Acasti Pharma Provides Business Update for the Second Quarter of Fiscal 2021

LAVAL, Quebec, Nov. 16, 2020 (GLOBE NEWSWIRE) — Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST) today provided a business update and announced its operating and financial results for the second quarter of fiscal 2021 ended September 30, 2020.

Recent Events
:

TRILOGY 1 & 2 Topline Results
. The Company’s two Phase 3 clinical trials, designated as TRILOGY 1 & 2, were designed to evaluate the efficacy, safety and tolerability of CaPre in patients with severe hypertriglyceridemia. The top-line results were announced on January 13, 2020 and August 31, 2020 respectively, and neither TRILOGY 1 nor TRILOGY 2 independently reached statistical significance, and therefore they did not meet their primary endpoint for lowering triglycerides. Although the triglyceride reduction in the CaPre arm was one of the largest seen amongst previously conducted triglyceride reduction studies, the Company will not file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for patients with severe hypertriglyceridemia and does not plan to conduct additional clinical trials for CaPre.

Engaged Oppenheimer & Co. Inc
.
to Assist in Strategic Review. On September 29, 2020, the Company announced that it had engaged Oppenheimer & Co. Inc. as its financial advisor to assist in the strategic review process. Potential strategic alternatives that may be explored or evaluated as part of this review include, but are not limited to, a merger, business combination or other strategic transaction involving Acasti and/or CaPre. There is no defined timeline for completion of the review process.

Reduction in Headcount and Discontinuation of Substantially all
Commercial and
R&D Activities. The Company initiated a plan in September 2020 to reduce personnel and expenses to preserve cash and further reduce its operations consistent with the decision to discontinue substantially all commercialization and research and development activities. The Company expects to devote significant time and resources to identifying and evaluating strategic alternatives, however, there can be no assurance that such activities will result in any agreements or transactions that will enhance shareholder value.

Jan D’Alvise, Chief Executive Officer of Acasti, commented, “We remain committed to maximizing value for our shareholders, and as previously disclosed, we are actively exploring and evaluating a range of strategic options. We have also taken a number of proactive steps to preserve our cash by reducing staff, discontinuing all commercialization activities and putting R&D activities on hold. This has resulted in certain one-time and non-cash charges as reflected in our financial statements this quarter. While we continue to pursue strategic alternatives, we plan to complete the full data analyses for TRILOGY as contemplated in the Statistical Analysis Plan, including the pooling of the data from TRILOGY 1 and 2. As previously disclosed, we plan to provide an update on the final TRILOGY data when feasible.”

Second
Quarter of Fiscal 2021
Financial Results
(US dollars):

The consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”).

  • Loss from operat
    ions for the three months September 30, 2020 was $7.8 million, compared to a loss from operations of $6.3 million for the three months ended September 30, 2019. The increase was due mainly to impairment charges of $5.3 million, $3.7 million related to intangible assets and $1.6 million related to production and lab equipment, offset by a reduction in R&D, general and administrative expenses, and sales and marketing expenses.
  • Net loss for the three months ended September 30, 2020 was $6.1 million or $0.06 per share, compared to a net loss of $21.2 million or $0.25 per share for the three months ended September 30, 2019. The reduction in net loss, resulted primarily from net financial expenses decreasing to a gain of $1.9 million for the three months ended September 30, 2020, as compared to net financial expenses of $14.9 million for the three months ended September 30, 2019. This is due mostly to a decreased impact from the change in fair value of the derivative warrant liability as compared to the comparative fiscal quarter in 2019, caused by a proportionately higher decrease in the quarter over quarter closing share price partly offset by a reduction in the number of warrants outstanding due to exercises during the prior year.
  • R&D expense
    s before depreciation, amortization and stock-based compensation expenses were $0.8 million for the three months ended September 30, 2020, compared to $3.3 million for the three months ended September 30, 2019. The net decrease was mainly attributable to a reduction in salaries and research contracts with the reduction in R&D activities.
  • General and Administrative expenses before stock-based compensation expenses were $1.1 million for the three months ended September 30, 2020, compared to $1.1 million for the three months ended September 30, 2019. This reflects a $0.27 million increase related to legal fees related offset by a decrease of $0.23 million related to salaries, due to a reversal of bonus accruals.
  • Sales and Marketing expenses before stock-based compensation expenses were $0.02 million for the three months ended September 30, 2020, compared to $0.66 million for the three months ended September 30, 2019. The decrease was mostly due to a reduction in professional fees as a result of a reclassification of professional and other expenses to R&D.
  • Cash flows Cash and cash equivalents totaled $11.6 million as of September 30, 2020, compared to $14.2 million at March 31, 2020. Acasti believes that existing cash will fully fund the Company’s operations through the second calendar quarter of 2021 or through to an eventual completion of the evaluation of strategic options, but there can be no assurance as to when or whether Acasti will complete any strategic transaction, collaboration or non-dilutive financings. If the Company cannot raise additional funds or find one or more strategic partners, it may not be able to realize its assets and discharge its liabilities in the normal course of business. As a result, there exists substantial doubt about the Company’s ability to continue as a going concern, and therefore, realize its assets and discharge its liabilities in the normal course of business.

NASDAQ
Minimum Bid Price Rule

On February 28, 2020, Acasti received written notification from the NASDAQ Listing Qualifications Department for failing to maintain a minimum bid price of $1.00 per share for the preceding 30 consecutive business days, as required by NASDAQ Listing Rule 5550(a)(2) – bid price (the “Minimum Bid Price Rule”). Under NASDAQ Listing Rule 5810(c)(3)(A) – compliance period, Acasti initially had 180 calendar days to regain compliance.

On April 17, 2020, Acasti was informed that NASDAQ had granted temporary regulatory relief related to the Minimum Bid Price Rule due to the COVID-19 pandemic for all NASDAQ-listed companies and therefore extended the deadline for Acasti to regain compliance to November 9, 2020.

On November 11, 2020, Acasti was further informed that NASDAQ had granted an additional 180 calendar days, or until May 10, 2021, for Acasti to regain compliance with the Minimum Bid Price Rule.


Retention Agreements

In connection with its strategic review process, the Company also announces that, upon the recommendation of the Governance and Human Resources Committee of the board of directors, it has entered into retention incentive agreements with Ms. Jan D’Alvise, the Company’s President and Chief Executive Officer, and Mr. Pierre Lemieux, the Company’s Chief Operating Officer and Chief Scientific Officer (the “Retention Agreements”).

The Retention Agreements provide that the Company will pay Ms. D’Alvise an employment retention incentive of US $100,000 provided that she remains employed with the Company until the earlier of April 30, 2021 or the closing of a merger or like transaction with a third party.

In addition, the Retention Agreements also provide that the Company will pay each of Ms. D’Alvise and Mr. Lemieux an amount of up to US $125,000 in the event that certain milestones are met in relation to the monetization by the Company of its assets relating to the Company’s drug candidate, CaPre.

The Company also announces the upcoming departure of Mr. Brian Groch, its Chief Commercial Officer, from his position with the Company effective December 31, 2020, until which date he is continuing in his role with Acasti. The Company would like to thank Mr. Groch for his contributions to the Company and wishes him well in his future endeavors.

About Acasti

Acasti is a biopharmaceutical innovator that has historically focused on the research, development and commercialization of prescription drugs using OM3 fatty acids delivered both as free fatty acids and bound-to-phospholipid esters, derived from krill oil. OM3 fatty acids have extensive clinical evidence of safety and efficacy in lowering triglycerides in patients with hypertriglyceridemia, or HTG. CaPre, an OM3 phospholipid therapeutic, was being developed for patients with severe HTG.

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Statements in this press release that are not statements of historical or current fact constitute “forward-looking information” within the meaning of Canadian securities laws and “forward-looking statements” within the meaning of U.S. federal securities laws (collectively, “forward-looking statements”). Such forward-looking statements involve known and unknown risks, uncertainties, and other unknown factors that could cause the actual results of Acasti to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements labeled with the terms “believes,” “belief,” “expects,” “intends,” “anticipates,” “potential,” “should,” “may,” “will,” “plans,” “continue”, “targeted”
or other similar expressions
to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Forward-looking statements in this press release include, but are not limited to, information or statements about
Acasti’s
strategy, future operations, prospects and the plans of management
;
the outcome of the
strategic
review process to explore and evaluate strategic alternatives to enhance shareholder value
; and
Acasti’s
ability to
successfully consummate a strategic transaction
.

The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the “
Special
Note Regarding Forward-Looking
Statements
” section contained in
Acasti’s
latest annual report on Form
10-K
and quarterly report on Form 10-Q
,
which
are
available on
EDGAR at

www.sec.gov/edgar/shtml

, on
SEDAR at www.sedar.com and on the investor section of
Acasti’s
website at www.acastipharma.com. All forward-looking statements in this press release are made as of the date of this press release. Acasti does not undertake to update any such forward-looking statements whether
as a result of
new information, future events or otherwise, except as required by law. The forward-looking
statements contained herein are also subject generally to assumptions and risks and uncertainties that are described from time to time in
Acasti’s
public securities filings with the Securities and Exchange Commission and the Canadian securities commissions, including
Acasti’s
latest annual report on Form
10-K
and quarterly report on Form 10-Q
under the caption “Risk Factors”
.

Neither NASDAQ, the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

A
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t
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C
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t:

Jan D’Alvise
Chief Executive Officer
Tel: 450-686-4555
Email: info@acastipharma.com
www.acastipharma.com

Investor
C
on
t
a
c
t:

Crescendo Communications, LLC
Tel: 212-671-1020
Email: [email protected]



Silvercorp Intersects 1.89 Metres Grading 37.08 Grams Per Tonne Gold in New Gold Zones at the LMW Mine, Ying Mining District, China

VANCOUVER, British Columbia, Nov. 16, 2020 (GLOBE NEWSWIRE) — Silvercorp Metals Inc. (“Silvercorp” or the “Company”) (TSX/NYSE American: SVM) is pleased to report the discovery of new gold zones and high grade intercepts from its 2020 exploration program at the LMW mine, Ying Mining District, Henan Province, China. Extensive exploration drilling and tunnelling are ongoing at the LMW mine, and all other mines at the Ying Mining District.

