On January 10, 2020 Saniona AB ("Saniona" or the "Company") reported that it has resolved on a directed issue of shares of SEK 25 million at a subscription price of SEK 25 per share (Press release, Saniona, JAN 10, 2020, View Source [SID1234552986]). Saniona has further entered into a loan facility agreement entitling the Company to draw loans in an aggregate amount of SEK 25 million (Press release, Saniona, JAN 10, 2020, View Source [SID1234552986]). The Company’s right to draw loans under the loan facility agreement is conditional upon that an extraordinary general meeting to be held on 7 February 2020 resolves to approve an issue of units (consisting of warrants in three different series) directed to the lenders and a rights issue of units (consisting of warrants in the same three series as issued to the lenders). The units in both the directed issue and the rights issue will be issued free of payment. A notice to the extraordinary general meeting will be issued through a separate press release. Due to the transactions, Saniona has resolved to change the date of release of the year-end report for 2019 to 7 February 2020 (previously intended to be released 20 February 2020) and to change the date of the release of the quarterly report for the first quarter in 2020 to 7 May 2020 (previously intended to be released on 27 May 2020).

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"The funding we have secured from Formue Nord, together with the proposed loan and additional capital received if the warrants are exercised, will allow Saniona to pursue further development of Tesomet by itself in Prader-Willi syndrome and hypothalamic obesity, two rare diseases that represent attractive commercial opportunities, while requiring limited investment to develop them to market. We have compiled encouraging proof of concept data on this promising treatment and are now preparing for meetings with U.S. and European regulators, with the aim of filing an Investigational New Drug (IND) application to initiate a pivotal Phase 2b/Phase 3 program, which will form the basis of our filings for approval," says Rami Levin, CEO of Saniona.

The Directed Share Issue and the Loan Facility in brief

The Directed Share Issue consists of 1,000,000 shares issued at a subscription price of SEK 25 per share resulting in aggregate gross proceeds of SEK 25 million (the "Directed Share Issue"). The Directed Share Issue has been resolved by the Board of Directors pursuant to the authorization granted by the annual general meeting held on 29 May 2019. The Directed Share Issue is directed to Formue Nord Markedsneutral A/S (SEK 19.5 million) and Formue Nord Fokus A/S (SEK 5.5 million) (Formue Nord Markedsneutral A/S and Formue Nord Fokus A/S, jointly the "Investors"). The subscription price in the Directed Share Issue corresponds to a discount of 10.2 % to the volume weighted average price of the Company’s share on Nasdaq Stockholm during the 10 trading days preceding the issue resolution. Payment for the shares subscribed in the Directed Share Issue shall be made in cash at the latest on 14 January 2020. The reasons for the deviation from the shareholders’ preferential right were mainly to enable a capital raise in a time and cost efficient manner.
Through the Directed Share Issue, the number of shares in the Company will increase by 1,000,000 to 29,412, 519 and the share capital will increase by SEK 50,000 to SEK 1,470,625.95. The Directed Share Issue entails a dilution of 3.4% for existing shareholders based on the number of shares in the Company after the Directed Share Issue.
The Company has also entered into a loan facility agreement with the Investors entitling Saniona to draw loans in an aggregate amount of SEK 25 million (the "Loan Facility"). The Company’s right to draw loans under the Loan Facility is conditional upon that an extraordinary general meeting to be held on 7 February 2020 resolves to approve (i) a directed issue of 465,518 units, consisting of warrants in three different series (in the aggregate 1,396,554 warrants) to the Investors (the "Directed Unit Issue") and (ii) a rights issue directed to the existing shareholders in Saniona of 1,014,224 units, consisting of warrants in the same three series as issued in the Directed Unit Issue to the Investors (in the aggregate 3,042,672 warrants) (the "Rights Issue"), see further below. Any loans drawn under the Loan Facility will carry interest on market terms and shall be repaid at the latest 12 months after the date of the extraordinary general meeting held on 7 February 2020.
Formue Nord is an asset management firm providing customized financing solutions for listed companies in the Nordics.

