On November 7, 2018 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and wet age‐related macular degeneration, reported financial results for the third quarter ended September 30, 2018 (Press release, Tracon Pharmaceuticals, NOV 7, 2018, View Source [SID1234530917]).

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Third Quarter 2018 and Recent Corporate Highlights

In September, we announced the publication of results from a Phase 1b clinical trial combining TRC105 with Inlyta (axitinib) in patients with advanced or metastatic renal cell carcinoma (RCC) in The Oncologist. These data were previously presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress in Copenhagen, Denmark. The open-label dose escalation and expansion Phase 1b study enrolled a total of 18 patients (17 of whom were evaluable for response) who had received at least one prior line of therapy with a VEGF receptor tyrosine kinase inhibitor. Patients in the trial received a combination of TRC105 and Inlyta and demonstrated an objective response rate (ORR) of 29%, an 88% overall disease control rate, and a median progression-free survival (PFS) of 11.3 months. For comparison, in a separate trial, the ORR seen in the large subgroup of VEGFR TKI-refractory patients treated with Inlyta (n=194) in the Inlyta AXIS Phase 3 study in second-line clear cell RCC patients was 11.3%, and median PFS was 4.8 months. The publication also noted that plasma levels of TGF-β receptor 3 (betaglycan) at baseline were significantly higher in patients who experienced a confirmed partial response, while levels of osteopontin were significantly lower at baseline for patients that achieved a confirmed partial response. Both markers correlated with time on study and their potential prognostic value will be investigated in the ongoing Phase 2b TRAXAR study. TRACON’s Phase 2b TRAXAR clinical trial of TRC105 in combination with Inlyta completed enrollment of 150 patients with advanced or metastatic RCC in Q3 2017 and top-line data are expected in December 2018.

In September, we announced that the sample size of the Phase 3 TAPPAS clinical trial of TRC105 in combination with Votrient was amended to increase the sample size to account for a higher than expected rate of withdrawal for progressive disease not confirmed by central review. The amended protocol was reviewed and accepted by the FDA, with retention of the special protocol assessment (SPA) agreement. We expect the interim analysis to determine the final sample size and eligible patient population of the trial in Q1 2019. The trial design was published in Annals of Oncology in October 2018 and was recognized as the Most Innovative Trial of 2017 by the Clinical and Research Excellence Awards.

In September, we submitted updated data from the Phase 1/2 trial of TRC105 and Nexavar in patients with hepatocellular carcinoma (HCC) to the Gastrointestinal Cancers Symposia of ASCO (Free ASCO Whitepaper), which meets in January 2019 in San Francisco. The trial completed Phase 1 enrollment and is currently enrolling up to 21 patients in the Phase 2 portion with overall response rate as the primary endpoint. Two of nine evaluable patients in the Phase 1 portion of the trial had durable confirmed partial responses (22%). For comparison, in separate Phase 3 trials, the durable confirmed partial responses seen with Nexavar in patients with HCC was 2% and 3%.

In October, we completed dose escalation of the Phase 1 trial of TRC105 in combination with Opdivo in lung cancer patients. We are currently enrolling two expansion cohorts of 12 patients each, one with patients naïve to PD-1/PD/L1 inhibitor therapy and one with patients who have relapsed following prior PD-1/PD-L1 therapy. We expect to provide top line safety and efficacy data from patients in the Phase 1 portion of the trial in December 2018.

In July, we completed the Phase 1 portion of a Phase 1/2 trial of TRC253 in patients with metastatic prostate cancer and are now enrolling patients in the Phase 2 portion of the trial at approximately 20 sites in the US. In the Phase 2 portion of the trial, we are incorporating circulating tumor DNA testing in order to allow for biomarker-directed therapy of prostate cancer patients who have progressed following treatment with an androgen receptor inhibitor. We now expect top line Phase 2 data in 2020, rather than 2019, due to slower than expected enrollment resulting from a lower than anticipated frequency of a specific tumor mutation targeted by TRC253 among metastatic prostate cancer patients. As a reminder, we licensed TRC253 from Janssen and if they exercise their right to reacquire the asset following Phase 2 proof of concept data, TRACON will be entitled to receive a $45M payment, up to $137.5M in additional potential milestones, and a low single digit royalty on sales.
"We anticipate significant potential catalysts over the next two quarters, including two randomized data points: top-line Phase 2 data from TRAXAR in renal cell carcinoma and interim Phase 3 results from TAPPAS in angiosarcoma" said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Of note, we continue to be encouraged by the rapid rate of accrual into the Phase 3 TAPPAS angiosarcoma trial."

