On October 24, 2023 Citius Pharmaceuticals, a biopharmaceutical company developing and commercializing first-in-class critical care products, and TenX Keane Acquisition ("TenX") (NASDAQ: TENKU), a publicly traded special purpose acquisition company (SPAC), reported that they have entered into a definitive agreement, dated October 23, 2023, for a proposed merger of TenX and Citius Pharma’s wholly owned oncology subsidiary that will continue as a public company listed on the Nasdaq exchange (Press release, Citius Pharmaceuticals, OCT 24, 2023, View Source [SID1234636309]). The newly combined public company will be named Citius Oncology, Inc. ("Citius Oncology"). Upon closing, pursuant to the terms of the merger agreement, Citius Pharma would receive 67.5 million shares in Citius Oncology at $10 per share and retain majority ownership of approximately 90%. The transaction has been approved by the Board of Directors of both companies and is expected to close in the first half of 2024.

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Citius Oncology will serve as a platform to develop and commercialize novel targeted oncology therapies. The company is seeking approval from the U.S. Food and Drug Administration (FDA) of LYMPHIR for an orphan indication in the treatment of persistent or recurrent cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkin lymphoma. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing and is underserved by existing therapies. If approved, LYMPHIR would be unique as the only IL-2 receptor targeted CTCL therapy, offering a novel option to patients cycling through multiple treatments. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology’s competitive positioning.

Preparations are underway for a Biologics License Application (BLA) resubmission in early 2024. If approved, LYMPHIR could be commercially available as early as the second half of 2024 for the treatment of CTCL. Additional value creating opportunities in larger markets include potential indications in peripheral T-cell lymphoma or as a combination therapy with CAR-T and PD-1 inhibitors, and in markets outside the U.S. Currently, two investigator-initiated trials are underway to explore LYMPHIR’s potential as an immuno-oncology combination therapy.

The transaction is expected to provide Citius Oncology with improved access to the public equity markets and thereby facilitate the commercialization of LYMPHIR and position the company to explore additional value creating opportunities more fully.

CITIUS PHARMA AND TENX COMMENTS

"We believe this transaction will allow us to unlock the value of LYMPHIR, and solidly position Citius Pharma to advance our diversified pipeline. This transaction will enable Citius Oncology, with access to the broader capital markets, to better support the successful commercialization of LYMPHIR, if approved, and explore additional potential targeted oncology therapies. Our majority ownership position and shared services agreement ensures that the Citius Pharma management team will remain fully engaged with the development and commercialization efforts at Citius Oncology. As previously announced, the Company is in the process of formulating a plan of distribution of a portion of the shares of Citius Oncology to its shareholders. At Citius Pharma, we intend to focus on completing the Mino-Lok trial and continuing to evaluate next steps with our Halo-Lido program," stated Leonard Mazur, Chairman and CEO of Citius Pharma.

"We are very pleased to announce the proposed merger with Citius Oncology," said Mr. Xiaofeng Yuan, Chairman and CEO of TenX. "After undertaking a comprehensive process with external advisors to explore and evaluate numerous potential business combination targets, our board and management team believe that this transaction with Citius Oncology represents the best opportunity to create substantial value for our stockholders. This business combination, if consummated, will result in TenX investors owning an equity stake in a company that is focused on developing and commercializing LYMPHIR to improve the lives of patients with CTCL and additional potential upside from combinations with other drugs as immuno-oncology therapies with even larger addressable markets. We are thrilled to support Citius Oncology at an inflection point in its development and to provide an avenue for Citius to expeditiously meet its development milestones."

THE PROPOSED MERGER AGREEMENT

Pursuant to the proposed agreement, TenX will acquire Citius Pharma’s wholly owned subsidiary via a merger, with the newly combined publicly traded company to be named Citius Oncology, Inc. In the transaction, all shares of Citius Pharma’s wholly owned subsidiary would be converted into the right to receive common stock of Citius Oncology. As a result, upon closing, Citius Pharma would receive 67.5 million shares of common stock of Citius Oncology which, at an implied value of $10.00 per share, would be $675 million in equity of Citius Oncology, before fees and expenses. As part of the transaction, Citius Pharma will contribute $10 million in cash to Citius Oncology. An additional 12.75 million existing options will be assumed by Citius Oncology.

At closing, any cash remaining in TenX’s trust account along with the cash provided by Citius Pharma will be contributed to Citius Oncology to support ongoing operations and planned commercialization efforts. References to available cash from the TenX trust account and retained transaction proceeds are subject to any redemptions by the public stockholders of TenX and payment of transaction fees and expenses.

Upon closing, Citius Oncology will operate under a shared services agreement with Citius Pharma, with fees payable quarterly to Citius Pharma, for the services of several key members of the Citius Pharma team, led by Leonard Mazur, Chief Executive Officer, Jaime Bartushak, Chief Financial Officer and Dr. Myron Czuczman, Chief Medical Officer. Myron Holubiak will serve as Executive Vice Chairman of the Citius Oncology Board of Directors.

The transaction, which has been unanimously approved by both Boards of Directors of Citius Pharma and TenX, is subject to approval by stockholders of TenX and other customary closing conditions. Citius Pharma, as the sole holder of Citius Oncology common stock, has approved the transaction. The proposed business combination is expected to be completed in the first half of 2024.

A more detailed description of the transaction terms and a copy of the business combination agreement will be included in a Current Report on Form 8-K to be filed by each of Citius Pharma and TenX with the United States Securities and Exchange Commission ("SEC"). In connection with the transaction, TenX intends to file a registration statement (which will contain a proxy statement/prospectus) with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or 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 jurisdiction.

CITIUS PHARMA AND TENX STOCKHOLDERS AND OTHER INTERESTED PERSONS ARE ADVISED TO READ, ONCE AVAILABLE, THE REGISTRATION STATEMENT AND THE PRELIMINARY PROXY STATEMENT/PROSPECTUS AND ANY AMENDMENTS THERETO AND, ONCE AVAILABLE, THE DEFINITIVE PROXY STATEMENT/PROSPECTUS IN CONNECTION WITH THE BUSINESS COMBINATION, BECAUSE THESE DOCUMENTS WILL CONTAIN IMPORTANT INFORMATION ABOUT CITIUS PHARMA, TENX, CITIUS ONCOLOGY AND THE PROPOSED MERGER.

ADVISORS

Maxim Group LLC is acting as exclusive financial advisor to Citius Pharma and Newbridge Securities Corporation is acting as exclusive financial advisor to TenX. Wyrick Robbins Yates & Ponton LLP is acting as legal advisor to Citius Pharma. The Crone Law Group P.C. is acting as legal advisor to TenX.

IMPORTANT INFORMATION ABOUT THE PROPOSED BUSINESS COMBINATION AND WHERE TO FIND IT

In connection with the proposed business combination, TenX intends to file a registration statement on Form S-4 that will include a proxy statement of TenX and a prospectus of Citius Oncology. The proxy statement/prospectus will be sent to all TenX stockholders. Before making any voting decision, securities holders of TenX are urged to read the proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC in connection with the proposed business combination as they become available because they will contain important information about the proposed business combination and the parties to the proposed business combination.

Investors and securities holders will be able to obtain free copies of the proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC by TenX and Citius Pharma through the website maintained by the SEC at www.sec.gov. In addition, the documents filed by Citius Pharma may be obtained free of charge from Citius Pharma’s website at www.citiuspharma.com, or by written request to Citius Pharmaceuticals, Inc., 11 Commerce Drive, 1st Floor, Cranford, New Jersey 07016, Attention Chief Financial Officer. The documents filed by TenX may be obtained free of charge by written request to TenX Keane Acquisition, 420 Lexington Avenue, Suite 2446, New York, New York 10170.

PARTICIPANTS IN THE SOLICITATION

Citius Pharma and Tenx and certain of their respective directors, executive officers, and other members of management and employees may, under SEC rules, be deemed to be participants in the solicitations of proxies from TenX’s shareholders in connection with the proposed transaction. Information regarding Citius Pharma’s directors and executive officers is available in its definitive proxy statement on Schedule 14A for the 2023 annual meeting of stockholders, which was filed with the SEC on December 22, 2022. Information about TenX’s directors and executive officers and their ownership of TenX’s securities is set forth in TenX’s filings with the SEC, including TenX’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, which was filed with the SEC on April 17, 2023. To the extent that holdings of TenX’s securities have changed since the amounts printed in TenX’s Annual Report, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the SEC.

Additional information regarding the participants in the proxy solicitation and a description of their direct and indirect interests will be included in the proxy statement/prospectus when it becomes available. Shareholders, potential investors, and other interested persons in respect of Citius Pharma and TenX should read the proxy statement/prospectus carefully when it becomes available before making any voting or investment decisions. You may obtain free copies of these documents from the sources indicated above.

On October 24, 2023 Avenge Bio, Inc. ("Avenge" or the "Company"), a biotechnology company developing the LOCOcyte Immunotherapy platform for the precision administration of potent immune effector molecules to treat solid tumors, reported their poster presentation at the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting (SITC 2023) on November 1-5, 2023, in San Diego, California (Press release, Avenge Bio, OCT 24, 2023, View Source [SID1234636310]).

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In September 2023, Avenge Bio received FDA Fast Tack designation for AVB-001. AVB-001 is an encapsulated cell product engineered to produce native human interleukin-2 (hIL-2) and is delivered intraperitoneally (IP) to patients. Avenge is currently enrolling patients in a First-in-Human, Phase 1/2, multicenter clinical trial (NCT05538624) designed to evaluate the safety and efficacy of AVB-001. The Company has advanced through multiple dose levels in a dose escalation cohort and expects to initiate a Phase 2 dose expansion trial in 1H 2024.

Abstract #: 1045
Poster Title: Overcoming immunosuppressive tumors by stimulating the adaptive and innate immune systems
Presenting Author: Guillaume Carmona, PhD
Location: Exhibit Halls A and B1
Date: Friday, November 3, 2023
Time: 9:00 AM-7:00 PM PDT

The poster will present how a single administration of either AVB-001 or AVB-002, engineered to produce native human IL-2 or native human IL-12 respectively, demonstrated complete responses as monotherapy and provided sustained eradication in various mouse tumor models. In addition, the poster will also present the commonalities and differences between AVB-001 and AVB-002 in modulating the innate and adaptive anti-tumor immune response. The poster will be available on the Presentations and Publications section of www.avengebio.com following the conference.

About LOCOcyte Platform
Our LOCOcyteTM allogeneic cell-based immunotherapy platform enables potent localized modulation of the immune system which also precipitates a systemic immune response, allowing us to treat previously intractable cancers. The technology leverages three unique advantages:

(1) Potent immune effector molecules are generated by synthetically engineering allogeneic cells creating a ready-to-use therapy,

(2) Therapy is localized in proximity to the primary tumor site and generates innate and adaptive immune response, and

(3) The immunomodulator trains the patient’s immune system generating a robust immune response that seeks and eradicates distal metastasis without systemic toxicity.

On October 24, 2023 Akeso reported poster presentation at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress from its cadonilimab ( PD-1/CTLA-4 bispecific antibody) combined with lenvatinib for first-line treatment of Advanced Hepatocellular Carcinoma (HCC) (Press release, Akeso Biopharma, OCT 24, 2023, View Source [SID1234636308]). The principal investigators of the study are Prof. Bai Li and Prof. Jiao Shunchang of the Chinese PLA General Hospital.

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The results indicated that the novel combination therapy of PD-1/CTLA-4 bispecific antibody plus lenvatinib demonstrated promising efficacy and manageable toxicity that could provide an option of treatment in first-line treatment of advanced HCC. At the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Akeso presented the preliminary therapeutic effect of cadonilimab combined with lenvatinib for first-line therapy of advanced HCC, showing promising anti-tumor activity and improved tolerability. The 2 years median follow-up results presented at the 2023 ESMO (Free ESMO Whitepaper) meeting further emphasized the efficacy of cadonilimab in improving overall survival (OS) among advanced patients.

Data Highlights:

Results demonstrated the outstanding efficacy of cadonilimab when combined with lenvatinib as a first-line treatment for HCC. The preliminary efficacy data outperformed those of approved therapies. As of July 28, 2023, the median follow-up period was 27.4 months.

When cadonilimab was dosed at 6 mg/kg Q2W, the objective response rate (ORR) was 35.5%, the median duration of response (mDoR) was 13.6 months, the median progression free survival (mPFS) was 8.61 months, and mOS was 27.1 months.
When the dose of cadonilimab was 15 mg/kg Q3W, the ORR was 35.7%, the mDoR was 13.7 months, the mPFS was 9.82 months, and the mOS was not yet reached.
The mPFS for first-line HCC treatment with the combination of cadonilimab and lenvatinib was higher compared to approved therapies. The study indicated that the improvement in PFS was more significant with the higher dose of cadonilimab (8.6 months at 6 mg/kg every 2 weeks vs. 9.8 months at 15 mg/kg every 3 weeks).
The adverse effects of the combination of cadonilimab and lenvatinib at all dosage levels were readily manageable without any new safety signals or cadonilimab-associated fatalities.
Akeso is currently conducting a randomized, double-blind, controlled Phase III clinical trial (AK104-306, NCT05489289) to evaluate the efficacy and safety of cadonilimab as adjuvant therapy for high-risk hepatocellular carcinoma after curative resection. The potential efficacy of cadonilimab for both operable and advanced HCC holds great promise for improving long-term survival rates for the entire HCC population.

About Cadonilimab(PD-1/CTLA-4 bispecific antibody)

Cadonilimab is a first-in-class bispecific antibody that targets both PD-1 and CTLA-4 developed by Akeso. It is a symmetric tetravalent bispecific antibody with a crystallizable fragment (Fc)-null design. In addition to demonstrating biological activity similar to that of the combination of CTLA-4 and PD-1 antibodies, cadonilimab possesses higher binding avidity in a high-density PD-1 and CTLA-4 setting than in a low-density PD-1 setting, while a mono-specific anti-PD-1 antibody does not demonstrate this differential activity. With no binding to Fc receptors, cadonilimab shows minimal antibody-dependent cellular cytotoxicity, antibody-dependent cellular phagocytosis, and interleukin-6 (IL-6)/IL-8 release. These features all likely contribute to significantly lower toxicities of cadonilimab observed in the clinic. Higher binding avidity of cadonilimab in a tumor-like setting and Fc-null design may lead to better drug retention in tumors and contribute to better safety while achieving anti-tumor efficacy.

Cadonilimab has been approved by the China National Medical Products Administration for recurrent or metastatic cervical cancer. Cadonilimab has been included and recommended in multiple clinical guidelines such as CSCO. In its first 12 months on the market, cadonilimab generated impressive sales revenue of 1.15 billion RMB. Cadonilimab has been engaged in more than 60 ongoing clinical trials including investigator-initiated studies. Patient enrollment has been completed for the phase 3 study of cadonilimab for first-line treatment of advanced cervical cancer as well as a phase 3 study of cadonilimab in combination with chemotherapy as first-line therapy in gastric cancer. A phase 3 study of cadonilimab as an adjuvant treatment for hepatocellular carcinoma is ongoing. Furthermore, a Phase 3 study comparing cadonilimab with chemotherapy to tislelizumab Injection with chemotherapy is underway for the first-line treatment of PD-L1 expression-negative non-small cell lung cancer.

On October 24, 2023 Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, reported that the U.S. Food and Drug Administration (FDA) has approved TIBSOVO (ivosidenib tablets) for the treatment of patients with isocitrate dehydrogenase 1 (IDH1)-mutated relapsed or refractory (R/R) myelodysplastic syndromes (MDS) (Press release, Servier, OCT 24, 2023, View Source [SID1234636307]). This is the fifth indication for TIBSOVO across IDH1-mutated cancers, and the first and only approved targeted therapy for people diagnosed with R/R MDS within this molecularly defined subset.

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"Servier is proud to lead the way in mutant IDH inhibition through continued innovations that support patients living with difficult and hard-to-treat cancers," said Arjun Prasad, Head of Commercial, Servier Pharmaceuticals. "As the first and only targeted therapy available for patients with IDH1-mutated relapsed or refractory myelodysplastic syndromes, today’s FDA approval for TIBSOVO reinforces our commitment to deliver significant advances in areas of high unmet need and bring the right treatment, to the right patient, at the right time."

The FDA approval of this indication is supported by a pivotal Phase 1, open-label study in IDH1-mutated R/R MDS patients (n=18) where a complete remission (CR) rate of 38.9% and objective response rate (ORR) of 83.3% were documented in patients treated with TIBSOVO. In addition, the median time to CR was 1.9 months (range: 1.0, 5.6). At the time of data cutoff, the median duration of CR had not been reached (range: 1.9, 80.8+*) and the median overall survival was 35.7 months (range: 3.7*, 88.7*). Additionally, of the nine patients who were transfusion dependent with red blood cells or platelets at baseline, 66.7% (n=6) became independent of transfusions during any ≥56-day post-baseline period. Overall, treatment-related adverse events were consistent with the known safety profile of TIBSOVO.

"The novel use of targeted therapy across IDH-mutated cancers has become a powerful therapeutic option for patients within this molecularly defined subset," said Amir Fathi, M.D., hematologist, medical oncologist, and expert in myeloid malignancies. "This new indication in IDH1-mutated relapsed or refractory myelodysplastic syndromes reinforces the importance of mutational testing to inform treatment decisions and potentially improve patient outcomes."

An estimated 16,000 people in the U.S. are diagnosed with MDS each year.1 Approximately 3.6% of MDS patients have an IDH1 mutation,2 which is considered an early "driver" mutation.3 For MDS patients with an IDH1 mutation, the prognosis has often been associated with worse overall outcomes and an increased risk of transformation to AML.

"This approval for TIBSOVO is welcome news for the MDS community," said Tracey Iraca, Executive Director, MDS Foundation. "Before today, there were no approved targeted therapies available to relapsed or refractory MDS patients harboring the IDH1-mutation. We want to thank the study participants, their families and caregivers, as well as the researchers at Servier and clinical investigators involved in this study for helping to bring a new treatment option to patients where there has been a significant unmet need."

"An MDS diagnosis is ambiguous. I remember feeling confused trying to make sense of my diagnosis, what having an IDH1-mutation meant, and what options were available for my treatment plan," said Susan, a patient living with IDH1-mutated MDS.** "The news of an FDA approval for a targeted therapy in IDH-1 mutated MDS has given me a tremendous sense of gratitude and provides hope to patients – like me – who are living with this disease. I want to thank everyone who played a role in this major step forward for the MDS community."

TIBSOVO was granted Breakthrough Therapy designation for the treatment of adult patients with R/R (MDS) with an IDH1 mutation and received Priority Review, which accelerated the review timeline and is granted to applications for medicines that, if approved, would provide significant improvements in the effectiveness or safety of the treatment, diagnosis, or prevention of serious conditions.4

The FDA also approved the Abbott RealTime IDH1 Assay as a companion diagnostic device to select patients for TIBSOVO.

