On August 13, 2018 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), reported financial results for the fiscal 2018 third quarter ended June 30, 2018 (Press release, Applied DNA Sciences, AUG 13, 2018, View Source [SID1234529276]).

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Commenting on Applied DNA’s results for the fiscal third quarter, Dr. James A. Hayward, president and CEO, stated, "Results for the quarter did not fulfill our expectations for recognized revenue due to the shipping of an initial cotton DNA order under extended payment terms. Nonetheless, our performance stands out for the progress we have made in driving commercial adoption of our DNA taggant platform through large commercial-scale feasibility activities:

·in pharmaceuticals, together with Colorcon we performed a larger scale production run for solid oral dosage form tagging;
·in leather, we are nearing the completion of a commercial-scale tagging and testing trial following the completion of the feasibility program supported by several global brands and supply chain stakeholders,
·and in cannabis, we designed, built and publicly unveiled our cannabis tracking system (CTS), a major milestone under our TheraCann agreement which will power seed-to-sale legal cannabis tracking.

In addition to these activities under existing development contracts, we signed new agreements with large marquee companies, UL and Everledger, that we expect will broaden our access to new markets and increase our value proposition to customers. Concurrently, business in our biopharma research and manufacturing offerings has been gaining promising momentum."

Continued, Dr. Hayward, "As global supply chains move to address growing business imperatives centered on supply chain traceability, transparency and trust, we are expanding our opportunities for revenue by seeding markets with partners that recognize the value proposition of our taggant technology. With momentum growing globally for the legalization of cannabis and supply chain participants seeking regulatory compliance, our launch of the industry’s first seed-to-sale cannabis tagging system with TheraCann is timely. Our partner Everledger, endorses our view that the linkage of digital blockchain-enabled transactions with a forensic physical goods identifier increases the value of the platform to global ecosystems. That identifier is our DNA taggant.

"We also reached new milestones in biotherapeutic contract research and contract manufacturing of linear DNA, with multiple firms throughout Europe and the US. We believe that our ability to deliver large-scale PCR-based DNA production for DNA/RNA vaccines, gene therapies, adoptive cell therapies and diagnostics, may eliminate the risks associated with current plasmid- and virus-based genetic methods. With these milestones, we demonstrate the potential to replace plasmid production methods and viral vectors, potentially opening large, high-value markets that will bring the benefits of our technology to patients.

Concluded Hayward, "Applied DNA sits at the nexus between global supply chains and market forces dictating the need for increased transparency and responsible procurement. With our taggant technology platform proven at scale, a foundation of recurring revenues, new commercial agreements that open previously untapped markets, we are well positioned to leverage tailwinds in the marketplace to deliver sustainable growth to our shareholders."

Fiscal Third Quarter Financial Results:

·Revenues decreased 43% for the third quarter of fiscal 2018 to $1.0 million, compared with $1.8 million reported in the third quarter of fiscal 2017, and remained flat as compared to revenues for the fiscal second quarter ended March 31, 2018. The year-over-year decrease in revenues is primarily attributable to shipments relating to the initial order of $1.2 million in our cotton vertical for the upcoming ginning season being recorded in deferred revenue at June 30, 2018 due to extended payment terms. This decrease was offset by an increase in revenues from feasibility pilots in pharmaceutical and cannabis industries.
·Deferred revenue increased to $2.3 million as of June 30, 2018 as compared to $352 thousand at September 30, 2017. The reason for this increase is due to the initial cotton order of $1.2 million noted above as well as fees paid for a variety of contracts that include specific milestones and therefore were not able to be fully recognized as revenue during the quarter ended June 30, 2018.
·Total operating expenses were $3.6 million, compared with $4.2 million in the prior year’s quarter, a decrease of approximately 13%. The decrease in year-over-year total operating expenses is primarily attributable to a decrease in stock-based compensation expense of $328 thousand and bad debt expense of $343 thousand.
·Net loss for the quarter ended June 30, 2017 was $2.9 million, or $0.10 per share, compared with a net loss of $2.6 million, or $0.10 per share for the same period in the prior fiscal year and a net loss of $2.1 million, or $0.07 per share for the first fiscal quarter ended March 31, 2018.
·Excluding non-cash expenses, Adjusted EBITDA for the quarter ended June 30, 2018 was negative $2.5 million, compared to negative Adjusted EBITDA of $1.5 million for the same quarter last fiscal year and negative Adjusted EBITDA of $2.3 million in the prior fiscal quarter. See below for information regarding non-GAAP measures.

