On August 9, 2019 AstraZeneca reported positive overall survival (OS) results from the Phase III FLAURA trial, a randomised, double-blinded, multi-centre trial of Tagrisso (osimertinib) in previously-untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations (Press release, AstraZeneca, AUG 9, 2019, View Source [SID1234538494]).

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Tagrisso showed a statistically-significant and clinically-meaningful improvement in OS, a secondary endpoint in the FLAURA Phase III trial, compared with erlotinib or gefitinib both of which were previous standard-of-care (SoC) treatments in this setting. The FLAURA trial met its primary endpoint in July 2017, showing a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS), increasing the time patients lived without disease progression or death from any cause. The safety and tolerability of Tagrisso was consistent with its established profile.

José Baselga, Executive Vice President, Oncology R&D said: "Today’s positive results show that Tagrisso provides an unprecedented survival outcome versus previous standard-of-care epidermal growth factor receptor tyrosine kinase inhibitors, reaffirming Tagrisso as the 1st-line standard-of-care for EGFR-mutated metastatic non-small cell lung cancer."

AstraZeneca plans to present the OS results from the FLAURA trial at a forthcoming medical meeting.

Tagrisso is currently approved in 74 countries, including the US, Japan and the EU, for 1st-line EGFRm metastatic NSCLC.

About lung cancer

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths, more than breast, prostate and colorectal cancers combined.1 Lung cancer is broadly split into NSCLC and small cell lung cancer (SCLC), with 80-85% classified as NSCLC.2 Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFR-mutated (EGFRm) NSCLC.3-5 These patients are particularly sensitive to treatment with EGFR-tyrosine kinase inhibitors (TKI) which block the cell-signalling pathways that drive the growth of tumour cells. Approximately 25% of patients with EGFRm NSCLC have brain metastases at diagnosis, increasing to approximately 40% within two years of diagnosis.6 The presence of brain metastases often reduces median survival to less than eight months.7

About Tagrisso

Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against central nervous system metastases. Tagrisso 40mg and 80mg once-daily oral tablets have now received approval in more than 70 countries, including the US, Japan and the EU, for 1st-line EGFRm advanced NSCLC, and in more than 80 countries, including the US, Japan, China and the EU, for 2nd-line use in patients with EGFR T790M mutation-positive advanced NSCLC. Tagrisso is also being developed in the adjuvant setting (ADAURA trial), in the locally-advanced unresectable setting (LAURA), in combination with chemotherapy (FLAURA2) and with potential new medicines (SAVANNAH, ORCHARD).

About FLAURA

The FLAURA trial assessed the efficacy and safety of Tagrisso 80mg orally once daily vs. comparator EGFR-TKIs (either erlotinib [150mg orally, once daily] or gefitinib [250mg orally, once daily]) in previously-untreated patients with locally-advanced or metastatic EGFRm NSCLC. The trial was double-blinded and randomised, with 556 patients across 29 countries.

About AstraZeneca in lung cancer

AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage clinical development for the treatment of different forms of lung cancer spanning several stages of disease, lines of therapy and modes of action. We aim to address the unmet needs of patients with EGFR-mutated tumours as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with our approved medicines Iressa (gefitinib) and Tagrisso, and ongoing Phase III trials ADAURA, LAURA, FLAURA and FLAURA2 as well as the Phase II combination trials SAVANNAH and ORCHARD.3-5

Our extensive late-stage Immuno-Oncology programme focuses on lung cancer patients without a known genetic mutation which represents up to 50% of all patients with lung cancer. Imfinzi (durvalumab), an anti-PDL1 antibody, is in development as monotherapy (Phase III trials ADJUVANT BR.31, PACIFIC-4, PACIFIC-5, and PEARL) and in combination with tremelimumab and/or chemotherapy (Phase III trials AEGEAN, PACIFIC-2, NEPTUNE, POSEIDON, ADRIATIC and CASPIAN).

About AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

On August 9, 2019 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing therapeutics and pharmaceutical products in China, U.S., and throughout the world, reported financial results for the second quarter and six months ended June 30, 2019 and provided a review of recent accomplishments and anticipated milestones (Press release, CASI Pharmaceuticals, AUG 9, 2019, View Source [SID1234538536]).

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "Our financial results remained strong through the second quarter of 2019. We look forward to launching the first product from our hematology oncology pipeline, EVOMELA, this quarter and fully transitioning into a commercial organization. We are enthusiastic about our growth and momentum, and continue to pursue additional strategic assets for our pipeline, both in our hematology/oncology space as well as other high quality treatment solutions for patients."

Second Quarter and Recent Business Highlights

Acquired exclusive worldwide rights to commercialize anti-CD19 T-cell therapy in China and worldwide – On June 17, 2019, CASI signed a license agreement for exclusive worldwide commercialization rights to an autologous anti-CD19 T-cell therapy product (CNCT19) from Juventas Cell Therapy Ltd. CNCT19 targets CD-19, a B-cell surface protein widely expressed during all phases of B-cell development and is a validated target for B-cell driven hematological malignancies. CD19 antigen is the most frequently used biomarker in CAR-T cell therapy clinical trials for hematological malignancies.

Acquired exclusive worldwide rights to a novel anti-CD38 monoclonal antibody (CID-103) – On April 17, 2019, CASI acquired exclusive global rights to a novel anti-CD38 monoclonal antibody (CID-103). CID-103 is a human monoclonal antibody targeting a specific epitope of the CD38 cell surface antigen. CID-103 is at the IND/IMPD submission stage of development with initiation of the Phase 1 study targeted for early 2020.

EVOMELA (Melphalan Hydrochloride for Injection) expected to launch in China this quarter – The Company has made significant progress and commercial preparations for the launch of EVOMELA and expects commercialization this quarter. It will be the only approved melphalan product available in China.

Second Quarter and First Half 2019 Financial Results

Cash Position: As of June 30, 2019, CASI had cash and cash equivalents of $70.3 million compared to $99.7 million as of March 31, 2019. The decrease in cash is primarily due to the Black Belt and Juventas investments made during the three months ended June 30, 2019.

R&D Expenses: Research and development (R&D) expenses for the three and six months ended June 30, 2019, were $3.0 million and $5.6 million, respectively, compared to $1.7 million and $3.4 million for the same periods in 2018. The increase in R&D expenses primarily reflects costs associated with regulatory, consulting and manufacturing related services, as well as an increase in personnel costs due to growth in the number of employees.

G&A Expenses: General and administrative (G&A) expenses for the three and six months ended June 30, 2019, were $7.0 million and $12.7 million, respectively, compared to $4.0 million and $5.3 million for the same periods in 2018. The increase in G&A for both the three and six months ended June 30, 2019 was related to a combination of factors primarily resulting from the Company’s growth in China. These factors include an increase in salary, benefits and recruitment expense and facilities costs due to increases in head count, sales and marketing efforts to prepare for the anticipated launch of the Company’s first commercial product (EVOMELA), professional services fees (including audit and legal services), and an increase in non-cash stock compensation expense largely attributed to stock options issued to the President of CASI China and other new employees.

Net Loss: The Company reported a net loss for the three and six months ended June 30, 2019 of ($15.3) million, or ($0.16) per share, and ($23.4) million, or ($0.25) per share, respectively, compared to ($5.9) million, or ($0.07) per share, and ($9.5) million, or ($0.12) per share for the same periods in 2018. The larger net loss is primarily due to acquired in-process research and development expenses related to the Black Belt license, and the increase in both G&A and R&D expenses primarily due to the Company’s growth in China to support the Company’s first commercial product (EVOMELA).

Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, can be found at www.casipharmaceuticals.com.

On August 9, 2019 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease, reported that John P. Butler, President and Chief Executive Officer of Akebia, will participate in the following investor conferences (Press release, Akebia, AUG 9, 2019, View Source [SID1234538552]):

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The BTIG Biotechnology Conference 2019 on Monday, August 12, 2019 in New York City, New York (no formal presentation).
The Morgan Stanley 17th Annual Global Healthcare Conference on Monday, September 9, 2019 at 8:45 a.m. in New York City, New York.
Where applicable, a live webcast and replay of the Company’s presentation will be available on the Company’s website at www.akebia.com.