Expected Upcoming Milestones

Announcement of safety and efficacy data from the Phase 2 trial of TRC102 in combination with Temodar in patients with glioblastoma at the Society for Neuro-Oncology annual meeting in November 2018.

Announcement of top-line data, including biomarker correlations, from the randomized Phase 2 TRAXAR trial of TRC105 in combination with Inlyta for patients with advanced or metastatic RCC is expected in December 2018.

Announcement of safety and efficacy data from the Phase 1b trial of TRC105 in combination with Opdivo in patients with non-small cell lung cancer is expected in December 2018.

Announcement of the results of the interim analysis from the Phase 3 pivotal TAPPAS trial of TRC105 in angiosarcoma is expected in Q1 2019.
Third Quarter 2018 Financial Results

Cash, cash equivalents and short-term investments were $47.2 million at September 30, 2018, compared to $34.5 million at December 31, 2017. We expect our current cash, cash equivalents and short-term investments to fund operations into Q4 2019.

Research and development expenses for the third quarter of 2018 were $7.0 million compared to $4.3 million for the third quarter of 2017. The increase was primarily attributable to increased TRC105 drug manufacturing activities and direct clinical trial expenses in the third quarter of 2018 as compared to the 2017 period.

General and administrative expenses for the third quarter of 2018 were $2.1 million compared to $1.8 million for the third quarter of 2017.

Net loss for the third quarter of 2018 was $9.1 million compared to net income of $1.2 million for the third quarter of 2017. The net income in the third quarter of 2017 was a result of receiving and recognizing as revenue a $7.0 million milestone payment from Santen.
Investor Conference Call

The Company will hold a conference call today at 4:30 p.m. EST / 1:30 p.m. PST to provide an update on corporate activities and to discuss the financial results of its third quarter of 2018. The dial-in numbers are (855) 779-9066 for domestic callers and (631) 485-4859 for international callers. Please use passcode 3189378. A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Carotuximab (TRC105)

TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in a pivotal Phase 3 trial in angiosarcoma and multiple Phase 2 clinical trials, in combination with VEGF inhibitors, as well as in a Phase 1 trial with Opdivo. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a randomized Phase 2 trial for patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.

About TRC102

TRC102 (methoxyamine) is a novel, clinical-stage small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute or Case Comprehensive Cancer Center. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.

About TRC253

TRC253 is a novel, orally bioavailable small molecule that is a potent, high affinity competitive inhibitor of the androgen receptor (AR) and AR mutations, including the F876L (also known as F877L) mutation. The AR F876L mutation results in an alteration in the AR ligand binding domain that confers resistance to therapies for prostate cancer. Activation of the AR is crucial for the growth of prostate cancer at all stages of the disease. Therapies targeting the AR have demonstrated clinical efficacy by extending time to disease progression, and in some cases, the survival of patients with metastatic castration-resistant prostate cancer. However, resistance to these agents is often observed and several molecular mechanisms of resistance have been identified, including gene amplification, overexpression, alternative splicing, and point mutation of the AR. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php

On November 7, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that Michael Kauffman, MD, PhD, Chief Executive Officer, will present at the Jefferies 2018 London Healthcare Conference on Wednesday, November 14, 2018 at 2:00 p.m. GMT at the Waldorf Hilton in London (Press release, Karyopharm, NOV 7, 2018, View Source [SID1234531000]).