Nine-Month Financial Highlights:

·Revenues for the first nine months of fiscal 2018 totaled $2.7 million, a decrease of 25% from $3.6 million from the same period in the prior fiscal year. The decrease in revenues was due to the deferral of approximately $1.2 million for product shipped for the marking of cotton with extended payment terms during the quarter ended June 30, 2018.
·Operating expenses for the nine months ended June 30, 2018 decreased by $2.8 million or 22% for the same period last fiscal year. The decrease is primarily attributable to a decrease in stock-based compensation, offset by an increase in R&D due to the government contract award.
·Net loss for the nine months ended June 30, 2018 was $8.2 million or $0.28 per share, compared with a net loss of $10 million or $0.38 per share for the nine months ended June 30, 2017.
·Excluding non-cash expenses and interest, Adjusted EBITDA for the nine months ended June 30, 2018 was a negative $7.6 million as compared to a negative $6.6 million for the same period in the prior fiscal year. See below for information regarding non-GAAP measures.

Recent Operational Highlights:

·On August 2, Applied DNA announced that it has reached new milestones in therapeutic contract research and contract manufacturing of Polymerase Chain Reaction (PCR)-produced linear DNA. PCR is a well-proven technique of DNA amplification that holds the potential to replace plasmid production methods and viral vectors in nucleic acid based therapeutics.

·On July 31, the Company announced the signing of a MOU with Everledger to build a CertainT Blockchain platform for high-end product markets. The molecular tag, test and track platform provides physical identity and traceability for Everledger’s digital platform with the leather supply chain as the first target market.

·On July 24, the Company announced that, in conjunction with TheraCann International, it will launch the cannabis industry’s first DNA based cannabis tagging system (CTS) using Applied DNA’s CertainT platform of tag, test and track. The device is designed to rapidly molecularly tag cannabis plants in commercial harvests of any scale.

·On July 17, Applied DNA announced the shipment of a $1.2 million order in its fiscal 2018 third quarter to tag cotton in the upcoming 2018/2019 ginning season. The order for the Company’s SigNature T platform technology will be used to tag, test and track three US cotton varietals, Pima, Acala and Delta. Revenues were deferred until payment is due.

·On July 10, the Company announced a strategic partnership with UL. The commercial agreement aims to expand product authentication and traceability solutions throughout the product supply chain.

·On May 8, Applied DNA announced that Louis Dreyfus Company (LDC) has installed Applied DNA Sciences’ SigNature T cotton traceability system at its Moree gin in Australia to tag, test and track pure HomeGrown Australian cotton.

Fiscal Third Quarter 2018 Conference Call Information

The Company will hold a conference call and webcast to discuss its fiscal third quarter-end 2018 results on Monday, August 13, 2018 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, due to the large number of expected participants, not all questions may be answered.

To Participate:

·Participant Toll Free: 1-844-887-9402
·Participant Toll: 1-412-317-6798
·Please ask to be joined to the Applied DNA Sciences call

Live webcast: View Source

Replay (available 1 hour following the conclusion of the live call through August 14, 2018):

·Participant Toll Free: 1-877-344-7529
·Participant Toll: 1-412-317-0088
·Participant Passcode: 10122259
·Webcast replay: View Source

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 August 13, 2018 Cellectar Biosciences (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to CLR 131, the company’s lead Phospholipid Drug Conjugate (PDC) product candidate, for the treatment of Ewing’s sarcoma, a rare pediatric cancer (Press release, Cellectar Biosciences, AUG 13, 2018, View Source [SID1234528817]).

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"We are delighted to announce receipt of our third RPDD from the FDA, which underscores Cellectar’s commitment to rare pediatric cancers. There is a critical need to develop new therapies to fight deadly childhood cancers such as Ewing’s sarcoma, and CLR 131 has shown early promise in this arena," said John Friend, M.D., chief medical officer of Cellectar Biosciences. "This designation, combined with our receipt of FDA Orphan Drug Designation for Ewing’s sarcoma last month, will help support our efforts to optimize the drug development path in this indication and, if successful, enable this new therapeutic candidate is made available to patients as rapidly as possible."

Since March 2018 the FDA has granted RPDDs to CLR 131 for the treatment of three separate rare disease indications including neuroblastoma, rhabdomyosarcoma and now Ewing’s sarcoma. Should CLR 131 be approved by the FDA in any of these indications, the RPDD may enable Cellectar to receive a priority review voucher. Priority review vouchers can be used by the sponsor to receive priority review designation for a future NDA or BLA submission, which could reduce the FDA review time from twelve months to eight months. Currently, these vouchers can also be transferred or sold to another entity. Since the beginning of 2017, six priority review vouchers were sold for between $80 million and $150 million each.

