On November 18, 2021 Nordic Nanovector ASA (OSE: NANOV) reported its results for the third quarter 2021 (Press release, Nordic Nanovector, NOV 18, 2021, View Source [SID1234595831]). A presentation by Nordic Nanovector’s senior management team will be held in-person today in Oslo and webcast live beginning at 8:30am CET – details below.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Erik Skullerud, CEO of Nordic Nanovector, said: "We are entering an exciting period for Nordic Nanovector, as the Company draws closer to completing patient recruitment for the PARADIGME trial, for which we expect readout of preliminary data in H1′ 2022. The Company is convinced that Betalutin is uniquely positioned to meet the need for a chemo-free, effective yet tolerable treatment for non-Hodgkin’s lymphoma patients, coupled with a convenient administration schedule. In the meantime, we look forward to sharing our vision for Nordic Nanovector and Betalutin as well as an update on our pipeline at our R&D day on 30 November."

Operational Highlights

102 of a targeted 120 patients have been enrolled into the pivotal PARADIGME Phase 2b trial for Betalutin as of 17 November 2021 (94 patients enrolled as of 26 August 2021)
Three patients were enrolled in the same quarter in 2020
Preliminary three-month data readout expected during H1’2022, following timeline revisions announced on 3 August 2021
Erik Skullerud appointed as new Chief Executive Officer (CEO)
Mr Skullerud brings more than 25 years’ experience in the biopharma industry including more than 15 years at Amgen, including as Marketing Director Europe Oncology/Hematology, and seven years at Bayer
He has launched numerous highly innovative products in therapeutic areas including oncology and haematology, and as a consultant, he has worked with some of the world’s top pharma and biotech companies as well as small, highly specialised start-ups on a wide range of projects
Pierre Dodion MD appointed as Chief Medical Officer
Dr Dodion has over 30 years’ experience in the biopharmaceutical industry, spent mostly in the oncology and haematology areas. He brings deep clinical development and medical affairs expertise and has provided strategic insight and overseen multiple clinical trials
Nordic Nanovector announced its support for The Health Policy Partnership’s initiative to improve readiness for the use of radioimmunotherapy and to facilitate appropriate integration of this innovative cancer treatment modality in lymphoma
The Company entered a research collaboration with the University of Pennsylvania to generate a novel CD37-targeting CAR-T cell therapy approach as a potential treatment for patients with B-cell malignancies
Nordic Nanovector will have an option to license exclusive worldwide rights to any CD37-targeting CAR-T cells that result from the collaboration
Financial Highlights

(Figures in brackets = same period 2020 unless otherwise stated)

Revenues for the third quarter 2021 and the first nine months of 2021 amounted to NOK 0.0 million (NOK 0.0 million)
Total operating expenses for the third quarter 2021 were NOK 104.3 million (NOK 88.1 million). Total operating expenses for the first nine months of 2021 were NOK 309.3 million (NOK 327.3 million)
Comprehensive loss for the third quarter 2021 amounted to NOK 103.6 million (loss of NOK 88.2 million). Comprehensive loss for the first nine months of 2021 was NOK 307.6 (NOK 305.4 million)
Cash and cash equivalents amounted to NOK 369.5 million at the end of September 2021, compared to NOK 450.1 million at the end of June 2021, and NOK 294.0 million at the end of December 2020
Outlook

Nordic Nanovector is close to completing patient enrolment into PARADIGME and is targeting the readout of preliminary three-month top line data during H1’2022.

The company’s current cash position will support its operations into H2’2022 and will enable further preparatory work on the potential Betalutin BLA filing and planning for commercialisation to be undertaken.

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

The company intends to discuss the development plan and opportunities for expanding the market for Betalutin into other NHL indications, together with other potential areas for pipeline expansion and collaboration based on CD37-targeting immunotherapies, at its R&D Day, which is planned to take place on 30 November 2021.

Presentation and Webcast

A presentation by Nordic Nanovector’s senior management team will take place in Oslo today at 8:30am CET at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: Bjørvika

The presentation will webcast live and will be available at www.nordicnanovector.com in the section: Investors & Media.

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2021.

On November 18, 2021 Medivir AB (Nasdaq Stockholm: MVIR) reported that results from the investigator-initiated phase II clinical study in patients with squamous cell carcinoma (SCC) has been published in JAMA Dermatology by Kilgour, JM et al (doi:10.1001/jamadermatol.2021.4549) (Press release, Medivir, NOV 18, 2021, View Source [SID1234595830]). The primary objective of the study was to assess the effects of topical remetinostat on biopsy-proven SCC and SCC in situ tumors. This clinical study was conducted at the Stanford University School of Medicine in California, USA under the leadership of the principal investigator, Dr Kavita Sarin. Medivir is providing remetinostat drug supply for this study, and has full access to, and the rights to use, all clinical data after the study is complete.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Four patients with five biopsy-proven cutaneous SCCs were included in this case series and treated with remetinostat gel 1%. All five tumours, including a range of histological subtypes, demonstrated complete clinical and pathological resolution at week 10. All patients experienced a localized cutaneous reaction in response to the treatment, which required one patient to discontinue therapy. No systemic adverse events were reported. Further details of the study can be found at www.clinicaltrials.gov, reference number NCT03875859.

– "This study further supports the potential of remetinostat to be used in multiple skin-associated cancers beyond cutaneous T-cell lymphoma (CTCL)" said Magnus Christensen, interim CEO of Medivir.

About squamous cell carcinoma

Squamous cell carcinoma (SCC) is the second most common form of cancer in humans occurring in the skin. Surgical excision is standard of care and there are currently no marketed products approved for the treatment of SCC. Other therapies for SCC exist, such as imiquimod, 5-fluorouracil and photodynamic therapy, however their use is limited to SCC in situ (SCCIS). There is a clear need for efficacious and safe treatments when surgery is impractical, e.g. multiple lesions and/or difficult treatment sites.

About remetinostat

Remetinostat is a topical histone deacetylase (HDAC) inhibitor. A clinical phase II study in mycosis-fungoides cutaneous T-cell lymphoma (MF-CTCL) has been completed demonstrating that remetinostat reduced severity of CTCL skin lesions with an objective response rate (ORR) of 40%. The study also showed a clinically significant reduction in the severity of pruritus (itching) in 80% of the patients. In addition, two investigator-initiated phase II studies have been conducted at Stanford University in the USA, demonstrating efficacy in both Basal Cell Carcinoma (BCC) and cutaneous Squamous Cell Carcinoma (SCC).

On November 18, 2021 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programing platform, reported that Mahesh Karande, President and Chief Executive Officer, Roger Sawhney, M.D., Chief Financial Officer, and Thomas McCauley, Ph.D., Chief Scientific Officer, will participate in a fireside chat at the Piper Sandler 33rd Annual Virtual Healthcare Conference taking place from November 29 – December 2, 2021 (Press release, Omega Therapeutics, NOV 18, 2021, View Source [SID1234595829]). A recording of the fireside chat will made available on Monday, November 22nd at 10:00 a.m. ET.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The recording of the fireside chat will be available on the Investors & Media section of the Company’s website at www.omegatherapeutics.com and can be accessed on the same website for approximately 90 days.

On November 18, 2021 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported financial results for the fiscal year ended September 30, 2021 (Press release, ESSA, NOV 18, 2021, View Source [SID1234595828]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"2021 has been a year of meaningful execution on all aspects of the development program of EPI-7386, our highly-selective, oral, small molecule inhibitor that uniquely targets the N-terminal domain of the androgen receptor for the treatment of patients with metastatic castration-resistant prostate cancer ("mCRPC")," stated David Parkinson, MD, President and CEO of ESSA. "During the year, we presented initial clinical data at a scientific conference that suggest a favorable pharmacological profile and provide clinical proof of concept for EPI-7386. In addition, we demonstrated through nuclear magnetic resonance ("NMR") studies that EPI-7386 binds to the N-terminal domain of the androgen receptor—the primary driver of prostate cancer growth. We were pleased to announce this year clinical collaborations with Janssen Research and Development LLC ("Janssen"), Astellas Pharma Inc. ("Astellas"), and Bayer, three leading companies with approved antiandrogen treatments for prostate cancer. These Phase 1/2 studies, anticipated to begin in late 2021 or early 2022, will evaluate EPI-7386 in combination with the companies’ respective antiandrogen therapies in earlier line mCRPC patients."

