On December 13, 2018 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in large-scale PCR-based DNA manufacturing, reported selected preliminary unaudited financial results for the full fiscal year and quarter ended September 30, 2018 (Press release, Applied DNA Sciences, DEC 13, 2018, View Source [SID1234532062]).

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Preliminary (Unaudited) Fiscal 2018 Financial Results:

Revenues for fiscal 2018 totaled $3.9 million, a decrease of 18% from $4.8 million from the same period in the prior fiscal year. The decrease in revenues was attributable to a decrease in revenues of approximately $2.2 million in the textile industry for protecting cotton and synthetic supply chains. This decrease was offset by an increase in revenue from Contract Manufacturing of DNA for diagnostics as well as an increase from development projects, primarily those associated with partners’ pre-commercial business initiatives in legal cannabis and pharmaceuticals.
Deferred revenue increased to $1.9 million as of September 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 shipped during June 2018 having extended payment terms and to be recognized to revenue as the payments become due. The extended payment terms for this shipment are three equal installments due 90, 180 and 270 days from shipment. One-third of the revenue was recognized during the fiscal fourth quarter of 2018. The increase in deferred revenue is also attributable to fees received for a variety of contracts that include specific milestones and therefore were not able to be fully recognized as revenue during the quarter ended September 30, 2018.
Operating expenses for the fiscal year ended September 30, 2018 decreased by $2.2 million or 13% as compared to the prior fiscal year. The decrease is primarily attributable to a decrease in stock-based compensation of approximately $1.9 million and bad debt expense of $403 thousand.
Net loss for the fiscal year ended September 30, 2018 decreased to $11.7 million or $0.40 per share, compared with a net loss of $12.9 million or $0.49 per share for the fiscal year ended September 30, 2017.
Preliminary (Unaudited) Fiscal Fourth Quarter Results:

Revenues increased 4% for the fourth quarter of fiscal 2018 to $1.2 million, compared to $1.1 million reported in the fourth quarter of fiscal 2017, and increased 18% as compared to revenues for the fiscal third quarter ended June 30, 2018 of $1.0 million. The year-over-year increase in revenues is primarily attributable to an increase in revenues from development and pre-commercial pilots in pharmaceuticals and cannabis. This increase was offset by a decrease in textile revenues.
Total operating expenses were $4.4 million, compared with $3.7 million in the prior year’s quarter, an increase of approximately 19%. The increase in year-over-year total operating expenses is attributable to an increase in stock-based compensation expense due to the timing of the annual employee grant, payroll and research and development expenses, offset by a decrease in depreciation and amortization expense.
Net loss for the quarter ended September 30, 2018 was $3.5 million, or $0.12 per share, compared with a net loss of $2.9 million, or $0.10 per share for the same period in the prior fiscal year and a net loss of $2.9 million, or $0.10 per share for the third fiscal quarter ended June 30, 2018.
The Company also announced that it anticipates filing its Annual Report on Form 10-K for the fiscal year ended September 30, 2018 with the Securities and Exchange Commission during the week of December 17, 2018, and will hold an investor call during the week of December 24, 2018.

"Our performance in fiscal 2018 reflects execution on pre-commercial sales and business development initiatives to sow new revenue streams by leveraging our proven DNA taggant technology platform and capitalizing on secular industry trends emphasizing supply chain security, sustainability and traceability all along the value chain," stated Dr. James A. Hayward, president and CEO of Applied DNA. "During the year we continued to expand our business beyond cotton with diverse partners using synthetic fibers and generating initial revenues from the legal cannabis and pharmaceutical markets while progressing other programs, such as leather traceability, towards commercialization while also implementing feasibility pilots with a diverse customer base.

"Notable advancements made during the year included: in textiles, we furthered adoption of our platform for the tagging of non-cotton synthetic textiles to complement our cotton business that itself has begun to expand internationally; in the nascent legal cannabis industry where compliance with governmental permitting requirements is fundamental to its future, our partnership with TheraCann has yielded a seed-to-sale tracking program powered by blockchain and molecular tagging technologies and the development of a tagging system specifically designed to meet the needs of commercial growers; in pharmaceuticals, we advanced the manufacturing scale-up of our on-dose solution for enhanced patient safety and supply chain security with partner Colorcon; in biotherapeutics, we formally launched our LineaRx subsidiary that has already expanded our opportunity-set to include the potentially high-reward therapeutics space. We also saw continued demand for development pilots that serve as an indicator of growing industry interest in our technology platform and its value proposition."

Concluded Dr. Hayward, "Building on these advancements, we anticipate revenue from our key business verticals in fiscal 2019 with opportunities for increased contributions from certain verticals, such as in textiles where we are progressing towards big-box and online retailer adoption of DNA-tagged synthetic fiber products manufactured by ecosystem partners. In pharmaceuticals, we are pursuing regulatory approval of our molecular tag that if realized during 2019 should generate a second revenue milestone from Colorcon and make our solution compelling for pharmaceutical manufacturers in an era of government-mandated serialization practices."

Preliminary Results
The financial data contained in this press release are unaudited, preliminary, based upon Applied DNA’s good faith estimates and subject to completion of Applied DNA’s financial closing procedures. While Applied DNA expects that its final financial results for the fiscal year and quarter ended September 30, 2018, following the completion of its financial closing procedures, will generally be consistent with the amounts provided in this press release, Applied DNA’s actual results may differ materially from these estimates as a result of the completion of its financial closing procedures, as well as final adjustments and other developments that may arise between now and the time that its financial results for the fiscal year and quarter ended September 30, 2018 are finalized.

The results provided in this press release are preliminary and subject to completion and audit of Applied DNA’s financial statements in conjunction with the Company’s 2018 Form 10-K filing with the Securities and Exchange Commission anticipated to occur during the week of December 17, 2018.

On December 12, 2018 NETRIS Pharma, a clinical-stage company developing novel anticancer therapies targeting dependence receptors, reported successful completion of the first-in-human study on the effects of netrin-1 inhibition in patients with advanced solid tumors (Press release, Netris Pharma, DEC 12, 2018, View Source [SID1234532018]). The Phase 1 dose-escalation study showed that NP137, a first-in-class monoclonal anti-netrin-1 blocking antibody, was safe and well tolerated up to 20mg/kg, with no dose limiting toxicity (DLT), meeting the primary objective. In addition, patients with advanced uterine cancers exhibited encouraging signs of anti-tumor activity, including prolonged stable disease and objective response.

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"We are very pleased with the safety and tolerability profile of NP137 in this study, which enabled evaluation of netrin-1 inhibition in advanced solid tumors," said Philippe Cassier, MD, PhD, Head of Phase 1 unit at Centre Léon Bérard and Principal Investigator of the NP137 study.

"I am really impressed by the preliminary anti-tumor activity observed in this study with patients showing objective response and prolonged one-year disease control," added Professor Jean Yves Blay, MD, Ph.D. General Director of the Centre Léon Bérard and past president of EORTC.

The Phase 1 study was designed to evaluate the maximum tolerated dose, pharmacokinetics and pharmacodynamics, and establish the recommended dose for the Phase 1b/2 expansion study. NP137 was dosed every other week starting from 1 mg/kg up to 20mg/kg in heavily pre-treated patients with advanced solid tumors. Additional study objectives were to evaluate the adverse events (AE), pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of NP137. The study enrolled a total of 19 patients in three French centers, the Centre Léon Bérard in Lyon, the Institut Claudius Régaud in Toulouse and the Institut de Cancérologie de l’Ouest in Nantes. A Phase 1 extension study with an additional 24 patients is ongoing to confirm the safety and tolerability of NP137, collect biopsies before and after treatment to allow measurement of potential biomarkers and confirm the preliminary clinical activity seen during dose escalation. The final phase 1a data will be submitted for presentation at an upcoming international medical conference.

"Meeting the primary objective of the dose-escalation part of this study and generating preliminary positive efficacy data, particularly in such chemotherapy-resistant patients, provide an important confirmation of our dependence receptor science and lay the groundwork for larger clinical studies with NP137 as a targeted approach to treat solid tumors in combination with chemotherapy, immune checkpoint inhibitors and tyrosine kinase inhibitors, » said Prof. Patrick Mehlen, Chief Executive Officer of NETRIS Pharma. « Additionally, we would like to thank the investigators, patients and caregivers for their participation in this study, and for contributing to our understanding of NP137 as we work to address a significant medical need. »

About NP137

Most types of tumors produce an abnormal amount of dependence receptors’ ligands, which prevents cells from dying. Netrin-1 is overexpressed in a large percentage of human cancers, including over two thirds of gynecologic cancers. Expression of netrin-1 often correlates with disease severity and no therapy has ever been tested against this new pathway.

NP137, a humanized monoclonal antibody of isotype IgG1 directed against netrin-1, is the first drug candidate developed by NETRIS Pharma. NP137 prevents the binding of netrin-1 on its dependence receptors, thereby re-inducing cancer cell death and impacting tumor cell plasticity. Pre-clinical studies show NP137 to have an anti-cancer effect as a monotherapy as well as synergistic effects in combination with chemotherapy, immune checkpoint inhibitors or tyrosine kinase inhibitors.

On December 12, 2018 Generex Biotechnology Corporation (OTCQB:GNBT) reported that the FDA had reviewed the company’s investigational new drug (IND) application and given notification that the study can proceed (Press release, Generex, DEC 12, 2018, View Source [SID1234532037]). The study: A Phase II Clinical Trial of Pembrolizumab (Keytruda) in Combination with the AE37 Peptide Vaccine in Patients with Metastatic Triple Negative Breast Cancer, is sponsored by Generex and conducted under a collaboration agreement with Merck and a clinical trial agreement with the NSABP Foundation, Inc. (NSABP).