The 2020 exploration program from July 1, 2019 to October 30, 2020 at the LMW mine has used in-fill drilling to target areas of known sub-vertical silver-lead-zinc veins that were previously believed to be uneconomic. Since June 2020, drilling has also targeted the gently-dipping zones believed to host gold mineralization, as reported in the May 28, 2020 news release. These gold zones were previously undiscovered and appear to have been over-printed by the sub-vertical silver-lead-zinc veins which are the focus of current mining operations.   Currently, ten rigs are drilling at the LMW mine and a total of 132 diamond drill holes, including 108 underground holes and 24 surface holes totaling 37,869 metres (“m”) have been completed. Assay results for 125 holes have been received with 72 holes intercepting many zones of higher-grade silver-lead mineralization, including veins LM7, LM7W1, LM8, LM8_1, LM12_1, LM13, LM14, LM16, LM22, LM25W, LM41E, LM41E1, and LM41E2. Most of these higher-grade silver-lead discoveries can be mined through existing tunnels which is expected to substantially reduce tunnel development costs at the LMW mine going forward.

Drilling to test the gold-bearing sub-horizontal shear zone LM22 has intersected high gold grades, including 37.08 g/t Au over 1.89m. In addition, at least three new gently-dipping (to the west at less than 15°), stacked gold mineralization zones, namely LM50, LM51 and LM53, have been discovered in this drill campaign. The gold mineralization is associated with k-feldspar-ankerite-quartz-pyrite-galena veinlets and stockwork alteration. The most-drilled LM50 vein has been defined by drilling and underground tunnelling over 450m along strike to the northeast and 350m down-dip in a 25m to 50m grid pattern and true thicknesses ranging from 0.5m to over 5.4m. Three rigs are drilling LM50 which is open in all directions.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9b26bc88-10c9-403e-a77f-76bdbb51a4ce

Highlights of selected drill hole intersections:

  • Hole
    ZKX0535 intersected a 1.89m interval (1.66m true width) of vein LM22 grading 37.08 grams per tonne (“g/t”) gold (“Au”), 4 g/t silver (“Ag”), and 0.53% copper (“Cu”), which includes a 1.25m interval (1.10m true width) grading 55.80 g/t Au, 5 g/t Ag, and 0.56% Cu.
  • Hole
    ZKX0723 intersected a 6.13m interval (4.89m true width) of vein LM50 grading 5.23 g/t Au, 30 g/t Ag, 0.21% lead (“Pb”), and 0.12% zinc (“Zn”), which includes a 1.58m interval (1.34m true width) grading 12.70 g/t Au, 19 g/t Ag, 0.10% Pb, and 0.12% Zn.
  • Hole ZKX0527 intersected a 2.34m interval (2.22m true width) of vein LM50 grading 8.51 g/t Au, and 16 g/t Ag, including a 1.22m interval (1.16m true width) grading 13.30 g/t Au, and 15 g/t Ag.
  • Hole ZKX0725 intercepted a 2.45m interval grading 4.33 g/t Au of an unknown vein, approximately 50m above the LM50 zone.
  • Hole
    ZKX0940 intersected a 1.63m interval (1.46m true width) of vein LM8_1 grading 1,984 g/t Ag, 3.86% Pb, 0.60% Zn, 0.07 g/t Au, and 0.49% Cu, which includes a 1.08m interval (0.97m true width) grading 2,985 g/t Ag, 5.26% Pb, 0.87% Zn, 0.10 g/t Au, and 0.73% Cu.
  • Hole
    ZKX0934 intersected a 4.43m interval (2.50m true width) of vein LM12_1 grading 343 g/t Ag, 6.21% Pb, 1.16% Zn, and 0.17 g/t Au, which includes two intersections:

    • A 1.24m interval (0.70m true width) grading 339 g/t Ag, 7.72% Pb, 0.28% Zn, and 0.17 g/t Au; and
    • A 0.89m interval (0.50m true width) grading 1,185 g/t Ag, 17.46% Pb, 4.84% Zn, and 0.50 g/t Au.
  • Hole ZKX0118 intersected a 1.81m interval (1.29m true width) of vein LM25W grading 1,715 g/t Ag, 1.53% Pb, 0.44% Zn, 0.44 g/t Au, and 0.30% Cu.

In addition, a total of 8,684m of exploration tunnels have been developed at the LMW mine during the period. These exploration tunnels (including 4,750m of drifts) were driven along and across major mineralized vein structures to upgrade the drill defined mineral resources and test for new parallel and splay structures, and are summarized in the following table:

Major Target Veins

Total

Tunne
l
ling

(m)

Channel
Samples
Collected

Drift

Included

(m)

Total Mineralization Exposed by Drifts

[1]
Length

(m)
Average
True Width


m)
Ag

(g/t)
Pb

(%)
Zn

(%)
Au

(g/t)
Cu

(%)
LM19W2, T27E, LM14,
LM16_1, LM16,LM17W,
LM12_1, LM12E, LM22,
LM8_4a, LM32, LM8, LM41E,
LM17
8,684 3,320 4,750 775 0.53 397 4.34 0.42 0.09 0.18

[1] Mineralization is defined by silver equivalent value (AgEq) greater than or equal to 155 g/t at the LMW mine (Formula used for AgEq calculation: AgEq = Ag g/t + 35.06 * (Pb% + Cu%) + 79.57 * Au g/t).

Highlights of selected mineralized zones exposed in the drift tunnels:

  • Drift Tunnel
    XPDS-LM17-575-26SYM2 exposed mineralization 25m long and 1.54m wide (true width) grading 894 g/t Ag, 9.35% Pb, 0.53% Zn, 0.17 g/t Au, and 1.16% Cu within vein structure LM17;
  • Drift Tunnel
    XPDS-LM16-675-115SYM exposed mineralization 10m long and 0.59m wide (true width) grading 1,740 g/t Ag, 0.96% Pb and 0.36% Zn within vein structure LM16;
  • Drift Tunnel
    PD1080-LM41E-1080-11NYM exposed mineralization 15m long and 0.74m wide (true width) grading 1,079 g/t Ag, 2.12% Pb, 0.15% Zn, 0.02 g/t Au, and 0.55% Cu within vein structure LM41E; and
  • Drift Tunnel
    PD918-W6-880-128NYM exposed mineralization 35m long and 0.68m wide (true width) grading 603 g/t Ag, 4.91% Pb, 2.12% Zn, 0.02 g/t Au, and 0.13% Cu within vein structure W6.