The Rights Issue in brief

The units in the Rights Issue will be issued free of payment and the purpose of the Rights Issue is to provide means to raise additional funds while at the same time compensate the existing shareholders for the dilution from the Directed Share Issue and the Directed Unit Issue.
The Rights Issue consists of 1,014,224 units consisting of warrants in three different series, in the aggregate 3,042,672 warrants. Each unit will consist of three warrants in three different series and in the aggregate 1,014,224 warrants will be issued in each series. The warrants issued in the Rights Issue will be of the same series as issued in the Directed Unit Issue.
Saniona’s shareholders have preferential rights to subscribe for one (1) new unit per twenty-nine (29) existing shares, i.e. at a subscription ratio of 1:29. Each unit consists of one (1) warrant of series TO 1, one (1) warrant of series TO 2, one (1) warrant of series TO 3.
The general public is not given the right to subscribe in the Rights Issue. Subscription without unit rights can only be done by such subscribers who have also subscribed for units with unit rights, regardless of whether the subscriber was a shareholder on the record date or not.
The record date for receiving unit rights in the Rights Issue is 13 February 2020. The last day of trading in the Saniona share including preferential right in the Rights Issue is 11 February 2020. The first day of trading in the Saniona share excluding preferential right in the Rights Issue is 12 February 2020.
The subscription period runs from and including 17 February 2020 up to and including 2 March 2020.
Trading in unit rights will take place on Nasdaq Stockholm from and including 17 February 2020 up to and including 27 February 2020.
Trading in subscribed for units (Sw. Betald Tecknad Unit, BTU) will take place on Nasdaq Stockholm from and including 17 February 2020 until the Swedish Companies Registration Office has registered the Rights Issue, which is expected to occur around 18 March 2020.
Once the warrants issued in the Rights Issue have been registered with the Swedish Companies Registration Office, issued BTU’s will automatically be converted into warrants in Euroclear Sweden’s system.
Since the units in the Rights Issue are issued free of charge, Saniona will not receive any issue proceeds in connection with the execution of the Rights Issue.
Each warrant gives the holder the right to subscribe for one (1) new share in Saniona at a subscription price corresponding to 70 percent of the volume weighted average price of the share during a two-week period prior to the subscription period which ends two trading days prior the first day of the warrant´s utilization period, but no less than SEK 25 and no more than SEK 30 per share. The utilization periods are: for series TO 1, 11-25 May 2020, for series TO 2, 7-21 September 2020 and for series TO 3, 6-20 April 2021.
Background and reasons for the Directed Share Issue, the Loan Facility, the Directed Unit Issue and the Rights Issue
Saniona is a research and development company focused on drugs for diseases of the central nervous system and eating disorders. The Company has five programs in clinical development. The research is focused on ion channels and the Company has a broad portfolio of preclinical programs. Saniona has partnerships with Boehringer Ingelheim GmbH, Productos Medix, S.A de S.V, Cadent Therapeutics and Treatment Research Center (TRC) at the University of Pennsylvania.

Saniona is developing products internally with the aim of attaining market approval itself in the U.S. and Europe for certain orphan indications where the required investments are limited, and the commercial opportunities substantial. For example, Saniona is currently developing Tesomet for Prader-Willi syndrome and hypothalamic obesity with emphasis on the U.S. and Europe. The market for such a product may be significant despite a relatively small number of patients. Furthermore, the required investments for developing Tesomet in these indications are comparatively small and the required commercial infrastructure for servicing these patients in the U.S. and Europe is manageable. In general, the majority of Saniona’s internal development programs may potentially be developed and commercialized for both orphan indications by Saniona and for larger indications in collaboration with partners.

