On October 23, 2018 Pulse Biosciences, Inc. (NASDAQ: PLSE), a novel medical therapy company bringing to market its proprietary Nano-Pulse Stimulation platform, reported that the Company will report third quarter 2018 operational highlights and financial results on Tuesday, October 30, 2018 (Press release, Pulse Biosciences, OCT 23, 2018, View Source [SID1234530070]). Pulse Biosciences management will host a conference call and webcast at 4:30 p.m. Eastern Time (ET) / 1:30 p.m. Pacific Time (PT).

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Analysts and investors can participate in the conference call by dialing (844) 494-0190 (domestic) and (508) 637-5580 (international) using the conference ID# 2098843. The webcast of the conference call can be accessed live on the Investor Relations section of the Pulse Biosciences website at www.pulsebiosciences.com.

On October 23, 2018 Immunomic Therapeutics, Inc. (ITI), a privately held, Maryland-based biotechnology company, reported that the company will present at the NYC Oncology Investor Conference. Immunomic’s Founder and Chief Executive Officer (CEO) William Hearl, Ph.D., will discuss Immunomic’s recently-expanded investigational UNiversal Intracellular Targeted Expression (UNITE) platform and its application in immuno-oncology, specifically glioblastoma multiforme (GBM) (Press release, Immunomics, OCT 23, 2018, View Source [SID1234530091]). The uniquely-comprehensive design features of the UNITE platform allow vaccines to broadly activate adaptive immunity, resulting in both humoral and cellular responses. UNITE aims to provide a solution to direct and enhance antigen processing and presentation, which in turn, increases the immunogenicity of nucleic acid vaccines. Immunomic’s technology platform has the potential to utilize the body’s natural biochemistry to develop a broad immune response and is currently being employed in a Phase II clinical trial as a cancer immunotherapy.

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Who: William Hearl, Ph.D., Founder and CEO of Immunomic Therapeutics

What: Presentation on UNITE Technology as applied to Oncology

When: Tuesday, October 30 at 3:30 p.m. EDT

Where: Rockefeller Center, 1270 6th Avenue, New York, NY, 10020

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

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."

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.

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.