On April 2, 2020 Dilon Technologies Inc., a world class global leader in breast cancer treatment and diagnosis and owner of the Navigator Gamma Probes reported that it has acquired substantially all the assets of Dune Medical, including Dune Medical’s "MarginProbe" (Press release, Dune Medical Devices, APR 2, 2020, View Source [SID1234556800]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"With the acquisition of the MarginProbe, Dilon will now offer the only FDA approved device for identifying positive margins during breast conservation surgery. MarginProbe’s patented RF technology differentiates cancerous versus healthy tissue in real-time. This allows surgeons to immediately remove additional tissue, helping to reduce avoidable surgeries" said Dilon’s Chairman, Bob Moussa, who continued, "The synergy between Dilon’s Navigator Gamma Probes and the MarginProbe will help patients and physicians answer the question, "did we get it all?" when that answer is most needed. In addition to the advantages to the patients, the reduction in re-excision rate will provide major savings to health care systems."

As a global provider of breast cancer solutions, Dilon’s Navigator Gamma Probes are used for radio-guided lymphatic mapping and tumor localization world-wide. "The combination of Dilon’s class leading Navigator Gamma Probes with the MarginProbe is a natural fit. Dilon’s already strong sales network is synergistic and well suited to expand the MarginProbe’s potential as the products are literally used side by side by the same physician; now they will be sold that way as well. The market in the United States alone exceeds $150m annually, and as a US based company, Dilon has a home field advantage in the MarginProbe’s biggest market. Luminaries and thought leaders have already adopted MarginProbe as their standard of care in the US. Our goal is to make MarginProbe the standard of care worldwide."

On April 2, 2020 Mateon Therapeutics Inc. (OTCQB:MATN) reported the publication of a peer-reviewed research article co-authored by Fatih Uckun MD PhD, Sanjive Qazi PhD, and Vuong Trieu, PhD in the oncology journal Cancer Reports and Reviews (Press release, Mateon Therapeutics, APR 2, 2020, View Source [SID1234556167]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

We previously reported the preliminary findings of a Phase II study (NCT00431561) confirmed its favorable safety profile and showed that OT101 can offer early disease control to R/R high-grade glioma patients at 6 months at a rate comparable to that achieved with the standard alkylating chemotherapy drug temozolomide. We are now reporting our analysis of the long-term follow-up data on the recalcitrant/resistant anaplastic astrocytoma (R/RR AA) patient subpopulation treated in the NCT00431561 study as proof of concept for the clinical utility of the Convection Enhanced Delivery of OT-101 platform (CEDOT). Notably, OT101 administered intratumorally via the CEDOT platform exhibited clinically meaningful single-agent activity and induced durable complete response (CR), partial response (PR) in more than half of the treated R/R AA patients. The median overall survival of patients receiving the CEDOT-delivered experimental therapy 1136 (95% CI:811 – 1743) days which was significantly better than the 590 (95% CI:287 – NA) days median OS (Log Rank χ2=6.5, P-value=0.011) of the TMZ-treated patient population.

"This work demonstrates superiority of OT-101 against an approved chemotherapeutic agent against AA and emphasizes our commitment to find effective new therapies for difficult-to-treat cancers," stated Dr. Vuong Trieu, Chairman and Chief Executive Officer of Mateon Therapeutics.

OT-101 has received orphan drug designation for glioblastoma, melanoma, and pancreatic cancer. Furthermore, FDA recently granted Rare Pediatric Designation for OT-101 against diffuse intrinsic pontine glioma (DIPG). OT-101 is also effective against coronavirus including COVID-19 and being deployed against the COVID-19 epidemic.

On April 2, 2020 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, reported the pricing of its initial public offering of 9,180,000 shares of common stock at a public offering price of $18.00 per share, for total gross proceeds of approximately $165.2 million, before deducting underwriting discounts and commissions and offering expenses payable by Zentalis. All of the common stock is being offered by Zentalis (Press release, Zentalis Pharmaceuticals, APR 2, 2020, View Source [SID1234556120]). The offering is expected to close on April 7, 2020, subject to customary closing conditions. In addition, Zentalis has granted the underwriters a 30-day option to purchase up to an additional 1,377,000 shares of its common stock at the initial public offering price less the underwriting discounts and commissions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Zentalis’ common stock is expected to begin trading on the Nasdaq Global Market on April 3, 2020, under the ticker symbol "ZNTL."

Morgan Stanley, Jefferies, SVB Leerink and Guggenheim Securities are acting as joint book-running managers for the offering.

A registration statement relating to the securities being sold in the offering has been declared effective by the U.S. Securities and Exchange Commission on April 2, 2020. This offering is being made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained, when available, by contacting:

Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, Second Floor, New York, New York 10014, Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, via telephone: 877-821-7388 or via email: [email protected], SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6218, or by emailing [email protected], Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-5548, or by email at [email protected].

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

On April 2, 2020 IntegraGen (FR0010908723 – ALINT – Eligible PEA PME), a company specializing in the decryption of the human genome, which performs interpretable genomic analyzes for academic and private laboratories, reported its financial results for the year ending December 31, 2019 (Press release, Integragen, APR 2, 2020, file:///C:/Users/komal/Downloads/press-release-2019-results-eng-corrected.pdf [SID1234556116]). The annual accounts were approved by the Board of Directors at a meeting held on April 2, 2020.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Bernard Courtieu, Chairman and CEO of IntegraGen said: "2019 was marked by a significant increase in our sales, in particular as a result of the start-up of the SeqOIA platform. IntegraGen recorded a positive gross operating surplus during the second half of the year, representing 6% of sales, which enables us to reach an EBIT close to breakeven over the entire year. This financial performance enables us to stabilize our cash flow needs. We have continued to develop our software for interpreting genomic data and are putting the resources in place to accelerate its commercialization in 2020."

SUSTAINED SALES GROWTH DURING 2019: +20%
In 2018, the GCS SeqOIA, made up of the Assistance Publique-Hôpitaux de Paris (AP-HP), the Institut Curie and the Gustave Roussy cancer center, selected IntegraGen’s bid to supply a service to operate a high-speed sequencing data production platform. The operation of this platform started in early 2019 and the first patient samples were sequenced in June 2019. This contract made it possible to achieve a turnover of 2,037 K€ during the financial year.

Genomic services activities, which include services provided to research laboratories clinical research teams, are now concentrated in our Evry site. In total, the IntegraGen team carried out more than 475 projects for 130 academic and private entities, while the clinical research platform has sequenced more than 900 samples from more than 310 patients included in prospective trials. After a slow start to the year, volumes and order intake rebounded sharply in the second quarter. IntegraGen also continues to provide services on behalf of the Institut Pasteur’s shared microbiology (P2M) platform. In 2019, this activity generated turnover of 1,010 K€, up 27% compared to the previous year. The contract was renewed in March 2020 for a period of 22 months ending in December 2021. The IntegraGen team is closely supporting the experts from the various National Reference Centers (CNR) of the Institut Pasteur. The P2M is currently primarily dedicated to the sequencing of the coronavirus during the Codiv-19 pandemic.

INCREASE IN SALES OF GENOMIC INTERPRETATION SOFTWARE
The company currently offers three distinct software for interpreting genomic data, available on the cloud as SaaS tools: MERCURY, for the interpretation of data from patients with cancerrelated tumors, SIRIUS for analyzing research samples, particularly for research applications in constitutional genetics, and, Galiléo, launched in 2019, for the analysis of RNA expression data. The sale of software tools generated revenue of 527,000 €, up 29% compared to the prior year.

This segment represents strong development potential for the company in both in Europe and the Americas. The agreement announced on March 26 with the Dana-Farber Cancer Institute, a U.S. leader in cancer research and treatment, for the use of MERCURY is a major step. The decision made by Dana-Farber’s use MERCURY demonstrates the utility of the software in the interpretation and reporting of oncology sequencing data

SIGNIFICANT IMPROVEMENT IN OPERATING RESULT

The company became cash flow positive in the second half as a result of the company’s commercial and scientific development efforts in recent years as well as the rigorous management of resources.

Operating revenues increased 18% while operating expenses increased only 5% compared to 2018.

Purchases of consumables amounted to 2,564 K€, down 7% compared to the previous year. New sequencing equipment installed in early 2019 has made it possible to take stepstowards lowering the company’s costs associated with sequencing services. While employee costs were up 4%, the company’s workforce increased by 7%. Other operating expenses amounted to 2,526 K€, the 16% increase being mainly related to new equipment leasing contracts concluded at the end of 2018.