In order to support Saniona’s overall objectives, the Company has resolved to carry out the Directed Share Issue and to enter into the agreement regarding the Loan Facility, in the aggregate providing a total amount of up to SEK 50 million, as well as the Directed Unit Issue and the Rights Issue which can provide the Company an additional SEK 111 –133 million, upon full exercise of the warrants issued and before transaction costs. Saniona’s aggregate transaction costs related to the Directed Share Issue are approximately SEK 0.4 million and Saniona’s aggregate transaction costs related to the Directed Unit Issue and the Rights Issue are approximately SEK 1.7 million.

The net proceeds from the Directed Share Issue and the Loan Facility, if and as needed and drawn, together with the potential subsequent proceeds from utilization of the warrants in the Directed Unit Issue and the Rights Issue will replace the existing financing agreement with Nice & Green dated 28 December 2017, and be used for general business purposes and the continued development of the Company’s key asset, Tesomet, for the rare diseases Prader-Willi syndrome and hypothalamic induced obesity.

Detailed terms of the Rights Issue
The units in the Rights Issue will be issued free of payment and the purpose of the Rights Issue is to provide means to raise additional funds while at the same time compensate the existing shareholders for the dilution from the Directed Share Issue and the Directed Unit Issue.

Those who are registered shareholders in Saniona in the share register maintained by Euroclear Sweden AB on the record day, 13 February 2020, have preferential right to subscribe for units in proportion to the number of shares that the holders already own. For each Saniona share held, one (1) unit right is received free of payment. Twenty-nine (29) unit rights entitle to subscription of one (1) new unit. Each unit consists of one (1) warrant of series TO 1, one (1) warrant of series TO 2, one (1) warrant of series TO 3.

If not all units are subscribed for by exercise of unit rights, allotment of the remaining units shall be made within the highest amount of the rights issue to those who have subscribed for units by exercise of unit rights (regardless of whether they were shareholders on the record date or not) and who have applied for subscription of units without exercise of unit rights and if allotment to these cannot be made in full, allotment shall be made pro rata in relation to the number of unit rights that each and every one of those, who have applied for subscription of units without exercise of unit rights, have exercised for subscription of units. To the extent that allotment cannot be done pro rata, allotment shall be determined by drawing of lots.

Subscription of units by exercise of unit rights shall be made on a subscription form during the time period from and including 17 February 2020 to and including 2 March 2020. The Board of Directors shall have the right to prolong the time period for subscription which, if applicable, will be announced by the Company in a press release not later than on 2 March 2020.

The general public is not given the right to subscribe in the Rights Issue. Subscription without unit rights can only be done by such subscribers who have also subscribed for units with unit rights, regardless of whether the subscriber was a shareholder on the record date or not. Subscription and allocation of units without preferential right can thus only be done with so-called "subsidiary" preferential right.

Terms for the warrants issued in the units in the Directed Unit Issue and the Rights Issue
Each unit issued in the Directed Unit Issue and the Rights Issue will consist of three warrants in three different series, TO 1, TO 2 and TO 3. The warrants issued in the Directed Unit Issue will be of the same series as the warrants issued in the Rights Issue.

Each warrant TO 1 will entitle the holder to subscribe for one (1) new share in Saniona against cash payment during the period from and including 11 May 2020 to and including 25 May 2020. The subscription price shall be 70 percent of the volume weighted average price of the share during the period from and including 22 April 2020 to and including 6 May 2020, provided that the subscription price shall be at least SEK 25 and not more than SEK 30. The aggregate number of TO 1 warrants will be 1,479,742 and upon full exercise of all TO 1 warrants, the number of shares in the Company will increase by 1,479,742 to 30,892,261 and the share capital will increase by SEK 73 987,10 to SEK 1,544,613.05.