On August 8, 2019 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, anticipated upcoming milestones, and financial results for the second quarter and first half of 2019 (Press release, BeiGene, AUG 8, 2019, View Source [SID1234538413]).

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"This quarter, our team continued to deliver across all functions, with the completion of enrollment in five Phase 3 or pivotal trials and the initiation of three new Phase 3 trials in oncology indications where we expect to have a profound impact on people fighting both hematologic and solid tumors. We believe that we are well-positioned to continue running our late-stage trials, including those for tislelizumab, for which we re-acquired full global rights from Celgene in advance of the closing of its pending acquisition by Bristol-Myers Squibb," said John V. Oyler, Co-Founder, Chief Executive Officer, and Chairman of BeiGene. "We are progressing well with our U.S. and China product launch preparations, including our commercial and manufacturing build-outs, and we expect the remainder of 2019 and 2020 to be transformative for BeiGene, with readouts from up to 10 ongoing Phase 3 or potentially registration-enabling studies in addition to planned commercial launches of two of our internally developed products."
Recent Business Highlights and Upcoming Milestones
Clinical Programs
Zanubrutinib, an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to maximize BTK occupancy and minimize off-target effects

Completed enrollment in the global Phase 3 SEQUOIA trial (NCT03336333) comparing zanubrutinib with bendamustine plus rituximab in patients with treatment-naive (TN) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL);

Achieved first patient dosing in a Phase 1b trial (NCT02914938) conducted by MEI Pharma of zanubrutinib in combination with ME-401, an investigational selective oral phosphatidylinositol 3-kinase (PI3K) delta inhibitor;

Presented data at the 15th International Conference on Malignant Lymphoma (ICML), including:
–
Clinical data from the pivotal Phase 2 trial (NCT03206918) in China in patients with relapsed/refractory (R/R) CLL or SLL;
–
Updated data from the pivotal Phase 2 trial (NCT03206970) in China in patients with R/R mantle cell lymphoma (MCL);
–
Updated data from the global Phase 1/2 trial (NCT02343120) in patients with different subtypes of B-cell malignancies, including MCL;
–
Updated data from the Phase 1b combination trial (NCT02569476) with GAZYVA (obinutuzumab) in patients with R/R or TN CLL or SLL, and patients with R/R follicular lymphoma (FL).

Presented data at the 24th Congress of European Hematology Association (EHA) (Free EHA Whitepaper), including:
–
Clinical data from the nonrandomized cohort in patients with MYD88wt Waldenström’s Macroglobulinemia (WM) from the Phase 3 ASPEN trial (NCT03053440). The randomized cohort of the study, in patients with MYD88mut WM, is ongoing;
–
Updated results from the ongoing Phase 1 trial (NCT02343120) of patients with WM;
–
Pooled safety data from six ongoing monotherapy studies in patients with B-cell malignancies; and

Published in Blood, the Journal of the American Society of Hematology (ASH) (Free ASH Whitepaper), an article on the Phase 1 trial of zanubrutinib in R/R B-cell malignancies, including CLL/SLL.
Expected Milestones for Zanubrutinib

Receive approvals in China for the treatment of patients with R/R MCL and R/R CLL/SLL in the first half of 2020. The Company expects manufacturing inspections to occur after the completion of the technical reviews. In addition, non-clinical and chemistry, manufacturing and controls (CMC) supplemental information was requested and has been provided;

File an initial New Drug Application (NDA) in the U.S. in 2019 or early 2020;

File a supplemental new drug application (sNDA) in China for WM in 2019;

Announce top-line results from the Phase 3 ASPEN trial comparing zanubrutinib to ibrutinib in patients with WM in 2019;

Announce top-line interim analysis from the SEQUOIA trial comparing zanubrutinib with bendamustine plus rituximab in patients with TN CLL or SLL as early as 2020; and