Table
1
:
Selected
results from the 2020 drill programs at the LMW mine

Hole ID From

(m)
To

(m)
Interval

(m)
True Width

(m)
Ag

(g/t)
Pb

(%)
Zn

(%)
Au

(g/t)
Cu

(%)
Vein Ore Type
ZKX0015 307.53 308.73 1.20 1.07 331 1.10 2.78 0.05 0.14 LM10W Ag-Pb
ZKX0015 349.68 350.51 0.83 0.78 3 0.01 0.01 1.03 0.29 LM51 [1] Au
ZKX0016 131.45 133.12 1.67 0.94 522 0.43 0.03 0.05 0.07 LM13 Ag-Pb
ZKX0017 278.50 280.97 2.47 1.34 273 0.25 0.03 0.16 0.26 LM26 [1] Au
ZKX0026 192.99 193.79 0.80 0.75 13 0.02 0.02 4.75 2.18 LM26 Au
ZKX0118 30.48 32.29 1.81 1.29 1,715 1.53 0.44 0.44 0.30 LM25W Ag-Pb
ZKX0118 146.71 148.17 1.46 1.27 3 0.01 0.01 3.52 0.33 LM22 [1] Au
ZKX0319 270.45 271.16 0.71 0.57 5 0.01 0.01 3.19 0.69 LM51 Au
ZKX0334 84.70 86.08 1.38 1.30 1 0.00 0.00 5.43 0.09 LM22 Au
ZKX0517 46.70 47.23 0.53 0.50 6 0.01 0.02 2.49 0.00 LM22a [1] Au
ZKX0527 162.82 165.16 2.34 2.22 16 0.64 0.07 8.51 0.01 LM50 [1] Au
Including 163.94 165.16 1.22 1.16 15 0.86 0.07 13.30 0.01 LM50 Au
ZKX0528 154.89 159.55 4.66 3.15 5 0.01 0.02 2.58 0.00 LM50 Au
Including 159.15 159.55 0.40 0.26 47 0.04 0.04 26.70 0.01 LM50 Au
ZKX0529 113.56 114.16 0.60 0.36 780 1.23 0.33 0.04 0.46 LM7W1 Ag-Pb
ZKX0529 168.28 176.06 7.78 4.68 256 0.76 0.07 0.01 0.08 LM7 Ag-Pb
Including 168.28 169.97 1.69 1.02 587 0.25 0.02 0.01 0.03 LM7 Ag-Pb
and 174.68 176.06 1.38 0.83 609 2.93 0.24 0.01 0.39 LM7 Ag-Pb
ZKX0531 105.26 105.97 0.71 0.61 5 0.02 0.01 21.10 1.14 LM22 Au
ZKX0535 92.91 94.80 1.89 1.66 4 0.00 0.01 37.08 0.53 LM22 Au
Including 92.91 94.16 1.25 1.10 5 0.00 0.01 55.80 0.56 LM22 Au
ZKX0723 184.27 190.40 6.13 4.89 30 0.21 0.12 5.23 0.00 LM50 Au
Including 184.27 185.85 1.58 1.34 19 0.10 0.12 12.70 0.01 LM50 Au
ZKX0725 126.41 128.86 2.45 2.06 2 0.01 0.01 4.33 0.01 ? [1], [2] Au
Including 126.41 127.36 0.95 0.80 3 0.02 0.01 10.03 0.01 ? Au
ZKX0725 166.07 167.37 1.30 1.18 1 0.02 0.06 1.87 0.01 LM50 Au
ZKX0726 165.59 166.44 0.85 0.65 15 0.59 0.33 9.74 0.01 LM50 Au
ZKX0726 207.06 208.56 1.50 0.92 370 0.59 0.08 0.01 0.04 LM8a Ag-Pb
ZKX0934 135.46 136.56 1.10 0.98 39 0.09 0.46 3.25 0.01 LM13 Ag-Pb
ZKX0934 323.27 327.70 4.43 2.50 343 6.21 1.16 0.17 0.04 LM12_1 Ag-Pb
Including 323.27 324.51 1.24 0.70 339 7.72 0.28 0.17 0.05 LM12_1 Ag-Pb
and 326.81 327.70 0.89 0.50 1,185 17.64 4.84 0.50 0.08 LM12_1 Ag-Pb
ZKX0940 249.22 250.85 1.63 1.46 1,984 3.86 0.60 0.07 0.49 LM8_1 Ag-Pb
Including 249.77 250.85 1.08 0.97 2,985 5.26 0.87 0.10 0.73 LM8_1 Ag-Pb
ZKX1103 56.48 57.34 0.86 0.72 156 0.91 0.05 0.03 0.01 LM7W1 Ag-Pb
ZKX1103 116.00 116.29 0.29 0.27 618 0.08 0.03 0.03 0.04 LM7W Ag-Pb
ZKX1104 157.45 157.70 0.25 0.23 2,133 1.99 0.14 0.05 0.18 LM41E Ag-Pb
ZKX1105 130.58 131.30 0.72 0.62 644 3.02 0.79 0.05 0.33 LM41E2 Ag-Pb
Including 130.58 130.82 0.24 0.21 1,842 8.37 2.25 0.05 0.94 LM41E2 Ag-Pb
ZKX1105 133.32 133.69 0.37 0.32 582 3.69 1.07 0.05 0.22 LM41E1 Ag-Pb
ZKX1108 130.04 131.52 1.48 0.85 330 0.63 0.02 0.01 0.02 LM12E Ag-Pb
ZKX1109 157.87 158.85 0.98 0.51 12 0.04 0.03 8.35 0.00 LM50 Au
ZKX1501 270.21 273.89 3.68 2.83 135 0.35 0.04 0.01 0.02 T22 Ag-Pb
Including 270.21 270.46 0.25 0.16 1,579 3.70 0.40 0.03 0.20 T22 Ag-Pb
ZKX4007 284.81 287.36 2.55 1.81 423 0.26 0.22 0.01 0.07 LM17 Ag-Pb
ZKX4008 296.43 297.54 1.11 0.80 29 13.52 0.04 0.01 0.00 LM17 Ag-Pb
Including 297.21 297.54 0.33 0.24 81 43.66 0.03 0.02 0.01 LM17 Ag-Pb
ZKX6801 121.67 122.94 1.27 1.22 2 0.25 0.02 1.99 0.02 LM53 [1] Au
Including 122.68 122.94 0.26 0.25 6 0.91 0.03 5.91 0.04 LM53 Au
ZKX6803 182.76 184.49 1.73 0.89 454 1.37 0.18 0.01 0.28 ? Ag-Pb
ZKX10105 336.91 337.16 0.25 0.20 20 9.13 1.00 0.03 0 LM8W Ag-Pb
ZKX10509 254.09 254.52 0.43 0.40 743 0.32 0.30 0.31 0.05 LM8W3 Ag-Pb
ZKX10509 282.06 282.41 0.35 0.27 723 1.57 0.14 0.33 0.01 LM8W2 Ag-Pb
ZKX10509 385.00 385.51 0.51 0.39 168 11.57 1.77 0.22 0.03 LM8 Ag-Pb
ZKX10708 247.43 249.99 2.56 2.15 394 2.96 0.22 0.03 0.07 LM8 Ag-Pb
ZKX10814 232.25 233.17 0.92 0.65 9 0.02 0.01 2.21 0.00 LM51 Au
ZKX10915 8.72 9.19 0.47 0.36 639 3.04 0.36 0.12 0.02 LM20 Ag-Pb
ZKX11402 259.04 259.84 0.80 0.54 527 2.21 0.43 0.07 0.12 LM8 Ag-Pb
ZKX11507 229.68 231.39 1.71 0.93 82 7.53 0.13 0.01 0.04 LM17W Ag-Pb
ZKX12503 174.73 175.88 1.15 0.99 475 1.68 0.13 0.05 0.02 LM14 Ag-Pb
ZKT4402 174.17 174.95 0.78 0.66 18 0.17 0.01 8.60 0.29 ? Au
ZKT4802 318.39 319.08 0.69 0.64 366 7.85 0.42 0.05 0.02 T11 Ag-Pb
Including 318.39 318.62 0.23 0.21 329 22.97 1.15 0.05 0.03 T11 Ag-Pb

[1] Veins discovered between July 1, 2019 and October 30, 2020.

[2] New veins with no name assigned.

Table
2
:
Selected
mineralized zones exposed by drift
tun
n
el
li
ng
at
the LM
W
mine

Tunnel ID Vein Ore
Length


(m)
True
Width


(m)
Ag

(g/t)
Pb

(%)
Zn

(%)
Au

(g/t)
Cu

(%)
XPDN-LM8-600-111NYM LM8 25 0.33 229 2.57 0.29 0.04 0.07
XPDN-LM8_4a-500-143NYM LM8_4a 35 0.42 301 1.07 1.39 0.00 0.00
PD969Shaft-LM12_1-600-12SYM LM12_1 45 0.77 344 3.37 0.19 0.00 0.00
PD924-LM12E-924-11NYM LM12E 35 0.46 201 1.33 0.15 0.00 0.00
XPDS-LM14-625-109SYM LM14 20 0.24 440 3.34 0.06 0.00 0.00
XPDS-LM14-575-113NYM1 LM14 15 0.47 135 3.58 0.19 0.00 0.00
XPDS-LM14-575-113NYM2 LM14 15 0.30 304 2.96 0.25 0.00 0.00
XPDS-LM16-675-115SYM LM16 10 0.59 1,740 0.96 0.36 0.00 0.00
XPDS-LM16_1-725-111NYM LM16_1 20 0.29 616 1.64 0.25 0.00 0.00
XPDS-LM17-575-26SYM1 LM17 40 0.70 96 4.02 0.35 0.00 0.00
XPDS-LM17-575-26SYM2 LM17 25 1.54 894 9.35 0.53 0.17 1.16
XPDS-LM17W-600-0NYM1 LM17W 20 0.40 377 4.37 0.66 0.00 0.00
XPDS-LM17W-600-0NYM2 LM17W 40 0.72 249 2.98 1.16 0.00 0.00
XPDN-LM17W-800-9ECM LM17W1 15 0.27 719 5.07 0.59 0.00 0.00
XPDN-LM19W2-700-122SYM LM19W2 70 0.63 499 2.72 0.45 0.00 0.00
PD969Shaft-LM19W2-600-114SYM LM19W2 12 0.52 195 1.22 0.18 0.00 0.00
PD969Shaft-LM19W2-600-114NYM LM19W2 15 0.56 381 1.63 0.15 0.00 0.00
SJ969-LM19W2-550-110NYM LM19W2 15 0.97 26 8.58 0.26 0.00 0.00
PD924-LM22-834-3NYM LM22 40 0.18 11 0.04 0.01 2.72 1.55
PD969Shaft-LM30-550-114SYM LM30 30 0.41 136 4.40 0.31 0.00 0.00
PD969Shaft-LM12_2-500-14SYM LM32 25 0.28 303 4.87 0.85 0.33 0.11
PD1080-LM41E-1080-11NYM LM41E 15 0.74 1,079 2.12 0.15 0.02 0.55
PD924-T27E-900-110SYM T27E 20 0.89 114 14.33 0.17 0.00 0.00
PD918-W6-880-128NYM W6 [1] 35 0.68 603 4.91 2.12 0.02 0.13

[1] Veins discovered between July 1, 2019 and October 30, 2020.

Quality Control

Drill cores are NQ size. Drill core samples, limited by apparent mineralization contacts or shear/alteration contacts, were split into halves by saw cutting. The half cores are stored in the Company’s core shacks for future reference and checks, and the other half core samples are shipped in securely sealed bags to the Chengde Huakan 514 Geology and Minerals Test and Research Institute in Chengde, Hebei Province, China, 226km northeast of Beijing, the Zhengzhou Nonferrous Exploration Institute Lab in Zhengzhou, Henan Province, China, and SGS-CSTC Standards Technical Services (Tianjin) Co., Ltd., Tianjin, China. All the three labs are ISO9000 certified analytical labs. For analysis, the sample is dried and crushed to minus 1mm and then split to a 200-300g subsample which is further pulverized to minus 200 mesh. Two subsamples are prepared from the pulverized sample. One is digested with aqua regia for gold analysis with atomic absorption spectroscopy (AAS), and the other is digested with two-acids for analysis of silver, lead, zinc and copper with AAS.

Channel samples are collected along sample lines perpendicular to the mineralized vein structure in exploration tunnels. Spacing between sampling lines is typically 5m along strike. Both the mineralized vein and the altered wall rocks are cut by continuous chisel chipping. Sample length ranges from 0.2m to more than 1.0m, depending on the width of the mineralized vein and the mineralization type. Channel samples are prepared and assayed with AAS at Silvercorp’s mine laboratory (Ying Lab) located at the mill complex in Luoning County, Henan Province, China. The Ying lab is officially accredited by the Quality and Technology Monitoring Bureau of Henan Province and is qualified to provide analytical services. The channel samples are dried, crushed and pulverized. A 200g sample of minus 160 mesh is prepared for assay. A duplicate sample of minus 1mm is made and kept in the laboratory archives. Gold is analysed by fire assay with AAS finish, and silver, lead, zinc and copper are assayed by two-acid digestion with AAS finish.

A routine quality assurance/quality control (QA/QC) procedure is adopted to monitor the analytical quality at each lab. Certified reference materials (CRMs), pulp duplicates and blanks are inserted into each batch of lab samples. QA/QC data at the lab are attached to the assay certificates for each batch of samples.

The Company maintains its own comprehensive QA/QC program to ensure best practices in sample preparation and analysis of the exploration samples. Project geologists regularly insert CRM, field duplicates and blanks to each batch of 30 core samples to monitor the sample preparation and analysis procedures at the labs. The analytical quality of the labs is further evaluated with external checks by sending approximately 3-5% of the pulp samples to higher level labs to check for lab bias. Data from both the Company’s and the labs’ QA/QC programs are reviewed on a timely basis by project geologists.