Each warrant TO 2 will entitle the holder to subscribe for one (1) new share in Saniona against cash payment during the period from and including 7 September 2020 to and including 21 September 2020. The subscription price shall be 70 percent of the volume weighted average price of the share during the period from and including 20 August 2020 to and including 2 September 2020, provided that the subscription price shall be at least SEK 25 and not more than SEK 30. The aggregate number of TO 2 warrants will be 1,479,742 and upon full exercise of all TO 2 warrants, the number of shares in the Company will increase further by 1,479,742 to 32,372,003 and the share capital will increase further by SEK 73 987,10 to SEK 1,618,600.15.

Each warrant TO 3 will entitle the holder to subscribe for one (1) new share in Saniona against cash payment during the period from and including 6 April 2021 to and including 20 April 2021. The subscription price shall be 70 percent of the volume weighted average price of the share during the period from and including 17 March 2021 to and including 30 March 2021, provided that the subscription price shall be at least SEK 25 and not more than SEK 30. The aggregate number of TO 3 warrants will be 1,479,742 and upon full exercise of all TO 3 warrants, the number of shares in the Company will increase further by 1,479,742 to 33,851,745 and the share capital will increase further by SEK 73 987,10 to SEK 1,692,587.25.

Saniona will publish the subscription price for the respective series of warrants at the latest on the day before the first day in the respective subscription period. The warrants will be subject to customary recalculation conditions.

Admittance to trading of the warrants issued in the Directed Unit Issue and the Rights Issue
The Company will apply for admission to trading of the warrants issued in the Directed Unit Issue and the Rights Issue on Nasdaq Stockholm. The Company will announce the estimated first day for trading of warrants in a separate press release.

Approval at extraordinary general meeting
The Directed Unit Issue and the Rights Issue have been resolved by the Board of Directors conditional upon approval at an extraordinary general meeting to be held on 7 February 2020. The two largest shareholders in Saniona, Jørgen Drejer and Thomas Feldthus, who together own approximately 14.3 % of the shares in the Company after the Directed Share Issue have undertaken to vote in favour of the Directed Unit Issue and the Rights Issue.

Indicative time table for the Rights Issue
7 February 2020 Extraordinary general meeting for approval of the Rights Issue and the Directed Unit Issue
11 February 2020 Last day of trading in Saniona’s share including right to participate in the Rights Issue
12 February 2020 First day of trading in Saniona’s share excluding right to participate in the Rights Issue
13 February 2020 Record date for participation in the Rights Issue, i.e. holders of shares who are registered in the share register on this day will receive unit rights for participation in the Rights Issue
14 February 2020 Estimated date for publication of the prospectus
17– 27 February 2020 Trading in unit rights
17 February – 2 March 2020 Subscription period for units
17 February – 18 March 2020 Trading in paid subscribed units (Sw. BTU)
Around 4 March 2020 Estimated day for announcement of outcome of the Rights Issue

Prospectus
A prospectus relating to the Rights Issue and the admittance to trading of the warrants issued in the Rights Issue and the Directed Unit Issue will be available on Saniona’s and Sedermera´s webpages www.saniona.com and www.sedermera.se, respectively before the start of the subscription period.

Changed date for publication of financial reports
Due to the transactions, Saniona has resolved to change the date of release of the year-end report for 2019 to 7 February 2020 (previously intended to be released 20 February 2020) and to change the date of the release of the quarterly report for the first quarter in 2020 to 7 May 2020 (previously intended to be released on 27 May 2020).

Financial and legal advisors
Sedermera Fondkommission is financial advisor and issuing agent and Setterwalls Advokatbyrå is legal advisor to Saniona in connection with the financing.

On January 10, 2020 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its fourth quarter and full year 2019 financial and operating results on Thursday, February 6, 2020, before the U.S. financial markets open (Press release, Regeneron, JAN 10, 2020, https://www.prnewswire.com/news-releases/regeneron-to-report-fourth-quarter-and-full-year-2019-financial-and-operating-results-and-host-conference-call-and-webcast-on-february-6-2020-300984444.html [SID1234553002]). The Company will host a conference call and simultaneous webcast at 8:00 AM Eastern Time that day.

