On May 14, 2019 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that it will announce its 2019 first quarter results on Wednesday, May 22, 2019 (Press release, Bavarian Nordic, MAY 14, 2019, View Source [SID1234536278]).

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The management of Bavarian Nordic will host a conference call at 2:00 pm CEST (8:00 am EDT) on the same day to present the interim results followed by a Q&A session. A live and replay version of the call and relevant slides will be available at http://bit.ly/2PNW058.

To join the Q&A session dial one of the following numbers and state the participant code 3096344: Denmark: +45 32 72 80 42, UK: +44 (0) 844 571 8892, USA: +1 631-510-7495.

Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations & Communications. Phone +45 61 77 47 43
U.S.: Graham Morrell, Paddock Circle Advisors (US), Tel: +1 781 686 9600

On May 14, 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, is reported a development update on its cancer vaccine program, the GD2-GD3 Vaccine (Press release, Y-mAbs Therapeutics, MAY 14, 2019, View Source [SID1234536277]).

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At the Advances in Neuroblastoma Research (ANR) conference in San Francisco in May 2018, Phase 2 data utilizing GD2-GD3 Vaccine for Stage 4 high-risk neuroblastoma was presented. A total of 84 pediatric patients received the GD2-GD3 Vaccine, all of whom had prior relapses and finally regained second or later remissions before vaccine treatment. An interim analysis shows a progression free survival (PFS) of 51% and overall survival (OS) of 90% at 2 years. The GD2-GD3 Vaccine appears to be well tolerated, with no reported grade 3 or grade 4 toxicities. To date, more than 230 patients have been treated with the GD2-GD3 Vaccine at Memorial Sloan Kettering Cancer Center (MSK) in New York under a MSK sponsored IND.

"Since Y-mAbs licensed the GD2-GD3 Vaccine in June 2018, we have explored our options to establish commercial scale cGMP production. We believe we now have a viable route forward for manufacturing, and plan to begin using the newly manufactured cGMP drug product in the fourth quarter of 2019. Establishment of a clear path towards approval has been a prerequisite for advancing the GD2-GD3 Vaccine program and we are very excited to move the program forward. We believe the GD2-GD3 Vaccine for relapsed high-risk neuroblastoma may offer meaningful improvement in the long-term treatment paradigm for pediatric patients, serving as a natural extension post immunotherapy treatment with our naxitamab antibody based product candidate," stated Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.

Dr. Claus Møller, Chief Executive Officer continued, "We believe that the more than 230 patients treated to date represents the largest population ever to receive a neuroblastoma vaccine. The 84 patients reported on at ANR received seven subcutaneous injections of the GD2-GD3 Vaccine in the outpatient clinic without any measurable pain or significant adverse side effects. We are very encouraged with the two year OS of approximately 90% in these 84 patients. We hope to replicate these data with the newly manufactured cGMP drug product in a multicenter trial."

On May 14, 2019 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that Briggs W. Morrison, M.D., Chief Executive Officer of Syndax, will present at the UBS Global Healthcare Conference on Tuesday, May 21, 2019 at 10:30 a.m. ET at the Grand Hyatt New York (Press release, Syndax, MAY 14, 2019, View Source [SID1234536276]).

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A live webcast of the Company’s presentation can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the events will also be available for a limited time.

On May 14, 2019 Medigene AG (FSE: MDG1, Frankfurt, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, reported financial results for the first three months of 2019 and provided a review of recent accomplishments and anticipated upcoming milestones (Press release, MediGene, MAY 14, 2019, View Source [SID1234536275]). The company further adjusted its financial guidance for the fiscal year 2019 following two business transactions announced in the second quarter of 2019.

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Major events since the beginning of 2019:
* Medigene treated the first patient in the Phase I/II clinical trial of the T cell receptor-modified T cell immunotherapy (TCR-T) MDG1011
* Medigene and Roivant affiliate Cytovant entered into a strategic partnership for the research and development of cell therapies in Asia
* bluebird bio presented preclinical data of first TCR candidate from ongoing collaboration with Medigene and announced plans to start clinical development of this MAGE-A4 targeting TCR in 2020
* Medigene licensed a chimeric co-stimulatory receptor to enhance TCR therapies for solid tumors
* Medigene sold the remaining rights and stocks of the legacy product Veregen
* Medigene presented positive results from in vitro tests to assess the potential TCR-mediated off-target toxicity for neuronal cells at the annual meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) and presented preclinical data on the selective killing of tumor cells by PRAME TCR-transduced T cells at the AACR (Free AACR Whitepaper) conference
* Medigene obtained two European patents for its dendritic cell (DC) vaccine platform and for the TCR building block library to develop neoantigen-specific TCRs
* Medigene appointed Axel-Sven Malkomes as CFO/CBDO

