Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage
precision oncology company, today reported its financial results
for the second quarter ended June 30, 2024 and provided an update
on its clinical development pipeline and other corporate
developments.
“Our team continues to make solid progress towards the Company’s
ambitious R&D objectives that we established for 2024 and
beyond. We are focused on advancing our two lead clinical programs,
including the first-in-class, highly selective SMARCA2 degrader,
PRT3789 and a potent and selective CDK9 inhibitor, PRT2527, both on
track to report initial clinical results this year,” stated Kris
Vaddi, Ph.D., Chief Executive Officer of Prelude.
Dr. Vaddi continued, “We believe that targeting the SMARCA
pathway has the potential to deliver a ‘pipeline in a program.’ We
are building on our leadership position by advancing the industry’s
first highly selective oral SMARCA2 degrader, PRT7732, into the
clinic, and will initiate a study of PRT3789 in combination with
KEYTRUDA in collaboration with Merck later this year. Additionally,
in collaboration with AbCellera, we are developing precision ADCs
with SMARCA payloads to extend the reach of our molecules to an
even broader set of cancers without SMARCA4 mutations.”
“Regarding our clinical development programs, we are very
pleased with the progress of both of our SMARCA2 degraders, PRT3789
and PRT7732,” added Jane Huang, M.D., President and Chief Medical
Officer of Prelude. “We are looking forward to sharing the initial
clinical data from the Phase 1 study of our highly selective
SMARCA2 degrader which has been chosen as the subject of an oral
presentation at the upcoming ESMO Congress in
September.”
Dr. Huang continued, “Additionally, based on the
continued progress of PRT2527, our selective CDK9 inhibitor, we
intend to present interim phase 1 clinical data, including a
potential best-in-class safety profile in the fourth quarter of
this year.”
Clinical Program Updates and Upcoming
Milestones
PRT3789 – A first-in-class, highly selective,
intravenous SMARCA2 Degrader
PRT3789 is a first-in-class SMARCA2 degrader, highly selective
for SMARCA2 and designed to treat patients with a SMARCA4 mutation.
Cancer patients whose tumors have SMARCA4 mutations have a poor
prognosis and as a result, this is an area of high unmet medical
need.
PRT3789 is in Phase 1 clinical development in biomarker selected
SMARCA4 mutant patients. Enrollment remains on track, and the
Company expects to conclude monotherapy dose escalation in 2024 and
identify a recommended Phase 2 dose. In addition, enrollment of
patients into back-fill cohorts enriched for NSCLC and SMARCA4
loss-of-function mutations is ongoing, as is enrollment of the
combination with docetaxel cohort.
Objectives for this first Phase 1 clinical trial are to
establish the safety and tolerability profile of PRT3789 as both
monotherapy and in combination with docetaxel, evaluate activity,
pharmacokinetics and pharmacodynamics and determine a dose and
potential indications for advancement into registrational clinical
trial(s).
Prelude recently launched an educational video series focused on
the science of SMARCA biology, the discovery of first-in-class,
highly selective SMARCA2 degraders and the unmet medical need for
patients with SMARCA4 mutated cancer. This series can be found on
the Company’s website under Highly Selective SMARCA2 Degraders -
Prelude Therapeutics (preludetx.com).
Interim Phase 1 data selected for an oral presentation
at the ESMO Congress 2024
The abstract titled “First Clinical Results from a Phase 1 Trial
of PRT3789, a First-in-Class Intravenous SMARCA2 Degrader, in
Patients with Advanced Solid Tumors with a SMARCA4 Mutation,” will
be presented by Robin Guo, M.D. from Memorial Sloan Kettering
Cancer Center. The ESMO Congress 2024 Scientific Committee selected
the abstract as an oral presentation.
The presentation is scheduled for September 13th, 2024, at 4:00
PM CEST (10:00 AM EST) in the Santander Auditorium (Hall 5) as part
of the Developmental Therapeutics Session.
Abstracts are anticipated to be available on the ESMO website on
September 9th, 2024 at 12:05 AM CEST (6:05 PM EST on September
8th).
Clinical collaboration announced with Merck to evaluate
PRT3789 in combination with KEYTRUDA® in patients
with SMARCA4-mutated cancers
In July 2024, Prelude announced a clinical collaboration with
Merck to evaluate PRT3789 in combination with KEYTRUDA® in patients
with SMARCA4-mutated cancers.
The mechanistic rationale and pre-clinical data to support the
SMARCA2 and anti-PD-1 monoclonal antibody (mAb) combination was
previously presented by the Company at the 2023 AACR
International Conference on Molecular Targets and Cancer
Therapeutics. In pre-clinical models, SMARCA2 degrader combined
with an anti-PD-1 mAb in SMARCA4-mutated cancers enhanced
anti-tumor immunity and demonstrated tumor regressions. Please see
the Company’s website under Publications - Prelude Therapeutics
(preludetx.com) for more information.
