On August 14, 2019 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported financial results and corporate updates for the first half of 2019 (Press release, Evotec, AUG 14, 2019, View Source;announcements/press-releases/p/evotec-se-reports-first-half-year-2019-results-and-corporate-updates-5843 [SID1234538724]).

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STRONG FINANCIAL PERFORMANCE
Group revenues up 16% to € 207.1 m (H1 2018: € 178.9 m)
Adjusted Group EBITDA up 51% to € 58.2 m (H1 2018: € 38.6 m)
Unpartnered R&D expenses of € 18.7 m (H1 2018: € 10.0 m)
Strong liquidity position of € 341.8 m (31 December 2018: € 149.4 m) following issue of € 250 m promissory note (Schuldschein) and final repayment of € 140 m acquisition bridge facility
STRONG OPERATIONAL PERFORMANCE
Strong performance across all business lines and important milestone achievements; multiple new and extended drug discovery and development agreements with Pharma, biotech, and foundations
Very important progress in co-owned clinical pipeline; P2x3 antagonist shows positive proof-of-concept results in Phase II Bayer trial in chronic cough (after period-end); very good progress in multiple other co-owned clinical, pre-clinical and discovery projects; termination of SGM-1019 programme by partner Second Genome and full impairment – all rights returned back to Evotec
Good progress and multiple new partnership agreements in EVT Innovate, and good progress in building infectious diseases footprint
Continued focus on expansion of iPSC platform: Acquisition of IP portfolio, iPSC-based products and experienced stem cell team from Ncardia AG (after period-end)
New academic BRIDGE LAB10x and progress in existing BRIDGE initiatives; equity participation (Eternygen); formation of spin-off company Breakpoint Therapeutics GmbH focused on DNA damage response (after period-end)
IMPORTANT STRATEGIC BUSINESS EXPANSION
Strategic expansion into biologics space through closing of the acquisition of Seattle-based Just.Bio – Evotec Biologics effective 02 July 2019
CORPORATE
Extension of Management Board contracts, election of new Supervisory Board
Conversion of the Company into European Company (SE)
FINANCIAL GUIDANCE 2019 INCREASED
Strong underlying business outlook and integration of Just.Bio – Evotec Biologics revenues support the increase of revenue and EBITDA guidance
Group revenues from contracts with customers without revenues from recharges are expected to increase by approx. 15% (previously: approx. 10%) (2018: € 364.0 m)
Adjusted Group EBITDA is expected to increase by >10% (previously: approx. 10%) (2018: € 92.0 m)
Guidance on unpartnered R&D expenses remains unchanged at € 30-40 m (2018: € 22.9 m)

1. STRONG FINANCIAL PERFORMANCE

In H1 2019, Evotec’s Group revenues significantly increased by 16% to € 207.1 m (H1 2018: € 178.9 m). This increase was driven primarily by the very strong performance in the base business across all business lines as well as higher milestone and licence revenues, also supported by favourable FX rates. Total revenues from milestones, upfronts and licences significantly increased to € 19.1 m in comparison to the previous year (H1 2018: € 15.5 m) and included, amongst others, payments from Bayer, Boehringer Ingelheim, and Celgene.

The gross margin in the first half of 2019 amounted to 30.8% (H1 2018: 28.1%). This increase in margin compared to 2018 reflects significant milestone and licence contributions and good margins in the base business.

Evotec focused its unpartnered R&D expenses of € 18.7 m primarily on internal initiatives in the fields of metabolic diseases, oncology, and neurology as well as academic BRIDGE initiatives in the first half of 2019. Its partnered R&D expenses of € 10.6 m on its infectious disease portfolio were fully reimbursed under other operating income by its partner Sanofi. This split into unpartnered and partnered R&D expenses had not been applied in H1 2018, where total R&D expenses of € 10.0 m were recorded compared to € 29.3 m in the reporting period.

The Group’s selling, general and administrative ("SG&A") expenses increased subproportionately by 10% to € 29.9 m (H1 2018: € 27.1 m) in the first half of 2019. This increase primarily reflects expenses of Evotec ID (Lyon) for six months as well as an increase in headcount in response to overall Company growth and transaction-related expenses.

