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Nordic Nanovector ASA: Results for the Third Quarter 2020

On November 18, 2020 Nordic Nanovector ASA (OSE: NANO) reported its results for the third quarter 2020 (Press release, Nordic Nanovector, NOV 18, 2020, View Source [SID1234571373]). A live webcast presentation by Nordic Nanovector’s management team will take place today in Oslo at 08.30 CET, see details below. A link to the webcast and the presentation is available from the company’s homepage (www.nordicnanovector.com).

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Lars Nieba, Interim CEO of Nordic Nanovector, said: "Following the successful interim analysis in August and completion of our private placement in September, we are progressing towards the major value inflection point of three-month top-line data from the PARADIGME clinical study, which is targeted for H2 2021. Generating these data will require us to successfully navigate the latest challenges of increased COVID-19 restrictions. We remain confident in our ability to achieve this goal, aided by the protocol amendments, the possibility to reduce the patient sample, and all the other measures we are actively implementing to drive patient recruitment into PARADIGME."

Q3’2020 Highlights

Result of PARADIGME Interim Analysis: Independent Review Committee recommendation to focus on single arm investigating the "40/15" dosing regimen
Target set to report three-month top-line data in H2’2021
Approval of amendments to PARADIGME protocol is proceeding as planned and completed in the best-recruiting countries
Designed to enlarge the eligible patient population and increase the rate of enrolment into the trial
Pivotal Phase 2b PARADIGME trial of Betalutin progressing in 3rd-line relapsed/refractory follicular lymphoma (3L R/R FL)
COVID-19 pandemic continues to have a negative impact on PARADIGME patient recruitment – the target patient population is a high-risk group for COVID-19
59 patients enrolled as of 18 November 2020
Private placement was oversubscribed and successfully completed raising approximately NOK 231 million (approximately USD 25 million) in gross proceeds, extending cash runway into Q3’2021
Funds to be used to advance PARADIGME study and conduct other essential activities to enable a timely filing pending top-line data
Dr Christine Wilkinson Blanc appointed Chief Medical Officer
Events after Q3’2020

Final two patients enrolled into Archer-1 Phase 1 safety trial of Betalutin plus rituximab in 2L R/R FL
Preliminary data readout expected in H1’2021
Trial to be paused pending analysis of data and evaluation of plans for further development
Results of preclinical studies demonstrating Betalutin reverses tumour resistance to rituximab in NHL disease models published in Journal of Nuclear Medicine
Financial Highlights

(Figures in brackets = same period 2019 unless otherwise stated)

Revenues for the third quarter and for the first nine months of 2020 amounted to NOK 0.0 million (NOK 0.0 million)
Total operating expenses for the third quarter were NOK 88.1 million (NOK 100.2 million); total operating expenses for the first nine months of 2020 were NOK 327.3 million (NOK 301.1 million)
Comprehensive loss for the third quarter amounted to NOK 88.2 million (loss of NOK 93.6 million); comprehensive loss for the first nine months of 2020 was NOK 305.4 (NOK 295.6 million)
Cash and cash equivalents amounted to NOK 380.7 million at the end of September 2020, compared to NOK 470.8 million at the end of December 2019
Outlook

The company continues to target the readout of three-month top line data from PARADIGME in H2’2021. Approval of protocol amendments is proceeding as planned and completed in the best-recruiting countries, and other initiatives to increase the rate of enrolment are underway. The company also targets the readout of three-month top line data from the second cohort of the Archer-1 trial in H1’2021.

However, the impact of the COVID-19 pandemic on patient recruitment has worsened in light of the emergence of a second wave resulting in severe travel restrictions being implemented in the various countries where we are executing our clinical studies. These restrictions and uncertainty around the duration, severity and geographic scope of the COVID-19 outbreak are projected to slow down the enrolment of patients due to re-prioritisation of hospital activities towards COVID-19 patients and away from clinical studies such as PARADIGME. In addition, travel restrictions could create logistical challenges for the shipment of clinical supplies. Several proactive actions have been taken to minimize the impact of these travel restrictions which could blunt further delays in completing enrolment and delivering preliminary results as targeted.