Guoliang Ma, P. Geo., Manager of Exploration and Resource of the Company, is the Qualified Person for Silvercorp under NI 43-101 and has reviewed and given consent to the technical information contained in this news release.

About Silvercorp

Silvercorp is a profitable Canadian mining company producing silver, lead and zinc metals in concentrates from mines in China. The Company’s goal is to continuously create healthy returns to shareholders through efficient management, organic growth and the acquisition of profitable projects. Silvercorp balances profitability, social and environmental relationships, employees’ wellbeing, and sustainable development. For more information, please visit our website at www.silvercorp.ca.

For further information

Lon Shaver
Vice President
Silvercorp Metals Inc.

Phone: (604) 669-9397
Toll Free: 1 (888) 224-1881
Email: [email protected]
Website: www.silvercorp.ca


CAUTIONARY DISCLAIMER – FORWARD LOOKING STATEMENTS

Certain of the statements and information in this news release constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of applicable Canadian provincial securities laws. Any statements or information that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events or performance (often, but not always, using words or phrases such as “expects”, “is expected”, “anticipates”, “believes”, “plans”, “projects”, “estimates”, “assumes”, “intends”, “strategies”, “targets”, “goals”, “forecasts”, “objectives”, “budgets”, “schedules”, “potential” or variations thereof or stating that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved, or the negative of any of these terms and similar expressions) are not statements of historical fact and may be forward-looking statements or information. Forward-looking statements or information relate to, among other things: the price of silver and other metals; the accuracy of mineral resource and mineral reserve estimates at the Company’s material properties; the sufficiency of the Company’s capital to finance the Company’s operations; estimates of the Company’s revenues and capital expenditures; estimated production from the Company’s mines in the Ying Mining District; timing of receipt of permits and regulatory approvals; availability of funds from production to finance the Company’s operations; and
access to and availability of funding for future construction, use of proceeds from any financing and development of the Company’s properties.

Forward-looking statements or information are subject to a variety of known and unknown risks, uncertainties and other factors that could cause actual events or results to differ from those reflected in the forward-looking statements or information, including, without limitation, social and economic impacts of COVID-19; risks relating to: fluctuating commodity prices; calculation of resources, reserves and mineralization and precious and base metal recovery; interpretations and assumptions of mineral resource and mineral reserve estimates; exploration and development programs; feasibility and engineering reports; permits and licenses; title to properties; property interests; joint venture partners; acquisition of commercially mineable mineral rights; financing; recent market events and conditions; economic factors affecting the Company; timing, estimated amount, capital and operating expenditures and economic returns of future production; integration of future acquisitions into the Company’s existing operations; competition; operations and political conditions; regulatory environment in China and Canada; environmental risks; foreign exchange rate fluctuations; insurance; risks and hazards of mining operations; key personnel; conflicts of interest; dependence on management; internal control over financial reporting as per the requirements of the Sarbanes-Oxley Act; and bringing actions and enforcing judgments under U.S. securities laws.

This list is not exhaustive of the factors that may affect any of the Company’s forward-looking statements or information. Forward-looking statements or information are statements about the future and are inherently uncertain, and actual achievements of the Company or other future events or conditions may differ materially from those reflected in the forward-looking statements or information due to a variety of risks, uncertainties and other factors, including, without limitation, those referred to in the Company’s Annual Information Form under the heading “Risk Factors”. Although the Company has attempted to identify important factors that could cause actual results to differ materially, there may be other factors that cause results not to be as anticipated, estimated, described or intended. Accordingly, readers should not place undue reliance on forward-looking statements or information.

The Company’s forward-looking statements and information are based on the assumptions, beliefs, expectations and opinions of management as of the date of this news release, and other than as required by applicable securities laws, the Company does not assume any obligation to update forward-looking statements and information if circumstances or management’s assumptions, beliefs, expectations or opinions should change, or changes in any other events affecting such statements or information. For the reasons set forth above, investors should not place undue reliance on forward-looking statements and information.


CAUTIONARY NOTE TO US INVESTORS

This news release has been prepared in accordance with the requirements of NI 43‐101 and the Canadian Institute of Mining, Metallurgy and Petroleum Definition Standards, which differ from the requirements of U.S. Securities laws. NI 43‐101 is a rule developed by the Canadian Securities Administrators that establishes standards for all public disclosure an issuer makes of scientific and technical information concerning mineral projects.

 



MATEON PROVIDES CORPORATE UPDATE AND ANNOUNCES THIRD QUARTER 2020 FINANCIAL RESULTS

AGOURA HILLS, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) — Mateon Therapeutics, Inc. (“Mateon” or the “Company”) (OTCQB: MATN) today announced financial results for the third quarter ended September 30, 2020 (“Q3 2020”), as well as an update on its therapeutic development initiatives, including those related to COVID-19.


Recent Operational Highlights

ArtiShield(outside of India)/ARTIVeda (India)
       
    o Signed an agreement with Windlas Biotech Pvt. Ltd. of India to commercialize ArtiShield/ARTIVeda, the Company’s lead ethnobiology dru,g designed to be a readily available and cost-effective agent to combat COVID-19;
    o ArtiShield/ARTIVeda approved for manufacture and marketing by the Ministry of AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy), license number UK.AY-401/2018, for the treatment of various symptoms like fever and inflammation frequently seen in COVID-19 patients;
    o Dr. Suhas Kshirsagar, B.A.M.S, M.D. (Ayurveda), a worldwide renowned ayurvedic expert, joined Mateon as an advisor for Mateon’s Ayurvedic product ARTIShield /ARTIVeda in its commercialization for COVID-19;
    o Dr. Suhas Kshirsagar led a successful symposium entitled: “Advancing Ayurveda Through Ethnobiology Drug Development.” Topics included Mateon’s ARTIShield/ ARTIVeda for the Treatment of COVID-19 and COVID-19/Influenza Coinfection. Presentations can be viewed at https://www.youtube.com/watch?v=0agiVypL_LU&feature=youtu.be.
    o Commenced patient enrollment for its ARTI-19 Phase IV multi-center interventional study to evaluate the safety and efficacy of ArtiShieldin the treatment of adults with COVID-19 in India. This global study will evaluate the safety and efficacy of ArtiShieldupto 3,000 total patients, 120 of whom are currently from India and further expandable to 300 patients from India. Top line data from ARTI-19 in India is expected between Q4 2020 and Q1 2021;
       
OT-101/COVID-19 program
       
    o Received clearance from regulatory authorities in Argentina and Peru to initiate a Phase II clinical trial of OT-101, a TGF-β antisense, for the treatment of patients with mild to severe COVID-19 infection. Top line data from the study is currently expected during or before Q1 2021. If the outcome is positive, the data will form the basis for Emergency Use Approval (EUA) application to global regulatory bodies. Including the US Food and Drug Administration (FDA);
       
    o Continuing our partnership with Golden Mountain Partners (GMP) and/or their designee with drawdown of the $2.0 M debt financial instrument with GMP to conduct OT-101/COVID-19 clinical trial.
       
Oxi4503/ Melanoma
       
    o Announced that the US FDA granted Rare Pediatric Disease (RPD) designation to OXi4503 (combretastatin A1-diphosphate; CA1P) for the treatment of acute myeloid leukemia due to genetic mutations that disproportionately affect pediatric patients. The FDA grants RPD designation for diseases with serious or life-threatening manifestations that primarily affect people aged from birth to 18 years, and that affect fewer than 200,000 people in the U.S.; and
       
Strengthened our scientific and management teams with the appointments of Anthony Maida, III, Ph.D., MA, MBA as Chief Clinical Officer – Translational Medicine to drive the Company’s clinical development activity.

“We are very encouraged by the progress being made at Mateon through the first nine months of 2020,” said Dr. Vuong Trieu, CEO of Mateon. “While our product portfolio addresses significant unmet needs with respect multiple disease states, including glioblastoma, melanoma, and pancreatic cancer, we are most excited by our strategy to focus on COVID-19 and COVID-19/influenza coinfection. We look forward to multiple clinical trial catalysts – notably top line data from our ARTI-19 Phase IV trial between Q4 2020 and Q2 2021 the end of this year – and are excited about the transformational opportunities that our therapies may provide.”

“We are excited about the commercialization of ARTIVeda in India. It is expected to be a cost-effective treatment and prophylactic for COVID-19. This is transformational for the Company, as we establish a consortium of manufacturers, distributors, and marketers for the equitable distribution of this COVID-19 therapy,” said Amit Shah, CFO of Mateon.


Q3 2020 Financial Results Overview –

MATEON THERAPEUTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE THREE MONTHS ENDED SEPTEMBER 30

(UNAUDITED)

    2020     2019     Variance  
Operating expense:                        
Research and development     936,196       343,789       592,407  
General and administrative     680,077       586,924       93,153  
Total operating expense     1,616,273       930,713       685,560  
Loss from operations     (1,616,273 )     (930,713 )     (685,560 )
Loss on conversion of debt     (88,817 )           (88,817 )
Change in the value of derivatives on debt     49,992             49,992  
Interest expense, net     (331,459 )     (60,413 )     (271,046 )
Net Loss   $ (1,986,557 )     (991,126 )     (995,431 )

Total operating expenses for Q3 2020 rose to $1.6 million from $0.9 million in Q3 2019, reflecting a $0.6 million increase in R&D expense and a $0.1 million increase in general & administrative expenses, both of which are to support ongoing clinical trial activity, including activity related to COVID-19.

Net loss attributable to common stockholders for Q3 2020 was $2.0 million, or ($0.02) per share, compared to a net loss of $1.0 million, or ($0.01) per share, for Q3 2019.

Cash and cash equivalents were $1.4 million as of September 30, 2020, compared to $0.6 million as of June 30, 2020, and $0.1 million as of December 31, 2019. Total assets increased from $23,684,781 to $24,628,545

“During Q3 2020 we raised proceeds of $2.3 million, net of costs, to help us advance our therapeutic development activities,” said Mr. Shah.“ Also, the Company has formally changed its name to Oncotelic Therapeutics, Inc. with the State of Delaware. We are working with the appropriate agencies to obtain approvals to change our name and establish our new ticker symbol.”

