Cullinan Oncology Provides Corporate Update and Reports First Quarter 2023 Financial Results
12 5월 2023 - 5:01AM
-- Cullinan Oncology, Inc. (Nasdaq: CGEM;
“Cullinan”) a biopharmaceutical company focused on
modality-agnostic targeted oncology therapies, today reported on
recent and upcoming business highlights and announced its financial
results for the first quarter ended March 31, 2023.
“We made important progress in the
first quarter of this year and believe that 2023 will be a
transformational year for Cullinan Oncology,” said Nadim Ahmed,
Chief Executive Officer of Cullinan. “Consistent with our guidance
on reporting first clinical data from two of our ongoing Phase 1
studies by mid-year, preliminary safety data for CLN-049 were
published in abstract form today as part of the 2023 EHA Congress
and first clinical data for CLN-619 will be presented during a
poster session at the upcoming ASCO Annual Meeting. Additionally,
enrollment in the zipalertinib pivotal study will now continue at
the 100mg BID dose only. We also continue to progress our diverse
pipeline: both CLN-978 and CLN-617 received FDA clearance of IND
applications in the first quarter, which will allow us to initiate
first-in-human studies this year. Finally, we recently
expanded our pipeline through the licensing of U.S. development and
commercial rights to CLN-418, a potential first-in-class B7H4x4-1BB
bispecific immune activator currently in a Phase 1 study across a
variety of solid-tumor indications. Together, these achievements
position us well with six programs in the clinic this year as we
work toward our mission of creating new standards of care for
patients with cancer.”
Portfolio
Highlights
- Zipalertinib:
Enrollment will continue solely at the 100 mg BID dose level in the
pivotal study of zipalertinib in EGFR exon 20 insertion mutation
non-small-cell lung cancer patients progressing after prior
systemic therapy.
- Further enrollment
in the 150mg BID cohort was recently discontinued based upon
recommendation of the safety review committee.
- CLN-049: CLN-049 is a
FLT3xCD3 T cell-engaging bispecific antibody being investigated in
patients with relapsed/refractory acute myeloid leukemia (AML) or
myelodysplastic syndrome (MDS).
- Preliminary safety data from an
ongoing first in human study were published in abstract form as
part of the 2023 EHA Congress.
- Cytokine production and low-grade
clinical cytokine release syndrome (CRS) consistent with the
postulated mechanism of action were observed at the initial dose
levels in the now completed single ascending dose study using IV
administration.
- Enrollment continues in the ongoing
Phase 1 multi-ascending dose study using subcutaneous
administration.
-
CLN-619: CLN-619 is a monoclonal
antibody that stabilizes expression of MICA/B on the tumor cell
surface to promote tumor cell lysis by both cytotoxic innate and
adaptive immune cells. CLN-619 has broad therapeutic potential and
is being investigated as both a monotherapy and in combination with
checkpoint inhibitor therapy in an ongoing Phase 1 dose escalation
study in patients with advanced solid tumors.
- First clinical data will be presented
during a poster session at the American Society of Clinical
Oncology (ASCO) 2023 Annual Meeting on June 3, 2023.
- New preclinical data on the anti-tumor
mechanism of CLN-619 were presented in a poster at the American
Association for Cancer Research (AACR) Annual Meeting in
April.
-
CLN-418: CLN-418 is a B7H4x4-1BB fully human
bispecific immune activator designed to achieve conditional
activation of 4-1BB by targeting B7H4, a tumor-associated antigen
that is highly expressed across multiple cancers with minimal
expression on normal tissues. Enrollment is ongoing in a Phase 1
dose escalation study at U.S. and Australian sites in patients with
advanced solid tumors, with initial clinical data expected in 2024.
- In February,
Cullinan Oncology licensed the exclusive U.S. development and
commercial rights to CLN-418 from Harbour Biomed for an upfront fee
of $25 million, with the potential for up to an additional $148
million in development and regulatory milestones and up to $415
million in sales-based milestones, as well as tiered royalties on
potential U.S. commercial sales.
-
CLN-978: CLN-978 is a novel CD19xCD3 bispecific
therapeutic with extended serum half-life and robust potency
against target cells expressing low levels of CD19.
- Cullinan received
FDA clearance of its IND application for CLN-978 in January and
anticipates initiating a Phase 1 clinical study in 2023.
