Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage
precision oncology company, today reported financial results for
the second quarter ended June 30, 2023, and provided a corporate
update.
Kris Vaddi, Ph.D., Chief Executive Officer of Prelude
stated, “With the recent financing that extended our cash
runway into 2026, we are in a strong position to advance our
diverse pipeline of potentially best and/or first-in-class
compounds to address the needs of patients with certain underserved
cancers. Our focus remains on generating critical data for each of
our molecules to make key strategic decisions. As disclosed
recently, and based on additional data generated in this quarter,
PRT2527 (CDK9 inhibitor) and PRT1419 (MCL1 inhibitor) demonstrated
differentiated clinical safety profiles and strong target
inhibition and are continuing to enroll patients with hematological
malignancies, which is where we see the best opportunities for
these molecules.”
“Our first-in-class selective SMARCA2 degrader, PRT3789, and
next generation CDK4/6 inhibitor, PRT3645, are progressing well in
Phase 1 and are on track to reach confirmation doses in the first
half of 2024 and by year end 2023, respectively,” added Dr. Vaddi.
“Based on meaningful progress made in the first half of the year,
we look forward to sharing updates and clarity around strategic
prioritization of our pipeline in the coming months.”
Pipeline Updates
PRT2527- CDK9 Inhibitor Program The Company
believes its highly selective CDK9 inhibitor, PRT2527, has the
potential to avoid off-target toxicities, achieve substantial
clinical activity and become the best-in-class CDK9 inhibitor,
making it amenable for combination with other therapies.
PRT2527 has completed a Phase 1 multi-dose escalation study
(NCT05159518) in patients with solid tumors. In this trial, PRT2527
was shown to achieve high levels of target inhibition and the
potential to be better tolerated than existing CDK9 inhibitors,
specifically, manageable neutropenia and an absence of meaningful
gastrointestinal events or hepatotoxicity. *
*AACR2023 Poster Presentation
A Phase 1 multi-dose escalation study (NCT05665530) is currently
ongoing in hematologic malignancies. Patient recruitment for
hematological clinical trials in the US is highly competitive and
this trial has recently been expanded to include global sites to
support patient recruitment.
The Company’s objective is to establish a biologically active
confirmation dose by Q1 2024. As part of this Phase 1 multi-dose
escalation trial, the Company intends to expand the Phase 1
clinical trial and evaluate PRT2527 in combination with
zanubrutinib.
Potential indications for PRT2527 include aggressive B-cell
lymphoma subtypes, mantle cell lymphoma (MCL), chronic lymphocytic
leukemia/small lymphocytic lymphoma (CLL/SLL) including Richter
syndrome, and T-cell lymphoma subtypes.
The Company intends to provide a program update by year end on
the CDK9 inhibitor program and present initial results at a future
scientific meeting.
PRT1419- MCL1 Inhibitor ProgramPRT1419 is a
potent and selective MCL1 inhibitor. With its optimized PK/PD
profile, the Company believes PRT1419 has the potential to achieve
greater target engagement and provide patients with better clinical
outcomes as well as improved safety and tolerability, as compared
to other MCL1 inhibitors in development.
PRT1419 has completed a Phase 1 multi-dose escalation study
(NCT04837677) in patients with solid tumors. In this study, PRT1419
demonstrated an acceptable safety and tolerability profile in
patients with advanced and metastatic solid tumors. No cardiac
toxicity was observed. Pharmacokinetics/pharmacodynamics and safety
data in the 80 mg/m2 QW dose cohort support further evaluation of
this dose in future studies.
A Phase 1 multi-dose escalation clinical trial of PRT1419 in
patients with hematologic malignancies is ongoing (NCT05107856). In
this trial, PRT1419 is being evaluated as monotherapy for myeloid
malignancies and in combination with azacitidine or venetoclax for
patients with relapsed/refractory myeloid or B-cell
malignancies.
The Company will provide a clinical update on PRT1419 by year
end.
PRT3645- Next Generation CDK4/6 Inhibitor
ProgramPRT3645 is a highly potent and selective next
generation CDK4/6 inhibitor with the potential to provide improved
safety and tolerability outcomes and higher, more effective brain
and tissue penetration than current CDK4/6 inhibitors.
