On March 10, 2022 IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies, based on its novel DPX platform, to treat solid and hematologic cancers, reported that it will hold a conference call and webcast on Thursday, March 17, 2022, at 8:00 a.m. ET to discuss the company’s 2021 fourth quarter and fiscal year-end financial and operational results (Press release, IMV, MAR 10, 2022, View Source [SID1234609900]).

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!

Financial analysts are invited to join the conference call by dialing 1-844-461-9932 (U.S. and Canada) or 1-636-812-6632 (international) and using the conference ID: 5049587

Other interested parties will be able to access the live audio webcast at this link: View Source The webcast will be recorded and will then be available on the IMV website for 30 days following the call.

On March 10, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, reported that Chief Executive Officer Dr. James A. Hayward will host a virtual fireside chat with the Company’s covering analyst, Managing Director and Senior Research Analyst Jonathan Aschoff, on Monday, March 14, 2022, at the 34th Annual ROTH Investor Conference (Press release, Applied DNA Sciences, MAR 10, 2022, View Source;id=225876&p=2222207&I=1206939-c7Z3G6f3m8 [SID1234609917]).

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!

Dr. Hayward, Beth Jantzen, chief financial officer, and Clay Shorrock, executive director of business development, will also host scheduled virtual one-on-one meetings with investors during the event.

To request a one-on-one meeting with Applied DNA, please email [email protected] or contact your Roth sales representative.

34th Annual Roth Investor Conference
Date: Monday, March 14, 2022
Time: 12:00 p.m. ET (9:00 a.m. ET)
Webcast: View Source

The fireside chat will be available for viewing and replay on the Investor Relations section of the Applied DNA website at www.adnas.com.

On March 10, 2022 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 that the Company will be presenting at the virtual Oppenheimer 32nd Annual Healthcare Conference on Thursday, March 17, 2022 at 2:40 p.m. Eastern Time (Press release, ESSA, MAR 10, 2022, View Source [SID1234609934]).

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!

David. R. Parkinson, President and Chief Executive Officer of ESSA Pharma, will participate in and host one-on-one meetings. Peter Virsik, ESSA’s Chief Operating Officer, and David S. Wood, ESSA’s Chief Financial Officer, will also be participating in the one-on-one meetings.

On March 10, 2022 Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, reported financial results for the full-year ended December 31, 2021 and provided a corporate update (Press release, Addex Therapeutics, MAR 10, 2022, View Source [SID1234609846]).

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!

"These are exciting times for Addex! We have three ongoing clinical trials with data starting to report as early as Q2 this year and multiple preclinical programs advancing rapidly through clinical candidate selection phase with strong novel IP across all programs," said Tim Dyer, CEO of Addex. "The extension of our collaboration with Indivior and the additional $4M of funding as well as the $10M financing from Armistice capital contributed to our completing the year with a strong cash position of $22.5M."

2021 Operating Highlights:

Phase 2 clinical trial with dipraglurant in blepharospasm patients on track to report data in Q2 2022
Phase 2b/3 dipraglurant study in dyskinesia associated with Parkinson’s disease expected to report data in H1 2023
Janssen Pharmaceuticals led Phase 2a clinical study of ADX71149 in epilepsy patients on track to report data in Q3 2022
Extended our strategic collaboration with Indivior to advance GABAB PAM until mid-2022 with $4M additional funding
Continued to advance GABAB PAM drug candidates through clinical candidate selection phase
Entered a research collaboration with the Charcot–Marie–Tooth Association (CMTA) to evaluate selected drug candidates in preclinical models of CMT1A
Advanced Eurostars / Innosuisse funded mGlu7 NAM program for post-traumatic stress disorder
Continued to advance preclinical programs to next value inflection points
Select Upcoming Milestones:

Q2 2022 – Phase 2a data: dipraglurant for blepharospasm
Q3 2022 – Phase 2a data: ADX71149 for epilepsy
H1 2023 – Phase 2b/3 data: dipraglurant for dyskinesia associated with Parkinson’s disease

Key 2021 Financial Data

Financial Summary:
Income decreased by CHF 0.7 million to CHF 3.2 million in 2021 compared to CHF 3.9 million in 2020, primarily due to amounts received under the licensing and research agreement with Indivior, recognized as related costs are incurred.

