Achieve Life Sciences Reports Financial Results for Fourth Quarter and Year-End 2021 and Provides Corporate Update

On March 10, 2022 Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, reported fourth quarter and year-end 2021 financial results and provided an update on the cytisinicline clinical development program (Press release, OncoGenex Pharmaceuticals, MAR 10, 2022, View Source [SID1234609851]).

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Recent Business Highlights

Initiated ORCA-3, the second Phase 3 trial, in 750 adult smokers at 15 clinical sites in the United States

Announced last subject and last follow-up visit in the Phase 3 ORCA-2 trial of cytisinicline for smoking cessation

Entered into a $25 million loan facility with Silicon Valley Bank

Facilitated Key Opinion Leader virtual roundtable on smoking and e-cigarette cessation

Received U.S. Food and Drug Administration (FDA) acceptance of Investigational New Drug (IND) application for investigation of cytisinicline as a treatment for nicotine e-cigarette/vaping cessation

"We finished 2021 strong achieving multiple milestones and are starting the new year off with continued momentum in the cytisinicline development program," commented John Bencich, Chief Executive Officer of Achieve. "We are eagerly anticipating topline results from the Phase 3 ORCA-2 trial in the coming months, as we enroll smokers in the recently initiated Phase 3 ORCA-3 trial at 15 clinical sites in the United States. Additionally, our cash position remains strong with funding into 2023, allowing us to execute on the final stages of clinical development needed to support an NDA for smoking cessation."

Phase 3 ORCA-3 Trial Initiated

Achieve announced it has initiated enrollment for the Phase 3 ORCA-3 trial at 15 clinical sites in the United States in January 2022. Similar to the ORCA-2 trial, ORCA-3 will evaluate the efficacy and safety of 3 mg cytisinicline dosed three times daily compared to placebo. Approximately 750 smokers will be randomized to one-of-three treatment arms to evaluate cytisinicline administered for either 6 or 12 weeks.

Phase 3 ORCA-2 Trial Completed Last Subject and Last Follow-up Visit

Achieve completed the last study follow-up visit for the last subject enrolled in the Phase 3 ORCA-2 trial in late December 2021. The ORCA-2 trial is the first Phase 3 trial in Achieve’s ORCA (Ongoing Research of Cytisinicline for Addiction) Program, designed to evaluate the smoking cessation effectiveness, safety, and tolerability of 3 mg cytisinicline taken three times daily for either 6 or 12 weeks, compared with placebo. ORCA-2 randomized 810 subjects across 17 clinical trial sites in the United States. Topline data regarding the primary results are expected in the second quarter of 2022.

$25 Million Loan Facility with Silicon Valley Bank

In December 2021, Achieve announced a $25 million debt agreement with Silicon Valley Bank and SVB Innovation Credit Fund VIII, L.P. (SVB). The proceeds and funds available under the debt agreement are expected to fund the completion of the cytisinicline smoking cessation clinical development program. SVB funded $15 million in the form of contingent convertible indebtedness and Achieve may borrow additional non-convertible term loans in an aggregate original principal amount of up to $10 million.

Virtual Smoking Cessation KOL Roundtable

Achieve hosted a Key Opinion Leader virtual roundtable on smoking and e-cigarette cessation in December 2021. Two esteemed smoking cessation experts discussed the current market for smoking and e-cigarette cessation, challenges with available treatments, and the potential of cytisinicline to be the first new FDA approved smoking cessation therapy in nearly two decades. Click here to view the event.

FDA Acceptance of IND for Cytisinicline in e-Cigarette and Vape Cessation

The FDA completed its review and accepted an IND application to investigate cytisinicline as a cessation treatment for nicotine e-cigarette users in November 2021. The Phase 2 ORCA-V1 study will enroll approximately 150 adult nicotine e-cigarette users in the United States and is expected to initiate in the second quarter of 2022. Grant funding to support the trial has been awarded in two phases from the National Institute on Drug Abuse of the National Institutes of Health. Completion of required milestones for the first phase of grant funding included the submission of the IND and clearance to proceed with the clinical trial by FDA. Achieve has submitted for completion of the first phase milestones and awaits clearance under the grant to proceed with ORCA-V1 study.

Financial Results

As of December 31, 2021, the company’s cash, cash equivalents, and restricted cash was $43.1 million. Total operating expenses for the fourth quarter and year ended December 31, 2021 were $7.1 million and $33.1 million, respectively. Total net loss for the fourth quarter and year ended December 31, 2021 was $7.2 million and $33.2 million, respectively. As of March 10, 2022, Achieve had 9,460,835 shares outstanding.

