On October 3, 2019 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 2020, which ended August 31, 2019 (Press release, AngioDynamics, OCT 3, 2019, View Source [SID1234540038]).

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!

"Our top-line and gross-margin performance in the quarter was in line with our expectations," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "We continue to build momentum and remain focused on driving growth by creating a suite of disruptive and differentiated technology. The divestiture of the NAMIC Fluid Management business allowed us to begin the year with a strong balance sheet, enabling strategic acquisitions like Eximo Medical, Ltd., which we announced this morning. Additionally, we continue to make steady progress with site initiation in our NanoKnife DIRECT study for pancreatic cancer."

First Quarter 2020 Financial Results

Net sales for the first quarter of fiscal 2020 were $66.0 million, an increase of 3.3%, compared to $63.9 million a year ago and representing a decline of 1.0% organically. Excluding the impact of Asclera, sales of which were discontinued during fiscal year 2019, net sales grew 5.6% year over year and grew 1.3% organically. Foreign currency translation did not have a significant impact on the Company’s sales in the quarter.

Oncology net sales were $14.0 million, an increase of 20.9% from $11.6 million a year ago, led by sales of the Company’s BioSentry Tract Sealant System, the Alatus and IsoLoc balloon products, NanoKnife, and Solero.
Vascular Interventions and Therapies ("VIT") net sales were $28.9 million, an increase of 1.1%, compared to $28.6 million a year ago. Excluding last year’s Asclera Sales of $1.4 million in the first quarter, VIT grew 6.4%, as strong growth in sales of the Company’s AngioVac and Thrombolytic product line offerings was partially offset by a decline in the overall Core VIT business.
Vascular Access net sales were $23.2 million, a decrease of 2.7% from $23.8 million a year ago, as lower sales of Ports and PICCs negatively offset growth in the Midlines and Dialysis businesses.
U.S. net sales in the first quarter of fiscal 2020 were $52.9 million, an increase of 2.8% from $51.5 million a year ago, and International net sales were $13.1 million, an increase of 5.3% from $12.4 million a year ago.

Gross margin for the first quarter of fiscal 2020 was 57.9%, an increase of 170 basis points compared to the first quarter of fiscal 2019, driven primarily by productivity and supply chain improvements as well as positive product mix.

The Company recorded a net loss from continuing operations of $1.3 million, or a loss of $0.03 per share, in the first quarter of fiscal 2020. This compares to a net loss from continuing operations of approximately $5.7 million, or a loss of $0.15 per share, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the first quarter of fiscal 2020 was $3.2 million, or $0.08 per share, compared to adjusted net income of $0.7 million, or $0.02 per share, in the first quarter of fiscal 2019.

Adjusted EBITDAS in the first quarter of fiscal 2020, excluding the items shown in the reconciliation table below, was $7.3 million, compared to $5.4 million in the first quarter of fiscal 2019.

In the first quarter of fiscal 2020, the Company used $6.5 million in operating cash flow and had capital expenditures of $1.4 million. As of August 31, 2019, the Company had $83.6 million in cash and cash equivalents and no debt outstanding.

Fiscal Year 2020 Financial Guidance

The Company continues to expect fiscal year 2020 net sales to be in the range of $280 to $286 million and gross margin to be in the range of 58% to 59%, inclusive of the Eximo acquisition.

Separately, the Company is updating its expectations for full-year adjusted earnings per share to account for investments related to the full-market launch of the products acquired from Eximo, anticipated in the second half of fiscal year 2020, and now expects adjusted earnings per share in the range of $0.10 to $0.15.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its fiscal 2020 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 13694372.

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, October 3, 2019, until 11:59 p.m. ET on Thursday, October 10, 2019. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13694372.