In the first six months of 2019, impairments of intangible assets and goodwill of € 11.9 m were recorded (H1 2018: impairment of intangible assets of € 4.2 m). The SGM-1019 programme was fully impaired (€ 10.3 m) as the project was discontinued by Evotec’s partner Second Genome. This impairment of intangible assets in addition triggered a goodwill impairment of € 1.3 m of the cash-generating unit Evotec (US) Innovate. All rights of the underlying asset will be returned to Evotec.

The significant increase in the adjusted Group EBITDA in H1 2019 to € 58.2 m (H1 2018: € 38.6 m) resulted mainly from the very strong performance in the base business, considerably higher milestone and licence contributions, and effects from the first-time application of the new accounting standard IFRS 16 (+€ 6.4 m), yielding an adjusted EBITDA margin of 28.1% (H1 2018: 21.6%).

Evotec’s operating result increased to € 24.0 m in H1 2019 (H1 2018: € 21.7 m) being positively impacted by reimbursed R&D expenses from Sanofi and R&D tax credits. The Company’s net result in H1 2019 amounted to € 10.7 m (H1 2018: € 17.9 m) and was affected by the one-off effect of the impairments on intangible assets and goodwill as well as tax expenses in the first half of 2019.

Evotec ended H1 2019 with a strong liquidity of € 341.8 m (31 December 2018: € 149.4 m), which was composed of cash and cash equivalents (€ 322.3 m) and investments (€ 19.5 m). In the first half of 2019, liquidity was primarily affected by the completion of the repayment of the € 140 m debt bridge facility drawn down in context of the acquisition of Aptuit in August 2017, the successful issue of the Company’s debut promissory note (Schuldschein) worth € 249.1 m, net, at very attractive interest rates of below 1.5%, as well as new bank loan agreements and the draw-down of another tranche of the European Investment Bank R&D loan.

2. STRONG OPERATIONAL PERFORMANCE – EVT EXECUTE & EVT INNOVATE
The EVT Execute segment continued its strong progress of previous quarters in the first half of 2019. Evotec signed multiple new (e.g. Astex, Exscientia, Yale) and extended (e.g. Dermira, Enterprise Therapeutics, Fibrocor, STORM Therapeutics) drug discovery and development agreements and recorded milestone achievements in the first half of 2019, such as in the chronic cough alliance with Bayer and the pain alliance with Boehringer Ingelheim, contributing to the strong performance of this segment. All business lines recorded a very strong performance in the first half of 2019 and efficiency and quality improvement initiatives continued to be undertaken at various sites.

EVT Innovate again recorded the acceleration of first-in-class science across various ventures in H1 2019. Existing co-owned clinical, pre-clinical and discovery pipeline projects continued to record strong progress in the first half of 2019 (e.g. Phase II start in Carrick alliance, initiation of toxicology testing with lead compound in Evotec/Exscientia alliance). After period-end, Evotec was notified by its partner Bayer about positive Phase II proof-of-concept results with a P2X3 antagonist for the treatment of chronic cough. However, the SGM-1019 programme with Second Genome was terminated in H1 2019, triggering a full impairment of this programme and all rights of the underlying asset will be returned to Evotec. New agreements were signed in the first half of 2019, e.g. with Galapagos, Indivumed, and The Mark Foundation. In addition, Evotec continued to broaden its infectious disease footprint and entered into new alliances with GARDP, GNA NOW (after period-end), Helmholtz Centre for Infection Research, and The Bill & Melinda Gates Foundation.

Regarding its strong focus on its iPSC research, Evotec continued to invest in the further development of its iPSC platform to prepare internal projects for future partnering and achieved further important progress in its iPSC-based Celgene alliance. Furthermore, after period-end and effective 01 July 2019, Evotec acquired certain assets from the stem cell company Ncardia AG to advance its iPSC platform, including intellectual property relevant for iPSC-based phenotypic drug discovery, an existing cellular product business around iPSC-derived cells, as well as a strong team of 15 stem cell biology experts operating from laboratories at the BioCampus Cologne.

Furthermore, Evotec’s BRIDGE model gained even more momentum in H1 2019 with the initiation of the Digital BRIDGE LAB10x with Sensyne Health plc, the University of Oxford, Oxford University Innovation Ltd, and Oxford Sciences Innovation and further projects being selected in its existing BRIDGE initiative LAB150. Following its strategy of spinning-off promising assets into virtual biotech companies, Evotec spun off Breakpoint Therapeutics GmbH with a VC consortium (total volume of € 30 m in series A funding round) shortly after period-end. This new company focuses on the further development of Evotec’s DNA damage response portfolio, comprising discovery-stage assets and drug targets that promise broad therapeutic application in a variety of cancers. Evotec holds below 50% of the company. In the first half of 2019, Evotec also participated in a further financing round of its portfolio company Eternygen.

