ESSA Pharma Inc. Reports Results of Annual General Meeting of Shareholders

On June 25, 2019 ESSA Pharma Inc. ("ESSA" or the "Company") (TSX-V: EPI,NASDAQ: EPIX), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, is reported the results of the votes on matters considered at its annual general meeting of shareholders of the Company (the "Shareholders") held on June 25, 2019 in Vancouver, British Columbia, Canada (the "Meeting") (Press release, ESSA, JUN 25, 2019, View Source [SID1234537259]).

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At the Meeting, the Shareholders set the number of directors at seven and re-elected to the board of directors (the "Board"), by ordinary resolution passed by ballot vote, David R. Parkinson, Richard M. Glickman, Raymond Andersen, Gary Sollis, Franklin M. Berger, Scott Requadt and Otello Stampacchia to serve in office until the next annual meeting of Shareholders or until their successors are duly elected or appointed. Detailed results of the voting in respect of the election of directors are as follows:

Nominee

Votes For

% Votes For

Votes Withheld

% Votes Withheld

David R. Parkinson

3,413,685

95.64%

155,625

4.36%

Richard M. Glickman

3,420,645

95.83%

148,665

4.17%

Raymond Andersen

3,413,685

95.64%

155,625

4.36%

Gary Sollis

3,560,520

99.75%

8,789

0.25%

Franklin M. Berger

3,415,107

95.68%

154,202

4.32%

Scott Requadt

3,224,071

90.33%

345,238

9.67%

Otello Stampacchia

3,224,062

90.33%

345,248

9.67%

At the Meeting, the Shareholders also approved the: (i) re-appointed of Davidson & Company LLP, Chartered Professional Accountants, as auditors of the Company; (ii) subject to the closing of the acquisition by the Company of all the issued and outstanding shares of Real Therapeutics plc, as announced in a press release dated May 16, 2019 (the "Realm Acquisition"), an amendment to the Company’s stock option plan; (iii) subject to the closing of the Realm Acquisition, an amendment to the Company’s restricted share unit plan; and (iv) subject to the closing of the Realm Acquisition, the Company’s employee stock purchase plan.

Medpace Holdings, Inc. to Report Second Quarter 2019 Financial Results on July 29, 2019

On June 25, 2019 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported that it will report its second quarter 2019 financial results after the market close on Monday, July 29, 2019 (Press release, Medpace, JUN 25, 2019, View Source [SID1234537258]). The Company will host a conference call the following morning, Tuesday, July 30, 2019, at 9:00 a.m. ET to discuss these results.

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To participate in the conference call, dial 800-219-7113 (domestic) or 574-990-1030 (international) using the passcode 6197355.

To access the conference call via webcast, visit the "Investors" section of Medpace’s website at investor.medpace.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A supplemental slide presentation will also be available at the "Investors" section of Medpace’s website prior to the start of the call.

A recording of the call will be available from 12:00 p.m. ET on Tuesday, July 30, 2019 until 12:00 p.m. ET on Tuesday, August 13, 2019. To hear this recording, dial 855-859-2056 (domestic) or 404-537-3406 (international) using the passcode 6197355.

Odonate Therapeutics Announces Public Offering of Shares of Common Stock

On June 25, 2019 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported that it has commenced an underwritten public offering of approximately $100 million of shares of its common stock (Press release, Odonate Therapeutics, JUN 25, 2019, View Source [SID1234537256]). In addition, Odonate has granted the underwriters a 30-day option to purchase up to an additional $15 million of shares of its common stock. All of the shares of common stock to be sold in the underwritten public offering are being offered by Odonate.

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Odonate intends to use the proceeds from the proposed underwritten public offering of its shares of common stock for development and regulatory activities relating to tesetaxel, as well as for working capital and general corporate purposes.

Jefferies and Cowen are acting as joint book-running managers. LifeSci Capital is acting as lead manager for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission (SEC) and became effective on February 28, 2019.