On October 3, 2019 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing potential new therapies for cancer, reported updated data from the ongoing Phase 1b study of investigational ME-401, a selective oral inhibitor of PI3K delta (Press release, MEI Pharma, OCT 3, 2019, View Source2019-10-03-MEI-Pharma-Announces-Updated-Clinical-Data-from-ME-401-Phase-1b-Study-in-Patients-with-Indolent-B-cell-Malignancies" target="_blank" title="View Source2019-10-03-MEI-Pharma-Announces-Updated-Clinical-Data-from-ME-401-Phase-1b-Study-in-Patients-with-Indolent-B-cell-Malignancies" rel="nofollow">View Source [SID1234540036]). These new data will be presented at MEI’s Investor and Analyst Event being held tomorrow, October 4, 2019, at 8:00 am ET.

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!

Highlights of the ME-401 updated data include:

Overall response rates of 78% in relapsed or refractory (r/r) follicular lymphoma (FL) and 89% in r/r chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).
Rates of Grade 3 adverse events of special interest related to ME-401 exposure were observed in <10% of patients dosed on an intermittent schedule (IS).
Median duration of response not yet reached in patients with FL or CLL/SLL on the IS regimen. Median follow-up for FL and CLL/SLL patients is 9.2 months (range 3.4-20.7 months) and 7.4 months (range 2.6-14.7 months), respectively.
At the Investor and Analyst event MEI will also review progress across the pipeline of its four clinical-stage oncology candidates with a focus on voruciclib, a cyclin-dependent kinase (CDK) inhibitor with potent CDK9 inhibition. Voruciclib is in a Phase 1b study in patients with r/r B-cell malignancies or Acute Myeloid Leukemia (AML) after failure of prior standard therapies. In addition, we plan to evaluate voruciclib in combination with venetoclax (marketed as Venclexta), a B-cell lymphoma (Bcl) 2 inhibitor, in patients with r/r AML.

"ME-401 continues to exceed expectations in the Phase 1b study; the overall response rate remains high at 81% with 73 evaluable FL and CLL/SLL patients being followed for treatment," Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "Currently, our primary focus is the ME-401 Phase 2 TIDAL study evaluating patients with relapsed or refractory follicular lymphoma, which may support an accelerated approval of a marketing application with FDA, as well as the continuing exploration of various combination regimens with ME-401."

Dr. Gold continued: "More broadly, MEI has a strong foundation to build value through advancing our pipeline, evaluating drug combination opportunities across the B-cell malignancy landscape, and continuing to create and explore strategic opportunities to most effectively leverage the potential of the pipeline. Each of our four clinical-stage oncology candidates is well positioned for continued clinical development."

Investor and Analyst Event Information

Date: Friday, October 4, 2019
Time: 8 am -11 am ET

The investor event will feature presentations from the following MEI Pharma executives:

Dan Gold, Ph.D., President and Chief Executive Officer, MEI Pharma.

Robert Mass, M.D., Chief Medical Officer, MEI Pharma.

Richard Ghalie, M.D., Senior Vice President, Clinical Development, MEI Pharma.
The event will also feature presentations by the following guest speakers:

Lewis C. Cantley, Ph.D., Meyer Director of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medical College, Professor of Cancer Biology in Medicine.

Nishitha M. Reddy, M.D., M.B.B.S., Associate Professor of Medicine at Vanderbilt University Medical Center.

Matthew J. Matasar, M.D., Medical Director, Memorial Sloan Kettering Bergen.
You can access the live webcast under the investor relations section of MEI’s website on the "Events and Presentation" page at: www.meipharma.com. A replay of the webcast will be archived for at least 30 days after the conclusion of the live event.

The full Investor and Analyst Event presentation will be available on the home page of the Investor Relations section of MEI Pharma’s website at: View Source

About MEI’s Clinical-Stage Oncology Pipeline

About ME-401
ME-401 is an oral, once-daily, selective phosphatidylinositol 3-kinase (PI3K) delta inhibitor in clinical development for the treatment of B-cell malignancies. MEI owns worldwide rights in all geographies except Japan, which we licensed to Kyowa Kirin Company (formerly "Kyowa Hakko Kirin Co., Ltd.") in 2018.