* Denotes a censored observation.
**Last name withheld to protect privacy.

About the NCT02074839 Clinical Trial5
This Phase I, open-label multinational study evaluated the safety, tolerability, and clinical activity of ivosidenib in patients with relapsed or refractory myelodysplastic syndromes with an IDH1 mutation. The primary endpoint was complete remission (CR) plus partial remission (PR) rate and key secondary endpoints included duration of CR+PR, duration of transfusion independence, and time to transfusion independence.

About TIBSOVO (ivosidenib tablets)
TIBSOVO is a precision medicine that targets a specific type of mutation known as isocitrate dehydrogenase 1 (IDH1). TIBSOVO is approved in five indications globally, including approvals in the U.S., European Union, Australia, and China.

In the U.S., TIBSOVO is approved for the treatment of adults with IDH1-mutant relapsed or refractory AML and in monotherapy or in combination with azacitidine for adults with newly diagnosed IDH1-mutant AML who are ≥75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy, as monotherapy for the treatment of adult patients with IDH1-mutant relapsed or refractory MDS, and for patients with previously treated IDH1-mutated cholangiocarcinoma.

Servier has granted CStone a co-exclusive license for the development and an exclusive license agreement for the commercialization of TIBSOVO in Mainland China, Taiwan, Hong Kong, Macao and Singapore.

For more information about TIBSOVO in the U.S., please visit www.tibsovo.com.

About Myelodysplastic Syndromes
Myelodysplastic Syndromes (MDS) are disorders in which progenitor (stem) cells do not mature into healthy blood cells.6 In the U.S., approximately 16,000 new cases of MDS are reported each year.1 Approximately 3.6% of MDS patients have an IDH1 mutation,2 which is considered an early "driver" mutation.3 For MDS patients with an IDH1 mutation, the prognosis has often been associated with worse overall outcomes and in an increased risk of transformation to AML. Prior to the approval of TIBSOVO, there were no approved targeted therapies for this molecularly defined subset.

On October 24, 2023 IDEAYA Biosciences, Inc. (Nasdaq: IDYA) reported the pricing of an underwritten public offering of common stock and pre-funded warrants (Press release, Ideaya Biosciences, OCT 24, 2023, View Source [SID1234636306]). IDEAYA is selling 5,000,000 shares of common stock and pre-funded warrants to purchase 319,150 shares of common stock in the offering. The shares of common stock are being sold at a public offering price of $23.50 per share, before underwriting discounts and commissions, and the pre-funded warrants are being sold at a public offering price of $23.4999 per pre-funded warrant. The exercise price of the pre-funded warrants is $0.0001 per share. In addition, IDEAYA has granted the underwriters a 30-day option to purchase up to an additional 797,872 shares of its common stock at the public offering price per share, before underwriting discounts and commissions. The aggregate gross proceeds to IDEAYA from this offering are expected to be approximately $125,000,000, before deducting underwriting discounts and commissions and other offering expenses, and excluding the exercise of any pre-funded warrants. The offering is expected to close on or about October 27, 2023, subject to the satisfaction of customary closing conditions.

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J.P. Morgan, Goldman Sachs & Co. LLC, Jefferies and RBC Capital Markets are acting as joint book-running managers for the offering.

The securities described above are being offered by IDEAYA pursuant to an automatically effective shelf registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission, or the SEC. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement, copies of which may be obtained, when available, by request from: J.P. Morgan, by mail at J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 866-803-9204, or by email at [email protected]; Goldman Sachs & Co. LLC by mail at Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at 866-471-2526, or by email at [email protected]; Jefferies, by mail at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at [email protected]; or RBC Capital Markets, by mail at RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, 8th Floor, New York, NY 10281, or by telephone at 877-822-4089, or by email 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.