On November 13, 2019 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that company executives will provide a corporate update at two upcoming investor relations conferences in November (Press release, GlycoMimetics, NOV 13, 2019, View Source [SID1234551129]). Details are as follows :

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STIFEL HEALTHCARE CONFERENCE (NEW YORK)
Date: Tuesday, November 19, 2019
Time: 4:10 p.m. ET
Presenter: GlycoMimetics CFO Brian Hahn

JEFFERIES 2019 LONDON Healthcare Conference
Date: Thursday, November 21, 2019
Time: 7:20 a.m. GMT
Presenter: GlycoMimetics CEO Rachel King

To access the live webcast and subsequent archived recordings for this presentation, please visit the GlycoMimetics website at www.glycomimetics.com.

On November 13, 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 financial results for the third quarter of 2019 (Press release, Y-mAbs Therapeutics, NOV 13, 2019, View Source [SID1234551145]).

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"We are very pleased with our third quarter results, highlighted by prudent spending combined with notable progress in the preparation of our BLAs for naxitamab and omburtamab, as well commercial ramp-up for the potential launch of both compounds. In addition, we succesfully completed a follow-on offering in November, securing gross proceeds of $143.8 million, which we believe will – together with our existing cash – be sufficient to cover our operating costs through 2022," stated Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.

Dr. Claus Moller, Chief Executive Officer, continued, "Over the third quarter, we have continued to work hard to make sure that our lead product candidates, naxitamab and omburtamab, advance towards rolling BLA submissions. We still expect the first portion of the rolling BLA for naxitamab to be submitted within the next few weeks, and we expect to file our BLA submission for omburtamab either via a rolling submission to begin in 2019 or early 2020 or via a single submission ahead of our expected completion date at the end of the first quarter of 2020.

Third Quarter 2019 and Recent Corporate Developments

Subsequent to the end of the third quarter, on November 1, 2019, Y-mAbs announced the pricing of a follow-on shelf public offering, resulting in gross proceeds to the Company of approximately $143.8 million.

·Also, subsequent to the end of the third quarter, on November 1, 2019, Y-mAbs announced that the requested omburtamab pre-BLA meeting with the FDA, had been converted to a general guidance meeting. Y-mAbs still expects to complete the omburtamab BLA submission by the end of the first quarter of 2020, and believes that the overall commercialization timeline will not be affected.

·Also, subsequent to the end of the third quarter, on October 28, 2019, Y-mAbs announced an update on omburtamab data, which was presented at the Interntional Society of Pediatric Oncology conference.

·After the close of the third quarter, on October 25, 2019, Y-mAbs announced an update on naxitamab data, which was presented at the Interntional Society of Pediatric Oncology conference.

On August 30, 2019, Y-mAbs announced the acceptance of abstracts concerning DSRCT for presentation at the Connective Tissue Oncology Society (CTOS) Annual Meeting for omburtamab.

· On July 8, 2019, Y-mAbs announced that it had completed a successful pre-BLA meeting with the FDA regarding a potential pathway for FDA approval of naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma. During the meeting, the Company reached alignment with the FDA on an Accelerated Approval Pathway for naxitamab along with a rolling BLA submission.

· On July 1, 2019, Y-mAbs announced the status of patient recruitment for the Company’s two pivotal phase II trials, one for omburtamab for the treatment of central nervous system/leptomeningeal metastasis (CNS/LM) from neuroblastoma and the other for naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma.

· Also, on July 1, 2019, Y-mAbs announced that the Company has entered into a development, manufacturing and supply agreement with SpectronRx in South Bend, Indiana, to secure access to clinical and commercial scale radiolabeling capacity for omburtamab. Under the terms of the agreement, SpectronRx has agreed to establish a manufacturing unit designated for Y-mAbs within its existing

facilities, at which Y-mAbs believes both clinical and commercial supply of radiolabeled omburtamab can be produced.

Third Quarter 2019 Financial Results

Y-mAbs reported a net loss of $23.9 million, or $0.70 per basic and diluted share, for the three months ended September 30, 2019, compared to a net loss of $11.4 million, or $0.42 per basic and diluted share, for the three months ended September 30, 2018.

For the nine months ended September 30, 2019, Y-mAbs reported a net loss of $57.9 million, or $1.69 per basic and diluted share, compared to a net loss of $29.2 million, or $1.08 per basic and diluted share, reported for the nine months ended September 30, 2018.

Operating Expenses

Research and Development

Research and development expenses were $19.7 million for the three months ended September 30, 2019, compared to $8.7 million for the three months ended September 30, 2018, an increase of $11.0 million. The increase in research and development expenses primarily reflects the following:

·$7.3 million increase in outsourced manufacturing for our two lead product candidates, naxitamab and omburtamab;

· $1.5 million increase in outsourced research and supplies to support expanding development activities; and

· $0.7 million increase in personnel costs.

