On May 16, 2019 Probiodrug AG (Euronext Amsterdam: PBD), reported its first quarter business update for the period ending March 31, 2019 (Press release, Vivoryon Therapeutics, MAY 16, 2019, View Source [SID1234537747]).

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The first quarter 2019 report is available for download on the company website (View Source).

KEY HIGHLIGHTS
In March, Probiodrug and Alzheimer’s Disease Cooperative Study (ADCS) announced the awarding of a 15 million USD grant from the National Institutes of Health (NIH) for U.S. Phase 2b core program for its lead compound PQ912
In April, Probiodrug raised EUR 8.2 million from a consortium of strategic investors in a successful capital increase primarily intended to initiate the European Phase 2b clinical study of PQ912
Expenditure and corresponding liquidity position of EUR 2.5 million on March 31, 2019, in line with management expectations

CORPORATE REVIEW

Financial Review (According to IFRS)

In the first quarter of 2019, research and development expenses amounted to EUR 443k, reduced significantly compared to the first quarter of 2018 (EUR 1.026k). General and administrative expenses declined to EUR 410k (Q1 2018: EUR 513k). The Company did not generate any revenue in the reporting period, in line with corporate planning. Correspondingly, the net loss of the period was EUR 859k, compared to EUR 1,511k in the first quarter of 2018.

All results are in line with management expectations.

Probiodrug held EUR 2.5 million in cash and cash equivalents as of March 31, 2019.

OPERATIONAL REVIEW

NIH grant awarded for lead compound PQ912 – a first-in-class highly specific and potent Glutaminyl Cyclase (QC) inhibitor

The Company announced on March 20, 2019, that Probiodrug and the Alzheimer’s Disease Cooperative Study (ADCS) will receive 15 million USD from the National Institutes of Health (NIH) for part funding of a US Phase 2b clinical trial to evaluate the efficacy and safety of Probiodrug’s PQ912 in patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease (AD).

POST PERIOD HIGHLIGHTS

Probiodrug AG mandated ODDO SEYDLER BANK AG as Designated Sponsor

Probiodrug announced on April 4, 2019, that shares in Probiodrug AG, which have been trading in the Open Market of the Frankfurt Stock Exchange, are now also listed on XETRA. Probiodrug AG has mandated ODDO SEYDLER BANK AG as its Designated Sponsor to ensure continuous liquidity in share trading on XETRA.

Raise of EUR 8.2 million from investors in successful private placement of new shares

Probiodrug announced on April 9, 2019, the successful execution of a capital increase by issuing 4,093,367 new shares against cash contributions. Of those new shares, 3.1 million were sold to a consortium of investors led by Mr. Claus Christiansen founder and chairman of the board of Nordic Bioscience, Denmark, who has a strategic interest in the Company and intends to support the Probiodrug’s further development on a long-term basis . The Company will use the proceeds to initiate the European Phase 2b clinical study of lead compound PQ912 in Alzheimer’s Disease and to advance Probiodrug’s new program for immune checkpoint inhibition.

Invitation to Probiodrug’s Ordinary General Meeting of Shareholders on May 29, 2019

On April 18, 2019 Probiodrug invited its shareholders to its ordinary general meeting of shareholders to be held on Wednesday, May 29, 2019 at 10:00 am (CEST), at the registered office, Weinbergweg 22, 06120 Halle (Saale), Germany. The relevant documents can be found at: www.probiodrug.de/investors/ordinary-general-meeting-of-shareholders-2019/.

For more information, please contact:

Probiodrug
Dr. Ulrich Dauer, CEO
Email: [email protected]

MC Services AG
Anne Hennecke, Susanne Kutter
Tel: +49 (0) 211 529 252 27
Email: [email protected]

On May 16, 2019 Immunocore Limited, a leading T cell receptor (TCR) biotechnology company, reported that it will present new mechanism of action data in advanced uveal and cutaneous melanoma from the tebentafusp clinical research programme at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago on 3 June 2019 (Press release, Immunocore, MAY 16, 2019, View Source [SID1234536361]). Tebentafusp (IMCgp100) is a novel bispecific biologic T cell receptor therapy with an anti-CD3 immune-redirecting effector function and specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma.

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"At ASCO (Free ASCO Whitepaper), we will present clinical and biomarker data from our lead bispecific tebentafusp programme that provide insight into its mechanism of action," said David Berman, Head of Research and Development at Immunocore. "We believe these data will translate across our ImmTAC platform and provide another step towards identifying which patient populations benefit."