3. IMPORTANT STRATEGIC BUSINESS EXPANSION
Effective 02 July 2019 (after period-end), Evotec closed the transaction to acquire Just Biotherapeutics (Just.Bio – Evotec Biologics), which had been signed on 20 May 2019. The Seattle site is currently being integrated into Evotec’s global offering, strengthening Evotec’s multimodality approach to R&D by adding biologics to its current offering in small molecules and cell therapy.

4. CORPORATE
EXTENSION OF MANAGEMENT BOARD CONTRACTS, ELECTION OF NEW SUPERVISORY BOARD

In the first half of 2019, the Supervisory Board extended the existing contracts with the Management Board members Dr Cord Dohrmann (CSO) for a term of five years and Enno Spillner (CFO) for a term of three years. Furthermore, Evotec’s shareholders at the Annual General Meeting 2019 elected a new Supervisory Board for a term of five years. The existing members Prof. Dr Wolfgang Plischke (Chairman), Prof. Dr Iris Löw-Friedrich (Vice Chairman), Dr Michael Shalmi and Dr Elaine Sullivan were re-elected. Dr Mario Polywka, Evotec’s COO until 31 December 2018, and Roland Sackers, CFO and Managing Director of QIAGEN N.V., were elected as new members of the Supervisory Board.

CONVERSION OF THE COMPANY INTO EUROPEAN COMPANY (SE)

Effective 29 March 2019, Evotec completed its conversion into a company under European law (Societas Europaea, "SE") with its registration in the commercial register.

5. FINANCIAL GUIDANCE 2019 INCREASED
The strong underlying business outlook and the integration of Just.Bio – Evotec Biologics revenues support the increase of revenue and EBITDA guidance.

Webcast/Conference Call
The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

Conference call details

Date: Wednesday, 14 August 2019

Time: 02.00 pm CEST (08.00 am EDT, 01.00 pm BST)

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From the UK: +44 20 3009 2470

From the USA: +1 877 423 0830

Access Code: 37215683#

A simultaneous slide presentation for participants dialling in via phone is available at View Source

On August 14, 2019 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of novel cancer therapies, reported the pricing of an underwritten public offering of 6,750,000 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and warrants to purchase up to an aggregate of 6,750,000 shares of common stock (Press release, DelMar Pharmaceuticals, AUG 14, 2019, View Source [SID1234538723]). Each share of common stock (or pre-funded warrant) is being sold together with one warrant to purchase one share of common stock at a combined effective price to the public of $1.00 per share and accompanying warrant. Gross proceeds, before underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $6.8 million.

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The warrants will be immediately exercisable at a price of $1.00 per share of common stock and will expire five years from the date of issuance. The shares of common stock (or pre-funded warrants) and the accompanying warrants, can only be purchased together in the offering, but will be issued separately and will be immediately separable upon issuance. The offering is expected to close on or about August 16, 2019, subject to customary closing conditions.

Maxim Group LLC is acting as the book-running manager and Dawson James Securities, Inc. is acting as a co-manager in connection with the offering.

DelMar has granted the underwriters a 45-day option to purchase up to an additional 1,012,500 shares of common stock and/or warrants to purchase up to 1,012,500 shares of common stock, at the public offering price less discounts and commissions.

The Securities and Exchange Commission (the "SEC") declared effective a registration statement on Form S-1 (File No. 333-232931) relating to these securities on August 14, 2019. A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at View Source The offering is being made only by means of a prospectus forming part of the effective registration statement. Electronic copies of the prospectus relating to this offering, when available, may be obtained from Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at (212) 895-3745. Before investing in this offering, interested parties should read in their entirety the registration statement that the Company has filed with the SEC, which provides additional information about the Company and this offering.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On August 14, 2019 AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) reported positive results from the Phase III PAOLA-1 trial in women with advanced ovarian cancer (Press release, AstraZeneca, AUG 14, 2019, View Source [SID1234538722]). The trial, in the 1st-line maintenance setting, compared Lynparza (olaparib) added to standard-of-care (SoC) bevacizumab vs. bevacizumab alone in women with or without BRCA gene mutations.

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The trial met its primary endpoint in the intent-to-treat* population with a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS), increasing the time women taking Lynparza plus bevacizumab lived without disease progression or death vs. those taking bevacizumab alone. The results, including biomarker sub-group analyses, will be presented at a forthcoming medical meeting. The safety and tolerability profiles observed in PAOLA-1 were generally consistent with those known for each medicine. PAOLA-1 is the second positive Phase III trial with Lynparza in 1st-line advanced ovarian cancer.

José Baselga, Executive Vice President, Oncology R&D, said: "The positive results from the PAOLA-1 trial demonstrate a clear potential benefit of adding Lynparza to the standard-treatment bevacizumab for women with advanced ovarian cancer. Following positive results from the SOLO-1 trial for women with a BRCA gene mutation, the PAOLA-1 trial marks yet another positive Phase III trial for Lynparza as a 1st-line maintenance treatment for women with advanced ovarian cancer. We look forward to discussing the results with global health authorities as soon as possible."

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: "The Phase III PAOLA-1 trial demonstrates MSD’s and AstraZeneca’s continued commitment to improving clinical outcomes for women with advanced ovarian cancer. In this co-operative group trial sponsored by ARCAGY Research, maintenance treatment with Lynparza when added to a standard-of-care treatment was evaluated in an environment representative of real clinical practice. By studying Lynparza in this broader patient population, we have learned more about how it may help even more patients with advanced ovarian cancer in the future."

Eric Pujade-Lauraine, Medical Director of ARCAGY Research, said: "The PAOLA-1 trial is a positive example of the strength and promise of academia-industry collaboration in advancing science and new treatment options for patients. We greatly appreciate the commitment of AstraZeneca and MSD in working with academic cooperative groups in ENGOT and look forward to sharing the full PAOLA-1 results at a forthcoming medical meeting."

PAOLA-1 is an ENGOT (European Network of Gynaecological Oncological Trial groups) trial, sponsored by ARCAGY Research (Association de Recherche sur les CAncers dont GYnécologiques) on behalf of GINECO (Groupe d’Investigateurs National des Etudes des Cancers Ovariens et du sein). ARCAGY-GINECO is an academic group specialising in clinical and translational research in patients’ cancers and a member of the GCIG (Gynecologic Cancer InterGroup).

About PAOLA-1

PAOLA-1 is a randomised, double-blind Phase III trial testing the efficacy and safety of Lynparza added to SoC bevacizumab vs. bevacizumab alone, as a 1st-line maintenance treatment for newly-diagnosed advanced FIGO Stage III-IV high grade serous or endometroid ovarian, fallopian tube, or peritoneal cancer patients who had a complete or partial response to 1st-line treatment with platinum-based chemotherapy and bevacizumab. The intent-to-treat* population refers to all patients randomised in the trial.

About ovarian cancer

Ovarian cancer is the eighth most common cause of death from cancer in women worldwide. In 2018, there were nearly 300,000 new cases diagnosed and around 185,000 deaths.1 Most women are diagnosed with advanced (Stage III or IV) ovarian cancer and have a five-year survival rate of approximately 30%.2 For newly-diagnosed advanced ovarian cancer, the primary aim of treatment is to delay progression of the disease for as long as possible and maintain the patient’s quality of life with the intent of achieving complete remission or cure.3,4,5,6

About Lynparza

Lynparza is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in homologous recombination repair, such as mutations in BRCA1 and/or BRCA2. Inhibition of PARP with Lynparza leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. Lynparza is being tested in a range of PARP-dependent tumour types with defects and dependencies in the DDR pathway.

Lynparza is currently approved in 64 countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer, regardless of BRCA status. It is approved in the US, the EU, Japan and several other countries as 1st-line maintenance treatment of BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy. It is also approved in 43 countries, including the US and Japan, for germline BRCA-mutated, HER2-negative, metastatic breast cancer, previously treated with chemotherapy; in the EU, this includes locally-advanced breast cancer. Regulatory reviews are underway in other jurisdictions for ovarian, breast and pancreatic cancers.