Prof. Dolores Schendel, CEO of Medigene AG, comments: "We have had a very productive start to 2019 with progress in our own clinical projects and in the development of partner programs. Patient treatment in our TCR-T study MDG1011 has started, and we anticipate accelerating patient recruitment following the upcoming expansion of the number of clinical centers in this trial. Additionally, our licensing agreement with Roivant/Cytovant will enable us to generate and deliver our TCR constructs and Dendritic Cell vaccine to Cytovant, who will ultimately develop, manufacture and commercialize these promising immunotherapies for the East Asian patient populations."
"Moreover, we were thrilled that the first TCR discovery project we developed for our partner bluebird bio yielded a TCR candidate displaying convincing preclinical data and has been selected for clinical development by bluebird bio."
"Finally, with the sale of the remaining Veregen rights, we have completed our transformation into a pure-play immuno-oncology company. With an improved financial forecast and sufficient liquid assets, we are well positioned to continue making further progress across our immunotherapy platform and development candidates."

Three months’ financial results:
* Revenue from immunotherapies stable at EUR 1.4 m
* Research and development expenses (R&D) increased as planned by 28% to EUR 5.5 m due to expansion of clinical activities
* EBITDA loss increased as planned by 31% to EUR 5.0 m due to progress in immunotherapy programs
* Net loss for the period increased as planned by 36% to EUR 5.7 m
* Cash and cash equivalents and time deposits of EUR 65.5 m as at March 31, 2019

Financial guidance 2019:

Medigene revises the financial guidance for 2019 published in the 2018 Annual Report following the Roivant/Cytovant partnership in cellular immunotherapies and the sale of remaining rights to Veregen, both closed in April 2019.
* The Company improves its revenue guidance and expects to generate total revenues of between EUR 10 – 11 m (previous guidance: EUR 5.5 – 6.5 m) in 2019, approximately EUR 5 m anticipated from the cell therapy deal with Roivant/Cytovant.
* Medigene continues to expect research and development expenses of EUR 24 -29 m in 2019 due to progress of the preclinical and clinical development programs including manufacturing costs for clinical trial material.
* The Company also confirms its EBITDA-guidance and continues to expect a loss at EBITDA level of EUR 23 – 28 m, as the additional revenue from the Roivant/Cytovant deal will be compensated by a non-cash effect of EUR -4 and -5 m resulting from the Veregen deal, as announced in the press release from April 8, 2019.

Outlook immunotherapies:
Medigene confirms its outlook for immunotherapies published in the Annual Report 2018:

T cell receptor-modified T cells (TCR-Ts)

Current Phase I/II clinical trial with MDG1011: In addition to the three active study centers to date, it is anticipated that up to five new centers will begin recruiting patients in the second quarter and early third quarter of 2019. The University Clinic of Dresden was the first new study center to open. In 2019, the focus of the trial will be the recruitment of the first dose cohorts to assess the safety and tolerability of the treatment with MDG1011.

Development of additional TCR candidates: In 2019, in addition to the MDG1011 clinical trial, Medigene will work on characterizing new TCR candidates for future clinical trials under the responsibility and funding of Medigene and collecting preclinical data to prepare further clinical TCR trials.

Evaluation of HA-1 TCR as a potential clinical candidate: Medigene is assessing the in-licensed HA-1-specific T cell receptor to determine if it is a suitable candidate for expansion of Medigene’s TCR-T clinical development program.

Optimization of future TCR therapies for solid tumors: In addition, the chimeric co-stimulatory receptor (the PD-1/4-1BB molecule) exclusively licensed from HMGU will be assessed in combination with Medigene’s tumor-specific T cells (TCR-Ts) in preclinical models in order to optimize future TCR therapies for solid tumors.

TCR partnerships: Within the framework of the collaboration entered into with Roivant/Cytovant, Medigene will now, together with the collaboration partner, undertake preparations to generate TCR constructs tailored specifically to Asian patients using its proprietary TCR discovery platform. In addition, Medigene continues the successful collaboration with bluebird bio.

IIT from academic partners: In addition to the Company’s own development activities, the start of the academic investigator initiated TCR-modified T cell therapy clinical trial (IIT) under the responsibility of Max-Delbrück-Center and Charité University Hospital in Berlin, Germany is expected.

