnosed, high-risk DLBCL patients.

"As our ENGINE trial nears completion, we are pleased to be working with QIAGEN on commercial development of our DB102 program to enable patients and physicians to potentially benefit from DB102 treatment," said Xiao-Xiong Lu, Denovo’s Chief Technology Officer. "As a pioneer in precision medicine QIAGEN brings extensive experience in companion diagnostics, including ten FDA-approved tests."

QIAGEN is the global leader in collaborations with pharmaceutical and biotechnology companies to co-develop companion diagnostics, which detect clinically relevant genetic abnormalities to provide insights that guide clinical decision-making in diseases such as cancer. The company has an unmatched depth and breadth of technologies from next-generation sequencing (NGS) to polymerase chain reaction (PCR) for companion diagnostic development. Its ten PCR-based CDx tests with FDA approval include therascreen EGFR for non-small cell lung cancer, therascreen KRAS for colorectal cancer, therascreen FGFR for urothelial cancer, therascreen PIK3CA for breast cancer based on tissue or plasma samples and the therascreen BRAF kit for colorectal cancer.

Currently, QIAGEN is working under master collaboration agreements with more than 25 companies to develop and commercialize companion diagnostic tests for their drug candidates – a deep pipeline of potential future products to advance Precision Medicine for the benefit of patients.