On August 8, 2019 Synlogic, Inc. (NASDAQ: SYBX) reported that Scott Plevy, M.D., Synlogic’s chief scientific officer, will provide a corporate update at the 2019 Wedbush PacGrow Healthcare Conference on Tuesday, August 13 at 9:45 am ET, in New York City (Press release, Synlogic, AUG 8, 2019, View Source [SID1234538444]).

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!

A live webcast of the presentation can be accessed under "Event Calendar" in the Investors & Media section of the Company’s website. An archived copy of the webcast will be available on the Synlogic website for approximately 30 days after the event.

On August 8, 2019 IMV Inc. (TSX: IMV; NASDAQ: IMV), a clinical stage immunotherapy company, reported its financial and operational results for the second quarter ended June 30, 2019 (Press release, IMV, AUG 8, 2019, View Source [SID1234538462]).

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!

"At IMV, we are leveraging DPX, our no-release delivery technology that enables us to program immune cells in vivo. We continue to believe this mechanism offers potential to produce a new class of immunotherapies that elicit a more rapid, robust and sustained immune response," said Frederic Ors, IMV’s Chief Executive Officer. "In the second quarter, we reported important updates from two Phase 2 studies of our lead program, DPX-Survivac, our T cell-activating immunotherapy harnessing the power of this approach to target survivin, which is present in more than 20 solid and hematological tumor types. These results continue to validate our DPX platform and this novel target, with encouraging signs of anti-tumor activity contributing to the body of data we have accumulated to demonstrate DPX-Survivac’s potential in hard-to-treat cancers, both as a monotherapy and in combination with other agents. We look forward to providing additional data from this program by year-end, including top-line results from our Phase 2 study evaluating DPX-Survivac as a monotherapy in ovarian cancer and additional results from our Phase 2 r/r DLBCL and basket trial, evaluating DPX-Survivac in combination with Keytruda in multiple solid tumor indications."

DPX-Survivac Clinical Program Updates:

Phase 1b/2 DeCidE1 Clinical Study in Advanced Recurrent Ovarian Cancer

In June 2019, IMV presented new data at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting from DeCidE1, its ongoing Phase 1b/2 study evaluating the safety and efficacy of DPX-Survivac and intermittent low-dose cyclophosphamide (CPA), with and without epacadostat, in advanced recurrent ovarian cancer. These results expand on data previously reported from this study, which exhibited a durable response. Highlights of the new data from evaluable patients in the Phase 2 monotherapy arm of the trial include:

Five out of seven patients showed signs of treatment benefits, including reduction of target lesions in two patients;
Three out of four patients with low tumor burden showed stable disease, including two with tumour regression at first CT scan;
Of the five patients evaluable for T cell responses, all showed survivin-specific T cell activation in the blood; and
Treatments were well-tolerated supporting our views of the favourable safety profile of our approach.
Additionally, longer-term follow-up data from the Phase 1b portion of the study continued to demonstrate the prolonged duration of clinical benefits, surpassing two years of progression-free survival from previous treatments, including platinum-based chemotherapy.

We have enrolled 16 additional patients in the expanded monotherapy arm of the DeCidE1 trial. IMV expects to provide the top-line clinical results from this study before the end of 2019.

Phase 2 SPiReL Study of DPX-Survivac in Combination with KEYTRUDA in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

In June 2019, IMV reported updated data from SpiRel, its ongoing investigator-sponsored Phase 2 clinical trial assessing DPX-Survivac in combination with intermittent low dose cyclophosphamide and Merck’s checkpoint inhibitor Keytruda, linking antitumor activity with T cell responses that correlate with expression of survivin.

At the first "on treatment" interim assessment, five of the first six patients demonstrated clinical benefit, including four patients with tumor regressions. Two patients reached a complete radiological response, one exhibited a partial response and two reached stable disease while on the study. In addition, the study continued to demonstrate an acceptable safety profile for the two therapies in combination.

Based on these data, IMV agreed with the principal investigator to increase the number of sites recruiting patients from 5 to 9. As of August 8, 2019, investigators had enrolled 12 patients across four different clinical sites in Canada. Additional patients are being screened and IMV expects to give another update on this trial before the end of 2019 and report top-line clinical data from this study in the first half of 2020.