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A live webcast of the event will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

On November 7, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported recent business highlights and financial results for the third quarter and first nine months of 2018 (Press release, BeiGene, NOV 7, 2018, View Source/phoenix.zhtml?c=254246&" target="_blank" title="View Source/phoenix.zhtml?c=254246&" rel="nofollow">View Source;p=RssLanding&cat=news&id=2375819 [SID1234531032]).

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"We now have three new drug applications currently under review with the China National Medical Products Administration, for zanubrutinib in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, as well as mantle cell lymphoma, and for tislelizumab in patients with relapsed/refractory classical Hodgkin’s lymphoma. Our team has accomplished a great deal advancing these promising oncology treatments towards potential commercial availability in China," said John V. Oyler, Co-Founder, Chief Executive Officer, and Chairman of BeiGene.

"The milestones this quarter pave the way for an exciting upcoming year that could further transform BeiGene," continued Oyler. "We expect to launch two innovative internally developed products in China, as well as have results from our global head-to-head study comparing zanubrutinib to ibrutinib in 2019."

Recent Business Highlights and Upcoming Milestones

Clinical Programs

Zanubrutinib (BGB-3111), an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK)

We are engaged in a series of continuing discussions with national regulatory authorities regarding new drug applications (NDAs) for zanubrutinib in Waldenström’s macroglobulinemia (WM) and other indications. We had previously announced a plan, based on discussions with the U.S. Food and Drug Administration (FDA), to file for accelerated approval in WM in the first half of 2019. Based on recent discussions with the FDA regarding our filing plans, we are revising guidance around the timing of our first NDA filing for zanubrutinib in the United States. We now expect to submit an initial NDA for zanubrutinib in the United States in 2019 or early 2020;

Submitted and received acceptance from the China National Medical Products Administration (NMPA) for our NDA for patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL);

Submitted and received acceptance by the NMPA for our NDA for patients with R/R chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL);

Initiated a global head-to-head Phase 3 trial versus ibrutinib in R/R CLL or SLL;

Announced updated results from the Phase 1 clinical trial in patients with WM that were presented at the 10th International Workshop on Waldenström’s Macroglobulinemia (IWWM). These data, in 73 evaluable patients with WM, continued to demonstrate that zanubrutinib was associated with high rates of overall (92%), major (82%) and very good partial response (VGPR; 41%) and was generally well-tolerated; and

Announced preliminary results from the Phase 1 clinical trial in Chinese patients with B-cell lymphomas from an oral presentation at the 21st Annual Meeting of the Chinese Society of Clinical Oncology (CSCO).
Expected Upcoming Milestones in 2018

Present full results of the pivotal Phase 2 trial in Chinese patients with R/R MCL in an oral presentation at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place December 1 to 4, 2018 in San Diego, CA;

BeiGene will hold an investor webcast from ASH (Free ASH Whitepaper) on Monday, December 3, at 8:00 pm PST. A live webcast and replay of the event will be available on BeiGene’s investor website, View Source;

Present updated safety and activity data from a global Phase 1 study in patients with MCL at ASH (Free ASH Whitepaper); and

Initiate a global Phase 2 trial in patients with R/R marginal zone lymphoma (MZL).
Tislelizumab (BGB-A317), an investigational humanized monoclonal antibody against the immune checkpoint receptor PD-1

Submitted and received acceptance from the China NMPA of our first NDA for tislelizumab as a treatment for patients with relapsed/refractory classical Hodgkin’s lymphoma (R/R cHL);

Announced preliminary results from the Phase 2 clinical trial in China of tislelizumab combined with chemotherapy as first-line treatment in patients with advanced lung cancer; and announced preliminary results of tislelizumab from the Phase 1/2 clinical trial in China in patients with non-small cell lung cancer from presentations at CSCO and the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer (WCLC);

Announced preliminary results from the Phase 1/2 trial in China in patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors at CSCO;

Completed enrollment in the Phase 2 pivotal trial in China for urothelial bladder cancer; and

Initiated the following trial:

° A Phase 2 trial in Chinese patients with MSI-H or dMMR solid tumors.
Expected Upcoming Milestones in 2018

Present data from the pivotal Phase 2 trial of tislelizumab in Chinese patients with R/R cHL in an oral presentation at ASH (Free ASH Whitepaper);

Present updated data from expansion cohorts in the Phase 1 trial at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) congress; and

Initiate additional global randomized frontline pivotal Phase 3 clinical trials in gastric and esophageal cancers in 2018 or early 2019, as well as additional pivotal trials in China in 2019.
Pamiparib (BGB-290), an investigational small molecule PARP inhibitor

Announced preliminary clinical data from an ongoing Phase 1 trial of pamiparib in combination with temozolomide in patients with locally advanced or metastatic solid tumors that were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress.
Expected Upcoming Milestones in 2018

Present Phase 1/2 trial data on pamiparib in combination with radiation therapy and/or temozolomide in patients with newly diagnosed or recurrent/refractory glioblastoma in an oral presentation at the 23rd Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO), being held November 15-18 in New Orleans, LA.
Sitravatinib, an investigational tyrosine kinase inhibitor of receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, MER), split family receptors (VEGFR2, KIT) and RET, licensed from Mirati Therapeutics in Asia (excluding Japan), Australia, and New Zealand

Initiated a Phase 1 trial in China and Australia in combination with tislelizumab in patients with advanced solid tumors.
Commercial Programs in China

Generated $38.45 million in product revenue from sales in China of ABRAXANE, REVLIMID and VIDAZA in the third quarter of 2018, a 22% increase quarter-over-quarter, and 146% growth compared to the fourth quarter of 2017, the first full quarter following the license of these products from Celgene; and

Received national reimbursement in China from the State Medical Insurance Administration (SMIA) for VIDAZA (azacitidine for injection) for the treatment of patients with intermediate-2 / high-risk myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) with 20-30% bone marrow blasts and chronic myelomonocyte leukemia (CMML).
Corporate Developments

Announced a global clinical collaboration with MEI Pharma, Inc. to evaluate the safety and efficacy of MEI’s ME-401, an investigational PI3K delta inhibitor, in combination with zanubrutinib for the treatment of patients with B-cell malignancies;

Announced a global clinical collaboration with SpringWorks Therapeutics to evaluate the safety, tolerability, and preliminary efficacy of combining lifirafenib and SpringWorks Therapeutics’ investigational MEK inhibitor, PD-0325901, in patients with advanced solid tumors; and

Appointed Dr. Jian (Jonathan) Liu as Senior Vice President of Bio-Manufacturing. Prior to joining BeiGene, Dr. Liu served on the Senior Leadership Team of Johnson & Johnson (J&J) Global Pharmaceutical Development & Manufacturing Sciences (PDMS) and China R&D, respectively, responsible for PDMS business strategy development and regional execution.
Third Quarter 2018 Financial Results

Cash, Cash Equivalents, Restricted Cash and Short-Term Investments were $2.10 billion as of September 30, 2018, compared to $1.40 billion as of June 30, 2018 and $837.52 million at December 31, 2017. The increase from the last quarter was primarily due to the net proceeds of $869.71 million from our global offering and listing on the Hong Kong Stock Exchange. Cash, cash equivalents, restricted cash and short-term investments as of September 30, 2018 include approximately $143.16 million held by our 95%-owned joint venture, BeiGene Biologics, to build a commercial biologics manufacturing facility under construction in Guangzhou, China, which includes restricted cash of $36.26 million related to BeiGene Biologics’ secured deposits.

Cash used by operations for the three months ended September 30, 2018 was $132.19 million, compared to cash generated by operations of $6.60 million for the same period in 2017. The increase in the use of cash was primarily attributable to the continued ramp-up in operating expenses in support of our ongoing and newly initiated late-stage pivotal clinical programs, preparation for regulatory filings and commercial launch of our late-stage drug candidates, and organizational growth, offset in part by revenue from product sales in China; in the prior period in 2017, cash generated by operations reflected receipt of the up-front payment from Celgene Corporation in connection with our license agreement for tislelizumab. Capital expenditures for the three months ended September 30, 2018 were $26.72 million, compared to $18.79 million for the same period in 2017. The increase was primarily attributable to the continued buildout of our manufacturing facility in Guangzhou.

