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OnKure Announces Closing of Merger with Reneo Pharmaceuticals and Concurrent Private Placement of $65 Million

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OnKure Therapeutics, Inc. (Nasdaq: OKUR) has completed its merger with Reneo Pharmaceuticals, Inc. and a concurrent $65 million private placement. The combined company, focused on developing precision medicines in oncology, will trade on Nasdaq as OKUR from October 7, 2024. OnKure's lead program, OKI-219, targets PI3KαH1047R mutations in breast cancer, with early clinical data expected in Q4-2024.

Post-merger, OnKure has approximately $139 million in cash, providing runway into Q4-2026. The company completed a 1-for-10 reverse stock split, resulting in about 13.3 million shares outstanding. Prior OnKure stockholders now own 53.6%, Reneo stockholders 25.1%, and new investors 21.3% of the company. Nicholas A. Saccomano, Ph.D., will lead OnKure as President and CEO, with a newly composed Board of Directors.

OnKure Therapeutics, Inc. (Nasdaq: OKUR) ha completato la sua fusione con Reneo Pharmaceuticals, Inc. e un contemporaneo collocamento privato da 65 milioni di dollari. La società combinata, focalizzata sullo sviluppo di farmaci di precisione in oncologia, sarà quotata su Nasdaq come OKUR a partire dal 7 ottobre 2024. Il programma principale di OnKure, OKI-219, mira a mutazioni PI3KαH1047R nel cancro al seno, con dati clinici iniziali attesi nel Q4-2024.

Dopo la fusione, OnKure dispone di circa 139 milioni di dollari in contanti, fornendo liquidità fino al Q4-2026. L'azienda ha completato uno scorporo azionario inverso 1 su 10, risultando in circa 13,3 milioni di azioni in circolazione. I precedenti azionisti di OnKure ora possiedono il 53,6%, gli azionisti di Reneo il 25,1% e i nuovi investitori il 21,3% della società. Nicholas A. Saccomano, Ph.D., guiderà OnKure come Presidente e CEO, con un nuovo Consiglio di Amministrazione.

OnKure Therapeutics, Inc. (Nasdaq: OKUR) ha completado su fusión con Reneo Pharmaceuticals, Inc. y un colocación privada de 65 millones de dólares simultáneo. La empresa combinada, centrada en el desarrollo de medicamentos de precisión en oncología, cotizará en Nasdaq como OKUR a partir del 7 de octubre de 2024. El programa líder de OnKure, OKI-219, se dirige a las mutaciones PI3KαH1047R en el cáncer de mama, con datos clínicos iniciales esperados para el Q4-2024.

Tras la fusión, OnKure cuenta con aproximadamente 139 millones de dólares en efectivo, lo que proporciona liquidez hasta el Q4-2026. La compañía completó una división de acciones inversa de 1 por 10, resultando en aproximadamente 13,3 millones de acciones en circulación. Los antiguos accionistas de OnKure ahora poseen el 53,6%, los accionistas de Reneo el 25,1% y los nuevos inversores el 21,3% de la empresa. Nicholas A. Saccomano, Ph.D., liderará OnKure como Presidente y CEO, con una nueva Junta Directiva.

OnKure Therapeutics, Inc. (Nasdaq: OKUR)는 Reneo Pharmaceuticals, Inc.와의 합병을 완료했으며, 동시에 6500만 달러 규모의 사모펀드를 마련했습니다. 정밀 의약품 개발에 중점을 둔 결합된 회사는 2024년 10월 7일부터 Nasdaq에서 OKUR로 거래됩니다. OnKure의 주요 프로그램인 OKI-219는 유방암에서 PI3KαH1047R 변이를 목표로 하며, 초기 임상 데이터는 2024년 4분기에 기대됩니다.

합병 후 OnKure는 약 1억3900만 달러의 현금을 보유하고 있어 2026년 4분기까지의 자금을 제공합니다. 이 회사는 10주 당 1주로 역분할을 완료하여 약 1330만 주의 유통 주식을 남겼습니다. 이전 OnKure 주주들은 이제 회사의 53.6%, Reneo 주주들은 25.1%, 신규 투자자들은 21.3%를 소유하고 있습니다. Nicholas A. Saccomano, Ph.D.가 새로운 이사회를 이끌며 OnKure의 대통령 겸 CEO로 발탁되었습니다.

OnKure Therapeutics, Inc. (Nasdaq: OKUR) a terminé sa fusion avec Reneo Pharmaceuticals, Inc. et un placement privé de 65 millions de dollars simultanément. La société combinée, axée sur le développement de médicaments de précision en oncologie, sera cotée sur Nasdaq sous le symbole OKUR à partir du 7 octobre 2024. Le programme phare d'OnKure, OKI-219, vise les mutations PI3KαH1047R dans le cancer du sein, avec des données cliniques préliminaires attendues pour le T4-2024.