Phase 2 Basket Trial of DPX-Survivac in Combination with KEYTRUDA in Multiple Solid Tumor Indications

Fifteen patients have been enrolled to date, while screening and enrollment of patients is ongoing across nine clinical sites in the U.S. and Canada for five cohorts of patients with bladder, liver (hepatocellular carcinoma), ovarian, or non-small cell lung (NSCLC) cancers, as well as tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker.

Patients have been treated in every cohort and IMV expects to report preliminary clinical results on several of the solid tumor indications included in this basket trial before the end of 2019.

Operational Highlights:

Modification of $5M loan agreement with the province of Nova Scotia. Previously, the entire loan was payable on August 9, 2020. Per this modification, the Corporation will now repay the loan over 60 months starting in January 2021. All the other terms remain the same. This revised repayment schedule will allow IMV to focus its cash resources towards developing its clinical programs.

Upcoming Milestones:

Milestones

Key dates

Preliminary clinical results from basket trial in 5 indications

H2 2019

Top-line monotherapy clinical results in ovarian cancer

H2 2019

Clinical results update in the DLBCL combination trial (investigator-sponsored)

H2 2019

Top-line clinical results in the DLBCL combination trial (investigator-sponsored)

H1 2020

Top-line clinical results from basket trial

H1 2020

Overview of Q2 2019 Financial Results

(In Canadian dollars)

At June 30, 2019, the Corporation had cash and cash equivalents of $26.9M and working capital of $28.3M, compared with $14.9M and $12.2M, respectively at December 31, 2018. Management believes that the Corporation’s cash resources of $26.9M and its additional potential cash resources of $3.1M will be sufficient to fund operations up to Q4-2020. For the six-month period ended June 30, 2019, IMV’s cash burn rate (defined as net loss and comprehensive loss adjusted for charges to operations not involving cash as described in the statement of cash flows) was $10.4 million. Based on the current business plan, the Corporation forecasts the quarterly cash burn rate to be between $5 million and $6 million for the remaining of 2019.

The net loss and comprehensive loss of $5.0M ($0.10 per share) for the three-month period ended June 30, 2019, was $0.2M lower than the net loss and comprehensive loss for three-month period ended June 30, 2018. This relates mainly to a $0.4M decrease in general and administrative expenses and a $0.9M increase in government assistance partly compensated by a $1.2M increase in research and development (R&D) expenses, in the three-month period ended June 30, 2019.

For the six-month period ended June 30, 2019, the net loss and comprehensive loss of $11.0M was $2.7M higher than the net loss and comprehensive loss for six-month period ended June 30, 2018. This relates mainly to a $3.3M increase in R&D expenses and a $0.2M increase in general and administrative expenses partly compensated by $1.0M increase in government assistance in the six-month period ended June 30, 2019. As of August 8, 2019, the number of issued and outstanding common shares was 50,612,125 and a total of 1,997,232 stock options, warrants, and deferred share units were outstanding at that date.

The Corporation’s unaudited interim condensed consolidated results of operations, financial condition and cash flows for the three and six-months ended June 30, 2019 and the related management’s discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.

Conference Call and Webcast Information

IMV will host a conference call and webcast tomorrow at 8:00 am ET to discuss these results and provide an update on the company.

Financial analysts are invited to join the conference call by dialing (844) 461-9932 (U.S. and Canada) or (636) 812-6632 (international) using the conference ID: 7148568.

Other interested parties will be able to access the live audio webcast at this link: View Source The webcast will be recorded and available on the IMV website for 30 days following the call.

About IMV

IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Corporation’s proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac as a monotherapy in advanced ovarian cancer, as well as a combination therapy in multiple clinical studies with Merck. Connect at www.imv-inc.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]).

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!

"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);
–
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]).

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!

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.

On August 8, 2019 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage immunotherapy company developing the next generation of novel T cell therapies for patients suffering from cancer, reported financial results for the second quarter ended June 30, 2019 and provided a corporate update (Press release, TCR2 Therapeutics, AUG 8, 2019, View Source [SID1234538445]).

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!

"In the second quarter of 2019, we made significant progress with our two lead programs TC-210 and TC-110," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "We began patient dosing in a Phase 1/2 clinical trial with TC-210 and partnered with the National Cancer Institute, an institution integral in the validation of targeting mesothelin, to further understand how our unique TRuC-T cells impact mesothelin-positive solid tumors. Additionally, we accelerated our ability to move programs toward and through the clinic by expanding our leadership team with experts that deepen our core competencies – manufacturing, IND enablement and innovation. We remain in a strong financial position with a cash runway into 2022 and look forward to providing updates on TC-210 as we progress through the clinic."

