On November 6, 2019 Arbutus Biopharma Corporation (Nasdaq: ABUS), a Hepatitis B Virus (HBV) therapeutic solutions company, reported its third quarter 2019 financial results and provides a corporate update (Press release, Arbutus Biopharma, NOV 6, 2019, View Source [SID1234550410]).

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!

"We remain committed to our mission of developing a portfolio of assets with differing mechanisms of action that we believe will form the basis for a functional cure of chronic Hepatitis B", said William Collier, Arbutus’ President and Chief Executive Officer. "Our current efforts are focused on completing the Phase 1a/b clinical trial of AB-729, rapidly selecting a next-generation capsid inhibitor for IND-enabling studies to replace our recently discontinued AB-506, evaluating our oral RNA destabilizer, AB-452, as well as next-generation compounds in this class, and research on compounds that inhibit PD-L1."

Recent Corporate Updates

AB-729

In July 2019, the Company initiated a single and multiple dose Phase 1a/1b clinical trial for AB-729, a subcutaneously delivered RNAi agent which has been shown in preclinical models to span all HBV transcripts, reduce all viral antigens, including hepatitis B surface antigen (HBsAg) expression, and inhibit HBV replication. In this trial, which is designed to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AB-729 in healthy volunteers and in subjects with chronic hepatitis B (CHB) infection, AB-729 will be dosed monthly.

Preliminary safety data in single-dose cohorts of healthy subjects and safety and efficacy data in single-dose cohorts of subjects with CHB infection are expected in the first quarter of 2020.

Capsid Inhibitors

In October 2019, Arbutus announced its decision to discontinue the clinical development of AB-506, an oral capsid inhibitor, in Phase 1a/1b clinical development for the treatment of CHB due to safety observations in a Phase 1a 28-day clinical trial in healthy volunteers. Arbutus intends to present results from the AB-506 Phase 1a/1b clinical trial program at the American Association for the Study of Liver Diseases meeting later this month.

Arbutus is evaluating a number of oral next-generation capsid inhibitor compounds with chemical scaffolding different from AB-506 that the Company believes have the potential to contribute to the inhibition of HBV replication as part of a combination regimen. The Company’s objective is to select one of several lead compounds for IND-enabling studies in December of this year.

AB 452

Arbutus remains committed to the development of oral RNA-destabilizers that have shown compelling anti-viral effects in multiple HBV preclinical models. AB-452, Arbutus’ lead oral RNA-destabilizer is being evaluated in a repeat 90-day preclinical safety study in two species before making a go/no-go decision. We expect that the results of this study will allow us to make that decision early in 2020. The Company is also continuing to advance back-up compounds with chemical scaffolding different from that of AB-452.

Early R&D Programs

Arbutus continues a focused discovery effort on follow-on compounds for its current HBV pipeline, including efforts to identify compounds potentially capable of reawakening patients’ HBV-specific immune response by inhibiting PD-L1.

New Appointment to Arbutus’ Board of Directors

Andrew Cheng, M.D., Ph.D., was appointed to the Arbutus Board of Directors. Previously, Dr. Cheng spent nearly two decades at Gilead Sciences, Inc., where he most recently served as Chief Medical Officer and Executive Vice President. Dr. Cheng is currently President and Chief Executive Officer of Akero Therapeutics (Nasdaq: AKRO).

Cash Position and Cash Guidance

The Company had approximately $90.1 million in cash and cash equivalents as of September 30, 2019. The discontinuation of the AB-506 development program is anticipated to reduce cash burn in the short term and the Company believes its existing cash and cash equivalents balance is sufficient to fund operations into early 2021.

Financial Results

Cash, Cash Equivalents and Investments

Arbutus had cash, cash equivalents and short-term investments totaling $90.1 million as of September 30, 2019, as compared to $124.6 million as of December 31, 2018. The decreased cash balance was due primarily to the $57.7 million used in operating activities during the first nine months of 2019, partially offset by $18.5 million in net proceeds from the sale of a portion of its royalty entitlement on net sales of ONPATTRO in the third quarter of 2019 and $4.7 million of net proceeds from the issuance of shares under its ATM program. Included in the $57.7 million used in operating activities is a $5.9 million payment for the award rendered in the arbitration proceeding with the University of British Columbia in the third quarter of 2019.

