Boston Scientific Announces Results For Third Quarter 2020

On October 28, 2020 Boston Scientific Corporation (NYSE: BSX) reported that sales of $2.659 billion during the third quarter of 2020 (Press release, Boston Scientific, OCT 28, 2020, View Source [SID1234569201]). This represents a decline of (1.8) percent on a reported basis, (2.5) percent on an operational1 basis and (5.7) percent on an organic2 basis, all compared to the prior year period. The company reported a GAAP net loss available to common stockholders of $(169) million or $(0.12) per share (EPS), compared to GAAP net income of $126 million or $0.09 per share a year ago, and achieved adjusted EPS of $0.37 for the period, compared to $0.39 a year ago.

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"We have a robust cadence of new product launches across our portfolio, and in the third quarter, we delivered strong sequential improvement in our financial performance," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "I am grateful to our global team for their winning spirit and remain confident that our pipeline of products and services positions us well to continue delivering growth at the high end of our peer group."

Third quarter financial results and recent developments:

Included within organic sales results is a negative 230 basis point impact associated with the conversion of U.S. WATCHMAN customers to a consignment inventory model and transition to the next-generation WATCHMAN FLX.

Reported a GAAP net loss available to common stockholders of $(0.12) per share and achieved adjusted EPS of $0.37. The company had not provided third quarter sales and EPS guidance due to ongoing uncertainty associated with the scope and duration of the COVID-19 pandemic.
Included in adjusted EPS is a $(0.04) impact from WATCHMAN discussed above, offset by a $0.06 tax benefit3.

Third quarter sales declined in each of our reportable segments5, compared to the prior year period:
MedSurg: (2.3) percent reported, (3.0) percent operational and (1.9) percent organic
Rhythm and Neuro: (3.0) percent reported, (3.9) percent operational and organic
Cardiovascular: (5.3) percent reported, (5.9) percent operational and (10.4) percent organic

Generated third quarter regional6 sales growth/(declines), compared to the prior year period:
U.S.: (4.2) percent reported and operational
EMEA (Europe, Middle East and Africa): 0.8 percent reported and (2.9) percent operational
APAC (Asia-Pacific): (2.6) percent reported and (4.1) percent operational
Emerging Markets4: (10.3) percent reported and (7.1) percent operational

Received FDA approval for the AVVIGO Guidance System, a tablet platform designed to provide ease of use and accuracy when utilizing fractional flow reserve wires during percutaneous coronary intervention procedures.

Received FDA approval for the high bleeding risk indication for the SYNERGY and SYNERGY XD Bioabsorbable Polymer Drug-Eluting Stent Systems (excluding the recently launched 48 mm stent size).

Obtained CE Mark and initiated a limited market release in Europe of the WaveWriter Alpha portfolio of spinal cord stimulator (SCS) systems, consisting of four full-body MRI conditional, Bluetooth-enabled devices to provide personalized treatment for chronic intractable pain.7

Obtained CE Mark and initiated a limited market release in Europe of the fourth generation Vercise Genus Deep Brain Stimulation (DBS) System to treat the symptoms of Parkinson’s disease, essential tremor and dystonia by delivering precisely targeted electrical stimulation, with full-body MRI conditional and Bluetooth capabilities to better meet individuals’ specific needs.8

Commenced the full global launch of the SpyGlass Discover Digital Catheter, the first single-use scope to enable physicians to take a single-stage approach to diagnostic and therapeutic procedures in the pancreaticobiliary system, including treating patients with bile duct stones.

Initiated the U.S. launch of the SpaceOAR Vue Hydrogel, a next-generation hydrogel spacer that is designed to reduce the side effects of prostate radiation therapy, while providing clinicians with the added ability to view the spacer using computerized tomography (CT) scans instead of magnetic resonance imaging (MRI).

Initiated the European launch of the ACURATE neo2 Aortic Valve System, a new transcatheter aortic valve implantation platform designed to minimize paravalvular leaking and facilitate highly accurate positioning, for patients with aortic stenosis.

Received a New Technology Add-on Payment (NTAP) designation from the U.S. Centers for Medicare and Medicaid Services for the Eluvia Drug-Eluting Vascular Stent System, developed for the treatment of PAD, providing eligible hospitals with incremental reimbursement for the Eluvia stent system. The NTAP designation is awarded to new medical devices determined to substantially improve the diagnosis or treatment of Medicare beneficiaries and went into effect on October 1, 2020.