The company has taken steps to conserve cash and following the recent successful private placement, Nordic Nanovector has a cash runway that extends into Q3’2021.

Despite the challenging times, the many positive actions the company has made in the last nine months have improved the prospects of delivering pivotal results from PARADIGME in H2’2021.

The company continues to believe that, if positive, these trial data could represent a significant value inflection point for the company and its shareholders, confirming Betalutin as a highly promising new targeted therapy that can address the unmet needs of R/R FL patients.

Presentation and live webcast – Q3 2020 results

A presentation and live webcast by Nordic Nanovector’s management team will take place today at 8:30 am CET.

The webcast can be accessed from www.nordicnanovector.com in the section: Investors & Media and a recording will also be available on this page after the event.

The results report and the presentation is available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2020.

Aflac Incorporated Announces 17.9% Increase in the First Quarter 2021 Dividend

On November 18, 2020 Aflac Incorporated (NYSE: AFL) reported that its Board of Directors has declared the first quarter dividend of $0.33 per share, payable on March 1, 2021, to shareholders of record at the close of business on February 17, 2021 (Press release, Aflac, NOV 18, 2020, View Source [SID1234571370]). This represents a 17.9% increase over the previously declared fourth quarter dividend.

Commenting on the announcement, Aflac Incorporated Chairman and Chief Executive Officer Daniel P. Amos said: "I am pleased with the Board’s action to increase the first quarter 2021 dividend. We treasure our record of 38 consecutive years of dividend increases, and we are looking to reward our shareholders by extending that track record in 2021. We remain committed to maintaining strong capital ratios on behalf of our policyholders and balance this financial strength with a focus on increasing the dividend, repurchasing shares and reinvesting in our business. Our dividend track record is supported by the strength of our capital and cash flows."

Bausch Health Announces Pricing And Upsize Of Private Offering Of Senior Notes And Conditional Redemption Of Additional Series Of Existing Senior Notes

On November 18, 2020 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that it has priced and upsized its previously announced offering of $1.0 billion aggregate principal amount of 5.000% senior notes due 2029 (the "2029 Notes") and $1.0 billion aggregate principal amount of 5.250% senior notes due 2031 (the "2031 Notes" and, together with the 2029 Notes, the "Notes") (Press release, Bausch Health, NOV 18, 2020, View Source [SID1234571367]). The size of the offering reflects an increase of $250 million from the previously announced offering size of $1.75 billion. The 2029 Notes will be sold to investors at a price of 100% of the principal amount thereof, and the 2031 Notes will be sold to investors at a price of 100% of the principal amount thereof.

The proceeds from the offering of the Notes, along with cash on hand, are expected to be used to fund the Company’s (i) previously announced conditional redemption (the "Euro Redemption") in full of its outstanding €1.5 billion aggregate principal amount of 4.50% Senior Notes due 2023 (the "Euro Notes") and (ii) conditional redemption (the "5.50% Redemption") in full of its outstanding $233 million aggregate principal amount of 5.50% Senior Notes due 2023 (the "5.50% Notes" and, together with the Euro Notes, the "Existing Notes"), and to pay related fees and expenses. With these redemptions, Bausch Health will have no note maturities until 2024.

The Notes will be guaranteed by each of the Company’s subsidiaries that are guarantors under the Company’s credit agreement and existing senior notes. Consummation of the offering of the Notes is subject to various closing conditions.

The Notes will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities law and may not be offered or sold in the United States absent registration or an applicable exemption from registration under the Securities Act and applicable state securities laws. The Notes will be offered in the United States only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act and outside the United States to non-U.S. persons pursuant to Regulation S under the Securities Act. The Notes have not been and will not be qualified for sale to the public by prospectus under applicable Canadian securities laws and, accordingly, any offer and sale of the Notes in Canada will be made on a basis, which is exempt from the prospectus requirements of such securities laws.

This announcement does not constitute a notice of redemption with respect to the Existing Notes. The Euro Redemption is conditioned upon the completion by the Company or its subsidiaries of one or more debt financings in an aggregate principal amount of at least $1.75 billion, which the Company expects to satisfy upon closing of the offering of the Notes.