In preclinical models in vivo, PRT3645 has been shown to be
efficacious in multiple cancers as monotherapy as well as when
combined with KRAS inhibitors, MEK inhibitors and with a brain
penetrant HER2 receptor kinase inhibitor. Additionally, oral
administration of PRT3645 has been shown to induce tumor
regressions in preclinical models that are resistant to currently
approved CDK4/6 inhibitors. Together, these data suggest that
PRT3645 may extend the benefit of CDK4/6 inhibition beyond HR+
breast cancer.
A Phase 1 multi-dose escalation clinical trial of PRT3645
(NCT05538572) is underway and the Company expects to reach a
biologically active dose confirmation in Q4 2023.
Potential indications for PRT3645 in combination with other
therapies, in addition to breast cancer with or without brain
metastases, include endometrial, sarcomas, glioblastomas, non-small
cell lung cancer, head and neck cancers.
The Company intends to provide a program update by year end and
present initial results at a future scientific meeting.
PRT3789- SMARCA2 Targeted Protein Degrader
ProgramPRT3789 is a first-in-class highly selective
degrader of SMARCA2 protein, which along with SMARCA4 controls gene
regulation through chromatin remodeling. Cancer cells with SMARCA4
mutations are dependent on SMARCA2 for their growth and survival
and selectively degrading SMARCA2 induces cell death in cancer
cells while sparing normal cells. PRT3789 is efficacious and well
tolerated in preclinical models of SMARCA4 deleted/mutated cancers
as monotherapy and in combination with standards of care. The
Company believes a selective SMARCA2 degrader has the potential to
be of benefit in up to 70,000 US/EU cancer patients with the
SMARCA4 mutation.
Patients with SMARCA4 mutations or deletions may have poor
clinical outcomes and limited treatment options. Therefore,
mutated, or deleted SMARCA4 cancers provides a potential biomarker
to select those patients most likely to respond to treatment with a
highly selective SMARCA2 degrader.
A Phase 1 multi-dose escalation clinical trial of PRT3789 is
ongoing (NCT05639751) in biomarker selected SMARCA4 mutated
cancers. The Company intends to evaluate PRT3789 as monotherapy as
well as in combination.
The Company intends to provide a program update by year end and
expects to reach confirmation dose in the first half of 2024.
SMARCA2- Oral
ProgramThe Company has also recently nominated a new
chemical entity as a potent, orally bioavailable and highly
selective SMARCA2 degrader candidate (>1000x over SMARCA4) and
intends to file an IND early in 2024.
Second Quarter 2023 Financial
Results
Cash, Cash Equivalents and Marketable
Securities: In May 2023, the Company completed a public
offering of common stock, raising gross proceeds of $113.0 million
before deducting underwriting discounts, commissions and offering
expenses. Net proceeds received, $110.4 million, will be focused on
the continued development and expansion of the Company’s product
pipeline.
Cash, cash equivalents, and marketable securities as of June 30,
2023, were $255.0 million. Prelude anticipates that its existing
cash, cash equivalents and marketable securities will fund the
Company’s operations into 2026.
Research and Development (R&D) Expenses:
For the second quarter of 2023, R&D expense increased to $25.0
million from $21.3 million for the prior year period. Research and
development expenses increased primarily due to the timing of our
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 2023,
G&A expenses decreased to $7.4 million from $8.2 million for
the prior year period. General and administrative expenses
decreased reflecting the Company’s careful management of its
G&A expenses.
Net Loss: For the three months ended June 30,
2023, net loss was $30.4 million, or $0.54 per share compared to
$27.4 million, or $0.58 per share, for the prior year period.
Included in the net loss for the quarter ended June 30, 2023, was
$6.7 million of non-cash expense related to the impact of expensing
share-based payments, including employee stock options, as compared
to $6.0 million for the same period in 2022.
About Prelude Therapeutics
Prelude Therapeutics is a clinical-stage precision oncology
company developing innovative drug candidates targeting critical
cancer cell pathways. The Company’s diverse pipeline is comprised
of highly differentiated, potentially best-in-class proprietary
small molecule compounds aimed at addressing clinically validated
pathways for cancers with selectable underserved patients.
Prelude’s pipeline includes four candidates currently in clinical
development: PRT1419, a potent, selective inhibitor of MCL1,
PRT2527, a potent and highly selective CDK9 inhibitor, PRT3645 a
next generation CDK4/6 inhibitor, PRT3789 an IV
administered, potent and highly selective SMARCA2 degrader, and a
preclinical oral candidate targeting SMARCA2.
