On August 27, 2020 LUNGevity Foundation, the nation’s leading lung cancer-focused nonprofit organization, reported the launch of new longitudinal study in collaboration with the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) titled Understanding the lung cancer Patient ExperiEnce in the Real-world setting (Project PEER) (Press release, LUNGevity Foundation, AUG 27, 2020, View Source [SID1234564120]). The overarching goal of Project PEER is to understand the lung cancer patient experience, irrespective of diagnosis (stage/histology), outside of the clinical trial setting.

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The Project PEER collaboration seeks to systematically understand how patients with lung cancer feel and function and whether this experience is affected by their specific diagnosis and treatment. The real-world data from Project PEER will be used to explore patterns in patient experiences and compare those patterns to what is seen in clinical trial data within the same patient population.

LUNGevity and the FDA have signed a multi-year Research Collaboration Agreement to work together on Project PEER. FDA OCE investigators will have the opportunity through the collaboration to understand different aspects of patient experience (e.g., impact of a diagnosis on physical role-functioning, emotional well-being) in a real-world setting using standardized patient-reported outcome (PRO) instruments commonly used in cancer clinical trials. De-identified data collected through Project PEER will be available to FDA-CDER investigators as well as third-party investigators free of charge. The data collected is not meant for registrational purposes and is meant to be exploratory and hypothesis-generating only.

"In the last few years, science has progressed at an unprecedented rate as new categories of therapies have become available and the application of existing therapies has expanded," says Dr. Upal Basu Roy, PhD, MPH, Vice President of Research at LUNGevity and project lead of Project PEER at LUNGevity. "However, reasons for treatment discontinuation (adverse events, progression, mechanisms of resistance, etc.) are not well documented beyond a clinical trial context. Similarly, how patients experience their disease in terms of symptoms, impacts, outcomes, and quality of life throughout their disease progression is unclear. We are excited to launch this study to better understand these issues and, ultimately, help provide the best care possible to the lung cancer community."

The project will be using the EmpiraMed PRO Portal Software Platform that deploys 100% site-less virtual studies to better evaluate patient experience in the real world. The EmpiraMed PRO Portal will be used to allow study participants to participate in Project PEER more easily while compensating them for their data and time in an engaging manner.

"LUNGevity is proud to collaborate with the FDA to better understand the lung cancer patient experience," says Andrea Ferris, President and CEO of LUNGevity. "Project PEER provides the Agency real-world data about how our patient population, particularly those underrepresented in clinical trials, respond to therapies. Our collaboration with the FDA has the potential to make an impact on the future of treatment for lung cancer, resulting in better outcomes for patients."

"Characterizing how patients with lung cancer experience treatment in the real-world setting is an important opportunity to improve our understanding of cancer therapy," said Paul Kluetz, MD, Deputy Director of the FDA’s Oncology Center of Excellence. "We are pleased to collaborate with LUNGevity to explore alternative data sources and increase our understanding of the patient experience."

You can find more information on Project PEER at the study website: View Source

Project PEER is an international study and open to any adult participant with lung cancer or caregiver who is able to read and respond to questions in English. There is no limit on the number of participants or countries included in Project PEER. LUNGevity hopes to enroll around 1,200 patients and 300 caregivers.

On August 27, 2020 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported that it will present at the following investor conference in September (Press release, Medpace, AUG 27, 2020, View Source [SID1234564119]):

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Baird’s Global Healthcare Conference
Date: Thursday, September 10, 2020
Presentation: 3:45 p.m. ET
Speakers: August Troendle, President & Chief Executive Officer, Jesse Geiger, Chief Financial Officer & Chief Operating Officer, Laboratory Operations, and Kevin Brady, Executive Director of Finance

This is a virtual conference available to registered participants only.

On August 27, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that due to demand, the underwriter has agreed to increase the size of the previously announced offering and purchase on a firm commitment basis 2,142,858 shares of common stock of the Company, at a price to the public of $2.10 per share, less underwriting discounts and commissions (Press release, Oncternal Therapeutics, AUG 27, 2020, View Source [SID1234564118]). The closing of the offering is expected to occur on or about September 1, 2020, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company also has granted to the underwriter a 30-day option to purchase up to an additional 321,428 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds to Oncternal, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter’s option to purchase additional common stock, are expected to be approximately $4.5 million. The Company intends to use the net proceeds from this offering for general corporate purposes, including expenses related to the clinical and preclinical development of cirmtuzumab and TK216, preclinical development of its ROR1 CAR-T program, and for working capital.

The shares of common stock are being offered by Oncternal pursuant to a "shelf" registration statement on Form S-3 (File No. 333-222268) previously filed with the Securities and Exchange Commission (the "SEC") on December 22, 2017 and declared effective by the SEC on January 5, 2018. The offering of the shares of common stock is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the shares of common stock being offered has been filed with the SEC and is available on the SEC’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source A final prospectus supplement and the accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a 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.

On August 27, 2020 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 the pricing of an underwritten public offering of 5,614,036 shares of its common stock, offered at a price of $14.25 per share (Press release, Odonate Therapeutics, AUG 27, 2020, View Source [SID1234564117]). In addition, Odonate has granted the underwriters a 30-day option to purchase up to an additional 842,105 shares of its common stock on the same terms and conditions. All shares of common stock sold in the offering are being sold by Odonate. The offering is expected to close on or about September 1, 2020, subject to customary closing conditions.

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The gross proceeds from the proposed underwritten public offering are expected to be $80 million before deducting customary underwriting discounts and offering expenses. Odonate intends to use the proceeds from the proposed underwritten public offering of its shares of common stock for development, regulatory and commercial preparation activities relating to tesetaxel, as well as for working capital and general corporate purposes.

Jefferies is acting as book-running manager, and LifeSci Capital is acting as lead manager for the offering.

The securities described above are being offered pursuant to a shelf registration statement (File No. 333‑233990), which became effective on October 18, 2019.

A final prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the U.S. Securities and Exchange Commission (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 supplement and an accompanying base 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]).

On August 27, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 1,666,667 shares of common stock of the Company, at a price to the public of $2.10 per share, less underwriting discounts and commissions (Press release, Oncternal Therapeutics, AUG 27, 2020, View Source [SID1234564116]). The closing of the offering is expected to occur on or about September 1, 2020, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company also has granted to the underwriter a 30-day option to purchase up to an additional 250,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds to Oncternal, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter’s option to purchase additional common stock, are expected to be approximately $3.5 million. The Company intends to use the net proceeds from this offering for general corporate purposes, including expenses related to the clinical and preclinical development of cirmtuzumab and TK216, preclinical development of its ROR1 CAR-T program, and for working capital.

The shares of common stock are being offered by Oncternal pursuant to a "shelf" registration statement on Form S-3 (File No. 333-222268) previously filed with the Securities and Exchange Commission (the "SEC") on December 22, 2017 and declared effective by the SEC on January 5, 2018. The offering of the shares of common stock is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the preliminary prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a 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.