Dr. Parkinson continued: "As a result of the successful financing earlier this year, our cash and short-term investments of $195 million are expected to provide us a cash runway into 2024 and fully fund the current development programs, including the Phase 1a/1b monotherapy studies, Phase 2, preparatory work for a Phase 3 confirmatory study as well as commitments around the four Phase 1/2 combination studies with approved antiandrogens. In the Phase 1 monotherapy dose escalation study, we are currently dosing patients with EPI-7386 at 800 mg administered as 400 mg BID, and our goal remains to establish a recommended Phase 2 dose ("RP2D") for monotherapy during the first half of 2022, while commencing the expansion Phase 1b study soon thereafter. We look forward to presenting a clinical readout of the Phase 1a monotherapy trial in the first half of 2022."

Clinical and Corporate Highlights for 2021 Fiscal Year

On October 7, 2021, at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR"), National Cancer Institute ("NCI"), and European Organisation for Research and Treatment of Cancer ("EORTC") Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), the Company presented preclinical data characterizing the mechanism of action of EPI-7386, including the results of NMR studies which confirm the binding of the compound to the N-terminal domain ("NTD") of the androgen receptor ("AR"), a region not currently targeted by other antiandrogen therapies. The data also demonstrate that the combination of EPI-7386 with enzalutamide results in complete inhibition of genome-wide androgen-induced AR binding, supporting the rationale for Phase 1/2 combination trials of EPI-7386 with approved antiandrogens in patients with mCRPC.
On April 28, 2021, the Company announced a clinical collaboration with Bayer to evaluate EPI-7386 in combination with Bayer’s androgen receptor inhibitor darolutamide in patients with mCRPC. Under the terms of the agreement, Bayer may sponsor and conduct a Phase 1/2 study to evaluate the safety, pharmacokinetics and efficacy of the combination of EPI-7386 and darolutamide in mCRPC patients. ESSA will supply EPI-7386 for the trial and will retain all rights to EPI-7386.
On April 10, 2021, the Company reported new preclinical data on EPI-7386 at the 2021 AACR (Free AACR Whitepaper) Annual Meeting demonstrating that in vitro EPI-7386 can prevent the androgen receptor from binding to genomic DNA and can inhibit AR related transcription in prostate cancer cell lines expressing AR splice variants including the AR-v567es variant. The results also demonstrate that combining EPI-7386 with enzalutamide in vitro results in a broader and deeper inhibition of the AR pathway.
On February 25, 2021, the Company announced a clinical collaboration with Astellas Pharma Inc. to evaluate the combination of EPI-7386 and Astellas/Pfizer’s androgen receptor inhibitor enzalutamide for patients with mCRPC. Under the terms of the agreement, ESSA will sponsor and conduct a Phase 1/2 study to evaluate the safety, tolerability and preliminary efficacy of the combination of EPI-7386 and enzalutamide in mCRPC patients who have not yet been treated with second-generation antiandrogen therapies. Astellas will supply enzalutamide for the trial. ESSA will retain all rights to EPI-7386.
On February 22, 2021, the Company completed an underwritten public offering for aggregate gross proceeds of $149,999,985, issuing a total of 5,555,555 common shares, at a public offering price of $27.00 per share.
On February 11, 2021, the Company presented favorable initial Phase 1 clinical pharmacology data of EPI-7386 for advanced forms of prostate cancer at the 2021 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium.
On January 13, 2021, the Company announced a clinical collaboration with Janssen to evaluate EPI-7386 in combination with abiraterone acetate/prednisone or apalutamide for patients with mCRPC. Under the terms of the agreement, Janssen may sponsor and conduct up to two Phase 1/2 studies evaluating the safety, tolerability and preliminary efficacy of the combination of EPI-7386 and apalutamide as well as the combination of EPI-7386 with abiraterone acetate plus prednisone in patients with mCRPC. Janssen will assume all costs associated with these studies other than the manufacturing costs associated with the clinical drug supply of EPI-7386. The parties will form a joint oversight committee for the clinical studies. ESSA will retain all rights to EPI-7386.
Summary Financial Results

Net Loss. ESSA recorded a net loss of $36.8 million ($0.96 loss per common share based on 38,480,378 weighted average common shares outstanding) for the year ended September 30, 2021, compared to a net loss of $23.4 million ($1.04 loss per common share based on 22,443,893 weighted average common shares outstanding) for the year ended September 30, 2020. For the year ended September 30, 2021, this included non-cash share-based payments of $9.5 million compared to $7.5 million for the prior year, recognized for stock options granted and vesting. The net loss for the fourth quarter ended September 30, 2021 was $8.5 million compared to a net loss of $4.6 million for the fourth quarter ended September 30, 2020.

