On November 19, 2019 Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company") reported its financial results (IFRS, unaudited) for the first nine months of 2019 (Press release, Epigenomics, NOV 19, 2019, View Source [SID1234551457]).

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Major Events After the End of the Reporting Period

On November 7, 2019, after the end of the reporting period, Epigenomics successfully completed a capital increase with gross proceeds of approximately EUR 8.3 million. The shares from the private placement were allocated to multiple investors, including, in particular, institutional investors from the U.S.A. and Germany.
On November 21, 2019, Dr. Elvira D’Andrea, one of the authors of the microsimulation model comparing outcomes of colorectal cancer screening methods, including the Epi proColon blood test, will present at the 12th European Public Health Conference of the European Public Health Association. In addition, Dr. D’Andrea, together with her colleague Dr. Medhi Najafzadeh, co-author of the model, will participate in an investor conference call on November 21 where they will discuss a summary of the presentation entitled "Quantifying the impact of adherence to screening on colorectal cancer incidence and mortality".
Greg Hamilton, CEO of Epigenomics AG: "I would like to take this opportunity to thank all our existing and new shareholders, who participated in our capital increase, for the confidence they have placed in Epigenomics. The funds raised will enable us to continue to execute on our major goal, reimbursement for our blood test Epi proColon in the U.S.A. In addition, we are looking forward to the conference call with Dr. D’Andrea and her co-author Dr. Najafzadeh in which they will present their positive study results of the microsimulation model to interested investors".

Key figures

Product revenue for the first nine months increased 28% to EUR 818 thousand compared to the same period last year. Total revenue for the period decreased year-on-year to EUR 847 thousand (9M 2018: EUR 1,315 thousand) due to lower licensing revenue.
Research and development costs increased by EUR 1.2 million to EUR 5.7 million in the 9-month period due to expenses related to the post-approval study for Epi proColon and the HCC study in the U.S.A.
Selling and administrative expenses increased from EUR 6.0 million (9M 2018) to EUR 6.9 million.
EBITDA (before share-based payment expenses) decreased from EUR -8.0 million in the comparable period of 2018 to EUR -9.7 million.
The net loss for the period was EUR -10.0 million (9M 2018: EUR -8.7 million); the loss per share fell to EUR 0.28 (9M 2018: EUR 0.36) due to the higher number of shares after the capital increase in the second half of 2018.
Cash consumption increased to EUR 10.9 million in the first three quarters of 2019 (9M 2018: EUR 6.9 million) mainly due to an increased R&D spend and changes in working capital.
As of September 30, 2019, liquidity amounted to EUR 6.3 million (including marketable securities) compared to EUR 17.1 million at year-end 2018.

Outlook 2019
Revenue

As disclosed in the prospectus for the capital increase in November 2019, the Company expects full-year 2019 revenue in a range of EUR 1.0 million to EUR 1.5 million.
EBITDA

For EBITDA before share-based payment expenses, Epigenomics forecasts a range of EUR -12.5 million to EUR -14.0 million for the full year 2019.
Further information
The interim statement for the first nine months of 2019 (unaudited) is available on the Epigenomics website: View Source

Conference call for analysts and investors
Epigenomics AG will host a conference call for analysts and investors today at 3:30 pm (CET) / 9:30 am (EST). The webcast can be accessed on the Company’s website: View Source

The dial-in numbers for the conference call are:
Dial-in number Germany: +49 30 2332 257 28
Dial-in number UK: +44 20 3872 0880
Dial-in number USA: +1 862-701-2734

Participants are kindly asked to dial in 10 minutes prior the start of the call.
An audio replay of the conference call will be provided on the Epigenomics’ website subsequently.

On November 19, 2019 Mallinckrodt plc (NYSE: MNK) reported (1) the early results of the previously announced offers by its wholly owned subsidiaries, Mallinckrodt International Finance S.A. and Mallinckrodt CB LLC (the "Issuers") to Eligible Holders (as defined below) to exchange (the "Exchange Offers") certain outstanding notes (collectively, the "Existing Notes") issued by the Issuers for new 10.000% Second Lien Senior Secured Notes due 2025 to be issued by the Issuers (collectively, the "New Notes") and solicitations of consents by the Issuers from Eligible Holders of each series of Existing Notes (other than the Existing 4.750% 2023 Notes) to Proposed Amendments (as defined below) to the indentures governing such Existing Notes (the "Consent Solicitations") and (2) the Existing Notes anticipated to be exchanged with the Issuers, separate from the Exchange Offers, pursuant to that certain exchange agreement, dated as of November 5, 2019, by and among Deerfield Partners, L.P., Deerfield Special Situations Fund, L.P. and Deerfield Private Design Fund IV, L.P. (such holders, the "Exchanging Holders") and the Issuers (the "Exchange Agreement") (Press release, Mallinckrodt, NOV 19, 2019, View Source [SID1234551491]).