Net Loss

Net loss attributable to common shares for the third quarter of 2019, including non-cash charges of $43.8 million related to the impairment of an in-process research and development ("IPR&D") intangible asset and $22.5 million for the impairment of goodwill described further below, was $85.3 million ($1.50 basic and diluted loss per common share) as compared to $27.1 million ($0.49 basic and diluted loss per common share) for the third quarter of 2018. Net loss attributable to common shares also included non-cash expense for the accrual of coupon on the Company’s convertible preferred shares of $2.8 million in the third quarter of 2019 and $2.6 million in the third quarter of 2018, as well as non-cash expense for a proportionate share of Genevant’s net losses of $3.5 million in the third quarter of 2019 and $2.8 million in the third quarter of 2018.

ONPATTRO Royalty Entitlement

Arbutus has a royalty entitlement on global net sales of ONPATTRO (Patisiran) for the lipid nanoparticle delivery (LNP) technology licensed by Arbutus to Alnylam Pharmaceuticals, Inc. (Alnylam) for this product. ONPATTRO is an RNAi therapeutic for the treatment of hereditary ATTR (hATTR) amyloidosis that has been approved by the U.S. Food and Drug Administration and the European Medical Agency. In July 2019, Arbutus sold this royalty entitlement to OCM IP Healthcare Portfolio LP, an affiliate of the Ontario Municipal Employees Retirement System (collectively, OMERS), effective as of January 1, 2019, for $20 million in gross proceeds before advisory fees. OMERS will retain this royalty entitlement until it has received $30 million in royalties, at which point 100% of this royalty entitlement will revert to Arbutus. OMERS has assumed the risk of collecting up to $30 million of future royalty payments from Alnylam and Arbutus is not obligated to reimburse OMERS if they fail to collect any such future royalties. Arbutus recognized the $20 million of gross proceeds from this transaction as a liability, net of transaction costs. The Company is amortizing the liability to non-cash interest expense and will continue to recognize the royalty revenue that Alnylam pays to OMERS as non-cash royalty revenue.

In addition to the royalty entitlement from the Alnylam LNP license agreement, Arbutus is also receiving a second, lower royalty entitlement on global net sales of ONPATTRO originating from a settlement agreement and subsequent license agreement with Acuitas Therapeutics. The royalty entitlement from Acuitas has been retained by Arbutus and is not part of the royalty entitlement sale to OMERS.

Operating Expenses

Research and development expenses were $17.7 million in the third quarter of 2019 compared to $16.6 million in the third quarter of 2018. Research and development expenses in the third quarter of 2019 included costs associated with the Company’s Phase 1a/1b clinical trial for its RNAi agent (AB-729), costs associated with the Company’s Phase 1a/1b clinical trial for its oral capsid inhibitor (AB-506) that was discontinued in October 2019, and toxicology studies for its HBV RNA Destabilizer (AB-452). The increase in research and development expenses was due primarily to increased spending in 2019 for the two Phase 1a/1b clinical trials for AB-729 and AB-506. General and administrative expenses were $3.3 million in the third quarter of 2019 compared to $2.6 million in the third quarter of 2018. The increase in general and administrative expenses was due primarily to increased stock compensation expense and an increase in insurance premiums.

In the third quarter of 2019, the Company also recorded a charge of $6.5 million related to an arbitration award from the Company’s arbitration with the University of British Columbia.

Impairment of IPR&D Intangible Assets and Goodwill

The Company has historically carried IPR&D and goodwill from its acquisition of technologies and business combination as assets. All acquired IPR&D intangible assets relate to the Company’s covalently closed circular DNA ("cccDNA") program. During the three months ended September 30, 2019, the Company recorded a $43.8 million non-cash impairment expense to reduce the carrying value of its IPR&D intangible assets to zero as of September 30, 2019. The Company also recognized a corresponding income tax benefit of $12.7 million related to the decrease in its deferred tax liability associated with the IPR&D intangible assets. The impairment was due to an indefinite delay in further development of the Company’s cccDNA program while the Company focuses on its other development programs.

Goodwill represents the excess of purchase price over the value assigned to the net tangible and identifiable intangible assets in connection with the business combination that formed Arbutus. For the third quarter of 2019, the Company assessed the changes in circumstances that occurred during the quarter to determine if it was more likely than not that the fair value of the Company was below its carrying amount. Due to a sustained decrease in the Company’s share price in recent months, the Company’s market capitalization was reduced below the book value of its net assets and the Company concluded that its fair value was below its carrying amount by an amount in excess of the carrying value

of the goodwill. As a result, the Company recorded a $22.5 million non-cash impairment expense to reduce the carrying value of its goodwill asset to zero as of September 30, 2019.

