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myFC Holding AB (publ) interim report January – September 2020

PR Newswire

STOCKHOLM, Nov. 13, 2020 /PRNewswire/ — Quarter July – September 2020

  • Net sales amounted to SEK 0 (0)
  • Operating loss amounted to SEK -11 million (-18)
  • Earnings per share amounted to SEK -0.07 (-0.16)

Significant events July – September 2020

  • Extraordinary general meeting resolves targeted new share issues
  • Ulf Henning to retire from role as CFO
  • myFC participates in feasibility study for development of a hybrid solution with combined battery and fuel cell system

Significant events after the end of the period

  • Directed share issues in myFC bring in SEK 36 million and a Share Subscription Agreement signed with Global Emerging Markets adds an additional SEK 150 million of available funding

Comment from CEO Michael Glantz:

“Last-mile delivery vehicles have fundamentally changed our cities. Delivery trucks, service vehicles, pod taxis and electric scooters are idling on every street corner. These vehicles are challenged for range, but also with uptime. They need all their auxiliary systems – the cooling of grocery deliveries, IT delivery systems for real-time communication, light and heating – in continuous operation at all time, and they obviously can’t rely on fossil fuel-based generators. These are perfect use cases for myFC, and they have been a major focus for us this quarter. We have evaluated specific client applications, including small trucks for last-mile electric delivery. We have defined our system for each vehicle’s specific use. We have run simulations and populated scenarios for varying effect and energy needs. And we can now show the business cases for increased runtime, reduced downtime and reduced total cost of ownership for switching to a clean, hydrogen-based solution. We can reduce the size of the battery with up to 60-70% compared to the original specification.  

We have deepened our understanding of bicycles. There is large interest from the major bicycle and bicycle component players, and we are in active engagements with several of the actors in the segment. They find our micro fuel cell, and the fact that it is thin and flexible with high modularity particularly attractive. Most of the companies in this segment are active on Asian markets, which are ahead of the rest of the world when it comes to hydrogen infrastructure and more mature in the discussions on commercial applications of fuel cells and hydrogen. This is an attractive prospective market for us.

We are well underway in the feasibility study we were selected for by the Swedish Energy Authority. The study covers the development of a hybrid solution with special consideration given to electrical vehicle performance in colder climates. We have gained new technical and commercial insights in how our technology fits into these types of applications. The work has also deepened our relationship with the other participants. This study is  a good example of authorities partnering with smaller, high-tech companies such as ourselves for new technology solutions. I am proud to see how many of these companies are Swedish.

The funds secured in our recent targeted share issues will help us take advantage of all the opportunities that are now opening up. I want to thank our investors for your faith in our technology and our offering – whether you are a new shareholder or have renewed your commitment. The continued investments by members of our board and senior executives mean a great deal to me in pursuing the commercialisation of myFC technology set by the board of directors and management.  When a very rapid expansion, such as running several commercial client projects simultaneously, becomes necessary, we have also secured the possibility of further funding through Global Emerging Markets.

A note on Covid-19: we face the same challenges as everybody else. Discussions are impacted when you can’t meet face to face and some decision-making processes are understandably delayed as we all learn to navigate this new normal. I am confident that we have found sustainable ways to maintain a high level of activity and momentum in our business at a time when market interest in our offering is so rapidly increasing.”

This disclosure contains information that myFC is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 13-11-202008:00 CET.

CONTACT:
myFC Press Office 
Mail:  [email protected] 
Phone: +46 738 09 33 83
Certified Adviser
Avanza Bank
Mail: [email protected]
Phone: +46-8-409-421-20

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Final Results from the Phase 3 HELP Study™ Open-Label Extension Support TAKHZYRO® (lanadelumab-flyo) Injection as a Long-term Preventive Treatment Option in Patients with Hereditary Angioedema

Final Results from the Phase 3 HELP Study™ Open-Label Extension Support TAKHZYRO® (lanadelumab-flyo) Injection as a Long-term Preventive Treatment Option in Patients with Hereditary Angioedema

Study Results Showed Long-term Findings Consistent with the Known Safety Profile of TAKHZYRO with Reductions in the Rate of HAE Attacks and Attack-free Periods

Data Presented at the 2020 American College of Allergy, Asthma and Immunology Virtual Annual Scientific Meeting

OSAKA, Japan–(BUSINESS WIRE)–
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced the final results from the Phase 3 HELP (Hereditary Angioedema Long-term Prophylaxis) Study™ Open-label Extension (OLE) showing that TAKHZYRO® (lanadelumab–flyo) helped prevent and reduce the frequency of hereditary angioedema (HAE) attacks long term in patients 12 years of age and older who received treatment for a mean (standard deviation) duration of 29.6 (8.2) months.1 Results were consistent with the safety and efficacy of TAKHZYRO in the pivotal trial. The mean (min, max) HAE attack rate was reduced by 87.4% (-100; 852.8) overall versus baseline (N=212) and in a pre-specified exploratory endpoint, nearly 70% (68.9%) of patients treated with TAKHZYRO 300 mg every two weeks experienced an attack-free period of more than 12 months (n=209).1, 2 The data are being presented at the 2020 American College of Allergy, Asthma and Immunology (ACAAI) Virtual Annual Scientific Meeting and will also be published in the November issue of ACAAI’s journal Annals of Allergy, Asthma & Immunology.

“The unpredictability of HAE attacks has a significant impact on the lives of HAE patients. HAE is a lifelong condition, so reducing the frequency and severity of attacks is an important therapeutic goal for many individuals living with HAE,” said Marc A. Riedl, M.D., investigator in the HELP Study OLE and Professor of Medicine and Clinical Director, U.S. Hereditary Angioedema Association Center at the University of California, San Diego. “The original placebo-controlled HELP Study demonstrated the efficacy and safety of TAKHZYRO over 26 weeks. The results from the open-label extension study are encouraging as they show that TAKHZYRO may help prevent attacks over the long term with continued treatment.”

The original Phase 3 HELP Study was conducted in 125 patients aged 12 years and older over 26 weeks, making it the largest randomized, controlled prevention study in HAE, with the longest active treatment duration, to date.3 The HELP Study OLE was designed to evaluate the long-term safety (primary endpoint) and efficacy of TAKHZYRO for up to 2.5 years. The complete results were based on data collected between May 2016 and October 2019 and included 109 rollover patients who were originally evaluated in the HELP Study, and 103 eligible non-rollover patients who did not participate in the initial study but had experienced at least one HAE attack in 12 weeks.1

“A significant amount of progress has been made in advancing the science to better understand and treat HAE over recent years. In 2018, we received the first regulatory approvals for TAKHZYRO as a first-of-its-kind monoclonal antibody preventive therapy in HAE, and we have already seen the difference it has made by preventing attacks in many patients around the world,” said Donatello Crocetta, M.D., Global Medical Head, Rare Immunology and Metabolic Diseases, Chief Medical Office, Takeda. “Continued research such as the HELP Study OLE is critical to further build our understanding of the potential of TAKHZYRO as a long-term preventive treatment option for those living with HAE.”

The complete results from the HELP Study OLE showed that the safety profile of TAKHZYRO was consistent with the original findings from the HELP Study, with treatment-related treatment emergent adverse events (TEAEs) occurring in 54.7% of patients (n=116) and the most common being injection-site pain, respiratory tract infection, or headache.1 In addition, data from the HELP Study OLE showed that the efficacy of TAKHZYRO 300 mg administered subcutaneously every two weeks in rollover patients was consistent with the original findings from the HELP Study. The mean (min, max) reduction in the attack rate compared to baseline observed in the study population (N=212) was of 87.4% (-100; 852.8), with approximately 93% of patients experiencing at least a 70% reduction of the attack rate.1 Additional pre-specified exploratory endpoints measured attack-free periods.2

The abstracts being presented on the HELP Study OLE, available via the ACAAI meeting website, are as follows:

  • Long-Term Efficacy and Safety of Lanadelumab: Final Results from the HELP Open-Label Extension Study (Poster #P150)
  • Attack-Free Status During Extended Treatment with Lanadelumab for Hereditary Angioedema: HELP OLE Study Final Results (Poster #P157)

About The HELP Study™ Open-label Extension

The HELP (Hereditary Angioedema Long-term Prophylaxis) Study™ Open-label Extension (OLE) is an evaluation of the long-term efficacy and safety of TAKHZYRO in hereditary angioedema (HAE) patients of at least 12 years of age and older. Two hundred and twelve patients received treatment with TAKHZYRO at the start of the OLE Study (109 rollover patients originally evaluated in the HELP Study and who continued into the OLE, and 103 eligible patients who did not participate in the HELP Study but who had experienced at least one attack in the last 12 weeks). Rollover patients received a dose of 300 mg TAKHZYRO on Day 0 and then every two weeks after their first attack. Non-rollover patients were treated with one 300 mg dose every two weeks, beginning on Day 0. One hundred and ninety-six participants completed at least 12 months of treatment and 173 participants completed at least 30 months of treatment.1

About Hereditary Angioedema

Hereditary angioedema (HAE) is a rare genetic disorder that results in recurring attacks of oedema – swelling – in various parts of the body, including the abdomen, face, feet, genitals, hands and throat. The swelling can be debilitating and painful.4-6 Attacks that obstruct the airways can cause asphyxiation and are potentially life threatening.6,7 HAE affects an estimated 1 in 50,000 people worldwide. It is often under recognized, under diagnosed and under treated.4, 6, 7

Takeda in Hereditary Angioedema

Hereditary Angioedema (HAE), like so many other rare diseases, is highly complex, and patients, their families and caregivers often undergo years of strain trying to understand their disease, get a definitive diagnosis and gain access to the medicines they need. At Takeda we are committed to be a champion for the patients we serve. Every individual living with HAE is unique and by listening and reacting to their needs, we translate the insights we gain into innovative solutions – from diagnosis to ongoing management. Advancing the science is crucial to the way we operate and we are unafraid to push at the boundaries of success in our mission to accelerate diagnosis and develop transformative and sustainable treatments that will make a difference to the lives of HAE patients, their support networks and those medical professionals who care for them.

