RayzeBio Reports Third Quarter 2023 Financial Results and Provides Corporate Update
14 11월 2023 - 6:01AM
RayzeBio, Inc. (Nasdaq: RYZB), a targeted radiopharmaceutical
company developing an innovative pipeline against validated solid
tumor targets, today reported financial results for the third
quarter ended September 30, 2023 and provided an update on key
corporate initiatives.
“We have made significant progress in 2023 and achieved several
clinical, discovery and corporate milestones as we continue to lead
innovation in developing targeted radiopharmaceuticals for the
benefit of patients with cancer,” said Ken Song, M.D., President
and CEO of RayzeBio. “Our lead asset, RYZ101, is the first
Actinium-225 based treatment in a Phase 3 clinical trial. We are on
track to file an IND in the first half of 2024 for our next
clinical drug candidate, which is focused on treating patients with
liver cancer. Additionally, our oversubscribed IPO in September
2023 provides us with a strong balance sheet to fully invest in our
initiatives.”
Recent Highlights and Upcoming Milestones
- Enrollment ongoing for the Phase 3 portion of the
ACTION-1 clinical trial as well as follow-up of patients from the
Phase 1b: Enrollment is ongoing in the registrational
global Phase 3 portion of the ACTION-1 clinical trial of RYZ101 for
patients with SSTR2 expressing GEP-NETs who have experienced
progression of their cancer following treatment with Lu177
somatostatin analog therapy. RayzeBio expects to present the Phase
3 interim analysis in late 2025 / early 2026. As part of the IPO
and subsequently at ESMO in October 2023, RayzeBio reported the
interim results of the Phase 1b portion of the ACTION-1 clinical
trial, where RayzeBio enrolled a total of 17 patients. As of the
last data cut off on June 30, 2023, treatment has been well
tolerated with no treatment-related serious adverse events or dose
discontinuations due to any adverse event. Additionally, five
patients have had a confirmed partial response, or PR, which is
based on two consecutive evaluations showing PR, representing a
confirmed objective response rate, or ORR, of 29%. RayzeBio is
continuing to monitor the patients and expects to present updated
Phase 1b data at a medical conference during the first half of
2024.
- RYZ801 and RYZ811 IND filing for HCC expected in 1H
2024: RYZ801 is a novel proprietary peptide which targets
GPC3 for delivery of Ac225 for the treatment of HCC. Using Gallium
68, or Ga68, an imaging radioisotope, RayzeBio has already shown
uptake of its novel proprietary peptide binder in patients with HCC
via early human imaging studies conducted outside of the United
States. RYZ801 is currently in IND enabling studies. Additionally,
RayzeBio is developing RYZ811, which is a paired diagnostic imaging
agent with the same peptide binder and chelator as RYZ801 but with
Ga68 as the radioisotope. The Company plans to file an IND for each
of RYZ801 and RYZ811 in the first half of 2024 followed by a Phase
1 clinical trial in HCC patients.
- Buildout of our state of the art manufacturing facility
on track to be completed by the end of 2023: RayzeBio
expects its in-house manufacturing facility in Indianapolis to be
completed by the end of 2023 with GMP drug production starting in
the first half of 2024. This facility will be an important
milestone in creating vertical integration, which is essential to
be a successful targeted radiopharmaceutical company.
- Completed $357 million upsized Initial Public
Offering: In September, the Company completed its upsized
IPO of 19,869,240 shares of common stock, at a price to the public
of $18.00 per share. RayzeBio sold 18,706,240 shares of common
stock and a selling stockholder sold 1,163,000 shares of common
stock. The aggregate gross proceeds to RayzeBio from the offering,
before deducting underwriting discounts and commissions and other
offering expenses payable by RayzeBio, were approximately $336.7
million.
- Strengthened team with key Board of Director
Appointments: RayzeBio added seasoned biotech executive
Christy Oliger to its board of directors in August 2023 to provide
commercial expertise. Additionally, in November 2023, RayzeBio
added Tim Van Hauwermeiren, co-founder and CEO of argenx to its
board of directors, further strengthening the board.
Third Quarter Financial Results
- Cash Position: As of September 30, 2023,
RayzeBio had cash, cash equivalents and short-term investments of
$540.2 million. RayzeBio projects its cash position is sufficient
to fund operations through various milestones across its clinical
programs.
- Research and Development (R&D) Expenses:
R&D expenses for the third quarter of 2023 were $18.2 million,
compared to $18.8 million for the third quarter of 2022. R&D
expenses decreased primarily due to reduction in expenses related
to license rights, offset by increases related to the clinical
advancement of RYZ101 in GEP-NETs, pre-clinical efforts for RYZ801
and personnel costs, including share-based compensation expense
associated with the growth of the Company’s R&D team.
- General and Administrative (G&A) Expenses:
G&A expenses for the third quarter of 2023 were $3.5 million,
compared to $2.1 million for the third quarter of 2022. The
increase of $1.4 million was primarily attributable to the increase
in personnel costs associated with increased headcount and legal
and other professional services conducted to support the growth of
the business.
- Net Loss: Net loss for the third quarter of
2023 was $18.2 million, compared to the net loss for the third
quarter of 2022 which was $20.4 million.
