Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage
precision oncology company, today reported financial results for
the first quarter ended March 31, 2023, and provided an update on
recent clinical and development pipeline progress.
“Our recent presentations at the 2023 AACR Annual Meeting
highlight the meaningful progress we made across our clinical and
preclinical pipeline programs. In addition to our clinical
presentations on PRT2527 (CDK9 inhibitor) and PRT1419 (MCL-1
Inhibitor) that demonstrated differentiated and potential
best-in-class PK/PD profiles of these molecules, our preclinical
research demonstrated the promise of our pipeline in addressing
unmet patient needs in cancer through combination approaches.
Patient enrollment in the phase 1 dose escalation of PRT3789
(first-in-class SMARCA2 selective degrader) is now underway. Our
teams are focused on advancing our pipeline to key milestones and
we look forward to reporting further updates in the coming
months,” said Kris Vaddi, Ph.D., Chief Executive Officer of
Prelude.
Recent Highlights
2023 AACR Annual Meeting: Prelude
participated in the 2023 American Association for Cancer Research
Annual Meeting, presenting two clinical and six preclinical poster
presentations. Initial safety, pharmacokinetic and pharmacodynamic
profiles in solid tumors for both PRT2527 and PRT1419 were
presented. Preclinical data for both the Company’s next generation
CDK4/6 inhibitor, PRT3645, and the SMARCA2 degrader, PRT3789, in
combination with other targeted therapies, demonstrated the
combinability of these compounds with standard of care medicines
and inform potential clinical development.
Program Updates and Upcoming Milestones
PRT2527- CDK9 Inhibitor Program PRT2527,
Prelude’s potentially best in class CDK9 inhibitor, is completing a
solid tumor dose escalation study. In adults with advanced solid
tumors, PRT2527 was generally well-tolerated with manageable
neutropenia and absence of significant gastrointestinal events or
hepatotoxicity. The short half-life of PRT2527 enables acute CDK9
inhibition over a defined period making it potentially suitable for
weekly administration without inducing significant toxicity. The
observed dose-dependent downregulation of CDK9 transcriptional
targets – MYC and MCL-1 mRNA expression in PBMCs isolated from
patients treated with PRT2527 –was consistent with the degree of
target engagement required for preclinical efficacy. The 15 m/mg2
QW dose of PRT2527 was selected for further evaluation in
dose-confirmation cohort.
The overall safety profile observed in this study supports
further development of PRT2527 in combination with other targeted
therapies, including in hematologic malignancies. The Company is on
track to establish a RP2D in hematological malignancies in 2H
2023.
PRT1419- MCL1 Inhibitor ProgramPRT1419
demonstrated an acceptable safety and tolerability profile in
patients with advanced and metastatic solid tumors, with the most
common TRAEs of nausea, vomiting, and diarrhea. Neutropenia was
deemed to be dose related. No cardiac toxicity was observed.
Pharmacokinetics/pharmacodynamics and safety data in the 80 mg/m2
QW PRT1419 dose cohort support further evaluation of this dose in
future studies. Induction of activated-BAX and cleaved caspase-3
was observed at 80 and 120 mg/m2 QW PRT1419, suggesting successful
MCL-1 inhibition. No tumor reductions met response criteria.
Further investigation of PRT1419 in patients with hematologic
malignancy is ongoing. The Company is on track to determine the
RP2D in hematological RP2D and will provide a clinical update at
year end.
PRT3645-Next Generation CDK4/6 Inhibitor
ProgramPrelude showed that PRT3645 is highly efficacious
when combined with KRAS/MEK inhibitors, and with a brain penetrant
HER2 receptor kinase inhibitor in in vivo preclinical models.
Additionally, oral administration of PRT3645 induces tumor
regression in palbociclib-resistant preclinical models. Dose
escalation phase of PRT3645 is progressing per plan and the Company
expects to provide an update by year end.
PRT3789 SMARCA2 Targeted Protein Degrader
ProgramPhase 1 dose escalation of PRT3789 (first-in-class
selective SMARCA2 degrader) is ongoing. The Company recently
presented preclinical data, showing that SMARCA2 selective
degraders demonstrate anti-proliferation activity and promote cell
differentiation in a wide range of indications demonstrating
activity as monotherapy, as well as in combination with KRAS G12C
inhibitors, chemotherapy and other targeted agents. Consistent with
the Company’s plans to nominate an orally bioavailable candidate in
early 2024, preclinical data at AACR showed that oral
administration of multiple internally developed compounds results
in significant tumor growth inhibition of SMARCA4-deficient lung
cancer xenografts at well-tolerated doses.
First Quarter 2023 Financial
Results
Cash, Cash Equivalents and Marketable
Securities: Cash, cash equivalents, and marketable
securities as of March 31, 2023, were $172.3 million. Prelude
anticipates that its existing cash, cash equivalents and marketable
securities will fund the Company’s operations into the fourth
quarter of 2024.
