Cullinan Oncology Provides Corporate Update and Reports Third Quarter 2023 Financial Results
08 Novembre 2023 - 1:00PM
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 third
quarter ended September 30, 2023.
“We have made tremendous strides
through the first three quarters of 2023, while positioning
Cullinan for a data-rich 2024,” said Nadim Ahmed, Chief Executive
Officer of Cullinan Oncology. “We are rapidly progressing CLN-619
and look forward to providing initial data from the combination
therapy module, as well as additional monotherapy data, from the
Phase 1 dose escalation study in the second quarter of 2024. We
also expect to provide initial data from our disease-specific
expansion cohorts in the first half of 2025. Our broad zipalertinib
development program, being conducted in collaboration with our
partners at Taiho, is also continuing, and we expect to complete
enrollment in the pivotal Phase 2b portion of the REZILIENT1 study
by the end of 2024. We expect to present data for CLN-049 and
CLN-418 in the second half of 2024 as well. We finished Q3 with
cash and investments of $482 million, which we now expect to
provide runway into the second half of 2026, two quarters beyond
previous guidance.”
Portfolio Highlights
- CLN-619
(Anti-MICA/MICB monoclonal antibody): Solid tumors
- Enrollment
continues in the ongoing Phase 1 study evaluating CLN-619 as both
monotherapy and in combination with checkpoint inhibitor therapy.
Accrual to the dose escalation phase of the combination module has
been completed. Recruitment continues to the monotherapy disease
specific expansion cohorts for patients with endometrial and
cervical cancers. Cullinan also continues to evaluate additional
disease specific expansion cohorts.
- At the 2023 SITC
Annual Meeting, initial biomarker data from the ongoing Phase 1
study of CLN-619 were presented at a poster session, providing
evidence for CLN-619’s mechanism of action and demonstrating that
clinical activity, including objective response, has been observed
in patients with tumor characteristics not typically responsive to
checkpoint inhibitor therapy.
- Zipalertinib (EGFR ex20ins
inhibitor): EGFR ex20ins NSCLC
- In August 2023, Cullinan Oncology,
in collaboration with our partners at Taiho Oncology, Inc.,
announced the initiation of REZILIENT3, a global Phase 3 study
evaluating zipalertinib plus chemotherapy versus chemotherapy alone
in patients with EGFR exon 20 insertion mutation non-small-cell
lung cancer (EGFR ex20ins NSCLC) in the first-line setting.
- Enrollment continues in the pivotal Phase 2b portion of the
REZILIENT1 study, evaluating zipalertinib in a cohort of patients
with EGFR ex20ins NSCLC who have progressed after prior systemic
therapy, as well as in a separate cohort of patients progressing
after prior treatment with a currently approved agent for EGFR
ex20ins NSCLC.
- CLN-049
(FLT3xCD3 T cell-engaging bispecific antibody): AML and
MDS
- Enrollment continues in the ongoing
Phase 1 multi-ascending dose study using subcutaneous
administration.
- CLN-418
(B7H4x4-1BB bispecific immune activator): Solid tumors
- Preclinical data, including target
expression profiling data and robust anti-tumor activity supporting
the development of CLN-418 in multiple solid tumors, were presented
at the 2023 SITC Annual Meeting.
- Enrollment continued in the ongoing
Phase 1 dose escalation study in patients with advanced solid
tumors.
- CLN-978
(CD19xCD3 T cell engager): B-NHL
- In August 2023, Cullinan dosed the
first patient in a Phase 1 study of CLN-978 in patients with R/R
B-NHL.
- Preclinical data demonstrating the
effectiveness of CLN-978 against lymphoma cells expressing very low
levels of CD19 were presented at the 2023 SITC Annual Meeting.
- CLN-617
(IL-2 and IL-12 cytokine fusion protein): Solid tumors
- Cullinan anticipates dosing the
first patient in the CLN-617 first-in-human Phase 1 study by year
end 2023.
- A poster at the 2023 SITC Annual Meeting highlighted
preclinical data demonstrating the mechanism by which CLN-617
mediates a robust abscopal anti-tumor effect in preclinical models.
A Trial in Progress poster for the ongoing Phase 1 study of CLN-617
in combination with pembrolizumab was also presented.
Upcoming Milestones
-
CLN-619
- Cullinan expects to
report initial data from the combination dose escalation module as
well as an update on the monotherapy dose escalation module at a
medical conference in the second quarter of 2024.
- Cullinan expects to report initial
data from disease specific dose expansion cohorts in the first half
of 2025.
- Zipalertinib
- Cullinan expects completion of
enrollment in the pivotal Phase 2b portion of the REZILIENT1 study
by year-end 2024.
- CLN-049
- Cullinan expects to provide a
clinical data update in the second half of 2024.
- CLN-418
- Cullinan expects to provide a
clinical data update in the second half of 2024.
Third Quarter 2023 Financial
Results
- Cash Position:
Cash, cash equivalents, investments, and interest receivable were
$481.9 million as of September 30, 2023. Cullinan now expects its
cash resources to provide runway into the second half of 2026 based
on its current operating plan. The extension from prior guidance is
primarily driven by the receipt of approximately $38 million in net
proceeds from Cullinan’s ATM equity program, increased interest
income, and the prioritization of development plans in the longer
term. Cullinan’s operating plan includes continued advancement of
all programs to key data milestones in the near term.