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Conference Call Information
To access this call, dial (800) 708-4540 (U.S.) or (847) 619-6397 (International). A link to the webcast may be accessed from the ‘Investors and Media’ page of Regeneron’s website at View Source A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

On January 10, 2020 Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, reported that topline results from its completed open-label Phase I/II clinical trial of Medigene’s autologous dendritic cell (DC) vaccine in 20 patients with acute myeloid leukemia (AML) (Press release, MediGene, JAN 10, 2020, View Source [SID1234552987]). The study was conducted at the Oslo University Hospital, Norway. Data were collected shortly after completion of the clinical trial, i.e. after 24 months of vaccination and follow-up of all patients.

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The trial’s primary outcome measures assessing 1) the feasibility of DC vaccine manufacturing/administration, and 2) its safety/tolerability over 2 years, were successfully achieved. The DC vaccinations were well tolerated with no serious adverse events (SAEs) related to the treatment.

The secondary outcome measures evaluating key clinical parameters show that after 24 months of treatment overall survival rate (OS) was 80% (16 of 20 patients, 95% confidence interval (CI): 55 to 92%) and progression free survival rate (PFS) was 55% (11 of 20 patients, 95% CI: 31 to 74%).

In the current AML treatment paradigm, patients 60 years of age or older are often ineligible for hematopoietic stem cell transplantation and have poorer treatment outcomes. This group accounted for 50% of patients in this trial (risk groups good, intermediate, poor: 4, 4, 2) and an excellent OS of 80% (8 of 10 patients, 95% CI: 41 to 95%) and a PFS of 50% (5 of 10 patients, 95% CI: 18 to 75%) was observed at 24 months. In the patient group younger than 60 years of age (risk groups good, intermediate, poor: 9, 1, 0), also an excellent OS of 80% (8 of 10 patients, 95% CI: 41 to 95%) and a PFS of 60% (6 of 10 patients, 95% CI: 25 to 83%) was observed at 24 months.

As disclosed at the time of the 12-months interim analysis in December 2018, in patients where disease relapsed, most cases (5 out of 8) occurred within the first 80 days after the start of the vaccination. These early relapses were investigated by molecular mutational analysis which suggested that some relapses had already begun on a molecular level at the time of entry into the study.

Dr. Yngvar Floisand, Head Physician of the Department of Hematology at the Oslo University Hospital and Principal Investigator of the trial, comments: "New treatment options are desperately needed for patients with AML. The disease progresses rapidly and may be fatal within a few weeks or months, if untreated. Even despite having received a treatment, the majority of predominantly elderly patients continue to experience minimal residual disease burden that sooner or later leads to relapse of the disease. Medigene’s DC vaccine trial was designed towards potentially making new treatments available for these patients, specifically aiming at reducing the risk of relapse in treated patients after completing conventional chemotherapy.

"The now final topline results from this Phase I/II clinical trial with patient-derived DCs confirm the previously published promising 12-months interim analysis. The clinical outcome is encouraging, not only regarding the excellent safety and tolerability profile, but also for an overall survival when it comes to secondary endpoints."

Prof. Dolores Schendel, CEO and CSO of Medigene AG, comments: "We are pleased with these positive and promising results from the first clinical trial of our DC vaccine. We thank all the patients for participating in the trial and the study team for their efforts and contributions. In the future, this novel clinical approach could offer a treatment possibility for AML patients who have insufficient treatment options and face the risk of relapse. We are looking forward to providing further updates. More detailed data and analyses will be presented at upcoming scientific conferences."

– end of press release –

Related news
10 December 2019, Interim 1-year clinical immune monitoring data from DC vaccine trial in AML presented at ASH (Free ASH Whitepaper) 2019 Annual Meeting
17 June 2019, Interim analysis from ongoing Phase I/II clinical trial with DC vaccines in AML patients presented at EHA (Free EHA Whitepaper)
8 January 2019, Additional European patent granted for Medigene’s DC vaccine platform
19 December 2018, Medigene publishes topline interim data from ongoing Phase I/II clinical trial with DC vaccines in AML patients
19 April 2018, Medigene presents data on the successful production of AML DC vaccines at AACR (Free AACR Whitepaper) conference

Further information

About Medigene’s DC vaccines
In addition to Medigene’s focus on T cell-receptor modified T cells (TCR-Ts), the Company has developed a new generation of antigen-tailored dendritic cell (DC) vaccines.

