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Turbine Secures €3 Million EUR Seed Fund to Expand the Potential of Simulation-first Drug Discovery

On November 13, 2019 Turbine, a simulation-based drug discovery company reported the closing of an institutional financing round led by Delin Ventures (Press release, Turbine, NOV 13, 2019, View Source [SID1234551170]). The seed fund will be used to redesign the failure-prone oncology drug discovery process into a series of rational steps facilitated by Turbine’s proprietary human cell model and simulation platform.

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The company’s first institutional financing round of €3m will be used to expand the rational, simulation-based drug discovery workflow into every phase of drug discovery from research to lifecycle management. Leading the round was computational biology venture fund, Delin Ventures with participation from follow-on angel investors such as health-tech veterans Esther Dyson, Vishal Gulati and Atlantic Labs. Newly joining investors include o2h Ventures, who have launched the UK’s first seed and enterprise investment scheme fund backing early stage biotech. Alan Barge, former VP & Head of Oncology Therapy Area at AstraZeneca and Partner at Delin Ventures, now joins the Board of Directors of Turbine.

Turbine was founded on the premise that a computational model of human cell biology would rationalize drug discovery the same way that computer-aided design revolutionized architecture. Based on a decade of research, Turbine’s biologists, bioinformaticians, data scientists, and AI engineers built the Simulated Cell. This platform is comprised of a dynamic computational model of the human cell and the underlying simulation technology to find the smartest route to novel targets, biomarkers, and combination therapies. Unlike other solutions in drug discovery, the Simulated Cell explains the response of cancer cells to drugs on a mechanistic level. The 50-strong team has also recently kicked-off its initial simulation-based drug discovery program centred around DNA Damage Repair (DDR).

Designing life-saving therapies for cancer patients demands a vast amount of financial investment, time and brainpower from pharmaceutical companies, yet 96.6% of new anticancer drugs still fail during clinical trials 1. Many of these failures can be attributed to the incredible complexity of biology. Current lab methodologies provide only a limited understanding of how and why cancer cells respond to drugs. Turbine believes that narrowing down true novelty will be a success rate booster in every step drug discovery can fail today.

Szabolcs Nagy, CEO of Turbine, said: "Over the last couple of years, we have guided the anti-cancer drug discovery process of leading pharmaceutical companies, allowing us to strengthen our simulation-first capabilities. We believe our methods have the potential to transform the current trial-and-error approach to drug discovery into an iterative process, marked by rational decisions, and leading to better drugs faster." Many of the Budapest-based team’s in silico predictions for pharmaceutical partners are now in the clinical validation phase.

Alan Barge, former VP & Head of Oncology Therapy Area at AstraZeneca, Partner at Delin Ventures, and Non-Executive Director at Turbine, commented: "We have been very impressed by Turbine’s capability to model and simulate complex biological problems first, and then decide on the fate of drugs based on a deep understanding of the problem. This resourcefulness is deeply rooted in the DNA of the team. They have come a long way in developing and validating the platform leaning on revenue from industry collaborations, while also arriving at promising in vitro validation of their simulation-first DDR drug discovery program within just a couple of months. We look forward to supporting this talented team during the next stage of its development."

Pacira BioSciences to Present at the Jefferies 2019 London Healthcare Conference

On November 13, 2019 Pacira BioSciences, Inc. (NASDAQ: PCRX) reported that it will present at the Jefferies 2019 London Healthcare Conference at 2:40 PM GMT (9:40AM ET) on Wednesday, November 20, 2019 (Press release, Pacira Pharmaceuticals, NOV 13, 2019, View Source [SID1234551167]). Live audio of the event can be accessed by visiting the "Events" page of the company’s website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

AC Immune Q3 2019 Financial Results and Business Update

On November 13, 2019 AC Immune SA (NASDAQ: ACIU), a Swiss-based biopharmaceutical company with a broad clinical-stage pipeline focused on neurodegenerative diseases, reported its consolidated financial results for the third quarter of 2019 (Press release, AC Immune, NOV 13, 2019, View Source [SID1234551166]).

Prof. Andrea Pfeifer, Ph.D., CEO of AC Immune, commented: "AC Immune, together with our leading pharmaceutical partners, is advancing one of the industry’s broadest, most diversified development pipelines targeting neurodegenerative diseases. This quarter, we continued to demonstrate strong progress across our pipeline of potentially best-in-class small molecule, antibody, and vaccine therapeutics, as well as our cutting-edge diagnostic agents. This resulted in milestones achieved totaling CHF 32 million which were comprised of CHF 30 million from Eli Lilly and Company and EUR 2 million (CHF 2.2 million) from Life Molecular Imaging."

