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.

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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.

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.

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 Sunovion Pharmaceuticals Inc. (Sunovion),its parent company Sumitomo Dainippon Pharma Co., Ltd. (Sumitomo Dainippon Pharma) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) reported that the companies have entered into a worldwide license agreement for the joint development and commercialization of four compounds: ulotaront (SEP-363856), non-racemic ratio of amisulpride enantiomers (SEP-4199), SEP-378614 and SEP-380135 (Press release, Sunovion, SEP 30, 2021, View Source [SID1234590587]).

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Leveraging their complementary therapeutic area expertise and capabilities, the companies expect to fully explore the medical potential of the compounds in the collaboration, and accelerate development timelines, to bring forward important treatments for people living with neuropsychiatric health conditions worldwide. Otsuka’s subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc., will jointly lead, together with Sunovion, the effort to advance the research and development program worldwide, as well as plan for future commercial activities.

"Sunovion, with our parent company Sumitomo Dainippon Pharma, is proud to collaborate with Otsuka in a shared mission to contribute towards improved lives and better health globally," said Antony Loebel, M.D., President and Chief Executive Officer of Sunovion. "Otsuka’s recognition of the significant value of these assets reflects the innovative discovery and development efforts at Sunovion over the past decade, as well as our neuropsychiatry commercialization expertise and capabilities. We look forward to working with Otsuka colleagues as we advance novel compounds to treat patients with serious neuropsychiatric conditions."

"We are pleased to have signed this agreement with Otsuka, which has wide global reach and significant neuropsychiatry expertise. We will work together to more rapidly and reliably develop and commercialize valuable pharmaceuticals for patients around the world with the expectation that these new medications will grow," said Hiroshi Nomura, President and Chief Executive Officer of Sumitomo Dainippon Pharma. "Sumitomo Dainippon Pharma aims to achieve sustained growth through global collaboration in anticipation of future changes in the business environment. This collaboration is a major step forward in this initiative."

"Otsuka has been committed to providing new antipsychotics that contribute to patients worldwide in the field of neuropsychiatry by leveraging internal capabilities and external collaborations, starting with the launch of antipsychotics in the U.S. in 2002," said Makoto Inoue, President and Representative Director of Otsuka. "We are advancing in new areas such as the development of drugs to treat agitation associated with dementia of the Alzheimer’s type and the deployment of the world’s first digital medicine. Through this agreement, we are confident the companies will be able to deliver even more value to patients through the experience and networks that we have cultivated over many years worldwide."

This collaboration recognizes that there is a great need for novel treatments in the area of neuropsychiatric medicine development. The companies are focused on working together on solutions to address these areas of unmet medical need by advancing four promising compounds―ulotaront (SEP-363856), SEP-4199, SEP-378614 and SEP-380135―that address serious neuropsychiatric disorders. The goal of the co-development programs is to contribute to changing the course of serious medical conditions and provide new treatment options to patients and healthcare providers globally.

Upon the completion of the agreement, in addition to an upfront payment of USD 270 million, Sunovion is eligible for development milestone payments of up to USD 620 million for the four compounds and relevant sales milestone payments. Sunovion and Otsuka will share profits from the four compounds, as well as all expenses for clinical studies, applications for approval, and commercialization in each country. Additional details regarding terms of the agreement are not being disclosed.

About Sunovion Compounds

The four clinical-stage assets―ulotaront (SEP-363856), non-racemic ratio of amisulpride enantiomers (SEP-4199), SEP-378614 and SEP-380135―included within the collaboration span early- to late-stage development. The compounds represent a scientifically unique approach to treating symptoms that are not adequately addressed by current therapeutic options and/or for which existing treatments have an unsatisfactory safety and tolerability profile.

Ulotaront (SEP-363856), in Phase 3, is a trace amine-associated receptor 1 (TAAR1) agonist with 5-HT1A agonist activity that is under investigation for the treatment of schizophrenia with additional indications under consideration. Ulotaront was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia. Ulotaront is the first TAAR1 agonist to enter into Phase 3 clinical studies in adults and adolescents (13 to 17 years) with schizophrenia.

Non-racemic amisulpride (SEP-4199) is in Phase 3 clinical development for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression). Sunovion discovered that the pharmacology of amisulpride is enantiomer-specific and increasing the ratio of R-amisulpride to S-amisulpride increases the potency for serotonin 5-HT7 receptors relative to dopamine D2 receptors. SEP-4199 was designed with an 85:15 ratio of R-amisulpride to S-amisulpride to increase levels of serotonin 5-HT7 activity intended to enhance antidepressant efficacy and produce reduced levels of D2 receptor occupancy appropriate for the treatment of bipolar depression. In September 2021 Sunovion initiated a global clinical Phase 3 study, which is a randomized, double-blind, placebo-controlled, parallel-group, fixed-dosed study for the treatment of bipolar I depression in the U.S. Japan will join this global clinical Phase 3 study.

SEP-378614 and SEP-380135 are in Phase 1 development and can be viewed on the Sunovion pipeline here.