Dendritic cells (DC) are a specialized type of immune cells. They patrol throughout our body, take up antigens, process them and present short peptides on their cell surface. These peptides are recognized by other types of immune cells such as T cells or natural killer (NK) cells, which then become activated. In this way, the activated immune cells are enabled to recognize and eliminate tumor cells.

The scientific team of Medigene has developed new, fast and efficient methods for generating autologous (patient-specific) mature DCs which have the relevant characteristics to generate very strong T cell and NK cell immune responses. The DCs can be loaded with various tumor antigens to treat different forms of cancer. Since an immune response builds up over the total time of administration of the DC vaccine, this form of therapy is particularly designed for patients who suffer from a tumor disease which has been reduced by chemotherapy to such an extent that the prevention of the recurrence of the tumor disease is the main goal.

About acute myeloid leukemia (AML)
Acute myeloid leukemia (AML) is a malignant disease of the hematopoietic system, affecting mainly adults above 60 years of age.

AML is a heterogeneous type of cancer affecting patients’ blood and bone marrow. It is characterized by an overproduction of myeloid progenitor cells named myeloblasts or leukemic blasts. These cells prevent the generation of normal blood cells, causing a decrease in erythrocytes and platelets, for example. Typical symptoms of AML include anemia, fever, increased risk of infection, and bleeding. AML progresses rapidly and may be fatal within a few weeks or months, if untreated.

AML is typically treated initially with intensive induction chemotherapy in order to achieve remission. Some patients are eligible to receive additional chemotherapy or an allogeneic hematopoietic stem cell transplant (HSCT), which increases the potential for eradication of residual tumor cells. However, HSCT induces high morbidity and mortality and only less than half of the AML patients can be treated with HSCT.

Additionally, elderly patients may be unable to complete the full regimen of intensive chemotherapy due to its high toxic side effects. Thus, the majority of elderly patients remain undertreated and continue to experience minimal residual disease (MRD) burden that sooner or later will lead to leukemia relapse*.

*Webster JA, Pratz KW. "Acute myeloid leukemia in the elderly: therapeutic options and choice." Leuk Lymphoma. 2018 Feb;59(2):274-287. Epub 2017 Jun 2. Review.

Löwenberg B, Ossenkoppele GJ, van Putten W, et al. 2009: "High-dose daunorubicin in older patients with acute myeloid leukemia." N Engl J Med ;361:1235-48.

Röllig C, Thiede C, Gramatzki M, Aulitzky W, Bodenstein H, Bornhäuser M, Platzbecker U, Stuhlmann R, Schuler U, Soucek S, Kramer M, Mohr B, Oelschlaegel U, Stölzel F, von Bonin M, Wermke M, Wandt H, Ehninger G, Schaich M; Study Alliance Leukemia. "A novel prognostic model in elderly patients with acute myeloid leukemia: results of 909 patients entered into the prospective AML96 trial." Blood. 2010 Aug 12;116(6):971-8. doi: 10.1182/blood-2010-01-267302. Epub 2010 May 4.

Wheatley K1, Brookes CL, Howman AJ, Goldstone AH, Milligan DW, Prentice AG, Moorman AV, Burnett AK; United Kingdom National Cancer Research Institute Haematological Oncology Clinical Studies Group and Acute Myeloid Leukaemia Subgroup. "Prognostic factor analysis of the survival of elderly patients with AML in the MRC AML11 and LRF AML14 trials." Br J Haematol. 2009 Jun;145(5):598-605. doi: 10.1111/j.1365-2141.2009.07663.x. Epub 2009 Mar 26.