Equity Investment Loss in Genevant

As of September 30, 2019, the Company owned approximately 40% of the common equity of Genevant Sciences Ltd. (Genevant), a company launched with Roivant Sciences Ltd. in April 2018. Arbutus recorded a loss of $3.5 million in the third quarter of 2019 for its proportionate share of Genevant’s net loss. Financial results of Genevant are recorded on a one-quarter lag basis.

Outstanding Shares

The Company had 56,850,172 common shares issued and outstanding as of September 30, 2019. In addition, the Company had approximately 9.1 million stock options outstanding and 1.164 million convertible preferred shares outstanding, which (including the annual 8.75% coupon) will be mandatorily convertible into approximately 23 million common shares on October 18, 2021.

Conference Call Today

Arbutus will hold a conference call and webcast today, Wednesday, November 6, 2019 at 8:45 AM Eastern Time to provide a corporate update. You can access a live webcast of the call through the Investors section of Arbutus’ website at www.arbutusbio.com. Alternatively, you can dial (866) 393-1607 or (914) 495-8556 and reference conference ID 7279188.

An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling (855) 859-2056 or (404) 537-3406, and reference conference ID 7279188.

On November 6, 2019 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that new preclinical data from its STING agonist program will be presented at the 34th annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Trillium Therapeutics, NOV 6, 2019, View Source [SID1234550409]). The meeting will be held November 6-10 in National Harbor, MD. The poster presentation will highlight the anti-tumor activity of TTI-10001, a novel small molecule STING agonist, when delivered intravenously or orally. Details of the presentation are listed 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!

Title: "TTI-10001, a next generation small molecule STING agonist, demonstrates potent anti-tumor activity in mice following intravenous or oral administration"

Presenter: Bob Uger, Ph.D., Chief Scientific Officer, Trillium Therapeutics Inc.

Date and Time: November 9, 2019 from 8:00 a.m. – 8:30 p.m. ET

Location: Gaylord National Hotel & Convention Center

Abstract Number: P668

On November 6, 2019 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported financial results for the third quarter ended September 30, 2019 and provided a corporate update (Press release, BioCryst Pharmaceuticals, NOV 6, 2019, View Source [SID1234550408]).

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!

"BioCryst is positioned for a transformational 2020, with the potential approval and launch of BCX7353 in the U.S., regulatory filings for BCX7353 in Japan and Europe, and data from our PNH proof of concept study with BCX9930 reading out in the first half of the year," said Jon Stonehouse, president and chief executive officer of BioCryst.

"We are also actively evaluating multiple approaches to add capital to the balance sheet by the end of 2019, as we did with the Japanese licensing agreement for BCX7353, which we announced earlier this week," Stonehouse added.

Upcoming Key Milestones

HAE Program – BCX7353

Submit a new drug application (NDA) for oral, once-daily BCX7353 for the prevention of hereditary angioedema (HAE) attacks with the U.S. Food and Drug Administration (FDA) (Q4 2019)

Submit a marketing authorization application for oral, once-daily BCX7353 for the prevention of HAE attacks with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the European Medicines Agency (EMA) (Q1 2020)

Commence ZENITH-2, a Phase 3 clinical trial of oral BCX7353 (750 mg) for the treatment of acute HAE attacks, in 2020, pending the completion of interactions with regulators on the Phase 3 program and additional work on the acute oral formulation (2020)
Complement Oral Factor D Inhibitor Program – BCX9930

Report data from a proof of concept study in paroxysmal nocturnal hemoglobinuria (PNH) patients receiving oral BCX9930 (1H 2020)
ALK-2 Inhibitor Program – BCX9250

Continue ongoing Phase 1 clinical trial of BCX9250, an oral ALK-2 kinase inhibitor for treatment of fibrodysplasia ossificans progressiva (FOP), in healthy subjects
Recent Corporate Developments

On November 6, 2019, the company provided a commercial update based on new 48-week clinical data from the APeX-2 and APeX-S trials, and detailed market research conducted with HAE patients, physicians who treat HAE and payors.

