Cullinan Oncology Provides Corporate Update and Reports Second Quarter 2022 Financial Results
August 10 2022 - 7:00AM
Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company
focused on developing a diversified pipeline of targeted
therapeutic candidates across multiple modalities for patients with
cancer, today reported on recent and upcoming business highlights
and announced its financial results for the second quarter ended
June 30, 2022.
“In the second quarter of 2022, Cullinan Oncology
demonstrated significant portfolio advancement, including the
closing of our agreement with Taiho Pharmaceutical for CLN-081, an
oral presentation for CLN-081 at the American Society of Clinical
Oncology (ASCO) 2022 Annual Meeting, and continued progression of
our pipeline of potential first-in-class and best-in-class oncology
assets. These achievements demonstrate our commitment to creating
new standards of care for patients with unmet need,” said Nadim
Ahmed, Chief Executive Officer of Cullinan Oncology.
“We are pleased with the
continued strengthening of CLN-081’s clinical profile,” Ahmed
continued. “Updated data released at ASCO highlighted a high
response rate, favorable safety and tolerability, and improving
durability of response from the ongoing Phase 1/2a study for
patients with EGFR exon 20 insertion mutation non-small-cell lung
cancer. Financially, the closing of the Taiho transaction for
CLN-081 has extended our cash runway through 2026, giving us the
financial flexibility to accelerate and expand the development of
our diverse pipeline as well as obtain promising new oncology
assets. Looking ahead, we continue to advance our earlier-stage
programs, including CLN-619 and CLN-049, with initial Phase 1 data
readouts expected by mid-2023, as well as CLN-617 and CLN-978, for
which we anticipate IND filings in the first half of next
year.”
Portfolio
Highlights
-
CLN-081: In June, Cullinan Oncology
completed its strategic agreement with Taiho Pharmaceutical Co.,
Ltd. (Taiho Pharmaceutical) pursuant to which Cullinan Oncology
received a $275 million upfront payment and is eligible to receive
an additional $130 million tied to EGFR exon 20 non-small-cell lung
cancer regulatory milestones in exchange for selling its equity
interest in Cullinan Pearl, which holds worldwide rights to CLN-081
outside of Japan and Greater China. Additionally, Cullinan Oncology
entered into an agreement with Taiho Oncology, Inc. (Taiho
Oncology), a subsidiary of Taiho Pharmaceutical, to jointly develop
and commercialize CLN-081 in the U.S. Pursuant to the
co-development agreement, Cullinan Oncology and Taiho Oncology will
share equally in the development expenses and future potential U.S.
profits and losses for CLN-081.
-
Also in June, Cullinan Oncology presented updated data from its
ongoing Phase 1/2a clinical study of CLN-081 in an oral
presentation at the ASCO 2022 Annual Meeting. The updated data
showed a median duration of response greater than 21 months, median
progression free survival of 12 months and a confirmed overall
response rate of 41% among 39 patients treated at the 100 mg BID
dose, along with a continued favorable safety and tolerability
profile. In collaboration with its partner, Taiho Oncology,
Cullinan Oncology intends to initiate a pivotal study for CLN-081
in the second half of 2022 under the co-development agreement.
-
CLN-049: Cullinan Oncology continued dosing
patients in its first-in-human clinical trial evaluating CLN-049 in
patients with relapsed/refractory acute myeloid leukemia (AML) or
myelodysplastic syndrome (MDS). Initial clinical data are expected
by mid-2023. CLN-049 is a FLT3/CD3-bispecific T cell-engaging
antibody in an IgG format for the treatment of AML and MDS. CLN-049
targets the extracellular domain of FLT3, regardless of mutant or
wild type FLT3 status.
-
CLN-619: Cullinan Oncology
continued dosing subjects in its first-in-human clinical trial
evaluating CLN-619 alone and in combination with pembrolizumab in
patients with advanced tumors. Initial clinical data are expected
by mid-2023. CLN-619 is a first-in-class monoclonal antibody with
broad therapeutic potential across multiple cancer indications.
CLN-619 stabilizes expression of MICA/MICB on the tumor cell
surface to promote an antitumor response via activation of both
natural killer (NK) cells and certain T cells.
- Preclinical
Portfolio:
- Cullinan Oncology
remains on track for Investigational New Drug (IND) submissions in
the first half of 2023 for its two most advanced preclinical
programs:
- CLN-617, 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, and
- CLN-978, a novel CD19/CD3-bispecific
construct with extended serum half-life and high potency against
target cells expressing low levels of CD19.
- Cullinan Oncology
continues to progress its additional 3 preclinical programs,
including Jade, Opal, and the HPK1 degrader collaboration with
Icahn Mount Sinai.
Second Quarter
2022 Financial Results
- Cash
Position: Cash and investments were $656 million
as of June 30, 2022. During the second quarter of 2022, we received
cash proceeds of $270 million from the sale of Cullinan Pearl. The
remaining $5 million of the $275 million upfront payment was held
in escrow as of June 30 and is expected to be released in the third
quarter of 2022. Based on current operating plans, the Company
expects that its cash and investments will be sufficient to fund
operations through 2026.
- R&D
Expenses: Research and development (R&D) expenses
were $26.4 million for the second quarter of 2022, compared to
$24.5 million for the first quarter of 2022. R&D expenses for
the second and first quarters of 2022 included $4.4 million and
$2.6 million of equity-based compensation expenses, respectively.
