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Salarius Pharmaceuticals to Present Trial-in-Progress Poster at Epigenetics Symposium: 15 Years of Lysine Demethylases: From Discovery to the Clinic

On December 12, 2019 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biotechnology company targeting the epigenetic causes of cancer, reported the acceptance of an abstract at the "Epigenetics Symposium: 15 Years of Lysine Demethylases: From Discovery to the Clinic" taking place Monday, December 16, 2019 at the Franklin Institute in Philadelphia, PA (Press release, Flex Pharma, DEC 12, 2019, View Source [SID1234552314]). The trial-in-progress poster presentation will include an overview of the ongoing Phase 1/2 clinical trial for Salarius’ lead drug candidate, Seclidemstat, a potent reversible LSD1 inhibitor being developed as a treatment for Ewing sarcoma, a rare pediatric bone cancer.

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Details of the symposium and poster presentation are as follows:

Abstract Title: Trials in progress: A phase I/II clinical trial of the reversible LSD1 inhibitor, seclidemstat, in patients with relapsed/refractory Ewing sarcoma
Where: The Franklin Institute, 222 North 20th Street, Philadelphia
When: Monday, December 16, 2019 at 8:30 a.m. EST to 7 p.m. EST
Symposium Website: Epigenetics Symposium: 15 Years of Lysine Demethylases: From Discovery to the Clinic

"The Epigenetics Symposium is an ideal event to showcase our progress bringing our lead drug candidate, Seclidemstat, into the clinic and the impact it could have on Ewing sarcoma, a rare and deadly bone cancer that most often strikes children and young adults and for which there are no targeted therapies approved," stated David Arthur, Chief Executive Officer of Salarius Pharmaceuticals. "Lysine demethylase enzymes are a well-known target for epigenetic-based drug development. We have developed Seclidemstat to be a differentiated LSD1 inhibitor, and we are excited that it has reached the clinical trial setting where its safety and therapeutic activity can be assessed. Research shows that LSD1 expression is elevated in 60% of Ewing sarcoma patients and correlates with poor patient prognosis and decreased overall survival. Given the potential of Seclidemstat to address this great unmet need, we look forward to releasing early cohort data next year from our Ewing sarcoma study and a Phase 1 study in advanced solid tumors."

Toronto Innovation Acceleration Partners ("TIAP") adds novel KRAS oncology project to its LAB150 portfolio

On December 12, 2019 Toronto Innovation Acceleration Partners ("TIAP") reported the launch of a new project developed under the BRIDGE LAB150, a partnership between Evotec SE and TIAP (Press release, Evotec, DEC 12, 2019, View Source;announcements/press-releases/p/toronto-innovation-acceleration-partners-tiap-adds-novel-kras-oncology-project-to-its-lab150-portfolio-5879 [SID1234552313]). The project will be focusing on breakthroughs in novel cellular drug screening systems in oncology-focused scientific KRAS research by Professor Igor Stagljar at the University of Toronto, a TIAP Member, and aims to develop therapeutics targeting the protein-protein interactions of KRAS and its downstream interacting partners.

The low survival rates of three of the four most lethal cancers in North America – pancreatic, colorectal and lung – are associated with KRAS mutations, a well-established cancer driver. Although there is an urgent need for KRAS-targeting therapeutics, so far there has been a lack of clinically available drugs as oncogenic KRAS is very difficult to target directly.

LAB150 accelerates academic research towards commercial outcomes by providing funding and access to pharmaceutically validated platforms and expertise. For further information on the new LAB150 projects

Zhejiang Medicine and Ambrx Present Positive Top Line Data from a Phase 1a/1b Clinical Trial of ARX788 in Metastatic HER2 Positive Breast Cancer

On December 12, 2019 Zhejiang Medicine, NovoCodex and Ambrx reported positive interim topline data from the ongoing "111" trial (CTR20171162) evaluating ARX788, a novel anti-HER2 ADC, in heavily pretreated patients with metastatic HER2 positive breast cancer (Press release, Zhejiang Medicine, DEC 12, 2019, View Source [SID1234552312]). All patients enrolled had failed prior therapy with trastuzumab and 47% had failed therapy with trastuzumab and lapatinib.

ARX788 was well tolerated at all dose levels with just two ≥ Grade 3 drug related reversible adverse events observed amongst 51 enrolled patients. ARX788 showed an excellent safety profile with dose escalation continuing. No DLT or MTD was observed as of the November 20, 2019 cut-off date.