The annual gross operating surplus (EBITDA) was close to breakeven. It amounted to (70) K€, compared to (1,038) K€ in 2018.

The operating loss is therefore a clear decrease compared to previous years amounting to 363 K€ in 2019 compared to 1,179 K€ in 2018 and 1,930 K€ in 2017.

The financial result represents a gain of 61 K€ against a loss of 14 K€ the previous year. The exceptional result is a net loss of 136 K€ compared to a loss of 139 K€ in 2018.

Research, development and innovation efforts have resulted in a tax credit of 153 K€, compared to 193 K€ in 2018.

IntegraGen limited its loss to 285 K€ compared to a loss of 1,140 K€ in 2018.

Net cash at the end of 2019 amounted to 2.7 M€ compared to 3.9 M€ at the end of 2018.

It includes:

-2,807 K€ in cash and investment securities.
-58 K€ of financial debts of less than 1 year, linked to the loan taken out in 2018 for an amount of 300 K€ with Société Générale, repayable over 5 years.

For 2019, operational cash consumption amounted to 0.7 M€, of which 0.6 M€ were related to short-term operating debts, recorded in the balance sheet in December 2018 and related to nonrecurring purchase of specific equipment for the SeqOIA platform.

2020 OUTLOOK: CONTINUED EXPECTED GROWTH

The SeqOIA project should contribute a minimum sale revenue of 2,700 K€, and as a result, we anticipate strong growth in sales for the financial year.

The company also plans to increase sales of software for interpreting sequencing data (SIRIUS, MERCURY and GALILEO) as SaaS tools (Software as a Service). The recent agreement with the Dana-Farber Cancer Institute noted above is a major validation of this software strategy.

The company’s contract with the Institut Pasteur was extended until December 2021, on the basis of a slightly higher level of service.

The available cash will finance operational and investment needs.

IMPACT OF THE HEALTH CRISIS

The company continues to fulfill its commitments to its customers and employees by making sure to rigorously adjust its resources. The team based at the Evry laboratory and the team based at the Pasteur Institute continue their activity. The company has set up a continuity plan, including teleworking for all IT and commercial teams, but also, from March 20, the implementation of partial unemployment measures, the deferral of payment of social and tax charges, and various other activities to preserve cash.

As of March 31, available cash was € 2.5 M€ and revenue (unaudited) was up 10% from the same period in 2019. Although IntegraGen is unable to assess the outlook to date of the second half of 2020, the company continues its sequencing operations, thanks to the commitment of the teams at our Evry site and the Pasteur Institute, and to the work of our bioinformatics experts via teleworking. The stability of the economic model of the company, based primarily on long-term guaranteed contracts and on academic and clinical research projects, in theory economic sectors which are less impacted by the crisis, should enable the company to resume normal activities when possible and the recovery of most of the lack of activity recorded during the pandemic.

On April 2, 2020 Nevro Corp. ("Nevro") (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported the pricing of concurrent underwritten public offerings of (a) 1,625,000 shares of its common stock at a public offering price of $84.00 per share for gross proceeds, before deducting underwriting discounts and commissions and estimated offering costs, of approximately $136,500,000 (the "common stock offering") and (b) $165,000,000 aggregate amount of its 2.75% convertible senior notes due 2025 (the "notes") (the "notes offering") (Press release, Nevro, APR 2, 2020, View Source [SID1234556114]). Nevro has granted the underwriters of the offerings a 30-day option to purchase an additional (a) 243,750 shares of common stock at the public offering price, less underwriting discounts and commissions and (b) $24,750,000 aggregate amount of notes, less underwriting discounts and commissions and solely to cover over-allotments with respect to the notes offering. All of the shares of common stock to be sold in the common stock offering are being offered by Nevro. The offerings of the shares and the notes are expected to close on April 6, 2020, subject to customary closing conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The notes will be senior, unsecured obligations of Nevro, and will bear interest at a rate of 2.75% per year. Interest will be payable semi-annually in arrears on April 1 and October 1 of each year, beginning on October 1, 2020. The notes will mature on April 1, 2025, unless earlier repurchased or converted. Nevro may not redeem the notes, and no sinking fund is provided for the notes. Holders of the notes will have the right to require Nevro to repurchase all or a portion of their notes upon the occurrence of a fundamental change (as defined in the indenture governing the notes) at a cash purchase price of 100% of their principal amount plus any accrued and unpaid interest to, but excluding, the fundamental change repurchase date.