Additional information is included in the Company’s Form 10-Q for the period ended September 30, 2020, filed on November 16, 2020, a copy of which is available free of charge at http://investor.mateon.com/sec-filings.


ARTIShield ™/ARTIVedaTM- an Ethnobiology Drug

Mateon is pursuing several avenues with respect to the development and commercialization of ARTIShield in the treatment of COVID-19. ARTIShield is Ayurveda – Dvipaantara Damanaka – and is labeled as a capsule containing Artemisia Powder 500mg. It is a demonstration of how Ethnobiology can be used to drive drug development against emerging pandemics.

The classical pharmaceutical regulatory pathways have failed to provide fast-track to treatment and vaccines. Government resources have concentrated on a few candidates most of which have failed. The Ayurvedic medicine route is proving to be an accelerated pathway to deploy a well-known, abundantly available and cost effective Ayurvedic medicine that is safe and being proven in-vitro and large-scale clinical trial to be effective.


ARTIShield



/ARTIVeda



– Commercialization in India

Mateon announced that ARTIShield /ARTIVeda has been approved for manufacture and marketing by the Ministry of AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy) in India for the treatment of various symptoms including fever and inflammation, which can be associated with COVID-19. ARTIShield is in co-development with Windlas Biotech Pvt. Ltd., Mateon’s commercial partner for India and is designed to be a readily available and cost-effective agent to combat COVID-19. ARTIVeda is the tradename for India and ArtiShieldTM is the tradename for outside of India. Mateon expects sales will commence in India before year end.


ARTI-19 Multi-national Phase IV Trial, Currently in India

Mateon announced the enrollment of its first patient in a Phase IV study ARTI-19, “A Prospective, Randomized, Multi-center, Open label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19”. This trial will compare the efficacy of oral doses with standard-of-care (SOC) versus SOC alone. This is a global study with India to contribute at least 300 patients to the total aggregate of 3000 patients. We expect preliminary top-line data for ARTI-19 sometime between Q420 and Q121.


About OT-101

OT-101 is an antisense against the host TGF-β protein required for viral replication and its overexpression likely to cause the wide range of clinical symptoms associated with COVID-19 including Kawasaki syndrome (Fatih M. Uckun, Vuong Trieu. Targeting Transforming Growth Factor-beta for Treatment of COVID-19-associated Kawasaki Disease in Children. Clin Res Pediatr 2020; 3(1): 1-3) and acute respiratory distress syndrome (ARDS) (Fatih M. Uckun, Larn Hwang, Vuong Trieu. Selectively targeting TGF-β with Trabedersen/OT-101 in treatment of evolving and mild ARDS in COVID-19. Clin. Invest. (Lond.) 2020; 10(2), 167-176. DOI: 10.4172/ Clinical-Investigation.1000166.).

TGF-β is elevated in COVID-19 (Xiong Y. et al. Transcriptomic characteristics of bronchoalveolar lavage fluid and peripheral blood mononuclear cells in COVID-19 patients. Emerging Microbes & infections 2020; 9:1, 761-770, DOI: 10.1080/22221751.2020.1747363. Agrati C. et al. Expansion of myeloid-derived suppressor cells in patients with severe coronavirus disease (COVID-19). Cell Death & Differentiation 2020; https://doi.org/10.1038/s41418-020-0572-6.).

OT-101 is also being developed as an adjuvant for second generation COVID-19 vaccine. To avoid the two potential issues with 1st generation vaccine against COVID-19, we will be combining the 1st generation COVID-19 DNA vaccine with a TGF-β inhibitor (OT-101) to stimulate a strong immune response while suppressing the IgA class switching that could aggravate the disease through Kawasaki reaction- IgA vasculitis. The company is aggressively pursuing the development of this 2nd generation COVID-19 vaccine expecting that the 1st generation vaccines would not be fully effective and may not be sufficiently protective to counter the current pandemic.

The development of OT-101 is important given the failure of other drugs leaving dexamethasone as the only clinically proven effective drug against COVID-19.


About Mateon Therapeutics

Mateon was created by the recent reverse merger with Oncotelic, which became a wholly owned subsidiary of Mateon, thereby creating an immuno-oncology company dedicated to the development of first in class RNA therapeutics as well as small molecule drugs against cancer and infectious diseases. OT-101, the lead immuno-oncology drug candidate of Mateon/Oncotelic, is a first-in-class anti-TGF-βRNA therapeutic that exhibited single agent activity in some relapsed/refractory cancer patients in clinical trial settings. OT-101 also has activity against SARS-CoV-2. Mateon/Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Mateon has rare pediatric designation for DIPG (OT-101), melanoma (CA4P), and AML (OXi4503).

For more information, please visit www.oncotelic.com and www.mateon.com.


Mateon’s Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as “may”, “expect”, “anticipate” “hope”, “vision”, “optimism”, “design”, “exciting”, “promising”, “will”, “conviction”, “estimate,” “intend,” “believe”, “quest for a cure of cancer”, “innovation-driven”, “paradigm-shift”, “high scientific merit”, “impact potential” and similar expressions are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about future plans, the progress, timing, clinical development, scope and success of future clinical trials, the reporting of clinical data for the company’s product candidates and the potential use of the company’s product candidates to treat various cancer indications. Each of these forward-looking statements involves risks and uncertainties and actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. These risks are not exhaustive, the company faces known and unknown risks, including the risk factors described in the company’s annual report on Form 10-K filed with the SEC on May 20, 2020 and in the company’s other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether as a result of new information future events, or otherwise.

Contact Information:

For Mateon Therapeutics, Inc.:
Amit Shah
[email protected]



Nordic American Tankers Ltd (NYSE: NAT) – Report for the 3rd quarter – 2020 as a whole is expected to be a very good year for NAT

November 16, 2020

Dear Shareholders and Investors, 

Highlights: 


   

  1. The average Time Charter Equivalent (TCE) for our trading fleet during the third quarter was $25,000 per day per ship. In perspective, this is the best third quarter TCE result for many years.

  2. As 2020 draws to a close, we see far less uncertainty in the market place.

    Asia is recovering strongly, the US election season is over and a vaccine for Covid-19 may be widely available by early 2021. The global pandemic short term impacted the strong fundamentals we saw for the tanker market going into 2020. Despite a temporary slowdown, we see that 2020 as a whole will be a very good year for NAT. We believe that these positive fundamentals will continue.

  3. Cash dividends are a priority for NAT, and reflect our earnings. In 2020 we have paid $60 million or 41 cents per share in dividends. With this report we announce our 93rd consecutive quarterly dividend. The dividend for 3Q2020 is
    4 cents ($0.04) per share, payable on or about December 15, 2020, to shareholders of record December 2, 2020. The accumulated dividend payments for the last four quarters represent an annualized yield of 14% on today’s share price.

  4. During the third quarter we took several of our vessels through drydockings and as such our net voyage revenues and net profit were affected. This was an optimal timing. Our Net Income for 3Q 2020 thus came in at – $10.0 million, which gave an Earnings Per Share (EPS) of -$0.07. Our Year-to-date Net Income was positive with $78.7 million which is equivalent to an EPS of $0.53. This was an improvement of about $100 million compared to the same period in 2019, which produced a Net Income of -$23.1 million.

  5. Our EBITDA (non-GAAP measure) for 3Q2020 was positive by $15.6 million. This was lower than second quarter, but the EBITDA was an improvement compared to the same quarter last year, which generated an EBITDA of $11.5 million.

  6. Our total long term liabilities as per Sept 30, 2020 stood at $313.3 million, a reduction of more than $63 million since year-end 2019. Our Net Debt is $255.4 million or about $11 million per ship.
  1. On Sept 23, 2020 we announced two newbuilding contracts placed with Samsung Heavy Industries. The two suezmaxes will be delivered first half 2022. Financing has been secured. This is a part of our strategy to renew and grow our fleet. The quality of the NAT fleet is first rate, reflecting the vetting record of our ships.

  2. Detailed financial information for 3Q 2020 and for other periods is included later in this report.


 

Best regards,

Herbjorn Hansson

Founder, Chairman & CEO

 

Nordic American Tankers Ltd.                                                           www.nat.bm  


 


 


 


 


 

 
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

Matters discussed in this press release may constitute forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides safe harbor protections for forward-looking statements in order to encourage companies to provide prospective information about their business. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements, which are other than statements of historical facts.

The Company desires to take advantage of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and is including this cautionary statement in connection with this safe harbor legislation. The words “believe,” “anticipate,” “intend,” “estimate,” “forecast,” “project,” “plan,” “potential,” “will,” “may,” “should,” “expect,” “pending” and similar expressions identify forward-looking statements.

The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions, including without limitation, our management’s examination of historical operating trends, data contained in our records and other data available from third parties. Although we believe that these assumptions were reasonable when made, because these assumptions are inherently subject to significant uncertainties and contingencies which are difficult or impossible to predict and are beyond our control, we cannot assure you that we will achieve or accomplish these expectations, beliefs or projections. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Important factors that, in our view, could cause actual results to differ materially from those discussed in the forward-looking statements include the strength of world economies and currencies, general market conditions, including fluctuations in charter rates and vessel values, changes in demand in the tanker market, as a result of changes in OPEC’s petroleum production levels and worldwide oil consumption and storage, changes in our operating expenses, including bunker prices, drydocking and insurance costs, the market for our vessels, availability of financing and refinancing, changes in governmental rules and regulations or actions taken by regulatory authorities, potential liability from pending or future litigation, general domestic and international political conditions, potential disruption of shipping routes due to accidents or political events, vessels breakdowns and instances of off-hires and other important factors described from time to time in the reports filed by the Company with the Securities and Exchange Commission, including the prospectus and related prospectus supplement, our Annual Report on Form 20-F, and our reports on Form 6-K.

NAT is a Bermuda based company.

Contacts:       

Gary J. Wolfe
Seward & Kissel LLP
New York, USA
Tel: +1 212 574 1223

Bjørn Giæver, CFO
Nordic American Tankers Limited
Tel: +1 888 755 8391 or +47 91 35 00 91       

Herbjørn Hansson, Chairman & CEO
Nordic American Tankers Limited
Tel: +1 866 805 9504 or +47 90 14 62 91 

Attachment



Fluor and Sargent & Lundy Agree to Collaborate on New Carbon-Free Small Modular Nuclear Reactor Projects

Fluor and Sargent & Lundy Agree to Collaborate on New Carbon-Free Small Modular Nuclear Reactor Projects

IRVING, Texas–(BUSINESS WIRE)–Fluor Corporation (NYSE: FLR) announced today that the company has reached an agreement with Sargent & Lundy to collaborate with joint marketing and design services for the execution of new NuScale Power small modular nuclear reactor plants in North America.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201116005104/en/

Fluor and Sargent & Lundy will collaborate on new NuScale Power small modular nuclear reactor plant development in North America. (Photo: Business Wire)

Fluor and Sargent & Lundy will collaborate on new NuScale Power small modular nuclear reactor plant development in North America. (Photo: Business Wire)

“Fluor has been a leader in serving the nuclear industry for more than 70 years including the design and construction support for more than 25 units, plus nearly 100 million hours of operations and maintenance work,” said Alan Boeckmann, Fluor’s executive chairman. “This collaboration agreement with one of the most respected companies serving the nuclear power industry brings nearly 150 years of combined experience and further solidifies the opportunity to bring new carbon-free energy to the U.S. and North America.”

“The opportunity to team with NuScale and Fluor for the design and construction of small modular reactor plants further extends Sargent & Lundy’s history of being at the forefront of nuclear new generation design,” said Sargent & Lundy Chairman, President and Chief Executive Officer Thomas R. White. “We’re excited to support NuScale’s groundbreaking technology – a simplified, scalable, resilient design that is poised to support global demand.”

Under the new agreement with Sargent & Lundy, Fluor will design the turbine island and balance-of-plant facilities with Sargent & Lundy providing the design for the nuclear island.

NuScale’s groundbreaking Nuclear Regulatory Commission-certified technology is the world’s first and only small modular reactor to gain design certification approval by the U.S. Nuclear Regulatory Commission. Sargent & Lundy and NuScale agreed to work together in late July 2019 with Sargent & Lundy providing standard plant design services as well as architect-engineering support.

In addition to previously announced strategic partners and investors in NuScale, which includes Sargent & Lundy, Fluor and NuScale continue to engage with potential customers, capital investors, manufacturers and other supply chain partners for new small modular reactor development efforts.

About Fluor Corporation

Fluor Corporation (NYSE: FLR) is a global engineering, procurement, fabrication, construction and maintenance company with projects and offices on six continents. Fluor’s 47,000 employees build a better world and provide sustainable solutions by designing, building and maintaining safe, well-executed projects. Fluor is ranked 181 among the Fortune 500 companies. With headquarters in Irving, Texas, Fluor has served its clients for more than 100 years. For more information, please visit www.fluor.com or follow Fluor on Twitter, LinkedIn, Facebook and YouTube.

#corp

Brian Mershon

Global Media Relations

864.281.6484

Jason Landkamer

Investor Relations

469.398.7222

KEYWORDS: United States North America Texas

INDUSTRY KEYWORDS: Engineering Manufacturing Commercial Building & Real Estate Energy Construction & Property Nuclear

MEDIA:

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Fluor and Sargent & Lundy will collaborate on new NuScale Power small modular nuclear reactor plant development in North America. (Photo: Business Wire)

Kodiak Sciences Completes Enrollment of DAZZLE Phase 2b/3 Pivotal Study of KSI-301 in Patients with Wet Age-Related Macular Degeneration

− On track for DAZZLE primary endpoint last patient last visit in late 2021 and topline results in early 2022

− Over 550 patients enrolled worldwide

− Phase 3 studies for diabetic macular edema and retinal vein occlusion enrolling well and on track for topline results also in 2022

PR Newswire

PALO ALTO, Calif., Nov. 16, 2020 /PRNewswire/ — Kodiak Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases, today announced that recruitment has concluded in its DAZZLE pivotal study of KSI-301, Kodiak’s anti-VEGF antibody biopolymer conjugate, in patients with neovascular (wet) age-related macular degeneration. DAZZLE was planned to enroll 550 treatment-naïve patients worldwide; the target enrollment has been exceeded and recruitment into the study is now closed.

“We are pleased to have exceeded our enrollment target for DAZZLE and to have recruited the study in just over one year despite the challenges presented by the COVID-19 pandemic. We are very grateful for the enthusiasm and support of the retina clinical trial community in working together with us to study KSI-301’s potential,” said Victor Perlroth, Chief Executive Officer of Kodiak Sciences. “With DAZZLE having a one-year primary efficacy endpoint, Kodiak is on track for a top-line data readout of the study in early 2022, an important milestone as part of our 2022 Vision.”

“Wet AMD remains a leading cause of vision loss in the elderly and real-world data show that vision outcomes are compromised by the unsustainable and intensive treatment burden of current medicines. In DAZZLE, we are studying a more pragmatic and achievable regimen of KSI-301 given once every three, four or five months,” said Jason Ehrlich, MD, PhD, Kodiak’s Chief Medical & Development Officer. “We look forward to the last DAZZLE patient’s one-year visit in late 2021 and to analyzing and releasing the primary results in early 2022. The Kodiak team is also executing well on the rest of the KSI-301 development program. Our pivotal studies in diabetic macular edema (DME) and retinal vein occlusion are off to a strong start. The recent presentation of KSI-301 data at the American Academy of Ophthalmology Virtual Meeting highlighted the promising combination of efficacy and durability seen with KSI-301 in DME, a leading cause of vision loss in working-aged people.”

About the DAZZLE Study

The Phase 2b/3 DAZZLE study is a global, multi-center, randomized study designed to evaluate the efficacy, durability and safety of KSI-301 in patients with treatment-naïve wet AMD. Patients are randomized to receive either KSI-301 on an individualized dosing regimen as infrequently as every five months and no more often than every three months or to receive aflibercept on its labeled every eight-week dosing regimen, each after three monthly initiating doses. The study has enrolled over 550 patients worldwide. The primary endpoint is at one year and each patient will be treated and followed for two years. Additional information about DAZZLE (also called Study KSI-CL-102) can be found on www.clinicaltrials.gov under Trial Identifier NCT04049266 (https://clinicaltrials.gov/show/NCT04049266).

About the GLEAM and GLIMMER Studies

The Phase 3 GLEAM and GLIMMER studies are global, multi-center, randomized studies designed to evaluate the efficacy, durability and safety of KSI-301 in patients with treatment-naïve diabetic macular edema (DME). In each study, patients are randomized to receive either intravitreal KSI-301 on an individualized dosing regimen every eight to 24 weeks after only three loading doses or intravitreal aflibercept every eight weeks after five loading doses per its label. Each study is expected to enroll approximately 450 patients worldwide. The primary endpoint for both studies is the change from baseline in best-corrected vision at one year, and patients will be treated and followed for two years. Additional information about the GLEAM study (also called Study KS301P104) and the GLIMMER study (also called Study KS301P105) can be found on www.clinicaltrials.gov under Trial Identifiers NCT04611152 and NCT04603937, respectively (https://clinicaltrials.gov/ct2/show/NCT04611152 and https://clinicaltrials.gov/ct2/show/NCT04603937).

About the BEACON Study

The Phase 3 BEACON study is a global, multi-center, randomized study designed to evaluate the efficacy, durability and safety of KSI-301 in patients with treatment-naïve macular edema due to retinal vein occlusion (RVO), including both branch and central subtypes. Patients are randomized to receive either intravitreal KSI-301 every eight weeks after only two loading doses or monthly intravitreal aflibercept per its label, for the first six months. In the second six months, patients in both groups will receive treatment on an individualized basis per protocol-specified criteria. The study is expected to enroll approximately 550 patients worldwide. The primary endpoint is the change from baseline in best-corrected vision at six months, and patients will be treated and followed for one year. Additional information about the BEACON study (also called Study KS301P103) can be found on www.clinicaltrials.gov under Trial Identifier NCT04592419 (https://clinicaltrials.gov/show/NCT04592419).

About KSI-301

KSI-301 is an investigational anti-VEGF therapy built on the Kodiak’s Antibody Biopolymer Conjugate (ABC) Platform and is designed to maintain potent and effective drug levels in ocular tissues for longer than existing agents. Kodiak’s objective with KSI-301 is to develop a new first-line agent to improve outcomes for patients with retinal vascular diseases and to enable earlier treatment and prevention of vision loss for patients with diabetic eye disease. The Company’s Phase 2b/3 DAZZLE pivotal study in patients with treatment-naïve wet AMD was initiated in October 2019, and Kodiak initiated the Phase 3 GLEAM, GLIMMER, and BEACON pivotal studies of KSI-301 in diabetic macular edema and retinal vein occlusion in September 2020. These studies are anticipated to form the basis of the Company’s initial BLA to support potential approval and commercialization. An additional pivotal study in patients with non-proliferative diabetic retinopathy is planned. Kodiak Sciences Inc. is developing KSI-301 and owns global rights to KSI-301.

About the KSI-301 Clinical Program

The KSI-301 Clinical Program is designed to assess KSI-301’s safety, efficacy and durability in wet AMD, DME, RVO and non-proliferative DR (without DME) through clinical studies run in parallel. We are conducting two Phase 3 studies in DME (the GLEAM and GLIMMER studies) to provide the mutually confirmatory studies required by FDA for initial demonstration of safety and efficacy. We also are conducting one study in wet AMD (our ongoing DAZZLE study) and one study in RVO (the BEACON study) to support approval in these indications. We intend to file this package together in a single BLA in 2022. We also plan to run an additional study in patients with non-proliferative DR without DME (the GLOW study). We expect that the global KSI-301 clinical program will be conducted at 150+ study sites in more than 10 countries.

About Kodiak Sciences Inc.

Kodiak (Nasdaq: KOD) is a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases. Founded in 2009, we are focused on bringing new science to the design and manufacture of next generation retinal medicines to prevent and treat the leading causes of blindness globally. Our ABC Platform™ uses molecular engineering to merge the fields of antibody-based and chemistry-based therapies and is at the core of Kodiak’s discovery engine. Kodiak’s lead product candidate, KSI-301, is a novel anti-VEGF antibody biopolymer conjugate being developed for the treatment of retinal vascular diseases including age-related macular degeneration, the leading cause of blindness in elderly patients in the developed world, and diabetic eye diseases, the leading cause of blindness in working-age patients in the developed world. Kodiak has leveraged its ABC Platform to build a pipeline of product candidates in various stages of development including KSI-501, our bispecific anti-IL-6/VEGF biopolymer conjugate for the treatment of neovascular retinal diseases with an inflammatory component, and we are expanding our early research pipeline to include ABC Platform based triplet inhibitors for multifactorial retinal diseases such as dry AMD and glaucoma. Kodiak is based in Palo Alto, CA. For more information, please visit www.kodiak.com.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our beliefs about the timing of top-line data readout of the DAZZLE study; KSI-301’s clinical efficacy, durability and safety, as well as KSI-301’s potential to be a more pragmatic and achievable regimen compared to current medicines; our ability to achieve our 2022 Vision; future development plans; clinical and regulatory objectives and the timing thereof, anticipated design of planned clinical trials, expectations regarding the potential efficacy and commercial potential of our product candidates; the anticipated presentation of data; the results of our research and development efforts and our ability to advance our product candidates into later stages of development. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “believe,” “intend,” “pursue,” and other similar expressions among others. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the preliminary safety, efficacy and durability data for our KSI-301 product candidates will not continue or persist; cessation or delay of any of the ongoing clinical studies and/or our development of KSI-301 may occur; future potential regulatory milestones of KSI-301, including those related to current and planned clinical studies may be insufficient to support regulatory submissions or approval; anticipated presentation of data at upcoming conferences may not occur; our research and development efforts and our ability to advance our product candidates into later stages of development may fail; any one or more of our product candidates may not be successfully developed, approved or commercialized; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our most recent Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Kodiak undertakes no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

Kodiak®, Kodiak Sciences®, ABC™, ABC Platform™ and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various global jurisdictions.

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SOURCE Kodiak Sciences Inc.

Moderna Announces Longer Shelf Life for its COVID-19 Vaccine Candidate at Refrigerated Temperatures

Moderna Announces Longer Shelf Life for its COVID-19 Vaccine Candidate at Refrigerated Temperatures

Vaccine candidate now expected to remain stable at standard refrigerator temperatures of 2° to 8°C (36° to 46°F) for 30 days, up from previous estimate of 7 days

Shipping and long-term storage conditions at standard freezer temperatures of -20°C (-4°F) for 6 months

mRNA-1273 to be distributed using widely available vaccine delivery and storage infrastructure

No dilution required prior to vaccination

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced new data showing that mRNA-1273, its COVID-19 vaccine candidate, remains stable at 2° to 8°C (36° to 46°F), the temperature of a standard home or medical refrigerator, for 30 days. Stability testing supports this extension from an earlier estimate of 7 days. mRNA-1273 remains stable at -20° C (-4°F) for up to six months, at refrigerated conditions for up to 30 days and at room temperature for up to 12 hours.

“We believe that our investments in mRNA delivery technology and manufacturing process development will allow us to store and ship our COVID-19 vaccine candidate at temperatures commonly found in readily available pharmaceutical freezers and refrigerators,” said Juan Andres, Chief Technical Operations and Quality Officer at Moderna. “We are pleased to submit these extended stability conditions for mRNA-1273 to regulators for approval. The ability to store our vaccine for up to 6 months at -20° C including up to 30 days at normal refrigerator conditions after thawing is an important development and would enable simpler distribution and more flexibility to facilitate wider-scale vaccination in the United States and other parts of the world.”

Shipping & Long-term Storage: For shipping and longer-term storage, Moderna expects that mRNA-1273 will be maintained at -20°C (-4°F), equal to most home or medical freezer temperatures, for up to 6 months. Using standard freezer temperatures of -20°C (range of -25° to -15°C or -13° to 5°F) is an easier and more established method of distribution and storage than deep freezing and most pharmaceutical distribution companies have the capability to store and ship products at -20°C (-4°F) worldwide.

Refrigeration Storage: After thawing, to facilitate storage at points of administration, Moderna expects that mRNA-1273 will remain stable at standard refrigerated conditions of 2° to 8°C (36° to 46°F) for up to 30 days within the 6-month shelf life. The stability at refrigerated conditions allows for storage at most pharmacies, hospitals, or physicians’ offices.

Room Temperature for Vaccination: Once the vaccine is removed from the refrigerator for administration, it can be kept at room temperature conditions for up to 12 hours.

No Dilution Required at Vaccination Site: The vaccine will not require onsite dilution or special handling, which facilitates vaccination across a range of settings including pharmacies and physicians’ offices.

The Company anticipates that it will continue to gather additional stability information over the coming months to assess whether mRNA-1273 can be shipped and stored under increasingly flexible conditions, which will be described in detail following regulatory approval.

The mRNA-1273 COVID-19 vaccine candidate is Moderna’s tenth mRNA vaccine to enter the clinic. With its experience in prophylactic vaccine development and investments in mRNA platform and delivery technology, Moderna has developed enhanced manufacturing processes, resulting in proprietary lipid nanoparticle technology that Moderna believes will enable the vaccine to be stored at standard pharmaceutical distribution temperatures.

Moderna is working with the U.S. Centers for Disease Control and Prevention (CDC), Operation Warp Speed and McKesson (NYSE: MCK), a COVID-19 vaccine distributor contracted by the U.S. government, as well as global stakeholders to be prepared for distribution of mRNA-1273, in the event that it receives an Emergency Use Authorization and/or similar global authorizations. The Company is also working closely with the U.S. Food and Drug Administration (FDA) to submit data from its ongoing stability testing for approval.

About mRNA-1273

mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID’s Vaccine Research Center. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the FDA granted mRNA-1273 Fast Track designation. On May 29, the first participants in each age cohort: adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of mRNA-1273. On July 8, the Phase 2 study completed enrollment.

Results from the second interim analysis of the NIH-led Phase 1 study of mRNA-1273 in the 56-70 and 71+ age groups were published on September 29 in The New England Journal of Medicine. On July 28, results from a non-human primate preclinical viral challenge study evaluating mRNA-1273 were published in The New England Journal of Medicine. On July 14, an interim analysis of the original cohorts in the NIH-led Phase 1 study of mRNA-1273 was published in The New England Journal of Medicine. mRNA-1273 currently is not approved for use by any regulatory body.

BARDA is supporting the continued research and development of mRNA-1273 with $955 million in federal funding under Contract no. 75A50120C00034. BARDA is reimbursing Moderna for 100 percent of the allowable costs incurred by the Company for conducting the program described in the BARDA contract. The U.S. government has agreed to provide up to $1.525 billion to purchase supply of mRNA-1273 under U.S. Department of Defense Contract No. W911QY-20-C-0100.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding the Company’s development of a potential vaccine (mRNA-1273) against the novel coronavirus, the conditions under which mRNA-1273 can be shipped, stored and administered, and the U.S. government’s potential purchases of mRNA-1273. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could”, “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company’s regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.

Moderna Contacts

Media:

Colleen Hussey

Director, Corporate Communications

617-335-1374

[email protected]

Investors:

Lavina Talukdar

Senior Vice President & Head of Investor Relations

617-209-5834

[email protected]

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: Health Infectious Diseases Other Health Clinical Trials Pharmaceutical Biotechnology

MEDIA:

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China Online Education Group to Report Third Quarter 2020 Financial Results on Monday, November 23, 2020

Earnings Call Scheduled for 8:00 a.m. EST on November 23, 2020

PR Newswire

BEIJING, Nov. 16, 2020 /PRNewswire/ — China Online Education Group (“51Talk”, or the “Company”) (NYSE: COE), a leading online education platform in China, with core expertise in English education, today announced that it will report its third quarter 2020 unaudited financial results on Monday, November 23, 2020, before the open of U.S. markets.

The Company’s management will host an earnings conference call at 8:00 a.m. U.S. Eastern Time on November 23, 2020 (9:00 p.m. Beijing/Hong Kong time on November 23, 2020).

Dial-in details for the earnings conference call are as follows:

United States Toll:

+1-866-264-5888

International:

+1-412-317-5226

Mainland China Toll:

400-120-1203

Hong Kong Toll:

800-905-945

Hong Kong-Local Toll:

+852-3018-4992

Participants should dial-in at least 10 minutes before the scheduled start time and ask to be connected to the call for “China Online Education Group.”

Additionally, a live and archived webcast of the conference call will be available on the Company’s investor relations website at http://ir.51talk.com.

A replay of the conference call will be accessible approximately one hour after the conclusion of the live call until November 30, 2020, by dialing the following telephone numbers:

United States Toll:

+1-877-344-7529

International Toll:

+1-412-317-0088

Replay Access Code:

10150031

About China Online Education Group

China Online Education Group (NYSE: COE) is a leading online education platform in China, with core expertise in English education. The Company’s mission is to make quality education accessible and affordable. The Company’s online and mobile education platforms enable students across China to take live interactive English lessons with overseas foreign teachers, on demand. The Company connects its students with a large pool of highly qualified foreign teachers that it assembled using a shared economy approach, and employs student and teacher feedback and data analytics to deliver a personalized learning experience to its students.

For more information, please visit http://ir.51talk.com.

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SOURCE China Online Education Group

Guardant Health, Inc. Announces Proposed Convertible Senior Notes Offering

Guardant Health, Inc. Announces Proposed Convertible Senior Notes Offering

REDWOOD CITY, Calif.–(BUSINESS WIRE)–
Guardant Health, Inc. (Nasdaq: GH) today announced its intention to offer, subject to market and other conditions, $1,000,000,000 aggregate principal amount of convertible senior notes due 2027 (the “notes”) in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). Guardant Health also expects to grant the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date notes are first issued, up to an additional $150,000,000 principal amount of notes.