Under the terms of the Agreement, Merck will provide KEYTRUDA®
to Prelude. Prelude will be the sponsor of the Phase 2 clinical
combination trial, anticipated to initiate in the fourth quarter of
2024. Prelude and Merck each retain all commercial rights to their
respective compounds, including as monotherapy or as combination
therapies.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
PRT7732 – A potent, highly selective and orally
bioavailable SMARCA2 Degrader
Prelude has identified a series of highly selective and orally
bioavailable SMARCA2 degraders. The lead oral candidate, PRT7732,
recently was granted IND authorization from the FDA and is expected
to enter Phase 1 clinical development in the second half of
2024.
PRT2527 – A potent and highly selective CDK9
Inhibitor
PRT2527 is a potent and highly selective CDK9 inhibitor that has
the potential to avoid off-target toxicities observed with other
less selective CDK9 inhibitors. The Company is currently advancing
PRT2527 as monotherapy in both lymphoid and myeloid hematological
malignancies, and in combination with zanubrutinib in B-cell
malignancies.
PRT2527 is expected to complete monotherapy dose escalation in
B-cell malignancies this year. Initiation of dose escalation in
myeloid malignancies occurred in the first half of 2024. Interim
Phase 1 data is on track for presentation in the fourth quarter of
2024.
Second Quarter 2024 Financial
Results
Cash, Cash Equivalents, and Marketable
securities: Cash, cash equivalents and
marketable securities as of June 30, 2024 were $179.8 million. The
Company anticipates that its existing cash, cash equivalents and
marketable securities will fund Prelude’s operations into
2026.
Research and Development (R&D)
Expenses: For the second quarter of 2024,
R&D expense increased to $29.5 million from $25.0 million for
the prior year period. Research and development expenses increased
primarily due to an increase in our chemistry, manufacturing, and
controls (CMC) expense to support our pre-clinical and clinical
research programs. We expect our R&D expenses to vary from
quarter to quarter, primarily due to the timing of our clinical
development activities.
General and Administrative (G&A)
Expenses: For the second quarter of 2024,
G&A expenses increased to $7.7 million from $7.4 million for
the prior year period. The increase is primarily due to an increase
in professional fees incurred as we expand our operations to
support our research and development efforts.
Net Loss: For the three months ended
June 30, 2024, net loss was $34.7 million, or $0.46 per share
compared to $30.4 million, or $0.54 per share, for the prior year
period. Included in the net loss for the quarter ended June 30,
2024, was $6.1 million of non-cash expenses related to the impact
of expensing share-based payments, including employee stock
options, as compared to $6.7 million for the same period in
2023.
About Prelude
Therapeutics
Prelude Therapeutics is a leading precision oncology company
developing innovative medicines in areas of high unmet need for
cancer patients. Our pipeline is comprised of several novel drug
candidates including first-in-class, highly selective IV and oral
SMARCA2 degraders, and a potentially best-in-class CDK9 inhibitor.
We are also leveraging our expertise in targeted protein
degradation to discover, develop and commercialize next generation
degrader antibody conjugates (“Precision ADCs”) with partners. We
are on a mission to extend the promise of precision medicine to
every cancer patient in need. For more information, visit
preludetx.com.
Cautionary Note Regarding
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the "safe harbor" provisions of
the Private Securities Litigation Reform Act of 1995, including,
but not limited to, anticipated discovery, preclinical and clinical
development activities for Prelude’s product candidates, the
potential safety, efficacy, benefits and addressable market for
Prelude’s product candidates, the expected timeline for initial
proof-of-concept data and clinical trial results for Prelude’s
product candidates, and the sufficiency of Prelude’s cash runway
into 2026. All statements other than statements of historical fact
are statements that could be deemed forward-looking statements. The
words “believes,” “anticipates,” “estimates,” “plans,” “expects,”
“intends,” “may,” “could,” “should,” “potential,” “likely,”
“projects,” “continue,” “will,” “schedule,” and “would” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. These forward-looking statements are predictions
based on the Company’s current expectations and projections about
future events and various assumptions. Although Prelude believes
that the expectations reflected in such forward-looking statements
are reasonable, Prelude cannot guarantee future events, results,
actions, levels of activity, performance or achievements, and the
timing and results of biotechnology development and potential
regulatory approval is inherently uncertain. Forward-looking
statements are subject to risks and uncertainties that may cause
Prelude's actual activities or results to differ significantly from
those expressed in any forward-looking statement, including risks
and uncertainties related to Prelude's ability to advance its
product candidates, the receipt and timing of potential regulatory
designations, approvals and commercialization of product
candidates, clinical trial sites and our ability to enroll eligible
patients, supply chain and manufacturing facilities, Prelude’s
ability to maintain and recognize the benefits of certain
designations received by product candidates, the timing and results
of preclinical and clinical trials, Prelude's ability to fund
development activities and achieve development goals, Prelude's
ability to protect intellectual property, and other risks and
uncertainties described under the heading "Risk Factors" in
Prelude’s Annual Report on Form 10-K for the year ended December
31, 2023, its Quarterly Reports on Form 10-Q and other documents
that Prelude files from time to time with the Securities and
Exchange Commission. These forward-looking statements speak only as
of the date of this press release, and Prelude undertakes no
obligation to revise or update any forward-looking statements to
reflect events or circumstances after the date hereof, except as
may be required by law.
PRELUDE THERAPEUTICS INCORPORATED |
|
STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
(UNAUDITED) |
|
|
|
Three Months Ended June 30, |
(in thousands, except
share and per share data) |
|
2024 |
|
2023 |
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
29,509 |
|
|
$ |
24,966 |
|
General and administrative |
|
|
7,655 |
|
|
|
7,432 |
|
Total operating expenses |
|
|
37,164 |
|
|
|
32,398 |
|
Loss from operations |
|
|
(37,164 |
) |
|
|
(32,398 |
) |
Other income, net |
|
|
2,424 |
|
|
|
1,967 |
|
Net loss |
|
$ |
(34,740 |
) |
|
$ |
(30,431 |
) |
Per share information: |
|
|
|
|
|
|
Net loss per share of common
stock, basic and diluted |
|
$ |
(0.46 |
) |
|
$ |
(0.54 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
75,762,152 |
|
|
|
56,240,491 |
|
Comprehensive loss: |
|
|
|
|
|
|
Net loss |
|
$ |
(34,740 |
) |
|
$ |
(30,431 |
) |
Unrealized (loss) gain on marketable securities, net of tax |
|
|
(55 |
) |
|
|
(313 |
) |
Comprehensive loss |
|
$ |
(34,795 |
) |
|
$ |
(30,744 |
) |
PRELUDE THERAPEUTICS INCORPORATED |
|
BALANCE SHEETS |
|
(in thousands, except
share data) |
|
June 30,2024 |
|
|
December 31,2023 |
Assets |
|
(unaudited) |
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
27,828 |
|
|
|
$ |
25,291 |
|
Marketable securities |
|
|
152,016 |
|
|
|
|
207,644 |
|
Prepaid expenses and other current assets |
|
|
2,870 |
|
|
|
|
2,654 |
|
Total current assets |
|
|
182,714 |
|
|
|
|
235,589 |
|
Restricted cash |
|
|
4,044 |
|
|
|
|
4,044 |
|
Property and equipment, net |
|
|
7,554 |
|
|
|
|
7,325 |
|
Operating lease right-of-use
asset |
|
|
29,574 |
|
|
|
|
30,412 |
|
Other assets |
|
|
405 |
|
|
|
|
295 |
|
Total assets |
|
$ |
224,291 |
|
|
|
$ |
277,665 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
|
$ |
6,170 |
|
|
|
$ |
4,580 |
|
Accrued expenses and other current liabilities |
|
|
11,426 |
|
|
|
|
15,768 |
|
Deferred revenue |
|
|
3,000 |
|
|
|
|
— |
|
Operating lease liability |
|
|
2,232 |
|
|
|
|
1,481 |
|
Finance lease liability |
|
|
507 |
|
|
|
|
— |
|
Total current liabilities |
|
|
23,335 |
|
|
|
|
21,829 |
|
Other liabilities |
|
|
3,215 |
|
|
|
|
3,339 |
|
Operating lease liability |
|
|
15,465 |
|
|
|
|
15,407 |
|
Total liabilities |
|
|
42,015 |
|
|
|
|
40,575 |
|
Commitments |
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
Voting common stock, $0.0001 par value: 487,149,741 shares
authorized; 42,158,224 and 42,063,995 shares issued and outstanding
at June 30, 2024 and December 31, 2023, respectively |
|
|
4 |
|
|
|
|
4 |
|
Non-voting common stock, $0.0001 par value: 12,850,259 shares
authorized; 12,850,259 shares issued and outstanding at both June
30, 2024 and December 31, 2023 |
|
|
1 |
|
|
|
|
1 |
|
Additional paid-in capital |
|
|
705,122 |
|
|
|
|
693,252 |
|
Accumulated other comprehensive (loss) income |
|
|
(290 |
) |
|
|
|
223 |
|
Accumulated deficit |
|
|
(522,561 |
) |
|
|
|
(456,390 |
) |
Total stockholders’ equity |
|
|
182,276 |
|
|
|
|
237,090 |
|
Total liabilities and stockholders’ equity |
|
$ |
224,291 |
|
|
|
$ |
277,665 |
|
|
|
|
|
|
|
|
|
|
|
Investor Contact: Robert A. Doody,
Jr.Senior Vice President, Investor RelationsPrelude Therapeutics
Incorporated 484.639.7235rdoody@preludetx.com
Prelude Therapeutics (NASDAQ:PRLD)
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