Lynparza, which is being jointly developed and commercialised by AstraZeneca and MSD, is approved for the treatment of advanced ovarian cancer and metastatic breast cancer and has been used to treat over 25,000 patients worldwide. Lynparza has the broadest and most advanced clinical-trial development programme of any PARP inhibitor, and AstraZeneca and MSD are working together to understand how it may affect multiple PARP-dependent tumours as a monotherapy and in combination across multiple cancer types. Lynparza is the foundation of AstraZeneca’s industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.

About GINECO

GINECO (Groupe d’Investigateurs National des Etudes des Cancers Ovariens et du sein) is the French Cooperative Group in Oncology labelled by INCA (Institut National du Cancer, or French NCI) developing and conducting gynaecological and metastatic breast cancer clinical trials at the national and international level. Founded in 1993, the GINECO group is a member of international consortia such as ENGOT and GCIG.

About ENGOT

ENGOT (European Network for Gynaecological Oncological Trial groups) is a research network of the European Society of Gynaecological Oncology (ESGO). Founded in 2007, ENGOT includes 21 cooperative groups from 25 European countries.

About GCIG

The GCIG (Gynecological Cancer InterGroup) aims to promote and facilitate high quality clinical trials in order to improve outcomes for women with gynaecological cancer. Founded in 1998, GCIG includes 23 cooperative groups from 28 countries worldwide.

About the AstraZeneca and MSD strategic oncology collaboration

In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza, the world’s first PARP inhibitor, and potential new medicine selumetinib, a MEK inhibitor, for multiple cancer types. Working together, the companies will develop Lynparza and selumetinib in combination with other potential new medicines and as monotherapies. Independently, the companies will develop Lynparza and selumetinib in combination with their respective PD-L1 and PD-1 medicines.

About AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZeneca’s main capabilities, the Company is actively pursuing innovative partnerships and investment that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

On August 14, 2019 AstraZeneca reported that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Calquence (acalabrutinib) as a monotherapy treatment for adult patients with chronic lymphocytic leukaemia (CLL), one of the most common types of leukaemia in adults (Press release, AstraZeneca, AUG 14, 2019, View Source [SID1234538721]).1

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José Baselga, Executive Vice President, Oncology R&D, said: "This is an important regulatory milestone for our work in haematology and for patients living with chronic lymphocytic leukaemia, a life-threatening disease. The Breakthrough Therapy Designation acknowledges the growing body of evidence that supports Calquence as a highly-selective Bruton tyrosine kinase inhibitor with the potential to offer patients a new, differentiated, chemotherapy-free treatment option with a favourable safety profile."

The FDA granted the BTD based on positive results from the interim analyses of the ELEVATE-TN and ASCEND Phase III clinical trials. Together the trials showed that Calquence alone or in combination significantly increased the time patients lived without disease progression or death, with safety and tolerability that was consistent with its established profile.

This is the 10th BTD that AstraZeneca has received from the FDA since 2014. An FDA BTD is designed to accelerate the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results which may demonstrate substantial improvement on a clinically-significant endpoint over currently-available medicines.

Calquence is currently approved for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL) in the US, Brazil, Qatar, the United Arab Emirates, Mexico, Argentina and recently Singapore and is being developed for the treatment of CLL and other blood cancers. The positive results from both the ELEVATE-TN and ASCEND trials will serve as the foundation for regulatory submissions later this year.

About ELEVATE-TN

ELEVATE-TN (ACE-CL-007) is a randomised, multicentre, open-label Phase III trial evaluating the safety and efficacy of Calquence alone or in combination with obinutuzumab vs. chlorambucil in combination with obinutuzumab in previously-untreated patients with CLL. In the trial, 535 patients were randomised (1:1:1) into three arms. Patients in the first arm received chlorambucil in combination with obinutuzumab. Patients in the second arm received Calquence (100mg twice daily until disease progression or unacceptable toxicity) in combination with obinutuzumab. Patients in the third arm received Calquence monotherapy (100mg twice daily until disease progression or unacceptable toxicity).2

The primary endpoint is progression-free survival (PFS) in the Calquence and obinutuzumab arm compared to the chlorambucil and obinutuzumab arm, assessed by an independent review committee (IRC), and a key secondary endpoint is IRC-assessed PFS in the Calquence monotherapy arm compared to the chlorambucil and obinutuzumab arm. Other secondary endpoints include objective response rate, time to next treatment and overall survival.2