Announced an expanded investment and exclusive acquisition option agreement with Farapulse, Inc., a privately-held company developing a pulsed field ablation system for the treatment of atrial fibrillation (AFib) and other cardiac arrhythmias via the creation of a therapeutic electric field.

1. Operational revenue growth excludes the impact of foreign currency fluctuations.

2. Organic revenue growth excludes the impact of foreign currency fluctuations and net sales associated with our Q3 2019 acquisition of BTG plc (BTG) for the period prior to mid-August, for which there were no prior period net sales. Organic revenue growth also excludes the impact of the divestiture of our global embolic microspheres portfolio, a transaction entered into in connection with obtaining the antitrust clearances required to complete the BTG transaction, also for the period prior to mid-August, as well as prior period net sales associated with our intrauterine health franchise, which we divested in Q2 2020.

3. We recorded a $0.06 non-cash tax benefit due to the resolution of the IRS examination of our 2014 through 2016 tax years.

4. We define Emerging Markets as the 20 countries that we believe have strong growth potential based on their economic conditions, healthcare sectors and our global capabilities.

5. We have three historical reportable segments comprised of Medical Surgical (MedSurg), Rhythm and Neuro, and Cardiovascular, which represent an aggregation of our operating segments that generate revenues from the sale of medical devices (Medical Devices). As part of our acquisition of BTG on August 19, 2019, we acquired an Interventional Medicine business, which is now included in our Peripheral Interventions operating segment’s revenues from the date of acquisition. We have revised amounts for the third quarter of 2019 to conform to the current year presentation..

6. As part of our acquisition of BTG on August 19, 2019, we acquired a specialty pharmaceuticals business (Specialty Pharmaceuticals). Subsequent to acquisition, Specialty Pharmaceuticals is now a stand-alone operating segment presented alongside our Medical Device reportable segments. We have revised amounts for the third quarter of 2019 to conform to the current year presentation. Specialty Pharmaceuticals net sales are substantially U.S. based. Our chief operating decision maker (CODM) reviews financial information of our globally managed Specialty Pharmaceuticals operating segment at the worldwide level without further disaggregation into regional results. As such, Specialty Pharmaceuticals net sales are presented globally, and our Medical Devices reportable segments regional net sales results do not include Specialty Pharmaceuticals.

7. The WaveWriter Alpha and WaveWriter Alpha Prime Spinal Cord Stimulator Systems provide safe access to full-body 1.5T MRI scans when used with specific components and exposed to the MRI environment under the defined conditions in the ImageReady MRI Full Body Guidelines for WaveWriter Alpha and WaveWriter Alpha Prime Spinal Cord Stimulator Systems.

8. 1.5 Tesla MRI conditional when all conditions of use are met.

*In the third quarter of 2019, we presented Interventional Medicine and Specialty Pharmaceuticals together as "BTG Acquisition" and outside of our operating and reportable segments net sales. Following the integration of BTG, we now include Interventional Medicine business within our Peripheral Interventions operating segment, within the Cardiovascular reportable segment. We present Specialty Pharmaceuticals business as a standalone operating segment alongside our reportable segments. We have revised amounts for the third quarter of 2019 to conform to the current year presentation.

*In the third quarter of 2019, we presented Interventional Medicine and Specialty Pharmaceuticals together as "BTG Acquisition" and outside of our operating and reportable segments net sales. Following the integration of BTG, we now include Interventional Medicine business within our Peripheral Interventions operating segment, within the Cardiovascular reportable segment. We present Specialty Pharmaceuticals business as a standalone operating segment alongside our reportable segments. We have revised amounts for the third quarter of 2019 to conform to the current year presentation.

Amounts may not add due to rounding. Growth rates are based on actual, non-rounded amounts and may not recalculate precisely.

Sales growth rates that exclude the impact of foreign currency fluctuations and/or the impact of recent aforementioned acquisitions / divestitures are not prepared in accordance with U.S. GAAP.

Conference Call Information

Boston Scientific management will be discussing these results with analysts on a conference call today at 8:00 a.m. EDT. The company will webcast the call to interested parties through its website: www.bostonscientific.com. Please see the website for details on how to access the webcast. The webcast will be available for approximately one year on the Boston Scientific website.

