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Oncocyte Prices $29.1 Million Equity Offering

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Oncocyte Corp. (OCX) has secured $29.1 million through a registered direct offering and concurrent private placement priced at $2.05 per share. The funding round was led by the company's five largest shareholders, including strategic partner Bio-Rad Laboratories, who also committed additional support for clinical trials and commercialization.

The proceeds, combined with current cash, will fully fund the development of Oncocyte's FDA In-Vitro Diagnostic (IVD) transplant assay program. The company's proprietary technology can detect kidney transplant rejection signs over 11 months earlier than standard protocols. The offering includes 3,609,755 shares in the registered direct offering and 7,536,708 shares plus pre-funded warrants for 3,069,925 shares in the PIPE offering.

The transaction is expected to close on February 10, 2025, with Needham & Company acting as financial advisor. The company aims to capture share in the $1 billion global transplant testing market.

Oncocyte Corp. (OCX) ha ottenuto 29,1 milioni di dollari attraverso un'offerta diretta registrata e una collocazione privata concomitante, con un prezzo di 2,05 dollari per azione. Il round di finanziamento è stato guidato dai cinque maggiori azionisti dell'azienda, incluso il partner strategico Bio-Rad Laboratories, che ha anche impegnato ulteriore supporto per prove cliniche e commercializzazione.

Il ricavato, combinato con la liquidità attuale, finanzierà completamente lo sviluppo del programma di test trasplantativi IVD (In-Vitro Diagnostic) approvato dalla FDA di Oncocyte. La tecnologia proprietaria dell'azienda può rilevare segni di rigetto del trapianto renale oltre 11 mesi prima rispetto ai protocolli standard. L'offerta include 3.609.755 azioni nell'offerta diretta registrata e 7.536.708 azioni più warrant pre-finanziati per 3.069.925 azioni nell'offerta PIPE.

Si prevede che la transazione si chiuda il 10 febbraio 2025, con Needham & Company che agirà come consulente finanziario. L'azienda mira a conquistare quota nel mercato globale dei test per trapianti, del valore di 1 miliardo di dollari.

Oncocyte Corp. (OCX) ha conseguido 29.1 millones de dólares a través de una oferta directa registrada y una colocación privada concurrente con un precio de 2.05 dólares por acción. La ronda de financiamiento fue liderada por los cinco mayores accionistas de la empresa, incluido el socio estratégico Bio-Rad Laboratories, que también se comprometió a brindar apoyo adicional para ensayos clínicos y comercialización.

Los ingresos, combinados con el efectivo actual, financiarán por completo el desarrollo del programa de ensayo de trasplante IVD (Diagnóstico In-Vitro) aprobado por la FDA de Oncocyte. La tecnología patentada de la compañía puede detectar signos de rechazo de trasplante renal más de 11 meses antes que los protocolos estándar. La oferta incluye 3.609.755 acciones en la oferta directa registrada y 7.536.708 acciones más garantías prefinanciadas para 3.069.925 acciones en la oferta PIPE.

Se espera que la transacción se cierre el 10 de febrero de 2025, con Needham & Company actuando como asesor financiero. La compañía aspira a capturar participación en el mercado global de pruebas de trasplantes, que tiene un valor de mil millones de dólares.

Oncocyte Corp. (OCX)는 주당 2.05달러의 가격으로 등록된 직접 발행과 동시 개인배치를 통해 2,910만 달러를 확보했습니다. 이 자금 조달 라운드는 회사의 다섯 주요 주주가 주도했으며, 그 중 전략적 파트너인 Bio-Rad Laboratories도 임상 시험 및 상업화를 위한 추가 지원을 약속했습니다.

모금된 자금은 현재 현금과 결합되어 Oncocyte의 FDA 승인 인비트로 진단(IVD) 이식 검사 프로그램 개발을 전액 지원합니다. 회사의 독점 기술은 표준 프로토콜보다 11개월 이상 앞서 신장 이식 거부 징후를 감지할 수 있습니다. 이번 발행에는 등록된 직접 발행에서 3,609,755주와 PIPE 발행에서 7,536,708주 및 3,069,925주에 대한 미리 발행된 증권이 포함됩니다.

이번 거래는 2025년 2월 10일에 마감될 것으로 예상되며, Needham & Company가 재정 고문 역할을 합니다. 회사는 10억 달러 규모의 글로벌 이식 검사 시장에서 점유율을 확보하는 것을 목표로 하고 있습니다.

Oncocyte Corp. (OCX) a obtenu 29,1 millions de dollars grâce à une offre directe enregistrée et une placement privé concomitant au prix de 2,05 dollars par action. Le tour de financement a été dirigé par les cinq plus grands actionnaires de l'entreprise, y compris le partenaire stratégique Bio-Rad Laboratories, qui s'est également engagé à soutenir davantage les essais cliniques et la commercialisation.

Les produits, combinés aux liquidités actuelles, financeront entièrement le développement du programme de test de transplantation IVD (In-Vitro Diagnostic) approuvé par la FDA d'Oncocyte. La technologie propriétaire de l'entreprise peut détecter des signes de rejet d'un greffon rénal plus de 11 mois plus tôt que les protocoles standards. L'offre comprend 3.609.755 actions dans l'offre directe enregistrée et 7.536.708 actions plus des bons de souscription préfinancés pour 3.069.925 actions dans l'offre PIPE.

La transaction devrait se conclure le 10 février 2025, Needham & Company agissant en tant que conseiller financier. L'entreprise vise à capturer des parts de marché dans le marché mondial des tests de transplantation d'une valeur d'un milliard de dollars.

Oncocyte Corp. (OCX) hat 29,1 Millionen Dollar durch ein registriertes Direktangebot und eine gleichzeitige Privatplatzierung zu einem Preis von 2,05 Dollar pro Aktie gesichert. Die Finanzierungsrunde wurde von den fünf größten Aktionären des Unternehmens geleitet, darunter der strategische Partner Bio-Rad Laboratories, der ebenfalls zusätzliche Unterstützung für klinische Studien und die Kommerzialisierung zugesagt hat.

Die Mittel, kombiniert mit den aktuellen Barmitteln, werden die vollständige Finanzierung der Entwicklung des FDA genehmigten In-Vitro-Diagnosetests (IVD) von Oncocyte sichern. Die proprietäre Technologie des Unternehmens kann Anzeichen einer Nierentransplantatabstoßung über 11 Monate früher erkennen als die Standardprotokolle. Das Angebot umfasst 3.609.755 Aktien im registrierten Direktangebot und 7.536.708 Aktien sowie vorfinanzierte Warrants für 3.069.925 Aktien im PIPE-Angebot.

Die Transaktion wird voraussichtlich am 10. Februar 2025 abgeschlossen, wobei Needham & Company als Finanzberater fungiert. Das Unternehmen hat sich zum Ziel gesetzt, Marktanteile im globalen Transplantationstestmarkt im Wert von 1 Milliarde Dollar zu gewinnen.

Positive
  • Secured $29.1M in funding at market price with no discounts
  • Strategic partner Bio-Rad increased investment and support
  • Technology detects transplant rejection 11 months earlier than standard protocols
  • Funding sufficient to complete FDA IVD clearance program
  • Targeting $1B global transplant testing market
Negative
  • Significant shareholder dilution through new share issuance
  • Additional registration requirements for PIPE offering shares

Insights

This $29.1M equity raise represents a significant strategic milestone for Oncocyte, particularly noteworthy for its favorable terms - priced at $2.05 per share with no discount or warrant sweeteners, indicating strong investor confidence. The participation of Bio-Rad, a major strategic partner, adds substantial credibility and operational support beyond the capital injection.

The funding structure is particularly impressive in the current biotech financing environment. The offering combines 3.61M shares in a registered direct offering with 7.54M shares and pre-funded warrants for 3.07M shares in the PIPE offering. This structure provides immediate capital while maintaining flexibility for future financing needs.

The strategic focus on the $1 billion global transplant testing market presents a compelling commercial opportunity. Their transplant assay technology's ability to detect rejection 11 months earlier than standard protocols could drive rapid market adoption post-FDA clearance. Bio-Rad's expanded support for clinical trials and commercialization significantly de-risks the regulatory pathway and potential market entry.

The participation of management in the private placement aligns interests with shareholders and demonstrates internal confidence in the company's trajectory. With the existing cash position plus this raise, Oncocyte appears well-positioned to reach FDA clearance - a critical value inflection point that could accelerate their path to self-sustaining revenue.

The clinical significance of Oncocyte's transplant assay technology cannot be overstated. The ability to detect rejection signatures 11 months earlier than current protocols represents a paradigm shift in transplant monitoring. This early detection window is important for intervention strategies and could significantly improve graft survival rates.

The technology's focus on simplicity and rapid results addresses key adoption barriers in transplant centers. Current monitoring methods often involve complex workflows and delayed results, which can compromise patient care. Oncocyte's streamlined approach, coupled with faster turnaround times, could drive swift market penetration post-FDA clearance.

The expanded partnership with Bio-Rad brings valuable technical expertise and commercial infrastructure support. This collaboration could accelerate both the regulatory process and market adoption, particularly given Bio-Rad's established presence in clinical diagnostics and their deep understanding of laboratory workflows.

  • Proceeds Expected to Fund Transplant Assay Through FDA IVD Clearance and Commercial Launch
  • Strategic Partner Bio-Rad Invests, Boosts Support for Trial and Commercialization

IRVINE, Calif., Feb. 10, 2025 (GLOBE NEWSWIRE) -- Oncocyte Corp. (Nasdaq: OCX), a pioneering diagnostics technology company, today announced that it has entered into securities purchase agreements with existing investors for a registered direct offering (“Registered Direct Offering”) and concurrent private placement (“PIPE Offering”).

The Company’s five largest shareholders, including Bio-Rad Laboratories, Inc., (NYSE: BIO) (“Bio-Rad”), a key strategic partner of the Company, led the funding round. The round is expected to result in gross cash proceeds to the Company totaling $29.1 million priced at $2.05 per share. Two members of the Company’s management team also participated in the private placement.

In addition to its equity investment, Bio-Rad has pledged to provide valuable financial support for the upcoming clinical trial and further commercialization assistance, underscoring the depth of its strategic partnership with Oncocyte.

Combined with Oncocyte’s current cash on hand, the offering proceeds are expected to fully fund the development of the Company's FDA In-Vitro Diagnostic (IVD) transplant assay program. FDA clearance of Oncocyte’s proprietary transplant assay is a key milestone to driving self-sustaining revenue.

Oncocyte remains committed to advancing its mission to improve patient outcomes by democratizing access to groundbreaking diagnostic solutions. The company’s immediate focus is on transplant diagnostics. Oncocyte’s proprietary technology is designed with the transplant center in mind. The assay’s simple workflow is easy to adopt and provides rapid results that allow doctors to make quicker, better decisions. Published clinical data, for example, show that Oncocyte’s technology can detect signs of kidney transplant rejection more than 11 months sooner than standard protocols. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes.

“We’re going to make it easier for transplant doctors to manage their patients’ care. Securing the necessary funding to complete our FDA IVD clearance program gets us closer to making that a reality,” said Josh Riggs, the Company’s President and Chief Executive Officer. “Early feedback from our beta sites is that we’ve built technology that is fast, reliable, and easy to use. Following FDA clearance, we expect rapid adoption for clinical use at transplant centers across the U.S.”

“We are thrilled at the support from existing shareholders in funding our expected future growth as we seek to capture share in the $1 billion global transplant testing market,” said Andrea James, the Company’s Chief Financial Officer. “Financial discipline and sound capital stewardship will remain two of our core values going forward.”

Important Details About the Offering

As noted above, the offerings were priced at $2.05 per share, which represented no discounts nor incentive warrants, and total gross proceeds of $29.1 million, before deducting offering expenses payable by the Company. The Company sold 3,609,755 shares of common stock in the registered direct offering and 7,536,708 shares of common stock and common stock equivalent pre-funded warrants to purchase 3,069,925 shares of common stock in the PIPE Offering.

The PIPE Offering was priced at least "at-the-market" under the rules and regulations of The Nasdaq Stock Market LLC and the closings of the Registered Direct Offering and the PIPE Offering are expected to occur on or about February 10, 2025, subject to the satisfaction of customary closing conditions. Needham & Company acted as a financial advisor to Oncocyte.

The Company has agreed to file a registration statement on Form S-1 under the Act with the Securities and Exchange Commission (the “SEC”), covering the resale of the shares of common stock and shares of common stock underlying the pre-funded warrants to be issued in the PIPE Offering no later than March 15, 2025, and to use reasonable best efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event 15 days thereafter.

The offer and sale of the securities in the PIPE Offering described above are being offered and sold in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”), and Regulation D promulgated thereunder, and have not been registered under the Act, or applicable state securities laws. Accordingly, such securities issued in the PIPE Offering 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 Act and such applicable state securities laws.

The offer and sale of the securities in the Registered Direct Offering described above are being offered and sold by the Company in a registered direct offering pursuant to a “shelf” registration statement on Form S-3, as amended (File No. 333-281159), that was originally filed with the Securities and Exchange Commission (the “SEC”) on August 1, 2024, and was declared effective by the SEC on August 7, 2024. The offering of the securities in the Registered Direct Offering is being made only by means of a base prospectus and prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering was filed with the SEC on February 10, 2025, and is available on the SEC’s website at www.sec.gov.

This press release does 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 other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

Forward-Looking Statements

This press release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements pertaining to the Company’s expectations regarding the completion of the offering, the satisfaction of customary closing conditions related to the offering, the intended use of proceeds from the offering in this press release constitute forward-looking statements.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors, such as market and other conditions, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include market conditions, the ability of the Company to satisfy all conditions precedent to the closing of the PIPE Offering and Registered Direct Offering, the completion of the PIPE Offering and Registered Direct Offering, the anticipated use of proceeds from the PIPE Offering and Registered Direct Offering, as well as those set forth in the Company’s annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

About Oncocyte
Oncocyte is a leading diagnostics technology company. The company’s tests are designed to help provide clarity and confidence to physicians and their patients. VitaGraft™ is a clinical blood-based solid organ transplantation monitoring test. GraftAssure™ is a research use only (RUO) blood-based solid organ transplantation monitoring test. DetermaIO™ is a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies. DetermaCNI™ is a blood-based monitoring tool for monitoring therapeutic efficacy in cancer patients.

Additional Information for Investors:

Please visit https://investors.oncocyte.com/ to find our latest investor materials.

A refreshed investor presentation has been posted to the Company’s investor site. You may access that here or by accessing this URL: https://investors.oncocyte.com/~/media/Files/O/Oncocyte-IR/events-and-presentations/ocx-presentation-feb-2025.pdf

Jeff Ramson
PCG Advisory
(646) 863-6893
jramson@pcgadvisory.com

Andrea James
CFO
Oncocyte
ajames@oncocyte.com


FAQ

How much funding did Oncocyte (OCX) raise in its February 2025 offering?

Oncocyte raised $29.1 million through a registered direct offering and concurrent private placement, priced at $2.05 per share.

What will Oncocyte (OCX) use the February 2025 funding proceeds for?

The proceeds will fund the development of Oncocyte's FDA In-Vitro Diagnostic (IVD) transplant assay program through FDA clearance and commercial launch.

How many shares did Oncocyte (OCX) issue in the February 2025 offering?

Oncocyte issued 3,609,755 shares in the registered direct offering and 7,536,708 shares plus pre-funded warrants for 3,069,925 shares in the PIPE offering.

What advantage does Oncocyte's (OCX) transplant assay technology offer?

Oncocyte's technology can detect signs of kidney transplant rejection more than 11 months sooner than standard protocols.

What is the size of the market Oncocyte (OCX) is targeting with its transplant testing?

Oncocyte is targeting the global transplant testing market, which is valued at $1 billion.

Oncocyte Corporation

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Diagnostics & Research
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