On November 5, 2019, the company announced it had licensed commercialization rights in Japan to Torii Pharmaceutical, Co. for BCX7353 for up to $42 million of upfront and potential milestone payments, including a $22 million upfront payment.
On November 1, 2019, the company announced it had begun enrollment of a Phase 1 trial of BCX9250, an oral ALK-2 inhibitor discovered and developed by BioCryst, for the treatment of FOP. The trial will evaluate the safety and tolerability and characterize the pharmacokinetic and pharmacodynamic profiles of BCX9250 in single and multiple ascending doses in healthy volunteers.
On November 1, 2019, the company announced results from a Phase 1 trial of BCX9930, an oral Factor D inhibitor discovered and developed by BioCryst, showing that BCX9930 was safe and generally well tolerated, and demonstrated rapid, sustained and >95% suppression of the alternative pathway of the complement system at 100 mg every 12 hours. Based on these results, the company is advancing the program into a proof of concept (PoC) study in PNH patients and plans to report data from the PoC study in the first half of 2020.
On September 26, 2019, the company announced the U.S. Department of Health and Human Services (HHS) had exercised its option to purchase an additional 10,000 doses of BioCryst’s approved antiviral influenza therapy, RAPIVAB (peramivir injection).
On September 23, 2019, the company announced it had appointed clinical rare disease expert, Helen Thackray, M.D., FAAP, to its board of directors.
Third Quarter 2019 Financial Results

For the three months ended September 30, 2019, total revenues were $1.8 million, compared to $1.5 million in the third quarter of 2018. The increase was primarily due to the recognition of $0.3 million of peramivir product sales to Shionogi & Co., Ltd., the company’s commercial partner in Japan.

Research and development (R&D) expenses for the third quarter of 2019 increased to $25.1 million from $22.0 million in the third quarter of 2018, primarily due to increased spending on our complement-mediated diseases programs, which entered Phase 1 clinical testing in June 2019.

Selling, general and administrative (SG&A) expenses for the third quarter of 2019 increased to $11.7 million, compared to $7.9 million in the third quarter of 2018. The increase was primarily due to increased spending on commercial activities and medical affairs to support the U.S. commercial launch of BCX7353 in 2020.

Interest expense was $3.0 million in the third quarter of 2019, compared to $2.3 million in the third quarter of 2018, and was primarily due to an increase in the outstanding balance of the company’s secured credit facility in February 2019.

Net loss for the third quarter of 2019 was $37.6 million, or $0.34 per share, compared to a net loss of $29.6 million, or $0.28 per share, for the third quarter of 2018.

Cash, cash equivalents and investments totaled $70.0 million at September 30, 2019, and reflect a decrease from $128.4 million at December 31, 2018. Operating cash use for the third quarter of 2019 was $24.5 million. Net operating cash use for the first nine months of 2019 was $77.9 million, as compared to $70.7 million for the first nine months of 2018.

Financial Outlook

BioCryst continues to expect full year 2019 net operating cash use to be in the range of $105 to $130 million, and its operating expenses to be in the range of $120 to $145 million. The company’s operating expense range excludes equity-based compensation expense due to the difficulty in reliably projecting this expense, as it is impacted by the volatility and price of the company’s stock, as well as by the vesting of the company’s outstanding performance-based stock options.

Conference Call and Webcast

BioCryst management will host a conference call and webcast at 8:00 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 4891026. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 4891026.

On November 6, 2019 Oncolytics Biotech Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that positive results from its previously announced phase 1b REO 024 study of pelareorep in combination with pembrolizumab (Merck’s Keytruda) have been published in the peer-reviewed medical journal Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Oncolytics Biotech, NOV 6, 2019, View Source [SID1234550407]). The study of 11 patients was conducted by Principal Investigator, Dr. Devalingam Mahalingam, Associate Professor of Medicine at Northwestern University Feinberg School of Medicine and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

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!

"Pelareorep and pembrolizumab added to chemotherapy was safe and well-tolerated and demonstrated encouraging efficacy results," said Dr. Mahalingam. "This study also highlighted the potential utility of several pre-treatment and on-treatment biomarkers for pelareorep therapy, which are currently being explored in our ongoing phase two study."

The phase 1b study was designed to assess the safety and tolerability of the treatment combination in patients with confirmed metastatic adenocarcinoma of the pancreas who failed or did not tolerate first-line treatment. In addition to a strong safety profile, positive findings from the study included objective responses indicating anti-tumor activity, long-term stabilization of disease and promotion of an inflamed phenotype in patients’ tumors. Importantly, these results supported advancing the combination regiment of pelareorep and Keytruda into phase 2 clinical development, which is currently ongoing.