Research and development expenses were $46.7 million for the nine months ended September 30, 2019, compared to $23.2 million for the nine months ended September 30, 2018, an increase of $23.5 million. The increase in research and development expenses primarily reflects the following:

· $14.5 million increase in outsourced manufacturing for our two lead product candidates, naxitamab and omburtamab;

· $5.0 million increase in outsourced research and supplies to support expanding development activities; and

·$1.9 million increase in personnel costs.

General and Administration

General and administrative expenses were $4.7 million for the three months ended September 30, 2019, compared to $2.7 million for the three months ended September 30, 2018, an increase of $2.0 million. Such increase in general and administrative expenses primarily reflects the following:

· $0.8 million increase in personnel costs; and

·$0.6 million increase in commercial infrastructure.

General and administrative expenses were $12.6 million for the nine months ended September 30, 2019, compared to $5.9 million for the nine months ended September 30, 2018, an increase of $6.7 million. Such increase in general and administrative expenses primarily reflects the following:

·$3.6 million increase in personnel costs; and

· $1.4 million increase in commercial infrastructure costs.

Cash and Cash Equivalents

The Company had approximately $98.2 million in cash and cash equivalents as of September 30, 2019, compared to $147.8 million as of December 31, 2018. The decrease of $49.6 million was primarily attributable to the increased costs of operation as the Company prepares for its submission of rolling BLAs for naxitamab and omburtamab and the build-up of the Company’s commercial infrastructure.

Webcast and Conference Call

The Company will host a conference call today at 4:30 pm eastern time. To participate in the call, please dial 877-407-0792 (domestic) or 201-689-8263 (international) and reference the access code 13696442. A webcast will be available at: View Source

On November 13, 2019 The Basser Center for BRCA at the Abramson Cancer Center of the University of Pennsylvania reported that it will host its third Basser Jean Bash on November 18th at Cipriani Wall Street (Press release, Basser Center for BRCA, NOV 13, 2019, View Source [SID1234551179]). This year’s Bash celebrates the remarkable progress made by the Basser Center for BRCA, the milestone of the cloning of BRCA1 25 years ago, and the scientific contributions that have advanced the understanding, treatment, and prevention of BRCA-related cancers.

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As part of this year’s event, the Basser Center for BRCA will officially launch the LATINX & BRCA initiative, a comprehensive effort to raise awareness, provide education and resources, and build community around BRCA-related cancers. Among the honorees of this year’s event is Nina Garcia, editor-in-chief of Elle magazine, who announced this year that she has a BRCA mutation and underwent preventative treatment, bravely sharing her story publicly along the way.

The Basser Center is the world’s first comprehensive center to focus solely on the prevention and treatment of cancers associated with inherited mutations of the BRCA genes. Founded by University of Pennsylvania alumni Mindy and Jon Gray, President and Chief Operating Officer at Blackstone, the Basser Center was established in 2012 in honor of Mindy’s sister, Faith Basser, who passed away at the age of 44 of BRCA-related ovarian cancer. The Grays have contributed more than $55 million to fund the mission of the Center, and in total the Basser Center has raised $100 million.

The Basser Jean Bash, which is expected to draw 1100 guests, is being generously underwritten so that every dollar raised will support the life-saving mission of the Basser Center for BRCA. To date, this event has raised $8 million, and this year a limited edition denim tote, customized with the distinct Basser logo, will be available for purchase the evening of the event with 100 percent of the proceeds supporting the Basser Center for BRCA.

On November 13, 2019, Exicure, Inc. (the "Company") reported that it has entered into a Collaboration, Option and License Agreement (the "Collaboration Agreement") with a wholly-owned subsidiary of Allergan plc, Allergan Pharmaceuticals International Limited ("Allergan") (Filing, 8-K, Exicure, NOV 13, 2019, View Source [SID1234551300]). Pursuant to the Collaboration Agreement, the Company granted to Allergan exclusive access and options to license spherical nucleic acid ("SNA") based therapeutics arising from two collaboration programs related to the treatment of hair loss disorders. Each such license would grant to Allergan exclusive, royalty-bearing, sublicenseable, nontransferable, worldwide rights to develop, manufacture, use and commercialize such SNA therapeutics. Upon written notice to the Company, Allergan may exercise its option at any time following the effective date of the Collaboration Agreement until the expiration of the corresponding collaboration program’s option exercise period (each, an "Option Exercise Period").

