On July 29, 2020 Omega Therapeutics, a company pioneering a new category of genomic medicine through epigenomic programming, reported the completion of an $85 million financing (Press release, Omega Therapeutics, JUL 29, 2020, View Source [SID1234562499]). The funding will support progression to first-in-human clinical trials of the company’s Epigenomic Controllers for programs in oncology, inflammation, autoimmune, metabolic, and rare genetic diseases.

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"We founded Omega with the long-term vision to create a controllable epigenomic programming platform that would identify novel epigenetic targets and therapeutically address them through a new class of genomic medicines," said Noubar Afeyan, Ph.D., Chief Executive Officer of Flagship Pioneering and Co-founder and Chairman of the Board for Omega Therapeutics. "Although human cells all share a common genetic code within their 23 pairs of chromosomes, epigenetic regulation determines identity and function at the tissue and cellular level. Coordinated changes in epigenomic programming drive the cellular variation that controls human biology, in both healthy and diseased states. Omega’s platform enables controllable and tunable epigenomic programming. It will provide patients and physicians with therapeutic alternatives to gene editing and gene therapy while offering the advantages of programmable, nucleic acid sequence-based targeting of medicines, while also avoiding the challenges of small molecule-based epigenetic approaches." Precision Genomic Control delivered through epigenomic programming. Omega’s novel engineered therapeutics, called Epigenomic Controllers, target optimal genomic loci with high specificity to deliver the required potent and durable therapeutic effect to precisely modulate or tune single or multiple genes, up or down, to unleash the human genome’s innate capacity to cure disease without altering native genomic nucleic acid codes.

"We are advancing the frontiers of medicine through epigenomic programming," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "We have engineered novel therapeutics that enable controllable epigenomic programming leading to single and multiple gene modulation. We have therapeutic programs in immunology, oncology, metabolism and other disease areas where our precision genomic modulation approach allows us to go after historically ‘undruggable’ targets," Mr. Karande continued. "Our approach utilizes well-proven aspects of mRNA-based therapeutics as well as drug delivery. We are privileged to continue the Flagship tradition of pioneering innovative genomic medicine-based therapeutic platforms with the potential to generate multiple products, the first of which we plan to have ready for the clinic in 2021."

Omega’s epigenomic programming platform is focused on selectively directing the human genome to treat and cure disease by precisely controlling genomic expression without altering native nucleic acid sequences. Omega has created a proprietary platform and knowledge base that identifies Insulated Genomic Domains (IGDs) and their biological functions in both healthy and diseased states across cell types. IGDs naturally function as the fundamental regulators of the human genome and can be modulated to up-or down-regulate single or multiple genes simultaneously. These scientific and product insights drive the discovery and development of disease-specific genomic modulators called Epigenomic Controllers, which are engineered to precisely tune genomic activity to desired therapeutic levels with high targeting specificity and durability of effect.

"Our Epigenomic Controllers comprise a DNA-binding domain and an epigenetic effector domain delivered as mRNA to modulate gene expression. Besides treating monogenic diseases, our therapeutics can, for example, target and modulate difficult-to-drug oncogenes and growth factors, treat complex multi-genic diseases, and control cellular programming and differentiation," said Thomas McCauley, Ph.D., the company’s Chief Scientific Officer. "A single intervention allows us to modulate single or multiple genes to the desired therapeutically-relevant level with high specificity and a controlled duration of effect through epigenomic programming. This is Precision Genomic Control at its best."

On July 29, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that it will host a conference call and webcast on Tuesday, August 4, 2020, at 4:30 pm ET to discuss a corporate update and financial results for the second quarter of 2020 (Press release, Oncolytics Biotech, JUL 29, 2020, https://ir.oncolyticsbiotech.com/news/detail/512/oncolytics-biotech-to-host-conference-call-to-discuss-second-quarter-financial-results-and-operational-highlights [SID1234562497]).

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Conference Call & Webcast

Date: Tuesday, August 4, 2020
Time: 4:30 pm ET
Dial In – Toll-Free: 1-(866)-269-4261
Dial In – International:1-(323)-347-3612
Conference ID:2366778
Webcast: Link

A live webcast of the call will also be available on the Investor Relations page of Oncolytics’ website at www.oncolyticsbiotech.com and will be archived for three months.

