Naxitamab Receives Positive Opinion for Orphan Medicinal Product Designation Approval in the EU

On October 23, 2018 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq:YMAB) reported that the Committee for Orphan Medicinal Products ("COMP") of the European Medicines Agency ("EMA") has recommended the granting of orphan medicinal product designation ("OMPD") in the European Union ("EU") for naxitamab, one of the Company’s lead product candidates, for the treatment of relapsed or refractory high-risk neuroblastoma (Press release, Y-mAbs Therapeutics, OCT 23, 2018, View Source [SID1234530055]). The positive opinion from the EMA’s COMP has been sent to the European Commission ("EC"), which is expected to grant the orphan drug designation within 30 days.

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Obtaining OMPD for naxitamab is part of an overall plan to expand the Company’s European development program and ultimately obtain orphan drug exclusivity to protect naxitamab in the EU for the treatment of relapsed or refractory high-risk neuroblastoma.

Under the EMA’s Regulation (EC) No. 141/2000 an orphan medicinal product designation gives companies access to protocol assistance and guidance on preparing a dossier that will meet European regulatory requirements and thereby maximize the chance of success at the time of marketing authorization. Once approved, an orphan drug is also granted 10 years of market exclusivity during which directly competitive similar products cannot normally be placed on the market.

The EMA grants orphan medicinal product designation based upon several criteria: the life threatening and debilitating nature of the condition; the medical plausibility of the proposed orphan indication; a prevalence in Europe of less than 5 cases for each 10,000 of population; no satisfactory method of diagnosis, prevention or treatment exists or if such method exists the medicinal product will be of significant benefit to those affected by that condition.

Y-mAbs Founder, President and Head of Business Development and Strategy, Thomas Gad said, "We are very pleased that the COMP has issued a positive opinion for orphan drug designation to naxitamab which will give us a string of development incentives."

Dr. Claus Møller, Chief Executive Officer, further notes, "The orphan designation strengthens our opportunity to bring naxitamab to patients who desperately need alternative methods of treatment. Further, the designation marks a substantial milestone in Y-mAbs’ expansion into European development."

Five Prime Therapeutics to Announce Third Quarter 2018 Financial Results and Host Conference Call on November 6

On October 23, 2018 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported that it will report its third quarter 2018 financial results on Tuesday, Nov. 6, 2018, after the U.S. financial markets close (Press release, Five Prime Therapeutics, OCT 23, 2018, View Source [SID1234530071]). Five Prime will host a conference call and live audio webcast on Tuesday, Nov. 6, 2018, at 4:30 p.m. (ET)/1:30 p.m. (PT) to discuss the company’s financial results and provide a general business update.

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The live audio webcast may be accessed through the "Events & Presentations" page in the "Investors" section of the company’s website at www.fiveprime.com. Alternatively, participants may dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 6489275.

The archived conference call will be available on Five Prime’s website beginning approximately two hours after the event and will be archived and available for replay for at least 30 days after the event.

Epigenomics AG successfully completes capital increase; gross proceeds of EUR 22.3 million

On October 23, 2018 Epigenomics AG (FSE: ECX; OTCQX: EPGNY) ("Company") reported that it has fully placed the new shares from the capital increase resolved on October 7, 2018 of up to EUR 12,007,180 (corresponds to 50% of the existing share capital) (Press release, Epigenomics, OCT 23, 2018, View Source [SID1234530229]). Accordingly, the Company’s share capital will be increased from currently EUR 24,014,360 to EUR 36,021,540 by 12,007,180 new registered shares of the Company against contribution in cash and partly in kind.

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The private placement with selected qualified investors was significantly oversubscribed. All shares of the private placement were allocated to multiple new institutional investors in the U.S.A, including healthcare funds.

Gross proceeds of the capital increase amount to EUR 22.33 million, thereof EUR 21.25 million in cash. Furthermore, the financial liabilities from the redemption of a convertible bond subscribed by Cathay Fortune International Company Limited are reduced by EUR 1.08 million from EUR 7.1 million to EUR 6.02 million.

The capital increase needs to be registered in the commercial register, which the Executive Board will apply for shortly. The inclusion of the new shares under the Company’s existing listing (ISIN DE000A11QW50) is currently expected at or around October 29, 2018.

Illumina Reports Financial Results for Third Quarter of Fiscal Year 2018

On October 23, 2018 Illumina, Inc. (NASDAQ: ILMN) reported its financial results for the third quarter of fiscal year 2018 (Press release, Illumina, OCT 23, 2018, View Source [SID1234530072]).

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Third quarter 2018 results:

Revenue of $853 million, a 20% increase compared to $714 million in the third quarter of 2017
GAAP net income attributable to Illumina stockholders for the quarter of $199 million, or $1.33 per diluted share, compared to $163 million, or $1.11 per diluted share, for the third quarter of 2017
Non-GAAP net income attributable to Illumina stockholders for the quarter of $227 million, or $1.52 per diluted share, compared to $163 million, or $1.11 per diluted share, for the third quarter of 2017 (see the table entitled "Itemized Reconciliation Between GAAP and Non-GAAP Net Income Attributable to Illumina Stockholders" for a reconciliation of these GAAP and non-GAAP financial measures)
Cash flow from operations of $292 million compared to $235 million in the third quarter of 2017
Free cash flow (cash flow from operations less capital expenditures) of $228 million for the quarter, compared to $153 million in the third quarter of 2017
Gross margin in the third quarter of 2018 was 70.0% compared to 67.5% in the prior year period. Excluding amortization of acquired intangible assets, non-GAAP gross margin was 71.1% for the third quarter of 2018 compared to 68.8% in the prior year period.

Research and development (R&D) expenses for the third quarter of 2018 were $159 million compared to $134 million in the prior year period. Non-GAAP R&D expenses as a percentage of revenue were 18.6%, including 0.9% attributable to Helix. This compares to non-GAAP R&D expenses as a percentage of revenue of 18.7% in the prior year period, including 0.8% attributable to Helix.

Selling, general and administrative (SG&A) expenses for the third quarter of 2018 were $197 million compared to $167 million in the prior year period. Non-GAAP SG&A expenses as a percentage of revenue were 23.2%, including 1.4% attributable to Helix. This compares to 23.2% in the prior year period, including 1.7% attributable to Helix.

Depreciation and amortization expenses were $46 million and capital expenditures for free cash flow purposes were $64 million during the third quarter of 2018. At the close of the quarter, the company held $3.4 billion in cash, cash equivalents and short-term investments, compared to $2.1 billion as of December 31, 2017.

"Illumina’s strong performance in the third quarter of 2018 reflected growth across our sequencing and arrays portfolios," said Francis deSouza, President and CEO. "Sequencing system revenue of $138 million was the strongest since 2015, reflecting strong demand within our sequencing family from the NovaSeq, the most powerful and flexible sequencer ever, to the iSeq, our most accessible and easiest-to-use sequencer."

Updates since our last earnings release:

Received regulatory approval for the MiSeqDx, Illumina’s first next-generation sequencing (NGS) system cleared by the National Medical Products Administration (NMPA) in China
Released the S4 200 cycle kit for the NovaSeq in response to customer requests to support high-throughput sequencing for whole exome, RNA and single-cell sequencing
Reached a legal settlement as well as a supply and license agreement with Premaitha, who will now license Illumina’s IP for NIPT, launch an IONA test that runs on Illumina sequencing technology, and work with customers to migrate to Illumina systems
Completed an offering of 0.0% convertible senior notes due 2023 for an aggregate principal amount of $650 million, plus an additional $100 million pursuant to the initial purchasers’ option to purchase additional notes, for total net proceeds of $735 million
Repurchased $103 million of common stock in the third quarter under the previously announced share repurchase program
Financial outlook and guidance

The non-GAAP financial guidance discussed below reflects certain pro forma adjustments to assist in analyzing and assessing our core operational performance. Please see our Reconciliation of Non-GAAP Financial Guidance included in this release for a reconciliation of the GAAP and non-GAAP financial measures.

For fiscal 2018, the company projects revenue growth of approximately 20%. The company now expects fiscal 2018 GAAP earnings per diluted share attributable to Illumina stockholders of $5.32 to $5.37 and non-GAAP earnings per diluted share attributable to Illumina stockholders of $5.70 to $5.75.

Quarterly conference call information

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Tuesday, October 23, 2018. Interested parties may access the live teleconference through the Investor Relations section of Illumina’s web site under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 800-708-4540, or 1-847-619-6397 outside North America, both with passcode 47554920.

A replay of the conference call will be available from 4:30 pm Pacific Time (7:30 pm Eastern Time) on October 23, 2018 through October 30, 2018 by dialing 1-888-843-7419, or 1-630-652-3042 outside North America, both with passcode 47554920.

Statement regarding use of non-GAAP financial measures

The company reports non-GAAP results for diluted net income per share, net income, gross margins, operating expenses, operating margins, other income, and free cash flow in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The company’s financial measures under GAAP include substantial charges such as amortization of acquired intangible assets, non-cash interest expense associated with the company’s convertible debt instruments that may be settled in cash, and others that are listed in the itemized reconciliations between GAAP and non-GAAP financial measures included in this press release. Management has excluded the effects of these items in non-GAAP measures to assist investors in analyzing and assessing past and future operating performance. Additionally, non-GAAP net income attributable to Illumina stockholders and diluted earnings per share attributable to Illumina stockholders are key components of the financial metrics utilized by the company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation.

The company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release.

CEL-SCI RECEIVES ABOUT $8 MILLION FROM WARRANT EXERCISES

On October 23, 2018 CEL-SCI Corporation (NYSE American: CVM) reported it has received just under $8 million through the exercise of warrants to purchase shares of the Company’s common stock during the past 3 months (Press release, Cel-Sci, OCT 23, 2018, View Source [SID1234530605]). As of October 22, 2018, CEL-SCI had 28,271,615 outstanding shares of common stock.

"We have raised $20 million this year as we are nearing the date for the final data readout on our pivotal, global Phase 3 study in head and neck cancer," stated CEL-SCI’s Chief Executive Officer Geert Kersten

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