Response rates correlated with increased dose levels. As of the cut-off date, the highest dose tested was 1.5mg/kg every three weeks. This cohort, which continues dosing and remains under observation, had already achieved a 63% overall response rate. Prior cohorts at 0.88, 1.1 and 1.3 mg/kg demonstrated overall response rates of 14%, 36% and 56% respectively. Further, the substantial increases in efficacy observed at higher doses was achieved with only mild increases in toxicity.

These data originate from the Fudan University Shanghai Cancer Center in China and are part of a broader global ARX788 development program (NCT03255070 and CTR20171162) that includes clinical sites in China, USA and Australia.

The 42nd Annual San Antonio Breast Cancer Symposium Poster is available at www.ambrx.com

Zhejiang Medicine licensed the commercial rights to ARX788 in China in 2013. The promising clinical data for ARX788 serves as a solid foundation to the second and more recent collaboration. Earlier this year, Ambrx and Zhejiang Medicine (via its subsidiary NovoCodex) entered into their second collaboration to develop and commercialize ARX305 in China. ARX305 is an anti-CD70 Antibody Drug Conjugate for the potential treatment of Renal Cell Carcinoma, Multiple Myeloma, and other solid tumors.

About HER2-Positive Breast Cancer

Almost 300,000 new cases of HER2 positive breast cancer may be diagnosed in 2020 in the US alone (approximately 15-20% of breast cancers are HER2 positive). HER2 positive breast cancer tends to be aggressive and more likely to recur than HER2 negative. There are currently no approved therapies demonstrating progression-free survival or overall survival benefit for the treatment of patients with HER2 positive metastatic breast cancer after progression on T-DM1 (which is not approved in China).

Aurinia Closes US$191.7 Million Public Offering of Common Shares and Full Exercise of Underwriters’ Option to Purchase Additional Common Shares

On December 12, 2019 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, reported the closing of its previously announced underwritten public offering of 12,782,439 common shares, including 1,667,274 common shares pursuant to the full exercise of the underwriters’ option to purchase additional common shares (the "Offering") (Press release, Aurinia Pharmaceuticals, DEC 12, 2019, View Source [SID1234552310]). The shares were sold at a public offering price of US$15.00 per share. The gross offering proceeds to the Company from this Offering are approximately US$191.7 million, before deducting underwriting discounts and commissions and other estimated offering expenses.

Jefferies LLC and SVB Leerink LLC acted as joint book-running managers for the Offering. H.C. Wainwright & Co. LLC, Oppenheimer & Co. Inc., and Bloom Burton Securities Inc. acted as co-managers for the Offering.

For the purposes of the TSX approval, the Company relied on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible inter-listed issuers on a recognized exchange, such as NASDAQ.

The Company intends to use the net proceeds of the Offering for pre-commercialization and launch activities, as well as working capital and general corporate purposes.

The Offering was made pursuant to a U.S. registration statement on Form F-10, declared effective by the United States Securities and Exchange Commission (the "SEC") on March 29, 2018 (the "Registration Statement"), and the Company’s existing Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated March 26, 2018. The prospectus supplements relating to the Offering (together with the Base Shelf Prospectus and the Registration Statement, the "Offering Documents") have been filed with the securities commissions in the provinces of British Columbia, Alberta and Ontario in Canada, and with the SEC in the United States. The Offering Documents contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed for more complete information about the Company and the Offering. Copies of the Offering Documents are available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov, as applicable. Alternatively, copies of the prospectus supplement are available upon request by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; or by e-mail at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6132, or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, nor will there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Applied DNA Reports 2019 Year End and Fiscal Fourth Quarter Financial Results

On December 12, 2019 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing for product authenticity, traceability solutions and nucleic acid-based biotherapeutic development reported consolidated financial results for the full fiscal year and quarter ended September 30, 2019 (Press release, Applied DNA Sciences, DEC 12, 2019, View Source [SID1234552309]).

"In fiscal 2019 total revenues increased 38%, and total operating expenses decreased by 5% as we sharpened our focus on our ability to produce linear DNA at scale for our tagging, diagnostics and preclinical biotherapeutic businesses," said Dr. James A. Hayward, chairman, president and CEO of Applied DNA.

Added Dr. Hayward, "Over the past year we focused on elevating the Company’s profile for preclinical biotherapeutics and diagnostic applications. With the Company’s unique ability – approximately 130 patents and patents pending – to produce large quantities of ultra-pure linear DNA, the Company’s linear DNA manufacturing platform is a potential industry disrupter that offers therapeutic developers a replacement to plasmid DNA that we believe is cheaper, faster and easily scalable. Over the past 15 months, we developed a robust pipeline of more than 15 contract research opportunities with top cancer, gene therapy, vaccine and RNA partners, which is already generating initial revenue."