"The publication of these encouraging clinical results in pancreatic cancer, which has extremely limited therapeutic options, serves as a validation for our approach to create inflammation within the tumour. As one of the final frontiers in oncology, we continue to evaluate pelareorep in patients with metastatic pancreatic cancer in our ongoing phase two study," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "While we remain focused, we do plan to expand our pipeline of indications and expect the results from our ongoing studies to show anti-tumor activity and confirm the predictive biomarker that will lay the groundwork to grow beyond our breast cancer program. We remain on track to report interim results from our ongoing phase two study in pancreatic cancer in the first half of 2020 and complete patient enrollment around mid-2020."

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On November 6, 2019 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 an update on the cytisinicline clinical development program and announced third quarter 2019 financial results (Press release, OncoGenex Pharmaceuticals, NOV 6, 2019, View Source [SID1234550406]).

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!

Q3 2019 Highlights

Announced extension of a strategic collaboration with the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH). As part of the collaboration, the NIH is funding and providing research efforts to conduct additional non-clinical development as requested by the FDA to support cytisinicline’s New Drug Application (NDA).

Presented positive efficacy and compliance results from the Phase 2b ORCA-1 dose-selection trial evaluating cytisinicline in 254 smokers at the Society for Research on Nicotine & Tobacco Europe (SRNT-E) 19th Annual Conference. Cytisinicline demonstrated a statistically significant improvement in quit rates for a simplified 3.0 mg, three times daily dose and was well-tolerated with no serious adverse events reported.

Hosted Company’s first Investor Day, including roundtable discussion with smoking cessation medical experts and presentation of final ORCA-1 data, including plans for Phase 3 development program.

Presented at the H.C. Wainwright 21st Annual Global Investment Conference and the Ladenburg Thalmann 2019 Healthcare Conference.

"It has been a busy and eventful quarter with progressive data analysis further reinforcing the strength of the ORCA-1 Phase 2b trial and the potential for cytisinicline as a new treatment for the millions of people who are battling nicotine addiction," commented Rick Stewart, Chairman and Chief Executive Officer of Achieve. "Our key priority in the fourth quarter is to advance the ongoing, extensive preparations for the Phase 3 clinical trials, including our upcoming meeting with the FDA to finalize the cytisinicline Phase 3 protocols."

Extended Collaboration with NIH

In July, Achieve announced an extension of its strategic collaboration with the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH). Under the extended collaboration, the NIH is funding and providing research efforts to conduct additional non-clinical studies as requested by the U.S. Food and Drug Administration (FDA) to be included in a cytisinicline New Drug Application (NDA). In discussions with the FDA in 2018, it was determined that a Good Laboratory Practice (GLP) non-clinical reproductive study would be required to support the NDA submission. NCCIH has agreed to sponsor this study which is expected to complete in 2020. In total, the NIH has committed approximately $6 million dollars to the development of cytisinicline.

Presented Final ORCA-1 Data at SRNT-E Conference

Achieve’s Chief Scientific Officer, Dr. Anthony Clarke, facilitated two oral presentations featuring data from the Phase 2b ORCA-1 trial at the SRNT-E Annual Conference in Oslo. The ORCA-1 trial of cytisinicline in 254 U.S. smokers demonstrated a statistically significant improvement in quit rates for the 3.0 mg, three times daily dosing (TID) schedule. In the 3.0 mg TID arm, a 54% abstinence rate at week 4, compared to 16% for placebo (p < 0.0001) was observed. Continuous abstinence at weeks 5 through 8 was 30% for cytisinicline compared to 8% for placebo (p= 0.005). Adherence to study treatment was 98% in the 3.0 mg TID arm and cytisinicline was well-tolerated with no serious adverse events reported.

Investor Day and KOL Roundtable Discussion

The Company hosted its first investor day on September 20th, 2019, featuring an updated ORCA-1 data presentation and a roundtable discussion of smoking cessation medical experts, Dr. Mitchell Nides, Dr. Nancy Rigotti, Dr. Judith Prochaska, and Dr. Scott Leischow. The experts highlighted the critical need for the availability of new treatments, like cytisinicline, as an aid to smoking cessation. A replay of the event can be found at View Source

Financial Results

As of September 30, 2019, the company’s cash, cash equivalents, and restricted cash was $7.4 million. Total operating expenses for the three and nine months ended September 30, 2019 were $3.7 million and $13.3 million, respectively. Total net loss for the three and nine months ended September 30, 2019 was $3.7 million and $13.2 million, respectively.

As of November 6, 2019 Achieve had 8,352,764 shares outstanding.

Conference Call Details

Achieve will host a conference call at 8:00 a.m. Eastern time today, Wednesday, November 6, 2019. 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 7196429. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.