Research and Development ("R&D") expenditures. R&D expenditures for the year ended September 30, 2021 were $24.3 million compared to $12.1 million for the year ended September 30, 2020 and includes non-cash costs related to share-based payments ($3.6M for year ended 2021 compared to $1.9M for year ended 2020). For the fourth quarter ended September 30, 2021, R&D expenditures were $6.3 million (net and gross), as compared to $2.2 million (net and gross) for the fourth quarter ended September 30, 2020. The increase in R&D expenditures for the full year and fourth quarter were primarily related to preclinical work leading to the filing of the IND for EPI-7386 in March 2020, the increased expenditure on chemistry and manufacturing of drug product, and clinical costs related to the Phase 1 clinical trial of EPI-7386 which commenced with the dosing of the first patient in July 2020.

General and administration ("G&A") expenditures. G&A expenditures for the year ended September 30, 2021 were $12.9 million compared to $11.4 million for the year ended September 30, 2020 and include non-cash costs related to share-based payments of $5.8M for the year ended 2021 compared to $5.6M for the year ended 2020. For the fourth quarter ended September 30, 2021, G&A expenditures were $2.9 million, compared to $2.2 million for the fourth quarter ended September 30, 2020. The increase in the full year and fourth quarter is the result of increased professional fees related to transitioning to be a domestic filer, higher salaries and benefits, as well as the non-cash share-based payments.
Liquidity and Outstanding Share Capital

At September 30, 2021, the Company had available cash reserves and short-term investments of $194.9 million, reflecting the gross proceeds of the February 2021 financing of approximately $150.0 million and July 2020 financing of $48.9 million, less operating expenses in the intervening period.

As of September 30, 2021, the Company had 43,984,346 common shares issued and outstanding.

In addition, as of September 30, 2021 there were 3,234,750 common shares issuable upon the exercise of warrants and broker warrants. This includes 2,920,000 prefunded warrants at an exercise price of $0.0001, and 314,750 warrants at a weighted average exercise price of $4.84. There were 6,803,230 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $5.20 per common share.

About EPI-7386
EPI-7386 is an investigational, highly-selective, oral, small molecule inhibitor of the N-terminal domain of the androgen receptor. EPI-7386 is currently being studied in a Phase 1 clinical trial (NCT04421222) in men with mCRPC whose tumors have progressed on current standard-of-care therapies. The Phase I clinical trial of EPI-7386 began in calendar Q3 of 2020 following FDA allowance of our Investigational New Drug application and Health Canada acceptance. The U.S. FDA has granted Fast Track designation to EPI-7386 for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment. ESSA retains all rights to EPI-7386 worldwide.

On November 18, 2021 Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, reported that it is giving notice of its intention to redeem the following Senior Notes (the "Redemption"), representing an aggregate total principal amount of approximately $2.2 billion, on December 3, 2021 (the "Redemption Date") (Press release, Thermo Fisher Scientific, NOV 18, 2021, View Source [SID1234595826]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

$1.1 billion aggregate principal amount of 4.133% Senior Notes due 2025 (the "2025 Notes"); and
$1.1 billion aggregate principal amount of 4.497% Senior Notes due 2030 (the "2030 Notes" and, together with the 2025 Notes, the "Notes").
The Notes will be redeemed at a redemption price equal to the greater of (1) 100% of the principal amount of the Notes to be redeemed and (2) the sum of the present values of the remaining scheduled payments of the Notes to be redeemed discounted to the Redemption Date on a semi-annual basis at a comparable treasury rate plus 50 basis points in the case of both the 2025 Notes and the 2030 Notes, plus, in each case, accrued and unpaid interest on the Notes to be redeemed to, but excluding, the Redemption Date. Thermo Fisher intends to fund the Redemption using cash on hand.