About TAKHZYRO® (lanadelumab-flyo) Injection

TAKHZYRO is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein and is indicated for prophylaxis to prevent HAE attacks in patients 12 years and older. TAKHZYRO is formulated for subcutaneous administration and has a half-life of approximately two weeks.8 TAKHZYRO is intended for self-administration or administration by a caregiver. The patient or caregiver should be trained by a healthcare professional.8

U.S. Indication and Important Safety Information

INDICATION

TAKHZYRO (lanadelumab-flyo) is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients ≥12 years of age.8

IMPORTANT SAFETY INFORMATION

Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment.8

Adverse Reactions: The most commonly observed adverse reactions (≥10% and higher than placebo) associated with TAKHZYRO were injection site reactions consisting mainly of pain, erythema, and bruising at the injection site; upper respiratory infection; headache; rash; myalgia; dizziness; and diarrhea. Less common adverse reactions observed included elevated levels of transaminases; one patient discontinued the trial for elevated transaminases.3, 8

Use in Specific Populations: The safety and efficacy of TAKHZYRO in pediatric patients <12 years of age have not been established.8

No data are available on TAKHZYRO in pregnant women. No data are available on the presence of lanadelumab in human milk or its effects on breastfed infants or milk production.8

To report SUSPECTED ADVERSE REACTIONS, contact Dyax Corp., a Takeda company, at 1-800-828-2088, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For U.S. audiences, please see the full Prescribing Information including Medication Guide for TAKHZYRO®.

For EU audiences, please see the Summary of Product Characteristics (SmPC) for TAKHZYRO®.

About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.

For more information, visit https://www.takeda.com.

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

References

1 Banerji A, Hao J, Ming Y et al; Long-Term Efficacy and Safety of Lanadelumab: Final Results from the HELP Open-Label Extension Study. ACAAI 2020.

2 Riedl MA, Johnston DT, Lumry WR et al; Attack-Free Status During Extended Treatment with Lanadelumab for Hereditary Angioedema: HELP OLE Study Final Results. ACAAI 2020.

3 Banerji A, Riedl MA, Bernstein JA, et al; for the HELP Investigators. Effect of lanadelumab compared with placebo on prevention of hereditary angioedema attacks: a randomized clinical trial. JAMA. 2018;320(20):2108-2121.

4 Cicardi M, Bork K, Caballero T, et al; on behalf of HAWK (Hereditary Angioedema International Working Group). Evidence-based recommendations for the therapeutic management of angioedema owing to hereditary C1 inhibitor deficiency: consensus report of an International Working Group. Allergy. 2012; 67(2):147-157.

5 Zuraw BL. Hereditary angioedema. N Engl J Med. 2008;359(10):1027-1036.

6 Banerji A. The burden of illness in patients with hereditary angioedema. Ann Allergy Asthma Immunol. 2013;111(5):329-336.

7 Longhurst HJ, Bork K. Hereditary angioedema: causes, manifestations, and treatment. Br J Hosp Med. 2006;67(12):654-657.

8 TAKHZYRO® (lanadelumab-flyo) injection Prescribing Information.

Media:

Japanese Media

Kazumi Kobayashi

[email protected]

+81 (0) 3-3278-2095

Media outside Japan

Emily Bunting

[email protected]

+41 79 866 9703

David Murdoch

[email protected]

+1 781 482 1741

KEYWORDS: Massachusetts United States Japan North America Asia Pacific

INDUSTRY KEYWORDS: Health Other Health Clinical Trials Research Science Pharmaceutical Biotechnology

MEDIA:

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Unaudited Results for the three and nine month periods ended 30 September 2020

For immediate release

            13 November 2020

Serabi Gold plc

(“Serabi” or the “Company”)

Unaudited Results for the three and nine month periods ended 30 September 2020

Serabi (AIM:SRB, TSX:SBI), the Brazilian focused gold mining and development company, today releases its unaudited results for the three and nine month periods ended 30 September 2020.

Financial Highlights

  • Cash Cost for the year to date of US$1,013 per ounce.
  • All-In Sustaining Cost for the year to date of US$1,298 per ounce.
  • EBITDA for the third quarter of 2020 of US$6.3 million (Q3 2019: US$4.6 million) an improvement of 36 per cent.
  • EBITDA for the year to date (“ytd”) of US$15.7 million (2019 ytd: US$12.1 million) an improvement of 28 per cent.
  • Post tax profit for the year to date of US$7.8 million (2019 ytd: US$2.8 million) an improvement of 175 per cent. 
  • Earnings per share for the year to date of 13.28 cents.
  • Average gold price of US$1,707 received on gold sales in 2020.
  • US$5.5 million now paid to date of the remaining US$12 million consideration for purchase of Coringa, due to Equinox Gold Corp. (“Equinox”).  The balance will continue to be paid in monthly instalments, until travel restrictions caused by Coronavirus are lifted.  US$3.5 million has been settled from cash flow with a total of US$2.0 million drawn down to date of the US$12 million Convertible Loan Notes (the “Loan Notes”) being subscribed for by Greenstone Resources II LP (“Greenstone”).

Key Financial Information

  9 months to

30 September 2020

US$ 		3 months to

30 September 2020

US$ 		9 months to
30 September 2019
US$		 3 months to
30 September 2019
US$
Revenue 45,403,793 15,941,963 43,939,510 14,353,771
Cost of sales (24,908,688) (8,487,475) (27,661,873) (8,496,884)
Gross operating profit 20,495,105 7,454,488 16,277,637 5,856,887
Administration and share based payments (4,838,661) (1,168,595) (4,051,905) (1,248,405)
EBITDA 15,656,444 6,285,893 12,225,732 4,608,482
Depreciation and amortisation charges (4,716,809) (1,484,715) (6,454,531) (2,204,030)
Operating profit / (loss) before finance and tax 10,939,635 4,801,178 5,771,201 2,404,452
         
Profit / (loss) after tax 7,828,409 3,671,944 2,849,341 1,129,701
Earnings per ordinary share (basic) 13.28c 6.23c 4.84c 1.92c
         
Average gold price received (US$/oz) US$1,707 US$1,881 US$1,351 US$1,472
         
    As at

30 September

2020

US$ 		As at
31 December 2019
US$		 As at
31 December 2018
US$
Cash and cash equivalents   10,968,059 14,234,612 9,216,048
Net assets   59,209,072 69,733,388 69,110,287
         

Cash Cost and All-In Sustaining Cost (“AISC”)
 		       
  9 months to 30 September 2020 9 months to 30 September 2019 12 months to
31 Dec 2019		 12 months to
31 Dec 2018
Gold production for cash cost and AISC purposes 24,748 ozs 29,878 ozs 40,101 ozs 37,108 ozs
         
Total Cash Cost of production (per ounce) US$1,013 US$844 US$832 US$821
Total AISC of production (per ounce) US$1,298 US$1,078 US$1,081 US$1,093

Operational Highlights

  • Third quarter gold production of 7,224 ounces, resulting in 24,748 ounces for the year to date.
  • 44,077 tonnes of ore mined during the quarter at 4.84 grams per tonne (“g/t”) of gold.
  • 46,135 tonnes of run of mine (“ROM”) ore were processed through the plant from the combined Palito and Sao Chico orebodies, with an average grade of 4.75 g/t of gold.
  • 3,037 metres of horizontal development completed during the quarter, the second consecutive quarter when more than 3,000 metres of development has been achieved.
  • Fourth quarter  production guidance of 8,000 oz, with full year guidance of 33,000 oz.
      SUMMARY PRODUCTION STATISTICS FOR 2020 AND FOR 2019
    Qtr 1 Qtr 2 Qtr 3 YTD Qtr 1 Qtr 2 Qtr 3 Qtr 4 Total
2020 2020 2020 2020 2019 2019 2019 2019 2019
                     
Gold production (1) (2) Ounces 9,020 8,504 7,224 24,478 10,164 9,527 10,187 10,223 40,101
Mined ore – Total Tonnes 42,036 43,519 44,077 129,632 42,609 44,784 44,757 44,092 176,243
  Gold grade (g/t) 6.54 5.85 4.84 5.73 7.47 6.72 7.14 6.69 7.00
Milled ore Tonnes 40,465 44,235 46,135 130,835 43,451 43,711 45,378 44,794 177,335
  Gold grade (g/t) 6.66 5.91 4.75 5.73 7.69 6.72 6.84 6.81 7.02
Horizontal development – Total Metres 2,878 3,004 3,037 8,919 1,868 2,419 2,433 2,908 9,628
  1. Gold production figures are subject to amendment pending final agreed assays of the gold content of the copper/gold concentrate and gold doré that is delivered to the refineries.
  2. Gold production totals for 2020 include treatment of 30,155 tonnes of flotation tails at a grade of 3.50g/t  (Q3 2019: 20,554 tonnes at a grade of 4.13 g/t)
  3. The table may not sum due to rounding.