MEI is conducting two ongoing studies evaluating ME-401. The first is a Phase 2 clinical trial evaluating ME-401 as a monotherapy for the treatment of adults with relapsed or refractory follicular lymphoma ("FL") after failure of at least two prior systemic therapies including chemotherapy and an anti-CD20 antibody. Subject to the results, upon completion of the Phase 2 clinical trial, we are planning a submission with the FDA to support an accelerated approval of a marketing application under 21 CFR Part 314.500, Subpart H. The second is a multi-arm, open-label, Phase 1b dose escalation and expansion trial evaluating ME-401 as a monotherapy and in combination with other therapies or investigational agents in patients with relapsed or refractory B-cell malignancies.

About Voruciclib
Voruciclib is an orally administered cyclin-dependent kinase (CDK) inhibitor differentiated by its potent in vitro inhibition of CDK9, in addition to CDK6, 4 and 1. Voruciclib is currently being evaluated in a Phase 1b dose ranging trial in patients with relapsed and/or refractory B-cell malignancies or acute myeloid leukemia (AML) after failure of prior standard therapies.

About ME-344
ME-344 is our novel and tumor selective, isoflavone-derived mitochondrial inhibitor drug candidate. It directly targets the OXPHOS complex 1, a pathway involved in ATP production in the mitochondria. ME-344 was recently studied in an investigator-initiated, multi-center, randomized clinical trial in combination with the vascular endothelial growth factor (VEGF) inhibitor bevacizumab (marketed as Avastin ) in a total of 42 patients with HER2 negative breast cancer. The data established significant biologic activity in the ME-344 treatment group as measured by Ki67 reductions (a measure of cell proliferation that is highly correlated with tumor response).

About Pracinostat
Pracinostat is an oral histone deacetylase (HDAC) inhibitor being evaluated in a pivotal Phase 3 global registration clinical trial for the treatment of adults with newly diagnosed AML who are unfit to receive intensive chemotherapy. Pracinostat is also being evaluated in a Phase 2 trial in patients with high or very high-risk myelodysplastic syndrome (MDS). In August 2016, we entered into an exclusive worldwide license, development, manufacturing and commercialization agreement with Helsinn Healthcare SA, a Swiss pharmaceutical corporation for pracinostat in AML, MDS and other potential indications.

On October 3, 2019 Heron Therapeutics, Inc. ("Heron") (NASDAQ: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that it intends to offer and sell shares of its common stock in an underwritten registered public offering (Press release, Heron Therapeutics, OCT 3, 2019, View Source [SID1234540035]). Heron intends to grant the underwriters of the offering a 30-day option to purchase up to an additional 15% of the shares sold in the public offering. All of the shares of common stock in the offering are to be sold by Heron. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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!

Heron intends to use the proceeds from the proposed sale of its shares of common stock for the commercial launch of HTX-011, if approved by the U.S. Food and Drug Administration, the continued commercialization and marketing of SUSTOL and CINVANTI, Heron’s ongoing and future clinical trials, including further clinical studies for HTX-011, preclinical development work, other product development activities and general corporate purposes.

Jefferies, Cowen and Evercore ISI are acting as joint book-running managers for the offering. Cantor is acting as lead manager for the offering, and JMP Securities, Needham & Company and Northland Capital Markets are acting as co-managers for the offering.

The offering is being made pursuant to a registration statement that was filed with the U.S. Securities and Exchange Commission (the "SEC") and became automatically effective on July 6, 2017. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC. The securities described above have not been qualified under any state blue sky laws. 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. Copies of the preliminary prospectus supplement and accompanying prospectus relating to these securities may also be obtained by sending a request to Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at (877) 821-7388, or by email at [email protected], Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; or Evercore Group L.L.C. at Attention Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected].

On September 30, 2019, Dova Pharmaceuticals, Inc., a Delaware corporation ("Dova"), reported that it entered into an Agreement and Plan of Merger (the "Merger Agreement") with Swedish Orphan Biovitrum AB (publ), a Swedish public limited liability company ("Sobi"), and Dragonfly Acquisition Corp., a Delaware corporation and an indirect wholly owned subsidiary of Sobi ("Purchaser") (Filing, 8-K, Dova Pharmaceuticals, OCT 3, 2019, View Source [SID1234540034]). The Merger Agreement provides that, upon the terms and subject to the conditions thereof, as promptly as practicable (but in no event more than ten business days following the date of the Merger Agreement), Purchaser will commence a tender offer (the "Offer") to purchase each issued and outstanding share of common stock of Dova, $0.001 par value per share (the "Shares"), at an offer price of (i) $27.50 per Share, net to the seller thereof in cash, without interest and subject to any withholding taxes (the "Cash Amount"), plus (ii) one non-transferable contingent value right per Share (each, a "CVR", and, the Cash Amount plus one CVR, collectively, or any higher amount per Share paid pursuant to the Offer, the "Offer Price"), which will represent the right to receive $1.50, net to the seller thereof in cash, without interest and subject to any withholding taxes, upon the achievement of a specified milestone (the "Milestone Payment"), pursuant to the terms of the Contingent Value Rights Agreement in the form attached as Annex II to the Merger Agreement (the "CVR Agreement"). Promptly following the completion of the Offer, upon the terms and subject to the conditions of the Merger Agreement, Purchaser will be merged with and into Dova, with Dova surviving as a wholly owned indirect subsidiary of Sobi (the "Merger"). The Merger Agreement contemplates that the Merger will be effected pursuant to Section 251(h) of the Delaware General Corporation Law (the "DGCL"), which permits completion of the Merger without a vote of the holders of Shares upon the acquisition by Purchaser of a majority of the outstanding Shares. At the effective time of the Merger (the "Effective Time"), each Share, other than the Shares accepted for payment in the Offer and shares held by stockholders who validly exercise appraisal rights under Section 262 of the DGCL or by Dova, Sobi or their respective wholly owned subsidiaries, will be cancelled and converted into the right to receive the Offer Price.

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!

Under the terms of the Merger Agreement, Purchaser’s obligation to accept and pay for Shares that are tendered in the Offer is subject to the satisfaction or waiver of customary conditions, including: (i) the condition that, prior to the expiration of the Offer, there have been validly tendered and not validly withdrawn a number of Shares that, together with Shares then owned by Purchaser and its affiliates, would represent at least one Share more than 50% of the then outstanding Shares; (ii) the expiration or termination of the applicable mandatory waiting period (and any extensions thereof) applicable to the Offer under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended; (iii) the accuracy of Dova’s representations and warranties in the Merger Agreement, subject to specified materiality qualifications; (iv) compliance by Dova with its covenants in the Merger Agreement in all material respects; (v) the absence of any change or effect which has had a material adverse effect on the business, assets, financial condition, or results of operations of Dova and its subsidiaries taken as a whole (subject to customary carveouts) that is continuing; and (vi) the absence of legal restraints prohibiting the consummation of the transactions.

The Merger Agreement provides that at the Effective Time: (i) all outstanding options (whether vested or unvested) that have an exercise price of less than $27.50 will be cancelled and the holders thereof will be entitled to receive the Offer Price in respect of each Share covered by such option, less the applicable exercise price; and (ii) all outstanding restricted stock units (whether vested or unvested) will be cancelled and the holders thereof will be entitled to receive the Offer Price in respect of each Share covered by such restricted stock unit. In addition, any options with an exercise price between $27.50 and $29.00 would also be entitled to receive a payment in respect of each Share covered by such option in the event that the Milestone Payment occurs in an amount equal to the excess of $29.00 over the applicable exercise price.

The Merger Agreement contains customary representations, warranties and covenants for both Dova and Sobi, including a covenant regarding the use of Sobi’s and Dova’s reasonable best efforts to cause the conditions to the transactions contemplated by the Merger Agreement to be satisfied. In addition, Dova has agreed to certain non-solicitation obligations related to alternative acquisition proposals.

