On February 25, 2021 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported business updates and financial results for the fourth quarter ended December 31, 2020 (Press release, Alector, FEB 25, 2021, View Source [SID1234575644]).

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"In 2020, we made significant progress across all of our key clinical programs," said Arnon Rosenthal, Ph.D., co-founder and chief executive officer of Alector. "As we look ahead to 2021, we will be sharing additional findings from our ongoing Phase 2 study evaluating AL001 in people with frontotemporal dementia at a medical conference this year and are pleased to be advancing our two Alzheimer’s disease development programs. Our progress across our immuno-neurology programs continues to put us one step closer to potentially offering new therapeutic options for the millions of patients living with various forms of dementia. In addition, we continue to progress research targets that could have broad implications across neurodegenerative diseases and various forms of cancer, underscoring the broad potential of our research platform."

2020 and Recent Clinical Pipeline Highlights and Business Updates

Progranulin Portfolio:

In July 2020, Alector dosed the first participant in INFRONT-3, a randomized, placebo-controlled, pivotal Phase 3 trial evaluating AL001 in people at risk for or with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). The ongoing trial is evaluating the efficacy and safety of AL001 in at-risk and symptomatic participants with FTD-GRN. Participants in the trial will be given the option to continue receiving treatment in an open-label extension study.

Alector plans to present updated data from the ongoing Phase 2 open-label study evaluating AL001, in 2021. The Company plans to present additional data in pre-symptomatic and symptomatic FTD-GRN participants at medical conferences in 2021. The data will include updated findings on safety, fluid and imaging biomarkers and clinical outcomes assessments, while also providing additional insights to the mechanism of action and safety of AL001 in this population.

In January 2021, the Company announced plans to evaluate AL001 in people with amyotrophic lateral sclerosis (ALS) caused by C9orf72 repeats, which share TDP-43 pathology with FTD-GRN. The Phase 2 study is planned for 2021.
In January 2020, a Phase 1a study evaluating AL101 was initiated in healthy volunteers. The U.S. Food and Drug Administration also granted Fast Track designation to AL101 for the treatment of patients with FTD-GRN in February 2020. The Company anticipates reporting preliminary findings from the Phase 1a study in 2021.
Alzheimer’s Disease Portfolio:

In January 2021, the Company announced that the first participant was dosed in INVOKE-2, Phase 2 trial evaluating AL002 in people with early Alzheimer’s disease. The randomized, double-blind, placebo-controlled, dose-ranging, multi-center Phase 2 study will enroll approximately 265 participants with early Alzheimer’s disease (AD) at up to 90 sites globally. The program is being developed in collaboration with AbbVie.

Data from the Phase 1b study evaluating AL003 in participants with Alzheimer’s disease is expected in 2021. Alector initiated the Phase 1b study in January 2020 and completed enrollment in 2020. The AL003 clinical development program is also being developed in collaboration with AbbVie. Preliminary results from the study are expected to be presented at a scientific medical meeting in 2021.
Early-Stage Pipeline with Potential in Neurodegenerative Diseases and Oncology

In March 2020, the Company entered into a collaboration with Innovent Biologics to develop and commercialize AL008 for oncology indications in China. Planning for the first-in-human study for AL008 is underway. AL008 is a novel, investigational, antibody product candidate with a dual mechanism of action that combines inhibition of the CD47-SIRP-alpha (SIRPα) pathway, with stimulation of activating Fc receptors that has the potential to yield a best-in-class product.

Plans are currently underway to initiate a first-in-human study of a product candidate in our AL009 development program, the Company’s latest prioritized investigational product candidate. Our AL009 program is developing a first-in-class multi-Siglec inhibitor that works to enhance the innate and adaptive immune system response by blocking a critical glycan checkpoint pathway that drives immune inhibition. The product candidate is initially being developed for oncology indications, but may also have therapeutic application in certain neurodegenerative disorders, such as AD.

The Company continues to plan for a first-in-human study for AL044, targeting the MS4A4A receptor within the next 18 months. MS4A4A is a major risk gene for AD that encodes a transmembrane receptor protein that is expressed selectively in microglia in the brain and is associated with control of microglia functionality and potential viability.
Ongoing COVID-19 Response Activities:

Alector continues to actively monitor the evolving COVID-19 pandemic and its ongoing impact on business and clinical operations.
Fourth Quarter and Full Year 2020 Financial Results

Revenue. Collaboration revenue for the quarter ended December 31, 2020, was $4.9 million, compared to $6.0 million for the same period in 2019. Collaboration revenue for the year ended December 31, 2020, was $21.1 million compared to $21.2 million for the same period in 2019. Alector recognizes revenue from the upfront payments under an agreement with AbbVie over time as the services are provided. Revenues are recognized as the program costs are incurred by measuring actual costs incurred to date compared to the overall total expected costs to satisfy the performance obligation. Changes in estimates for revenue recognized over time are recognized on a cumulative basis.

R&D Expenses. Total research and development expenses for the quarter ended December 31, 2020, were $44.4 million, compared to $25.8 million for the same period in 2019. Total research and development expenses for the year ended December 31, 2020, were $156.9 million compared to $100.5 million for the same period in 2019. This increase was mainly driven by an increase in expenses to support the advancement of the clinical and pre-clinical programs across several therapeutic programs and an increase in personnel-related expenses.

G&A Expenses. Total general and administrative expenses for the quarter ended December 31, 2020, were $13.2 million, compared to $12.6 million for the same period in 2019. Total general and administrative expenses for the year ended December 31, 2020 were $59.4 million compared to $35.1 million for the same period in 2019. This increase was primarily due to an increase in personnel-related expenses due to increased headcount and an increase in legal costs associated with our arbitration proceedings.

Net Loss. For the quarter ended December 31, 2020, Alector reported a net loss of $52.2 million, compared to a net loss of $30.5 million for the same period in 2019. For the year ended December 31, 2020, Alector reported a net loss of $190.2 million, compared to a net loss of $105.4 million for the same period in 2019.

Cash Position. Cash, cash equivalents, and marketable securities were $413.3 million as of December 31, 2020. The Company believes that its cash and investments as of December 31, 2020, will be sufficient to fund its anticipated operations through mid-2022.

On February 25, 2021 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported its financial results for the fourth quarter and full year of 2020 and provided a corporate update (Press release, Aclaris Therapeutics, FEB 25, 2021, View Source [SID1234575672]).

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"As we reflect on 2020, we are proud of how we have progressed our immuno-inflammatory development programs," said Dr. Neal Walker, President & CEO of Aclaris. "We are very excited about the platform potential of ATI-450, an oral MK2 inhibitor which we have shown to inhibit TNFα, IL1β, and IL6. Given its novel mechanism, there are several immuno-inflammatory indications that ATI-450 may potentially address. We are also excited about the potential of our pipeline which is internally generated from KINect, our proprietary drug discovery platform, for various immuno-inflammatory indications. We look forward to building on this momentum in 2021."

Research and Development Highlights:

The global COVID-19 pandemic continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its research and development and regulatory activities listed below.

ATI-450, an investigational oral small molecule MK2 inhibitor compound:

ATI-450-RA-201: A Phase 2a, multicenter, randomized, investigator and patient-blind, sponsor-unblinded, parallel group, placebo-controlled clinical trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450 in subjects with moderate to severe rheumatoid arthritis.
Positive preliminary topline data announced in January 2021. In this trial, ATI-450 demonstrated durable clinical activity, as defined by a marked and sustained reduction in DAS28-CRP and improvement of ACR20/50/70 responses over 12 weeks. This clinical activity was further supported by pharmacodynamic analyses showing a marked and durable inhibition of TNFα, IL1β, IL6, and IL8 in ex vivo stimulated samples as well as an endogenous inflammation biomarker analysis which also demonstrated a marked and sustained inhibition of median concentrations of hsCRP, TNFα, IL6, IL8, and MIP1β in the treatment arm over the 12 week period.
ATI-450 was generally well tolerated. The most common adverse events (AE) (each reported in 2 subjects) were urinary tract infection (UTI), elevated lipids and ventricular extrasystoles, all of which were determined to be unrelated to treatment except for one UTI. There was one non-treatment-related serious adverse event (COVID-19) reported in the four-week safety follow-up phase of the trial in a subject who was no longer receiving treatment.
Aclaris intends to progress ATI-450 into a Phase 2b trial in moderate to severe rheumatoid arthritis in the second half of 2021.
Aclaris is currently evaluating additional potential indications driven by TNFα, IL1β and IL6 as part of its planned expansion of its Phase 2 immuno-inflammatory clinical development programs.

ATI-450-PKPD-102: A Phase 1, placebo-controlled, randomized, observer-blind clinical trial to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ATI-450 at 80 mg and 120mg twice daily in health subjects.
Positive preliminary topline data announced in January 2021. Pharmacodynamic analysis demonstrated incremental cytokine suppression at these higher doses. ATI-450 was generally well tolerated. The most common AEs (reported by 2 or more subjects who received ATI-450) were headache, dizziness, nausea, parasthesia and, in the post-dosing safety follow-up phase of the trial, dry skin. These AEs were all mild in severity.
A final analysis of this trial is underway.

ATI-450-CAPS-201: A Phase 2a, multicenter, open-label, single-arm clinical trial to investigate the safety, tolerability, efficacy and pharmacodynamics of ATI-450 for the maintenance of remission in subjects with cryopyrin-associated periodic syndrome (CAPS) previously managed with anti-IL1 therapy. Due to the COVID-19 pandemic, subject enrollment in this trial was paused. As a result of the ongoing pandemic and given the positive preliminary topline data from the ATI-450-RA-201 trial, Aclaris has decided to focus its efforts and resources on other immuno-inflammatory diseases.
ATI-1777, an investigational topical "soft" Janus Kinase (JAK) 1/3 inhibitor compound:

ATI-1777-AD-201: An ongoing Phase 2a, multicenter, randomized, double-blind, vehicle-controlled, parallel-group clinical trial to investigate the efficacy, safety, tolerability and pharmacokinetics of ATI-1777 in subjects with moderate to severe atopic dermatitis. The primary endpoint is the percentage change from baseline in the Eczema Area and Severity Index (EASI) score at week 4. Data from this trial are expected mid-year 2021.
ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound:

Aclaris is developing ATI-2138 as a potential treatment for T-cell mediated diseases such as psoriasis and/or inflammatory bowel disease and expects to submit an Investigational New Drug Application for ATI-2138 in the second half of 2021.
Financial Highlights:

Liquidity and Capital Resources

As of December 31, 2020, Aclaris had aggregate cash, cash equivalents, restricted cash and marketable securities of $54.1 million compared to $75.0 million as of December 31, 2019. The changes in cash and cash equivalents and marketable securities during the year included:

Net cash used in operating activities was $38.6 million resulting from net loss of $51.0 million and changes in operating assets and liabilities of $2.4 million, partially offset by non-cash adjustments of $14.7 million.

Net borrowings of $10.9 million pursuant to a Loan and Security Agreement.

Net proceeds of $7.7 million from the sale of 2.1 million shares of common stock under an equity line of credit agreement.
In January 2021, Aclaris closed a public offering in which it sold approximately 6.3 million shares of common stock. Proceeds from the offering were $103.5 million, net of underwriting discounts, commissions and offering expenses. Aclaris anticipates that its cash, cash equivalents and marketable securities as of December 31, 2020 in combination with the proceeds from the January 2021 public offering will be sufficient to fund its operations through the end of 2023, without giving effect to any potential business development transactions or financing activities.

Financial Results

Fourth Quarter 2020

Net loss was $13.2 million for the fourth quarter of 2020 compared to $18.6 million for the fourth quarter of 2019. Loss from continuing operations was $13.6 million for the quarter ended December 31, 2020 compared to $19.2 million for the prior year period.
Total revenue was $1.6 million for the fourth quarter of 2020 compared to $1.1 million for the fourth quarter of 2019.

Research and development (R&D) expenses were $9.0 million for the quarter ended December 31, 2020 compared to $11.5 million for the prior year period.

The quarter-over-quarter decrease of $2.6 million was primarily the result of expenses related to Aclaris’ legacy JAK inhibitors ATI-501 and ATI-502, including the substantial completion of Aclaris’ various Phase 2 clinical trials, and the substantial completion of two pivotal Phase 3 clinical trials of A-101 45% Topical Solution in 2019.
General and administrative (G&A) expenses were $4.9 million for the quarter ended December 31, 2020 compared to $5.8 million for the prior year period.

The quarter-over-quarter decrease of $0.9 million was primarily the result of lower non-cash stock-based compensation expense resulting from headcount reductions. Stock-based compensation expense was $1.6 million compared to $2.6 million in the prior year period.
Full Year 2020

Net loss was $51.0 million for the year ended December 31, 2020 compared to $161.4 million for the year ended December 31, 2019. Loss from continuing operations was $51.2 million for the year ended December 31, 2020 compared to $113.5 million for the prior year period. Income from discontinued operations was $0.1 million for the year ended December 31, 2020 compared to a loss from discontinued operations of $47.8 million for the year ended December 31, 2019.

