On June 8, 2020 Quantum Leap Healthcare Collaborative (Quantum Leap) reported an evaluation of SAR439859, an oral estrogen receptor degrader (SERD) in a new I-SPY 2 study arm targeting patients with newly diagnosed hormone receptor-positive (HR+) clinical stage 2/3 invasive breast cancer (Press release, QuantumLeap, JUN 8, 2020, View Source [SID1234560884]).

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This study arm, known as the I-SPY-2 Endocrine Optimization Pilot Protocol (EOP), is focused on patients with molecularly low risk (MammaPrint low risk signature), clinically high risk, hormone receptor positive (HR+), and HER2-negative breast cancer. These patients historically have been excluded from the I-SPY2 trial due to the predicted lack of chemotherapy benefit. However, these patients often have late risk of recurrence (after 5 years), and thus also need novel strategies that are more tolerable and more effective than the current standard. The EOP is a sub-study within the main I-SPY-2 clinical trial utilizing an endocrine therapy backbone for patients whose tumors are predicted to be sensitive to endocrine therapy but for whom chemotherapy provides little or no benefit.

The selective estrogen receptor degrader (SERD) class of compounds have demonstrated benefit in HR+ HER2-negative metastatic breast cancer, including tumors with estrogen receptor activating mutations. They appear to be very well tolerated. Next-generation orally-bioavailable SERDs with improved pharmacokinetic properties are promising potential therapies for HR+ breast cancer. The EOP study will use an oral SERD as the endocrine therapy backbone. Sanofi’s SAR439859 has been selected as the oral SERD for this study. SAR439859 is a potent, orally bioavailable, and selective estrogen receptor (ER) inhibitor that belongs to the selective estrogen receptor degrader (SERD) class of compounds. SAR439859 antagonizes the binding of estradiol to ER but also promotes the transition of ER to an inactive conformation that results in up to 98% receptor degradation at nanomolar concentrations in cellular assays. These dual properties of SAR439859 we hope will translate to a deeper inhibition of ER pathways and a more effective antiproliferative activity in ER-dependent breast cancer cell lines driven by mutant or wild-type ER compared to other ER inhibitors. SAR439859 is an investigational compound and its safety and efficacy have not been evaluated by any regulatory authority.

In EOP, Sanofi’s oral SERD will be evaluated alone and in combination with up to three other investigational agents for a total of up to four study arms. The combination partner agents will be selected based on complementary biology utilizing orthogonal mechanisms of action. I-SPY 2 principal investigator, Dr. Laura Esserman of the University of California San Francisco, stated, "The whole I-SPY team is excited to have Sanofi as a partner in this endeavor. This is an important advance for patients with hormone positive high clinical risk breast cancer profiles who are not responsive to chemotherapy and for whom standard hormonal therapies may not be sufficient. As well, we need endocrine therapies that are easier for women to tolerate. We are committed to finding more effective, less toxic treatments and this partnership with Sanofi will help us to achieve this goal. Using the I-SPY model we can accelerate the development of new cancer treatments and target new and innovative treatments to the patients who will benefit most."

Sanofi will supply SAR439859 and provide financial support for this study. Quantum Leap, as sponsor, will provide the clinical sites and clinical expertise.

On June 8, 2020 Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of immune reset to more patients, reported that the company will participate in a fireside chat and hold investor meetings at the 41st annual Goldman Sachs Healthcare Conference on June 11th, 2020 (Press release, Magenta Therapeutics, JUN 8, 2020, View Source [SID1234560900]). The Company will also hold investor meetings and participate in a panel discussion on novel approaches for gene therapy on Monday, June 15th at the Raymond James Human Health Innovation Conference.

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A live webcast of the fireside chat at the Goldman Sachs conference can be accessed on the Magenta Therapeutics website at View Source The webcast replay will be available for 90 days following the event.

On June 8, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that the company plans to present at the following virtual conferences in June (Press release, Iovance Biotherapeutics, JUN 8, 2020, View Source [SID1234560936]):

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Goldman Sachs 41st Annual Global Healthcare Conference
Date/Time: Thursday, June 11, at 3:00 p.m. ET

JMP Securities Hematology and Oncology Forum
Date/Time: Thursday, June 18, at 2:20 p.m. ET
Live and archived webcasts of the presentations will be available in the Investors section of the Iovance website at View Source

On June 8, 2020 Enzo Biochem, Inc. (NYSE:ENZ), a leading biosciences and diagnostics company, reported results for the third quarter ended April 30, 2020 (Press release, Enzo Biochem, JUN 8, 2020, View Source [SID1234560901]).