-
CLN-617: CLN-617 is a cytokine
fusion protein uniquely combining IL-12 and IL-2 with a collagen
binding domain designed for retention in the tumor microenvironment
(TME) following intratumoral injection.
- Cullinan received
FDA clearance of its IND application for CLN-617 in March and
anticipates initiating a Phase 1 clinical study in 2023.
- New preclinical data
highlighting the therapeutic potential of CLN-617 was presented in
a poster at the American Association for Cancer Research (AACR)
Annual Meeting in April.
First Quarter 2023 Financial
Results
- Cash Position: Cash,
cash equivalents, investments, and interest receivable were $503.5
million as of March 31, 2023. This balance reflects the $25 million
upfront payment to Harbour Biomed upon the execution of the
licensing agreement for CLN-418. Cullinan expects its cash
resources to provide runway into 2026 based on its current
operating plan.
- R&D
Expenses: Research and development (R&D) expenses
were $52.1 million for the first quarter of 2023, compared to $21.3
million for the fourth quarter of 2022. R&D expenses for the
first quarter of 2023 and fourth quarter of 2022 included $3.1
million and $2.9 million of equity-based compensation expenses,
respectively. Excluding the impact of equity-based compensation
expenses, the increase in R&D expenses was primarily related to
the upfront payment to Harbour Biomed upon the execution of the
licensing agreement for CLN-418, and higher clinical and clinical
supply costs driven by the advancement and expansion of our
pipeline.
- G&A
Expenses: General and administrative (G&A)
expenses were $10.7 million for the first quarter of 2023, compared
to $11.3 million for the fourth quarter of 2022. G&A expenses
in the first quarter of 2023 and fourth quarter of 2022 included
$4.2 million and $4.6 of equity-based compensation expenses,
respectively. The decrease in G&A expenses, excluding
equity-based compensation, was primarily driven by a decrease in
professional fees.
- Net Loss: Net
loss (before items attributable to noncontrolling interest) for the
first quarter of 2023 was $58.1 million, compared with net loss of
$27.1 million for the fourth quarter of 2022. Net losses included
the items described above, partially offset by interest income of
$4.5 million and $3.4 million in the first quarter of 2023 and
fourth quarter of 2022, respectively, and an income tax benefit of
$1.9 million in the fourth quarter of 2022.
About Cullinan
Oncology
Cullinan Oncology, Inc. (Nasdaq: CGEM)
is a biopharmaceutical company dedicated to creating new standards
of care for patients with cancer. We innovate without borders to
find the most promising clinic-ready cancer therapies, whether from
our own discovery efforts or through exceptional engagement with
our academic and industry partners. Anchored in a deep
understanding of immuno-oncology and translational cancer medicine,
we leverage our scientific excellence in small molecules and
biologics to create differentiated ideas, identify unique targets,
and select the optimal modality to develop transformative
therapeutics across cancer indications. Powered by our novel
research model, we push conventional boundaries from candidate
selection to cancer therapeutic, applying rigorous early
experimentation to fast-track only the most promising assets to the
clinic and ultimately commercialization. As a result, our
diversified pipeline is strategically built with assets that
activate the immune system or inhibit key oncogenic drivers across
a wide range of modalities, each with the potential to be the best
or first in their class.
Our people possess deep scientific
expertise, seek innovation openly, and exercise creativity and
urgency to deliver on our promise to bring new therapeutic
solutions to patients with cancer. Learn more about our Company
at www.cullinanoncology.com, and follow us
on LinkedIn and Twitter.
Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. These forward-looking statements include, but
are not limited to, express or implied statements regarding
Cullinan’s beliefs and expectations regarding our preclinical and
clinical development plans and timelines, clinical trial designs,
clinical and therapeutic potential, and strategy of our product
candidates; our ability to evaluate strategic opportunities to
accelerate development timelines; our ability to optimize the
impact of our collaborations and license agreements with external
parties; our ability to continue our growth; our expectations
regarding our use of capital; and our plans regarding future data
presentations. The words “anticipate,” “believe,” “continue,”
“could,” “estimate,” “expect,” “hope,” “intend,” “may,” “plan,”
“potential,” “predict,” “project,” “target,” “should,” “would,” and
similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words.
