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Bicycle Therapeutics to Present BT5528 Interim Phase I Data at AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics

On September 30, 2021 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that interim Phase I results from its Phase I/II trial of BT5528, a second-generation Bicycle Toxin Conjugate (BTC) targeting EphA2, has been selected for a plenary oral presentation at the upcoming AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), being held October 7-10, 2021 (Press release, Bicycle Therapeutics, SEP 30, 2021, View Source [SID1234590592]). The Company will host a conference call to discuss the results and provide an update on preliminary findings from the BT8009 program on Thursday, October 7, 2021 at 3:00 p.m. ET.

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AACR-NCI-EORTC Plenary Oral Presentation Details:
Title: A first in class phase I/II Study of the Novel Bicyclic Peptide and MMAE Conjugate, BT5528, in patients with Advanced Malignancies Associated with EphA2 Expression
Presenter: Meredith McKean, M.D., Sarah Cannon Research Institute at Tennessee Oncology
Session Title: Tumor-targeted Conjugates: A Growing Family
Date/Time: Thursday, October 7 at 12:50 p.m. ET

Conference Call Details
Bicycle Therapeutics will host a conference call and webcast on Thursday, October 7 at 3:00 p.m. ET to review the data being presented and provide an update on preliminary findings from the BT8009 program. To access the call, please dial (800) 377-9118 (domestic) or (409) 937-8920 (international) and provide the Conference ID 2287246. A live webcast of the presentation will be available on the Investors & Media section of the Bicycle website, bicycletherapeutics.com.

Susan G. Komen®: Year of Screening Delays and Treatment Disruptions Due to COVID-19 Threaten Breast Cancer Progress

On September 30, 2021 Susan G. Komen, the world’s leading breast cancer organization, reported that it is warning that decades of progress in lowering breast cancer mortality rates may be in jeopardy due to the ongoing COVID-19 pandemic and called for a united response to help save lives during this year’s National Breast Cancer Awareness month (Press release, Susan G Komen, SEP 30, 2021, View Source [SID1234590591]). Komen noted that in response to the growing need for financial support and overcoming barriers to care, the organization has increased its focus on providing care and support directly through its Patient Care Services Center, the demand for which has more than doubled over the past year.

"Facing a breast cancer diagnosis is difficult in the best of times, but more so during the uncertainty of a pandemic," said Paula Schneider, a breast cancer survivor and Komen’s CEO. "More people than ever are encountering challenges in accessing and continuing needed care. Many have lost their jobs, health insurance and are facing new financial challenges. The pandemic has also highlighted persistent and tragic racial disparities, like the startling reality that Black women in the U.S. are about 40 percent more likely to die from breast cancer than white women. Our support is needed now, more than ever. Yet meeting those needs will only be possible thanks to the generosity and passion of our donors and fundraisers."

Komen noted that there are many ways that people can help support Komen’s advocacy, research and patient care programs, from fundraising through one of the organization’s local Race for the Cure or MORE THAN PINK Walk events, supporting someone walking in the Komen 3-Day, 60 mile walk, supporting one of Komen’s LIVE Pink partners, or by doing a personal fundraiser that is meaningful to you, such as hosting a Dress Up to Take Down Breast Cancer educational session or fundraiser at work.

The need for support is clear and growing more urgent by the day. Komen noted that while progress has been made in lowering mortality rates from breast cancer by 41 percent in the U.S. since 1989 thanks to more than three decades of increased access to early detection and more effective treatments, the trajectory of that progress is now in jeopardy due to COVID-19’s lingering impact on breast health care.

Without a renewed focus on early detection and efforts to maintain people in the continuum of care, as well as investments in improved treatments, we are likely to see more people die from the disease. Even without taking the impact of COVID-19 on screening and treatment into account, more than 44,000 people are expected to die this year from breast cancer in the U.S. alone. Now, due to the pandemic, which has caused people to become hesitant to get screened or see a doctor, suddenly become uninsured or face new financial challenges, people are facing new delays and barriers to care that are likely to have tragic consequences.