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Elazar Rabbani, PhD., Chairman and Chief Executive Officer, said: "The COVID-19 pandemic has brought unique challenges as well as opportunities for Enzo. The company has applied several years of investment in technology and product development and rapidly launched a COVID-19 test on its proprietary GenFlex molecular diagnostics platform and serological tests for antibodies on its ELISA platform.

"The value proposition for Enzo is clear with its distinct advantage as a vertically integrated company. By leveraging control of our own supply chain in conjunction with our proprietary platforms, we are able to address the unprecedented needs underlying this health crisis. The result is the launch of an extensive COVID-19 program that goes beyond testing alone and spans virus detection, immunity, inflammation and therapy. This is further testament to our ability to deliver high performance, open, flexible, adaptable and cost-effective products, devices and services. It demonstrates how we are uniquely positioned to gain momentum within the broader molecular diagnostics market."

Third Quarter Highlights

·Enzo Life Sciences launched COVID-19 related molecular diagnostics products as well as serological related products under the FDA’s Emergency Use Authorization.
·Enzo Clinical Labs launched comprehensive molecular COVID-19 testing services, rolled out a drive-through facility for COVID-19 testing on Long Island, New York and introduced serological IgG antibody detection testing.
·Enzo Therapeutics had two significant patents issued, including one regarding Enzo’s proprietary compound SK1-I (a potential option as a therapeutic treatment for COVID-19) and another for methods of producing monoclonal antibodies against the osteoporosis drug target Sclerostin.
Third Quarter Results

·Total third quarter revenue was $16.9 million, a decrease of 14% from $19.7 million in the third quarter last year. Clinical Services revenue decreased 11% to $10.5 million from $11.8 million in the third quarter last year. This was driven by a 28% reduction in accession volume due to factors related to the COVID-19 pandemic. Product revenue of $6.4 million decreased 19% from $7.9 million in the third quarter last year also due to the impact of COVID-19, partially offset by a 19% increase in average product order value.
·Consolidated gross margin was 26.2% compared to 27.0% a year ago. Clinical services gross margin increased to 12.9% from 6.7% in the third quarter last year, primarily due to cost efficiencies and supplemental grant income, partially offset by accession volume declines due to the COVID-19 pandemic. Product gross margin declined to 47.9% from 57.1% in the third quarter last year due to the impact of the COVID-19 pandemic.
·Net loss was ($9.9) million, or ($0.21) per share, compared to net income of $22.3 million, or $0.47 per share a year ago. Adjusted EBITDA loss was ($7.4) million, or ($0.16) per share, compared to Adjusted EBITDA loss of ($6.1) million, or ($0.13) per share, in the third quarter of 2019. Last year’s third quarter results benefitted from legal settlements and licensing payments, net of $28.9 million related to a patent infringement and contract case in New York and a patent infringement case in Delaware.
·Adjusted EBITDA is described below under "Adjusted Financial Measures" and is reconciled to the most directly comparable GAAP financial measure, GAAP income (loss), in the accompanying tables.
·At quarter-end, cash, cash equivalents and restricted cash totaled $55 million. The company added $10.6 million of capital in the third quarter to strengthen its balance sheet through various grants, loans and advanced payments.
Barry Weiner, President, said: "Our third quarter results reflect the substantial challenges affecting our core business operations during this unprecedented time. The dedication of our staff ensured our ability to maintain operations and launch new processes and systems in a difficult environment. Our operating performance was impacted by revenue loss related to the coronavirus pandemic, partially offset by supplemental grant income and improvements in cost of goods sold and other spending. Despite these dynamics, we saw favorable trends in average product order value and year-over-year expansion in clinical services gross margins. We continue to make positive progress across the cost efficiency measures we have implemented and have recognized more than $8 million towards our $10 million target.

"Our strategic goal remains investing in key focus areas including our proprietary lab developed tests. This investment should have a significant positive impact on gross margins in a post-COVID environment. While accession volume increased slightly subsequent to the quarter-end, along with the rest of the industry we remain affected by lower volume in the clinical lab segment, in addition to COVID-19 impacted revenue in the life sciences segment. We expect these issues to be partially counterbalanced by new opportunities related to the COVID-19 pandemic. These opportunities include prospects ranging from academic and research institutions to commercial, laboratory, and government entities. In Enzo Life Sciences, we are offering a full range of COVID-19 products including sample collection, molecular, and IgG antibody kits on a global basis as well as instrumentation. On the Enzo Clinical Lab side, we expect to ramp up substantially throughout the year from our initial weekly capacity of approximately 10,000 COVID-19 molecular tests and 10,000 ELISA serological antibody tests."

Conference Call

The third quarter 2020 earnings conference call and webcast will be held today, Monday, June 8, 2020, at 5:00 p.m. Eastern Time. Enzo Biochem management will host the call, followed by a question and answer session. All interested parties may dial +1 323-794-2590 and reference confirmation code "9751599" to listen to the quarterly conference call or participants may join the audio webcast. A replay of the call will be available via webcast for on-demand listening shortly after completion of the call on the Investor Relations section of the company’s website, View Source, and will remain available for approximately 90 days.

Adjusted Financial Measures

To comply with Regulation G promulgated pursuant to the Sarbanes-Oxley Act, Enzo Biochem attached to this news release and will post to the investor relations section of the company’s website (View Source) any reconciliation of differences between GAAP and Adjusted financial information that may be required in connection with issuing the Company’s quarterly financial results.

The Company uses EBITDA as a measure of performance to demonstrate earnings exclusive of interest, taxes, depreciation and amortization. Adjustments to EBITDA are for items of a non-recurring nature and are reconciled on the table provided. The Company manages its business based on its operating cash flows. The Company, in its daily management of its business affairs and analysis of its monthly, quarterly and annual performance, makes its decisions based on cash flows, not on the amortization of assets obtained through historical activities. The Company, in managing its current and future affairs, cannot affect the amortization of the intangible assets to any material degree, and therefore uses EBITDA as its primary management guide. Since an outside investor may base its evaluation of the Company’s performance based on the Company’s net loss not its cash flows, there is a limitation to the EBITDA measurement. EBITDA is not, and should not be considered, an alternative to net loss, loss from operations, or any other measure for determining operating performance of liquidity, as determined under accounting principles generally accepted in the United States (GAAP). The most directly comparable GAAP reference in the Company’s case is the removal of interest, taxes, depreciation and amortization.

We refer you to the tables attached to this press release, which includes reconciliation tables of GAAP to Adjusted net income (loss) and EBITDA to Adjusted EBITDA.

On June 8, 2020 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company" or "Pulse Biosciences"), a novel bioelectric medicine company, reported preliminary results of its rights offering, which expired at 5:00 p.m. Eastern Time on June 8, 2020 (the "Expiration Date") (Press release, Pulse Biosciences, JUN 8, 2020, View Source [SID1234560918]).

In accordance with the pricing structure described in the prospectus relating to the rights offering, the final subscription price for the units offered (the "Units") is $7.01 per Unit, which is the initial price established at commencement of the rights offering. Each Unit consisted of one share of the Company’s common stock, par value $0.001 per share, and 0.15 warrants to purchase shares of common stock. Each warrant will be exercisable for one share of the Company’s common stock at an exercise price that shall be equal to $7.01, the subscription price for the Units. Warrants are exercisable immediately and expire on the fifth anniversary of the completion of this rights offering.

Based on a preliminary tabulation by Broadridge Corporate Issuer Solutions, Inc. (the "Subscription Agent"), as of the Expiration Date, the Company received basic subscriptions and over-subscriptions exceeding the maximum number of up to 4,279,600 Units offered in the rights offering. Available Units will be allocated proportionately among rights holders who exercised their over-subscription right based on the number of Units each rights holder subscribed for under their basic subscription rights, in accordance with the procedures described in the prospectus relating to the rights offering. The common stock and warrants comprising the Units will separate upon the closing of the rights offering and will be issued individually. The Company expects the Subscription Agent to distribute such shares and warrants, as well as the sale proceeds, on or about June 11, 2020.

The Company will receive aggregate gross proceeds from the rights offering of $30 million, excluding proceeds of up to $4.5 million from the exercise of warrants issued in the rights offering (if any such exercises occur). The results of the rights offering are preliminary and subject to change pending finalization of subscription procedures by the Subscription Agent.

A registration statement, as amended, relating to the Units was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on May 8, 2020. A prospectus relating to the offering was filed with the SEC on May 14, 2020 and is available on the SEC’s website. Subscription rights that were not exercised by 5:00 p.m. Eastern Time on June 8, 2020 have expired.

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