Conference Call Details

Achieve will host a conference call at 4:30 PM EST today, Thursday, March 10, 2022. To access the webcast, log on to the investor relations page of the Achieve website at View Source Alternatively, access to the live conference call is available by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 8066623. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.

Chemomab Therapeutics to Present at the 32nd Annual Oppenheimer Healthcare Conference

On March 10, 2022 Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, reported that management will be presenting a corporate overview and participating in 1-on-1 meetings on March 15, 2022, at the 32nd Annual Oppenheimer Healthcare Conference (Press release, Chemomab, MAR 10, 2022, View Source [SID1234609849]).

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32nd Annual Oppenheimer Healthcare Conference (virtual)

Date: March 15, 2022
Time: 10:00am – 10:30am ET
Registration: Webcast Registration Link

To request a virtual 1-on-1 meeting with Chemomab management, investors should speak with an Oppenheimer representative.

An archived version of the presentation webcast will also be available at the Investor Relations section of the company’s website at investors.chemomab.com/events

BioLineRx to Report 2021 Annual Results on March 16, 2022

On March 10, 2022 BioLineRx Ltd. (NASDAQ: BLRX), (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported it will release its audited financial results for the year ended December 31, 2021 on Wednesday, March 16, 2022, before the US markets open (Press release, BioLineRx, MAR 10, 2022, View Source [SID1234609847]).

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The Company will host a conference call on Wednesday, March 16, 2022 at 10:00 a.m. EST featuring remarks by Philip Serlin, Chief Executive Officer. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

To dial into the conference call, please dial +1-866-744-5399 from the U.S. or +972-3-918-0644 internationally. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until March 18, 2022; please dial +1-888-295-2634 from the U.S. or +972-3-925-5904 internationally.

Addex Reports Full Year 2021 Financial Results and Provides Corporate Update

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]).

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"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.

Astellas Announces Completion of Acquisition of Own Shares, and Cancellation of Treasury Stock

On March 10, 2022 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported the status and the completion of acquisition of its own shares based on the resolution of the Board of Directors’ meeting held on February 2, 2022, pursuant to the Articles of Incorporation in accordance with Article 459, paragraph 1 of the Companies Act (Press release, Astellas, MAR 10, 2022, View Source [SID1234609839]).

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The Company also announced the number of shares to be canceled on March 29, 2022 pursuant to Article 178 of the Companies Act has been finalized.

Particulars

Status of acquisition of own shares
(1) Class of shares acquired: Common stock of the Company
(2) Total number of shares acquired: 11,096,700 shares
(3) Total amount of acquisition cost: 20,642,021,200 yen
(4) Period of acquisition: From March 1, 2022 to March 9, 2022
(5) Method of acquisition: Purchased on the Tokyo Stock Exchange

Details of the cancellation of treasury stock
(1) Class of shares to be cancelled: Common stock of the Company
(2) Number of shares to be cancelled: 25,935,500 shares
(Ratio to the total number of shares outstanding [excluding treasury stock]: 1.40%)
(3) Cancellation date: March 29, 2022

(Reference)

Details of the resolution at the meeting of the Board of Directors on February 2, 2022
(1) Class of shares to be acquired: Common stock of the Company
(2) Total number of shares to be acquired: Up to 29 million shares
(Ratio to the total number of shares outstanding [excluding treasury stock): 1.57%]
(3) Total amount of acquisition cost: Up to 50 billion yen
(4) Period of acquisition: From February 3, 2022 to March 24, 2022

Accumulated Company’s own shares acquired pursuant to the above board resolution
(1) Total number of shares acquired: 25,935,500 shares
(2) Total amount of acquisition cost: 49,999,849,800 yen
(Ratio to the total number of shares outstanding [excluding treasury stock]: 1.40%)

Details of the decided cancellation of treasury stock (February 2, 2022)
(1) Class of shares to be cancelled: Common stock of the Company
(2) Total number of shares to be cancelled: All of the shares repurchased as stated in 2 above
(3) Scheduled cancellation date: March 29, 2022

Status of shares after cancellation
(1) Number of shares issued: 1,835,851,575 shares (expected)
(2) Number of the Company’s treasury stock: 8,845,998 shares (expected)
[Estimated numbers of shares described above (1) and (2) were calculated on the basis of the issued shares and the Company’s treasury stock as of February 28, 2022, respectively.]