Initiate a global Phase 3 clinical trial (NCT04002297) comparing zanubrutinib plus rituximab versus bendamustine plus rituximab in patients with previously untreated MCL who are ineligible for stem cell transplant in 2019.
Tislelizumab, an investigational humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages

Filed an sNDA in China for patients with previously treated locally-advanced or metastatic urothelial carcinoma (UC); the sNDA has been granted priority review status from the China National Medical Products Administration (NMPA);

Regained full global rights from Celgene in advance of its pending acquisition by Bristol-Myers Squibb, and received a payment of $150 million in connection with the termination;

Completed enrollment in the Phase 3 trials in China of tislelizumab combined with chemotherapy in the front-line setting for patients with advanced squamous (NCT03594747) and non-squamous (NCT03663205) non-small cell lung cancer (NSCLC);

Initiated the following trials:
–
A Phase 3 randomized trial (NCT04005716) in China of platinum plus etoposide with or without tislelizumab in patients with untreated extensive-stage small cell lung cancer (SCLC);
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A Phase 3 randomized trial (NCT03967977) in China of tislelizumab in combination with chemotherapy versus chemotherapy alone in patients with previously untreated locally advanced or metastatic UC; and
–
A Phase 3 randomized trial (NCT03957590) in China of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized esophageal squamous cell carcinoma (ESCC).

Presented updated clinical results from the pivotal Phase 2 trial (NCT03209973) in China in patients with R/R classical Hodgkin lymphoma (cHL) at EHA (Free EHA Whitepaper); and

Presented preliminary Phase 2 results from the Phase 1/2 trial (NCT03924986) in China in patients with nasopharyngeal cancer (NPC) at ASCO (Free ASCO Whitepaper).
Expected Milestones for Tislelizumab

Receive NDA approval in China for treatment of patients with R/R cHL in 2019;

Announce top-line results from the global Phase 2 trial (NCT03419897) in second- or third-line patients with hepatocellular carcinoma (HCC) in 2019 or early 2020 and have regulatory discussions;

Announce top-line results from the Phase 3 trial (NCT03594747) in first-line squamous NSCLC in China in 2019 or 2020;

Announce top-line results from the Phase 3 trial (NCT03663205) in first-line non-squamous NSCLC in China in 2020; and

Complete enrollment in the global first-line Phase 3 trial (NCT03412773) in HCC in 2019 and the global portion of the second-line Phase 3 trial (NCT03358875) in NSCLC in 2019 or early 2020.
Pamiparib, an investigational small molecule PARP inhibitor

Completed enrollment in the Phase 3 randomized trial in China (NCT03519230) of pamiparib versus placebo as a potential maintenance treatment in patients with platinum-sensitive recurrent ovarian cancer;

Completed enrollment in the pivotal Phase 2 trial in China (NCT03333915) in third-line and above patients with ovarian cancer with germ-line BRCA mutation; and

Published in The Lancet Oncology an article on the Phase 1A/B trial of pamiparib in combination with tislelizumab in patients with advanced solid tumors.
Expected Milestones for Pamiparib

Announce top-line results from the pivotal Phase 2 trial in Chinese patients with previously treated ovarian cancer in 2020; and

Announce top-line results from the Phase 3 trial in China of pamiparib versus placebo as a potential maintenance treatment in patients with platinum-sensitive recurrent ovarian cancer in 2020.
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 1/2 trial (NCT03941873) in China of sitravatinib in combination with tislelizumab in patients with unresectable locally advanced or metastatic HCC or gastroesophageal junction cancer.
BGB-A1217, an investigational TIGIT monoclonal antibody discovered by BeiGene scientists
Expected Milestones for BGB-A1217

Initiate patient enrollment in a Phase 1a/1b trial in China and Australia investigating the safety, tolerability, pharmacokinetics and preliminary antitumor activity of BGB-A1217 in combination with tislelizumab in patients with advanced solid tumors in 2019.
Manufacturing Facilities