The Company also announced that it has issued today a conditional notice of redemption to redeem the full aggregate principal amount of outstanding 5.50% Notes. The 5.50% Redemption will be conditioned upon the completion by the Company or its subsidiaries of one or more debt financings in an aggregate principal amount of at least $2.0 billion (the "5.50% Condition"), which the Company expects to satisfy upon closing of the offering of the Notes.

A copy of the conditional notice of redemption with respect to the 5.50% Notes has been issued to the record holders of the 5.50% Notes. Payment of the redemption price and surrender of the 5.50% Notes for redemption will be made through the facilities of the Depository Trust Company in accordance with the applicable procedures of the Depository Trust Company on Dec. 18, 2020, unless the 5.50% Condition is not satisfied, in which case the redemption date will be delayed until the 5.50% Condition is satisfied. The name and address of the paying agent are as follows: The Bank of New York Mellon Trust Company, N.A., c/o The Bank of New York Mellon; 111 Sanders Creek Parkway, East Syracuse, N.Y. 13057; Attn: Redemption Unit; Tel: (800) 254- 2826.

This news release is being issued pursuant to Rule 135c under the Securities Act and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

AbCellera Expands Technology Stack with Acquisition of Trianni for $90 Million

On November 18, 2020 AbCellera, a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that can be developed to prevent and treat disease, reported it has acquired Trianni, Inc. in an all-cash transaction valued at US$90 million (Press release, AbCellera, NOV 18, 2020, View Source [SID1234571365]). The acquisition deepens AbCellera’s technology stack with a suite of genetically engineered mice for generating diverse panels of human antibodies with drug-like properties.

"Trianni marks our fourth and largest strategic technology addition to date. With its technology and team, Trianni amplifies our capability to generate human antibodies and provides a strong foundation for developing increasingly powerful transgenic mouse technologies," said Carl Hansen, Ph.D., CEO of AbCellera. "Trianni adds a key pillar to our platform, which now includes genetically engineered rodents, microfluidic single-cell screening, repertoire sequencing, AI-powered computation, and bispecific protein engineering. By integrating these technologies, we aim to provide our partners with access to a modern operating system that improves the speed and probability of success of antibody drug development."

Trianni’s genetic engineering technology is a platform for developing humanized mice. The flagship Trianni Mouse was designed to maximize immune responses, increase antibody diversity, and preserve natural maturation of fully human antibodies in rodents. The Trianni Mouse is also a core platform that supports the rapid development of new mouse strains tailored to address the most challenging antibody discovery programs. Several next-generation humanized mice are currently being developed and when launched aim to provide partners with the following benefits:

Generate multispecific antibodies and access difficult targets with the Heavy-Chain Only (HCO) Mouse, which expresses smaller, single domain antibodies that can reach target sites conventional IgG molecules cannot. HCO antibodies are ideally suited for applications in cell therapy and for bispecific and multispecific antibody therapeutics.
Break immune tolerance with the All-Epitope Mouse, which generates robust immune responses against highly-conserved, high-value drug targets such as GPCRs and ion channels that are prevalent in multiple diseases and indications, including cardiovascular diseases, cancer, neurological diseases, inflammation, and pain.
Target new epitopes with the DD Mouse, which has long CDR3 loops that can access "hidden" or recessed binding sites that are unreachable by conventional IgG molecules.
Maximize efficiency with the Eazysort Mouse, which allows up-front enrichment of immune cells that recognize the target to focus discovery efforts on only high-value antibodies of interest.

ImmunoGen Announces Webcasts of Presentations at Upcoming Virtual Conferences

On November 18, 2020 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the following presentations by Company management at upcoming investor conferences will be webcast (Press release, ImmunoGen, NOV 18, 2020, View Source [SID1234571364]):

Piper Sandler 32nd Annual Virtual Healthcare Conference
November 23 at 10:00am ET
Evercore ISI Annual HealthCONx Conference
December 1 at 12:10pm ET
A webcast of each presentation will be accessible through the Investors and Media section of the Company’s website, www.immunogen.com. Following the live webcast, a replay will be available at the same location.