Sunovion discovered ulotaront, SEP-378614, and SEP-380135 in collaboration with PsychoGenics based in part on a mechanism-independent approach using the in vivo phenotypic SmartCube platform and associated artificial intelligence algorithms.

Sunovion has a robust portfolio of clinical and pre-clinical compounds, not included in this agreement, which the company continues to advance for some of the most prevalent, challenging, and underserved neuropsychiatric conditions.

About Neuropsychiatric Disorders

Neuropsychiatric disorders are among the most complex and difficult to treat. Disorders of the brain are often associated with significant and disabling effects on patients, impacting their loved ones and society more broadly. Nearly one in six people worldwide live with a neurological disorder,1 29 million people worldwide are living with bipolar disorder,2 and 20 million people worldwide are living with schizophrenia.3

On September 30, 2021 Isarna Therapeutics reported the appointment of Claus Schalper as Chief Executive Officer. Mr. Schalper joins Isarna with over 20 years of experience as an executive and serial entrepreneur in the life science and biotech industries (Press release, Isarna Therapeutics, SEP 30, 2021, View Source [SID1234590586]). His appointment expands Isarna’s management team, which includes Prof. Marion R. Munk as Chief Medical Officer, Dr. René Rückert as Chief Operating Officer and Chris Huiskamp as Chief Financial Officer. The leadership team will be focused on developing Isarna’s lead product ISTH0036 as a promising therapeutic candidate for diseases of the eye.

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"Isarna has reached an exciting stage of development for its lead program, ISTH0036, which has broad applicability in a range of ophthalmology indications," said Claus Schalper, CEO of Isarna Therapeutics. "I value the opportunity to work together with Marion, René and Chris as we move ISTH0036 toward the next clinical trial to further evaluate its potential to benefit patients with retinal diseases that continue to have a high level of unmet medical need."

Claus Schalper, MBA, joins Isarna from Pieris Pharmaceuticals, a company that he co-founded in 2001 and where he held the position of Chief Financial Officer among other roles, playing an important part in the company’s evolution into a US-NASDAQ listed biotechnology company. Mr. Schalper also co-founded XL-protein GmbH and led the company to profitability by executing a series of collaborations with pharma and biotech companies. Mr. Schalper began his career with Arthur Andersen and subsequently served as CEO for several companies in the technology industry. He holds a Master of Business Administration from the University of Bamberg, Germany.

"Claus brings a broad range of leadership and corporate development experience to Isarna. With the management team now in place, the company is well-positioned to implement its product development strategy and reach the next value inflection points for ISTH0036 in ophthalmology," said Matthias Kromayer, Managing Partner and member of the Executive Board at MIG Capital, Isarna’s lead investor.

Prof. Marion R. Munk, MD, PhD, FEBO, joined Isarna as Chief Medical Officer in 2019. She brings over 10 years of clinical expertise in retina, uveitis and age-related macular degeneration research and is a board-certified ophthalmologist currently serving as attending retina specialist and Managing Director of the Bern Photographic Reading Center at the University Hospital Bern, Switzerland. She previously worked at the Feinberg School of Medicine, Chicago, Illinois and the AKH Vienna, Austria, and serves as a consultant for many key players in the ophthalmology drug and device development space. Prof. Munk holds a bachelor’s degree in theoretical physics as well as a MD and PhD in ophthalmology and clinical neuroscience from the Medical University, Vienna.

René Rückert, MD, MBA, joined Isarna in 2018 as interim CMO and in 2019 took the role of the Chief Operating Officer. He brings extensive experience in ophthalmology drug development including many years as a leader and global manager at Bayer and Novartis where he led the global development of the current gold standard therapies in AMD and DME, Eylea and Lucentis. Dr. Rückert previously served as Clinical Vice President, Chief Medical Officer and Chief Operating Officer at a number of innovative biotech and Medtech Companies. In his role at Isarna, Dr. Rückert oversees the company’s operations and clinical development programs and supports the company with his business acumen and his global network. Dr. Rückert is a trained immunologist and board-certified for biochemistry; he received his medical degree from the Charité Berlin, Germany and an MBA from the Warwick Business School, UK.

Isarna Therapeutics has extensive expertise in antisense therapies targeting the messenger RNA (mRNA) transcript for transforming growth factor (TGF)-β, a protein that is chronically elevated in ophthalmic and fibrotic diseases and is used as escape mechanisms by tumors during immune therapy. In ophthalmic indications, fibrosis is a key driver of reduced vision and lack of long-term efficacy of current therapies, TGF-β is a key driver of fibrosis, so ISTH0036 could be the first therapy to prevent the fibrotic changes in patients with retinal pathologies. The company’s Phase 2 candidate, ISTH0036, blocks TGF-β 2, which is a major driver of severe retinal diseases such as, wet (neovascular) age-related macular degeneration (AMD) and diabetic macular edema (DME). Preclinical evidence supports a key role of TGF-β 2 in macular edema and neovascularization, supporting the development in AMD and DME as an intravitreal injection. Animal data support target engagement and therefore suppression of TGF-β 2 beyond four months after a single intravitreal injection. The company previously presented data from its Phase 1 dose-escalation trial with ISTH0036 in which the compound showed excellent safety and was well-tolerated at all dose levels.