Cullinan Oncology Provides Corporate Update and Reports Second Quarter 2023 Financial Results
10 Agosto 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 second
quarter ended June 30, 2023.
“We have continued to advance our
broad portfolio of modality-agnostic cancer therapies during the
first half of this year and are poised to continue our momentum,”
said Nadim Ahmed, Chief Executive Officer of Cullinan. “With our
partners at Taiho Oncology, we recently announced the launch of the
REZILIENT-3 study, a randomized phase 3 trial, which will evaluate
zipalertinib as a first-line treatment for EGFR exon 20 NSCLC
patients. We also shared encouraging initial monotherapy clinical
data for CLN-619 at ASCO in June. Based on that data, we announced
monotherapy expansion cohorts in endometrial and cervical cancers.
We look forward to presenting the first data from the pembrolizumab
combination arm at a medical congress in the future. Further, we
recently brought our fifth development program into the clinic with
the dosing of the first patient in our Phase 1 study of CLN-978 in
relapsed/refractory B cell non-Hodgkin lymphoma. Following an IND
clearance earlier this year, we remain on track to bring our sixth
program, CLN-617, into the clinic by year-end. With $512.1 million
in cash and investments at the end of Q2, we remain well
capitalized to continue executing on our strategic objectives and
creating value for all of our key stakeholders.”
Portfolio
Highlights
- Zipalertinib: In
August 2023, Cullinan Oncology, in collaboration with our partners
at Taiho Oncology, Inc., announced the initiation of REZILIENT-3, 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 (EGFRex20 NSCLC) in the
first-line setting.
- Enrollment continued in the Phase 2b
pivotal study of zipalertinib in patients with EGFRex20 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 EGFRex20 NSCLC.
-
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
for CLN-619 monotherapy in patients with advanced solid tumors were
presented during a poster session at the American Society of
Clinical Oncology (ASCO) 2023 Annual Meeting in June 2023. Data
demonstrated monotherapy anti-tumor activity of CLN-619 in heavily
pre-treated patients with multiple tumor types and an acceptable
safety profile with no dose limiting toxicities up to the highest
dose tested. Best responses among 22 evaluable patients receiving
doses ≥1 mg/kg included 1 confirmed complete response (parotid
cancer), 2 confirmed partial responses (endometrial cancer), and 7
patients with stable disease (cervical, ovarian, breast, and
salivary gland cancers).
- Based on these
clinical observations, Cullinan has initiated monotherapy expansion
cohorts in endometrial and cervical cancers and is evaluating
potential additional future expansion cohorts.
- Cullinan intends to
present initial data from the combination dose escalation arm of
the study at a medical meeting in the future.
-
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 in June 2023.
- Enrollment continues in the ongoing
Phase 1 multi-ascending dose study using subcutaneous
administration.
-
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 continued in the ongoing
Phase 1 dose escalation study in patients with advanced solid
tumors. Initial clinical data are expected in 2024.
-
CLN-978: CLN-978 is a CD19xCD3 T cell engager with
extended serum half-life and robust potency against target cells
expressing low levels of CD19.
- In August 2023, Cullinan dosed the
first patient in a Phase 1 study of CLN-978 in patients with R/R
B-NHL.
-
CLN-617: CLN-617 is a cytokine
fusion protein uniquely combining IL-2 and IL-12 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 the second half of 2023.
Second Quarter 2023 Financial
Results
- Cash Position:
Cash, cash equivalents, investments, and interest receivable were
$512.1 million as of June 30, 2023. This balance includes proceeds
of approximately $38.4 million from sales of common stock under the
company’s at-the-market offering program. 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 $27.4 million for the second quarter of 2023, compared to
$52.1 million for the first quarter of 2023. R&D expenses for
the second and first quarters of 2023 included $3.2 million and
$3.1 million of equity-based compensation expenses, respectively.
The decrease in R&D expenses was primarily related to a
one-time $25 million upfront payment in the first quarter of 2023
to in-license U.S. rights to CLN-418 and higher clinical costs,
partially offset by lower chemistry, manufacturing and controls
costs.
- G&A
Expenses: General and administrative (G&A)
expenses were $10.2 million for the second quarter of 2023,
compared to $10.7 million for the first quarter of 2023. G&A
expenses in the second and first quarters of 2023 included $4.7
million and $4.2 million of equity-based compensation expenses,
respectively. The decrease in G&A expenses, excluding
equity-based compensation, was primarily driven by lower
professional services fees.