R&D costs increased by CHF 2.4 million to CHF 12.8 million in 2021 compared to CHF 10.4 million in 2020, mainly due to increased outsourced R&D expenses for CHF 2.0 million of which CHF 0.6 million relates to our dipraglurant PD-LID program and CHF 0.6 million for our dipraglurant blepharospasm program. R&D expenses consist primarily of costs associated with research, preclinical and clinical testing, and related staff costs. They also include depreciation of laboratory equipment, costs of materials used in research, costs associated with renting and operating facilities and equipment, as well as fees paid to consultants, patent costs and other outside service fees and overhead costs. These expenses include costs for proprietary and third-party R&D.

G&A expenses remained stable around CHF 5.8 million in 2021 and 2020.

The net loss was CHF 15.4 million in 2021 compared to CHF 12.9 million in 2020 primarily due to increased R&D expenses. Basic and diluted loss per share decreased to CHF 0.45 for the year ended December 31, 2021, compared to CHF 0.48 for the year ended December 31, 2020.

Cash and cash equivalents increased to CHF 20.5 million at December 31, 2021, compared to CHF 18.7 million at December 31, 2020. This increase of CHF 1.8 million is mainly due to the two offerings executed on January 8, 2021 and December 16, 2021 for total net proceeds of CHF 16 million partially offset by our net loss of CHF 15.4 million. During the same period, non-cash items mainly relating to the value of share-based services amounted to CHF 1.4 million have been partially off-set by the net effect of the increased net working capital of CHF 0.6 million.

2021 Consolidated Financial Statements:
The full-year 2021 financial report can be found on the Company’s website in the investor/download section here.

Conference Call Details:
A conference call will be held today, March 10, 2022, at 16:00 CET (15:00 GMT / 10:00 EST / 07:00 PST) to review the financial results. Tim Dyer, Chief Executive Officer, Roger Mills, Chief Medical Officer and Robert Lütjens, Head of Discovery Biology will deliver a brief presentation followed by a Q&A session.

Joining the Conference Call:
1: In the 10 minutes prior to the call start time, call the appropriate participant dial-in number.
Dial-In Numbers:

2: Provide the Operator with the Participation Confirmation Code: 5484873

Link to live event online:
In the 10 minutes prior to the call start time, sign in online by following this Webex Link.

On March 10, 2022 TG Therapeutics, Inc. (NASDAQ: TGTX), reported the U.S. Food and Drug Administration (FDA) has set a date of April 22, 2022 for the previously announced meeting of the Oncologic Drugs Advisory Committee (ODAC) in connection with its review of the Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ (umbralisib) (combination referred to as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) (Press release, TG Therapeutics, MAR 10, 2022, View Source [SID1234609869]). Background material and the link to the online teleconference meeting room will be available at View Source

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 Company previously announced that the FDA extended the Prescription Drug User Fee Act (PDUFA) goal date to June 25, 2022 for the BLA/sNDA for U2 to treat CLL and SLL.

Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, "As noted on our recent year-end call, the team, as well as our external consultants, have been working hard to prepare and we look forward to sharing the data with everyone during the ODAC meeting."

ABOUT THE ODAC MEETING
In general, the Oncologic Drugs Advisory Committee (ODAC) reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes appropriate recommendations to the Commissioner of Food and Drugs. Although the FDA will consider the recommendation of the ODAC Committee, the final decision regarding the approval of a product is made solely by the FDA.

