IDEAYA Announces Closing of Public Offering Including Full Exercise of Underwriters’ Option to Purchase Additional Shares

On July 11, 2024 IDEAYA Biosciences, Inc. (Nasdaq: IDYA) reported the closing of its underwritten public offering of 8,355,714 shares of its common stock at a public offering price of $35.00 per share, before underwriting discounts and commissions, and pre-funded warrants to purchase 285,715 shares of common stock at a public offering price of $34.9999 per pre-funded warrant, before underwriting discounts and commissions (Press release, Ideaya Biosciences, JUL 11, 2024, View Source [SID1234644795]). This includes the exercise in full by the underwriters of their option to purchase up to an additional 1,127,142 shares of common stock in the offering. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by IDEAYA, were approximately $302.4 million.

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

The public offering was made 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 was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained 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.

Revolution Medicines Announces Publication Demonstrating Robust Anti-Tumor Activity of RAS(ON) Inhibitors in Preclinical Models of Refractory KRAS-Mutated Non-Small Cell Lung Cancer

On July 11, 2024 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for patients with RAS-addicted cancers, reported the publication of a peer-reviewed research paper in Cancer Discovery (Press release, Revolution Medicines, JUL 11, 2024, View Source [SID1234644794]). The scientific paper demonstrates that the RAS(ON) multi-selective inhibitor RMC-7977 (a preclinical tool compound representative of the investigational drug candidate RMC-6236) exhibited robust and durable anti-tumor activity in multiple preclinical models of KRAS-mutated NSCLC. The data show this activity was further enhanced in the doublet combination with a RAS(ON) G12C-selective inhibitor RMC-4998 (a preclinical tool compound representative of the investigational drug RMC-6291), in preclinical models of KRAS G12C-mutated NSCLC. These findings are the result of original, collaborative research between scientists at Revolution Medicines and The University of Texas MD Anderson Cancer Center.

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Oncogenic RAS proteins drive up to 30 percent of all human cancers, most notably NSCLC, pancreatic ductal adenocarcinoma and colorectal cancer. RAS G12 mutations, such as G12D, G12V and G12C, predominate in these RAS-addicted cancers. Approved RAS-targeted cancer therapies target only one RAS mutation, KRAS G12C, which is present in approximately 13 percent of NSCLC. There remains a large unmet medical need for improved clinical outcomes with KRAS G12C-selective inhibitors and for extending therapy options to patients harboring KRAS non-G12C-driven tumors.

The paper highlights that direct RAS inhibition with a RAS(ON) multi-selective inhibitor monotherapy, alone or in combination with a RAS(ON) G12C-selective inhibitor, elicited rapid, deep and sustained tumor regressions and significantly prolonged time to tumor doubling in preclinical models of refractory KRAS G12C-mutated NSCLC. The combination dramatically improved anti-tumor activity as compared to RAS(ON) multi-selective inhibitor monotherapy and elicited cures (defined as recurrence free survival following treatment withdrawal) in all of the preclinical models bearing alterations in genes associated with the subsets of KRAS G12C-mutated NSCLC (e.g. KEAP1 and SMARCA4). The RAS(ON) multi-selective inhibitor overcame acquired resistance to RAS(OFF) and RAS(ON) G12C-selective inhibitors in these models of advanced KRAS G12C-mutated NSCLC, further underscoring the robust activity of this inhibitor.

The paper also unveils a conserved mucinous regenerative program, apparent upon treatment cessation, that may support long-term tumor cell persistence in the context of sustained RAS pathway inhibition. Characterization of this emergent population of persister cells, a rare slow cycling group of cancer cells that may endure despite ongoing inhibitor treatment, provides insights into potential therapeutic strategies that could prevent them from driving recurrent tumor growth.

"RAS-addicted cancers are widely known for being resistant to current cancer therapies and recent studies have highlighted mechanisms of clinical resistance to RAS(OFF) G12C-inhibitors. We evaluated the anti-tumor activity of a broad spectrum RAS(ON) multi-selective inhibitor alone and in combination with a RAS(ON) G12C mutant-selective inhibitor in models of clinically challenging subsets of KRAS G12C-mutated NSCLC. Given the novel mechanism of action of these inhibitors, directly targeting oncogenic RAS, a key question was whether primary, adaptive or acquired resistance mechanisms would emerge following treatment," said Jan Smith, Ph.D., Chief Scientific Officer of Revolution Medicines. "These encouraging preclinical data provide a strong rationale for our ongoing combination study of RMC-6236 as a doublet with RMC-6291 in patients with advanced KRAS G12C-mutated cancers."

The investigational oral drug RMC-6236 is a RAS(ON) multi-selective inhibitor designed to treat patients with cancers driven by a wide range of common RAS mutations. Revolution Medicines is currently evaluating RMC-6236 as monotherapy in a Phase 1/1b trial in patients with advanced solid tumors harboring G12X, G13X and Q61X mutations (NCT05379985). Following promising preliminary data in this Phase 1/1b study, planning is underway to initiate pivotal studies of RMC-6236 as monotherapy in PDAC and NSCLC. RMC-6236 is also being evaluated in combination with pembrolizumab with or without chemotherapy in patients with advanced RAS-mutated solid tumors (NCT06162221) and in combination with RMC-6291, the company’s investigational RAS(ON) G12C-selective inhibitor, for patients with advanced KRAS G12C-mutated solid tumors (NCT06128551).

The publication, entitled, "Mechanisms of response and tolerance to active RAS inhibition in KRAS-mutant NSCLC," is available online at:
View Source

Oncternal Therapeutics to Present in JonesTrading Healthcare Summit

On July 11, 2024 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that James Breitmeyer, M.D, Ph.D., Oncternal’s President and Chief Executive Officer will present at the JonesTrading Healthcare Seaside Summit being held July 14-16, 2024 in San Diego, California (Press release, Oncternal Therapeutics, JUL 11, 2024, View Source [SID1234644793]).

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JonesTrading Healthcare Seaside Summit
Presentation Date and Time: Monday, July 15, 2024 at 2:30pm PT
Webcast Registration: Link

Please contact your JonesTrading institutional salesperson to participate in the event. Links to the replay will be accessible on the Events & Presentations page of the Investors section on the Company’s website at investor.oncternal.com, for at least 30 days after the event.

Entry into a Merial Definitive Agreement

On July 11, 2024, Onconetix, Inc., a Delaware corporation (the "Company"), reported to have entered into common stock preferred investment options exercise inducement offer letters (the "Inducement Letter") with certain holders of existing preferred investment options ("PIOs") to purchase shares of the Company’s common stock at the original exercise prices of $2.546 and $1.09 per share, issued on August 11, 2022 and August 2, 2023, respectively (collectively, the "Existing PIOs"), pursuant to which the holders agreed to exercise for cash their Existing PIOs to purchase an aggregate of 7,458,642 of the Company’s common stock, at a reduced exercise price of $0.15 per share, in consideration for the Company’s agreement to issue new PIOs (the "Inducement PIOs") to purchase up to an aggregate of 22,375,926 shares of the Company’s common stock (the "Inducement PIO Shares") (Filing, 8-K, Onconetix, JUL 11, 2024, View Source [SID1234644792]). The Company expects to receive aggregate gross proceeds of approximately $1,118,796 from the exercise of the Existing PIOs by the holders and the sale of the Inducement PIOs, before deducting placement agent fees and other offering expenses payable by the Company. The Company expects to use the net proceeds of these transactions for general corporate and working capital purposes. The closing of the transactions contemplated pursuant to the Inducement Letter is expected to occur on July 12, 2024 (the "Closing Date"), subject to satisfaction of customary closing conditions.

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The Company engaged H.C. Wainwright & Co., LLC ("Wainwright") to act as its exclusive placement agent in connection with the transactions summarized herein and will pay Wainwright a cash fee equal to 7.5% of the gross proceeds received from the exercise of the Existing PIOs as well as a management fee equal to 1.0% of the gross proceeds from the exercise of the Existing PIOs. The Company also agreed to reimburse Wainwright for its expenses in connection with the exercise of the Existing PIOs and the issuance of the Inducement PIOs, up to $50,000 for fees and expenses of legal counsel and other out-of-pocket expenses and agreed to pay Wainwright for non-accountable expenses in the amount of $35,000 for non-accountable expenses. The Company also agreed to issue to Wainwright or its designees warrants (the "Placement Agent Warrants," and such shares of common stock issuable thereunder, the "Placement Agent Warrant Shares") to purchase (i) 522,105 shares of common stock which will have the same terms as the Inducement PIOs except for an exercise price equal to $0.1875 per share and a term of five (5) years following the date of stockholder approval and (ii) upon any exercise for cash of the Inducement PIOs, 7.5% of the aggregate exercise price and that number of shares of common stock equal to 7.0% of the aggregate number of such shares of common stock underlying the Inducement PIOs that have been exercised, which will have substantially the same terms as the Placement Agent Warrants.

The resale of the shares of the Company’s common stock issuable upon exercise of the Existing PIOs are registered pursuant to an existing Registration Statement on Form S-1 (File No. 333-277066), declared effective by the Securities and Exchange Commission (the "SEC") on July 1, 2024.

The Company also agreed to file a registration statement covering the resale of the Inducement PIO Shares issued or issuable upon the exercise of the Inducement PIOs (the "Resale Registration Statement") within 30 days after the date of the Inducement Letter and to use commercially reasonable efforts to cause such Resale Registration Statement to be declared effective by the SEC within 60 days following the date of the Inducement Letter (or within 90 days following the date of the Inducement Letter in the case of full review of the Resale Registration Statement by the SEC). In the Inducement Letter, the Company agreed not to issue any shares of common stock or common stock equivalents or to file any other registration statement with the SEC (in each case, subject to certain exceptions) until the later of (i) the filing of a definitive proxy statement on Schedule 14A for the purpose of obtaining the requisite stockholder approval (as described below) and (ii) 30 days after the Closing Date. The Company also agreed not to effect or agree to effect any variable rate transaction (as defined in the Inducement Letter) until six (6) months after the Closing Date (subject to certain exceptions).

Inducement PIO Terms

The following summary of certain terms and provisions of the Inducement PIOs is not complete and is subject to, and qualified in its entirety by, the provisions of the Inducement PIOs, the form of which is filed as Exhibit 4.1 to this Current Report on Form 8-K and is incorporated herein by reference. The following description of the Inducement PIOs is qualified in its entirety by reference to such exhibit.

Stockholder Approval

The shares of common stock issuable upon exercise of the Inducement PIOs is subject to stockholder approval. The Company agreed to convene a stockholders’ meeting on or before 90 days following the Closing Date, to obtain such approval.

Duration and Exercise Price

Each Inducement PIO will have an exercise price equal to $0.15 per share. The Inducement PIOs will be exercisable at any time on or after the date upon the stockholders’ approval of the issuance of the Inducement PIO Shares upon the exercise of the Inducement PIOs. 7,458,642 Inducement PIOs will have a term of exercise of five (5) years following the date of stockholder approval, and the remaining 14,917,284 Inducement PIOs will have a term of exercise of twenty-four (24) months following the date of stockholder approval. The exercise price and number of shares of common stock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, subsequent rights offerings, pro rate distributions, reorganizations, a Fundamental Transaction (as defined in the Inducement PIOs) or similar events affecting our common stock and the exercise price.

Exercisability

The Inducement PIOs will be exercisable (following the stockholders’ approval), at the option of each holder, in whole or in part, by delivering to the Company a duly executed exercise notice accompanied by payment in full for the number of shares of our common stock purchased upon such exercise (except in the case of a cashless exercise as discussed below). A holder (together with its affiliates) may not exercise any portion of such holder’s Inducement PIOs to the extent that the holder would own more than 4.99% (or 9.99% at such holder’s election) of the outstanding common stock immediately after exercise, except that upon at least 61 days’ prior notice from the holder to the Company, the holder may increase the amount of ownership of outstanding stock after exercising the holder’s Inducement PIOs up to 9.99% of the number of shares of the Company’s common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Inducement PIOs.