Total revenue was $6.5 million for the year ended December 31, 2020 compared to $4.2 million for the year ended December 31, 2019.

R&D expenses were $31.7 million for the year ended December 31, 2020 compared to $64.9 million for the prior year period.

The decrease of $33.2 million was primarily the result of expenses related to ATI-501 and ATI-502, including the substantial completion of Aclaris’ various Phase 2 clinical trials, and the substantial completion of two pivotal Phase 3 clinical trials of A-101 45% Topical Solution in 2019.
R&D expenses in 2020 included non-cash stock-based compensation expense of $2.9 million compared to $5.1 million in the prior year period.
G&A expenses were $20.5 million for the year ended December 31, 2020 compared to $27.8 million for the prior year period.

The decrease of $7.3 million was primarily the result of lower personnel and non-cash stock-based compensation resulting from headcount reductions.
G&A expenses in 2020 included non-cash stock-based compensation expense of $7.3 million compared to $10.3 million in the prior year period.
For the year ended December 31, 2019, there was also a $18.5 million non-cash charge for the impairment of goodwill.

On February 25, 2021 Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, reported financial results for its fourth quarter and full year ended December 31, 2020 (Press release, Lantheus Medical Imaging, FEB 25, 2021, View Source [SID1234575688]).

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"While 2020 presented extraordinary challenges, I thank our team for continuing to manufacture and deliver products to our customers throughout the year"

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The Company’s worldwide revenue for the fourth quarter of 2020 totaled $94.2 million, compared with $89.3 million for the fourth quarter of 2019, representing an increase of 5.4% over the prior year period. Full year 2020 worldwide revenues were $339.4 million, compared with $347.3 million for the full year 2019, representing a decrease of 2.3% over the prior year period.

The Company’s fourth quarter 2020 net loss was $3.4 million, or $0.05 per fully diluted share, as compared to net income of $10.5 million, or $0.26 per fully diluted share for the fourth quarter of 2019. Full year 2020 net loss was $13.5 million, or $0.25 per fully diluted share, as compared to net income of $31.7 million, or $0.79 per fully diluted share for the full year 2019.

The Company’s fourth quarter 2020 adjusted fully diluted earnings per share were $0.07, as compared to $0.34 for the fourth quarter of 2019, representing a decrease of 79.9% over the prior year period. The Company’s full year 2020 adjusted fully diluted earnings per share were $0.47, as compared to $1.17 for the full year 2019, representing a decrease of 59.5% over the prior year period.

Lastly, net cash provided by operating activities was $0.6 million and $16.4 million for the fourth quarter and full year 2020. Free Cash Flow was $(3.2) million for the fourth quarter of 2020, representing a decrease of approximately $20.9 million from the prior year period. Full year 2020 free cash flow was $3.9 million, as compared to $58.3 million for the full year 2019, representing a decrease of approximately $54.4 million from the prior year period.

"While 2020 presented extraordinary challenges, I thank our team for continuing to manufacture and deliver products to our customers throughout the year," said Mary Anne Heino, President and CEO. "Our fourth quarter revenue growth was 5.4% over the prior year period and also represented steady improvement over the prior two quarters of 2020. During 2020, we advanced our strategic mandate by closing the Progenics acquisition in June and receiving FDA approval for DEFINITY RT in November as well as FDA acceptance and Priority Review designation for our PyL NDA in December. In 2021, we will continue to drive sustainable growth, expand product offerings to our customers, improve the lives of the patients we serve, and create value for our shareholders."

Outlook

The Company guidance for the first quarter and full year 2021 is as follows:

On a forward-looking basis, the Company does not provide GAAP income per common share guidance or a reconciliation of adjusted fully diluted EPS to GAAP income per common share because the Company is unable to predict with reasonable certainty business development and acquisition-related expenses, purchase accounting fair value adjustments, and any one-time, non-recurring charges. These items are uncertain, depend on various factors, and could be material to results computed in accordance with GAAP. As a result, it is the Company’s view that a quantitative reconciliation of adjusted fully diluted EPS on a forward-looking basis is not available without unreasonable effort.

Internet Posting of Information

The Company routinely posts information that may be important to investors in the "Investors" section of its website at www.lantheus.com. The Company encourages investors and potential investors to consult its website regularly for important information about the Company.