Exploration and Development Highlights

  • The acquisition of two new highly prospective tenements to complement the Sao Chico exploration potential including highly prospective Sao Domingos exploration tenement, immediately to the west of Sao Chico.  Sao Domingos hosts multiple past and present artisanal working.
  • Licença Prévia (LP) for the Coringa gold project issued by SEMAS on 8 October 2020.
  • Regional exploration activities at Calico and Juca prospects resumed during the quarter.

Key Objectives for 2020

  • Continue advancing the licensing process for Coringa along with ongoing engineering studies.
  • Advance financing package for the Coringa project to fund plant assembly and other site developments.
  • Continue exploration drilling at Sao Chico with a view to producing a new resource estimation.
  • Complete exploration discovery drilling programme over the geophysical anomalies to the west and south of Sao Chico.
  • Maintain payment programme required to complete acquisition of Coringa gold project.
  • The Company hopes to be able to commence an initial drilling programme at Toucano prior to the end of 2020.

2020 Production Guidance

The impact of CV-19 pandemic has resulted in production of 24,748 ounces of gold for the first nine months of the year.  The third quarter was probably the worst period for the pandemic, to date, in Brazil, with private operations suspended and listed companies reducing operations significantly. However, the Company has managed to keep its mines operational and maintain production and cash flow throughout.  By the end of September 2020, with almost a full workforce complement back at the mine sites, many ancillary activities were resumed.  We anticipate fourth quarter production being approximately 8,000 ounces resulting in full year production of approximately 33,000 ounces.

Outlook for 2021

With a successful surface and underground drilling campaign over the next six months to guide a concentrated mine development programme, management are confident that production levels can start to be built up to the levels that were expected prior to the intervention of COVID-19 from the beginning of the second quarter of 2021.

Clive Line, CFO of Serabi has been interviewed by Crux Investors and BRR Media.  These interviews can be accessed using the following links

Crux Investors –

https://youtu.be/HwchInuUwuk

BRR Media –

https://www.brrmedia.co.uk/broadcasts-embed/5fabf3ae39bad9268170c31d/?serabi-gold&popup=true

Clive Line, CFO of Serabi commented,

“Notwithstanding the lower than hoped for production for the third quarter, the strong gold price has meant that the results for the third quarter of 2020 have shown a slight improvement compared with second quarter which itself was one of our best ever quarters.

“Cash flow generation has again been strong with cash flow from operations of US$5.75 million and after accounting for capital expenditures, the net operational cash flow of US$3.74 million, slightly lower than was reported for the second quarter but reflecting an increased level of expenditure on improvements to the mining fleet.

“Operating profit (before finance costs) of US$4.8 million is at the same level as for the preceding quarter and represents a 100 per cent improvement compared to the same quarter in 2019.  For the year to date the operating profit (before finance costs) of US$10.94 million represents a 90 per cent improvement year on year. 

“The financial performance has been assisted by the strong gold price and the continued weakness of the Brazilian Real with the average gold price for the third quarter of approximately US$1,908.  For the year to date the Group has averaged a realised price of US$1,707 for the sales completed to the end of September 2020 which compares with the LBMA average for the year to the end September 2020 of US$1,735.

“During the quarter the Company has repaid a further US$2.5 million for the outstanding acquisition obligation for the Coringa project and subsequent to the quarter end has settled a further US$2.0 million leaving a balance, of the principal outstanding, of US$6.5 million.  Based on the current schedule of monthly repayments this remaining obligation should be settled during in the second quarter of 2021.  With the cash flow generated, the Company has been able to fund US$2.0 million of these payments from cash flow drawing down since the start of July 2020 only a further US$0.5 million of the US$12 million Convertible Loan Note facility (the “Loan Note Facility”) that was entered into with Greenstone Resources II LP (“Greenstone”) in April 2020.  Currently only US$2.0 million has been drawn down to date against this facility which was initially put in place when gold prices were weaker and the impacts of CV-19 difficult to assess, to provide certainty that the Company had funding available to it to meet this acquisition obligation.  Management will continue to try to pay the on-going instalment payments for Coringa from cash flow generated from operations and minimise the requirement to make further drawdowns against the Loan Note Facility.

“The cash cost per ounce and the AISC per ounce for the year to date need to be viewed in context.  Gold production for the year to date has been quite significantly lower than was originally forecast.  In the first quarter this was the result of a breakdown of the largest of the three ball mils during February, whilst production levels for the second and third quarters have been affected by the need to reduce the workforce on site to allow socially distanced working conditions.  As a result the on-site workforce over the last two quarters has been approximately 65 per cent of the normal staffing complement for much of the time those staff who were at site, voluntarily extended their work rosters with many spending up to three months at site to maintain the mining operations as restrictions on travel and a lack of testing capacity at the time rendered team changes very difficult.  Had production for the second and third quarters been at the original levels expected, this would have potentially translated into a 21 per cent improvement in the AISC and Cash Costs.

“Looking at the operational statistics during the first nine months of the 2020, mined tonnage and plant throughput have been at similar levels to the same period in 2019 with lower processed grades being the major contributor to the reduction in gold production.  The original plan for 2020 was to increase mining rates compared with 2019, and to use the ore sorter to beneficiate the lower grade material and deliver a sorted higher grade product to the process plant.  The mine plan was therefore deliberately designed to undertake more development (more diluted ore given the mining method) as well as more lower grade stopes.  The intention was to beneficiate this lower grade material through the ore sorter, screen out the majority of the waste and send the resultant lower volume of higher grade product to the plant.  The Company has continued to follow the original mine plan, but with the reduced workforce it has been necessary to simplify the operations, reducing the number of faces available at any one time but this has in turn resulted in a reduction of total volume and in so doing reducing the overall level of optionality for selecting the ore.  As a result, lower grade ore that might normally have been stockpiled has been processed whilst there was plant capacity available. 

“By the end of September 2020, operations were returning to something resembling normality and an aggressive surface and underground drilling programme is underway, along with an accelerated underground development programme targeted to replenish the reserve and resource base and allow the Company to regain the optionality and flexibility that it has benefitted from in the past.  This will not be achieved overnight, and it will take some time to recover the six months that have been lost.  With exploration and mine development activity being stepped up together with the usual higher labour expense of settlement of the standard “13th salary” payments that are due in November and December this will impact on the level of cash generation for the rest of the year.  Nonetheless I expect that if our production estimates are attained the Company can end in the year in a comfortable financial position.”

This announcement is inside information for the purposes of Article 7 of Regulation 596/2014.  The person who arranged the release of this statement on behalf of the Company was Clive Line, Director.

Enquiries:

Serabi Gold plc  
Michael Hodgson Tel: +44 (0)20 7246 6830
Chief Executive Mobile: +44 (0)7799 473621
   
Clive Line Tel: +44 (0)20 7246 6830
Finance Director Mobile: +44 (0)7710 151692
   
Email: [email protected]  
Website:  www.serabigold.com  
   
Beaumont Cornish Limited

Nominated Adviser 		 
Roland Cornish Tel: +44 (0)20 7628 3396
Michael Cornish Tel: +44 (0)20 7628 3396
   
Peel Hunt LLP

UK Broker 		 
Ross Allister Tel: +44 (0)20 7418 8900
   

Copies of this announcement are available from the Company’s website at www.serabigold.com.

Neither the Toronto Stock Exchange, nor any other securities regulatory authority, has approved or disapproved of the contents of this announcement.

The following information, comprising, the Income Statement, the Group Balance Sheet, Group Statement of Changes in Shareholders’ Equity, and Group Cash Flow, is extracted from these financial statements.