On July 29, 2020 Boston Scientific Corporation (NYSE: BSX) reported sales of $2.003 billion during the second quarter of 2020 (Press release, Boston Scientific, JUL 29, 2020, View Source [SID1234562496]). This represents a decline of (23.9) percent on a reported basis, (23.1) percent on an operational1 basis and (28.7) percent on an organic2 basis, all compared to the prior year period. The company reported a GAAP loss of $147 million or $(0.11) per share (EPS), compared to GAAP earnings of $154 million or $0.11 per share a year ago, and achieved adjusted earnings per share of $0.08 for the period, compared to $0.39 a year ago.

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"We remain focused on the safety of our team, our customers and the patients they serve, and were pleased to see the business recovering over the course of the quarter," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "With a strong pipeline of differentiated products and an agile global team, we’ll continue to execute on our strategy and make prudent decisions to position us for success as deferred procedures resume."

Second quarter financial results and recent developments:

Reported a GAAP loss of $(0.11) per share. Achieved adjusted earnings per share of $0.08. The company did not provide second quarter sales and EPS guidance due to ongoing uncertainty associated with the scope and duration of the COVID-19 pandemic.
Second quarter sales declined in each of our reportable segments4, compared to the prior year period:

MedSurg: (29.6) percent reported, (29.1) percent operational and (28.4) percent organic
Rhythm and Neuro: (33.2) percent reported, (32.7) percent operational and (33.4) percent organic
Cardiovascular: (18.7) percent reported, (17.6) percent operational and (25.3) percent organic

Second quarter regional5 sales declined, compared to the prior year period:

U.S.: (28.4) percent reported and operational
EMEA (Europe, Middle East and Africa): (27.2) percent reported and (25.6) percent operational
APAC (Asia-Pacific): (14.8) percent reported and (14.0) percent operational
Emerging Markets3: (19.7) percent reported and (14.6) percent operational