Completed equipment installation and systems qualification of the Company’s biologics manufacturing facility in Guangzhou, China. We expect manufacturing and validation of tislelizumab drug substance to begin later this year.
Commercial Product Portfolio

Generated $58.14 million in product revenue in the three months ended June 30, 2019, from sales in China of ABRAXANE, REVLIMID and VIDAZA, which represents an 85.0% increase compared to the same period in 2018; and

Announced that the China National Medical Products Administration (NMPA, formerly known as CFDA) accepted the supplemental import drug application for ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), in combination with gemcitabine, as a potential first-line treatment of patients with metastatic adenocarcinoma of the pancreas (mPC).
Corporate Developments

Received approval from the Stock Exchange of Hong Kong Limited (HKEX) to transition into a general listing under Rule 8.05(3) by meeting its specified revenue and market capitalization thresholds. As a result of the approval, the "B" marker was removed from the Company’s stock symbol in the HKEX, and the Company’s ordinary shares may become eligible for listing in the Hang Seng indices;

Along with SpringWorks Therapeutics, announced the formation of MapKure, LLC to develop BGB-3245, an investigational, selective next-generation RAF kinase inhibitor discovered by BeiGene scientists;

Appointed Qingyi "Anita" Wu as Chief Commercial Officer, Greater China. Prior to joining BeiGene, Anita served as General Manager of the Specialty Care business unit at Sanofi China; and

Appointed Yan "Lily" Liu as Vice President, Head of Marketing, Greater China. Lily was most recently Vice President, Head of the Specialty Care business unit at Takeda China.

Second Quarter 2019 Financial Results
Cash, Cash Equivalents, Restricted Cash and Short-Term Investments were $1.56 billion as of June 30, 2019, compared to $1.64 billion as of March 31, 2019 and $1.81 billion as of December 31, 2018.

The decrease of $76.07 million in the second quarter of 2019 was primarily due to $46.10 million of cash used in operating activities, $21.45 million for investments in property, plant and equipment, and $20 million for an upfront payment related to the BioAtla collaboration agreement.
Revenue for the quarter ended June 30, 2019 was $243.35 million, compared to $52.80 million in the same period in 2018. The increase is primarily attributable to the $150 million payment received in connection with the termination of the tislelizumab collaboration agreement with Celgene, the recognition of previously deferred revenue from the collaboration as well as increased product revenue from sales of the in-licensed products from Celgene in China.

Product revenue from sales of ABRAXANE, REVLIMID and VIDAZA in China totaled $58.14 million for the second quarter ended June 30, 2019, compared to $31.43 million for the same period in 2018.

Collaboration revenue totaled $185.20 million for the second quarter ended June 30, 2019, compared to $21.38 million for the same period in 2018. The increase is due primarily to the $150 million payment in connection with the termination of our tislelizumab collaboration agreement with Celgene, as well as the recognition of previously deferred revenue from the collaboration.
Expenses for the second quarter ended June 30, 2016 were $329.18 million, compared to $215.85 million in the same period in 2018.

Cost of sales for the second quarter ended June 30, 2019 were $17.84 million, compared to $6.26 million in the same period in 2018. Cost of sales related to the cost of acquiring ABRAXANE, REVLIMID and VIDAZA for distribution in China.

R&D Expenses for the second quarter ended June 30, 2019 were $228.76 million, compared to $164.25 million in the same period in 2018. 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 submissions and commercial launch of our late-stage drug candidates, and manufacturing costs related to pre-commercial activities and supply. Additionally, we expensed $20.0 million for the upfront payment related to the BioAtla collaboration agreement. Employee share-based compensation expense also contributed to the overall increase in R&D expenses, and was $18.15 million for the second quarter ended June 30, 2019, compared to $10.72 million for the same period in 2018, due to increased headcount.

SG&A Expenses for the second quarter ended June 30, 2019 were $82.25 million, compared to $45.16 million in the same period in 2018. 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 commercial products in China and the potential launches of our late-stage drug candidates, as well as higher professional service fees and costs to support our growing operations. The overall increase in SG&A expenses was also attributable to higher SG&A-related share-based compensation expense, which was $14.45 million for the second quarter ended June 30, 2019, compared to $7.92 million for the same period in 2018, due to increased headcount.