Integra LifeSciences Reports Third Quarter 2020 Financial Results

On October 28, 2020 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the third quarter ending September 30, 2020 (Press release, Integra LifeSciences, OCT 28, 2020, View Source [SID1234569198]).
Third Quarter 2020 Financial Summary

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Reported revenues were $370.2 million, representing a decrease of 2.3% on a reported basis and a decrease of 1.5% on an organic basis compared to the prior year. These results were at the high end of the preliminary range provided on October 6, 2020;

Third quarter reported revenues increased 43.1% compared to the second quarter 2020;

GAAP earnings per diluted share were $0.38, compared to a GAAP loss of ($0.32) in the third quarter of 2019. Adjusted earnings per diluted share were $0.80, compared to $0.68 in the prior year;

The Company’s full-year 2020 guidance remains withdrawn due to the uncertainty related to COVID-19 and ongoing variability in the recovery in surgical procedure volumes.
"Better than expected performance in the third quarter was driven by stronger recovery trends and solid execution across the organization," said Peter Arduini, Integra’s president and chief executive officer. "I am proud of the ongoing commitment from our Integra colleagues, who are working tirelessly to deliver life-saving products to customers and patients. Barring significant worsening of the pandemic, we believe these efforts will result in a further sequential revenue improvement in the fourth quarter."

The Company reported GAAP gross margin of 63.6%, compared to 62.4% in the third quarter of 2019. Adjusted gross margin was 68.6% compared to 67.0% in the prior year.
Adjusted EBITDA for the third quarter of 2020 was $103.2 million, or 27.9% of revenue, compared to $91.6 million, or 24.2% of revenue in the prior year.
The Company reported GAAP net income of $32.3 million, or $0.38 per diluted share, in the third quarter of 2020, compared to a GAAP net loss of ($27.6) million, or ($0.32) per diluted share in the prior year. The GAAP loss in

the third quarter of 2019 included a charge of $59.9 million related to an in-process R&D charge associated with the Rebound Therapeutics acquisition.
Adjusted net income for the third quarter of 2020 was $67.7 million, or $0.80 per diluted share, compared to $58.7 million, or $0.68 per diluted share in the prior year.
Integra’s financial position and liquidity remain strong. The Company ended the quarter with $396 million in cash and cash equivalents, $1.2 billion in undrawn revolver capacity, and a consolidated total leverage ratio of 3.2x.
On September 29, 2020, the Company announced it had entered into a definitive agreement to sell its Extremity Orthopedics business. The transaction is expected to close at or around the end of 2020, subject to the satisfaction of customary conditions including regulatory approvals and consultation with employee representative bodies.
2020 Full-Year Outlook
Due to the ongoing uncertainty around the scope and duration of the pandemic and the timing of recovery across the globe, the Company’s guidance for the full-year 2020 remains withdrawn. Barring significant worsening of the pandemic, the Company expects further sequential revenue improvement in the fourth quarter. The Company does not expect all markets or all product lines to improve at the same rate. The level and location of COVID-19 case emergence or recurrence and its associated impact on surgical procedure volumes and economic recovery, will shape the Company’s financial progress.
Supplemental financial and operational information is included in a presentation that can be found in the "Investor" section of the Company’s website at investor.integralife.com under "Events & Presentations".
In the future, the Company may record, or expects to record, gains or losses, expenses, or charges as described in the Discussion of Adjusted Financial Measures below, which will be excluded from the calculation of adjusted EBITDA, adjusted earnings per share for historical periods and in adjusted earnings per share guidance.

Conference Call and Presentation Available Online
Integra has scheduled a conference call for 8:30 a.m. ET today, Wednesday, October 28, 2020, to discuss financial results for the third quarter. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question and answer session following the prepared remarks.
Integra’s management team will reference a presentation during the conference call. The presentation can be found on investor.integralife.com.
Access to the live call is available by dialing (800) 353-6461 and using the passcode 9501226. The call can also be accessed via a webcast link provided on investor.integralife.com. A replay of the call will be available until November 2, 2020 by dialing (888) 203-1112 and using the passcode 9501226. The webcast will also be archived on the website.