Initial reports from the National Cancer Institute in 2020 suggested there could be an excess of 10,000 deaths due to breast and colorectal cancer by 2030 due to the pandemic.
A newer model in July 2021, suggests about 2,500 excess deaths from breast cancer by 2030 are expected to occur due to reduced screening, delays in diagnosis and decreased chemotherapy use among women with estrogen receptor positive early breast cancer.
While screening rates are rebounding from the pandemic lows, we are still catching up for many people who should have already been screened and diagnosed. This may lead to a surge of new breast cancers, with later stage diagnoses and increased mortality.
While healthcare systems were able to adapt and adjust treatment regimens to better support patients during this challenging time, many people experienced a change or delay in treatment in the midst of the pandemic.
In response to the growing and evolving demand for direct support for those facing breast cancer today, Komen has developed a new national Patient Care Center to help people overcome barriers to care, no matter where they live. These services include a free Breast Care Helpline, where callers are connected to a trained oncology social worker who provides emotional support education, and access to resources such as financial assistance, patient navigation and more. The need for these care services continues to grow. For example, this year:

Demand for Komen’s free Breast Care Helpline has increased by 35 percent year-over-year.
Komen’s Treatment Assistance Program has provided financial support for thousands of patients and has seen a 155% increase in the number of patients served compared to last year.
Komen recently added eight patient navigators to its team to connect patients to support and resources that will help keep them in the continuum of care. The organization plans to add nine more navigators by the spring of 2022 to meet the growing need.
"In a single moment, a person’s life changes forever – there is life before breast cancer, and life after," noted Schneider. "This October, as part of National Breast Cancer Awareness Month, we are asking people to take a moment to make a difference in the lives of their neighbors. One action can help save a life."

Rocket Pharmaceuticals to Participate in the Chardan Virtual 5th Annual Genetic Medicines Conference

On September 30, 2021 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, reported that Gaurav Shah, M.D., chief executive officer, will participate in a fireside chat on Tuesday, October 5, 2021, at 10:30 am ET at the Chardan Virtual 5th Annual Genetic Medicines Conference (Press release, Rocket Pharmaceuticals, SEP 30, 2021, View Source [SID1234590590]). In addition, Jonathan Schwartz, M.D., chief medical officer, will be part of a panel discussion: "Genetic Medicines: The Ongoing Emergence of the Heart as a Target Tissue" on Monday, October 4, at 3:00 pm ET.

The live webcast of the fireside chat will be accessible via Rocket’s website on the Events page. An archived copy of the webcast will be available on the Rocket website for 30 days after the event.

OncoNano Medicine to Present at The American Association for Cancer Research Virtual Conference on Tumor Immunology and Immunotherapy

On September 30, 2021 OncoNano Medicine, Inc. reported a poster presentation at The American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Conference on Tumor Immunology and Immunotherapy to be held on October 5-6, 2021 (Press release, OncoNano Medicine, SEP 30, 2021, View Source [SID1234590589]).

Full details of the presentation are listed below:

TITLE: ONM-501 ― A Synthetic Polyvalent STING Agonist for Cancer Immunotherapy

PRESENTER: Qintai Su, Ph.D.
DATE: October 5-6, 2021
LOCATION: Virtual

The development of ONM-501 represents a new concept in STING activation that could overcome the challenges observed with earlier STING agonists. ONM-501 encapsulates the endogenous STING agonist cGAMP with a proprietary micelle that induces polyvalent STING condensation and prolongs innate immune activation to offer dual ‘burst’ and ‘sustained’ STING activation for a potential highly effective immunotherapy against cancer.

AngioDynamics Reports Fiscal 2022 First Quarter Financial Results; Updates Guidance

On September 30, 2021 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported financial results for the first quarter of fiscal year 2022, which ended August 31, 2021 (Press release, AngioDynamics, SEP 30, 2021, View Source [SID1234590588]).

