On December 5, 2019 Applied DNA Sciences, Inc. (NASDAQ: APDN), reported it plans to release financial results for its fiscal 2019 fourth quarter ended September 30, 2019 after market close on Thursday, December 12, 2019 (Press release, Applied DNA Sciences, DEC 5, 2019, View Source [SID1234551955]). In conjunction with the release, the Company has scheduled a conference call at 4:30 p.m. Eastern Time that will also be broadcast live over the Internet.

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What: Applied DNA’s Fiscal 2019 Fourth Quarter Financial Results Conference Call
When: Thursday, December 12, 2019, at 4:30 p.m. Eastern Time
Where: Via phone by dialing +1 844-887-9402 or +1 412-317-6798 and ask to join the Applied DNA call; via webcast.

A telephonic replay of the conference call will be available for one day and may be accessed by calling +1 877-344-7529 or +1 412-317-0088 with the passcode 10136194. The webcast will be archived within the ‘Events and Presentations’ portion of the ‘Investors’ page to the company’s website.

On December 5, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that it will host an R&D event and live webcast featuring several key opinion leaders ("KOLs") to discuss the Company’s advanced antibody-based therapeutic pipeline and recent clinical and corporate developments on Wednesday, December 11, 2019 from 12:00-2:00pm EST in New York City (Press release, Y-mAbs Therapeutics, DEC 5, 2019, View Source [SID1234551972]).

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The event will feature presentations by KOLs Dr. Shakeel Modak, M.D., MRCP, Memorial Sloan Kettering Cancer Center ("MSK"), Dr. Kim Kramer, M.D., MSK, and Dr. Jaume Mora, M.D., Ph.D., SJD Barcelona Children’s Hospital, who will discuss the current treatment landscape and unmet medical needs for treating patients with high-risk pediatric neuroblastoma and other solid tumors. Drs. Modak, Kramer, and Mora will be available to answer questions at the conclusion of the event.

Y-mAbs management will also provide an in-depth overview of the Company’s broad and advanced product pipeline as well as a review of recent corporate and clinical developments. Y-mAbs is advancing two pivotal-stage product candidates, naxitamab and omburtamab, targeting tumors that express GD2 and B7-H3, respectively.

Members of the media and public may access the event via a live webcast.

On December 5, 2019 Akoya Biosciences, Inc., The Spatial Biology Company, reported the completion of a $50 million financing from both new and existing investors (Press release, Akoya Biosciences, DEC 5, 2019, View Source [SID1234551974]). The round will fund significant growth through expansion of commercial and operational resources as well as continued product development of Akoya’s CODEX and Phenoptics platforms for spatial biology for research and clinical markets.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The financing was led by Piper Jaffray Merchant Banking, a division of Piper Jaffray, with continued participation from Telegraph Hill Partners. New strategic partners also include Agilent Technologies and Innovatus Capital Partners, LLC. This financing follows Akoya’s September 2018 Series C funding used to support the acquisition of the Phenoptics Portfolio from PerkinElmer.

Brian McKelligon, Chief Executive Officer of Akoya, will present on Thursday, December 5, 2019 at the Piper Jaffray 31st Annual Healthcare Conference taking place at the Lotte New York Palace, New York. The session will be held in the SoHo Track – Hubbard 1, 5th floor from 2:10-2:30 PM.

"2019 was an exciting year of growth for Akoya, led by new product introductions for both CODEX and Phenoptics platforms," said Mr. McKelligon. "This support from industry leading investors and partners provides the vital endorsement and resources necessary for Akoya to continue to deliver innovative tools to enable a better understanding of the pathophysiology of cancer and provide more informative results for clinical decisions.

Thomas Schnettler, managing director at Piper Jaffray, has joined Akoya’s Board of Directors and commented, "Akoya is transforming how immunotherapies are developed, from discovery of novel biomarkers in the tumor microenvironment, to deploying high throughput, highly sensitive information to direct patient therapies." Schnettler continued, "Our investment represents our confidence in Akoya’s relentless execution to deliver the next generation of pathology tools."

"We are excited to support Akoya’s efforts to commercialize multispectral imaging solutions to unlock the full potential of spatial biology," said Claes Ekstrom, Managing Director at Innovatus.

The new financing will enable further product development of the CODEX and Phenoptics platforms for multiplexed immunofluorescence imaging and analysis, commercial expansion, and the scale up of operations and manufacturing. These expansions are driven by dramatic growth in the immuno-oncology market and mounting evidence that spatial analysis using multiplex immunofluorescence is critical to understanding cancer’s complexity, and potentially provides more power for predicting patient response to immunotherapies.

On December 5, 2019 NeuClone Pharmaceuticals Ltd (NeuClone), a clinical-stage biopharmaceutical company exclusively focused on developing high-quality biosimilar products, reported that NeuCeptin, a biosimilar candidate of Herceptin (trastuzumab), has successfully met all primary and secondary endpoints in a Phase I clinical trial (Press release, NeuClone Pharmaceuticals, DEC 5, 2019, View Source [SID1234551975]). This includes all pre-specified criteria demonstrating clinical pharmacokinetic (PK) similarity of NeuCeptin, compared to US- and EU-sourced Herceptin. Additionally, the safety and tolerability profiles were equivalent between all three treatment arms.

