- Strengthened Board and management with
appointments of experienced biotech leaders Troy Ignelzi, Sarah
Boyce, John Healy and Kristina Haeckl -
- Strong cash position of $219 million at the
end of Q2 will support multiple clinical readouts -
Contineum Therapeutics, Inc. (Nasdaq: CTNM), a clinical stage
biopharmaceutical company focused on discovering and developing
novel, oral small molecule therapies that target biological
pathways associated with specific clinical impairments in the
treatment of neuroscience, inflammation and immunology (NI&I)
indications, today reported financial results for the second
quarter ended June 30, 2024, and highlighted recent corporate
progress.
“Our team has made great progress in the last several months
with a continued focus on achieving our corporate milestones. We
accelerated enrollment in our ongoing Phase 2 clinical trial of
PIPE-307 for relapsed-remitting multiple sclerosis (RRMS), added
top-level talent to our leadership team and Board of Directors, and
significantly strengthened our balance sheet and extended our cash
runway with our successful IPO,” said Carmine Stengone, Contineum’s
Chief Executive Officer. “As we look towards the second half of
2024, we are focused on the initiation of our Phase 1b open-label
PET trial of PIPE-791 in the fourth quarter and the continued
enrollment in our Phase 2 VISTA trial of PIPE-307 for RRMS, while
also expanding our precision-medicine approach to additional
potentially high-value NI&I indications.”
Second Quarter 2024 and Recent Business Highlights
- Appointed Troy Ignelzi and Sarah Boyce to Board of
Directors. In May and June 2024, Contineum appointed biotech
veterans Troy Ignelzi and Sarah Boyce as independent members of its
Board of Directors, respectively. Mr. Ignelzi brings nearly two
decades of financial leadership and industry experience to
Contineum’s Board and currently serves as the Chief Financial
Officer at Rapport Therapeutics, Inc. (Nasdaq: RAPP), a precision
neuromedicines company. Ms. Boyce, who currently serves as
President and Chief Executive Officer of Avidity Biosciences, Inc.
(Nasdaq: RNA), brings over 25 years of global commercial and
clinical development expertise in the life sciences industry to
Contineum’s Board and has a proven track record of scaling
companies and successfully bringing over 20 products to
market.
- Strengthened Management Team with Appointments of John Healy
and Kristina Haeckl. In June 2024, Contineum expanded its
management team with the appointments of John Healy as General
Counsel & Corporate Secretary and Kristina Haeckl as Senior
Vice President, Regulatory Affairs. Mr. Healy is a business and
transactional attorney with over two decades of experience in the
biotechnology industry, including as a corporate associate within
top tier law firms, as a public company general counsel and as a
trusted legal advisor providing a broad range of legal consulting
support to the executive management teams of his private and public
consulting clients. Ms. Haeckl brings over 30 years of experience
in global regulatory affairs in the pharmaceutical/biotech industry
with expertise working for companies through all phases of
development.
- Enrollment On Track in PIPE-307 Phase 2 VISTA Clinical Trial
in RRMS. During the second quarter, enrollment of patients
continued in the ongoing Phase 2 VISTA clinical trial evaluating
the efficacy and safety of PIPE-307, a selective inhibitor of the
M1 receptor, in patients with RRMS. Enrollment in the study is on
track and Contineum expects to complete enrollment of this trial in
2025.
- Published Preclinical and Clinical Results on PIPE-307 in
PNAS. In August 2024, a manuscript titled “Targeting the
muscarinic M1 receptor with a selective, brain-penetrant antagonist
to promote remyelination in multiple sclerosis” was published
online in the peer-reviewed scientific journal the Proceedings of
the National Academy of Sciences (PNAS). The published data
provided early encouraging evidence that PIPE-307 is a potentially
first-in-class, novel, small molecule, selective inhibitor of the
muscarinic type 1 M1 receptor. The full manuscript is available
here.
- Presented Preclinical Proof-of-Concept Results at IASP
2024. Preclinical data was presented on PIPE-791, Contineum’s
LPA1 receptor antagonist, at the International Association for the
Study of Pain (IASP) World Congress on Pain meeting, held August 5,
2024 through August 9, 2024, in Amsterdam. PIPE-791 was evaluated
in a Cynomolgus macaque model of neuropathic pain using functional
magnetic resonance imaging (fMRI) as a quantitative biomarker of
stimulus-evoked pain following chronic constriction injury (CCI) of
the sciatic nerve. Based on suppression of brain regions mediating
pain intensity and affect, the findings support the notion that
blocking LPA1 receptors with PIPE-791 leads to antinociception and
highlight the potential in treating neuropathic pain. The
presentation can be found here.