About the DC study design
The DC study (NCT02405338) was designed as an open-label trial at Oslo University Hospital, Norway. A total of 20 subjects (median age 59, range 24 to 73) with AML (risk groups good, intermediate, poor: 13, 5, 2), in morphologic complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) after induction or consolidation therapy, not eligible for allogeneic hematopoietic stem cell transplantation, were enrolled into this safety and feasibility Phase I/II trial.

Patients participating in the trial had AML that was positive for Wilms Tumor-1 (WT-1) antigen with or without positivity for Preferentially Expressed Antigen in Melanoma (PRAME). Patients were vaccinated with their WT-1/PRAME DC vaccines monthly over a 24-month period (with a higher frequency within the first 6 weeks). AML diagnoses had been established with a median of 9.8 months before the first vaccination (range 4.5 to 17.5 months), and the last chemotherapy infusion had been performed at a median of 6.9 months (range 2 to 14.8 months).

On January 10, 2020 Neptune Wellness Solutions Inc. ("Neptune" or the "Company") (Nasdaq: NEPT) (TSX: NEPT), a health and wellness company focused on extraction, purification and formulation of cannabinoids, reported that would like to provide the following corporate updates and outlook ahead of its participation at the Annual ICR Conference in Orlando, Florida being held on January 13-15, 2020, where Neptune’s CEO, Michael Cammarata, will present and meet with investors (Press release, Neptune Technologies et Bioressources inc, JAN 10, 2020, View Source [SID1234553003]).

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Consumer Brands Initiatives
Several efforts have been deployed internally to accelerate the Company’s growth in the B2C markets. The official launch of the Forest Remedies brand is expected to occur in February 2020, supported by a public relations campaign and a marketing campaign under our partnership with American Media LLC. The launch will consist of hemp-derived wellness products including ingestibles, such as soft gels and oils, topicals and a pet soother. The Forest Remedies brand launch will also include aromatherapy products developed in collaboration with International Flavors & Fragrances Inc. ("IFF"). Neptune will first launch Forest Remedies online and expects the brand to be available at U.S. retailers shortly thereafter. A media event will be held this spring at IFF’s headquarters to celebrate the brand’s debut.

Neptune is also rebranding OCEANO³ to Ocean Remedies, under which the Company’s omega-3 products will be commercialized. Other product launches under the Ocean Remedies brand are expected this year.

Health Canada License Amendments
At our Sherbrooke facility, the expansion of Neptune’s packaging and warehousing capabilities is tracking as planned. Neptune expects to request an amendment to include these packaging and warehousing areas under the Company’s license granted by Health Canada, in the near future. Licensing these additional areas is expected to significantly increase Neptune’s capabilities to provide turnkey solutions to its customers such as formulation, purification, blending, manufacturing and packaging services. Neptune will also seek to add significant warehouse space, which can be kept at sub-zero temperatures and which should improve logistics to store cannabis biomass and finished products.

Neptune is also in the process of applying to receive permission to sell cannabis products from Health Canada. Upon the addition of the authorization to sell cannabis to the conditions of its license, the Company will be able to sell finished products directly to licensed cannabis distributors and retailers, enabling Neptune to position itself closer to the end customer. Neptune initially expects to launch cannabis products in Canada under its Forest Remedies, Ocean Remedies and Neptune brands.

The Company will utilize some of its future capacity which has recently become available, due in part to delays in the ramp-up of the Canadian cannabis market, to produce its own finished products.

Production Update
In light of the new cannabis product forms recently allowed in Canada, Neptune is progressing well to broaden its product offering into turnkey solutions for Canadian License Holders ("LHs"). The Company recently produced and shipped cannabinoid-infused powder sachets to a LH customer. In addition, Neptune, in combination with this LH customer, has completed development of cannabinoid-infused teas and commercial production is expected to start soon. These finished products are manufactured at our Sherbrooke facility and several other product forms, including but not limited to, sprays, vape pens, capsules and tinctures are expected to be produced this year.

