Cullinan Oncology Provides Corporate Update and Reports Fourth Quarter and Full Year 2022 Financial Results
March 09 2023 - 7:00AM
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 fourth
quarter and full year ended December 31, 2022.
“2022 was a year of remarkable
execution at Cullinan Oncology, and the momentum with which we
ended the year has continued into early 2023. With our partners at
Taiho Oncology, we initiated the pivotal study of zipalertinib in
the fourth quarter, while continuing to advance enrollment in the
Phase 1 trials of CLN-049 and CLN-619, with initial clinical data
expected mid-year," said Nadim Ahmed, Chief Executive Officer of
Cullinan. “The first two months of 2023 have resulted in similarly
exciting developments, as 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. This transaction provides us with the opportunity to
have six programs in the clinic by the end of the year, as we
recently received IND clearance for CLN-978 and also recently filed
the IND for CLN-617, consistent with prior guidance. Importantly,
our cash position following the CLN-418 transaction provides us
with runway into 2026 which gives us the flexibility needed to fund
our ongoing development efforts and reach multiple potential value
creating milestones.”
Portfolio
Highlights
-
Zipalertinib: In the fourth quarter of 2022,
Cullinan Oncology, in collaboration with our partners at Taiho
Oncology, Inc., initiated a pivotal study of zipalertinib in EGFR
exon 20 insertion mutation non-small-cell lung cancer patients
progressing after prior systemic therapy. As previously planned,
the study will enroll patients at the 100mg BID dose under fasted
conditions, and also will include a limited cohort of patients to
evaluate safety and efficacy at 150mg BID administered with
food.
- 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). Enrollment continues in the ongoing
Phase 1 dose escalation clinical study with initial clinical data
expected in mid-2023.
-
CLN-619: CLN-619 is a monoclonal
antibody that stabilizes expression of MICA/MICB 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 monotherapy and in combination with
checkpoint inhibitor therapy in an ongoing Phase 1 dose escalation
study in patients with advanced solid tumors with initial clinical
data expected in mid-2023.
-
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. Consistent with prior guidance, Cullinan received FDA
clearance of its Investigational New Drug (IND) application for
CLN-978 in January and anticipates initiating a Phase 1 clinical
study by the end of 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. Consistent with prior
guidance, Cullinan recently filed the IND application for CLN-617
in February 2023 and intends to initiate a Phase 1 clinical study
by the end of 2023, pending IND clearance.
Fourth Quarter 2022 Financial
Results
- Cash Position: Cash
and investments were $550.1 million as of December 31, 2022. During
the fourth quarter of 2022, Cullinan acquired additional equity in
its subsidiary, Cullinan Mica, which holds the worldwide rights to
CLN-619, for $33 million, increasing its ownership from 54% to 95%
of the entity. In the first quarter of 2023, the Company spent $25
million on the upfront payment under the recently announced
licensing agreement for CLN-418 with Harbour Biomed. 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 $21.3 million for the fourth quarter of 2022, compared to
$19.7 million for the third quarter of 2022. R&D expenses for
the fourth and third quarters of 2022 included $2.9 million and
$1.1 million of equity-based compensation expenses, respectively.
Excluding the impact of equity-based compensation expenses, the
decrease in R&D expenses was primarily related to a decrease in
preclinical costs, partially offset by increased personnel
costs.
- G&A
Expenses: General and administrative (G&A)
expenses were $11.3 million for the fourth quarter of 2022,
compared to $10.1 million for the third quarter of 2022. G&A
expenses in the fourth and third quarters of 2022 included $4.6
million and $4.2 of equity-based compensation expenses,
respectively. The increase in G&A expenses was primarily driven
by increased personnel costs.
- Net Loss: Net
loss (before items attributable to noncontrolling interest) for the
fourth quarter of 2022 was $27.1 million, compared with net loss of
$24.9 million for the third quarter of 2022. Net losses included
the items described above, partially offset by interest income of
$3.4 million and $2.4 million and income tax benefit recognized of
$1.9 million and $2.5 million in the fourth and third quarters of
2022, respectively.
Full Year 2022 Financial
Results
- R&D
Expenses: R&D expenses were $91.9 million for
2022, compared to $57.8 million for 2021. R&D expenses for 2022
and 2021 included $11.0 million and $8.9 million of equity-based
compensation expenses, respectively. The increase in R&D
expenses was primarily related to CRO and CMC activities to support
our ongoing clinical trials and pre-clinical research and CMC costs
to support IND enabling activities.
- G&A
Expenses: G&A expenses were $40.2 million for
2022, compared to $29.1 million in 2021. G&A expenses in 2022
and 2021 included $16.9 million and $15.4 million of equity-based
compensation expenses, respectively. The increase in G&A
expenses was primarily driven by increase in personnel and
professional services due to increased headcount to support our
expanded operations, and non-recurring costs related to the
previously announced Cullinan Pearl sale, described below.