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Successful completion of the Phase I trial is a significant milestone in the development of a biosimilar as Phase II trials and in some instances Phase III trials are not required to achieve regulatory approval. As of March 2019, no biosimilar found to be highly similar in analytical and human PK studies failed to be approved in the US, EU, Canada or Australia due to clinical inequivalence.1

NeuCeptin is one of several biosimilars developed in partnership between NeuClone and Serum Institute of India Pvt Ltd (Serum Institute), and references trastuzumab, a HER2-targeting monoclonal antibody approved by the FDA and EMA to treat HER2-positive breast and gastric cancer. Trastuzumab was originally commercialised under the brand name Herceptin and generated global sales of USD 7.0 billion in 2018.2

"Positive results from the NeuCeptin trial reflect our dedication to provide high-quality, affordable biologics to a greater number of patients," stated Dr Noelle Sunstrom, CEO and Founder of NeuClone. "Pharmacokinetics are pivotal to the demonstration of biosimilarity and these successful results greatly de-risk this particular program and also validate NeuClone and Serum Institute’s development approach to be replicated for many biosimilars in our pipeline."

"It is extremely pleasing to see the progress of our biosimilar portfolio with co-development partner, NeuClone. We have now achieved successful Phase I results of NeuCeptin (trastuzumab), nearly completed dosing of the Phase I trial for NeuLara (ustekinumab), and palivizumab and pertuzumab biosimilars are both progressing into preclinical and clinical testing," stated Mr. Adar Poonawalla, CEO of Serum Institute. "This clearly speaks of our commitment to make highly cost-effective biosimilars available to all."

NeuClone has 20 biosimilars in various stages of development including clinical-stage candidates NeuCeptin (trastuzumab) and NeuLara (ustekinumab). Several other biosimilars are set to begin clinical development over the coming years. As part of its strategy for biosimilar products, NeuClone remains open to potential development and commercialisation collaborations.

About the Study
The Phase I clinical trial (registration number ACTRN12618001657213) was a randomised, double-blind, single-dose, three-arm study to evaluate the pharmacokinetics (PK) and safety of NeuCeptin compared to Herceptin (trastuzumab). Over 100 healthy volunteers were enrolled in sites across Australia and randomised (1:1:1) to receive either NeuCeptin biosimilar, Herceptin sourced from the US, or Herceptin sourced from the EU, administered as a single intravenous infusion. PK endpoints included: area under the concentration-time curve from first to last timepoint measured (AUC0-last), area under the concentration-time curve from time zero extrapolated to infinity (AUC0-inf), and maximum serum concentration (Cmax). The 90% confidence intervals of each endpoint were contained within pre-specified bioequivalence margins of 80% to 125%, for all 3 pairwise comparisons. The trial was conducted under the Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN) scheme offering a streamlined approach with data output supported by global regulatory agencies such as the EMA and US FDA.

On December 5, 2019 Xspray Pharma reported the company has successfully carried out a directed share issue at a subscription price of SEK 73 per share (the "Issue") (Press release, Xspray, DEC 5, 2019, View Source [SID1234650106]). The subscription price is in line with the volume-weighted average price of the Xspray share during the last 30 days. The subscription price has been determined through an accelerated book-building procedure.

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A group of Swedish and international institutional investors, among others C WorldWide Asset Management, Fourth Swedish National Pension Fund, Swedbank Robur, TIN Fonder, Third Swedish National Pension Fund and Unionen have subscribed for shares in the Issue. The Company believes that using the flexibility provided by a non-pre-emptive placing is the most appropriate transaction structure at this time in order to raise capital for the development of ongoing projects in a time and cost-effective manner. Moreover, through the Issue, the Company will further strengthen the shareholder base with institutional investors.

The Company intends to use the net proceeds from the Issue to:

enhance the Company’s financial flexibility ahead of anticipated registration application of its lead product, HyNap-Dasa, in 2020 and anticipated deal making pertaining to the launch of this candidate;
establish second source manufacturing;
working capital requirement at expected listing on Nasdaq Stockholm’s Main Market during the first half of 2020;
continue to expand its product portfolio;
general corporate purposes.
The Issue is expected to raise proceeds for the Company of approximately SEK 122 million before transaction costs. The subscription price has been determined through an accelerated book-building procedure. The Issue will result in an increase in the number of shares in Xspray of 1,675,162, from 15,076,460 to 16,751,622, and an increase in the share capital by SEK 1,675,162, from SEK 15,076,460 to SEK 16,751,622, resulting in a dilution of approximately 10 percent.

In connection with the Issue, the Company has, with customary exceptions, agreed to a lock-up undertaking on future share issuances for a period of 90 days after the Issue. In addition, the management and Board of Directors have undertaken not to sell any shares in Xspray during the same period, subject to customary exceptions.

The reason for using the flexibility provided by a non-pre-emptive placing is to raise capital for the development of ongoing projectsand to further strengthen the Company’s shareholder base in a time and cost-effective manner.