Any forward-looking statements in this press release are based
on management's current expectations and beliefs of future events
and are subject to known and unknown risks and uncertainties that
may cause our actual results, performance or achievements to be
materially different from any expressed or implied by the
forward-looking statements. These risks include, but are not
limited to, the following: uncertainty regarding the timing and
results of regulatory submissions; success of our clinical trials
and preclinical studies; risks related to our ability to protect
and maintain our intellectual property position; risks related to
manufacturing, supply, and distribution of our product candidates;
the risk that any one or more of our product candidates, including
those that are co-developed, will not be successfully developed and
commercialized; the risk that the results of preclinical studies or
clinical studies will not be predictive of future results in
connection with future studies; and success of any collaboration,
partnership, license or similar agreements. These and other
important risks and uncertainties discussed in our filings with the
Securities and Exchange Commission, including under the caption
“Risk Factors” in our most recent Annual Report on Form 10-K and
subsequent filings with the SEC, could cause actual results to
differ materially from those indicated by the forward-looking
statements made in this press release. While we may elect to update
such forward-looking statements at some point in the future, we
disclaim any obligation to do so, even if subsequent events cause
our views to change, except to the extent required by law. These
forward-looking statements should not be relied upon as
representing our views as of any date subsequent to the date of
this press release. Moreover, except as required by law, neither
Cullinan nor any other person assumes responsibility for the
accuracy and completeness of the forward-looking statements
included in this press release. Any forward-looking statement
included in this press release speaks only as of the date on which
it was made.
Cullinan Oncology,
Inc.Condensed Consolidated Balance
Sheets(in thousands)
|
|
|
|
|
|
|
|
March 31, 2023 |
|
|
December 31, 2022 |
|
|
(unaudited) |
|
|
(unaudited) |
Cash, cash equivalents, investments, and interest receivable |
|
$ |
503,494 |
|
|
$ |
550,118 |
Total assets |
|
$ |
514,990 |
|
|
$ |
561,117 |
Total current liabilities |
|
$ |
26,171 |
|
|
$ |
22,498 |
Total liabilities |
|
$ |
29,341 |
|
|
$ |
26,088 |
Total stockholders’ equity |
|
$ |
485,649 |
|
|
$ |
535,029 |
Total liabilities and stockholders’ equity |
|
$ |
514,990 |
|
|
$ |
561,117 |
|
|
|
|
|
|
|
|
|
|
|
|
Cullinan Oncology,
Inc.Consolidated Statements of
Operations(in thousands, except per share
amounts)
|
|
Three Months Ended |
|
|
March 31, 2023 |
|
December 31, 2022 |
|
|
(unaudited) |
|
(unaudited) |
Operating expenses: |
|
|
|
|
Research and development |
|
$ |
52,096 |
|
|
$ |
21,321 |
|
General and administrative |
|
|
10,660 |
|
|
|
11,287 |
|
Total operating expenses |
|
|
62,756 |
|
|
|
32,608 |
|
Income (loss) from operations |
|
|
(62,756 |
) |
|
|
(32,608 |
) |
Other income (expense): |
|
|
|
|
Interest income |
|
|
4,508 |
|
|
|
3,364 |
|
Other income (expense), net |
|
|
107 |
|
|
|
298 |
|
Net loss before income taxes |
|
|
(58,141 |
) |
|
|
(28,946 |
) |
Income tax benefit |
|
|
— |
|
|
|
(1,858 |
) |
Net loss |
|
|
(58,141 |
) |
|
|
(27,088 |
) |
Net loss attributable to noncontrolling interests |
|
|
(179 |
) |
|
|
(306 |
) |
Net loss attributable to common stockholders of Cullinan |
|
$ |
(57,962 |
) |
|
$ |
(26,782 |
) |
|
|
|
|
|
Net loss per share: |
|
|
|
|
Basic and diluted |
|
$ |
(1.42 |
) |
|
$ |
(0.59 |
) |
|
|
|
|
|
Weighted-average shares used in computing net loss per share: |
|
|
|
|
Basic and diluted |
|
|
40,682 |
|
|
|
45,751 |
|
|
|
|
|
|
Contacts:
InvestorsChad Messer+1
203.464.8900cmesser@cullinanoncology.com
Media Rose Weldon +1
215.801.7644 rweldon@cullinanoncology.com
Cullinan Therapeutics (NASDAQ:CGEM)
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