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The combination study builds on previous clinical studies of both AE37 and Keytruda. AE37, a cancer vaccine, was the subject of a 300 patient prospective, randomized and single-blinded Phase II study in patients with breast cancer. That study showed a strong trend toward reduced relapses,particularly in patients with triple negative breast cancer. Keytruda also has shown encouraging results in patients with triple negative breast cancer when used as monotherapy. The complementary mechanisms of action of the two drugs suggest the combination may have the potential to be better than either alone.

AE37 is unique among therapeutic cancer vaccines in that it ensures specific activation of CD4+ T helper cells, which are critical in generating an effective immune response. Its improved immunological potency, along with an excellent safety profile, offers particular advantages for combination studies. In addition to the Phase II study in breast cancer patients, AE37 also has been tested in a Phase I study in prostate cancer patients. AE37 treated patients have consistently displayed a robust, long-lasting and specific response to the vaccine.

Liesha Emens, M.D., Ph.D., Principal Investigator for the study and Professor of Medicine at the University of Pittsburgh Medical Center commented: "So far, metastatic triple negative breast cancer patients treated upfront with immunotherapy benefit clinically from immune checkpoint immunotherapy only if their tumors contain PDL1+ cells. Increasing the number of patients with immune-activated tumors should bring the benefit of immunotherapy to even more patients. This Phase II trial will test whether the AE37 vaccine may trigger immunity in triple negative breast cancer patients, priming them for clinical benefit from immune checkpoint blockade."

Eric von Hofe, President of NuGenerex-ImmunoOncology commented: "We are gratified to see this important trial moving forward. While we have tested AE37 in breast and prostate cancer patients, there is good rationale for inclusion of AE37 in the treatment regimen of a variety of additional cancer types of high unmet need. Gastric, colon, ovarian and bladder cancers all express the same tumor target expressed in breast and prostate cancer that AE37 activates the immune system to recognize."

About AE37

AE37 is an investigational therapeutic cancer vaccine being developed to treat certain types of breast cancer. It is a combination of portions of two proteins that together stimulate the immune system to fight cancer cells.

Up to 80 percent of breast cancers express some level of a protein called HER2. While treatments exist to target HER2 in breast cancer patients with the highest level of HER2 expression (roughly 25%), the majority of patients who have lower levels of expression have more limited treatment options. AE37 consists of a protein derived from the HER2 protein combined with a portion of the MHC class II associated invariant chain which has been termed Ii-Key.

AE37 does not directly target HER2, but rather acts as a vaccine to activate the immune system to recognize the HER2 protein, which is expressed on cancer cells as foreign. AE37 ensures activation of CD4-positive lymphocytes, immune cells that are important in stimulating both the antibody response (antibodies against HER2) and cellular responses directed against the HER2 protein in breast cancer cells. The Ii-Key peptide is coupled with the HER2 protein to ensure a more robust and long-lasting response.

On December 12, 2018 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that it has commenced an underwritten public offering of its common shares (Press release, VBI Vaccines, DEC 12, 2018, View Source [SID1234532101]). VBI also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of common shares offered in the public offering. The offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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BMO Capital Markets, Canaccord Genuity LLC, and Oppenheimer & Co. Inc. are acting as joint book-runners for the underwritten public offering.

VBI intends to use the net proceeds from the offering to progress its research and development programs, which include, among other things, funding the continued clinical development of Sci-B-Vac, including the ongoing Phase 3 clinical program in the United States, Europe and Canada; the Phase 1/2a clinical study of the therapeutic vaccine candidate, VBI-1901, for glioblastoma (GBM); the prophylactic vaccine candidate, VBI-1501, for cytomegalovirus (CMV); and the immuno-therapeutic candidate, VBI-2601, for hepatitis B. The net proceeds will also be used for general corporate purposes, including working capital and capital expenditures.

A shelf registration statement relating to the common shares was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on June 8, 2017. A preliminary prospectus supplement and accompanying prospectus relating to the underwritten public offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement (when available) and accompanying prospectus may be obtained from BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036 or by e-mail at [email protected], or from Canaccord Genuity LLC, Attention: Equity Syndicate Department 99 High Street, 12th Floor, Boston, MA 02110 or by e-mail at [email protected], or from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004 or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

The securities will not be offered or sold, directly or indirectly, in Canada or to any resident of Canada.

On December 12, 2018 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, reported that Aron Knickerbocker, Chief Executive Officer, will present at the 37th Annual J.P. Morgan Healthcare Conference, Wednesday, January 9, 2019 at 2:00 pm PT (Press release, Five Prime Therapeutics, DEC 12, 2018, View Source [SID1234532039]).

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The presentation will be webcast and may be accessed at the "Events & Presentations" section of the Company’s website at View Source Five Prime will maintain an archived replay of the webcast on its website for 30 days after the conference.