On September 30, 2021 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported that details of the trial design and scientific rationale for its first in human (FIH) Phase 1/1b trial (KN-8701: NCT04913285) evaluating KIN-2787 has been selected for a poster 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), October 7-10, 2021 (Press release, Kinnate Biopharma, SEP 30, 2021, View Source [SID1234590569]).

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KIN-2787, Kinnate’s most advanced product candidate, is an orally available small molecule pan-RAF inhibitor being developed for the treatment of patients with lung cancer, melanoma, and other solid tumors. Unlike currently available treatments that target only Class I BRAF kinase mutations, Kinnate has designed KIN-2787 to target Class II and Class III BRAF alterations, where it has the potential to be a first-line targeted therapy, in addition to covering Class I BRAF mutations.

"We are looking forward to sharing additional details of the KN-8701 trial which is actively recruiting at the first three centers in the United States with additional centers planned to activate soon," said Richard Williams, MBBS, Ph.D., Chief Medical Officer of Kinnate. "The first patient in this trial commenced treatment at Sarah Cannon Research Institute at Tennessee Oncology and we appreciate their ongoing collaboration in this important clinical trial of KIN-2787."

The poster (#P226), titled "Design and rationale of a first in human (FIH) Phase 1/1b study evaluating KIN-2787, a potent and highly selective pan-RAF inhibitor, in adult patients with BRAF mutation positive solid tumors," will be delivered by co-investigator Meredith McKean, MD, MPH, Associate Director, Melanoma and Skin Cancer Research Program, Sarah Cannon Research Institute at Tennessee Oncology.

Additional information on the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual International Conference can be found online at: View Source

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]).

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"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.

On September 30, 2021 Jubilant Therapeutics Inc., a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, reported the successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development plan, clinical study design and dosing strategy for the Phase I/II trial of JB1-802, a dual inhibitor of LSD1 and HDAC6, for the treatment of small cell lung cancer, treatment-induced neuro-endocrine prostate cancer and other mutation-defined neuroendocrine tumors (Press release, Jubilant Therapeutics, SEP 30, 2021, View Source [SID1234590604]).

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A pre-IND meeting provides the drug development sponsor an opportunity for an open communication with the FDA to discuss the IND development plan and to obtain the agency’s guidance regarding planned clinical evaluation of the sponsor’s new drug candidate. After reviewing the preclinical data provided, plans for additional data generation and the Phase I/II clinical trial protocol, the FDA addressed Jubilant Therapeutics’ questions, provided guidance and aligned with the sponsor on the proposed development plan for JBI-802.

"We appreciate the FDA’s guidance as we endeavor to find an innovative new treatment for high unmet-need tumors with devastatingly low survival rates," said Hari S Bhartia, Chairman, Jubilant Therapeutics Inc.

"We are pleased with the outcome of the pre-IND meeting with the FDA and plan to submit the IND application by the end of 2021," said Syed Kazmi, Chief Executive Officer, Jubilant Therapeutics Inc.

On September 30, 2021 Aileron Therapeutics (Nasdaq: ALRN), a chemoprotection oncology company focused on fundamentally transforming the experience of chemotherapy for cancer patients, reported it will present new preclinical data at the upcoming AACR (Free AACR Whitepaper)-NCI-EORTC 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) demonstrating a potential secondary application of its novel, selective chemoprotective agent ALRN-6924 to also protect against radiation-induced toxicities (Press release, Aileron Therapeutics, SEP 30, 2021, View Source [SID1234590571]).

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Aileron is currently developing ALRN-6924, a first-in-class MDM2/MDMX dual inhibitor, to selectively protect healthy cells in patients with cancers that harbor p53 mutations to reduce or eliminate chemotherapy-induced side effects while preserving chemotherapy’s attack on cancer cells. ALRN-6924 is designed to activate p53 in normal cells, which in turn upregulates p21, which pauses cell cycle in normal cells but not in p53-mutated cancer cells. A Phase 1b randomized, double-blind, placebo-controlled study is currently underway in the United States and Europe evaluating ALRN-6924 in patients with advanced p53-mutated non-small cell lung cancer undergoing treatment with first-line carboplatin plus pemetrexed with or without immunotherapy. Aileron is pursuing a clinical development strategy designed to advance its vision to bring selective chemoprotection to all patients with
p53-mutated cancer regardless of type of cancer or chemotherapy.

In the AACR (Free AACR Whitepaper)-NCI-EORTC poster presentation, Aileron will share data showing ALRN-6924’s activity as a radioprotective agent in preclinical models of acute radiation toxicity, leveraging the same mechanism of action that enables ALRN-6924 to protect against chemotherapy-induced toxicities. The poster details are as follows:

Poster Title: The Investigational Chemoprotection Drug ALRN-6924, a Dual Inhibitor of MDMX and MDM2, Shows Potential for Radioprotection

Poster #: P211

Date/Time: All poster presentations will be made available by the conference at the opening of the meeting on October 7, 2021 at 9:00 a.m. ET.

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]).

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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.