Dendritic cell vaccines (DCs)

Conclusion of the Phase I/II clinical trial at the end of 2019: Medigene will continue the current Phase I/II clinical trial for DC vaccines for the treatment of acute myeloid leukemia (AML) as planned and bring it to a conclusion at the end of 2019. The data from the interim analysis will be presented beforehand at the Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) taking place from June 13 – 16 in Amsterdam. The final data will be available towards the end of 2019/beginning of 2020.

The full version of the quarterly statement 3M-2019 can be downloaded here: View Source

Conference call and webcast: A telephone conference (webcast) in English will be held today at 3:00 pm CET (Munich/Frankfurt) / 9:00 am EST (New York) and transmitted live via webcast. Access and transmission of the synchronized presentation slides and a recording of the presentation is available on the homepage of Medigene at View Sourcewebcasts/

On May 14, 2019 ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported its operational and financial results for the three months ended March 31, 2019 (Press release, ProMIS Neurosciences, MAY 14, 2019, View Source [SID1234536274]).

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"Over the course of the first quarter of 2019, the value of our unique discovery and development platform was further evidenced as we made considerable progress in expanding our portfolio of opportunities in neurodegenerative diseases," stated Eugene Williams, ProMIS’ Executive Chairman. Antibody candidates selectively targeting toxic forms of alpha synuclein for Parkinson’s disease (PD) and toxic, aggregated forms of TDP43 for amyotrophic lateral sclerosis (ALS) were identified and further characterized to support ongoing pharmaceutical partnering discussions."

Corporate Highlights

In January 2019, we completed a private placement of 9,560,000 common share units at a price of $0.23 per unit resulting in gross proceeds of approximately $2,198,800. Each unit consisted of one common share and one common share warrant. The common shares are subject to a four-month hold period from the date of issuance. The expiry of the warrant is subject to acceleration under certain conditions.
In February 2019, we announced the identification of several antibody drug candidates showing best-in-class selectivity for toxic forms of alpha synuclein compared to other therapeutic antibodies in development for PD.
Following this announcement, Dr. Neil Cashman, our CSO presented further results of the Company’s PD program at the International AD/PD 2019 Conference on March 31. The data presented showed how our novel drug discovery and development platform created antibodies that: 1) selectively bind to toxic forms of alpha synuclein while sparing healthy forms of alpha synuclein that are critical for proper cell metabolism and communication, and 2) block the neurotoxicity and the spread of the toxic forms of alpha synuclein in vitro.
In January 2019, we appointed Timothy G. Rothwell to our Business Advisory Board. Mr. Rothwell is a highly accomplished pharmaceutical leader with more than 30 years of experience directing the development and commercialization of new therapies.
Financial Results

Results of Operations – Three months ended March 31, 2019 and 2018

Net loss for the three months ended March 31, 2019 was $2,446,577, compared to a net loss of $1,556,872 for the three months ended March 31, 2018, respectively. Included in the net loss amount for the three months ended March 31, 2019 were non-cash expenses of $263,872, representing share-based compensation and amortization of an intangible asset, compared to $329,011 for the three months ended March 31, 2018. The increase in the net loss in the three months ended March 31, 2019 reflects the costs associated with operating the Company’s AD therapeutics program, increased contracted research and consultant salaries and associated costs, supporting its patent portfolio and general corporate expenditures.

Research and development expenses for the three months ended March 31, 2019 were $1,770,653, as compared to $698,007 in the three months ended March 31, 2018. The increase in research and development expense for the three months ended March 31, 2019 is primarily attributed to increased spending on external contract research organizations for internal programs, higher contracted research salaries and associated costs, patent costs, and higher share-based compensation.

General and administrative expenses for the three months ended March 31, 2019 were $675,924, as compared to $858,870 in the three months ended March 31, 2018. The decrease in general and administrative expense for the three months ended March 31, 2019 is primarily attributable to decreased share-based compensation offset by increased consultant salaries and associated costs.

Outlook

As a prelude to the first PMN310 clinical trial in AD, we anticipate using a novel biomarker approach that may show evidence of slowing of neuronal death early in the development program. To accomplish this, we plan to initiate a natural history evaluation of biomarker changes in untreated, early AD patients.

We will also continue to further characterize the potential benefits of our programs selectively targeting toxic aggregates of TDP43 in ALS and toxic forms of alpha synuclein in PD to further support ongoing pharmaceutical partnering discussions.