Poster discussion/poster: Pharmacodynamic effect of IMCgp100 (TCR–CD3 bispecific) on peripheral cytokines and association with overall survival in patients with advanced melanoma (Abstract #9523, Poster #94)

Highlighting new mechanism of action results for tebentafusp (IMCgp100), this poster will be presented by Mark Middleton, MD, Head, Department of Oncology, University of Oxford, on Monday 3 June, 1:15-4:45 p.m. CDT in Hall A.
The poster will also be discussed by Sophie Piperno-Neumann, MD, Department of Medical Oncology, Institut Curie, in the Melanoma/Skin Cancers poster discussion session on Monday 3 June, 4:30-6:00 p.m. CDT in Room E451.
Poster: Relationship between clinical efficacy and AEs of IMCgp100, a novel bispecific TCR–anti-CD3, in patients with advanced melanoma (Abstract #9530, Poster #101)

In a retrospective analysis, reporting the potential association of rash with overall survival and temporal association of key cytokines with cytokine mediated adverse events for tebentafusp (IMCgp100), this poster will be presented by Omid Hamid, MD, Chief of Translational Research and Immunotherapy and Director of Melanoma Therapeutics, Angeles Clinic, in the Melanoma/Skin Cancers poster session on Monday 3 June, 1:15-4:45 p.m. CDT in Hall A.
Analyses presented at the meeting stemmed from a Phase 1 clinical trial assessing the safety and tolerability of tebentafusp (NCT01211262).

About Tebentafusp

Tebentafusp is a novel bispecific biologic T cell redirection therapy with an anti-CD3 immune-redirecting effector function that specifically targets the melanoma associated antigen gp100. It is now in pivotal studies for metastatic uveal melanoma. Tebentafusp has Fast Track Designation and Orphan Drug Designation in the US and Promising Innovative Medicine designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. For more information about enrolling tebentafusp clinical trials for metastatic uveal melanoma, please visit ClinicalTrials.gov (NCT03070392).

On May 16, 2019 Eli Lilly and Company (NYSE:LLY) reported that it will attend the UBS Global Healthcare Conference on Tuesday, May 21, 2019 (Press release, Eli Lilly, MAY 16, 2019, View Source [SID1234536408]). Christi Shaw, president of Lilly Bio-Medicines, will participate in a fireside chat at 9:30 a.m., Eastern Time.

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

On May 16, 2019 NGM Biopharmaceuticals, Inc. (Nasdaq: NGM), a clinical stage biotechnology company focused on developing transformative therapeutics for patients, reported first quarter 2019 financial results for the period ending March 31, 2019 (Press release, NGM Biopharmaceuticals, MAY 16, 2019, View Source [SID1234536424]).

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"We’ve had a productive 2019 thus far, making progress on multiple fronts, including the initiation of a Phase 2b clinical trial evaluating NGM282 in patients with non-alcoholic steatohepatitis (NASH) and F2-F3 liver fibrosis," said David J. Woodhouse, Ph.D., chief executive officer of NGM. "Bolstered by the successful completion of our IPO in April and a strong cash position, we continue to advance our broad clinical and preclinical pipeline of next generation medicines. We look forward to sharing further developments regarding these programs later this year."

First Quarter 2019 and Recent Highlights

Completed Initial Public Offering (IPO) and concurrent private placement with Merck. The company’s common stock commenced trading on the Nasdaq Global Select Market under the ticker symbol "NGM" on April 4, 2019. The IPO, priced at a public offering price of $16.00 per share, raised $111.9 million in aggregate net proceeds, including shares sold to the underwriters pursuant to the partial exercise of their overallotment option and after deducting the underwriting discounts and commissions. The company received $65.9 million in additional proceeds from a concurrent private placement of shares of common stock to Merck Sharp & Dohme Corp. (Merck) at the IPO public offering price of $16.00 per share.

Dosed first patient in Phase 2b ALPINE 2/3 clinical study in NASH patients with F2-F3 fibrosis for NGM282. The Phase 2b ALPINE 2/3 study is expected to enroll approximately 150 patients with biopsy-confirmed NASH and stage F2-F3 liver fibrosis, and will assess the efficacy, safety and tolerability of NGM282 compared to placebo. The primary efficacy objective is to evaluate the treatment effect after 24 weeks of three dose levels of NGM282 (0.3 mg, 1 mg and 3 mg) on liver histology, which is defined as an improvement in liver fibrosis (³ 1 stage change) with no worsening of NASH or a resolution of NASH (defined as a NAFLD activity score for inflammation of 0 or 1 and ballooning score of 0) with no worsening of fibrosis. NGM anticipates announcing preliminary results from this Phase 2b clinical study in 2020.