West Announces Increase to Fourth-Quarter 2020 Dividend

On October 28, 2020 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that the Company’s Board of Directors has approved a fourth-quarter 2020 dividend of $0.17 per share, a 6.25% increase over the $0.16 per share declared for each of the four preceding quarters (Press release, West Pharmaceutical Services, OCT 28, 2020, View Source [SID1234569197]). This is the twenty-eighth consecutive annual increase in the Company’s dividend. The dividend will be paid on November 18, 2020, to shareholders of record as of November 11, 2020.

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Enhertu granted Priority Review in the US for the treatment of HER2-positive metastatic gastric cancer

On October 28, 2020 AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) reported that it has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for the treatment of patients with HER2-positive metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma (Press release, AstraZeneca, OCT 28, 2020, View Source [SID1234569181]).

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The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that offer significant advances over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, will be during the first quarter of 2021.

There are more than 27,000 new cases of gastric cancer in the US each year, of which approximately one in five are HER2 positive.1,2 For patients with metastatic gastric cancer who progress on initial treatment with an anti-HER2 medicine, there are no other approved HER2-directed medicines.

José Baselga, Executive Vice President, Oncology R&D, said: "Once patients with HER2-positive metastatic gastric cancer progress following initial treatment with an anti-HER2 regimen, there are no approved HER2-directed medicines. The prognosis for these patients is poor, as available treatment options offer only limited clinical benefit. This milestone brings us one step closer to delivering a potentially practice-changing medicine to patients with gastric cancer in the US."

Antoine Yver, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo, said: "The results of the DESTINY-Gastric01 trial are unprecedented as they represent the first time a HER2-directed medicine has demonstrated an improvement in survival following chemotherapy and HER2 treatment in the metastatic setting. Building on the recent Breakthrough Therapy Designation, the filing of the application and Priority Review by the FDA for this potential new indication for Enhertu reflects the importance of the data and the significant unmet need for patients with previously treated HER2-positive metastatic gastric cancer."

The sBLA was based on results from the DESTINY-Gastric01 randomised Phase II trial, which demonstrated a statistically significant and clinically meaningful improvement in objective response rate (ORR), the primary endpoint, and overall survival (OS), a key secondary endpoint, for patients treated with Enhertu versus chemotherapy (paclitaxel or irinotecan monotherapy).

The safety and tolerability profiles of Enhertu in DESTINY-Gastric01 were consistent with that observed in the gastric cancer cohort of the Phase I trial and previously reported Enhertu trials in other tumours.3 The most common Grade 3 or higher treatment-emergent adverse events were decreased neutrophil count, anaemia, decreased white blood cell count and decreased appetite. There were 12 (9.6%) cases of confirmed treatment-related interstitial lung disease (ILD) or pneumonitis in 125 patients treated with Enhertu as determined by an independent review committee. The majority of cases were Grade 1 or 2 with two Grade 3, one Grade 4 and no Grade 5 (ILD-related deaths).

The results from the trial were presented during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program and simultaneously published online in The New England Journal of Medicine in May 2020.4

Enhertu received Breakthrough Therapy Designation from the FDA in May 2020 for patients with unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma who have received two or more prior regimens including trastuzumab and Orphan Drug Designation for patients with gastric cancer, including GEJ adenocarcinoma. Enhertu has not been approved in the US for gastric or GEJ adenocarcinoma.

Gastric cancer

Gastric (stomach) cancer is the fifth most common cancer worldwide and the third leading cause of cancer mortality with a five-year survival rate of 5% for metastatic disease; there were approximately one million new cases reported in 2018 and 783,000 deaths.5,6 In the US, it is estimated that 27,600 new cases of gastric cancer will be diagnosed in 2020 and more than 11,000 people will die from the disease.1

Approximately one in five gastric cancers are HER2 positive.2 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast, gastric, lung and colorectal cancers. Gastric cancer is usually diagnosed in the advanced stage, but even when diagnosed in earlier stages of the disease, the survival rate remains modest.7 Recommended 1st-line treatment for HER2-positive advanced or metastatic gastric cancer is combination chemotherapy plus trastuzumab, an anti-HER2 medicine, which has been shown to improve survival outcomes when added to chemotherapy. For metastatic gastric cancer that progresses on 1st-line treatment, there are no other approved HER2-targeted medicines.8