Net Loss for the second quarter ended June 30, 2019 was $85.57 million, or $0.11 per share, or $1.43 per American Depositary Share (ADS), compared to $156.89 million, or $0.22 per share, or $2.92 per ADS in the same period in 2018.

[1] The bank loan is attributable to BeiGene Biologics, a joint venture that is 95% owned by BeiGene, Ltd., which totaled $84.49 million as of June 30, 2019, and the current portion of long-term debt for a term note secured by our Suzhou manufacturing facility.
[2] The shareholder loan is attributable to a RMB900 million convertible note obtained in 2017 from our joint venture partner for the construction and operation of our manufacturing facilities in Guangzhou.

On August 8, 2019 Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, reported an update on the cytisinicline clinical development program and second quarter 2019 financial results (Press release, OncoGenex Pharmaceuticals, AUG 8, 2019, View Source [SID1234538429]).

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Q2 2019 Highlights

Reported positive results from the Phase 2b ORCA-1 dose-selection trial evaluating cytisinicline in 254 smokers. Cytisinicline demonstrated a statistically significant improvement in quit rates for a simplified 3.0 mg, three times daily dose. Cytisinicline was well-tolerated with no serious adverse events reported.

Announced ORCA-1 data has been accepted for an oral presentation at the Society for Research on Nicotine & Tobacco Europe (SRNT-E) 19th Annual Conference to be held in Oslo, Sept. 12-14, 2019

Patent granted in the U.S. for new cytisinicline succinate salt formulation designed to enhance product stability and long-term potency

Received $4.2 million in proceeds from exercise of warrants

"It has been an exciting quarter with the release of the positive ORCA-1 Phase 2b trial results that demonstrated impressive smoking cessation efficacy, safety, and cytisinicline treatment adherence," commented Rick Stewart, Chairman and Chief Executive Officer of Achieve. "The data exceeded our expectations and provide a clear path forward for our future Phase 3 program."

ORCA-1 Positive Study Results

The Phase 2b ORCA-1 trial of cytisinicline in 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.

Cytisinicline Data Accepted for Presentation

Data from the Phase 2b ORCA-1 trial has been accepted for oral presentation at the SRNT-E Annual Conference, to be held in Oslo, September 12-14, 2019. The abstract "A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2b Trial of Cytisinicline in Adult Smokers" and two, oral presentations will include updated cytisinicline data from the recently completed trial.

Patent Granted in the U.S. for Novel Formulation of Cytisinicline

The U.S. Patent and Trademark Office has granted Achieve a patent on succinate salt of cytisinicline and use thereof. The patent covers a novel salt form of cytisinicline, namely cytisinicline succinate, and pharmaceutical compositions and dosage forms. Achieve has been pursuing cytisinicline

succinate salt as a novel new drug product formulation that may further enhance cytisinicline product stability and long-term potency.

Received $4.2 Million from Exercise of Warrants

Achieve announced that it had entered into an agreement with a single investor to exercise outstanding warrants that provided an aggregate of $4.2 million in total proceeds. In exchange for the warrant exercise, Achieve issued to the investor a new warrant, exercisable for six years, to purchase up to 1,200,000 shares of Common Stock at an exercise price of $4.50 per share. The Company filed an S-1 registration statement on July 24, 2019 covering the resale of the shares issuable upon exercise of the new warrant.

Financial Results

As of June 30, 2019, the company’s cash, cash equivalents, and restricted cash was $10.5 million. Total operating expenses for the three and six months ended June 30, 2019 were $3.7 million and $9.6 million, respectively. Total net loss for the three and six months ended June 30, 2019 was $3.6 million and $9.5 million, respectively.

As of August 8, 2019 Achieve had 8,097,763 shares outstanding.

Conference Call Details

Achieve will host a conference call at 4:30 p.m. Eastern time today, Thursday, August 8, 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 6587726. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.