Extended strategic collaboration with Merck. In March, Merck exercised its option to extend its broad, strategic collaboration with NGM for an additional two-year period from March 2020 to March 2022. During the two-year extension period, Merck will continue to fund NGM’s research and development efforts at the same levels as the original collaboration terms and, in lieu of a $20 million extension fee payable to NGM, Merck will make additional payments totaling $20 million in support of NGM’s research and development activities during 2021 and the first quarter of 2022. The companies also announced that Merck will terminate its license to NGM’s growth differentiation factor 15 (GDF15) receptor agonist program, effective May 31, 2019, at which time the program rights will return to NGM.

Appointed Hsiao D. Lieu, M.D., as Senior Vice President, Chief Medical Officer. In March, NGM announced the appointment of Hsiao D. Lieu, M.D. as Senior Vice President, Chief Medical Officer. Dr. Lieu most recently served as Vice President of Early Clinical Development at Genentech, where he was responsible for early phase drug development for all non-oncology indications, including ophthalmology, metabolic, neurology and inflammation. Concurrent with Dr. Lieu’s appointment, Alex DePaoli, M.D., who had served as NGM’s founding Chief Medical Officer, transitioned to the role of Senior Vice President, Chief Translational Officer. In this new role, Dr. DePaoli is focused on guiding NGM’s robust discovery portfolio into clinical development.

First Quarter Financial Results

Related party revenue for the first quarter of 2019 was $25.6 million compared to $18.6 million for the same period in 2018.

Research and development expenses for the first quarter of 2019 were $29.5 million, as compared to $19.5 million for the same period in 2018. The increase in research and development expense was primarily related to an increase in external research and development expenses associated with the advancement of NGM’s growing pipeline and increased NGM282 program expenses due to the ongoing Phase 2 clinical trials.

General and administrative expenses for the first quarter 2019 were $5.4 million, as compared to $3.9 million for the same period in 2018. The increase in general and administrative expenses was primarily attributable to personnel-related expenses and an increase in legal and professional service expenses required to support NGM’s ongoing operations.

For the first quarter of 2019, NGM reported a net loss of $8.3 million, compared to a net loss of $3.9 million for the same period in 2018.

Cash, cash equivalents and short-term marketable securities were $193.4 million as of March 31, 2019, which does not include the net proceeds from NGM’s initial public offering and the private placement of shares with Merck, which closed in April, compared to $206.6 million as of December 31, 2018.

On May 16, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported data presentations on its investigational anti-PD-1 antibody tislelizumab and its investigational BTK inhibitor zanubrutinib from four posters at the 24th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), taking place June 13-16, 2019 in Amsterdam (Press release, BeiGene, MAY 16, 2019, View Source [SID1234536440]).

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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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Poster Presentations:

Title: Tislelizumab (BGB-A317) for relapsed/refractory classical Hodgkin lymphoma: updated follow-up efficacy and safety results from a Phase 2 study
Abstract Code: PF469
Session Title: Hodgkin lymphoma – Clinical
Date: Friday, June 14
Time: 17:30 – 19:00 (CEST)
Lead Author: Yuqin Song, M.D., Ph.D.

Title: Major responses in MYD88 wildtype (MYD88WT) Waldenström Macroglobulinemia (WM) patients treated with Bruton Tyrosine Kinase (BTK) inhibitor zanubrutinib (BGB-3111)
Abstract Code: PF487
Session Title: Indolent and mantle-cell non-Hodgkin lymphoma – Clinical
Date: Friday, June 14
Time: 17:30 – 19:00 (CEST)
Lead Author: Meletios A. Dimopoulos, M.D.

Title: Updated safety and efficacy data in a Phase 1/2 trial of patients with Waldenström Macroglobulinaemia (WM) treated with the Bruton Tyrosine Kinase (BTK) inhibitor zanubrutinib (BGB-3111)
Abstract Code: PF481
Session Title: Indolent and mantle-cell non-Hodgkin lymphoma – Clinical
Date: Friday, June 14
Time: 17:30 – 19:00 (CEST)
Lead Author: Judith Trotman, MBChB, FRACP, FRCPA

Title: Pooled analysis of safety data from monotherapy studies of the Bruton Tyrosine Kinase (BTK) inhibitor, zanubrutinib (BGB-3111), in B-cell malignancies
Abstract Code: PS1159
Session Title: Chronic lymphocytic leukemia and related disorders – Clinical
Date: Saturday, June 15
Time: 17:30 – 19:00 (CEST)
Lead Author: Constantine S. Tam, M.D.
About BeiGene

BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team