On November 2, 2021 Perrigo Company plc (NYSE; TASE: PRGO), a leading global provider of Quality, Affordable Self-Care Products, reported that its Board of Directors declared a quarterly dividend of $0.24 per share, payable on December 21, 2021 to shareholders of record on December 3, 2021 (Press release, Perrigo Company, NOV 2, 2021, View Source [SID1234594090]).

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On November 2, 2021 DURECT Corporation (Nasdaq: DRRX) reported financial results for the three months ended September 30, 2021 and provided a corporate update (Press release, DURECT, NOV 2, 2021, View Source [SID1234594108]).

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"I am proud of the progress we have made in expanding clinical trial sites and the pace of enrollment in the AHFIRM study, particularly given the challenges faced by many of the hospitals where our study is being conducted in dealing with the Delta variant surge." stated James E. Brown, DVM, President and CEO of DURECT. "I am also pleased with the progress made in our POSIMIR licensing process."

Third Quarter and Recent Business Highlights:

Continued progress in clinical study site openings – DURECT has increased the total number of planned sites for the Phase 2b AHFIRM study to 60+. Since the last earnings call, the Company has opened an additional 10 clinical trial sites. There are now 36 global AHFIRM study sites open, more than 50% of the planned locations.

Opening of first ex-US sites – DURECT also recently opened the first ex-US study sites in Australia. This marks the beginning of the ex-US expansion of the AHFIRM study.

USAN Council name approved – The United States Adopted Names (USAN) Council has approved ‘larsucosterol’ as the nonproprietary (generic) name for DUR-928.

Progress with POSIMIR partnering – POSIMIR licensing negotiations continue to advance.

Upcoming Key Milestones:

DURECT is focused on advancing DUR-928 (larsucosterol) for the treatment of AH

At the AASLD Liver Meeting November 12-15, Suthat Liangpunsakul, M.D. will present a poster reporting the growing prevalence of AH hospitalizations in the U.S., highlighting the growing unmet need for these patients.
With strong interest from hepatologists to join the study, we plan to continue to expand the AHFIRM study to more than 60 total clinical trial sites across the U.S., E.U., U.K., and Australia.
We expect to initiate ex-US dosing in the AHFIRM study in the coming weeks.
We are on track to complete a POSIMIR license deal with a U.S. partner who would subsequently launch the product.
We will determine next steps for larsucosterol in non-alcoholic steatohepatitis (NASH).
Financial highlights for Q3 2021:

Total revenues were $2.2 million and net loss was $10.0 million for the three months ended September 30, 2021, compared to total revenues of $1.8 million and net loss of $9.3 million for the three months ended September 30, 2020.
At September 30, 2021, cash and investments were $80.9 million, compared to cash, cash held in escrow and investments of $56.9 million at December 31, 2020. Debt at September 30, 2021 was $20.5 million, compared to $20.8 million at December 31, 2020
Conference Call:

We will host a conference call today at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss third quarter 2021 results and provide a corporate update:

The conference call will also be available by webcast on DURECT’s homepage at www.durect.com under the "Investors" tab. If you are unable to participate during the webcast, the call will be archived on DURECT’s website under "Event Calendar" in the "Investors" section.

About the AHFIRM Trial
Enrollment is ongoing in our Phase 2b study in subjects with severe acute AH to evaluate saFety and effIcacy of DUR-928 treatMent (AHFIRM). AHFIRM is a randomized, double-blind, placebo-controlled, international, multi-center Phase 2b study to evaluate the safety and efficacy of larsucosterol (also known as DUR-928) in approximately 300 patients with severe AH. The study is comprised of three arms targeting enrollment of approximately 100 patients each: (1) Placebo plus standard of care (SOC, which may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician); (2) larsucosterol (30 mg); and (3) larsucosterol (90 mg). All patients in the trial receive supportive care. The primary outcome measure is 90-day survival rate for patients treated with larsucosterol compared to those treated with placebo plus SOC. The Company is targeting more than 60 clinical trial sites across the U.S., E.U., U.K., and Australia. Reflecting the life-threatening nature of AH and the lack of therapeutic options for this devastating condition, the FDA has granted larsucosterol Fast Track Designation for the treatment of AH. We believe demonstration of a robust survival benefit in the AHFIRM trial would support an NDA filing.