Revenue for the three months ended September 30, 2018 was $54.20 million, compared to $220.21 million in the same period in 2017. The decrease is primarily attributable to the upfront payment recognized in the prior year period under our collaboration agreement with Celgene for tislelizumab.

Product revenue from sales of ABRAXANE, REVLIMID and VIDAZA in China totaled $38.45 million for the third quarter of 2018, compared to $31.43 million for the three months ended June 30, 2018, and $8.82 million for the three months ended September 30, 2017 (which only included one month of product sales following the in-license from Celgene), respectively.

Collaboration revenue totaled $15.76 million for the third quarter of 2018, compared to $21.38 million for the three months ended June 30, 2018, and $211.39 million for the three months ended September 30, 2017, respectively. The decrease, compared to the second quarter of 2018, is primarily due to lower research and development costs in the period on clinical trials that are being reimbursed by Celgene. The decrease, compared to the third quarter of 2017, is due primarily to the upfront revenue recognized in the third quarter of 2017 from the Celgene collaboration.
Expenses for the three months ended September 30, 2018 were $205.30 million, compared to $105.31 million in the quarter ended September 30, 2017, consisting primarily of the following:

Cost of sales for the three months ended September 30, 2018 were $8.71 million, compared to $1.94 million in the third quarter of 2017 (which only included one month of sales), an increase of 348.97 percent. Cost of sales relates to the cost of acquiring ABRAXANE, REVLIMID and VIDAZA for distribution in China.

R&D Expenses for the three months ended September 30, 2018 were $147.59 million, compared to $87.66 million in the same period in 2017, an increase of 68.4%. The increase in R&D expenses was primarily attributable to increased spending on our ongoing and newly initiated late-stage pivotal clinical trials, preparation for regulatory filings and commercial launch of our late-stage drug candidates, manufacturing costs related to pre-commercial activities and supply, as well as increases in spending related to our preclinical-stage programs. The overall increase in R&D expenses was also attributable to increased R&D-related employee share-based compensation expense, which was $15.52 million for the three months ended September 30, 2018, compared to $10.38 million for the same period in 2017, due to increased headcount and a higher share price.

SG&A Expenses for the three months ended September 30, 2018 were $48.82 million, compared to $15.64 million in the same period in 2017, an increase of 212.1%. The increase in SG&A expenses was primarily attributable to increased headcount, including the expansion of our commercial team to support the distribution of our existing commercial products in China and the potential launches of our late-stage drug candidates, higher professional service fees and costs to support our growing operations, and higher SG&A-related share-based compensation expense, which was $9.61 million for the three months ended September 30, 2018, compared to $2.95 million for the same period in 2017, due to increased headcount and a higher share price.

Net Loss for the third quarter of 2018 was $144.03 million, or $2.53 per American Depositary Share (ADS), compared to net income of $117.39 million, or $2.79 per ADS in the same period in 2017. For the third quarter of 2018, net loss per ordinary share was $0.19, compared to net income of $0.21 in the same period in 2017.

On November 7, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported that Marty Duvall, chief executive officer, reported that it will present at the following upcoming investor conferences (Press release, Tocagen, NOV 7, 2018, View Source;p=RssLanding&cat=news&id=2375950 [SID1234531165]):

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Wednesday, November 14, 11:00-11:40 a.m. ET in New York City
Stifel Nicolaus Healthcare Conference

Tuesday, November 27, 4:35-4:55 p.m. ET in Boston
Evercore ISI Biopharma Catalyst/Deep Dive Conference

The live audio webcasts from the conferences and subsequent replay may be accessed by visiting the "Events & Presentations" page in the investors section of Tocagen’s website. The webcasts will be available shortly after conclusion of the presentation and archived on the company’s website for 90 days following the presentation.

