Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage
precision oncology company, today reported its financial results
for the third quarter ended September 30, 2024 and provided an
update on its clinical development pipeline and other corporate
developments. “Our third quarter
was marked by dedicated execution and the achievement of essential
milestones for our lead clinical programs targeting SMARCA2,”
stated Kris Vaddi, Ph.D., Chief Executive Officer of Prelude. “We
have demonstrated the first-ever clinical proof of concept with our
first-in-class, highly selective IV SMARCA2 degrader, PRT3789, in
patients with aggressive SMARCA4 mutated cancers including
non-small cell lung cancer (NSCLC) and esophageal cancers as
monotherapy. We also demonstrated an encouraging early safety
profile with no overlapping toxicities in our ongoing PRT3789
combination study with docetaxel. We are focused on completing
monotherapy dose escalation and rapidly enrolling combination arms
to support advancement of PRT3789 into next phase of development,
initially in these two cancer types.”
Dr. Vaddi continued, “Additional accomplishments for the quarter
include the commencement of patient enrollment for our
first-in-class, highly selective oral SMARCA2 degrader, PRT7732 in
a biomarker selected phase 1 trial. With two highly differentiated
SMARCA2 degraders in the clinic, we are well-positioned to build on
our leadership in this novel and important therapeutic class and
provide optionality for patients. We look forward to reporting our
progress on both of these programs beginning early 2025.”
Dr. Vaddi also added, “Other milestones for the quarter included
presentation of first preclinical data from our Precision ADC
program demonstrating the potential of SMARCA2/4 degrader as a
potent and effective payload on multiple antibodies, as well as
acceptance of interim clinical data in hematological malignancies
of our potential best-in-class CDK9 inhibitor, PRT2527 at the
American Society of Hematology Meeting in December.”
Clinical Program Updates and Upcoming
Milestones
PRT3789 – A first-in-class, highly selective,
intravenous SMARCA2 DegraderPRT3789 is designed to treat
patients with a SMARCA4 mutation. Patients with SMARCA4-mutated
cancer have a poor prognosis. This represents an area of high unmet
medical need.
PRT3789 is in Phase 1 clinical development in patients with
biomarker selected SMARCA4-mutated cancers. Enrollment remains on
track, and the Company expects to conclude monotherapy dose
escalation by year-end 2024 and identify a dose for advancement to
registrational trials. 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. The Company also initiated a Phase 2 clinical
trial evaluating PRT3789 in combination with KEYTRUDA®
(pembrolizumab) in patients with SMARCA4-mutated cancers, per the
previously announced collaboration with Merck (known as MSD outside
of the US and Canada).
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Interim Phase 1 data presented at medical congresses in
Q3 2024The Company presented the first interim clinical
data updates of the Phase 1 dose escalation study of PRT3789 in
SMARCA4 mutated cancers at ESMO Congress 2024 and the 36th
EORTC-NCI-AACR Symposium. The presentations can be found at
Publications - Prelude Therapeutics.
As reported by investigators, PRT3789 was generally safe and
well-tolerated at doses tested to date. Of the 26 advanced NSCLC or
esophageal patients with Class 1 (loss of function) mutations who
were evaluable for efficacy, RECIST confirmed partial responses
(PRs) were observed in 4 patients (2 esophageal, 2 NSCLC). Of the 9
patients with Class 1 mutations treated at doses of 283 mg or
higher, two had RECIST confirmed partial responses and both were
NSCLC patients. Tumor shrinkage was observed in patients with both
Class 1 and Class 2 SMARCA4 mutations. Additional patients on-study
demonstrated clinical benefit as measured by prolonged SD,
including one advanced NSCLC patient who remains stable and on
study having been treated for more than a year.
Initial observations of safety from evaluable patients in the
PRT3789 plus docetaxel combination dose escalation arm of the trial
were also presented. To date, PRT3789 in combination with docetaxel
demonstrated an acceptable safety profile, with no dose limiting
toxicities or study drug serious adverse events reported.
PRT7732 – A potent, highly selective and orally
bioavailable SMARCA2 DegraderPRT7732 is a highly selective
and orally bioavailable SMARCA2 degrader. The Company initiated and
enrolled our first patients in a phase 1 multi-dose escalation
trial of PRT7732 (NCT06560645) in biomarker selected SMARCA4
mutated cancers.
Pfizer Ignite CollaborationPrelude has entered
into a collaboration agreement with Pfizer Ignite enabling
streamlined access to Ignite services in support of Prelude’s
SMARCA2 degrader development programs. Per Pfizer, Ignite is a
service offering providing partners access to Pfizer’s significant
resources, scale and expertise in developing potentially
breakthrough medicines. Under the terms of the collaboration
agreement, Prelude retains full ownership and global license rights
to all of its programs. Precision ADC with
SMARCA2/4 dual degrader payloadPrelude is developing
potent SMARCA2/4 dual degraders that robustly inhibit cancer cell
growth and induce cell death across multiple cancer types. The
Company presented the first preclinical data from its Precision ADC
platform at the 36th EORTC-NCI-AACR Symposium in October. The data
demonstrated potent activity of a SMARCA 2/4 degrader payload when
conjugated to a range of commercially available antibodies,
including PSMA, TROP2, C-MET, CEACAM5, and CD33. The SMARCA2/4
degrader payload conjugated to an anti-PSMA antibody demonstrated
tumor regressions and significantly better in vivo efficacy
compared to a traditional PSMA-targeted cytotoxic ADC in xenograft
models of prostate cancer at well tolerated doses. The presentation
can be found at Publications - Prelude Therapeutics.