For more information, visit our website and follow us on
LinkedIn and Twitter.
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, the timing and/or announcements relating to
the reporting of expected findings for PRT1419, PRT2527, PRT3645,
PRT3789, and its preclinical oral SMARCA2 degrader, the potential
benefits of Prelude’s product candidates and platform, and the
sufficiency of cash and cash equivalents to fund operating expenses
and capital expenditures into 2026. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements. 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
documents 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.
PRELUDE THERAPEUTICS
INCORPORATED
STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(UNAUDITED)
|
|
Three Months Ended June 30, |
|
(in thousands, except
share and per share data) |
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
24,966 |
|
|
$ |
21,310 |
|
General and administrative |
|
|
7,432 |
|
|
|
8,151 |
|
Total operating expenses |
|
|
32,398 |
|
|
|
29,461 |
|
Loss from operations |
|
|
(32,398 |
) |
|
|
(29,461 |
) |
Other income, net |
|
|
1,967 |
|
|
|
2,087 |
|
Net loss |
|
$ |
(30,431 |
) |
|
$ |
(27,374 |
) |
Per share information: |
|
|
|
|
|
|
Net loss per share of common
stock, basic and diluted |
|
$ |
(0.54 |
) |
|
$ |
(0.58 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
56,240,491 |
|
|
|
47,276,684 |
|
Comprehensive loss |
|
|
|
|
|
|
Net loss |
|
$ |
(30,431 |
) |
|
$ |
(27,374 |
) |
Unrealized (loss) gain on marketable securities, net of tax |
|
|
(313 |
) |
|
|
19 |
|
Comprehensive loss |
|
$ |
(30,744 |
) |
|
$ |
(27,355 |
) |
PRELUDE THERAPEUTICS
INCORPORATED
BALANCE
SHEETS(UNAUDITED)
(in thousands, except
share data) |
|
June 30,2023 |
|
|
December 31,2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
26,446 |
|
|
$ |
30,605 |
|
Marketable securities |
|
|
228,543 |
|
|
|
171,123 |
|
Prepaid expenses and other current assets |
|
|
5,221 |
|
|
|
2,652 |
|
Total current assets |
|
|
260,210 |
|
|
|
204,380 |
|
Restricted cash |
|
|
4,044 |
|
|
|
4,044 |
|
Property and equipment, net |
|
|
6,082 |
|
|
|
4,908 |
|
Right-of-use asset |
|
|
918 |
|
|
|
1,792 |
|
Prepaid expenses and other
non-current assets |
|
|
9,357 |
|
|
|
5,376 |
|
Total assets |
|
$ |
280,611 |
|
|
$ |
220,500 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
5,585 |
|
|
$ |
6,777 |
|
Accrued expenses and other current liabilities |
|
|
8,667 |
|
|
|
13,093 |
|
Operating lease liability |
|
|
938 |
|
|
|
1,832 |
|
Total current liabilities |
|
|
15,190 |
|
|
|
21,702 |
|
Other liabilities |
|
|
3,361 |
|
|
|
3,361 |
|
Total liabilities |
|
|
18,551 |
|
|
|
25,063 |
|
Commitments (Note 8) |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Voting common stock, $0.0001 par value: 487,149,741 shares
authorized; 41,958,456 and 36,496,994 shares issued and outstanding
at June 30, 2023 and December 31, 2022, respectively |
|
|
4 |
|
|
|
4 |
|
Non-voting common stock, $0.0001 par value: 12,850,259 shares
authorized; 12,850,259 and 11,402,037 shares issued and outstanding
at June 30, 2023 and December 31, 2022, respectively |
|
|
1 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
655,473 |
|
|
|
531,682 |
|
Accumulated other comprehensive loss |
|
|
(711 |
) |
|
|
(1,692 |
) |
Accumulated deficit |
|
|
(392,707 |
) |
|
|
(334,558 |
) |
Total stockholders’ equity |
|
|
262,060 |
|
|
|
195,437 |
|
Total liabilities and stockholders’ equity |
|
$ |
280,611 |
|
|
$ |
220,500 |
|
Investor Contact:Lindsey TrickettVice
President, Investor
Relations240.543.7970ltrickett@preludetx.com
Media Contact:Helen ShikShik Communications
617.510.4373Helen@ShikCommuncations.com
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