Received U.S. Food and Drug Administration (FDA) approval for the WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device which is indicated to reduce the risk of stroke in patients with non-valvular atrial fibrillation. This next-generation implant is the first LAAC device that can be fully recaptured, repositioned and redeployed in the left atrial appendage, with additional design features to enhance safety and performance while treating a wider range of patient anatomies than the previous WATCHMAN LAAC device.
Received FDA approval for the SYNERGY XD Bioabsorbable Polymer (BP) Drug-Eluting Stent (DES) System, the next-generation SYNERGY BP-DES platform with the only 48 mm length DES available in the U.S. and enhanced deliverability features to enable improved arterial navigation in percutaneous coronary intervention (PCI) cases. The system was recently launched in Japan following approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
Received FDA 510(k) clearance and began limited market release for the LUX-Dx Insertable Cardiac Monitor (ICM) System, a new, long-term diagnostic device implanted in patients to detect arrythmias associated with conditions such as atrial fibrillation (AF), cryptogenic stroke and syncope. The LUX-Dx ICM System can be programmed remotely and have settings adjusted without requiring patients to visit their physician’s office and is designed with a dual-stage algorithm that detects and then verifies potential arrhythmias before an alert is sent to clinicians.
Received approval for the Eluvia Drug-Eluting Vascular Stent System from China’s Center for Medical Device Evaluation and will begin a limited market release by the end of the year. Also announced results of a sub-study of patients from the IMPERIAL trial who were treated with the Eluvia stent during the 2020 Vascular Interventional Advances (VIVA) Late-Breaking Clinical Trials Livestream event. Data demonstrated the Eluvia stent offers durable and consistent results in complex and long lesions, with an average lesion length of 162.8 mm and that patients treated with the Eluvia stent had a 77.2% Kaplan-Meier primary patency rate, a 13.6% clinically-driven target lesion revascularization rate and no stent thrombosis, despite long, heavily calcified lesions.
Received CE Mark and began limited European release for the INTELLANAV STABLEPOINT Ablation Catheter enabled with DIRECTSENSE Technology. This first-of-its-kind catheter combines measures of mechanical contact, or contact force, with local impedance to provide insight into the cardiac tissue’s response to ablation.
Received Centers for Medicare & Medicaid Services (CMS) approval for a new transitional pass-through (TPT) payment category to describe single-use endoscopes, including the EXALT Model D Single-Use Duodenoscope, to facilitate Medicare beneficiary access to the advantages of new and innovative devices by allowing for adequate payment while cost data is collected, starting July 1, 2020. The EXALT duodenoscope is the world’s first and only single-use, flexible duodenoscope cleared by the U.S. Food and Drug Administration (FDA), which eliminates the risk of infection from inadequate scope reprocessing between procedures.
Presented positive findings from the largest reported clinical experience to date with the LOTUS Edge Aortic Valve System at TVT Connect. Data from a pre-specified interim analysis of the first 50 patients enrolled in the European RESPOND EDGE post-market registry demonstrated no reports of mortality, no repeat procedures for valve-related dysfunction or re-hospitalization for valve-related symptoms and excellent valve hemodynamics, the lowest PVL rates in this valve category and a reduced permanent pacemaker implantation rate in line with competitive valves in real-world experience.
Commenced enrollment of the FROZEN-AF investigational device exemption (IDE) clinical trial which will evaluate the safety and effectiveness of the POLARx Cryoablation System for the treatment of paroxysmal atrial fibrillation (AF), an intermittent form of AF which causes an irregular and often abnormally fast heart rate.
Announced at HRS 2020 Science final results from the UNTOUCHED study of the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) System, the only FDA-approved implantable defibrillator without wires touching the heart, demonstrating high efficacy and safety of the device and a lower rate of inappropriate shock than many similar devices. Also presented as a late-breaking clinical trial at the virtual meeting were results from the investigator-sponsored PRAETORIAN trial confirming that the S-ICD can be the preferred therapy choice for the majority of ICD-indicated patients without a need for pacing.
Published a meta-analysis of 1,011 prostate cancer patients in The Journal of the American Medicine Association (JAMA) Network Open which found that placing SpaceOAR Hydrogel before radiation is an effective preventative strategy to reduce treatment-induced rectal complications. Each year, more than 1.1 million men are diagnosed with prostate cancer worldwide and approximately 400,000 men will undergo prostate radiotherapy. Recently, SpaceOAR surpassed 100,000 patients treated worldwide.
Announced The Lancet Neurology publication of the INTREPID study—a double-blind, randomized study evaluating the Vercise Deep Brain Stimulation (DBS) system for Parkinson’s disease. One-year results demonstrated a significant 51% improvement in motor symptoms (UDPRS III scores) compared to pre-surgery screening and six additional hours of ON time – or daily symptom control – over medication.
Launched a multi-year program to combat racism, inequity and injustice, including $3.5 million in philanthropic commitments, focused on five pillars: community, economic empowerment, education, healthcare disparities and government/legislative change.
Increased financial flexibility by completing a public offering of $1.7 billion aggregate principal amount of Senior Notes, as well as completing an approximately $2.0 billion public offering of common stock and mandatory convertible preferred stock, and using a portion of the proceeds of both offerings to repay borrowings under our revolving credit facility and a significant portion of our pre-payable bank debt.

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

2. Organic revenue growth excludes the impact of foreign currency fluctuations and sales from the recent acquisitions of Vertiflex, Inc. and BTG plc (BTG), each with no prior year comparable 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, as well as the Q2 divestiture of our intrauterine health franchise.

3. 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.

4. 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.

5. 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. 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.

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.

On July 29, 2020 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) reported the pricing of an underwritten public offering of 52,173,913 shares of its common stock (Press release, Sunesis, JUL 29, 2020, View Source [SID1234562495]). The public offering price of each share of common stock is $0.23.

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Sunesis expects to receive gross proceeds of approximately $12 million from this offering, before deducting the underwriting discounts and estimated offering expenses. Sunesis has granted the underwriters a 30-day option to purchase up to an additional 7,826,086 shares of common stock to cover over-allotments, if any. This offering is expected to close on or about July 31, 2020, subject to customary closing conditions. Sunesis anticipates using the net proceeds from the proposed offering to fund ongoing development of PDK1 inhibitor SNS-510 and general corporate purposes.

Oppenheimer & Co. Inc. is acting as the sole book-running manager in this offering.

The securities described above are being offered by Sunesis pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission (the "SEC"), originally filed with the SEC on June 8, 2017 and which the SEC declared effective on November 21, 2017. A preliminary prospectus supplement related to the offering has been filed with the SEC and a final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the preliminary and final prospectus supplements and the accompanying prospectus relating to this offering, when available, may be obtained on the SEC’s website or from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, by telephone at 212-667-8055, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On July 29, 2020 Alkermes plc (Nasdaq: ALKS) reported financial results for the second quarter of 2020 and provided updated financial expectations for full-year 2020 (Press release, Alkermes, JUL 29, 2020, View Source [SID1234562494]). The company had previously withdrawn its 2020 financial expectations due to uncertainties regarding the impact of the COVID-19 pandemic on its business.

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"During the second quarter, we adapted in response to the changing conditions in a complex environment. As we enter the second half of 2020, we are focused on three strategic imperatives. The first is commercial execution, as we drive to maximize the opportunities for ARISTADA and VIVITROL and prepare for the potential launch of ALKS 3831. The second is aggressive development of our pipeline programs, focusing on high-value opportunities that we believe have the potential to address patient needs and drive significant value in the near- and long-term. ALKS 4230, our lead oncology candidate, is the most prominent of these opportunities. The third is efficient management of our operating structure, with a focus on rigorous expense management and careful prioritization of our investments," said Richard Pops, Chief Executive Officer of Alkermes.

"We distinguish ourselves from other biopharmaceutical companies through our efforts in serious mental illness and addiction — chronic, highly prevalent conditions that affect millions of people and represent some of the most challenging public health issues of our time. We have built our organization with purpose and invested in specialized commercial capabilities to navigate fragmented treatment systems as we help address the complex challenges that patients with these diseases face," continued Mr. Pops. "As the nation’s response to COVID-19 continues, it is critical that we work to mitigate the pandemic’s secondary impacts related to social isolation, economic hardship and anxiety. For many patients struggling with serious mental illness and addiction, the current environment has amplified the barriers to treatment that Alkermes has worked for many years to address. We believe it is our responsibility to help ensure that the treatment system continues to function for these patients."

Quarter Ended June 30, 2020 Financial Highlights

Total revenues for the quarter were $247.5 million, compared to $279.9 million for the same period in the prior year.

Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $29.4 million for the quarter, or a GAAP net loss per share of $0.19. This compared to GAAP net loss of $42.0 million, or a GAAP net loss per share of $0.27, for the same period in the prior year.

Non-GAAP net income was $8.9 million for the quarter, or a non-GAAP basic and diluted earnings per share of $0.06. This compared to non-GAAP net income of $13.7 million, or a non-GAAP basic and diluted earnings per share of $0.09, for the same period in the prior year.

Quarter Ended June 30, 2020 Financial Results

Revenues

Net sales of proprietary products were $130.4 million, compared to $136.6 million for the same period in the prior year.

Net sales of VIVITROL were $71.6 million, compared to $88.2 million for the same period in the prior year, representing a decrease of approximately 19%, driven primarily by a decline in new patient starts and more restricted access to healthcare providers that resulted from COVID-19-related disruptions.

Net sales of ARISTADA1 were $58.8 million, compared to $48.4 million for the same period in the prior year, representing an increase of approximately 21% driven primarily by increased breadth of the ARISTADA provider base and growth of the ARISTADA two-month dose.

Manufacturing and royalty revenues were $116.5 million, compared to $127.9 million for the same period in the prior year.

Manufacturing and royalty revenues from RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA were $83.1 million, compared to $91.9 million for the same period in the prior year, primarily driven by a decrease in manufacturing and royalty revenues related to RISPERDAL CONSTA.

Costs and Expenses

Total operating expenses were $281.2 million, compared to $315.8 million for the same period in the prior year.

Research and Development (R&D) expenses were $94.2 million, compared to $104.4 million for the same period in the prior year.

Selling, General and Administrative (SG&A) expenses were $132.0 million, compared to $155.1 million for the same period in the prior year.

Balance Sheet

At June 30, 2020, Alkermes recorded cash, cash equivalents and total investments of $539.6 million, compared to $549.7 million at March 31, 2020. Cash on hand at June 30, 2020 significantly exceeded the company’s total debt outstanding of $276.1 million under its term loan, which matures in March 2023.