The increase in R&D expenses is primarily related to expanded
clinical activities for CLN-049 and CLN-619 and IND-enabling
activities for CLN-617, which were partially offset by a decrease
in chemistry, manufacturing, and control activities for
CLN-081.
- G&A
Expenses: General and administrative (G&A)
expenses were $10.7 million for the second quarter of 2022,
compared to $8.1 million for the first quarter of 2022. G&A
expenses in the second and first quarters of 2022 included $4.2
million and $3.8 million of equity-based compensation expenses,
respectively. Nonrecurring expenses related to the Cullinan Pearl
transaction were $1.7 million in the second quarter and $0.3
million in the first quarter.
- Gain on sale
of Cullinan Pearl: The Company recognized a gain on the
sale of Cullinan Pearl of $276.8 million, which includes the
upfront payment of $275 million, as well as the impact of net
liabilities transferred to Taiho. As of June 30, 2022, the Company
also recognized an income tax liability related to this gain of
$46.5 million. The Company estimates the net income tax liability
will be reduced to approximately $41 million based on our
utilization of net operating losses we anticipate incurring during
the remainder of 2022. We expect to make estimated tax payments in
an amount equal to 75% of our tax liability in the third quarter of
2022 and the remainder in the fourth quarter of 2022.
- Net
Income: The Company generated net income (before
items attributable to noncontrolling interest) of $174.1 million
for the second quarter of 2022 compared to a net loss of $12.9
million for the first 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 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 receipt of
escrowed funds related to our transaction with Taiho
Pharmaceutical; 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)
|
June 30, 2022 |
|
March 31, 2022 |
|
(unaudited) |
|
(unaudited) |
Cash, cash equivalents, investments, and interest receivable |
$ |
655,623 |
|
$ |
410,063 |
Total
assets |
$ |
667,249 |
|
$ |
437,463 |
Total current liabilities |
$ |
62,035 |
|
$ |
17,257 |
Total liabilities |
$ |
62,631 |
|
$ |
17,993 |
Total stockholders’
equity |
$ |
604,618 |
|
$ |
419,470 |
Total liabilities and
stockholders’ equity |
$ |
667,249 |
|
$ |
437,463 |
|
|
|
|
|
|
Cullinan Oncology,
Inc.Consolidated Statements of
Operations(in thousands, except per share
amounts)
|
|
Three Months Ended |
|
Six Months Ended June 30, |
|
|
June 30, 2022 |
|
March 31, 2022 |
|
|
2022 |
|
|
|
2021 |
|
|
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
License revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
18,943 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
26,411 |
|
|
|
24,536 |
|
|
|
50,947 |
|
|
|
24,193 |
|
General and administrative |
|
|
10,695 |
|
|
|
8,121 |
|
|
|
18,816 |
|
|
|
9,982 |
|
Total operating expenses |
|
|
37,106 |
|
|
|
32,657 |
|
|
|
69,763 |
|
|
|
34,175 |
|
Gain on sale of Cullinan Pearl |
|
|
276,785 |
|
|
|
— |
|
|
|
276,785 |
|
|
|
— |
|
Income (loss) from operations |
|
|
239,679 |
|
|
|
(32,657 |
) |
|
|
207,022 |
|
|
|
(15,232 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest income |
|
|
697 |
|
|
|
197 |
|
|
|
894 |
|
|
|
222 |
|
Other income (expense), net |
|
|
(241 |
) |
|
|
- |
|
|
|
(241 |
) |
|
|
(10 |
) |
Net income (loss) before income
taxes |
|
|
240,135 |
|
|
|
(32,460 |
) |
|
|
207,675 |
|
|
|
(15,020 |
) |
Income tax expense (benefit) |
|
|
66,070 |
|
|
|
(19,568 |
) |
|
|
46,502 |
|
|
|
— |
|
Net income (loss) |
|
|
174,065 |
|
|
|
(12,892 |
) |
|
|
161,173 |
|
|
|
(15,020 |
) |
Net income (loss) attributable to noncontrolling interests |
|
|
(833 |
) |
|
|
(794 |
) |
|
|
(1,627 |
) |
|
|
686 |
|
Net income (loss) attributable to
common stockholders of Cullinan |
|
$ |
174,898 |
|
|
$ |
(12,098 |
) |
|
$ |
162,800 |
|
|
$ |
(15,706 |
) |
|
|
|
|
|
|
|
|
|
Earnings (net loss) per
share: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
3.90 |
|
|
$ |
(0.27 |
) |
|
$ |
3.65 |
|
|
$ |
(0.37 |
) |
Diluted |
|
$ |
3.77 |
|
|
$ |
(0.27 |
) |
|
$ |
3.51 |
|
|
$ |
(0.37 |
) |
|
|
|
|
|
|
|
|
|
Weighted-average shares used in
computing earnings (net loss) per share: |
|
|
|
|
|
|
|
|
Basic |
|
|
44,873 |
|
|
|
44,432 |
|
|
|
44,654 |
|
|
|
42,713 |
|
Diluted |
|
|
46,381 |
|
|
|
44,432 |
|
|
|
46,389 |
|
|
|
42,713 |
|
Contacts:
InvestorsChad Messer+1
203.464.8900cmesser@cullinanoncology.com
Media Rose Weldon +1
215.801.7644 rweldon@cullinanoncology.com
1 Includes cash, cash equivalents, investments, and interest
receivable.
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