The notes may be converted at an initial conversion rate of 9.5238 shares of Nevro’s common stock per $1,000 principal amount of notes (which is equivalent to an initial conversion price of approximately $105.00 per share and represents a conversion premium of 25.0% to the public offering price of Nevro’s common stock in the common stock offering). Prior to the close of business on the business day immediately preceding October 1, 2024, the notes will be convertible at the option of the holders of the notes only upon the satisfaction of specified conditions and during certain periods. On or after October 1, 2024 until the close of business on the second scheduled trading day preceding the maturity date, the notes will be convertible at the option of the holders of notes at any time regardless of these conditions. Conversions of the notes will be settled in cash, shares of Nevro’s common stock or a combination thereof, at Nevro’s election.

In connection with the pricing of the notes, Nevro entered into privately-negotiated convertible note hedge transactions with one or more of the underwriters and/or their respective affiliates and/or other financial institutions (the "option counterparties"). These transactions cover, subject to customary anti-dilution adjustments, the number of shares of Nevro’s common stock that will initially underlie the notes, and are expected generally to reduce the potential equity dilution, and/or offset any cash payments in excess of the principal amount due, as the case may be, upon conversion of the notes. Nevro entered into separate, privately-negotiated warrant transactions with the option counterparties at a higher strike price relating to the same number of shares of Nevro’s common stock, subject to customary anti-dilution adjustments, pursuant to which Nevro will sell warrants to the option counterparties. The warrants could have a dilutive effect on Nevro’s outstanding common stock to the extent that the price of Nevro’s common stock exceeds the strike price of those warrants. The strike price of the warrants will initially be $147.00 per share, which represents a premium of approximately 75% over the public offering price of Nevro’s common stock in the common stock offering and is subject to certain adjustments under the terms of the warrant transactions.

If the underwriters exercise their option to purchase additional notes, Nevro expects to enter into additional convertible note hedge transactions and additional warrant transactions with the option counterparties, which will initially cover the number of shares of Nevro’s common stock that will initially underlie the additional notes sold to the underwriters.

Morgan Stanley is acting as bookrunning manager for the offerings.

Nevro has been advised that in connection with establishing their initial hedges of the convertible note hedge and warrant transactions, the option counterparties or their respective affiliates expect to enter into various derivative transactions with respect to Nevro’s common stock concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of Nevro’s common stock or the notes at that time. The option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Nevro’s common stock and/or purchasing or selling Nevro’s common stock or other securities of Nevro in secondary market transactions from time to time following the pricing of the notes and prior to maturity of the notes (and are likely to do so during any observation period related to a conversion of the notes).

The potential effect, if any, of these transactions and activities on the market price of Nevro’s common stock or the notes will depend in part on market conditions and cannot be ascertained at this time, but any of these activities could adversely affect the value of Nevro’s common stock, which could affect the ability to convert the notes, the value of the notes and the amount of cash, if any, and the number of and value of the shares of Nevro’s common stock, if any, holders would receive upon conversion of the notes.

Nevro intends to use a portion of the net proceeds from the common stock offering and the notes offering to pay the cost of the convertible note hedge transactions (after such cost is partially offset by the proceeds to Nevro from the sale of the warrants). Nevro expects to use the remainder of the net proceeds from the common stock offering for general corporate purposes, including the repayment of its 1.75% Convertible Senior Notes due 2021 (the "existing convertible notes") at maturity and Nevro may use a portion of the remaining net proceeds to repurchase a portion of the existing convertible notes prior to their maturity. If the underwriters exercise their option to purchase additional notes, then Nevro intends to use a portion of the net proceeds from the sale of additional notes, together with the proceeds from the sale of additional warrants, to enter into additional convertible note hedge transactions with the option counterparties and Nevro intends to use the remaining net proceeds from the sale of such additional notes as set forth above.

A shelf registration statement on Form S-3 (including a base prospectus) relating to the common stock offering and the notes offering was automatically declared effective by the Securities and Exchange Commission ("SEC"). Preliminary prospectus supplements related to each of the common stock offering and the notes offering (together with such base prospectus, each a "prospectus"), have been filed with the SEC and are available on the SEC’s website located at www.sec.gov. Copies of the prospectus relating to the common stock offering and the notes offering may be obtained, when available, from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale, of these securities in any state or 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 jurisdiction.