The Merger Agreement provides certain termination rights for both Dova and Sobi and further provides that a termination fee of $32 million will be payable by Dova to Sobi upon termination of the Merger Agreement under certain circumstances, including if the board of directors of Dova enters into a transaction agreement in respect of a "superior offer" or if Sobi terminates the Merger Agreement as a result of an adverse change recommendation of the board of directors of Dova.

Concurrently with the execution and delivery of the Merger Agreement, Paul B. Manning (and certain related entities) and Sean Stalfort (each such person or entity, a "Tendering Stockholder") entered into Tender and Support Agreements (each, a "Tender Agreement") with Sobi and Purchaser, pursuant to which each Tendering Stockholder agreed, among other things, to tender his, her or its Shares into the Offer and, if necessary and subject to the terms of the Tender Agreement, vote his, her or its Shares (i) in favor of any matter necessary to the consummation of the transactions contemplated by the Merger Agreement and considered and voted upon by the Dova stockholders, (ii) against any alternative acquisition proposal, (iii) against the adoption of any definitive agreement in respect of an alternative acquisition proposal and (iv) against any other action that would in any manner (A) change the voting rights of any class of capital stock of Dova or (B) otherwise reasonably be expected to prevent, materially interfere with or materially impede the Offer or the Merger.

The Tendering Stockholders are generally prohibited from transferring their Shares (subject to certain exceptions), and over a majority of Dova’s outstanding Shares are covered by the Tender Agreements. However, in the event the board of directors of Dova makes an adverse change recommendation in compliance with the terms of the Merger Agreement, the number of Shares that would continue to be covered by the Tender Agreements would be decreased to 30% of the outstanding Shares.

The foregoing description of the Merger Agreement does not purport to be complete and is qualified in its entirety by the full text of the Merger Agreement, a copy of which is filed as Exhibit 2.1 hereto and is incorporated by reference herein. The Merger Agreement has been attached to provide investors with information regarding its terms. It is not intended to provide any other factual information about Sobi, Purchaser or Dova. In particular, the representations, warranties and covenants of each party set forth in the Merger Agreement have been made only for the purposes of, and were and are solely for the benefit of the parties to, the Merger Agreement, may be subject to limitations agreed upon by the contracting parties, including being qualified by a confidential disclosure letter made for the purposes of allocating contractual risk between the parties to the Merger Agreement instead of establishing these matters as facts, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors. The confidential disclosure letter contains information that modifies, qualifies and creates exceptions to the representations and warranties and certain covenants set forth in the Merger Agreement. Accordingly, the representations and warranties may not describe the actual state of affairs at the date they were made or at any other time, and investors should not rely on them as statements of fact.

CVR Agreement

Pursuant to the Merger Agreement, at or prior to the effective time of the Merger, Sobi and a rights agent (the "Rights Agent") will enter into the CVR Agreement governing the terms of the CVRs issued as part of the Offer Price. The Rights Agent will maintain an up-to-date register of the holders of CVRs (the "Holders"). Holders shall not be permitted to transfer CVRs (subject to certain limited exceptions).

Each CVR will entitle its Holder to receive $1.50 upon approval of avatrombopag for the treatment of Chemotherapy-Induced Thrombocytopenia by the United States Food and Drug Administration. Sobi has agreed to use "Diligent Efforts" (as defined in the CVR Agreement) to achieve the foregoing milestone.

The foregoing summary of the principal terms of the CVR Agreement does not purport to be complete and is qualified in its entirety by reference to the full form of the CVR Agreement, a copy of which is included as an exhibit to the Merger Agreement filed as Exhibit 2.1 hereto and incorporated by reference herein.

On October 3, 2019 Oncternal Therapeutics presented the corporate presentation (Presentation, Oncternal Therapeutics, OCT 3, 2019, View Source [SID1234540033]).

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!