In recent weeks, following the optimization of our extraction parameters on Neptune’s Phase I CO2 extraction equipment, extraction yields at Neptune’s Sherbrooke facility have increased by more than 10 percentage points to reach levels above 95% and allowed the team to increase process throughput.

Our Phase II equipment for ethanol extraction represents an improvement over CO2 extraction and allows us to winterize oils through an inline process, eliminating an additional manufacturing step. Management decided to upgrade the coolant system utilized in the Phase II extraction process to be consistent with the Company’s standards regarding organic processes and highest possible production standards and is looking at environmentally-friendly alternatives, such as liquid nitrogen, to maintain the intended cold temperatures throughout the manufacturing process. This decision has led to a small delay in reaching Phase II’s full extraction capacity. Future capacity utilization will be dependent on market conditions, the pace of growth of the Canadian cannabis market and the success our customers have with the rollout of their cannabis 2.0 products.

The capacity expansion at Neptune’s North Carolina SugarLeaf facility is nearing completion, as expected and on budget. With a second centrifuge installed, Neptune will be able to run multiple batches concurrently, providing more flexibility and reducing downtime. Management is putting the final touches to get the facility ready for a Good Manufacturing Practice ("GMP") pre-inspection audit which should occur in the coming weeks. A GMP certification will enable Neptune to broaden its client base. Recently, the R&D teams from both production facilities collaborated to develop an in-house technology to make a water solubility emulsion of cannabinoids. While testing is still undergoing, the initial stability tests were very positive.

Management Additions
Neptune is pleased to welcome Denis Maranda as head of production for the Sherbrooke facility. Mr. Maranda has a Bachelor’s degree in Mechanical Engineering from McGill University and a Master’s degree in Total Quality, from Concordia’ John Molson School of Business. He was previously a Plant Manager at Thyssenkrupp Aerospatiale and worked at Dart Aerospace.

Eric Dodge recently joined Neptune in the role of Senior Brand Manager, with responsibilities to oversee the growth of Forest Remedies and other Neptune’s brands. Mr. Dodge holds a Bachelor’s degree in Political Science and Economics as well as a Master of Business Administration specializing in Brand and Product Management from the University of Wisconsin – Madison. He was most recently Brand Manager – Oral Care Innovation at Tom’s of Maine, a subsidiary of Colgate-Palmolive.

To support the Company’s consumer brands, Neptune recently hired Tyler Segel as Creative Manager. Mr. Segel will be responsible for creative work on all of Neptune’s brands. He previously held the position of Creative Director for Factory North where he worked on the development of the Schmidt’s Naturals brand. Mr. Segel holds an Associate Degree in Graphic Design from Portland Community College.

On January 10, 2020 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) reported that it will announce results for the third quarter ended December 31, 2019 on Monday, January 27, 2020 after the Board Meeting (Press release, Dr Reddy’s, JAN 10, 2020, View Source [SID1234552988]).

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Summary of Events

Event

Date and Time

Medium

Release of financial results

January 27th, after the Board Meeting

Stock Exchange, Media, Company website, Business wire, Email

Press meet presentation

Will be available on the Company’s website

Company’s website www.drreddys.com

Earnings Call

January 27th, 6:30 PM IST / 8:00 AM EST

Hosted by the Company

(Details below)

Playback of Earnings Call

After the earnings call till February 3rd, 2020

Details below

Transcript of the Earnings call

Will be available on the Company’s website

URL available on Company’s website, www.drreddys.com

Earnings Call
Following the release, the management of the Company will host an earnings call to discuss the Company’s financial performance. (Dial In and other details given below)

Play Back
The play back will be available after the earnings call, till February 3rd, 2020. For play back dial in phone No: 022 7194 5757 / 022 6663 5757, and Playback Code is 58113.