The FDA has notified the Company that potential questions and discussion topics for the ODAC include: the benefit-risk of the U2 combination in the treatment of CLL or SLL, and the benefit-risk of UKONIQ in relapsed/refractory marginal zone lymphoma (MZL) or follicular lymphoma (FL). In addition, as part of the benefit-risk analysis, the overall safety profile of the U2 regimen, including adverse events (serious and Grade 3-4), discontinuations due to adverse events, and dose modifications, is expected to be reviewed. The FDA’s concern giving rise to the ODAC meeting appears to stem from an early analysis of overall survival from the UNITY-CLL trial.

Overall survival was designated as a secondary efficacy outcome in the UNITY-CLL protocol but was not part of the primary analysis in accordance with the study’s statistical analysis plan agreed upon via a Special Protocol Assessment (SPA), and therefore, was not analyzed or included in the BLA/sNDA. Additionally, the study was not powered for overall survival. As part of the ongoing review of the BLA/sNDA, the FDA requested an early analysis of overall survival from the UNITY-CLL trial. As of September 2021, the cut-off date for the overall survival analysis requested by the FDA during their review, there was an imbalance in favor of the control arm (HR: 1.23) though this result was not statistically significant. However, when excluding deaths related to COVID-19, the two arms were approximately balanced (HR: 1.04) with again no statistically significant difference between the treatment groups with regard to overall survival. In February 2022, the Company submitted updated overall survival data with the same September 2021 cut-off date. FDA considered the updated OS data a substantial amendment and extended the PDUFA date for the BLA/sNDA to June 25, 2022. The Company will continue to evaluate this endpoint over time as more events are available and will continue to analyze how COVID-19 may be impacting the analysis.

The ODAC meeting is scheduled to take place on April 22, 2022.

ABOUT UNITY-CLL PHASE 3 TRIAL AND THE BLA/sNDA SUBMISSION
UNITY-CLL is a global, Phase 3, randomized, controlled clinical trial comparing the combination of ublituximab plus UKONIQ (umbralisib), or U2, to an active control arm of obinutuzumab plus chlorambucil in patients with both treatment-naïve and relapsed or refractory chronic lymphocytic leukemia (CLL). The trial randomized patients into four treatment arms: ublituximab single agent, UKONIQ single agent, ublituximab plus UKONIQ, and an active control arm of obinutuzumab plus chlorambucil. A prespecified interim analysis was conducted to assess the contribution of ublituximab and UKONIQ in the U2 combination arm and allowed for the termination of the single agent arms. Accordingly, the UNITY-CLL Phase 3 trial continued enrollment in a 1:1 ratio into the two combination arms: the investigational arm of U2 and the control arm of obinutuzumab plus chlorambucil. Approximately 420 subjects enrolled to the two combination arms and approximately 60% of patients were treatment-naïve and 40% were relapsed or refractory. The primary endpoint for this study was superior progression-free survival (PFS) for the U2 combination compared to the control arm. The trial met its primary endpoint, with U2 significantly prolonging independent review committee (IRC) assessed PFS vs. control (median 31.9 months vs 17.9 months; hazard ratio 0.546 (p<0.0001)) at a median follow-up of 36.7 months, and results were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2020. The UNITY-CLL Phase 3 trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).

The BLA/sNDA submissions of U2 to treat CLL were based on the results of the UNITY-CLL trial. The FDA previously granted Fast Track designation to the U2 combination for the treatment of adult patients with CLL and orphan drug designation for ublituximab in combination with UKONIQ for the treatment of CLL.

ABOUT CHRONIC LYMPHOCYTIC LEUKEMIA
Chronic lymphocytic leukemia (CLL) is the most common type of adult leukemia. It is estimated there will be more than 20,000 new cases of CLL diagnosed in the United States in 2020 and approximately 45,000 new cases globally in 2020.1,2 Although signs and symptoms of CLL may disappear for a period of time after initial treatment, the disease is considered incurable and many people will require additional treatment due to the return of malignant cells.