Research and Development (R&D) Expenses:
For the first quarter of 2023, R&D expense decreased to $21.8
million from $22.8 million for the prior year period. Research and
development expenses decreased 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 first quarter of 2023, G&A
expenses were relatively unchanged as compared to the three months
ended March 31, 2022.
Net Loss: For the three months ended March 31,
2023, net loss was $27.7 million, or $0.58 per share compared to
$29.5 million, or $0.63 per share, for the prior year period.
Included in the net loss for the quarter ended March 31, 2023, was
$6.3 million of non-cash expense related to the impact of expensing
share-based payments, including employee stock options, as compared
to $6.8 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, and PRT3789 an
IV administered, potent and highly selective SMARCA2 degrader.
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
and PRT3789, 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 the fourth
quarter of 2024. 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, the impact of the
COVID-19 pandemic on Prelude’s business, clinical trial sites,
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
INCORPORATEDSTATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(UNAUDITED) |
|
|
|
Three Months Ended March 31, |
|
(in thousands, except
share and per share data) |
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
21,834 |
|
|
$ |
22,821 |
|
General and administrative |
|
|
7,281 |
|
|
|
7,467 |
|
Total operating expenses |
|
|
29,115 |
|
|
|
30,288 |
|
Loss from operations |
|
|
(29,115 |
) |
|
|
(30,288 |
) |
Other income, net |
|
|
1,397 |
|
|
|
823 |
|
Net loss |
|
$ |
(27,718 |
) |
|
$ |
(29,465 |
) |
Per share information: |
|
|
|
|
|
|
Net loss per share of common
stock, basic and diluted |
|
$ |
(0.58 |
) |
|
$ |
(0.63 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
47,737,190 |
|
|
|
47,066,427 |
|
Comprehensive loss |
|
|
|
|
|
|
Net loss |
|
$ |
(27,718 |
) |
|
$ |
(29,465 |
) |
Unrealized gain (loss) on marketable securities, net of tax |
|
|
1,294 |
|
|
|
(1,602 |
) |
Comprehensive loss |
|
$ |
(26,424 |
) |
|
$ |
(31,067 |
) |
PRELUDE THERAPEUTICS INCORPORATEDBALANCE
SHEETS(UNAUDITED) |
|
(in thousands, except
share data) |
|
March 31,2023 |
|
|
December 31,2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
18,201 |
|
|
$ |
30,605 |
|
Marketable securities |
|
|
154,054 |
|
|
|
171,123 |
|
Prepaid expenses and other current assets |
|
|
3,008 |
|
|
|
2,652 |
|
Total current assets |
|
|
175,263 |
|
|
|
204,380 |
|
Restricted cash |
|
|
4,044 |
|
|
|
4,044 |
|
Property and equipment, net |
|
|
5,371 |
|
|
|
4,908 |
|
Right-of-use asset |
|
|
1,360 |
|
|
|
1,792 |
|
Prepaid expenses and other
non-current assets |
|
|
12,282 |
|
|
|
5,376 |
|
Total assets |
|
$ |
198,320 |
|
|
$ |
220,500 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
7,082 |
|
|
$ |
6,777 |
|
Accrued expenses and other current liabilities |
|
|
11,190 |
|
|
|
13,093 |
|
Operating lease liability |
|
|
1,390 |
|
|
|
1,832 |
|
Total current liabilities |
|
|
19,662 |
|
|
|
21,702 |
|
Other liabilities |
|
|
3,361 |
|
|
|
3,361 |
|
Total liabilities |
|
|
23,023 |
|
|
|
25,063 |
|
Commitments |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Voting common stock, $0.0001 par value: 487,149,741 shares
authorized; 36,514,218 and 36,496,994 shares issued and outstanding
at March 31, 2023 and December 31, 2022, respectively |
|
|
4 |
|
|
|
4 |
|
Non-voting common stock, $0.0001 par value: 12,850,259 shares
authorized; 11,402,037 and 11,402,037 shares issued and outstanding
at March 31, 2023 and December 31, 2022, respectively |
|
|
1 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
537,966 |
|
|
|
531,682 |
|
Accumulated other comprehensive loss |
|
|
(398 |
) |
|
|
(1,692 |
) |
Accumulated deficit |
|
|
(362,276 |
) |
|
|
(334,558 |
) |
Total stockholders’ equity |
|
|
175,297 |
|
|
|
195,437 |
|
Total liabilities and stockholders’ equity |
|
$ |
198,320 |
|
|
$ |
220,500 |
|
Investor Contact:Lindsey TrickettVice
President, Investor
Relations240.543.7970ltrickett@preludetx.com
Media Contact:Helen ShikShik Communications
617.510.4373Helen@ShikCommuncations.com
Prelude Therapeutics (NASDAQ:PRLD)
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Prelude Therapeutics (NASDAQ:PRLD)
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