Cashless Exercise

If, at the time a holder exercises its Inducement PIOs, a registration statement registering the resale of the Inducement PIO Shares by the holder under the Securities Act (as defined herein) is not then effective or available, then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula set forth in the Inducement PIOs.

Trading Market

There is no established trading market for the Inducement PIOs, and the Company does not expect an active trading market to develop. The Company does not intend to apply to list the Inducement PIOs on any securities exchange or other trading market. Without a trading market, the liquidity of the Inducement PIOs will be extremely limited.

Rights as a Stockholder

Except as otherwise provided in the Inducement PIOs or by virtue of the holder’s ownership of shares of the Company’s common stock, such holder of Inducement PIOs does not have the rights or privileges of a holder of the Company’s common stock, including any voting rights, until such holder exercises such holder’s Inducement PIOs. The Inducement PIOs provide that the holders of the Inducement PIOs have the right to participate in distributions or dividends paid on the Company’s shares of common stock.

Waivers and Amendments

The Inducement PIOs may be modified or amended or the provisions of the Inducement PIOs waived with the Company’s and the holder’s written consent.

The form of Inducement Letter and Inducement PIO are attached as Exhibits 10.1 and 4.1, respectively. The description of the terms of the Inducement Letter and the Inducement PIO is not intended to be complete and is qualified in its entirety by reference to such exhibits. The Inducement Letter contains customary representations, warranties and covenants by the Company which were made only for the purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements and may be subject to limitations agreed upon by the contracting parties.

Ipsen and Foreseen Biotechnology announce exclusive global licensing agreement for antibody-drug conjugate with first-in-class potential

On July 11, 2024 Ipsen (Euronext: IPN; ADR: IPSEY) and Foreseen Biotechnology (Foreseen) reported an exclusive global licensing agreement for FS001, an antibody-drug conjugate (ADC) with first-in-class potential (Press release, Ipsen, JUL 11, 2024, View Source [SID1234644791]). FS001 targets a novel tumor-associated antigen that is overexpressed in many solid tumors and plays a critical role in tumor proliferation and metastasis. This novel tumor antigen was identified using Foreseen’s high throughput, integrated translational proteomics, and artificial intelligence (AI)-powered screening platforms, to analyze their vast collection of well-characterized clinical tumor samples. FS001 utilized an innovative, stable and cleavable linker coupled to a potent topoisomerase I inhibitor. Preclinical efficacy of FS001 was demonstrated in multi-drug resistant cancer models. The agreement gives Ipsen exclusive worldwide rights to develop, manufacture and commercialize FS001.

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"We are excited to add FS001, the second ADC Ipsen has in-licensed this year, to our growing pipeline. Using cutting-edge proteomics technology and AI-powered screening platforms the Foreseen team has uncovered a novel and clinically relevant target which could unlock the potential of ADCs for even more people living with hard-to-treat forms of cancer," said Mary Jane Hinrichs, SVP and Head of Early Development at Ipsen. "As we prepare for the initiation of a Phase I clinical trial, we will evaluate FS001 in selected solid tumor types, which we hope will deliver critical new treatments for people living with cancer around the world."

"Our strategic partnership with Ipsen provides a strong endorsement to our high throughput integrated translational proteomics platform approach to discover and develop innovative therapeutic products with first-in-class potential", said Catherine Wong, Founder and Chairman of Foreseen. "We are pleased to be collaborating with Ipsen to advance FS001 globally, harnessing Ipsen’s robust track record in accelerating the clinical development and commercialization of innovative therapeutics. We believe FS001 has the potential to treat multiple cancers as a single agent or in combination with standard of care."

Foreseen Biotechnology is eligible to receive up to $1.03bn comprising upfront, development, regulatory and commercial milestone payments, and tiered royalties on global sales, contingent upon successful development and regulatory approvals. Under the terms of the agreement, Ipsen will assume responsibility for Phase I preparation activities, including submission of the Investigational New Drug (IND) application, and all subsequent clinical-development, manufacturing, and global commercialization activities.