Après la fusion, OnKure dispose d'environ 139 millions de dollars en liquidités, offrant des ressources jusqu'au T4-2026. L'entreprise a réalisé une opération de division inversée 1 pour 10, entraînant environ 13,3 millions d'actions en circulation. Les anciens actionnaires d'OnKure détiennent désormais 53,6%, les actionnaires de Reneo 25,1% et les nouveaux investisseurs 21,3% de la société. Nicholas A. Saccomano, Ph.D., dirigera OnKure en tant que Président et CEO, avec un nouveau Conseil d'administration.

OnKure Therapeutics, Inc. (Nasdaq: OKUR) hat seine Fusion mit Reneo Pharmaceuticals, Inc. und eine gleichzeitige Privatplatzierung in Höhe von 65 Millionen US-Dollar abgeschlossen. Das kombinierte Unternehmen, das sich auf die Entwicklung von Präzisionsmedikamenten in der Onkologie konzentriert, wird ab dem 7. Oktober 2024 unter Nasdaq als OKUR gehandelt. Das Hauptprogramm von OnKure, OKI-219, zielt auf PI3KαH1047R-Mutationen bei Brustkrebs ab, wobei erste klinische Daten im Q4-2024 erwartet werden.

Nach der Fusion verfügt OnKure über etwa 139 Millionen US-Dollar in Barreserven und hat eine finanzielle Laufzeit bis Q4-2026. Das Unternehmen hat einen 1-zu-10-Rückwärtsaktien-Split durchgeführt, wodurch etwa 13,3 Millionen ausstehende Aktien verbleiben. Die ehemaligen Aktionäre von OnKure besitzen jetzt 53,6%, die Reneo-Aktionäre 25,1% und neue Investoren 21,3% des Unternehmens. Nicholas A. Saccomano, Ph.D., wird OnKure als Präsident und CEO leiten, mit einem neu zusammengesetzten Vorstand.

Positive
  • Completed merger with Reneo Pharmaceuticals and $65 million private placement
  • Post-transaction cash of approximately $139 million, providing runway into Q4-2026
  • Lead program OKI-219 targeting PI3KαH1047R mutations in breast cancer
  • Early clinical data for OKI-219 expected in Q4-2024
  • Strong investor support from notable biotech investment firms
Negative
  • Significant dilution for existing Reneo shareholders, now owning only 25.1% of the combined company
  • Reverse stock split implemented, potentially indicating previous low share price

-- OnKure is focused on advancing a pipeline of candidates targeting oncogenic mutations in phosphoinositide 3-kinase alpha (PI3Kα), initially in breast cancer

-- On track to announce early clinical data for its lead program, OKI-219, in Q4-2024

-- Post-transaction cash, cash equivalents, and short-term investments of approximately $139 million expected to provide funding through multiple clinical readouts and runway into Q4-2026

-- Shares to trade on Nasdaq under the new ticker symbol “OKUR” commencing on October 7, 2024

BOULDER, Colo., Oct. 04, 2024 (GLOBE NEWSWIRE) -- OnKure Therapeutics, Inc. (Nasdaq: OKUR) (“OnKure”), a clinical-stage biopharmaceutical company focused on the development of novel precision medicines in oncology, today announced the completion of its previously announced merger of OnKure, Inc. and Reneo Pharmaceuticals, Inc. (“Reneo”). The combined company will operate under the name OnKure Therapeutics, Inc., and its shares are expected to begin trading on the Nasdaq Global Market on October 7, 2024 under the ticker symbol "OKUR".

Concurrent with the closing of the merger, the company completed a $65 million private placement with a group of new and existing investors, including Acorn Bioventures, Cormorant Asset Management, Deep Track Capital, Perceptive Advisors, Samsara BioCapital, Surveyor Capital (a Citadel company), Vestal Point Capital, and other undisclosed investors. Following the transactions, OnKure is expected to have a cash runway through multiple clinical readouts and into Q4-2026.

“We are ecstatic to finalize this merger, and move to accelerate the development of our mutant-specific PI3Kα inhibitor portfolio. Combined with our unique expertise in PI3K-mutated cancers, we aim to fully target and exploit the vulnerabilities of this oncogenic menace for the benefit of patients suffering needlessly,” said Nicholas Saccomano, Ph.D., President and Chief Executive Officer of OnKure. “Our lead program OKI-219, a highly selective inhibitor of PI3KαH1047R, has the potential to provide benefit to breast cancer patients. With the PIKture-01 trial of OKI-219 well underway, we look forward to releasing early clinical data in the fourth quarter of 2024 and initiating planned combination arms of the PIKture-01 trial.”

Transaction Details

In connection with the closing of the merger, Reneo effected a 1-for-10 reverse stock split of its common stock. Following the reverse stock split and based on the final exchange ratios of 0.0236 shares of Reneo common stock for each share of OnKure common stock and 0.1448 shares of Reneo common stock for each share of OnKure preferred stock, at the closing of the merger there were approximately 13.3 million shares of common stock outstanding, with prior Reneo stockholders owning approximately 31.8% and prior OnKure, Inc. stockholders holding approximately 68.2% of the combined company's outstanding common stock before the concurrent financing. Following the consummation of the private placement of $65.0 million of newly issued common stock, prior OnKure, Inc. stockholders own approximately 53.6%, prior Reneo stockholders own approximately 25.1%, and the private placement investors own approximately 21.3% of the combined company’s outstanding stock.

Leerink Partners served as exclusive financial advisor for Reneo. Jones Day and Cooley LLP served as legal counsel for Reneo for the transactions. Leerink Partners, Evercore ISI and LifeSci Capital served as the placement agents for the private placement financing. Covington & Burling LLP served as legal counsel to the placement agents in connection with the private placement financing. Oppenheimer & Co. served as capital markets advisor to OnKure, Inc., and Wilson Sonsini Goodrich & Rosati, P.C. served as legal counsel to OnKure, Inc.

Leadership Team and Board of Directors Updates

The combined company will be led by Nicholas A. Saccomano, Ph.D. as President and Chief Executive Officer of OnKure. In addition to Dr. Saccomano, the OnKure leadership team includes Samuel Agresta, M.D., as Chief Medical Officer, Dylan Hartley, Ph.D., as Chief Scientific Officer, and Jason Leverone, as Chief Financial Officer.

The Board of Directors of OnKure will be composed of Dr. Saccomano, Isaac Manke, Ph.D., R. Michael Carruthers, Andrew Philips, Ph.D., who join from OnKure, Inc.’s Board of Directors, Michael Grey and Edward T. Mathers, who continue from Reneo’s Board of Directors, and Valerie M. Jansen, who joined the Board at the closing of the merger.

About PI3Kα and OKI-219

PI3Kα is the most frequently mutated oncogene in cancers, and PI3KαH1047R is the most common mutation in this gene, being found in 15% of breast cancer and 4% of cancers overall. While novel drugs targeting PI3Kα have been approved for treatment, the lack of mutant selectivity of these therapeutics drives considerable on-target toxicity by inhibiting the normal version of this protein in various tissues.

OnKure is discovering and developing a portfolio of highly mutant-selective PI3Kα inhibitors with the goal of improving efficacy and safety with molecules that fully inhibit the mutant oncogene while sparing the wild-type enzyme in normal tissues. OnKure’s lead product candidate, OKI-219, is an orally bioavailable, highly selective inhibitor of PI3KαH1047R with approximately 80-fold selectivity for the mutated form of the enzyme compared to wild-type. OnKure believes that the wild-type-sparing properties of OKI-219 should significantly improve the activity and safety relative to currently approved PI3Kα inhibitors. Currently, OKI-219 is being evaluated in a Phase 1 clinical trial in solid tumor patients with PI3KαH1047R mutations, including breast cancer.

About OnKure

OnKure is a clinical-stage biopharmaceutical company focused on the discovery and development of best-in-class precision medicines that target biologically validated drivers of cancers that are underserved by available therapies. Using a structure-based drug design platform, OnKure is building a robust pipeline of tumor-agnostic candidates that are designed to achieve optimal efficacy and tolerability. OnKure is currently developing OKI-219, a selective PI3KαH1047R inhibitor, as its lead program. OnKure aims to become a leader in targeting oncogenic PI3Kα and has multiple programs designed to enable best-in-class targeting of this key oncogene.

For more information about OnKure, visit us at www.onkure.com and follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our future financial condition, results of operations, business strategy and plans, and objectives of management for future operations, as well as statements regarding industry trends, are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of, and expectations regarding, OnKure’s product candidates and programs, including OKI-219; OnKure’s ability to advance additional programs; the expected milestones and timing of such milestones, including for OKI-219 and its discovery programs; and statements regarding OnKure’s financial position, including its liquidity, cash runway and the sufficiency of its cash resources. In some cases, you can identify forward-looking statements by terminology such as “estimate,” “intend,” “may,” “plan,” “potentially” “will” or the negative of these terms or other similar expressions.

The company based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things, those risks described in the section entitled “Risk Factors” in documents that OnKure files from time to time with the Securities and Exchange Commission (“SEC”), including Reneo’s Quarterly Report on Form 10-Q filed with the SEC on August 13, 2024 and the final 424B3 proxy statement/prospectus filed with the SEC on August 26, 2024. These risks are not exhaustive. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this press release.

Contact:

Dan Ferry
LifeSci Advisors
daniel@lifesciadvisors.com


FAQ

What is the new ticker symbol for OnKure Therapeutics (OKUR) after the merger?

OnKure Therapeutics will trade on the Nasdaq Global Market under the ticker symbol OKUR starting October 7, 2024.

How much funding did OnKure Therapeutics (OKUR) raise in the private placement?

OnKure Therapeutics raised $65 million in a private placement concurrent with the closing of the merger.

When does OnKure Therapeutics (OKUR) expect to release early clinical data for OKI-219?

OnKure Therapeutics expects to release early clinical data for its lead program OKI-219 in the fourth quarter of 2024.

What is the cash runway for OnKure Therapeutics (OKUR) after the merger and private placement?

OnKure Therapeutics expects to have a cash runway through multiple clinical readouts and into Q4-2026.

Who will lead OnKure Therapeutics (OKUR) as CEO after the merger?

Nicholas A. Saccomano, Ph.D., will lead OnKure Therapeutics as President and Chief Executive Officer after the merger.

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