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The following table sets forth a summary of the total (a) tenders and consents validly received and not withdrawn pursuant to the Exchange Offers and Consent Solicitations, as of 5:00 p.m., New York City time, on November 19, 2019 (the "Early Delivery Time"), according to D.F. King & Co, Inc., the exchange agent and information agent for the Exchange Offers and Consent Solicitations and (b) Existing Notes anticipated to be exchanged and associated consents anticipated to be provided under the Exchange Agreement:

Title of Series of
Existing Notes

CUSIP Number

Aggregate
Principal
Amount
Outstanding

Principal Amount
of Existing Notes
Tendered
Pursuant to the
Exchange Offers
and to be
Exchanged Under
the Exchange
Agreement(1)

Percentage of
Existing Notes
Tendered
Pursuant to the
Exchange Offers
and to be
Exchanged
Under the
Exchange
Agreement(1)

Principal
Amount of New
Notes to be
Delivered(1)

Existing 4.875% 2020 Notes

561233 AB3; L6233L AB2

$698,000,000

$72,641,000

10.4%

$61,744,850

Existing 5.750% 2022 Notes

561233 AA5; L6233L AA4

$663,200,000

$52,546,000

7.9%

$24,959,350

Existing 4.750% 2023 Notes

561234 AE5

$350,076,000

$265,921,000

76.0%

$98,390,770

Existing 5.625% 2023 Notes

561233 AD9; L6233L AD8

$659,360,000

$144,485,000

21.9%

$61,406,125

Existing 5.500% 2025 Notes

561233 AC1; L6233L AC0

$596,137,000

$157,465,000

26.4%

$66,922,625

_____________________

(1)

Includes tenders pursuant to the Exchange Offers, as of the Early Delivery Time, of (a) approximately $5.1 million aggregate principal amount of the Existing 4.875% 2020 Notes in exchange for approximately $4.3 million aggregate principal amount of New Notes, (b) approximately $52.5 million aggregate principal amount of the Existing 5.750% 2022 Notes in exchange for approximately $25.0 million aggregate principal amount of New Notes, (c) approximately $7.2 million aggregate principal amount of the Existing 4.750% 2023 Notes in exchange for approximately $2.7 million aggregate principal amount of New Notes, (d) approximately $46.0 million aggregate principal amount of the Existing 5.625% 2023 Notes in exchange for approximately $19.5 million aggregate principal amount of New Notes, and (e) approximately $82.3 million aggregate principal amount of the Existing 5.500% 2025 Notes in exchange for approximately $35.0 million aggregate principal amount of New Notes.

As of the Early Delivery Time, Mallinckrodt plc has not received the requisite consents from the holders of any series of Existing Notes that was the subject of a Consent Solicitation to amend (such amendments, the "Proposed Amendments") the indenture governing such series of the Existing Notes (such indentures, the "Existing Indentures") to eliminate substantially all of the restrictive covenants under the Existing Indentures, modify or eliminate certain other provisions of the Existing Indentures, and waive certain defaults and events of default, if any, under the Existing Indentures.

Eligible Holders who did not tender at or prior to the Early Delivery may still tender Existing Notes in the Exchange Offers until 11:59 p.m., New York City time, on December 4, 2019 (the "Expiration Time"), unless the Exchange Offers are extended or earlier terminated. Tenders may not be withdrawn after the Early Delivery Time, unless required by law.

As set forth in the Issuers’ confidential offering memorandum and consent solicitation statement, dated November 5, 2019 (the "Offering Memorandum and Consent Solicitation Statement"), for each $1,000 principal amount of Existing Notes tendered after the Early Delivery Time and at or prior to the Expiration Time, Eligible Holders will receive the following consideration:

Mallinckrodt plc currently expects that the settlement date on which we will deliver the New Notes to participating Eligible Holders and to the Exchanging Holders will be December 6, 2019. The New Notes will be secured by a second lien security interest in all collateral that currently secures Mallinckrodt plc’s senior secured credit facilities (subject to certain exceptions described in the Offering Memorandum and Consent Solicitation Statement). The New Notes will be guaranteed by each entity that currently guarantees Mallinckrodt plc’s senior secured credit facilities (subject to certain exceptions described in the Offering Memorandum and Consent Solicitation Statement). The New Notes will accrue interest from the date of issuance. Eligible Holders will receive a cash payment for any amounts of accrued and unpaid interest on the Existing Notes.