Prof. Pfeifer continued, "We anticipate multiple catalysts in 2019 and 2020, highlighted by expected Phase 2 data for semorinemab, our anti-Tau antibody partnered with Genentech/Roche, which we anticipate will be the first Phase 2 data available for a Tau-targeted therapy in Alzheimer’s disease (AD). We also anticipate achieving further progress across our development pipeline with both early and late stage data readouts that we believe will build substantial value for the Company."

AC Immune’s unique, multi-pronged approach is designed to address the full spectrum of neurodegenerative diseases. By selectively targeting misfolded pathological proteins both intracellularly and extracellularly, and by creating state-of-the-art diagnostic imaging agents that enable early detection of multiple disease pathologies and tracking of disease progression, AC Immune is pioneering a personalized medicine approach to deliver the right therapy to the right patient at the right time.

Research & Development Highlights

Earned a EUR 2 million (CHF 2.2 million) milestone following initiation of longitudinal Phase 2 clinical development of next-generation Tau positron emission tomography (PET) tracer PI-2620 by partner Life Molecular Imaging
Received first CHF 30 million milestone payment from Lilly based on achievement of preclinical milestones related to the oral small molecule Tau Morphomer program, which is currently advancing in a Phase 1 clinical study. A second CHF 30 million milestone payment is scheduled for Q1 2020, linked to achievement of further development milestones
Vaccinated the first patient in a Phase 1b/2a study of anti-phospho-Tau (anti-pTau) vaccine candidate ACI-35.030 in collaboration with Janssen Pharmaceuticals. ACI-35.030 is intended as a disease-modifying treatment for AD and other Tauopathies
Recently hosted a key opinion leader (KOL) event focused on the therapeutic and diagnostic potential of targeting Tau pathology, which highlighted AC Immune’s differentiated Tau pipeline candidates and key updates from the ACI-3024 Tau Morphomer small molecule and ACI-35.030 programs
Awarded a new grant from The Michael J. Fox Foundation for the Company’s pioneering alpha-synuclein (a-syn) PET tracer program. If successful, AC Immune’s program could deliver the world’s first imaging agent capable of accurately detecting and monitoring progression of Parkinson’s disease
Analysis of Financial Statements for the Three and Nine Months Ended September 30, 2019

Cash Position: The Company had a total cash balance of CHF 302.5 million, comprised of CHF 212.5 million in cash and cash equivalents and CHF 90.0 million in short-term financial assets. This compares to a total cash balance of CHF 186.5 million as of December 31, 2018. The increase of CHF 116 million is principally due to the CHF 80 million upfront payment, USD 50 million convertible equity note, and CHF 30 million milestone payment related to the agreement with Lilly. The total shareholders’ equity position increased from December 31, 2018 to CHF 292.4 million from CHF 177.6 million. Further details are available in our corresponding Financial Statements filed on the accompanying Form 6-K

Revenues: Revenues for the three and nine months ended September 30, 2019 totaled CHF 33.4 million and CHF 110 million, respectively. This represents an increase of CHF 31.1 million and CHF 104.2 million compared to the respective periods in 2018. The increase for the three-month period relates to the recognition of CHF 30.0 million for the first installment of the first milestone achieved with Lilly and EUR 2 million (CHF 2.2 million) in connection with the initiation of a Phase 2 Trial of Tau PET Tracer with Life Molecular Imaging. The increase for the nine-month period is driven by the recognition of CHF 74.6 million from the right-of-use license and research and development activities linked to the 2018 Lilly agreement and a CHF 30 million payment for the first installment of the first milestone achieved with Lilly

R&D Expenditures: R&D expenditures decreased by CHF 0.1 million (-0.6%) and increased CHF 3.6 million (+11%) for the three and nine months ended September 30, 2019 compared to the comparable periods in 2018, respectively. The increase in R&D expenditures in 2019 was largely due to increased investments in non-AD and new discovery programs. For non-AD, the Company increased investment in its Morphomer alpha-synuclein programs and continued to advance the clinical development of its anti-Abeta vaccine ACI-24 in Down Syndrome (DS). In new discovery, the Company continued to focus on its neuroinflammation discovery programs while also increasing investment in its anti-a-synuclein antibody. For AD, the Company’s expenditures for the anti-pTau vaccine program decreased due to the completion of certain toxicology and manufacturing work in the prior year as well as a decrease for ACI-24 related to higher costs for the initiation of the Phase 2 study in the prior period

G&A Expenses: For the three and nine months ended September 30, 2019, G&A increased CHF 1.0 million (+35%) and CHF 2.1 million (+24%) to CHF 4.0 million and CHF 10.8 million, respectively. Increases are driven by rental, personnel and IT expenses

IFRS Income/(Loss) for the period: The Company recorded net income after taxes of CHF 18.2 million and CHF 64.9 million for the three and nine months ended September 30, 2019, respectively, compared with net losses of CHF 13.5 million and CHF 36.3 million for the comparable periods in 2018

Oncology Venture advancing towards next milestone in its clinical development of IXEMPRA®.

