Heron Therapeutics Announces Proposed Public Offering of Common Stock

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.

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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].

Entry into a Material Definitive Agreement

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.

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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.

Corporate Slide Presentation as of October 3, 2019

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

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Clarity Receives US FDA response on its Theranostic Investigational New Drug (IND) Application that the study may proceed

On October 3, 2019 Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is reported that it has received a response on its Investigational New Drug (IND) application that the study may proceed from the U.S. Food and Drug Administration (FDA) for a Phase 1-2a theranostic (i.e. diagnostic and therapy) trial with 64Cu-SARTATE and 67Cu-SARTATE in paediatric patients (Press release, Clarity Pharmaceuticals, OCT 3, 2019, View Source [SID1234540032]).

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This trial will be using Clarity’s lead product, SARTATE, administered to paediatric patients with somatostatin receptor-2 positive, relapsed or refractory, high-risk neuroblastomas. It is a multi-centre, dose escalation, open-label, non-randomised, Phase 1-2a theranostic clinical trial planned for up to 34 patients using 64Cu-SARTATE for PET imaging and 67Cu-SARTATE for therapy.

The FDA response suggests not only the importance of the study in the treatment of neuroblastoma, but also validates the manufacturing of 64Cu-SARTATE and 67Cu-SARTATE to levels suitable for diagnostic and therapeutic use, as well as the suitability of the centralised manufacturing concept of this theranostic pairing.

Neuroblastoma is a disease that occurs most often in infants and young children, usually in children younger than 5 years old. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 13% of paediatric cancer mortality. High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%.

This study is supported by a human imaging study in 10 adults with neuroendocrine tumours and preliminary results of a first-in-human study of adult patients with meningioma, who were administered a diagnostic dose of 64Cu-SARTATE followed by up to four doses of the therapeutic product,67Cu-SARTATE.

Dr Alan Taylor, Clarity’s Executive Chairman, commented on the IND approval "The acceptance of Clarity’s first IND application in a relatively short time indicates the quality and importance of work conducted by our preclinical, clinical and manufacturing teams in the field of theranostics and reflects the support for the development of novel treatments for children with cancer. We are very pleased to have achieved this significant milestone. Our Team is looking forward to progressing this trial at some of the leading cancer centres in the U.S. and we are hoping to commence recruitment shortly which will get us one step closer to our goal of better treating children and adults with cancer."

Media Contact
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Executive Chairman

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BerGenBio to Present Clinical Data From Phase II Trial With Selective AXL Inhibitor at 34th Annual SITC Meeting

On October 2, 2019 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, is reported it has been accepted for an oral presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 34th Annual Meeting, which is being held from 6-10 November 2019 in Maryland (Press release, BerGenBio, OCT 2, 2019, View Source [SID1234540031]).

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The presentation will provide updates on its phase II study of bemcentinib (BGB324) in combination with pembrolizumab in patients with advanced NSCLC.

Abstract titles have been announced online at View Source (abstracts # O26). Details of the presentation are below.

Title: A phase II study of bemcentinib (BGB324), a first-in-class selective AXL inhibitor, in combination with pembrolizumab in patients with advanced NSCLC: Updated analysis.

Date: Friday 8th November 2019

Time: 5:10 pm – 5:25 pm (during High Impact Clinical Trials session)

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases.

About bemcentinib

Bemcentinib (formerly known as BGB324), is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme. Ongoing clinical trials are investigating bemcentinib in multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity. Increase in AXL function has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers.