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FDA Approves New Oncology Drug for Clinical Trials
Research Report

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The first in-human trial of this investigative small molecule is expected to start in Q4/23, noted a Wedbush report.

IDEAYA Biosciences Inc. (IDYA:NASDAQ) investigative compound, GSK101 (IDE705), was greenlighted by the U.S. Food and Drug Administration for clinical testing, reported Wedbush analyst Dr. Robert Driscoll in an August 21 research note. Upon clearance of the investigational new drug application, Ideaya received a US$7 million (US$7M) milestone payment from its collaboration partner, GlaxoSmithKline (GSK).

"We continue to believe GSK101 is a compelling program with clear clinical paths that could provide significant upside to our Ideaya estimates," Driscoll wrote.

Offers Attractive Return

As such, Wedbush maintained its US$40 per share 12-month price target on the California-based precision medicine oncology biopharma, currently trading at about US$26.92 per share.

The return to target from the current share price indicates a compelling return for investors of 49%.

Ideaya is rated Outperform.

First Clinical Trial

Next for GSK101 is the evaluation via a Phase 1/2 trial in combination with the PARP (poly-ADP ribose polymerases) inhibitor, niraparib (Zejula), in solid tumors with homologous recombination deficiency, Driscoll reported.

These tumors include BRCA1/2-mutated tumors, of which ovarian cancers comprise about 50% and breast cancers comprise 10−14%.

Wedbush expects that GSK, responsible for the clinical development of GSK101, will launch this initial trial in Q4/23.

When the Phase 1 dose expansion starts, noted Driscoll, Ideaya is due to receive another milestone payment from GSK, this one for US$10M.

Synergy With PARP Inhibitors

GSK101 is a small molecule inhibitor of polymerase theta, a high-interest target due to its critical role in repairing DNA. The drug specifically targets the ATPase domain of polymerase theta.

Driscoll pointed out that polymerase theta inhibitors, in general, have been shown to "play nice" or "be synergistic" with PARP inhibitors and "eliminate a subset of PARP inhibitor-resistant tumors." Specifically, in one example, Ideaya demonstrated in preclinical studies that GSK101 strongly synergizes with niraparib in vivo and may overcome or prevent resistance to PARP inhibitors. This bodes well for GSK101 in its first clinical trial.

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Important Disclosures:

  1. Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor.
  2. The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
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Disclosures for Wedbush, IDEAYA Biosciences Inc., August 21, 2023

Analyst Certification We, Robert Driscoll, Sam Ravina, Ritika Das and Martin Fan, certify that the views expressed in this report accurately reflect our personal opinions and that we have not and will not, directly or indirectly, receive compensation or other payments in connection with our specific recommendations or views contained in this report.

The Distribution of Ratings is required by FINRA rules; however, WS' stock ratings of Outperform, Neutral, and Underperform most closely conform to Buy, Hold, and Sell, respectively. Please note, however, the definitions are not the same as WS' stock ratings are on a relative basis. The analysts responsible for preparing research reports do not receive compensation based on specific investment banking activity. The analysts receive compensation that is based upon various factors including WS' total revenues, a portion of which are generated by WS' investment banking activities. Company Specific Disclosures

1. WS makes a market in the securities of Ideaya Biosciences, Inc..

3. WS co-managed a public offering of securities for Ideaya Biosciences, Inc. within the last 12 months.

5. WS provided Ideaya Biosciences, Inc. with investment banking services within the last 12 months.

Wedbush disclosure price charts are updated within the first fifteen days of each new calendar quarter per FINRA regulations. Price charts for companies initiated upon in the current quarter, and rating and target price changes occurring in the current quarter, will not be displayed until the following quarter. Additional information on recommended securities is available on request. Disclosure information regarding historical ratings and price targets is available: Research Disclosures *WS changed its rating system from (Strong Buy/ Buy/ Hold/ Sell) to (Outperform/ Neutral/ Underperform) on July 14, 2009. Applicable disclosure information is also available upon request by contacting the Research Department at (212) 833-1375, by email to [email protected]. You may also submit a written request to the following: Wedbush Securities, Attn: Research Department, 142 W 57th Street, New York, NY 10019.

OTHER DISCLOSURES The information herein is based on sources that we consider reliable, but its accuracy is not guaranteed. The information contained herein is not a representation by this corporation, nor is any recommendation made herein based on any privileged information. This information is not intended to be nor should it be relied upon as a complete record or analysis: neither is it an offer nor a solicitation of an offer to sell or buy any security mentioned herein. This firm, Wedbush Securities, its officers, employees, and members of their families, or any one or more of them, and its discretionary and advisory accounts, may have a position in any security discussed herein or in related securities and may make, from time to time, purchases or sales thereof in the open market or otherwise. The information and expressions of opinion contained herein are subject to change without further notice. The herein mentioned securities may be sold to or bought from customers on a principal basis by this firm. Additional information with respect to the information contained herein may be obtained upon request. Wedbush Securities does and seeks to do business with companies covered in its research reports. Thus, investors should be aware that the firm may have a conflict of interest that could affect the objectivity of this report. Investors should consider this report as only a single factor in making their investment decision. Please see pages 3–7 of this report for analyst certification and important disclosure information.

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