Olema Oncology Announces New Clinical Trial Collaboration and Supply Agreement with Novartis in Frontline Metastatic Breast Cancer as well as $250 Million Equity Private Placement
Olema Oncology has announced two major developments: a clinical trial collaboration with Novartis and a $250 million private placement. The Novartis agreement will provide ribociclib drug supply for the planned Phase 3 OPERA-02 trial in frontline ER+/HER2- metastatic breast cancer, expected to start mid-2025. The private placement involves issuing shares at $9.08 and pre-funded warrants, with participation from notable investors including Adage Capital Partners, Bain Capital Life Sciences, and others. The funding will support OPERA-02, the ongoing Phase 3 OPERA-01 trial (with top-line data expected in 2026), and Phase 1/2 study of OP-3136.
Olema Oncology ha annunciato due importanti sviluppi: una collaborazione per un trial clinico con Novartis e un collocamento privato di 250 milioni di dollari. L'accordo con Novartis fornirà rifornimenti del farmaco ribociclib per il previsto trial di fase 3 OPERA-02 nel carcinoma mammario metastatico ER+/HER2-, che dovrebbe iniziare a metà del 2025. Il collocamento privato prevede l'emissione di azioni a 9,08 dollari e warrant pre-finanziati, con la partecipazione di investitori notevoli come Adage Capital Partners, Bain Capital Life Sciences e altri. Il finanziamento supporterà OPERA-02, il trial di fase 3 OPERA-01 in corso (con dati preliminari attesi nel 2026) e lo studio di fase 1/2 di OP-3136.
Olema Oncology ha anunciado dos desarrollos importantes: una colaboración en un ensayo clínico con Novartis y una colocación privada de 250 millones de dólares. El acuerdo con Novartis proporcionará suministro del medicamento ribociclib para el ensayo de fase 3 OPERA-02 en cáncer de mama metastásico ER+/HER2-, que se espera que comience a mediados de 2025. La colocación privada implica la emisión de acciones a 9.08 dólares y warrants prefinanciados, con la participación de inversionistas notables como Adage Capital Partners, Bain Capital Life Sciences y otros. La financiación apoyará OPERA-02, el ensayo de fase 3 OPERA-01 en curso (con datos preliminares esperados en 2026) y el estudio de fase 1/2 de OP-3136.
올레마 온콜로지는 두 가지 주요 개발 사항을 발표했습니다: 노바르티스와의 임상 시험 협력 및 2억 5천만 달러의 사모펀드입니다. 노바르티스와의 협정은 ER+/HER2- 전이성 유방암에 대해 예정된 3상 OPERA-02 시험을 위한 리보시클립 약물 공급을 제공할 것입니다. 시험은 2025년 중반에 시작될 것으로 예상됩니다. 이번 사모펀드는 9.08달러로 주식을 발행하고 사전 자금 조달된 보증을 포함하며, 아다지 캐피탈 파트너스, 베인 캐피탈 생명과학 등 주요 투자자들이 참여하고 있습니다. 이번 자금은 OPERA-02, 진행 중인 3상 OPERA-01 시험(2026년 주요 결과 예상) 및 OP-3136의 1/2상 연구를 지원할 것입니다.
Olema Oncology a annoncé deux développements majeurs : une collaboration pour un essai clinique avec Novartis et un placement privé de 250 millions de dollars. L'accord avec Novartis fournira un approvisionnement en médicament ribociclib pour l'essai prévu de phase 3 OPERA-02 dans le cadre du cancer du sein métastatique ER+/HER2-, qui devrait commencer au milieu de 2025. Le placement privé implique l'émission d'actions à 9,08 dollars et des bons préfinancés, avec la participation d'investisseurs notables tels qu'Adage Capital Partners, Bain Capital Life Sciences et d'autres. Le financement soutiendra OPERA-02, l'essai en cours de phase 3 OPERA-01 (avec des données principales attendues en 2026) et l'étude de phase 1/2 de OP-3136.
Olema Oncology hat zwei wichtige Entwicklungen bekannt gegeben: eine klinische Studienzusammenarbeit mit Novartis und eine private Platzierung in Höhe von 250 Millionen Dollar. Die Vereinbarung mit Novartis sichert die Lieferung des Medikaments Ribociclib für die geplante Phase-3-Studie OPERA-02 bei metastasiertem Brustkrebs ER+/HER2-, die voraussichtlich Mitte 2025 beginnen wird. Die private Platzierung umfasst die Ausgabe von Aktien zu 9,08 Dollar und vorfinanzierten Warrants, mit Beteiligung bedeutender Investoren wie Adage Capital Partners, Bain Capital Life Sciences und anderen. Die Finanzierung wird OPERA-02 unterstützen, die laufende Phase-3-Studie OPERA-01 (mit Hauptdaten, die 2026 erwartet werden) und die Phase-1/2-Studie von OP-3136.
- Secured $250 million through private placement financing
- Obtained drug supply agreement with Novartis for Phase 3 OPERA-02 trial
- Funding extends operations beyond key milestones through 2026
- Trial collaboration maintains global commercial rights for palazestrant
- Significant shareholder dilution through new share issuance
- Pre-funded warrants could lead to additional dilution
Insights
This is a highly significant development for Olema Oncology with two major announcements. The
The collaboration with Novartis for the OPERA-02 trial is strategically valuable, as it secures drug supply for a large 1,000-patient Phase 3 study without Olema bearing the cost of ribociclib. This partnership validates Olema's clinical strategy in frontline metastatic breast cancer treatment.
The company is now funded through multiple key catalysts, including OPERA-01 Phase 3 data in 2026 and initial OP-3136 results. This financial runway significantly de-risks the company's development programs and strengthens its negotiating position for future partnerships.
The clinical collaboration with Novartis is particularly noteworthy as it positions palazestrant for potential use in combination with ribociclib, a well-established CDK4/6 inhibitor, in the lucrative frontline ER+/HER2- metastatic breast cancer market. This combination approach could potentially offer improved efficacy over existing treatments.
The joint ownership of clinical data from OPERA-02 while maintaining commercial rights to palazestrant represents favorable terms for Olema. The planned 1,000-patient trial size suggests a robust study design that could support regulatory approval if successful. The timing of trial initiation in mid-2025 aligns well with the company's development timeline for their lead asset.
- Clinical trial collaboration and supply agreement enables pivotal Phase 3 OPERA-02 clinical trial of palazestrant in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer; trial initiation expected in mid-2025
$250.0 million equity private placement with participation by new and existing investors including Adage Capital Partners LP, Bain Capital Life Sciences, BVF Partners L.P., Driehaus Capital Management, Janus Henderson Investors, Paradigm BioCapital Advisors, Wellington Management, Woodline Partners LP, and a large investment manager- Olema well capitalized to fund operations beyond key milestones including OPERA-01 Phase 3 top-line data in 2026, initial OP-3136 KAT6 Phase 1/2 monotherapy and combination data, and execution of the Phase 3 OPERA-02 clinical trial
SAN FRANCISCO, Dec. 02, 2024 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced a new clinical trial collaboration and supply agreement with Novartis in frontline metastatic breast cancer. Olema has also entered into a securities purchase agreement for the private placement of approximately
"We are now fully enabled to initiate our planned pivotal Phase 3 clinical trial, OPERA-02, for palazestrant in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer. Our new agreement with Novartis, which includes sufficient ribociclib drug supply for the planned approximately 1,000 patient trial, is a major milestone. When combined with our Private Placement of
New Clinical Trial Collaboration and Supply Agreement Enables Phase 3 OPERA-02 Trial
Under the terms of the agreement, Novartis will provide Olema with ribociclib drug supply for the planned, Olema-sponsored, Phase 3 OPERA-02 trial of palazestrant in combination with ribociclib in ER+/HER2- frontline advanced or metastatic breast cancer. All clinical data and inventions from the trial will be jointly owned while Olema maintains global commercial and marketing rights to palazestrant.
Private Placement Funds Expanded Clinical Development Activities
The Private Placement is expected to close on or about December 4, 2024, subject to the satisfaction of customary closing conditions. The financing included participation by new and existing investors Adage Capital Partners LP, Bain Capital Life Sciences, BVF Partners L.P., Driehaus Capital Management, Janus Henderson Investors, Paradigm BioCapital Advisors, Wellington Management, Woodline Partners LP, and a large investment manager. Pursuant to the terms of the securities purchase agreement, Olema will issue 19,928,875 shares of common stock at a purchase price of
Jefferies is acting as lead placement agent with J.P. Morgan, Goldman Sachs & Co. LLC, Citigroup, LifeSci Capital, Oppenheimer & Co., and H.C. Wainwright & Co. acting as placement agents in the Private Placement.
Olema intends to use the net proceeds from the Private Placement, together with its current cash, cash equivalents and marketable securities, to fund the OPERA-02 trial, the Phase 1/2 study of OP-3136, and its ongoing Phase 3 OPERA-01 monotherapy trial of palazestrant, and for working capital and general corporate purposes.
The securities described above have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state’s securities laws, and are being issued and sold pursuant to an exemption from registration provided for under the Securities Act. Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Olema has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the “SEC”) registering the resale of the shares of common stock issued and sold in the Private Placement. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
About Palazestrant (OP-1250)
Palazestrant (OP-1250) is a novel, orally available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In preclinical studies, palazestrant completely blocks ER-driven transcriptional activity in both ESR1 wild-type and mutant forms of breast cancer. In Olema’s ongoing clinical trials for advanced or metastatic ER+/HER2- breast cancer, palazestrant has demonstrated anti-tumor activity along with attractive pharmacokinetics and exposure, favorable tolerability, and combinability with CDK4/6 inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. It is being evaluated both as a single agent in an ongoing Phase 3 clinical trial, OPERA-01, and in Phase 1/2 combination studies with CDK4/6 inhibitors (palbociclib and ribociclib), a PI3Ka inhibitor (alpelisib), and an mTOR inhibitor (everolimus).
About Olema Oncology
Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for women living with cancer. Olema is advancing a pipeline of novel therapies by leveraging our deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Olema’s lead product candidate, palazestrant (OP-1250), is a proprietary, orally available complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD), currently in a Phase 3 clinical trial called OPERA-01. In addition, Olema is developing a potent KAT6 inhibitor (OP-3136). Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as “anticipate,” “expect,” “will,” “may,” “goal,” “potential” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to the completion of the Private Placement, the use of proceeds therefrom, the anticipated filing of a registration statement to cover resales of the securities issued in the Private Placement, Olema's expectation that the proceeds from the Private Placement, together with current cash, cash equivalents and marketable securities, is expected to be sufficient to fund Olema’s planned OPERA-02 trial, the Phase 1/2 study of OP-3136, and the ongoing Phase 3 OPERA-01 trial. Because such statements deal with future events and are based on Olema’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of Olema could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled “Risk Factors” in Olema’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, and future filings and reports that Olema makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements.
Media and Investor Relations Contact
Courtney O’Konek
Vice President, Corporate Communications
Olema Oncology
media@olema.com
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