The notes will be senior, unsecured obligations of Guardant Health, will accrue interest payable semi-annually in arrears and will mature on November 15, 2027, unless earlier repurchased, redeemed or converted. Noteholders will have the right to convert their notes in certain circumstances and during specified periods. Guardant Health will settle conversions by paying or delivering, as applicable, cash, shares of its common stock or a combination of cash and shares of its common stock, at Guardant Health’s election. The notes will be redeemable, in whole or in part, for cash at Guardant Health’s option at any time, and from time to time, on or after November 20, 2024 and on or before the 25th scheduled trading day immediately before the maturity date, but only if the last reported sale price per share of Guardant Health’s common stock exceeds 130% of the conversion price for a specified period of time. The interest rate, initial conversion rate and other terms of the notes will be determined at the pricing of the offering.

Guardant Health intends to use a portion of the net proceeds from the offering to fund the cost of entering into the capped call transactions described below. Guardant Health intends to use the remainder of the net proceeds from the offering for general corporate purposes and working capital, including increasing investment in research and development and sales and marketing activities to expand its business, as well as general and administrative matters. Guardant Health may also use a portion of the net proceeds to acquire complementary products, technologies, intellectual property or businesses as part of its growth strategy; however, Guardant Health currently does not have any agreements or commitments to complete any such transactions and is not involved in negotiations regarding such transactions. If the initial purchasers exercise their option to purchase additional notes, then Guardant Health intends to use a portion of the additional net proceeds to fund the cost of entering into additional capped call transactions as described below.

In connection with the pricing of the notes, Guardant Health expects to enter into privately negotiated capped call transactions with one or more of the initial purchasers and/or their respective affiliates and/or other financial institutions (the “option counterparties”). The capped call transactions will cover, subject to customary adjustments, the number of shares of common stock initially underlying the notes. The capped call transactions are expected generally to reduce potential dilution to Guardant Health’s common stock upon conversion of the notes or at Guardant Health’s election (subject to certain conditions) offset any cash payments Guardant Health is required to make in excess of the aggregate principal amount of converted notes, as the case may be, with such reduction or offset subject to a cap.

In connection with establishing their initial hedges of the capped call transactions, the option counterparties or their respective affiliates expect to purchase shares of Guardant Health’s common stock and/or enter into various derivative transactions with respect to Guardant Health’s common stock concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of Guardant Health’s common stock or the notes at that time. In addition, the option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Guardant Health’s common stock and/or purchasing or selling Guardant Health’s common stock or other securities issued by Guardant Health in secondary market transactions following the pricing of the notes and prior to the maturity of the notes (and are likely to do so on each exercise date of the capped call transactions, which are expected to occur during the 25 trading day period beginning on the 26th scheduled trading day prior to the maturity date of the notes, or following any termination of any portion of the capped call transactions in connection with any repurchase, redemption or early conversion of the notes). This activity could also cause or avoid an increase or a decrease in the market price of Guardant Health’s common stock or the notes, which could affect a noteholder’s ability to convert the notes and, to the extent the activity occurs during any observation period related to a conversion of the notes, it could affect the number of shares and value of the consideration that a noteholder will receive upon conversion of the notes.

In addition, if any such capped call transaction fails to become effective, whether or not this offering of the notes is completed, the option counterparty party thereto may unwind its hedge positions with respect to Guardant Health’s common stock, which could adversely affect the value of Guardant Health’s common stock and, if the notes have been issued, the value of the notes.

The offer and sale of the notes and any shares of common stock issuable upon conversion of the notes have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes and any such shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the notes or any shares of common stock issuable upon conversion of the notes, nor will there be any sale of the notes or any such shares, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful.

About Guardant Health

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360®, Guardant360 CDx and GuardantOMNI® tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.

Forward-Looking Statements

This press release includes forward-looking statements, including statements regarding the completion, timing and size of the proposed offering, the intended use of the proceeds, the terms of the notes being offered, the anticipated terms of, and the effects of entering into, the capped call transactions described above and the actions of the option counterparties and their respective affiliates. Forward-looking statements represent Guardant Health’s current expectations regarding future events and are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those implied by the forward-looking statements. Among those risks and uncertainties are market conditions, including market interest rates, the trading price and volatility of Guardant Health’s common stock and risks relating to Guardant Health’s business, including those described in periodic reports that Guardant Health files from time to time with the SEC. Guardant Health may not consummate the proposed offering described in this press release and, if the proposed offering is consummated, cannot provide any assurances regarding the final terms of the offer or the notes or its ability to effectively apply the net proceeds as described above. The forward-looking statements included in this press release speak only as of the date of this press release, and Guardant Health does not undertake to update the statements included in this press release for subsequent developments, except as may be required by law.

Investor Contact:

Carrie Mendivil

[email protected]

Media Contact:

Anna Czene

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Biotechnology Health Data Management Technology Oncology

MEDIA:

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Mallinckrodt Announces Real World Data on Hepatorenal Syndrome (HRS) and Acute Kidney Injury (AKI) in Patients with Liver Disease at The Liver Meeting Digital Experience

Advancing American kidney health has been identified as a key public health priority by a 2019 Presidential Executive Order

U.S. data on HRS and AKI in patients with liver disease may help advance kidney health

PR Newswire

DUBLIN, Nov. 16, 2020 /PRNewswire/ — Mallinckrodt plc, a global biopharmaceutical company, today announced findings from a large U.S. database review of patient profiles and outcomes of patients hospitalized with hepatorenal syndrome (HRS) and acute kidney injury (AKI). The descriptive data on HRS and AKI patients with liver disease may help advance kidney health, aligned with a recent U.S. Executive Order (No. 13879). Findings were presented during a poster presentation at The Liver Meeting Digital Experience, the annual meeting of the American Association for the Study of Liver Diseases (AASLD). The poster can be accessed here on the company’s website.

HRS is a life-threatening complication that may occur in patients with advanced liver disease.1 HRS is classified into two distinct types – hepatorenal syndrome type-1 and type-2.1 Hepatorenal syndrome type 1 (HRS-1) is a rapidly progressive condition that leads to renal failure.1 It is often a challenge to effectively diagnose in a timely manner due to its diagnosis of exclusion.2

The Premier Healthcare Database, a U.S. hospital-based database with over 1,000 contributing hospitals, was used to identify adult patients with an International Classification of Diseases diagnosis of HRS or AKI and liver cirrhosis in 2017 and 2018. A total of 54,945 patients met study inclusion criteria, including 13,061 patients in the HRS cohort and 41,884 in the AKI cohort. Majority of the patients (90.2 percent) in the HRS cohort also had an AKI diagnosis. Comparing the HRS and AKI cohorts, in-hospital mortality rates were 26.4 percent versus 9.1 percent, respectively.3 Hospice discharge rates and proportion discharged home or self-care were 19 percent and 21.4 percent in the HRS cohort and 6.9 percent and 39.2 percent in the AKI cohort. Between the HRS and AKI cohorts, the average hospital length of stay was 10.9 versus 8.1 days.3

“Hepatorenal syndrome is difficult to diagnose and typically met with high mortality rates if left untreated. Identifying the disease from a large national hospital database, although with limitations, is important as it enables us to understand national practice patterns and outcomes,” said Andrew Allegretti, M.D. MSc, Director of Critical Care Nephrology, Massachusetts General Hospital. “The descriptive data from this study may help advance kidney health in line with a 2019 Executive Order and may help support future research to help identify healthcare resource utilization and costs in this population.”

HRS-1 has a median survival time of approximately two weeks and greater than 80 percent mortality within three months if left untreated.2,4 At present, there are no drug therapies approved for the treatment of HRS-1 in the U.S. or Canada.5 HRS-1 is estimated to affect between 30,000 and 40,000 patients in the U.S. annually.6,7

“The work of Dr. Allegretti and his team around hepatorenal syndrome, and more specifically HRS-1, helps us better understand this complex disease and the potential costs that may be associated with it,” said George Wan, Ph.D., MPH, Vice President, Global Head of Health Economics and Outcomes Research at Mallinckrodt Pharmaceuticals.

The study was funded by Mallinckrodt.

ABOUT MALLINCKRODT 
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company’s Specialty Brands reportable segment’s areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements with regard to the study described in this release, including its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the “Risk Factors” section of Mallinckrodt’s most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

CONTACT


Media Inquiries


Caren Begun

Green Room Communications
201-396-8551
[email protected]


Investor Relations


Daniel J. Speciale

Vice President, Finance and Investor Relations Officer
314-654-3638
[email protected]

Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2020 Mallinckrodt. US-1901525 11/20


References


1 National Organization for Rare Disorders. Hepatorenal Syndrome. Available at: https://rarediseases.org/rare-diseases/hepatorenal-syndrome/. Accessed November 3, 2020.
2 Gines P, Sola E, Angeli P, et al. Hepatorenal syndrome. Nature Reviews. 2018; 4:23. 
3 Allegretti A, Böing E, Ahn S, Zhou H, Jamil K, Cort S, Huang X. Hepatorenal syndrome and acute kidney injury in patients with liver disease: National practice patterns and outcomes from a large U.S. database. Poster presented at: The Liver Meeting Digital Experience; November 13-16, 2020; Boston, MA.
4 Colle I and Laterre PF. Hepatorenal syndrome: the clinical impact of vasoactive therapy. Expert Review of Gastroenterology & Hepatology. (2018) 12:2, 173-188, DOI: 10.1080/17474124.2018.1417034. 
5 Boyer TD, Medicis JJ, Pappas SC, et al. A randomized, placebo-controlled, double-blind study to confirm the reversal of hepatorenal syndrome type 1 with terlipressin: the REVERSE trial design. Open Access Journal of Clinical Trials 2012:4. https://www.dovepress.com/a-randomized-placebo-controlled-double-blind-study-to-confirm-the-reve-peer-reviewed-article-OAJCT
6 C Pant, B S Jani, M Desai, A Deshpande, Prashant Pandya, Ryan Taylor, R Gilroy, M Olyaee. Hepatorenal syndrome in hospitalized patients with chronic liver disease: results from the Nationwide Inpatient Sample 2002–2012. Journal of Investigative Medicine. 2016;64:33–38.
United States Census Bureau: Quick Facts. Available at: https://www.census.gov/quickfacts/fact/table/US/PST045218. Accessed November 3, 2020.

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SOURCE Mallinckrodt plc