Conference Call and Webcast

As previously announced, the Company will host a conference call and webcast on Thursday, February 25, 2021 at 4:30 p.m. ET. To access the live conference call via telephone, please dial 1-866-498-8390 (U.S. callers) or 1-678-509-7599 (international callers) and provide passcode 5247866. A live webcast will be available in the Investors section of the Company’s website at www.lantheus.com.

A replay of the audio webcast will be available in the Investors section of our website at www.lantheus.com approximately two hours after completion of the call and will be archived for 30 days.

The conference call will include a discussion of non-GAAP financial measures. Reference is made to the most directly comparable GAAP financial measures, the reconciliation of the differences between the two financial measures, and the other information included in this press release, our Form 8-K filed with the SEC today, or otherwise available in the Investor Relations section of our website located at www.lantheus.com.

The conference call may include forward-looking statements. See the cautionary information about forward-looking statements in the safe-harbor section of this press release.

On February 25, 2021 INmune Bio, Inc. (NASDAQ: INMB) (the "Company" or "INmune"), a clinical-stage immunology company focused on developing treatments that harness a patient’s innate immune system to fight disease, reported that it will host a conference call on Thursday, March 4, 2021 at 4:30 PM Eastern Time to discuss results for its fourth quarter and year ended December 31, 2020 and to provide a corporate update (Press release, INmune Bio, FEB 25, 2021, View Source [SID1234575922]).

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Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio Fourth Quarter Conference Call when reaching an operator.

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through March 11, 2021 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13715561.

On February 25, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that two abstracts have been accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, including two corresponding posters (Press release, Greenwich LifeSciences, FEB 25, 2021, View Source [SID1234575591]). The AACR (Free AACR Whitepaper) 2021 conference will be held in a virtual format from April 10-15, 2021. The AACR (Free AACR Whitepaper) plans to publish the titles on March 10, 2021 at 4:30 pm EST, the abstracts on April 9, 2021 at 12:01 am EST, and the posters on April 10, 2021.

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Snehal Patel, CEO of Greenwich LifeSciences, commented, "We are pleased that both of our abstracts were accepted by the AACR (Free AACR Whitepaper). On December 9, 2020, we presented the Phase IIb clinical trial Kaplan Meier analysis of disease free survival for HER2/neu 3+ patients treated with GP2 immunotherapy, which showed 100% survival over 5 years of follow-up (0% breast cancer recurrences, p = 0.0338) if the patients received their primary GP2 treatments following surgery and Herceptin treatment. In the first abstract and poster, we are excited to present the final 5 year analysis of the immune response over time for all patients in the Phase IIb clinical trial."

Patel added, "As the immune response is the primary mechanism of action, this final analysis assessing GP2’s effectiveness in creating peak immunity is important in further validating the clinical outcome, where we observed the 0% recurrence rate, and will provide more insight into the design of the Phase III clinical trial, which is our second abstract and poster. Immune response data is critical in developing dosing and booster treatment strategies designed to achieve and sustain peak immunity, providing protection against metastatic breast cancer recurrence for as long as possible."

The first abstract and poster will present the final 5 year immune response data across all patient populations from the completed prospective, randomized, placebo-controlled, single-blinded, multicenter, Phase IIb clinical trial. The presentation will include analysis of the various methods used to measure immune responses for both HER2/neu 3+ and HER2/neu 1-2+ patient populations, including comparison of peak immune response versus baseline immune response at multiple time points.

The second abstract and poster, jointly sponsored with Baylor College of Medicine, will present the design of the planned Phase III clinical trial. The clinical trial is designed as a single registration trial that will include an interim analysis seeking conditional marketing approval from the FDA upon the interim analysis data read out followed by the submission of a Biologics Licensing Application (BLA). Additional features of the clinical trial design will be presented to breast cancer key opinion leaders as we recruit clinicians and clinical sites for participation in the Phase III clinical trial.

About the AACR (Free AACR Whitepaper) Annual Meeting 2021

The AACR (Free AACR Whitepaper) is the first and largest cancer research organization dedicated to accelerating the conquest of cancer and has more than 48,000 members residing in 127 countries and territories. The AACR (Free AACR Whitepaper) Annual Meeting program covers the latest discoveries across the spectrum of cancer research — from population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy — and highlights the work of the best minds in research and medicine from institutions all over the world.

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.