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. The offering can be made only by means of a prospectus, copies of which may be obtained at the SEC’s website at www.sec.gov, or by request to Jefferies LLC (Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022; telephone: 877-821-7388; email: [email protected]) or Cowen and Company, LLC (c/o Broadridge Financial Services, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717; telephone: 631-274-2806; email: [email protected]).

TILT Biotherapeutics Initiates Collaboration With Merck KGaA, Darmstadt, Germany and Pfizer Investigating the Combination of Oncolytic Virus, TILT-123, And Anti-PDL1 Antibody, Avelumab

On June 25, 2019 TILT Biotherapeutics Ltd, the leading company globally working in the area of enabling tumor T-cell therapies and checkpoint inhibiting antibodies with oncolytic viruses, reported that it has entered into an agreement with Merck KGaA, Darmstadt, Germany and Pfizer to evaluate its armed oncolytic virus, TILT-123, with avelumab in patients with solid tumors refractory to routine modalities (Press release, TILT Biotherapeutics, JUN 25, 2019, View Source [SID1234537255]).

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"We are pleased to initiate a collaboration with Merck KGaA, Darmstadt, Germany and Pfizer to translate our findings into patients. Preclinical results with TILT-technology and anti-PD(L)1 agents suggest immune activation and efficacy in certain animal models", explains Akseli Hemminki (MD, PhD, eMBA), CEO and Founder of TILT Biotherapeutics.

*Avelumab is under clinical investigation in combination with TILT-123 for treatment of solid tumors and has not been demonstrated to be safe and effective for this use. There is no guarantee that avelumab in combination with TILT-123 will be approved by any health authority worldwide.

About Avelumab

Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. Avelumab has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models. Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

Avelumab Approved Indications

Avelumab (BAVENCIO) in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

The US Food and Drug Administration (FDA) also granted accelerated approval for avelumab (BAVENCIO) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with MCC in more than 45 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

Avelumab Important Safety Information from the US FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions [which can be severe and have included fatal cases]), infusion-related reactions, major adverse cardiovascular events (MACE), and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash. Additional common adverse reactions reported in patients receiving BAVENCIO in combination with axitinib include hypertension, mucositis, palmar-plantar erythrodysesthesia, dysphonia, hypothyroidism, hepatotoxicity, cough, dyspnea, abdominal pain, and headache. Clinical chemistry and hematology laboratory value abnormalities have been reported including but not limited to grade 3-4 lymphopenia, anemia, elevated cholesterol and liver enzymes.

For full Prescribing Information and Medication Guide for BAVENCIO, please see www.BAVENCIO.com.

MIRATI THERAPEUTICS ANNOUNCES PRICING OF PUBLIC OFFERING OF COMMON STOCK

On June 25, 2019 Mirati Therapeutics, Inc. (Nasdaq: MRTX) reported the pricing of an underwritten public offering of 2,100,000 shares of its common stock at a price to the public of $97.00 per share (Press release, Mirati, JUN 25, 2019, View Source [SID1234537250]). The aggregate gross proceeds from this offering are expected to be approximately $203.7 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Mirati. The offering is expected to close on or about June 27, 2019, subject to customary closing conditions. Mirati has also granted the underwriters a 30-day option to purchase up to an additional 315,000 shares of common stock in connection with the public offering. All of the shares are being sold by Mirati.

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Mirati expects to use the net proceeds from this offering for general corporate purposes, including expenses related to the clinical development of sitravatinib and MRTX849, the preclinical development of its KRAS G12D inhibitor and the development of other preclinical programs, and for working capital.

Cowen, Credit Suisse and Barclays are acting as joint book-running managers in the offering. Guggenheim Securities and Oppenheimer & Co. are acting as co-lead managers and H.C. Wainwright & Co. is acting as co-manager in the offering.

The shares of common stock described above are being offered by Mirati pursuant to a shelf registration statement filed by Mirati with the Securities and Exchange Commission ("SEC") that became automatically effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY,11717, Attn: Prospectus Department, or by telephone: (631) 592-5973, or by emailing [email protected]; from Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, Eleven Madison Avenue, 3rd floor, New York, NY 10010, or by telephone: (800) 221-1037, or by emailing [email protected]; or from Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by calling (888) 603-5847, 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.