On November 12, 2019 Oncology Venture A/S ("OV" or the Company) reported an update on the progress of its planned Phase 2 clinical trial for IXEMPRA (Ixabepilone) for the treatment of breast cancer (Press release, Oncology Venture, NOV 13, 2019, View Source [SID1234551165]).

OV holds an exclusive option to in-license the European rights to IXEMPRA (ixabepilone) from the pharmaceutical company R-Pharm U.S., LLC, which previously acquired global rights to the drug from Bristol-Myers Squibb (BMS). The drug is approved in the USA since 2007 for the treatment of breast cancer. OV has recently announced this drug as one of its top priority programs.

The Company is currently advancing a protocol to evaluate IXEMPRA for the treatment of newly diagnosed breast cancer (neoadjuvant setting) in a DRP-guided Phase 2 clinical trial, with sites planned in Europe. The Company’s protocol aims towards an enrollment target of nearly 40 patients. Through use of DRP patient selection, OV aims to provide a superior clinical benefit, to breast cancer patients receiving IXEMPRA, as compared to other approved therapy options. Enrollment of patients is expected in 1H 2020

Steve R. Carchedi, CEO of Oncology Venture, commented "We are pleased to announce the ongoing progress of our planned Phase 2 clinical trial for IXEMPRA, one of our top priority pipeline programs. Phase 2 development of this asset in EU positions us to advance the drug to market and commercialization in both of these top, global oncology markets. The potential approval and use of microtubulin inhibitors, such as IXEMPRA in the front-line setting for breast cancer is an exciting therapeutic area. We are confident our Phase 2 study will prove the merits of this drug, together with its DRP companion diagnostic, as we advance towards approval and commercialization of this priority asset in our pipeline."

Saniona publishes its interim report for the third quarter 2019

On November 13, 2019 Saniona reported its interim report for the third quarter 2019 (Press release, Saniona, NOV 13, 2019, View Source [SID1234551164]).

Financial highlights

Jan – Sep 2019 (Jan – Sep 2018)

Net revenues were SEK 2.7 M (52.7 M)
EBIT was SEK -75.8 M (-19.9 M)
Net profit/loss was SEK -72.3 M (-17.7)
Earnings per share were SEK -2.89 (-0.80)
Diluted earnings per share were SEK -2.89 (-0.80)
Q3 2019 (Q3 2018)

Net revenues were SEK 0.3 M (44.6 M)
EBIT was SEK -26.0 M (19.9 M)
Net profit/loss was SEK -27.7 (15.3 M)
Earnings per share were SEK -1.00 (0.68)
Diluted earnings per share were SEK -1.00 (0.68)
Business highlights in Q3 2019

Saniona reported positive Tesomet Phase 2a clinical results in adolescent patients with Prader-Willi syndrome. Tesomet was safe and well tolerated in growing adolescent patients with PWS at both tested doses. Reduction in body weight and improvement of BMI observed at the high dose with hyperphagia score reduced to low single digits. Data provides additional guidance for the Phase 2b and Phase 3 studies now in planning.
Saniona selected a development candidate, SAN903, in the IK program. Based on work done to date, Saniona has elected to focus SAN903 initially on the treatment of Crohn’s disease and colitis.
In July Saniona received the gross proceeds of SEK 66.5 million (SEK 53.7 million after transaction costs) from the Rights Issue, which was completed in June.
Significant events after the reporting period

Saniona recruited the last patient in the Phase 2a clinical study for Tesomet in hypothalamic obesity. Patients will receive either Tesomet or matching placebo for 24 weeks followed by an open-label extension study where all patients will receive Tesomet for 24 weeks resulting in a total treatment period of 48 weeks. Saniona expects to report top line results from double-blind part of the study in Q2 2020
Comments from the CEO

"The results from our Phase 2a study in PWS provide strong de-risking and guidance for the pivotal Phase 2b/3 studies that we are now planning in PWS and other rare eating disorders, including hypothalamic obesity. Tesomet has the potential to significantly reduce weight and body mass index (BMI), and treat debilitating hyperphagia in these severe, rare and highly underserved eating disorders. By pursuing such orphan indications, we are creating a unique opportunity to develop and bring our own product to the market," says Jørgen Drejer, CEO of Saniona.

Read the complete Interim Report attached below.

For more information, please contact

Thomas Feldthus, EVP and CFO, Saniona, Mobile: +45 2210 9957, E-mail: [email protected]

This information is such information as Saniona AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:00 a.m. CET on November 13, 2019.