About ASCEND

ASCEND (ACE-CL-309) is a global, randomised, multicentre, open-label Phase III trial evaluating the efficacy of Calquence in previously-treated patients with CLL.2 In the trial, 310 patients were randomised (1:1) into two arms. Patients in the first arm received Calquence monotherapy (100mg twice daily until disease progression or unacceptable toxicity). Patients in the second arm received physician’s choice of either rituximab in combination with idelalisib or rituximab in combination with bendamustine.3,4

The primary endpoint is PFS assessed by an IRC, and key secondary endpoints include physician-assessed PFS, IRC- and physician-assessed overall response rate and duration of response, as well as overall survival, patient-reported outcomes and time to next treatment.3,4

About Calquence

Calquence (acalabrutinib) was granted accelerated approval by the US FDA in October 2017 for the treatment of adult patients with MCL who have received at least one prior therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Calquence is an inhibitor of Bruton tyrosine kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting its activity.5 In beta (B) cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.

As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating Calquence in 26 company-sponsored clinical trials. Calquence is being developed for the treatment of multiple B-cell blood cancers including CLL, MCL, diffuse large B-cell lymphoma, Waldenström macroglobulinaemia, follicular lymphoma, and multiple myeloma and other haematologic malignancies. Several Phase III clinical trials in CLL are ongoing, including ASCEND, ELEVATE-TN, ELEVATE-RR (ACE-CL-006) evaluating acalabrutinib vs. ibrutinib in patients with previously-treated high-risk CLL, and ACE-CL-311 evaluating acalabrutinib in combination with venetoclax and with/without obinutuzumab in patients with previously-untreated CLL without 17p deletion or TP53 mutation.

About chronic lymphocytic leukaemia

Chronic lymphocytic leukaemia (CLL) is one of the most common type of leukaemia in adults, with an estimated 105,000 new cases globally and 20,720 new cases in the US annually, and prevalence that is expected to grow with improved treatment.1,6,7,8 In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections.1 As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells and platelets.1 This could result in anaemia, infection and bleeding.1 B-cell receptor signalling through BTK is one of the essential growth pathways for CLL.

About AstraZeneca in haematology

Leveraging its strength in oncology, AstraZeneca has established haematology as one of four key oncology disease areas of focus. The Company’s haematology franchise includes two US FDA-approved medicines and a robust global development programme for a broad portfolio of potential blood cancer treatments. Acerta Pharma serves as AstraZeneca’s haematology research and development arm. AstraZeneca partners with like-minded science-led companies to advance the discovery and development of therapies to address unmet need.

In October 2018, AstraZeneca and Innate Pharma announced a global strategic collaboration that included Innate Pharma licensing the US commercial rights of Lumoxiti (moxetumomab pasudotox-tdfk), and with support from AstraZeneca, will continue EU development and commercialisation, pending regulatory submission and approval.

About AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly-growing portfolio of

new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline

of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZeneca’s main capabilities, the Company is actively pursuing innovative partnerships and investment that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

On August 14, 2019 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported financial results for its first fiscal quarter, ended June 30, 2019, and provided an update on its business (Press release, Replimune, AUG 14, 2019, View Source [SID1234538717]).

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"All programs are on track and progressing as expected," said Robert Coffin, Ph.D., co-founder, President and CEO of Replimune. "The second half of this year will be important for Replimune, with the release of the initial Phase 1 data from our ongoing Phase 1/2 clinical trial of RP1 alone and in combination with nivolumab in the fourth quarter, the initiation of a registration-directed randomized controlled Phase 2 clinical trial in cutaneous squamous carcinoma (CSCC), and the initiation of clinical development with our second product candidate, RP2. In particular, we look forward to sharing the initial Phase 1 results with RP1 in patients with advanced solid tumors later in the year."

Recent Business Highlights and Upcoming Events

RP1 – Data from the Phase 1 part of the Phase 1/2 clinical trial of RP1 alone and in combination with nivolumab expected to be reported at a medical conference in the fourth quarter of 2019. The Phase 1 part of the clinical trial enrolled patients with advanced heavily pre-treated cancers, who have failed available therapy. Initially, single-agent RP1 was administered into a single tumor up to five times at a range of dose levels by direct injection into superficial tumors or by imaging-guided injection into deeper, including visceral, tumors. Following determination of the recommended Phase 2 dose, an expansion group of advanced cancer patients then received RP1 in combination with nivolumab. The main goals of the Phase 1 part of the clinical trial were to assess safety, to determine the optimal dose to administer in combination with nivolumab in the Phase 2 portion of the study, and to gather evidence of clinical activity in line with the expected profile of RP1. This clinical trial is being conducted under a clinical trial collaboration and supply agreement with Bristol Myers Squibb (BMS) for the supply of nivolumab.