The FDA grants RPDD for diseases that primarily affect children from birth to age 18, and affect fewer than 200,000 persons in the U.S. This program is intended to encourage development of new drugs and biologics for the prevention and treatment of rare pediatric diseases.

Cellectar plans to evaluate CLR 131 in a Phase 1 clinical study for the treatment of pediatric patients with Ewing’s sarcoma, rhabdomyosarcoma, osteosarcoma, neuroblastoma, high-grade glioma and lymphomas. Cellectar has received clearance from the FDA for an accelerated Phase 1 trial designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CLR 131 in pediatric patients with these cancer types. Further details about the trial can be found at clinicaltrials.gov using the identifier number NCT03478462.

About Ewing’s Sarcoma

Ewing’s sarcoma is the second most common bone malignancy among children and adolescents. According to a study published in the Journal of Hematology/Oncology, the incidence is about 3 cases per 1 million per year in children younger than age 20. Despite the favorable prognosis, an American Cancer Society study showed that approximately 30-40% of patients develop metastases or local recurrence, and the long-term survival rate for refractory or recurrent disease is only 22-24%. The relapsed and refractory statistics underscore the need for new treatment options.

About CLR 131

CLR 131 is Cellectar’s investigational radioiodinated PDC therapy that exploits the tumor-targeting properties of the company’s proprietary phospholipid ether (PLE) and PLE analogs to selectively deliver radiation to malignant tumor cells, thus minimizing radiation exposure to normal tissues. CLR 131, is in a Phase 2 clinical study in relapsed or refractory (R/R) MM and a range of B-cell malignancies and a Phase 1 clinical study in patients with (R/R) MM exploring fractionated dosing. The company is currently initiating a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma and is planning a second Phase 1 study in combination with external beam radiation for head and neck cancer.

On August 13, 2018 ArQule, Inc. (Nasdaq:ARQL), reported the publication of preclinical study data for ARQ 531, the Company’s rationally-designed, reversible inhibitor of both wild type and C481S-mutant Bruton’s tyrosine kinase (BTK) (Press release, ArQule, AUG 13, 2018, View Source [SID1234532694]). The studies, published in Cancer Discovery, were conducted in collaboration with researchers at The Ohio State University. Data from these studies demonstrated efficacy in in vitro and in vivo hematologic malignancy models that recapitulate the most common mechanisms of resistance to irreversible BTK inhibitors, including ibrutinib.

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Highlights from the manuscript (link here) include:

Differentiated Crystal Structure and Biochemical Profile

The crystal structure of ARQ 531 bound to BTK elucidates the mechanism of BTK inhibition that is not dependent on the specific amino acid residue at position 481 (eg. C or S)
Recombinant BTK biochemical assays of ARQ 531 and ibrutinib show similar inhibition for wild type BTK, however ibrutinib has dramatically lower inhibition, binding affinity and residence time for mutant BTK
"Relapsed and refractory patients that develop resistance to ibrutinib have poor outcomes and limited treatment options," said Brian Schwartz, M.D., Chief Medical Officer and Head of R&D at ArQule. "ARQ 531 was rationally-designed and selected to address this unmet need by inhibiting both wild type and mutant BTK. The published crystal structure and biochemistry clearly demonstrate the mechanism by which ARQ 531 maintains binding and inhibition of mutant BTK in conditions where ibrutinib cannot."

Established Activity in Multiple Cellular and Murine Models of Hematological Malignancies

Exhibited dose dependent toxicity in human primary CLL cells (mutant and wild type)
Inhibited CLL cell migration in vitro
Established superiority to ibrutinib in an engraftment murine model of CLL
Showed activity against other B-cell signaling pathways
Demonstrated efficacy in a murine model of Richter’s transformation
John Byrd, M.D., the Warren Brown Chair of Leukemia Research at The Ohio State University stated, "The inhibition profile of ARQ 531 may confer distinct advantages over ibrutinib, potentially expanding the patient population beyond those with a C481S mutation who may benefit from treatment. Targeting multiple kinases in the B cell activation pathway may provide more durable responses to treatment while also delaying the emergence of treatment resistance. Jennifer Woyach, M.D., Associate Professor of Medicine at The Ohio State University, added, "I am particularly encouraged by the CLL mouse model data which established the superior efficacy of ARQ 531 compared to ibrutinib and the efficacy of ARQ 531 in the model of Richter’s transformation as this is an extremely aggressive disease with very few treatment options."