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Under the terms of the Collaboration Agreement, the Company will conduct discovery and development in two collaboration programs for hair loss disorders. The Company shall be solely responsible for all costs and expenses of conducting each collaboration program through the completion of initial preclinical activities, and, if Allergan pays the option extension payment described below, all additional activities that are necessary to enable the first filing of an investigational new drug application ("IND"), except to the extent Allergan elects to conduct any formulation assessment activities or in vivo efficacy models. In the event that Allergan exercises an option, Allergan will be responsible for further development from the license effective date and commercialization of the corresponding licensed product.

Under the terms of the Collaboration Agreement, the Company will receive an upfront payment of $25 million, and, if Allergan exercises any of its option rights, Allergan will pay to the Company an option exercise fee equal to $10 million for each exercised option, if such option is exercised during the initial option exercise period. Should Allergan wish to extend an option exercise period beyond the applicable initial exercise period for a particular program, Allergan must pay the Company a one-time option extension payment in the amount of $10 million for each such option exercise period extension and the option payment to exercise the option during such option period extension shall then be $15 million for each exercised option.

If Allergan exercises an option for a program, development and regulatory milestones will be payable for that program upon the initiation of certain clinical trials, and acceptance of the filing for processing by the FDA in the United States and by 2 additional regulators outside the United States of a marketing application for review, per program, with an aggregate total of up to $195 million if both options are exercised. Commercial milestones will be payable for that program upon first commercial sale of a licensed product in certain jurisdictions and the achievement of specified aggregate sales thresholds for all licensed products from that program, with an aggregate total of up to $530 million if both options are exercised. In the event a therapeutic candidate subject to the collaboration results in commercial sales, the Company is eligible to receive tiered royalties at percentages ranging from the mid-single digits to the mid-teens on future net product sales of such commercialized therapeutic candidates. A percentage of the aforementioned payments will be due to Northwestern University ("Northwestern") upon receipt, pursuant to the Company’s existing license agreements with Northwestern (the "Northwestern License Agreements").

The Collaboration Agreement will remain in effect, unless earlier terminated, until (a) the expiration of the later-to-expire option exercise period, if Allergan does not exercise either option, or (b) the expiration of the last-to-expire royalty term for any licensed product in such country on a licensed product-by-licensed product and country-by-country basis, if Allergan exercises one or both options. Upon expiration of the royalty term with respect to a particular licensed product in a country, the license for such product in such country will convert to a worldwide, fully-paid, irrevocable and perpetual license.

The Collaboration Agreement also contains customary provisions for termination by either party, including in the event of breach of the Collaboration Agreement, subject to cure, by Allergan for convenience and by the Company upon a challenge of the licensed patents, subject, in certain cases, to customary reversion rights. Upon termination of the Collaboration Agreement by Allergan for convenience or by either party for the other’s breach or bankruptcy, all licenses granted by the Company to Allergan will terminate.

The Collaboration Agreement includes customary representations and warranties on behalf of both the Company and Allergan. The Collaboration Agreement also provides for customary mutual indemnities.

Either party may assign the Collaboration Agreement or delegate its obligations to an affiliate or to a successor without the consent of the other party.

In connection with the entry into the Collaboration Agreement, the Company, Allergan and Northwestern entered into a side letter to the Northwestern License Agreements (the "Side Letter"). Pursuant to the Side Letter, the parties thereto clarified certain provisions of the Northwestern License Agreements as they apply to the sublicenses granted to Allergan pursuant to the Collaboration Agreement, including providing for the survival of Allergan’s sublicense to the applicable Northwestern intellectual property rights should the Northwestern License Agreements terminate or if the Company’s licenses to such intellectual property rights are rendered non-exclusive in accordance with the Northwestern License Agreements (other than as a result of an act or omission on the part of Allergan or any of its Affiliates or sublicensees). Additionally, the Side Letter clarified Allergan’s rights to grant further sublicenses under such intellectual property rights granted to the Company pursuant to the Northwestern License Agreement.

The foregoing summaries of the Collaboration Agreement and the Side Letter do not purport to be complete and are qualified in its entirety by reference to the full text of the Collaboration Agreement and the Side Letter, copies of which, subject to any applicable confidential treatment, will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2019.

On November 13, 2019 Perrigo Company plc (NYSE; TASE: PRGO), reported that CEO and President, Murray S. Kessler and CFO, Ray Silcock, will present at the Morgan Stanley Global Consumer & Retail Conference at 10:00 AM EST on Wednesday, December 4, 2019 (Press release, Perrigo Company, NOV 13, 2019, View Source [SID1234551130]). Interested parties can access the presentation webcasts at View Source

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Discover why more than 1,500 members use 1stOncology™ to excel in:

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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