"Our second quarter results reflect solid execution across the business. The performance of the ARISTADA product family, together with disciplined management of expenses, partially offset the negative impact on VIVITROL net sales that resulted from COVID-19-related decreases in patient visits to healthcare providers and treatment centers. With increased visibility into the expected impact of COVID-19 on our commercial portfolio, today we are issuing financial expectations for 2020 that reflect current trends and underscore our commitment to driving non-GAAP profitability," commented James Frates, Chief Financial Officer of Alkermes. "Over the past five years, we have grown our topline while investing in the future growth drivers of our business. Directly as a result of those investments, we established VIVITROL as an important therapeutic option for patients with opioid and alcohol dependence; we secured FDA approvals for the ARISTADA product family; we developed ALKS 3831 and submitted a New Drug Application for schizophrenia and bipolar I disorder; we built commercial psychiatry capabilities that support the growth of ARISTADA and which are also fully leverageable for ALKS 3831; we successfully developed VUMERITY and entered into a commercial collaboration that will provide 100% gross margin royalty revenues from net sales; we advanced development of ALKS 4230 while retaining optionality for strategic collaboration; and, we acquired a platform of histone deacetylase (HDAC) inhibitors that we believe will provide compelling pipeline opportunities in

neurodegeneration and oncology. We are focused on executing our business strategy and believe these investments have positioned the business to drive long-term profitability and value creation."

Financial Expectations for 2020

The following financial expectations for 2020 reflect the anticipated net impacts of the COVID-19 pandemic on Alkermes’ operating and financial results. Alkermes anticipates that the negative impact of COVID-19 on VIVITROL net sales will be partially offset by a decrease in operating expenses, notably within R&D. The ranges provided are based on current trends and assume that treatment provider practices and patient flow will continue to normalize. Additional wide-spread COVID-19-related restrictions or resurgence of COVID-19 could negatively impact the company’s ability to meet these expectations. All line items are according to GAAP, except as otherwise noted.

Governance Update

"Over the past 12 months, we conducted extensive shareholder outreach and engaged with shareholders representing approximately 60% in value of our outstanding ordinary shares. The Board values the views of our shareholders and, after considering their feedback, is taking actions to further strengthen our business and corporate governance practices. The Board believes these actions will help to position the company for long-term growth as we execute on our strategy," said David Anstice, Lead Independent Director of the Alkermes Board of Directors (the Board).

The company announced today that it plans to take a series of actions as part of its commitment to corporate governance best practices and regular Board refreshment.

First, the Board will recommend that shareholders approve, at the company’s 2021 Annual General Meeting of Shareholders, an amendment to the company’s Articles of Association to declassify the Board. Currently, the Board has three classes of directors, with directors in each class elected to three-year terms. Once the Board is declassified, the directors will be combined into a single class elected annually.

Second, the Board has engaged a leading recruitment firm to identify independent director candidates whose experience and expertise offer valuable insights and strategic leadership at this stage in Alkermes’ evolution. As part of this process, the company expects certain of its longer-serving directors will retire from the Board. This Board refreshment process will continue and build on the efforts undertaken by the company in the fall of 2019 that led to the addition of two highly-qualified, independent directors, Dr. Richard Gaynor and Mr. Andy Wilson, to the Board.

Recent Events

Schizophrenia portfolio

In May 2020, presented new research from the company’s schizophrenia portfolio at the American Society of Clinical Psychopharmacology (ASCP) 2020 Annual Meeting, including data from patient-reported evaluations relating to treatment with ALKS 3831 and satisfaction data relating to treatment with ARISTADA.

In July 2020, announced a new survey conducted by The Harris Poll for Alkermes, which explored the current use and future potential of telepsychiatry services during and after the COVID-19 pandemic.

ALKS 4230

In June 2020, presented positive preclinical data from a study designed to evaluate the combination potential of ALKS 4230, Alkermes’ investigational engineered interleukin-2 (IL-2) variant immunotherapy, with lucitanib, Clovis Oncology, Inc.’s investigational angiogenesis inhibitor, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II.

Corporate citizenship

In June 2020, announced that 10 nonprofit organizations were awarded grants from the company’s COVID-19 Relief Fund, a special edition of the company’s signature Alkermes Inspiration Grants program, that was established to assist nonprofit organizations in their work to rapidly address pandemic-related needs for people living with addiction, serious mental illness, or cancer.

In July 2020, published Alkermes’ latest Corporate Responsibility Report which outlines how the company integrates environmental, social and governance considerations into all aspects of its business. A copy of the report is available on the Responsibility section of Alkermes’ website.

Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, July 29, 2020, to discuss these financial results, financial expectations, and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Wednesday, July 29, 2020, through Wednesday, Aug. 5, 2020, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay conference ID is 13707215.