About RayzeBioRayzeBio is building a vertically
integrated radiopharmaceutical therapeutics (RPT) company to treat
various cancers, with its lead program in a Phase 3 clinical trial.
RayzeBio has created a pipeline of multiple drug candidates in
therapeutic areas with significant market opportunities. Much like
antibody drug conjugates emerged as a new and transformative
treatment modality in certain cancers, the company sees an
opportunity for innovative radiopharmaceutical therapeutics to
follow a similar path. RayzeBio believes its strategic investments
in building a robust product pipeline, development capabilities,
and manufacturing infrastructure position the company to be an
industry-leading pioneer in the broad application of RPT for
cancer.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Statements in
this press release that are not statements of historical fact are
forward-looking statements. Such forward-looking statements
include, without limitation, statements regarding the Company’s
ambition to become the leading targeted radiopharmaceutical
company; the Company’s expectations regarding plans for its current
and future product candidates and programs; the potential
therapeutic benefits of the Company’s current and future product
candidates; the planned clinical development of RYZ101, RYZ801 and
the timing thereof, including anticipated timing of completion of
enrollment of the ACTION-1 clinical trial and interim results
thereof, as well as timing of IND submission for RYZ801; the
expected timing of operationalizing the Company’s manufacturing
facility; and expectations regarding the time period over which the
Company’s capital resources will be sufficient to fund its
anticipated operations. Words such as “believe,” “anticipate,”
“plan,” “expect,” “intend,” “will,” “may,” “goal,” “potential” and
similar expressions are intended to identify forward-looking
statements, though not all forward-looking statements necessarily
contain these identifying words. These forward-looking statements
are based on the beliefs of the management of the Company as well
as assumptions made by and information currently available to the
Company. Such statements reflect the current views of the Company
with respect to future events and are subject to known and unknown
risks and uncertainties, including business, regulatory, economic
and competitive risks and uncertainties about the Company,
including, without limitation, risks inherent in developing drug
candidates, future results from the Company’s ongoing and planned
clinical trials, the Company’s ability to obtain adequate financing
to fund its planned clinical trials and other expenses, risks that
future clinical trial results may not be consistent with interim,
initial or preliminary results or results from prior preclinical
studies or clinical trials, trends in the industry, the legal and
regulatory framework for the industry and future expenditures. In
light of these risks and uncertainties, the events or circumstances
referred to in the forward-looking statements may not occur. The
actual results may vary from the anticipated results and the
variations may be material. Other factors that may cause the
Company’s actual results to differ from current expectations are
discussed in the Company’s filings with the Securities and Exchange
Commission, including the section titled “Risk Factors” in the
Company’s Quarterly Report on From 10-Q for the quarter ended
September 30, 2023. You are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the
date this press release is given. Except as required by law, the
Company undertakes no obligation to publicly update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Contact: Arvind Kush Email: info@rayzebio.com
RayzeBio, Inc.Condensed Statements of Operations
and Comprehensive Loss(in thousands, except share and per
share data)(unaudited) |
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating
Expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
18,170 |
|
|
$ |
18,828 |
|
|
$ |
48,759 |
|
|
$ |
46,416 |
|
General and administrative |
|
3,481 |
|
|
|
2,122 |
|
|
|
9,479 |
|
|
|
8,244 |
|
Total operating expenses |
|
21,651 |
|
|
|
20,950 |
|
|
|
58,238 |
|
|
|
54,660 |
|
Loss from operations |
|
(21,651 |
) |
|
|
(20,950 |
) |
|
|
(58,238 |
) |
|
|
(54,660 |
) |
Total other income, net |
|
3,460 |
|
|
|
503 |
|
|
|
9,436 |
|
|
|
762 |
|
Net loss |
|
(18,191 |
) |
|
|
(20,447 |
) |
|
|
(48,802 |
) |
|
|
(53,898 |
) |
Dividends |
|
(1,209 |
) |
|
|
(4,550 |
) |
|
|
(1,209 |
) |
|
|
(4,550 |
) |
Net loss attributable to
common stockholders |
|
(19,400 |
) |
|
|
(24,997 |
) |
|
|
(50,011 |
) |
|
|
(58,448 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
$ |
(1.26 |
) |
|
$ |
(6.55 |
) |
|
$ |
(5.99 |
) |
|
$ |
(17.14 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
15,399,901 |
|
|
|
3,817,307 |
|
|
|
8,350,628 |
|
|
|
3,409,940 |
|
|
RayzeBio, Inc.Selected Condensed Balance Sheet
Data(in
thousands)(unaudited) |
|
|
September 30,2023 |
|
December 31,2022 |
Cash and cash equivalents |
$ |
251,964 |
|
|
$ |
129,159 |
|
Short-term investments |
|
288,205 |
|
|
|
167,087 |
|
Total assets |
|
603,513 |
|
|
|
324,776 |
|
Total liabilities |
|
28,191 |
|
|
|
20,812 |
|
Accumulated deficit |
|
(180,127 |
) |
|
|
(130,116 |
) |
RayzeBio (NASDAQ:RYZB)
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