Each Exchange Offer and corresponding Consent Solicitation for a series of Existing Notes is being made independently of the Exchange Offers and Consent Solicitations for the other series of Existing Notes and is not conditioned upon the completion of any of the other Exchange Offers and Consent Solicitations. The Issuers reserve the right to terminate, withdraw or amend each Exchange Offer or Consent Solicitation without also terminating, withdrawing or amending any of the other Exchange Offers and Consent Solicitations. The consummation of each Exchange Offer and corresponding Consent Solicitation is subject to, and conditional upon, the satisfaction or waiver of customary conditions, as described in the Offering Memorandum and Consent Solicitation Statement.

The New Notes have not been registered under the Securities Act of 1933, as amended (the "Securities Act") or any state or foreign securities laws. The New Notes may not be offered or sold in the United States or to any U.S. persons except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. The Exchange Offers and Consent Solicitations are only being made to persons who certify that they are (a) "qualified institutional buyers" as defined in Rule 144A under the Securities Act or (ii) are not, and are not acting on behalf of, a "U.S. person" as defined in Rule 902 of Regulation S under the Securities Act (such persons, "Eligible Holders"). As such, documents relating to the Exchange Offers and Consent Solicitations will only be distributed to holders of Existing Notes who complete and return an eligibility letter ("Eligibility Letter") confirming that they are Eligible Holders of Existing Notes.

The complete terms and conditions of the Exchange Offers and Consent Solicitations are described in the Offering Memorandum and Consent Solicitation Statement, copies of which may be obtained by Eligible Holders by contacting D.F. King Co., Inc., the exchange agent and information agent in connection with the Exchange Offers and Consent Solicitations, at: (866) 356-7814 (toll free) or: (212) 269-5550 (bankers and brokers call collect) or email at [email protected]. The Eligibility Letter is available electronically at: www.dfking.com/mnk. A copy of the Exchange Agreement was filed as Exhibit 10.1 to the Current Report on Form 8-K filed by Mallinckrodt with the Securities and Exchange Commission on November 5, 2019.

On November 19, 2019 Aptus Clinical reported that it has been appointed full service clinical CRO partner by Artelo Biosciences Inc. (through their fully owned UK subsidiary, Trinity R&D Ltd.) to deliver the upcoming Phase 1B/2A trial of their synthetic cannabinoid, ART27.13 (Press release, Aptus Clinical, NOV 19, 2019, View Source [SID1234551458]). This latest agreement builds on an earlier research and development partnership agreement, where Aptus successfully designed and supported the critical path pre-clinical experiments and completed key clinical strategy and planning activities for Artelo.

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Andrew Yates, ART27.13 Project Director at Trinity R&D said "We are delighted with the progress that this project has made in transitioning through the discovery phase and into preparation for clinical testing in just 16 months. The depth and breadth of experience that our Aptus colleagues have brought to this project and their flexible collaborative approach has been key in helping us achieve this significant project milestone for ART27.13. We look forward to continuing to work with Aptus and our investigators in testing the clinical utility of ART27.13 in patients with cancer associated weight loss."

Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences, commented, "Aptus Clinical have proved themselves to be a true partner with us on the ART27.13 project. They have approached the inevitable challenges associated with any drug project in a fully supportive and flexible way with a total focus on doing the right things to move the project forward. We look forward to continuing our collaboration Aptus on this next phase of the ART27.13 journey.

Steve McConchie, Chief Executive Officer of Aptus Clinical, added, "Cancer related anorexia affects about 60% of advanced cancer patients and is an area where new treatment options are desperately needed. As a full-service Clinical CRO focused on transforming promising projects into valued medicines we are honoured to have been selected to deliver a trial that is so important for both Artelo and patients with cancer."

Photo (Left to right): William O’Brien, FD Trinity R&D; Andy Yates ART273 Project Leader, Trinity R&D; Kath Lowry, Snr Project Manager, Aptus Clinical; Greg Gorgas, President and CEO Artelo Biosciences; Steve McConchie, CEO Aptus
Clinical

On November 19, 2019 Medicure Inc. ("Medicure" or the "Company") (TSXV: MPH, OTC: MCUJF), a cardiovascular pharmaceutical company, reported that it will release financial results for the quarter ended September 30, 2019 on Tuesday, November 26, 2019 (Press release, Medicure, NOV 19, 2019, View Source [SID1234551492]). The third quarter financial statements will be made available on the Company’s website at www.medicure.com. Medicure will hold a conference call and webcast regarding the results on Wednesday, November 27, 2019 at 7:30 AM Central Time (8:30 AM Eastern Time).