"We had a solid first quarter, and our team continues to deliver strong revenue performance and invest in our growth drivers while advancing our ongoing transformation," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics. "We remain committed to investing in our Med Tech platforms to drive sustainable growth while managing through COVID-related headwinds to both our revenue and gross margin. Auryon and NanoKnife accelerated their strong trajectories while continuing to gain support from clinicians, and we commenced the limited market release of our AlphaVac mechanical thrombectomy device. I am excited about the future of AngioDynamics, as our team continues to execute against the strategic plan that we laid out at our Investor & Technology Day."

First Quarter 2022 Financial Results

Net sales for the first quarter of fiscal 2022 were $77.0 million, an increase of 9.6% compared to the prior-year quarter.

Foreign currency translation did not have a significant impact on the Company’s sales in the quarter.

Med Tech net sales were $17.6 million, a 68.0% increase from $10.5 million in the year-ago period, while Med Device net sales were $59.4 million, roughly flat compared to $59.7 million in the year ago period, which included the previously disclosed non-recurring $5.2 million order from the National Health Service (NHS) in the UK. Med Tech includes the Auryon platform, mechanical thrombectomy and the NanoKnife irreversible electroporation platform.

Endovascular Therapies (formerly Vascular Interventions and Therapies) net sales were $38.1 million, an increase of 27.5%, compared to $29.9 million a year ago. Growth was driven by broad strength across the business relative to the prior-year period, led by sales of the Auryon platform of $5.9 million.
Oncology net sales were $14.0 million, an increase of 13.9%, compared to $12.3 million in the prior-year period. The year-over-year growth was primarily due to increased sales of both NanoKnife capital and disposables, partially offset by continued softness in our international markets.
Vascular Access net sales were $25.0 million, a decline of 11.2%, compared to $28.1 million a year ago. Excluding the non-recurring $5.2 million NHS sale in the year-ago period, Vascular Access revenue increased 9.0%.
U.S. net sales in the first quarter of fiscal 2022 were $64.5 million, an increase of 19.1% from $54.1 million a year ago. International net sales were $12.5 million, a decrease of 22.4%, compared to $16.1 million a year ago.

Gross margin for the first quarter of fiscal 2022 was 52.1%, an increase of 120 basis points compared to the first quarter of fiscal 2021, which included costs related to the Company’s COVID-related operating plan that did not recur in the first quarter of fiscal 2022. During the quarter, gross margin was negatively impacted by macro forces including labor shortages and increased expenses for labor, raw materials and freight. Gross margins also continued to be impacted by Auryon startup costs.

The Company recorded a net loss of $7.0 million, or a loss per share of $0.18, in the first quarter of fiscal 2022. This compares to a net loss of $4.3 million, or a loss per share of $0.11, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net loss for the first quarter of fiscal 2022 was $0.9 million, and adjusted loss per share was $0.02, compared to adjusted net income in the prior-year period of $0.6 million and adjusted earnings per share of $0.02.

Adjusted EBITDA in the first quarter of fiscal 2022, excluding the items shown in the reconciliation table below, was $3.6 million, compared to $4.5 million in the first quarter of fiscal 2021.

During the first quarter of fiscal 2022, the Company made a tuck-in acquisition of a support catheter product for use in conjunction with the Auryon atherectomy platform. The Company drew $5.0 million against its revolving credit facility during the quarter to fund this acquisition.

In the first quarter of fiscal 2022, the Company used $8.9 million in operating cash, had capital expenditures of $1.0 million and additions to Auryon placement and evaluation units of $4.5 million. As of August 31, 2021, the Company had $35.5 million in cash and cash equivalents compared to $48.2 million in cash and cash equivalents on May 31, 2021. The Company had debt outstanding of $25.0 million on August 31, 2021 compared to $20.0 million on May 31, 2021.

Updating Fiscal Year 2022 Financial Guidance

The Company now expects its fiscal year 2022 net sales to be in the range of $310 to $315 million, an increase from its prior guidance of $305 to $310 million. The Company expects gross margin to be approximately 55.0% and adjusted earnings per share in the range of $0.00 to $0.05 as it continues to invest in new product launches to drive future growth.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its first quarter results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13723182.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Thursday, September 30, 2021, until 11:59 p.m. ET on Thursday, October 7, 2021. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13723182.