Statement of Comprehensive Income

For the three and nine month periods ended 30 September 2020

    For the three months ended
30 September		 For the nine months ended
30 September
    2020 2019 2020 2019
(expressed in US$) Notes (unaudited) (unaudited) (unaudited) (unaudited)
CONTINUING OPERATIONS          
Revenue   15,941,963 14,353,771 45,403,793 43,939,510
Cost of sales   (8,487,475) (8,496,884) (24,908,688) (28,161,873)
Release of inventory impairment provision   — — — 500,000
Depreciation and amortisation charges   (1,484,715)  (2,204,030) (4,716,809) (6,454,531)
Total cost of sales   (9,972,190)  (10,700,914) (29,625,497) (34,116,404)
Gross profit   5,969,773 3,652,857 15,778,296 9,823,106
Administration expenses   (1,042,013) (1,174,204) (4,705,158) (3,973,168)
Share-based payments   (182,740) (65,484) (344,578) (196,455)
Gain on sales of assets disposal   56,158 (8,717) 211,075 117,718
Operating profit   4,801,178 2,404,452 10,939,635 5,771,201
Foreign exchange loss   51,642 (169,113) (99,032) (235,216)
Finance expense 2 (484,457) (735,003) (1,583,318) (1,871,914)
Finance income 2 16,547 — 737,705 175,129
Profit before taxation   4,384,910 1,500,336 9,994,990 3,839,200
Income tax expense 3 (712,966) (370,635) (2,166,581) (989,859)
Profit after taxation   3,671,944 1,129,701 7,828,409 2,849,341
             
Other comprehensive income (net of tax)          
Items that may be reclassified subsequently to profit or loss      
Exchange differences on translating foreign operations   (1,259,213) (5,187,377) (18,873,162) (4,695,527)
Total comprehensive profit /(loss) for the period(1)   2,412,731 (4,057,676) (11,044,751) (1,846,186)
           
Profit per ordinary share (basic) 4 6.23c 1.92c 13.28c 4.84c
Profit per ordinary share (diluted) 4 5.80c 1.85c 12.36c 4.67c

(1)           The Group has no non-controlling interests and all losses are attributable to the equity holders of the parent company.

Balance Sheet as at 30 September 2020

      As at As at As at
      30 September 30 September 31 December
      2020 2019 2019
(expressed in US$)     (unaudited) (unaudited) (audited)
Non-current assets          
Deferred exploration costs     25,583,666 28,439,970 30,686,652
Property, plant and equipment     27,788,820 36,704,931 37,597,100
Right of use assets     2,207,297 2,102,183 1,997,176
Taxes receivable     828,083 1,549,463 848,845
Deferred taxation     229,464 1,542,803 1,321,782
Total non-current assets     56,637,330 70,339,350 72,451,555
Current assets          
Inventories     5,308,012 6,610,477 6,577,968
Trade and other receivables     2,076,263 872,325 802,275
Prepayments and accrued income     2,329,770 4,390,107 3,473,288
Cash and cash equivalents     10,968,059 13,440,173 14,234,612
Total current assets     20,682,104 25,313,082 25,088,143
Current liabilities          
Trade and other payables     4,573,988 7,158,839 6,113,789
Acquisition payment outstanding     8,909,397 11,810,372 12,000,000
Other interest bearing liabilities     2,060,558 6,949,152 6,952,542
Derivative financial liabilities     411,123 – –
Accruals     293,062 344,502 319,670
Total current liabilities     16,248,128 26,262,865 25,386,001
Net current assets     4,433,976 (949,783) (297,858)
Total assets less current liabilities     61,071,306 69,389,567 72,153,697
Non-current liabilities          
Trade and other payables     82,261 564,524 183,043
Other interest bearing liabilities     181,348 – –
Provisions     1,598,625 1,364,487 2,237,266
Total non-current liabilities     1,862,234 1,929,011 2,420,309
Net assets     59,209,072 67,460,556 69,733,388
Equity          
Share capital     8,905,116 8,882,803 8,882,803
Share premium reserve     21,905,976 21,752,430 21,752,430
Option reserve     984,358 1,171,501 1,019,589
Other reserves     9,970,276 6,464,152 7,149,274
Translation reserve     (63,152,108) (45,502,650) (44,278,946)
Retained surplus     80,595,454 74,692,320 75,208,238
Equity shareholders’ funds     59,209,072 67,460,556 69,733,388

The interim financial information has not been audited and does not constitute statutory accounts as defined in Section 434 of the Companies Act 2006. Whilst the financial information included in this announcement has been compiled in accordance with International Financial Reporting Standards (“IFRS”) this announcement itself does not contain sufficient financial information to comply with IFRS.  The Group statutory accounts for the year ended 31 December 2019 prepared under IFRS as adopted in the EU and with IFRS and their interpretations adopted by the International Accounting Standards Board have been filed with the Registrar of Companies following their adoption by shareholders at the 2020 Annual General Meeting. The auditor’s report on these accounts was unqualified.  The auditor’s report did not contain a statement under Section 498 (2) or 498 (3) of the Companies Act 2006.

Statements of Changes in Shareholders’ Equity

For the three and nine month periods ended 30 September 2020

(expressed in US$)              
(unaudited) Share
 capital		 Share
premium		 Share option reserve Other reserves (1) Translation reserve Retained Earnings Total equity
Equity shareholders’ funds at 31 December 2018 8,882,803 21,752,430 1,363,367 4,763,819 (40,807,123) 73,154,991 69,110,287
Foreign currency adjustments — — — — (4,695,527) — (4,695,527)
Profit for the period — — — — — 2,849,341 2,849,341
Total comprehensive income for the period — — — — (4,695,527) 2,849,341 (1,846,186)
 Transfer to taxation reserve — — — 1,700,333 — (1,700,333) —
Share options lapsed in period — — (388,321) — — 388,321 —
Share option expense — — 196,455 — — — 196,455
Equity shareholders’ funds at 30 September 2019 8,882,803 21,752,430 1,171,501 6,464,152 (45,502,650) 74,692,320 67,460,556
Foreign currency adjustments — — — — 1,223,704 — 1,223,704
Profit for the period — — — — — 983,643 983,643
Total comprehensive income for the period — — — — 1,223,704 983,643 2,207,347
Transfer to taxation reserve — — — 685,122 — (685,122) —
Share options lapsed in period — — (217,397) — — 217,397 —
Share option expense — — 65,485 — — — 65,485
Equity shareholders’ funds at 31 December 2019 8,882,803 21,752,430 1,019,589 7,149,274 (44,278,946) 75,208,238 69,733,388
Foreign currency adjustments — — — — (18,873,162) — (18,873,162)
Profit for the period — — — — — 7,828,409 7,828,409
Total comprehensive income for the period — — — — (18,873,162) 7,828,409 (11,044,753)
Shares issued in the period 22,313 153,546 — — — — 175,859
Transfer to taxation reserve — — — 2,821,002 — (2,821,002) —
Share options exercised in period — — (31,752) — — 31,752 —
Share options lapsed in period — — (348,057) — — 348,057 —
Share option expense — — 344,578 — — — 344,578
Equity shareholders’ funds at 30 September 2020 8,905,116 21,905,976 984,358 9,970,276 (63,152,108) 80,595,454 59,209,072

(1)            Other reserves comprise a merger reserve of US$361,461 and a taxation reserve of US$9,608,815 (31 December 2019: merger reserve of US$361,461 and a taxation reserve of US$6,787,813).

Cash Flow Statement

For the three and nine month periods ended 30 September 2020

  For the three months

ended

30 September 		For the nine months

 ended

30 September
  2020 2019 2020 2019
(expressed in US$) (unaudited) (unaudited) (unaudited) (unaudited)
Operating activities        
Post tax (loss) / profit for period 3,671,944 1,129,701 7,828,409 2,849,341
Depreciation – plant, equipment and mining properties 1,484,715 2,204,030 4,716,809 6,454,531
Net financial expense 416,268 904,116 944,645 1,932,001
Provision for impairment of inventory — — — (500,000)
Provision for taxation 712,966 370,635 2,166,581 989,859
Share-based payments 182,740 65,484 399,284 196,455
Foreign exchange (loss) / gain (79,732) 22,685 (125,537) (360,116)
Changes in working capital        
  (Increase)/decrease in inventories 55,650 (193,156) (733,883) 1,972,184
  (Increase) in receivables, prepayments and accrued income (997,396) 119,905 (1,997,572) (993,117)
  Increase/(decrease) in payables, accruals and provisions 277,539 461,603 220,307 1,979,991
Net cash inflow from operations 5,724,694 5,085,003 13,419,043 14,521,129
         
Investing activities        
         
Purchase of property, plant and equipment and assets in construction (860,020) (1,138,120) (2,049,973) (2,599,412)
Mine development expenditure (784,203) (1,342,675) (2,005,880) (2,835,238)
Geological exploration expenditure (267,338) (290,503) (1,352,610) (1,087,027)
Pre-operational project costs (149,457) (433,526) (627,097) (1,277,048)
Acquisition of mining project (2,500,000) — (3,500,000) —
Acquisition of other property rights (150,789) (196,037) (483,302) (1,352,112)
Proceeds from sale of assets 72,188 16,741 400,047 169,822
Interest received — — 911 2,217
Net cash outflow on investing activities (4,639,619) (3,384,120) (9,617,904) (8,978,798)
         
Financing activities        
Drawdown of convertible loan 500,000 — 2,000,000 —
Repayment of secured loan — — (6,983,492) —
Payment of finance lease liabilities (203,080) (125,804) (249,354) (588,025)
Interest paid and other finance costs (2,753) (117,308) (265,751) (421,241)
Net cash (outflow) / inflow from financing activities 294,167 (243,112) (5,498,597) (1,009,266)
         
Net increase / (decrease) in cash and cash equivalents 1,379,242 1,457,771 (1,697,458) 4,533,065
Cash and cash equivalents at beginning of period 9,627,412 12,366,683 14,234,612 9,216,048
Exchange difference on cash (38,596) (384,281) (1,569,095) (308,940)
Cash and cash equivalents at end of period 10,968,059 13,440,173 10,968,059 13,440,173

Notes

1.             Basis of Preparation

These interim condensed consolidated financial statements are for the three and nine month periods ended 30 September 2020. Comparative information has been provided for the unaudited three and nine month periods ended 30 September 2019 and, where applicable, the audited twelve month period from 1 January 2019 to 31 December 2019. These condensed consolidated financial statements do not include all the disclosures that would otherwise be required in a complete set of financial statements and should be read in conjunction with the 2019 annual report.
The condensed consolidated financial statements for the periods have been prepared in accordance with International Accounting Standard 34 “Interim Financial Reporting” and the accounting policies are consistent with those of the annual financial statements for the year ended 31 December 2019 and those envisaged for the financial statements for the year ending 31 December 2020.
.


Accounting standards, amendments and interpretations effective in 2020

The Group has not adopted any standards or interpretations in advance of the required implementation dates.

The following Accounting standard has come into effect as of 1 January 2020 have been

IAS 8 Accounting Policies, Changes in Accounting Estimates and Errors (Amendment – Definition of Material)

The adoption of this standard has had no effect on the financial results of the Group.

There are a number of standards, amendments to standards, and interpretations which have been issued that are effective in future periods and which the Group has chosen not to adopt early.  None of these are expected to have a significant effect on the Group, in particular

IAS 1 Presentation of Financial Statements
IFRS 3 Business Combinations (Amendment – Definition of a Business)

These financial statements do not constitute statutory accounts as defined in Section 434 of the Companies Act 2006


Going concern and availability of finance


As at 30 September 2020 the Group had cash in hand of US$10.97 million and net assets of US$59.21 million. 

The occurrence of the Coronavirus (COVID-19) pandemic has created significant uncertainty for all business sectors including Serabi.  Whilst unable to operate at expected production levels during the second and third quarters of 2020, the Group has nonetheless maintained its gold mining operations without interruption.  The levels of workforce at site were reduced as a pre-cautionary measure to improve social distancing whilst additional accommodation and other facilities could be put in place prior to a return to full workforce numbers.  Whilst production levels during the second and third quarters of 2020 have been below the levels that the Group had originally forecast, the weakness of the Brazilian Real and the increased gold price that prevailed during the same period, resulted in strong cash flow being generated by the Group.  In addition to paying off a US$6.9 million secured loan during 2020, the Group has also made payments totalling US$5.5 million (as at 12 November 2020) to Equinox Gold Inc. (“Equinox”) for the outstanding sum due for the acquisition of the Coringa project.

At the current time the Directors have assumed that mining operations and gold production will continue at the Palito Complex at similar levels of production for the fourth quarter and expect that, with a return to a full workforce during the fourth quarter and the reintroduction of surface and underground drilling crews for mine planning purposes that production can be expected to improve during the early part of 2021.  There is no evidence, at this time, to suggest that the authorities in Brazil have any intention to try and close down or suspend mining activities as a result of the current Coronavirus pandemic.  On 20 March 2020, it was stipulated in Decree 10,282/20 that mineral activity was considered an essential business sector and further actions have subsequently been invoked to prevent any restrictive measures being applied to the supplies required by the mining industry including transportation of supplies, availability of materials required for processing, and the sale and transportation of the mineral products.

The Group has renegotiated the terms relating to the settlement of a final acquisition payment of US$12 million due to Equinox in respect of the purchase of Chapleau Resources Limited and its Coringa gold project (the “Coringa Deferred Consideration”). Under the revised arrangement the Group began paying monthly instalments commencing 1 May 2020 of US$500,000 per month, increasing to US$1 million per month from 1 August 2020 and payable thereafter (“the “Deferral Period”) until such time as certain conditions relating to travel into and within Brazil are lifted (the “Travel Restriction Conditions”).  Within 6 weeks of the satisfaction of the Travel Restriction Conditions the remaining portion of the Coringa Deferred Consideration will become payable.

The Company announced on 22 January 2020 that it had entered into an agreement with Greenstone Resources II LP (“Greenstone”) for the issue of and subscription by Greenstone of US$12 million of Convertible Loan Notes the proceeds of which would be used to satisfy the Coringa Deferred Consideration.  However, due to the uncertainties created by the impact of the Coronavirus, the Company and Greenstone agreed to extend the period for the satisfaction of the conditions required for completion of the subscription by Greenstone. On 24 April 2020 the Company announced that it had agreed certain amendments to the original agreement with Greenstone (the “Amended Subscription Deed”).

Under the Amended Subscription Deed and a further subsequent amendment agreed with Greenstone
(a)           the Company may, prior to the satisfaction of the Travel Restriction Condition only submit a subscription request in respect of Convertible Loan Notes in the amount of US$500,000 each month. Following the satisfaction of the Travel Restriction Condition, the Company may then issue further subscription request for amounts of not less than US$100,000 and not exceeding an amount equal to US$12,000,000 less the sum of the aggregate principal amount of all Notes outstanding at that time.
(b)           the Convertible Loan Notes were initially unsecured and subordinated to the Sprott Loan.  Following the completion of the repayment of the Sprott Loan on 30 June 2020, the security interests of Sprott have been discharged and the Company has granted to Greenstone the security package as originally envisaged save that a pledge of the shares of Chapleau Resources Limited (“CRL”) will continue to be held by Equinox until such time as the Coringa Deferred Consideration is settled in full. CRL holds 100% of the shares of Chapleau Exploração Mineral Ltda which in turn holds the exploration licences for the Coringa gold project
(d)           The period during which the Company may issue an Issue Notice to Greenstone expires on 30 September 2021
(e)           Subject to Greenstone not having exercised its option to convert the amount outstanding into Conversion Shares, the Convertible Loan Notes are due to be repaid 16 months after the first Issue Date which was 30 April 2020.

The Balance Sheet of the Group shows a net current asset position of US$4.43 million at 30 September 2020 including the fair value of a cash liability (including accrued interest) of US$8.9 million in respect of Coringa Deferred Consideration of which a further US$2.0 million has been settled subsequent to the period end.  The Group plans to try to continue to finance this liability as much as possible from its operational cash flow but can also obtain additional working capital through the issue of the balance of the US$12 million of Convertible Loan Notes to Greenstone which will not be repayable until 31 August 2021. As at the current date, US$2.0 million has been drawn down against the Convertible Loan Notes and US$6.5 million remains outstanding in respect of the Coringa Deferred Consideration.

Whilst the Directors consider that the assumptions they have used are reasonable and based on the information currently available to them, there remains significant uncertainty regarding further actions that have not been anticipated but which may be required or imposed and may impact on the ability of the Group to meet the operational plan and cash flow forecast.

Whilst recognising all the above uncertainties, the Directors have prepared the financial statements on a going concern basis.  In the event that additional short term funding is required, the Directors believe there is a reasonable prospect of the Group securing further funds as and when required in order that the Group can meet all liabilities including the Coringa Deferred Consideration as and when they fall due in the next 12 months.  The Directors have been successful in raising funding as and when required in the past and consider that the Group continues to have strong support from its major shareholders who been supportive of and provided additional funding when required on previous occasions.

As at the date of this report both the medium and long term impact of COVID-19 on the underlying operations, and the outcome of raising any further funds that may be required, remains uncertain and this represents a material uncertainty surrounding going concern.  If the Group fails to achieve the operational plan or to raise any additional necessary funds, the Group may be unable to realise its assets and discharge its liabilities in the normal course of business. The matters explained indicate that a material uncertainty exists that may cast significant doubt on the Group and Company’s ability to continue as a going concern. These financial statements do not show the adjustments to the assets and liabilities of the Group or the Company if this was to occur

2.             Finance expense and income

  3 months ended

30 September 2020

(unaudited) 		3 months ended
30 September 2019
(unaudited)		 9 months ended

30 September 2020

(unaudited) 		9 months ended
30 September 2019 (unaudited)
  US$ US$ US$ US$
Interest expense on secured loan — (173,637) (203,127) (474,177)
Interest expense on convertible loan (33,899) — (72,806) —
Interest expense on mineral property acquisition liability (239,071) — (823,361) —
Unwinding of discount on mineral property acquisition liability   (280,344) — (812,615)
Expense in respect of non-substantial modification (155,237) (39,900) (390,274) (53,212)
Amortisation of arrangement fee for convertible loan (56,250) — (93,750) —
Loss on revaluation of derivatives — (241,122) — (531,910)
  (484,457) (735,003) (1,583,318) (1,871,914)
Gain in respect of non-substantial modification — — 724,438 172,912
Gain on revaluation of derivatives 16,547 — 12,356 —
Interest income — — 911 2,217
Net finance expense (467,910) (735,003) (845,613) (1,696,785)

3.             Taxation

The Group has recognised a deferred tax asset to the extent that the Group has reasonable certainty as to the level and timing of future profits that might be generated and against which the asset may be recovered.  The Group has released the amount of US$794,044 as a deferred tax charge during the nine month period to 30 September 2020.

The Group has also incurred a tax charge in Brazil for the nine month period of US$1,372,535.  

4.             Earnings per Share

                3 months ended

30 September 2020

(unaudited) 		3 months ended

30 September 2019

(unaudited) 		9 months ended

30 September 2020

(unaudited) 		9 months ended

30 September 2019

(unaudited)
Profit attributable to ordinary shareholders (US$) 3,671,944 1,129,701 7,828,409 2,849,341
Weighted average ordinary shares in issue 58,981,290 58,909,551 58,946,229 58,909,551
Basic profit per share (US cents) 6.23c 1.92c 13.28c 4.84c
Diluted ordinary shares in issue (1) 63,362,694 60,997,145 63,327,628 60,997,145
Diluted profit per share (US cents) 5.80c 1.85c 12.36c 4.67c

(1) Based on 2,345,088 options vested and exercisable as at 30 September 2020 and 2,036,316 shares that could be issued pursuant to any exercise of conversion rights attaching to the Convertible Loan Notes as at 30 September 2020 (30 September 2019: 2,087,594 options)

4.             Post balance sheet events

Subsequent to the end of the quarter, there has been no item, transaction or event of a material or unusual nature likely, in the opinion of the Directors of the Company to affect significantly the continuing operation of the entity, the results of these operations, or the state of affairs of the entity in future financial periods.

Qualified Persons Statement

The scientific and technical information contained within this announcement has been reviewed and approved by Michael Hodgson, a Director of the Company. Mr Hodgson is an Economic Geologist by training with over 26 years’ experience in the mining industry. He holds a BSc (Hons) Geology, University of London, a MSc Mining Geology, University of Leicester and is a Fellow of the Institute of Materials, Minerals and Mining and a Chartered Engineer of the Engineering Council of UK, recognising him as both a Qualified Person for the purposes of Canadian National Instrument 43-101 and by the AIM Guidance Note on Mining and Oil & Gas Companies dated June 2009.

Assay Results

The assay results reported within this release include those provided by the Company’s own on-site laboratory facilities at Palito which may not have been independently verified.  Serabi closely monitors the performance of its own facility against results from independent laboratory analysis for quality control purpose.  As a matter of normal practice the Company sends duplicate samples derived from a variety of the Company’s activities to accredited laboratory facilities for independent verification. Based on the results of this work, the Company’s management are satisfied that the Company’s own facility shows good correlation with independent laboratory facilities. The Company would expect that in the preparation of any future independent Reserve/Resource statement undertaken in compliance with a recognised standard, the independent authors of such a statement would not use Palito assay results but only use assay results reported by an appropriately certificated laboratory.

Forward Looking Statements

Certain statements in this announcement are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as ‘‘believe’’, ‘‘could’’, “should” ‘‘envisage’’, ‘‘estimate’’, ‘‘intend’’, ‘‘may’’, ‘‘plan’’, ‘‘will’’ or the negative of those, variations or comparable expressions, including references to assumptions. These forward looking statements are not based on historical facts but rather on the Directors’ current expectations and assumptions regarding the Company’s future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements reflect the Directors’ current beliefs and assumptions and are based on information currently available to the Directors. A number of factors could cause actual results to differ materially from the results discussed in the forward looking statements including risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets, reliance on key personnel, uninsured and underinsured losses and other factors, many of which are beyond the control of the Company. Although any forward looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward looking statements.

ENDS

Attachment

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PureTech to Commence Trading on Nasdaq on November 16, 2020

PureTech to Commence Trading on Nasdaq on November 16, 2020

BOSTON–(BUSINESS WIRE)–
PureTech Health plc (LSE: PRTC) (“PureTech” or the “Company”), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, today announced, further to the Company’s announcement on October 28, 2020, that it expects trading of American Depository Shares of the Company (“ADSs”) on the Nasdaq Global Market (“Nasdaq”) will commence on Monday, November 16, 2020, under the ticker symbol “PRTC” following Nasdaq’s approval of the ADSs for listing yesterday, November 12, 2020. Each ADS represents 10 ordinary shares of the Company (“Ordinary Shares”). PureTech filed registration statements on Form 20-F and Form F-6 with the Securities and Exchange Commission (the “U.S. Listing”) that were declared effective yesterday, November 12, 2020.

In addition to the planned U.S. Listing, the Company will maintain its premium listing on the Official List of the UK Financial Conduct Authority and trading on the main market of the London Stock Exchange. The Company’s Ordinary Shares will continue to trade on the London Stock Exchange and be registered with their existing ISIN number GB00BY2Z0H74 and the Company’s ticker symbol in the UK will continue to be PRTC.

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

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, including intractable cancers, lymphatic and gastrointestinal diseases, central nervous system disorders and inflammatory and immunological diseases, among others. The Company has created a broad and deep pipeline through the expertise of its experienced research and development team and its extensive network of scientists, clinicians and industry leaders. This pipeline, which is being advanced both internally and through PureTech’s Founded Entities, is comprised of 24 products and product candidates, including two that have received U.S. Food and Drug Administration (FDA) clearance and European marketing authorization. All of the underlying programs and platforms that resulted in this pipeline of product candidates were initially identified or discovered and then advanced by the PureTech team through key validation points based on the Company’s unique insights into the biology of the brain, immune and gut, or BIG, systems and the interface between those systems, referred to as the BIG Axis.

For more information, visit www.puretechhealth.com or connect with us on Twitter @puretechh.

Forward-Looking Statements

This press release contains statements that are or may be forward-looking statements, including statements that relate to the commencement of trading of the ADSs on the Nasdaq Global Market, and timing related thereto, future prospects, developments, and strategies. The forward looking statements are not historical facts but are based on current expectations, estimates and projections and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks and uncertainties described in the regulatory filings for PureTech Health plc. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. The company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the company only as at the date of this press release. Except as required by law and regulatory requirements, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

Investors

Allison Mead Talbot

+1 617 651 3156

[email protected]

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Software Biotechnology Pharmaceutical General Health Health Medical Devices Technology Other Health

MEDIA:

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RenalytixAI to Participate in the Stifel 2020 Healthcare Conference

NEW YORK, Nov. 12, 2020 (GLOBE NEWSWIRE) — Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX), an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes and advance value-based care, today announced the company will be participating in the upcoming Stifel Virtual Healthcare Conference.

RenalytixAI’s management is scheduled to present on Tuesday, November 17 at 10:40 a.m. Eastern Time. Interested parties may access a live and archived webcast of the presentation on the “Investors” section of the company website at www.investors.renalytixai.com.

About RenalytixAI

RenalytixAI is a developer of artificial intelligence-enabled clinical in vitro diagnostic solutions for kidney disease, one of the most common and costly chronic medical conditions globally. RenalytixAI’s products are being designed to make significant improvements in kidney disease diagnosis, transplant management, clinical care, patient stratification for drug clinical trials, and drug target discovery. For more information, visit www.renalytixai.com.

Disclosure Information

Renalytix AI plc uses filings with the Securities and Exchange Commission, its website (www.renalytixai.com), press releases, public conference calls, public webcasts and its social media accounts as means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

Investor
Contact
:

[email protected]

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Ærfugl phase 1 project starts production

PR Newswire

TRONDHEIM, Norway, Nov. 13, 2020 /PRNewswire/ —

Operator Aker BP and partners Equinor, Wintershall Dea and PGNiG report that production has started from Ærfugl phase 1 in the Norwegian Sea.

– I am very proud of the excellent performance shown by the Aker BP project team and our alliance partners to deliver this profitable project safely and efficiently on time and cost. This truly is One Team at its best, says CEO in Aker BP, Karl Johnny Hersvik. 

Ærfugl is one of the most profitable development projects on the Norwegian continental shelf. The initial estimated break-even oil price was USD 18.5 per barrel (converted from gas). Due to increased reserves, earlier production, stronger dollar and accelerated tax depreciation, the break-even price has improved to below USD 15 per barrel.

– Aker BP’s goal is to produce oil and gas as efficiently as possible to return greater value from our oil and gas resources to investors and the society. The successful start-up of production from Ærfugl phase 1 demonstrates our ability to deliver on this strategy, Hersvik adds.

300 million barrels

The Ærfugl development is a major subsea project in two phases. Both phases are tied into the existing production vessel (FPSO) on the Skarv field, which is located approx. 210 km west of Sandnessjøen.

The Plan for Development and Operation (PDO) for Ærfugl was approved by the Ministry of Petroleum and Energy in April 2018.

The reservoir holds a total of around 300 million barrels of producible oil equivalents. 

Total investment costs for the Ærfugl project (phase 1 and 2) are around NOK 8 billion.

Improvements

Reorganizing the value chain through strategic partnerships and alliances is an important part of Aker BP’s strategy.

-The subsea alliance, semi alliance and modification alliance have all been vital in this project. The alliances have not only been delivering on cost and schedule, despite Covid-19 related challenges; they have as well achieved major improvements since the PDO was approved, including significantly accelerated development of phase 2 and better economics, says SVP Projects, Knut Sandvik.

Development of Ærfugl is enabled in particular by two new technologies:           

  • More efficient drainage of reservoir through new vertical valve trees.            
  • Long distance, electrically heated flow lines to avoid hydrates in the gas pipelines. This technology significantly improves heat efficiency compared with regular technology and enables longer tie-backs. 

Reserves have as well increased since PDO due to continuous work to better understand the elongated reservoir.

Strengthening the Skarv area

The Ærfugl field development is adding five years lifetime extension to the Skarv FPSO.

-Ærfugl is an important part of the area development and value creation in the area. When both phases of Ærfugl come on stream, we will significantly increase our utilization at the Skarv FPSO, representing roughly a doubling of production compared to current levels, says Sverre Isak Bjørn, VP Operations & Asset Development, Skarv area.

-Production from the Ærfugl reservoir will also improve the energy efficiency. Consequently it will bring down CO2 emissions by 30-40% per barrel produced from Skarv FPSO, Bjørn adds.

Exploration success in the area in 2019 gave fresh perspectives on the geology around Skarv, generating new ideas on drilling prospects in the coming years. 

-We are collaborating closely with our license partners. Together we have developed a solid strategic foundation to bring Skarv into the future, Bjørn adds.

Full speed for Phase 2

Phase 1, which develops the southern part of the Ærfugl field, consists of three new wells. Phase 2 consists of an additional three wells in the northern part of the field.

-The successful start-up of production from Phase 1 is a major milestone and a great achievement. However, there is no time to relax; we will keep momentum to safely deliver phase 2 on time and cost by the end of next year. Then we will celebrate, says Project manager for the Ærfugl development project, Tom Storvik. 

He points at the close and efficient collaboration in- and between the involved alliances as a key success factor for the successful execution.

-The Subsea alliance between Aker BP, Subsea 7 and Aker Solutions has demonstrated substantial improvements and increased value creation over several years. The performance by the rig alliance with Odfjell and Halliburton and the Modification alliance with Aker Solutions in collaboration with Kongsberg Maritime, has been key to these achievements. The production start-up of from Phase 1 shows how the alliances enable us to increase the value creation and to deliver in line with our ambitious improvement agenda, Storvik adds.

FACTS ABOUT THE ÆRFUGL FIELD            

  • The more than 60 km long and 2-3 km wide Ærfugl reservoir is a gas reservoir.            
  • It holds a total of around 300 million barrels of producible oil equivalents.           
  • Total investment costs for the Ærfugl project (phase 1 and 2) are around NOK 8 billion.            
  • The total `life of field’ project has a break-even-price of below USD 15 per barrel (converted from gas). This makes the field development one of the most profitable being implemented on the Norwegian shelf.            
  • Ærfugl was first put on stream with the test producer A-1H in 2013 and has since produced via Skarv FPSO.           
  • In April this year, production started from the first Ærfugl phase 2 well – more than three years ahead of the original plan.            
  • The remaining two “phase 2 wells” will come on stream in 2021.The Ærfugl field produces via Skarv FPSO approximately 210 km west of Sandnessjøen.           
  • The subsea modules have been completed in Sandnessjøen and then transported offshore. The Ærfugl project has brought significant local ripple effects for local suppliers in the Helgeland region.

CONTACT:

Contacts:

Investor contact: Kjetil Bakken, VP Investor Relations, tel.: +47 918 89 889
Media contact: Ole-Johan Faret, Press Spokesman, tel.: +47 402 24 217

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/aker-bp-asa/r/aerfugl-phase-1-project-starts-production,c3236392

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SOURCE Aker BP ASA

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CooTek to Participate in November Investor Conferences

PR Newswire

SHANGHAI, Nov. 13, 2020 /PRNewswire/ — CooTek (Cayman) Inc. (NYSE: CTK) (“CooTek” or the “Company”), a fast-growing global mobile internet company, today announced that the Company will present and meet with institutional investors at the following virtual investor conferences. For more information on CooTek presentations, please visit investor relations website https://ir.cootek.com.

  • BofA Securities 2020 China Conference
    Panel or one-on-one Discussion on November 2 – November 13, 2020;
  • dbVIC – Deutsche Bank American Depositary Receipt (ADR) Virtual Investor Conference
    Presentation on Wednesday, November 18, 2020 at 09:30 a.m. ET

The Company’s management will participate in virtual meetings with institutional investors throughout these events. For additional information, please contact your respective institutional sales representative at each sponsoring bank.

About CooTek (Cayman) Inc.

CooTek is a fast-growing mobile internet company with a global vision, offering mobile applications. Our mission is to empower everyone to enjoy relevant content seamlessly. The Company’s user-centric and data-driven approach has enabled it to release appealing products to capture mobile internet users’ ever-evolving content needs and helps it rapidly attract targeted users. CooTek has developed and brought to market content-rich mobile applications, focusing on three categories: online literature, scenario-based content apps and casual games.

For more information on CooTek, please visit https://ir.cootek.com.  

For more information, please contact:

CooTek (Cayman) Inc.

Mr. Robert Cui
[email protected]  

Christensen

In China
Mr. Rene Vanguestaine
Phone: +86-10-5900-1548
E-mail: [email protected]   
In U.S.
Ms. Linda Bergkamp
Phone: +1-480-614-3004
Email: [email protected]

Cision View original content:http://www.prnewswire.com/news-releases/cootek-to-participate-in-november-investor-conferences-301172564.html

SOURCE CooTek

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Sanofi selects Jeito Capital as its first investment into a private French-based fund

Sanofi selects Jeito Capital as its first investment into a private French-based fund

Paris, France, 13 November 2020 – Jeito Capital (“Jeito”), a rapidly emerging independent investor dedicated to biotech and biopharma, today announced that Sanofi has made a €50 million investment in Jeito Capital. The investment will be deployed by Jeito’s highly experienced team of pharmaceutical and biotech experts in line with its investment criteria to provide an additional gateway for Sanofi to support French and European healthcare innovation. The coming together of a leader in industry with a leading investor will strengthen the ever-important healthcare eco-system and accelerate access to therapeutic innovation.

Rafaèle Tordjman, Founder and CEO at Jeito, said:
“We are delighted that Sanofi chose to become a major strategic investor in Jeito. Receiving such support from one of the global leaders in healthcare and France’s largest R&D investor underlines Jeito’s commitment to improving healthcare in France and Europe. By bringing together industry and science and providing access to significant capital, Jeito is ideally positioned to deliver on its mission to improve healthcare for patients in France and beyond.”

Paul Hudson, CEO of Sanofi, said:
“We are pleased to collaborate with Jeito Capital and its international team of pharma and biotech experts who are renowned for creating value through innovation. This investment provides Sanofi with access to the very best in French and European healthcare innovation and reinforces our commitment to investing in our medium and long-term development pipeline. We strongly believe in the potential of France and Europe to become a world-class hub for innovation in life sciences, which just needs the appropriate conditions and a stimulating environment in order to thrive.”

Jeito’s unique investment strategy is to provide long-term strategic support to new and established entrepreneurs, primarily in France and Europe, who are aspiring to help patients in need by pioneering novel, groundbreaking medicines that rethink traditional approaches. Leveraging their synergistic experience, Jeito’s team provides continuity from clinical development to market access, especially in Europe and the Unites States, for breakthrough drugs with validated proofs of concept. This continuity is expressed both in the support provided to entrepreneurs by the Jeito team and by the investment of significant capital to ensure the growth of companies, the acceleration towards commercialization and faster access to these major innovations.

This investment is part of Sanofi’s leading contribution to the development of an innovative healthcare eco-system in France and Europe. The company previously collaborated with Bpifrance to launch two public-private investment funds dedicated to French and European life sciences. Sanofi also stands as France’s leading private R&D investor, with more than €2 billion spent locally each year researching new treatments for patients, totaling half of the private research effort in France. Nearly 5,000 researchers and scientists work in a variety of therapeutic areas, mainly focusing on oncology, immuno-oncology, vaccines and rare diseases.

ENDS

About Jeito Capital

Jeito Capital is an international investment company with a patient benefit driven approach that focuses both on financing ground-breaking medical innovation and promoting positive societal impact. Jeito has a unique, long-term investment strategy, with the aim of providing continuity from clinical development to market access for breakthrough drugs with validated proofs of concept. This continuity is expressed both in the support provided to entrepreneurs by the Jeito Capital team and by the investment of significant capital to ensure the growth of companies, the acceleration towards commercialization and faster access to these major innovations.  Jeito Capital is based in Paris with a presence in Europe and the United States.  

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, and provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

For more information please contact:

Jeito Capital

Rafaèle Tordjman, Founder and CEO

[email protected]

Consilium Strategic Communications

Mary-Jane Elliott / Melissa Gardiner / Kris Lam

[email protected]

Steele & Holt (France)

Servane Taslé : [email protected]

Anaïs Miegeville : [email protected]

Sanofi

Chrystel Baude : [email protected]

 

 Tel: +33 6 35 36 35 00

 

 

Tel: +44 (0) 20 3709 5700

 

 

 

Tel: +33 6 66 58 84 28

Tel: +33 6 33 73 85 16

 

Tel: +33 1 53 77 46 46

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ObsEva SA to present at Jefferies Virtual London Healthcare Conference, November 17 – 19, 2020

Geneva, Switzerland and Boston, MA – November 13, 2020 – ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health today announced that Company Management will present an update on the Company and its pipeline at the 11th Annual Jefferies (Virtual) London Healthcare Conference, taking place November 17 – 19, 2020.