Recent Developments

TCR2 has begun dosing in its Phase 1/2 clinical trial of TC-210 to treat patients with mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma or cholangiocarcinoma.

TCR2 announced that it entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to collaborate on the use of TCR2’s proprietary TRuC-T cells as a cancer therapeutic agent against mesothelin in the Company’s ongoing Phase 1/2 trial of TC-210.

TCR2 expanded its manufacturing and immuno-oncology expertise by hiring Vice Presidents Nigel Williams, Robert Tighe and Dario Gutierrez, Ph.D. The expansion of the leadership team strengthens the Company’s core competencies of manufacturing, IND enablement and innovation as it advances a broad portfolio of next generation TRuC-T cells.

The United States Patent and Trademark Office issued patents with claims covering TCR2’s T cell receptor (TCR) Fusion Construct T cells (TRuCTM-T cells) that express anti-B-cell maturation antigen (BCMA) and anti-CD19 TCR fusion proteins, including TC-110.

TC-210 Clinical Trial Design

The Phase 1/2 clinical trial (NCT03907852) is evaluating the safety and efficacy of TC-210, TCR2’s T-cell receptor fusion construct against mesothelin at Sarah Cannon Research Institute, MD Anderson Cancer Center and the NCI. The trial is enrolling patients with mesothelin expressing non-small cell lung cancer (NSCLC), ovarian cancer, cholangiocarcinoma or malignant pleural/peritoneal mesothelioma.

The Phase 1 portion of the clinical trial utilizes a 3+3 design with four escalating dose levels for TC-210. At each dose level, TC-210 is first administered without lymphodepletion and then following lymphodepleting chemotherapy. The primary objective for the study is patient safety with a key secondary objective to determine the recommended Phase 2 dose (RP2D). In addition to standard measures of safety and efficacy, translational work includes the assessment of TC-210 T cells for expansion, trafficking, persistence and phenotypic changes.

Under the terms of the CRADA, NCI will conduct translational studies, measuring potential biomarkers in patients treated with TCR2 Therapeutics’ proprietary mesothelin-specific T cell-based therapy to better understand the pharmacodynamics of TC-210.

In the Phase 2 portion of the clinical trial, approximately 50 patients are initially planned to receive TC-210 at the RP2D in four distinct cohorts according to their cancer diagnosis: NSCLC, ovarian cancer, malignant pleural/peritoneal mesothelioma and cholangiocarcinoma. Each cohort includes ten patients, except the NSCLC cohort which includes 20 patients with eight patients to receive TC-210 as single agent and 12 to receive TC-210 in combination with a programmed cell death 1 (PD-1) blocking antibody.

Financial Highlights

Cash Position: TCR2 ended the second quarter of 2019 with $180.7 million in cash, cash equivalents, and investments compared to $123.2 million as of December 31, 2018. Net cash used in operations was $21.0 million in the first half of 2019 compared to $7.7 million in the first half of 2018.

R&D Expenses: Research and development expenses were $8.8 million for the second quarter of 2019 compared to $5.2 million for the second quarter of 2018. The increase in R&D expenses is primarily related to increase in headcount and activities related to the start of the Phase 1/2 clinical trial of the Company’s lead solid tumor product candidate, TC-210.

G&A Expenses: General and administrative expenses were $3.3 million for the second quarter of 2019 compared to $1.6 million for the second quarter of 2018. The increase in general and administrative expenses was primarily due to an increase in personnel costs and cost associated with operations as a public company.

Net loss: Net loss was $11.1 million for the second quarter of 2019 compared to $6.2 million for the second quarter of 2018, driven predominantly by increased R&D expense in the quarter.

Upcoming Events

TCR2 Therapeutics management are scheduled to participate at the following upcoming conferences.

BTIG Biotechnology Conference 2019: Ian Somaiya, Chief Financial Officer of TCR2 Therapeutics, will be available for one-on-one meetings on Monday, August 12, 2019 in New York, NY.

2019 Wedbush PacGrow Healthcare Conference: Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics, will present on Tuesday, August 13, 2019 at 8:00am ET in New York, NY.