On August 13, 2018 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies based on its novel, universal Antibody-Coupled T Cell Receptor (ACTR) technology platform, reported that an investigational new drug (IND) application is now active for ACTR T cells in combination with trastuzumab for the treatment of patients with HER2+ advanced cancers (Press release, Unum Therapeutics, AUG 13, 2018, View Source [SID1234528936]). This represents the first solid tumor product candidate based on Unum’s novel, universal ACTR technology, and the fourth clinical trial program for the Company.

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"We are very happy to reach this important milestone for patients and for Unum," said Chuck Wilson, Chief Executive Officer of Unum. "ACTR represents a promising novel technology that can be used to target different tumor types and it’s exciting to expand its application to target solid tumors. We are committed to developing ACTR for patients with HER2+ advanced cancers who need better treatment options."

Under this IND, Unum is preparing to initiate a multi-center Phase I trial, called ATTCK-34-01, by the end of 2018 in patients with HER2+ advanced cancers. ATTCK-34-01 is designed as a dose escalation study where both the ACTR T cell drug product and trastuzumab doses are escalated in order to define the safety, tolerability, and anti-tumor activity of the combination. Expansion at the recommended Phase 2 dose is planned.

On August 13, 2018 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported that preliminary safety and efficacy data from a Phase 1/2 clinical trial of CK101 (also known as RX518), a third-generation epidermal growth factor receptor ("EGFR")
tyrosine kinase inhibitor ("TKI") being evaluated in advanced non-small cell lung cancer, has been selected for a late-breaking oral presentation at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer, to be held September 23-26, 2018, in Toronto (Press release, Checkpoint Therapeutics, AUG 13, 2018, View Source [SID1234528977]).

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"We are thrilled to announce that preliminary data from the Phase 1/2 trial of our novel thirdgeneration EGFR inhibitor has been selected for a late-breaking oral presentation at the World Conference on Lung Cancer. This marks the first clinical data to be reported by Checkpoint, an important clinical and corporate milestone," said James F. Oliviero, President and Chief Executive Officer of Checkpoint Therapeutics. "Third-generation EGFR inhibitors are highly selective and have the potential to demonstrate improved safety and tolerability versus earlier-generation
therapies. There is currently only one third-generation EGFR inhibitor approved and we believe CK-101 could be second to market potentially with a differentiated safety profile."
Details of the presentation are as follows:

Title: CK-101 (RX518), a Third Generation Mutant-Selective Inhibitor of EGFR in NSCLC: Results of an Ongoing Phase I/II Trial
Date: Monday, Sept. 24, 2018
Session: Novel Therapies in ROS1, HER2 and EGFR
Presenter: Melissa L. Johnson, M.D., Associate Director, Lung Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology, PLLC, Nashville, Tenn.
The full abstract will be posted on the conference website on Wednesday, Sept. 5, 2018, at 5 p.m. ET. For additional information, please visit: View Source Checkpoint holds an exclusive worldwide license (except with respect to certain Asian countries) to CK‐101, which it acquired from NeuPharma, Inc. in 2015.

About CK-101
CK-101 (also known as RX518) is an oral, third-generation, irreversible kinase inhibitor against selective mutations in the EGFR gene. Activating mutations in the tyrosine kinase domain of EGFR, such as L858R and exon 19 deletion, are found in approximately 20 percent of patients with advanced non-small cell lung cancer ("NSCLC").
Compared to chemotherapy, first-generation EGFR inhibitors significantly improved objective response rate and progression-free survival in previously untreated NSCLC patients carrying EGFR mutations. However, tumor progression could develop due to resistance mutations, often within months of treatment with first-generation EGFR inhibitors. The EGFR T790M "gatekeeper" mutation is the most common resistance mutation found in patients treated with first-generation EGFR inhibitors. The mutation decreases the affinity of first-generation inhibitors to EGFR kinase domain, rendering the drugs ineffective. Second-generation EGFR inhibitors have improved
potency against the T790M mutation, but have not provided meaningful benefits in NSCLC patients due to toxicity from also inhibiting wild-type EGFR. Third-generation EGFR inhibitors are designed to be highly selective against both EGFR-TKI-sensitizing and resistance mutations, with minimal activity on wild-type EGFR, thereby improving tolerability and safety profiles. Checkpoint Therapeutics is developing CK-101 for the treatment of NSCLC patients carrying the
susceptible EGFR mutations. These include the EGFR T790M mutation in second-line NSCLC patients, as well as the EGFR L858R and exon 19 deletion mutations in first-line NSCLC patients.