RP1 – Enrollment is ongoing in the Phase 2 part of the Phase 1/2 trial of RP1 in combination with nivolumab. The Phase 2 part of the clinical trial is currently enrolling 30-patient cohorts of patients with melanoma, non-melanoma skin cancers and metastatic bladder cancer. Enrollment in a fourth, microsatellite instability high (MSI-H) tumor cohort, is expected to open once a protocol-required MSI-H patient is evaluable for safety from Phase 1 (expected in September). The patients enrolled into the melanoma cohort will either be treatment naïve or have received prior systemic therapy, including anti-PD1 and/or anti-CTLA-4 therapy, and the patients enrolled into the other three cohorts will all be naïve to anti-PD1 therapy. Efficacy and biomarker data will be evaluated within each tumor-type cohort.

RP1 – Phase 2 clinical trial of RP1 in combination with cemiplimab remains on track to open in August 2019. This registration-directed randomized controlled Phase 2 clinical trial is planned to enroll approximately 240 patients with CSCC, comparing treatment with cemiplimab alone to treatment with cemiplimab in combination with RP1, under the Company’s collaboration with Regeneron. Cemiplimab is Regeneron’s anti-PD1 therapy which was approved by the U.S. Food and Drug Administration (FDA) for the treatment of locally recurrent or metastatic CSCC in 2018.

RP2 – Phase 1 clinical trial of RP2 as a single agent and in combination with nivolumab remains on track to initiate in the current quarter.RP2 is a further armed oncolytic immuno-gene therapy that, in addition to expressing GALV-GP-R- and GM-CSF, also expresses a genetically encoded anti-CTLA-4 antibody intended to block the inhibition of the initiation of immune response caused by CTLA-4. As with the clinical trial with RP1 in combination with nivolumab, this clinical trial will be conducted under a clinical trial collaboration and supply agreement with BMS for the supply of nivolumab.

RP3 – Phase 1 clinical trial of RP3 as a single agent and in combination with anti-PD1 therapy to initiate in 2020.RP3 is a further armed oncolytic immuno-gene therapy which expresses two immune co-stimulatory activating ligands (CD40L and 4-1BBL) in addition to the GALV-GP R- fusogenic protein and anti-CTLA-4. The Phase 1 trial of RP3 as a single agent and in combination with anti-PD1 therapy remains on track to be initiated in 2020.

Paper describing the development of Replimune’s Imylytic platform published in the Journal for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (JITC). A paper describing the design, underlying characteristics and pre-clinical data for the Company’s enhanced potency oncolytic immuno-gene therapy product platform and entitled "Development of a new fusion-enhanced oncolytic immunotherapy platform based on herpes simplex virus type 1" was recently published in JITC.

Build-out of Replimune’s manufacturing facility to support late-stage development and commercialization is on track. The 63,000-square-foot facility in Framingham, MA is intended to provide multi-product manufacturing capabilities for Replimune’s Immulytic product candidates. The capacity of this facility will be sufficient to support full commercialization of the Company’s product candidates and is expected to be operational in the first half of 2020.
Financial Highlights

Replimune reported a net loss of $9.5 million for the quarter ended June 30, 2019 compared with $10.0 million for the same period in the prior year.

Research and development expenses for the quarter ended June 30, 2019 were $7.5 million compared with $3.9 million for the same period in the prior year. The increase in research and development expenses was primarily driven by additional costs related to Replimune’s preclinical and clinical development activities for its pipeline, as well as an increase in employee headcount.

General and administrative expenses were $3.5 million for the quarter ended June 30, 2019 compared with $1.9 million for the same period in the prior year. The increase in general and administrative expenses was primarily due to an increase in employee headcount and the impact of stock-based compensation in 2019.

Replimune ended the quarter with $120.8 million in cash and cash equivalents and short-term investments, compared with $134.8 million as of March 31, 2019.

Based on its current operating plan, Replimune expects that its current cash and cash equivalents and short-term investments will enable it to fund its operating expenses and capital expenditure requirements into the second half of calendar 2021.