- Published Preclinical Results on PIPE-791 in Scientific
Reports. In May 2024, a manuscript titled “Discovery of a brain
penetrant small molecule antagonist targeting LPA1 receptors to
reduce neuroinflammation and promote remyelination in multiple
sclerosis” was published online in the peer-reviewed scientific
journal Scientific Reports. The published data shows that PIPE-791
promotes remyelination and mitigates neuroinflammation in both in
vitro and in vivo models and functional remyelination in a mouse
MOG-induced EAE model of inflammatory demyelination. The full
manuscript is available here.
- Completed the Company’s Initial Public Offering. In
April 2024, Contineum completed its initial public offering (IPO)
resulting in net proceeds of $107.9 million.
Second Quarter 2024 Financial Results
- Cash, Cash Equivalents and Marketable Securities. As of
June 30, 2024, Contineum had cash, cash equivalents and marketable
securities of $218.7 million, compared to $125.2 million at the end
of 2023.
- Research and Development Expenses. Research and
development expenses were $7.9 million for the three months ended
June 30, 2024, compared to $9.5 million for the three months ended
June 30, 2023. The decrease of $1.6 million for the three months
ended June 30, 2024, compared to the three months ended June 30,
2023 was primarily driven by a $4.8 million decrease in consulting
and manufacturing expenses which were offset by increases in
expenses related to our on-going Phase 2 clinical trial for
PIPE-307 for RRMS and our completed Phase 1 healthy volunteer
clinical study for PIPE-791, expenses for toxicology studies for
PIPE-791 and personnel related costs.
- General and Administrative Expenses. General and
administrative expenses were $3.0 million for the three months
ended June 30, 2024, compared to $1.6 million for the three months
ended June 30, 2023. The increase of $1.4 million for the three
months ended June 30, 2024, compared to the three months ended June
30, 2023 was primarily driven by $0.6 million increase in
consulting expenses and $0.7 million increase in personnel
costs.
About Contineum Therapeutics
Contineum Therapeutics (Nasdaq: CTNM) is a clinical stage
biopharmaceutical company focused on discovering and developing
novel, oral small molecule therapies for NI&I indications with
high unmet need. Contineum is focused on targeting biological
pathways associated with specific clinical impairments, that
Contineum believes, once modulated, may demonstrably impact the
course of disease. Contineum has a pipeline of internally-developed
programs to address multiple NI&I disorders. Contineum has two
drug candidates in clinical trials, PIPE-791, an LPA1 receptor
antagonist in clinical development for idiopathic pulmonary
fibrosis and progressive multiple sclerosis (MS) and PIPE-307, a
selective inhibitor of the M1 receptor, in clinical development for
relapse remitting MS. PIPE-307 is being developed pursuant to a
global license and development agreement between Contineum and
Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical
Companies of Johnson & Johnson, who has also announced plans to
initiate a Phase 2 trial of PIPE-307 in depression in 2024.
Contineum is headquartered in San Diego, CA. For more
information, please visit www.contineum-tx.com
Forward-Looking Statements
Certain statements contained in this press release, other than
historical information, constitute forward-looking statements
within the meaning of the federal securities laws. Forward-looking
statements include, but are not limited to, statements regarding
the Company’s clinical trial and product development plans and
timelines; the indications, anticipated benefits of, and market
opportunities for its drug candidates; its cash runway; and its
business strategies and plans. These statements involve known and
unknown risks, uncertainties and other important factors that are
in some cases beyond the Company’s control and may cause its 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 and
uncertainties, include, but are not limited to, the following: the
Company is heavily dependent on the success of PIPE-791 and
PIPE-307, both of which are in the early stages of clinical
development, and neither of these drug candidates may progress
through clinical development or receive regulatory approval; the
results of earlier preclinical studies and clinical trials,
including those conducted by third parties, may not be predictive
of future results and unexpected adverse side effects or inadequate
efficacy of the Company’s drug candidates may limit their
development, regulatory approval and/or commercialization; the
timing and outcome of research, development and regulatory review
is uncertain; clinical studies and preclinical studies may not
proceed at the time or in the manner expected, or at all; risks
associated with reliance on third parties to successfully conduct
clinical trials and, in the case of PIPE-307, the Company’s
reliance upon Johnson & Johnson to develop PIPE-307 for
depression or any other indication other than RRMS and, after
completion of the VISTA trial, Johnson and Johnson’s decision, in
its sole discretion, whether or not further develop PIPE-307 for
RRMS; the Company has incurred significant operating expenses since
inception and it expects that its operating expenses will continue
to significantly increase for the foreseeable future; the Company’s
license agreement with Johnson & Johnson may not result in the
successful development of PIPE-307; and the Company may be unable
to obtain, maintain and enforce intellectual property protection
for its technology and drug candidates. Additional risks and
uncertainties that could affect the Company’s business, operations
and results are included under the captions, “Risk Factors” and
"Management’s Discussion and Analysis of Financial Condition and
Results of Operations” in its most recent filing on Form 10-Q and
in other filings that it makes with the SEC from time to time.