PRT2527 – A potent and highly selective CDK9
InhibitorPRT2527 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 clinical data with potentially best-in-class CDK9
inhibitor, PRT2527 in hematological malignancies will be presented
at the American Society of Hematology Annual Meeting in December
2024. Third Quarter 2024 Financial
Results
Cash, Cash Equivalents, and Marketable
securities: Cash, cash equivalents and
marketable securities as of September 30, 2024 were $153.6 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 third quarter of 2024,
R&D expense increased to $29.5 million from $26.3 million for
the prior year period. Included in the R&D expense for the
three months ended September 30, 2024 was $3.4 million of non-cash
expense related to stock-based compensation expense, including
employee stock options, compared to $3.3 million for three months
ended September 30, 2023. Research and development expenses
increased primarily due to an increase in our chemistry,
manufacturing, and controls (CMC) costs supporting our pre-clinical
and clinical 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 third quarter of 2024,
G&A expenses increased to $7.9 million from $7.1 million for
the prior year period. Included in general and administrative
expenses for the three months ended September 30, 2024, was $2.5
million of non-cash expense related to stock-based compensation
expense, including employee stock options, compared to $3.4 million
for three months ended September 30, 2023. General and
administrative expenses increased primarily due to an increase in
professional fees incurred to support our research and development
efforts.
Net Loss: For the three months ended
September 30, 2024, net loss was $32.3 million, or $0.43 per share
compared to $30.6 million, or $0.45 per share, for the prior year
period. Included in the net loss for the quarter ended September
30, 2024, was $5.9 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. Our corporate presentation can be found at
Events & Presentations - Prelude Therapeutics. 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 September 30, |
|
(in thousands, except
share and per share data) |
|
2024 |
|
|
2023 |
|
Revenue from license agreement |
|
$ |
3,000 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
Research and development |
|
|
29,457 |
|
|
|
26,261 |
|
General and administrative |
|
|
7,919 |
|
|
|
7,124 |
|
Total operating expenses |
|
|
37,376 |
|
|
|
33,385 |
|
Loss from operations |
|
|
(34,376) |
|
|
|
(33,385) |
|
Other income, net |
|
|
2,105 |
|
|
|
2,777 |
|
Net loss |
|
$ |
(32,271) |
|
|
$ |
(30,608) |
|
Per share information: |
|
|
|
|
|
|
Net loss per share of common
stock, basic and diluted |
|
$ |
(0.43) |
|
|
$ |
(0.45) |
|
Weighted average common shares
outstanding, basic and diluted |
|
|
75,855,949 |
|
|
|
67,639,993 |
|
Comprehensive loss: |
|
|
|
|
|
|
Net loss |
|
$ |
(32,271) |
|
|
$ |
(30,608) |
|
Unrealized gain (loss) on marketable securities, net of tax |
|
|
457 |
|
|
|
106 |
|
Comprehensive loss |
|
$ |
(31,814) |
|
|
$ |
(30,502) |
|
PRELUDE THERAPEUTICS
INCORPORATED
BALANCE SHEETS
(in thousands, except
share data) |
|
September 30,2024 |
|
|
December 31,2023 |
|
Assets |
|
(unaudited) |
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
11,134 |
|
|
$ |
25,291 |
|
Marketable securities |
|
|
142,492 |
|
|
|
207,644 |
|
Prepaid expenses and other current assets |
|
|
2,761 |
|
|
|
2,654 |
|
Total current assets |
|
|
156,387 |
|
|
|
235,589 |
|
Restricted cash |
|
|
4,044 |
|
|
|
4,044 |
|
Property and equipment, net |
|
|
7,202 |
|
|
|
7,325 |
|
Operating lease right-of-use
asset |
|
|
29,182 |
|
|
|
30,412 |
|
Other assets |
|
|
405 |
|
|
|
295 |
|
Total assets |
|
$ |
197,220 |
|
|
$ |
277,665 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
5,921 |
|
|
$ |
4,580 |
|
Accrued expenses and other current liabilities |
|
|
13,579 |
|
|
|
15,768 |
|
Operating lease liability |
|
|
2,365 |
|
|
|
1,481 |
|
Finance lease liability |
|
|
359 |
|
|
|
— |
|
Total current liabilities |
|
|
22,224 |
|
|
|
21,829 |
|
Other liabilities |
|
|
3,153 |
|
|
|
3,339 |
|
Operating lease liability |
|
|
15,412 |
|
|
|
15,407 |
|
Total liabilities |
|
|
40,789 |
|
|
|
40,575 |
|
Commitments |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Voting common stock, $0.0001 par value: 487,149,741 shares
authorized; 42,178,012 and 42,063,995 shares issued and outstanding
at September 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
September 30, 2024 and December 31, 2023 |
|
|
1 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
711,091 |
|
|
|
693,252 |
|
Accumulated other comprehensive income |
|
|
167 |
|
|
|
223 |
|
Accumulated deficit |
|
|
(554,832) |
|
|
|
(456,390) |
|
Total stockholders’ equity |
|
|
156,431 |
|
|
|
237,090 |
|
Total liabilities and stockholders’ equity |
|
$ |
197,220 |
|
|
$ |
277,665 |
|
Investor Contact: Robert A. Doody,
Jr.Senior Vice President, Investor RelationsPrelude Therapeutics
Incorporated 484.639.7235rdoody@preludetx.com
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