On November 2, 2021 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported that it will report its financial results for the third quarter of 2021, on Tuesday, November 9, 2021, before the U.S. financial markets open (Press release, Concert Pharmaceuticals, NOV 2, 2021, View Source [SID1234594130]). The Company will host a conference call and webcast at 8:30 a.m. ET to discuss its third quarter 2021 financial results and provide a business update. Individuals interested in participating in the call should dial (855) 354-1855 (U.S. and Canada) or (484) 365-2865 (International).

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A live webcast of the conference call may be accessed in the Investors section of the Company’s website at www.concertpharma.com. A replay of the webcast will be available on Concert’s website for three months.

On November 2, 2021 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that an article highlighting preclinical data from BT7480, a tumor-targeted immune cell agonist (TICA) targeting Nectin-4 and agonizing CD137 (4-1BB), was published in the Journal for ImmunoTherapy of Cancer (JITC) (Press release, Bicycle Therapeutics, NOV 2, 2021, View Source [SID1234594149]). The article, titled "BT7480, a novel fully synthetic Bicycle tumor-targeted immune cell agonist (Bicycle TICA) induces tumor localized CD137 agonism" is available online via this link.

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"CD137 is an important co-stimulatory receptor expressed on multiple components of the immune system. CD137 activation can drive anti-tumor immunity but activation outside of the tumor may give rise to toxicity. To that end, we have developed BT7480, a novel, first-in-class Nectin-4/CD137 Bicycle TICA, that activates CD137 only in the presence of Nectin-4 expressing tumor cells," said Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. "The data published today in JITC describe BT7480’s ability to elicit rapid reprogramming of the tumor immune microenvironment, which leads to complete regressions and anti-tumor immunity with only intermittent drug exposure in syngeneic mouse tumor models. We believe this work supports the clinical investigation of BT7480 for the treatment of cancer, and we look forward to dosing the first patient in our Phase I/II clinical trial which we plan to commence by the end of this year."

On November 2, 2021 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported its financial results for the third quarter of 2021 and provided a corporate update (Press release, Aclaris Therapeutics, NOV 2, 2021, View Source [SID1234594070]).

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"This quarter we are pleased to announce the submission of an investigational new drug application for ATI-2138, our investigational oral ITK/TXK/JAK3 inhibitor, the third novel clinical candidate generated by our proprietary KINect drug discovery platform," said Dr. Neal Walker, President & CEO of Aclaris. "If allowed, we plan to progress ATI-2138 into a Phase 1 trial. We also continue to make progress toward initiating a Phase 2b trial of zunsemetinib (ATI-450) in moderate to severe rheumatoid arthritis and Phase 2 trials of zunsemetinib in psoriatic arthritis and moderate to severe hidradenitis suppurativa, as well as our Phase 2b trial of ATI-1777 in moderate to severe atopic dermatitis."

Research and Development Highlights:

The global COVID-19 pandemic continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its research and development and regulatory activities listed below.

Clinical Programs
MK2 Inhibitor Asset
Zunsemetinib (ATI-450), an investigational oral small molecule MK2 inhibitor compound:
Zunsemetinib has been adopted as the nonproprietary name for ATI-450.
Aclaris plans to progress zunsemetinib into a Phase 2b trial in moderate to severe rheumatoid arthritis in the fourth quarter of 2021.
Aclaris also plans to progress zunsemetinib into Phase 2 trials in psoriatic arthritis and moderate to severe hidradenitis suppurativa.
In pre-clinical studies, positive effects on MK2 inhibition have been observed for breast cancer metastasis and cancer-associated bone loss.
"Soft" JAK Inhibitor Asset
ATI-1777, an investigational topical "soft" Janus kinase (JAK) 1/3 inhibitor compound:
Aclaris plans to progress ATI-1777 into a Phase 2b trial in moderate to severe atopic dermatitis in the first half of 2022. In this trial, Aclaris plans to explore multiple concentrations of twice daily treatment with ATI-1777 and a single concentration of once daily treatment with ATI-1777.
Preclinical Programs
ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound:
Currently being developed as a potential treatment for T-cell mediated diseases such as psoriasis and/or inflammatory bowel disease.
Aclaris submitted an Investigational New Drug Application (IND) for ATI-2138 for the treatment of psoriasis in October 2021 and, if allowed, Aclaris plans to progress to a first-in-human Phase 1 single ascending dose trial of ATI-2138 in healthy volunteers.
ATI-2231, an investigational oral MK2 inhibitor compound:
Second MK2 inhibitor generated from Aclaris’ proprietary KINect drug discovery platform and designed to have a long half-life.
Currently being explored as a potential treatment for pancreatic cancer and metastatic breast cancer as well as in preventing bone loss in patients with metastatic breast cancer.
IND-enabling studies are underway.
Discovery Programs
Currently developing oral gut-restricted JAK inhibitors with limited systemic exposure as potential treatments for inflammatory bowel disease.
Central nervous system (CNS) kinase inhibitor targets
Currently engaged in research to identify brain penetrant kinase inhibitor candidates and assess their impact on neuronal pro-inflammatory cytokine production, microglia growth and survival, and neurodegeneration.
Planned Retirement
Kamil Ali-Jackson, Co-Founder, Chief Legal Officer, Chief Compliance Officer and Corporate Secretary has announced her retirement, effective January 3, 2022. "Kamil was one of the co-founders of Aclaris in 2012 and on behalf of the entire Aclaris team and our Board of Directors, I thank Kamil for her hard work and dedication to the company," said Dr. Walker. "During her tenure, Kamil has been responsible for building and overseeing Aclaris’ Legal, Compliance, Corporate Communications, Human Resources, and Quality functions and her significant contributions have contributed to the success of the company. We wish Kamil the very best in her retirement."
Financial Highlights:

Liquidity and Capital Resources

As of September 30, 2021, Aclaris had aggregate cash, cash equivalents and marketable securities of $243.6 million compared to $54.1 million as of December 31, 2020. The primary factors for the change in cash, cash equivalents and marketable securities during the nine months ended September 30, 2021 included:

Net cash used in operating activities of $35.1 million. This amount was comprised of the following:
$68.1 million net loss
$0.8 million cash used from changes in operating assets and liabilities
$22.1 million of non-cash charges for the revaluation of contingent consideration
$10.2 million of non-cash stock-based compensation expense
$1.5 million of other non-cash charges
Net cash used to repay outstanding debt and fees of $11.5 million in July 2021.
Net proceeds of $238.2 million from public offerings in January and June 2021 in which Aclaris sold a total of 14.4 million shares of common stock.
Aclaris anticipates that its cash, cash equivalents and marketable securities as of September 30, 2021 will be sufficient to fund its operations through the end of 2024, without giving effect to any potential business development transactions or financing activities.

Financial Results

Third Quarter 2021

Net loss was $21.1 million for the third quarter of 2021 compared to $10.7 million for the third quarter of 2020.
Total revenue was $1.7 million for the third quarter of 2021 compared to $1.4 million for the third quarter of 2020.
Research and development (R&D) expenses were $14.0 million for the quarter ended September 30, 2021 compared to $6.2 million for the prior year period.
The $7.7 million increase was primarily the result of additional zunsemetinib expenses, including costs associated with drug product manufacturing and clinical development activities for a Phase 2b trial for moderate to severe rheumatoid arthritis and a Phase 2 trial for moderate to severe hidradenitis suppurativa.
General and administrative (G&A) expenses were $6.0 million for the quarter ended September 30, 2021 compared to $3.9 million for the prior year period.
The $2.1 million increase was primarily the result of higher compensation-related costs, including stock-based compensation as well as higher accounting, compliance and professional fees.
Revaluation of contingent consideration charges related to the Confluence acquisition was $0.9 million for the quarter ended September 30, 2021 compared to $0.6 million for the prior year period.
Year-to-date 2021

Net loss was $68.1 million for the nine months ended September 30, 2021 compared to $37.8 million for the nine months ended September 30, 2020.
Total revenue was $5.3 million for the nine months ended September 30, 2021 compared to $4.9 million for the nine months ended September 30, 2020.
R&D expenses were $29.7 million for the nine months ended September 30, 2021 compared to $20.4 million for the prior year period.
The $9.3 million increase was primarily the result of additional zunsemetinib expenses, including costs associated with drug product manufacturing and clinical development activities for a Phase 2b trial for moderate to severe rheumatoid arthritis and a Phase 2 trial for moderate to severe hidradenitis suppurativa. Continued investment in the further development of Aclaris’ immuno-inflammatory drug development pipeline also contributed to the increase as Aclaris progressed towards an IND submission for ATI-2138.
G&A expenses were $16.7 million for the nine months ended September 30, 2021 compared to $15.6 million for the prior year period.
The $1.0 million increase was primarily the result of higher accounting, compliance and professional fees.
Revaluation of contingent consideration charges related to the Confluence acquisition was $22.1 million for the nine months ended September 30, 2021 compared to $2.4 million for the prior year period.