- Net Loss: Net
loss (before items attributable to noncontrolling interest) for the
second quarter of 2023 was $32.2 million, compared with net loss of
$58.1 million for the first quarter of 2023. Net losses included
the items described above, partially offset by interest income of
$5.3 million and $4.5 million in the second quarter and first
quarter of 2023, respectively.
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 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) |
|
|
|
|
|
|
|
|
|
June 30, 2023 |
|
|
December 31, 2022 |
|
Cash, cash equivalents, investments, and interest receivable |
|
$ |
512,117 |
|
|
$ |
550,118 |
|
Total assets |
|
$ |
521,984 |
|
|
$ |
561,117 |
|
|
|
|
|
|
|
|
Total
current liabilities |
|
$ |
19,676 |
|
|
$ |
22,498 |
|
Total
liabilities |
|
$ |
22,410 |
|
|
$ |
26,088 |
|
Total
stockholders’ equity |
|
$ |
499,574 |
|
|
$ |
535,029 |
|
Total liabilities and stockholders’ equity |
|
$ |
521,984 |
|
|
$ |
561,117 |
|
|
|
|
|
|
|
|
|
Cullinan Oncology, Inc.Consolidated
Statements of
Operations(unaudited)(in
thousands, except per share amounts) |
|
|
|
Three Months Ended June 30 |
|
Six Months Ended June 30 |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
27,391 |
|
|
$ |
26,411 |
|
|
$ |
79,487 |
|
|
$ |
50,947 |
|
|
General and administrative |
|
|
10,214 |
|
|
|
10,695 |
|
|
|
20,874 |
|
|
|
18,816 |
|
|
Total operating expenses |
|
|
37,605 |
|
|
|
37,106 |
|
|
|
100,361 |
|
|
|
69,763 |
|
|
Gain on sale of Cullinan Pearl |
|
|
— |
|
|
|
276,785 |
|
|
|
- |
|
|
|
276,785 |
|
|
Income (loss) from operations |
|
|
(37,605 |
) |
|
|
239,679 |
|
|
|
(100,361 |
) |
|
|
207,022 |
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
|
Interest income |
|
|
5,322 |
|
|
|
697 |
|
|
|
9,830 |
|
|
|
894 |
|
|
Other income (expense), net |
|
|
69 |
|
|
|
(241 |
) |
|
|
176 |
|
|
|
(241 |
) |
|
Net income
(loss) before income taxes |
|
|
(32,214 |
) |
|
|
240,135 |
|
|
|
(90,355 |
) |
|
|
207,675 |
|
|
Income tax expense |
|
|
— |
|
|
|
66,070 |
|
|
|
— |
|
|
|
46,502 |
|
|
Net income
(loss) |
|
|
(32,214 |
) |
|
|
174,065 |
|
|
|
(90,355 |
) |
|
|
161,173 |
|
|
Net loss attributable to noncontrolling interests |
|
|
— |
|
|
|
(833 |
) |
|
|
(179 |
) |
|
|
(1,627 |
) |
|
Net income
(loss) attributable to common stockholders of Cullinan |
|
$ |
(32,214 |
) |
|
$ |
174,898 |
|
|
$ |
(90,176 |
) |
|
$ |
162,800 |
|
|
|
|
|
|
|
|
|
|
|
|
Net income
(loss) per share: |
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.82 |
) |
|
$ |
3.90 |
|
|
$ |
(2.24 |
) |
|
$ |
3.65 |
|
|
Diluted |
|
$ |
(0.82 |
) |
|
$ |
3.77 |
|
|
$ |
(2.24 |
) |
|
$ |
3.51 |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares used in computing net income (loss) per
share: |
|
|
|
|
|
|
|
Basic |
|
|
39,952 |
|
|
|
44,873 |
|
|
|
40,315 |
|
|
|
44,654 |
|
|
Diluted |
|
|
39,952 |
|
|
|
46,381 |
|
|
|
40,315 |
|
|
|
46,389 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contacts:
InvestorsChad Messer+1
203.464.8900cmesser@cullinanoncology.com
Media Rose Weldon +1
215.801.7644 rweldon@cullinanoncology.com
Grafico Azioni Cullinan Therapeutics (NASDAQ:CGEM)
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