- Gain on sale of Cullinan
Pearl: In June 2022, Cullinan sold its equity interest in
its subsidiary, Cullinan Pearl, which has worldwide rights to
zipalertinib, excluding Japan and Greater China, to Taiho
Pharmaceutical Co., Ltd. (Taiho). Cullinan recognized a gain from
the sale of $276.8 million, which includes the upfront payment of
$275 million, as well as the impact of net liabilities transferred
to Taiho. Cullinan also recognized income tax expenses of $42.1
million as a result of the gain and offsetting operating
expenses.
- Net Income
(Loss): Net income (before items attributable to
noncontrolling interest) for 2022 was $109.2 million, compared with
a net loss of $67.5 million in 2021. Net income in 2022 was related
to the items described above, as well as $6.6 million of interest
income. In 2021, operating expenses described above were partially
offset by $18.9 million of license revenue.
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
Statements
This 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; and our expectations regarding our use of capital. 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;
risks related to the impact of COVID-19 affecting countries or
regions in which we have operations or do business, including
potential negative impacts on our employees, customers, supply
chain and production as well as global economies and financial
markets; 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)
|
|
December 31, 2022 |
|
September 30, 2022 |
|
|
(unaudited) |
|
(unaudited) |
Cash, cash equivalents, investments, and interest receivable |
|
$ |
550,118 |
|
|
$ |
606,737 |
|
Total assets |
|
$ |
561,117 |
|
|
$ |
617,237 |
|
Total current liabilities |
|
$ |
22,498 |
|
|
$ |
27,117 |
|
Total liabilities |
|
$ |
26,088 |
|
|
$ |
31,109 |
|
Total stockholders’
equity |
|
$ |
535,029 |
|
|
$ |
586,128 |
|
Total liabilities and stockholders’ equity |
|
$ |
561,117 |
|
|
$ |
617,237 |
|
Cullinan Oncology,
Inc.Consolidated Statements of
Operations(in thousands, except per share
amounts)
|
|
Three Months Ended |
|
Year Ended |
|
|
December 31,2022 |
|
September 30,2022 |
|
December 31,2022 |
|
December 31,2021 |
|
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
(audited) |
License revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
18,943 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
21,321 |
|
|
|
19,680 |
|
|
|
91,948 |
|
|
|
57,751 |
|
General and administrative |
|
|
11,287 |
|
|
|
10,086 |
|
|
|
40,189 |
|
|
|
29,146 |
|
Total operating expenses |
|
|
32,608 |
|
|
|
29,766 |
|
|
|
132,137 |
|
|
|
86,897 |
|
Gain on sale of Cullinan Pearl |
|
|
— |
|
|
|
— |
|
|
|
276,785 |
|
|
|
— |
|
Income (loss) from operations |
|
|
(32,608 |
) |
|
|
(29,766 |
) |
|
|
144,648 |
|
|
|
(67,954 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest income |
|
|
3,364 |
|
|
|
2,353 |
|
|
|
6,611 |
|
|
|
477 |
|
Other income (expense), net |
|
|
298 |
|
|
|
— |
|
|
|
57 |
|
|
|
(8 |
) |
Net income (loss) before
income taxes |
|
|
(28,946 |
) |
|
|
(27,413 |
) |
|
|
151,316 |
|
|
|
(67,485 |
) |
Income tax expense (benefit) |
|
|
(1,858 |
) |
|
|
(2,523 |
) |
|
|
42,121 |
|
|
|
— |
|
Net income (loss) |
|
|
(27,088 |
) |
|
|
(24,890 |
) |
|
|
109,195 |
|
|
|
(67,485 |
) |
Net loss attributable to noncontrolling interests |
|
|
(306 |
) |
|
|
(86 |
) |
|
|
(2,019 |
) |
|
|
(1,915 |
) |
Net income (loss) attributable
to common stockholders of Cullinan |
|
$ |
(26,782 |
) |
|
$ |
(24,804 |
) |
|
$ |
111,214 |
|
|
$ |
(65,570 |
) |
|
|
|
|
|
|
|
|
|
Earnings (net loss) per
share: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.59 |
) |
|
$ |
(0.54 |
) |
|
$ |
2.46 |
|
|
$ |
(1.52 |
) |
Diluted |
|
$ |
(0.59 |
) |
|
$ |
(0.54 |
) |
|
$ |
2.38 |
|
|
$ |
(1.52 |
) |
|
|
|
|
|
|
|
|
|
Weighted-average shares used
in computing earnings (net loss) per share: |
|
|
|
|
|
|
|
|
Basic |
|
|
45,751 |
|
|
|
45,611 |
|
|
|
45,164 |
|
|
|
43,077 |
|
Diluted |
|
|
45,751 |
|
|
|
45,611 |
|
|
|
46,640 |
|
|
|
43,077 |
|
Contacts:
InvestorsChad Messer+1
203.464.8900cmesser@cullinanoncology.com
Media Rose Weldon +1
215.801.7644 rweldon@cullinanoncology.com
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