"The recent acquisition of the assets and IP of Vitatex, Inc. gives us a second compelling branch to the linear DNA story that we believe lends itself to the diagnostics, prognostics and therapeutics of invasive circulating tumor cells (iCTC). Within just three months of acquisition, we signed an agreement with Tyme Technologies, Inc. for the supply of our Vita-AssayTM iCTC capture assay and associated services for iCTC detection in their pivotal stage pancreatic cancer clinical trial. In addition, our protocols for obtaining and studying iCTCs in colorectal cancer have recently been approved by an Institutional Review Board."

Continued Dr. Hayward, "Within our product authenticity and traceability solutions segment, our textile business, led by an experienced sales team, broadened awareness and adoption of our CertainT platform. Expanding beyond our relationship with Himatsingka for cotton home textiles, we established a technology partnership that gives us entrée into the cotton apparel market. We continued the global implementation of our tagging platform by completing commercial scale pilots at approximately 20 textile manufacturing sites using varied materials throughout China, Southeast Asia and India. In synthetic textiles, brands and retailers are increasingly relying on materials that offer high performance, sustainability and transparency and the promise of circular manufacturing. Our efforts have yielded strategic alliances that position us alongside key participants along multiple points in the global textile value chain to more broadly drive adoption of our authentication technology platform. We have begun to integrate our CertainT platform to provide end-to-end material traceability to multiple related categories, including leather, wool, down and feather, specialty coatings and additives, recycled PET, viscose, and other synthetics. We believe we are well positioned for uptake by brands and retailers."

Concluded Dr. Hayward, "Looking ahead, we have set our sights on generating top-line growth from our linear DNA manufacturing platform, that should be driven by textiles and cannabis, as well as biotherapeutic and diagnostics, as we begin to convert our business-building activities in fiscal 2019 into pre-commercial and commercial revenues in fiscal 2020. Having recently completed an equity raise, re-established our compliance with the Nasdaq listing requirements, and eliminated our Going Concern opinion, we have our strongest balance sheet in years and the financial resources to support a sustainable growth trajectory."

2019 Full Fiscal Year Financial Highlights

Revenues for fiscal 2019 totaled $5.4 million, an increase of 38% from $3.9 million from the prior fiscal year. The increase in revenues was due to an increase in service revenues of $1.2 million, or 57%, and an increase in product revenues of $308 thousand, or 17%. The increase in revenue was primarily attributable to an increase of $1 million from our now terminated cannabis licensing agreement, as well as an $889 thousand increase in textiles relating to shipments of DNA concentrate to protect the cotton supply chain. These increases in revenue were offset by a decrease in consumer asset marking sales.
·Effective October 1, 2018, the Company was required to adopt Accounting Standards Update (ASU; the "Update") No. 2014-09, Revenue from Contracts with Customers (Topic 606), utilizing the modified retrospective method. Had the Company not adopted the Update, the Company would have recognized additional revenue of approximately $915 thousand during fiscal 2019. This amount was primarily comprised of the recognition of $766 thousand during the twelve-month period ended September 30, 2019, under a $1.15 million cotton order shipped in June 2018, with extended payment terms. The total cumulative impact of the Update that was recorded to opening retained earnings in fiscal 2019 was approximately $493 thousand. See Cumulative Effect Adjustment and the Impact on Current Period Financial Statements of Adopting Topic 606 attached.
·Operating expenses for the fiscal year ended September 30, 2019 decreased by $707 thousand or 5% as compared to the prior fiscal year. The decrease is primarily attributable to approximately an $890 thousand decrease in payroll, due to a realignment of the sales force and reductions in overall headcount. This decrease in payroll was offset by an increase in legal fees.
·Net loss for the twelve months ended September 30, 2019 was $8.6 million or $9.69 per share, compared with a net loss of $11.7 million or $15.86 per share for the twelve months ended September 30, 2018, an improvement of 26%.
·Excluding non-cash expenses and interest, Adjusted EBITDA for the fiscal year ended September 30, 2019 was a negative $7.6 million as compared to a negative $9.8 million for the prior fiscal year, an improvement of 22%. See below for information regarding non-GAAP measures.