ObsEva’s presentation will take place on Wednesday November 18 at 12:55 p.m. Greenwich Mean Time (GMT).  A live presentation link will be available under “Events Calendar” in the investors section of ObsEva’s website at www.ObsEva.com

About ObsEva

ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor, and improving ET outcomes following IVF. ObsEva is listed on the Nasdaq Global Select Market and is trading under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is trading under the ticker symbol “OBSN”. For more information, please visit www.ObsEva.com.

Cautionary Note Regarding Forward Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan,” “potential,” “will,” and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of ObsEva’s product candidates. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, clinical development and related interactions with regulators, , ObsEva’s reliance on third parties over which it may not always have full control, the impact of the novel coronavirus outbreak, and other risks and uncertainties that are described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2019, the Risk Factors disclosed in ObsEva’s Report on Form 6-K filed with the Securities and Exchange Commission (SEC) on November 5, 2020 and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at http://www.obseva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

For further information, please contact:

CEO Office contact

Shauna Dillon
Shauna.dillon@obseva.ch
+41 22 552 1550

 

 

 

Attachment

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Kiadis announces presentations at the 2020 ASH Annual Meeting and Exposition

Amsterdam, The Netherlands, November 13, 2020 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company developing innovative NK-cell-based medicines for the treatment of life-threatening diseases, today announces that five abstracts related to its K-NK-cell therapy platform were accepted for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition being held virtually from December 5-8, 2020.

The ASH abstracts are now available online through the ASH conference website at www.hematology.org/Annual-Meeting/Abstracts/.

Details of the oral presentation are as follows:

  • Oral Presentation #68: Haploidentical MbIL-21 Ex Vivo Expanded NK Cells (FC21-NK) for Patients with Multiple Relapsed and Refractory Acute Myeloid Leukemia
    Presenter: Piyanuch Kongtim, MD
    Affiliation: MD Anderson Cancer Center, Houston, TX
    Session: 704. Immunotherapies: Beyond T to NK
    Presentation Date: Saturday, December 5, 2020: 8:45 AM

Details of the poster presentations are as follows:

  • Poster #825: Optimizing Ex-vivo Expanded NK Cell- Mediated Antibody-Dependent Cellular Cytotoxicity (ADCC) Combined With NKTR-255 in Chronic Lymphocytic Leukemia (CLL), Follicular Lymphoma (FL), and Burkitt Lymphoma (BL)
    Presenter: Yaya Chu
    Affiliation: New York Medical College, Valhalla, NY
    Session: 203. Lymphocytes, Lymphocyte Activation, and Immunodeficiency, including HIV and Other Infections: Poster I
    Presentation Date: Saturday, December 5, 2020: 7:00 AM-3:30 PM Poster Hall
  • Poster #2151: A Phase I Trial of Incorporating Natural Killer (K-NK) Cells for Patients with Chronic Myeloid Leukemia (CML) and Molecular Residual Disease after Tyrosine Kinase Inhibitor (TKI) Therapy
    Presenter: Lindsay Rein, MD
    Affiliation: Duke University Medical Center, Durham, NC
    Session: 632. Chronic Myeloid Leukemia: Therapy: Poster II
    Presentation Date: Sunday, December 6, 2020: 7:00 AM-3:30 PM, Poster Hall
  • Poster #2341: BMT CTN 1803: Haploidentical Natural Killer Cells (K-NK002) to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM)
    Presenter: Sumithira Vasu, MD
    Affiliation: The Ohio State University, Columbus, OH
    Session: 703. Adoptive Immunotherapy: Mechanisms and New Approaches: Poster II
    Presentation Date: Sunday, December 6, 2020: 7:00 AM-3:30 PM, Poster Hall
  • Poster #2347: A Phase I Clinical Trial Testing the Safety of IL-21-Expanded, Off-the-Shelf, Third-Party Natural Killer Cells for Relapsed/Refractory Acute Myeloid Leukemia and Myelodysplastic Syndrome
    Presenter: Sumithira Vasu
    Affiliation: The Ohio State University, Columbus, OH
    Session: 704. Immunotherapies: Poster II
    Presentation Date: Sunday, December 6, 2020: 7:00 AM-3:30 PM, Poster Hall

Dutch Translation/Nederlandse vertaling


Kiadis Pharma N.V.

(“Kiadis”) is een Nederlands beursgenoteerd biotechbedrijf in de klinische fase dat nieuwe geneesmiddelen ontwikkelt tegen ernstige ziekten. Het maakt daarbij gebruik van Natural Killer-cellen (NK-cellen), grote witte bloedlichamen die de eerste verdedigingslinie in het menselijk afweersysteem vormen tegen kankercellen en infecties. Kiadis maakt dat vijf ‘abstracts’ over het K-NK-celtherapieplatform zijn geaccepteerd voor presentatie op de 62e American Society of Hematology (ASH) Annual Meeting and Exposition die virtueel wordt gehouden van 5 tot 8 december 2020.

De ASH-samenvattingen zijn nu online beschikbaar via de ASH-conferentiewebsite op www.hematology.org/Annual-Meeting/Abstracts/.

Details van de presentaties zijn als volgt:

  • Poster #2151: Een fase I-onderzoek naar het opnemen van Natural Killer-cellen (K-NK) voor patiënten met chronische myeloïde leukemie (CML) en moleculaire restziekte na therapie met tyrosinekinaseremmers (TKI)
    Presentator: Lindsay Rein, MD
    Gelieerd aan: Duke University Medical Center, Durham, NC
    Sessie: 632. Chronische myeloïde leukemie: therapie: poster II
    Presentatiedatum: zondag 6 december 2020: 7:00 – 15:30 uur, Posterzaal
  • Mondelinge presentatie #68: Haplo-identieke MbIL-21 ex vivo geëxpandeerde NK-cellen (FC21-NK) voor patiënten met meervoudige recidiverende en refractaire acute myeloïde leukemie
    Presentator: Piyanuch Kongtim, MD
    Gelieerd aan: MD Anderson Cancer Center, Houston, TX
    Sessie: 704. Immuuntherapie: voorbij T tot NK
    Presentatiedatum: zaterdag 5 december 2020: 8.45 uur
  • Poster #825: Optimalisatie van ex-vivo geëxpandeerde NK-celgemedieerde antilichaamafhankelijke cellulaire cytotoxiciteit (ADCC) gecombineerd met NKTR-255 bij chronische lymfatische leukemie (CLL), folliculair lymfoom (FL) en Burkitt lymfoom (BL)
    Presentator: Yaya Chu
    Gelieerd aan: New York Medical College, Valhalla, NY
    Sessie: 203. Lymfocyten, lymfocytactivering en immunodeficiëntie, inclusief hiv en andere infecties: poster I
    Presentatiedatum: zaterdag 5 december 2020: 07:00 – 15:30 uur Posterzaal
  • Poster #2341: BMT CTN 1803: Haploidentical Natural Killer Cells (K-NK002) ter voorkoming van terugval na transplantatie bij AML en MDS (NK-REALM)
    Presentator: Sumithira Vasu, MD
    Gelieerd aan: The Ohio State University, Columbus, OH
    Sessie: 703. Adoptieve immunotherapie: mechanismen en nieuwe benaderingen: poster II
    Presentatiedatum: zondag 6 december 2020: 7:00 – 15:30 uur, Posterzaal
  • Poster #2347: Een fase I klinisch onderzoek naar de veiligheid van IL-21-uitgebreide, off-the-shelf natural killer-cellen van derden voor recidiverende/refractaire acute myeloïde leukemie en myelodysplastisch syndroom
    Presentator: Sumithira Vasu
    Gelieerd aan: The Ohio State University, Columbus, OH
    Sessie: 704. Immuuntherapie: Poster II
    Presentatiedatum: zondag 6 december 2020: 7:00 – 15:30 uur, Posterzaal

Dit persbericht vormt een samenvatting van het gepubliceerde Engelstalige persbericht. Bij eventuele verschillen is de tekst van het Engelstalige persbericht altijd leidend.

Contacts

Kiadis:

Maryann Cimino, Sr. Manager, Corporate Affairs
Tel: +1 (617) 710-7305
[email protected]

 

 LifeSpring Life Sciences Communication:

Leon Melens (Amsterdam)
Tel: +31 538 16 427
[email protected]

Optimum Strategic Communications:
Mary Clark, Supriya Mathur
Tel: +44 203 950 9144
[email protected]

About Kiadis

Founded in 1997, Kiadis is building a fully integrated biopharmaceutical company committed to developing innovative cell-based medicines for patients with life-threatening diseases. With headquarters in Amsterdam, The Netherlands, and offices and activities across the United States, Kiadis is reimagining medicine by leveraging the natural strengths of humanity and our collective immune system to source the best cells for life.

Kiadis is listed on the regulated market of Euronext Amsterdam and Euronext Brussels since July 2, 2015, under the symbol KDS. Learn more at www.kiadis.com.

Forward Looking Statements

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect Kiadis’ or, as appropriate, Kiadis’ officers’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of known and unknown risks, uncertainties and assumptions that could cause actual results, performance, achievements or events to differ materially from those expressed, anticipated or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, regulation, competition and technology, can cause actual events, performance, achievements or results to differ significantly from any anticipated or implied development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, Kiadis expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or projections, or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither Kiadis nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the anticipated or implied developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.