DESTINY-Gastric01

DESTINY-Gastric01 is a Phase II, open-label, multi-centre, randomised controlled trial testing the safety and efficacy of Enhertu versus investigator’s choice of chemotherapy in a primary cohort of 188 patients from Japan and South Korea with HER2-positive (defined as IHC3+ or IHC2+/ISH+), advanced gastric or GEJ adenocarcinoma who have progressed on two or more prior treatment regimens including fluoropyrimidine and platinum chemotherapy and trastuzumab. Patients were randomised 2:1 to receive Enhertu or investigator’s choice of chemotherapy (paclitaxel or irinotecan monotherapy). Patients were treated with Enhertu 6.4mg/kg once every three weeks or chemotherapy.

The primary endpoint of the trial is ORR, as assessed by independent central review. OS, a key secondary endpoint, was to be evaluated hierarchically at a prespecified interim analysis if the primary endpoint was statistically significant. Additional efficacy endpoints include progression-free survival, duration of response, disease control rate and confirmed ORR assessed in those responses confirmed by a follow-up scan of at least four weeks after initial independent central review.9

Enhertu

Enhertu (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the US) is a HER2-directed antibody drug conjugate (ADC) and is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy (‘payload’) to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Enhertu is comprised of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload by a tetrapeptide-based linker.

Enhertu (5.4mg/kg) is approved in the US and Japan for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting based on the DESTINY-Breast01 trial, and is under accelerated assessment in the EU for HER2-positive metastatic breast cancer. In September 2020, Enhertu (6.4mg/kg) was approved in Japan for patients with HER2-positive unresectable advanced or recurrent gastric cancer that progressed after chemotherapy.

Enhertu clinical development

Enhertu clinical development table
aTrials led by AstraZeneca bNew trials that have been added to the clinical development programme and have achieved FPCD cEnhertu arm added to ongoing AstraZeneca trial.

Collaboration between AstraZeneca and Daiichi Sankyo

AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu (a HER2-directed ADC) in March 2019, and DS-1062 (a TROP2-directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for manufacturing and supply of Enhertu and DS-1062.

AstraZeneca in gastrointestinal cancers

AstraZeneca has a broad development programme for the treatment of gastrointestinal (GI) cancers across several medicines spanning a variety of tumour types and stages of disease. In 2018, GI cancers collectively represented nearly five million new cancer cases leading to more than 3.5 million deaths.5 Within this programme, the Company is committed to improving outcomes in gastric, liver, oesophageal, pancreatic, and colorectal cancers.

The Company aims to understand the potential of Enhertu in the two most common GI cancers, colorectal and gastric cancers.5 Lynparza (olaparib) is a first-in-class PARP inhibitor with a broad and advanced clinical trial programme across multiple GI tumour types including pancreatic and colorectal cancers. Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. inside the US and Canada). Imfinzi (durvalumab) is being assessed both as monotherapy and in combinations including with tremelimumab across the two main types of liver cancer, hepatocellular carcinoma and biliary tract cancer, and in oesophageal and gastric cancers.10

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 seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

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.

Aptose to Release Third Quarter Ended September 30, 2020 Financial Results and Hold Conference Call on November 10, 2020

On October 27, 2020 Aptose Biosciences Inc. (Nasdaq: APTO; TSX: APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, reported that it will release its financial results for the quarter ended September 30, 2020 on Tuesday, November 10, 2020, after the close of the market (Press release, Aptose Biosciences, OCT 27, 2020, View Source [SID1234573619]).

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Conference Call & Webcast:

Date: Tuesday, November 10, 2020
Time: 5:00 PM ET
Dial In – Toll-Free: 1 844-882-7834
Dial In – International: 1 574-990-9707
Passcode: 5539639
Webcast: LINK
Replay available through November 24, 2020:

Dial In – Toll-Free: 1 855-859-2056
Dial In – International: 1 404-537-3406
Replay Passcode: 5539639
The live conference call can also be accessed through a link on the Investor Relations section of Aptose’s website at View Source An archived version of the webcast along with a transcript will be available on the company’s website for 30 days.

The press release, the financial statements and the management’s discussion and analysis for the quarter ended September 30, 2020, will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml.