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 OncocyteOncocyte 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 RamsonPCG Advisory(646) 863-6893jramson@pcgadvisory.com
Andrea JamesCFOOncocyteajames@oncocyte.com
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