These documents are available on the Company’s website at
www.contineum-tx.com under the Investor section and on the SEC’s
website at www.sec.gov. Accordingly, readers should not rely upon
forward-looking statements as predictions of future events. Except
as required by applicable law, the Company undertakes no obligation
to update publicly or revise any forward-looking statements
contained herein, whether as a result of any new information,
future events, changed circumstances or otherwise.
Contineum Therapeutics, Inc. Condensed Balance Sheets
(Unaudited) (in thousands) June 30,
2024 December 31, 2023 Assets Cash, cash
equivalents and marketable securities
$
218,653
$
125,190
Prepaid expenses and other current assets
1,667
2,516
Property and equipment, net
801
678
Other long-term assets
3
1,283
Operating lease right-of-use assets
231
719
Total assets
$
221,355
$
130,386
Liabilities, convertible preferred stock and
stockholders' equity (deficit) Current liabilities
$
3,739
$
5,484
Long-term liabilities
113
218
Convertible preferred stock
-
192,620
Total stockholders' equity (deficit)
217,503
(67,936
)
Total liabilities, convertible preferred stock and stockholders'
equity (deficit)
$
221,355
$
130,386
Contineum Therapeutics, Inc. Condensed Statement
of Operations (Unaudited) (in thousands,
except share and per share data)
Three Months Ended June
30,
Six Months Ended June
30,
2024
2023
2024
2023
Revenue: License revenue
$
-
$
50,000
$
-
$
50,000
Operating expenses: Research and development
7,901
9,460
15,679
13,092
General and administrative
3,043
1,603
5,195
3,086
Total operating expenses
10,944
11,063
20,874
16,178
Income (loss) from operations
(10,944
)
38,937
(20,874
)
33,822
Other income (expense): Interest income
2,001
679
3,637
1,080
Interest expense
-
(116
)
-
(208
)
Change in fair value of warrant liability
11
2
(107
)
2
Change in fair value of investor rights and obligations liability
-
2,867
-
2,867
Other expense, net
(77
)
(76
)
(82
)
(94
)
Total other income
1,935
3,356
3,448
3,647
Income (loss) before income taxes
(9,009
)
42,293
(17,426
)
37,469
Provision for income taxes
-
(729
)
-
(729
)
Net income (loss)
$
(9,009
)
$
41,564
$
(17,426
)
$
36,740
Other comprehensive income (loss): Unrealized gain (loss) on
marketable securities
(69
)
(56
)
(235
)
11
Comprehensive income (loss)
$
(9,078
)
$
41,508
$
(17,661
)
$
36,751
Net income (loss) attributable to common stockholders, basic
$
(9,009
)
$
5,869
$
(17,426
)
$
5,521
Net income (loss) attributable to common stockholders, diluted
$
(9,009
)
$
2,949
$
(17,426
)
$
2,601
Net income (loss) per share, basic (a)
$
(0.39
)
$
2.56
$
(1.35
)
$
2.42
Net income (loss) per share, diluted (a)
$
(0.39
)
$
0.84
$
(1.35
)
$
0.74
Weighted-average shares of common stock outstanding, basic
23,355,588
2,291,866
12,862,328
2,284,750
Weighted-average shares of common stock outstanding, diluted
23,355,588
3,511,757
12,862,328
3,513,596
_____________ (a) Basic and diluted per share amounts are the same
for Class A and Class B shares.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240813901040/en/
Peter Slover CFO pslover@contineum-tx.com
IR@contineum-tx.com
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