Fiscal Fourth Quarter 2019 Financial Results:

·Revenues increased 40% for the fourth quarter of fiscal 2019 to $1.7 million, compared with $1.2 million reported in the same period of the prior fiscal year and decreased 19% from $2.1 million for the third quarter of fiscal 2019. The increase in revenues year over year was due primarily to an increase in product revenues from shipments of DNA concentrate to protect the cotton supply chain. The decrease in revenue quarter over quarter was due to the recognition of $1 million in revenue from a licensing agreement in the cannabis industry during the third fiscal quarter of fiscal 2019.
·Total operating expenses decreased to $3.2 million for the fourth fiscal quarter of 2019, compared with $4.4 million in the prior fiscal year’s fourth quarter. This decrease is primarily attributable to an approximate $231 thousand decrease in payroll, due to a realignment of the sales force and reductions in overall headcount as well as a decrease of $954 thousand in stock-based compensation expense.
·Net loss for the quarter ended September 30, 2019 was $1.2 million, or $1.44 per share, compared with a net loss of $3.5 million, or $4.62 per share, for the quarter ended September 30, 2018, an improvement of 69%, and a net loss of $1.5 million, or $1.60 per share, for the quarter ended June 30, 2019.
·Excluding non-cash expenses, Adjusted EBITDA was negative $1.6 million and a negative $2.2 million for the quarters ended September 30, 2019 and 2018, respectively. See below for information regarding non-GAAP measures.

Select Recent Operational Highlights:

·On November 26, Applied DNA’s majority-owned subsidiary focused on next-generation biotherapeutics and diagnostics, LineaRx, signed a definitive agreement with Tyme Technologies, Inc. to supply the Company’s Vita-AssayTM invasive Circulating Tumor Cell (iCTC) capture assay and associated services for use in the pivotal stage of the TYME-88-PANC clinical trial for patients with third-line pancreatic cancer. The potential value of the Agreement is the largest contract to-date for LineaRx, and we believe the largest in the development history of the iCTC assay;
·On November 12, the Company announced the successful DNA tagging of leather at one of the world’s largest tanneries based in Asia. The work follows a successful research project undertaken within the UK that demonstrated SigNature DNA could be successfully used to trace the hide of an animal from a farm to the product in a store;
·On October 16, Applied DNA announced that it had entered into a partnership with Molecular Isotope Technologies, LLC ("MIT LLC"), a pioneer and leader in the application of natural-abundance stable-isotopic analysis provided under the trademarks Nature’s Fingerprint and IsoPedigree. MIT LLC’s technology utilizes stable isotopic "fingerprints" as a method for verification of product origin and supply chain processing to support product claims. MIT LLC’s technology will be offered by Applied DNA as an additional component of its CertainT platform to tag, test and track raw materials and finished goods. MIT LLC will support and promote the CertainT platform as a service complementary to its own;
·On October 1, LineaRx announced that its invasive Circulating Tumor Cells (iCTCs) platform demonstrated superior correlation over Prostate Specific Antigen (PSA) in an ongoing Phase II trial in recurrent prostate cancer. The Company believes that the study shows that iCTCs may be used to accurately follow therapy success in prostate cancer while also providing new tools for cell and gene therapy design and production;
·On September 24, the Company announced that it received a $1 million order to supply SigNature T taggant for cotton in the upcoming 2019 – 2020 ginning season that began in October. The Company’s SigNature T technology, paired with its genotyping and digital systems, will be used to tag, test and track the Pima cotton variety grown in the San Joaquin Valley, California that is sold under the PimaCott brand nationwide and online by the largest home goods retailer in the U.S. Since 2014, and including the cotton tagged with this order, over 250 million pounds of cotton will have been tagged as the key to a total end-to-end traceability solution that is substantiated by forensic test data;
·On September 19, LineaRx announced that its collaborators Takis/Evvivax have completed pre-clinical animal studies of two vaccine candidates produced with linear DNA. Tests of both vaccines in mouse models demonstrated their ability to eliminate tumors in vivo, and to potentially prevent initial occurrence. Clinical data accumulated from linear DNA vaccines for companion animals can be used to accelerate translation to human therapies by Evvivax and Takis;
·On September 5, Applied DNA announced a sales and marketing partnership with Navarpluma that extends the Company’s Textiles business to include the global down and feather supply chain. Navarpluma S.L., one of the world’s premier suppliers of down and feathers to the textile industry, will be the first to offer this new system to its customer base that counts some of the world’s most prestigious brands as clients.

Fiscal Fourth Quarter 2019 Conference Call Information

The Company will hold a conference call and webcast to discuss its fiscal fourth quarter-end 2019 results on Thursday, December 12, 2019 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 December 19, 2019):

·Participant Toll Free: 1-877-344-7529
·Participant Toll: 1-412-317-0088
·Participant Passcode: 10136194
·Webcast replay: View Source

For those investors unable to attend the live call, a copy of management’s PowerPoint presentation will be available for review under the ‘Events and Presentations’ section of the company’s Investor Relations web site: 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.