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Conference Call Info:

Topic: Medicure’s Q3 2019 Results

Call date: Wednesday, November 27, 2019

Time: 7:30 AM Central Time (8:30 AM Eastern Time)

Canada toll-free: 1 (888) 465-5079 Canada toll: 1 (416) 216-4169

United States toll-free: 1 (888) 545-0687

Passcode: 7343307#

Webcast: This conference call will be webcast live over the internet and can be accessed from the Medicure investor relations page at the following link: View Source

You may request international country-specific access information by e-mailing the Company in advance. Management will accept and answer questions related to the financial results and operations during the question-and-answer period at the end of the conference call. A recording of the call will be available following the event at the Company’s website.

On November 19, 2019 Genprex, Inc.("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company, reported that its collaborators from The University of Texas MD Anderson Cancer Center ("MD Anderson") presented positive preclinical data for the combination of TUSC2 immunogene therapy with an anti-PD1 antibody, pembrolizumab, and for the combination of TUSC2 immunogene therapy, pembrolizumab, and chemotherapy for the treatment of some of the most resistant metastatic lung cancers, including the KRAS and LKB1 mutations, at the American Association of Cancer Research Tumor Immunology and Immunotherapy Meeting 2019 (Press release, Genprex, NOV 19, 2019, View Source [SID1234551459]). The TUSC2 gene is a tumor suppressor gene and is the active agent in Genprex’s Oncoprex immunogene therapy.

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The poster, entitled "Efficacy of Novel Immunogene-Combinations for KRAS and LKB1 mutant NSCLC in a Humanized Mouse Model" shows that TUSC2 confers sensitivity to checkpoint blockade for some of the most resistant metastatic human cancers, including the KRAS and LKB1 mutations, in mice with human immune cells (humanized mice) with lung metastases. When TUSC2 was combined with anti-PD1 therapy, pembrolizumab, in humanized mice with KRAS and LKB1 lung metastases, there was significantly increased antitumor activity than when compared to either agent alone. This combination and model also demonstrated TUSC2-related NK (Natural Killer) cell activation. A significantly higher percentage of CD56+NK and CD56+CD59+active NK cells, which are immune cells that have been activated to kill cancer cells, were found in the mice that received TUSC2 alone and in those that received the combination of TUSC2 and pembrolizumab than in those that received pembrolizumab alone.

The poster also shows that TUSC2 increases the effectiveness of anti-PD1 checkpoint blockade combined with platinum chemotherapy in humanized mice with lung metastases with KRAS and LKB1 mutations, thus demonstrating that TUSC2 may improve on first-line standard of care for lung cancer. The combination of TUSC2 with pembrolizumab and carboplatin, a platinum chemotherapy, in humanized mice with KRAS and LKB1 lung metastases resulted in metastasis regression significantly greater than either TUSC2 alone or pembrolizumab combined with carboplatin treatments. This model showed significantly fewer or no visible tumor nodules after treatment with the TUSC2 combination as compared with other groups, and it showed strong antitumor efficacy. The combination of TUSC2 with pembrolizumab and carboplatin resulted in complete eradication of anti-PD1 resistant lung metastases in the humanized mouse model.

"These data not only further support existing preclinical data showing that Oncoprex immunogene therapy is synergistic with anti-PD1 therapy, but they also offer new data demonstrating that Oncoprex improves on the combination of anti-PD1 therapy and chemotherapy, today’s first line standard of care for lung cancer," said Julien L. Pham, MD, MPH, President and Chief Operating Officer of Genprex. "In a sophisticated humanized mouse model, the combination of TUSC2 with pembrolizumab and carboplatin resulted in complete eradication of anti-PD1 resistant lung metastases in some of the most resistant cancer mutations. This is highly encouraging and provides us with a strong indication that the combination could lead to similar results in the clinic."

The poster authors are Ismail M. Meraz, Mourad Majidi, Meng Feng, RuPing Shao, Min Jin Ha, Jeffrey Morris, Elizabeth J. Shpall, Jack A. Roth, all of MD Anderson Cancer Center, Houston, TX. Jack A. Roth has ownership interest in and is a consultant/advisory board member for Genprex, Inc.