On November 7, 2018 Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, reported third quarter 2018 financial results (Press release, OncoGenex Pharmaceuticals, NOV 7, 2018, View Source [SID1234531181]).

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Recent Highlights

The United States Adopted Name Council, or USAN, adopted cytisinicline as the nonproprietary (generic) name for the substance also known as cytisine

Announced initiation of the first trial in the ORCA (Ongoing Research of Cytisinicline for Addiction) Program. This Phase 2b optimization study will evaluate approximately 250 smokers in the U.S.

Reported results of a clinical study evaluating the effect of food on the bioavailability of a new formulation for cytisinicline

Closed registered direct offering for gross proceeds of $5.6 million

Announced positive cytisinicline data published in the International Journal of Drug Policy

Rick Stewart, Chairman and Chief Executive Officer of Achieve Life Sciences commented, "We are pleased with our continued progress made in the third quarter, particularly the initiation of the ORCA-1 trial that will provide critical insights to inform our Phase 3 program expected to initiate in the second-half of 2019."

"Cytisinicline" Designated as New Generic Name for Cytisine

The United States Adopted Names (USAN) Council adopted cytisinicline as the nonproprietary (generic) name in Q3 2018. USAN is responsible for selecting simple, informative, and unique generic drug names. The USAN Council establishes logical nomenclature classifications based on pharmacological and/or chemical relationships.

Initiated Phase 2b "ORCA-1"Optimization Trial

ORCA-1 is the first in Achieve’s ORCA (Ongoing Research of Cytisinicline for Addiction) Program that aims to evaluate the effectiveness of cytisinicline for smoking cessation and potentially other indications. This Phase 2b trial will evaluate both the 1.5mg and 3mg doses of cytisinicline on a declining titration schedule over 25 days, as well as three times daily dosing. The trial is randomized and blinded to compare the effectiveness of the cytisinicline doses and schedules to respective placebo groups. The primary efficacy endpoint is reduction in the number of cigarettes smoked during treatment with secondary analyses to be conducted on smoking cessation rates, safety, and compliance. ORCA-1 is being conducted at eight centers across the U.S. and results are expected in mid-2019.

Announced Study Results for New Formulation

The study evaluated the bioavailability of a new formulation of cytisinicline under fed and fasted conditions in 12 healthy volunteer smokers. Results demonstrated bioequivalence when cytisinicline was administered with or without food and that the 3mg dose of this new formulation was well tolerated.

Completed $5.6M Financing

Achieve announced the closing of a registered direct offering that raised total gross proceeds of $5.6 million and after deducting approximately $0.6 million in placement agent fees and offering expenses, receiving net proceeds of $5.0 million.

Publication of New Cytisinicline Data in the International Journal of Drug Policy

Results of an observational study comparing the effectiveness of cytisinicline and nicotine replacement therapy (NRT) as an aid to smoking cessation in the Russian Federation determined that smokers in the cytisinicline group were approximately three times more likely to achieve 90-days abstinence compared to those who attempted to quit with NRT (p=0.011). The authors concluded the findings support previous trial evidence indicating that cytisinicline is superior to NRT for achieving short- and long-term abstinence and should be considered a first-line pharmacologic treatment for smoking cessation.

Financial Results

As of September 30, 2018, the company’s cash, cash equivalents, short-term investments and restricted cash were $13.2 million. Total operating expenses for the three and nine months ended September 30, 2018 were $3.3 million and $9.1 million, respectively. Total net loss for the three and nine months ended September 30, 2018 was $3.2 million and $9.1 million, respectively

As of November 7, 2018 Achieve had 6,721,103 shares outstanding.

Conference Call Details

Achieve will host a conference call at 4:30 p.m. Eastern time today, Wednesday, November 7, 2018, to provide an update on the cytisinicline clinical development program and announce third quarter 2018 financial results. To access the webcast, log on to the Investor Relations page of the Achieve website at View Source Alternatively, you may access the live conference call by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 9922429. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.