- R&D
Expenses: Research and development (R&D) expenses
were $33.8 million for the third quarter of 2023, compared to $27.4
million for the second quarter of 2023. R&D expenses for the
third and second quarters of 2023 included $3.2 million and $3.2
million of equity-based compensation expenses, respectively. The
increase in R&D expenses was primarily related to increased
chemistry, manufacturing and controls costs and higher clinical
costs.
- G&A
Expenses: General and administrative (G&A)
expenses were $11.0 million for the third quarter of 2023, compared
to $10.2 million for the second quarter of 2023. G&A expenses
in the third and second quarters of 2023 included $4.5 million and
$4.7 million of equity-based compensation expenses, respectively.
The increase in G&A expenses, excluding equity-based
compensation, was primarily driven by higher personnel costs.
- Net Loss: Net
loss (before items attributable to noncontrolling interest) for the
third quarter of 2023 was $39.2 million, compared with net loss of
$32.2 million for the second quarter of 2023. Net losses included
the items described above, partially offset by interest income of
$5.9 million and $5.3 million in the third quarter and second
quarter of 2023, respectively.
- Shares Outstanding:
As of October 31, 2023, Cullinan had 42,780,644 common shares
outstanding plus 647,500 shares of non-voting preferred stock
outstanding, each of which is convertible into 10 shares of common
stock.
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; our expectations regarding our cash
runway and 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 future results, performance or
achievements 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(unaudited)(in
thousands) |
|
|
|
|
|
|
|
|
|
September 30, 2023 |
|
|
December 31, 2022 |
|
Cash, cash equivalents, investments, and interest receivable |
|
$ |
481,940 |
|
|
$ |
550,118 |
|
Total assets |
|
$ |
494,707 |
|
|
$ |
561,117 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
$ |
23,444 |
|
|
$ |
22,498 |
|
Total liabilities |
|
$ |
25,890 |
|
|
$ |
26,088 |
|
Total stockholders’ equity |
|
$ |
468,817 |
|
|
$ |
535,029 |
|
Total liabilities and stockholders’ equity |
|
$ |
494,707 |
|
|
$ |
561,117 |
|
|
|
|
|
|
|
|
Cullinan Oncology, Inc.Consolidated
Statements of
Operations(unaudited)(in
thousands, except per share amounts) |
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, 2023 |
|
June 30, 2023 |
|
September 30, 2023 |
|
September 30, 2022 |
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
33,821 |
|
|
$ |
27,391 |
|
|
$ |
113,308 |
|
|
$ |
70,627 |
|
General and administrative |
|
|
10,982 |
|
|
|
10,214 |
|
|
|
31,856 |
|
|
|
28,902 |
|
Total operating expenses |
|
|
44,803 |
|
|
|
37,605 |
|
|
|
145,164 |
|
|
|
99,529 |
|
Impairment of long-lived assets |
|
|
(440 |
) |
|
|
— |
|
|
|
(440 |
) |
|
|
- |
|
Gain on sale of Cullinan Pearl |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
276,785 |
|
Income (loss) from operations |
|
|
(45,243 |
) |
|
|
(37,605 |
) |
|
|
(145,604 |
) |
|
|
177,256 |
|
Other income (expense): |
|
|
|
|
|
|
|
|
Interest income |
|
|
5,880 |
|
|
|
5,322 |
|
|
|
15,710 |
|
|
|
3,247 |
|
Other income (expense), net |
|
|
180 |
|
|
|
69 |
|
|
|
356 |
|
|
|
(241 |
) |
Net income (loss) before income taxes |
|
|
(39,183 |
) |
|
|
(32,214 |
) |
|
|
(129,538 |
) |
|
|
180,262 |
|
Income tax expense (benefit) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
43,979 |
|
Net income (loss) |
|
|
(39,183 |
) |
|
|
(32,214 |
) |
|
|
(129,538 |
) |
|
|
136,283 |
|
Net loss attributable to noncontrolling interests |
|
|
— |
|
|
|
— |
|
|
|
(179 |
) |
|
|
(1,713 |
) |
Net income (loss) attributable to common stockholders of
Cullinan |
|
$ |
(39,183 |
) |
|
$ |
(32,214 |
) |
|
$ |
(129,359 |
) |
|
$ |
137,996 |
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share attributable to common stockholders of
Cullinan: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.91 |
) |
|
$ |
(0.82 |
) |
|
$ |
(3.15 |
) |
|
$ |
3.07 |
|
Diluted |
|
$ |
(0.91 |
) |
|
$ |
(0.82 |
) |
|
$ |
(3.15 |
) |
|
$ |
2.96 |
|
|
|
|
|
|
|
|
|
|
Weighted-average shares used in computing net income (loss) per
share attributable to common stockholders of Cullinan: |
|
|
|
|
|
|
|
|
Basic |
|
|
42,734 |
|
|
|
39,952 |
|
|
|
41,130 |
|
|
|
44,966 |
|
Diluted |
|
|
42,734 |
|
|
|
39,952 |
|
|
|
41,130 |
|
|
|
46,580 |
|
|
|
|
|
|
|
|
|
|
Contacts:
InvestorsChad Messer+1
203.464.8900cmesser@cullinanoncology.com
Media Rose Weldon +1
215.801.7644 rweldon@cullinanoncology.com
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