Delaware

001-39527

81-1384762

(State or other jurisdiction of
incorporation or organization)

(Commission
File Number)

(I.R.S. Employer
Identification No.)

200 Powder Mill Road

Wilmington, Delaware

19803

(Address of principal executive offices)

(Zip Code)

Title of each class

Trading
Symbol(s)

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

PRLD

Nasdaq Global Select Market

Exhibit
Number

Description

99.1

Press release issued by Prelude Therapeutics Incorporated regarding its financial results for the year ended December 31, 2020, dated March 16, 2021.

PRELUDE THERAPEUTICS INCORPORATED

Date: March 16, 2021

By:

/s/ Brian Piper

Brian Piper

Chief Financial Officer

•

Phase 1 Dose Escalation Complete; Additional Expansion Cohorts to Open in the Second Quarter. The Company today announced that the dose escalation portion of the Phase 1 trial of its lead product candidate, PRT543, is now complete, and that a recommended expansion dose with adequate safety, pharmacokinetics, and target engagement profile has been established. PRT543 is designed to be a potent, selective, and oral inhibitor of PRMT5. The dose expansion portion of the Phase 1 trial is currently open for the patient cohort with adenoid cystic carcinoma, and will be open for additional patient cohorts with solid tumor and hematologic malignancies early in the second quarter. As previously announced, preliminary data from the dose escalation portion of the trial demonstrated early signs of clinical activity and tolerability. The Company anticipates presenting initial clinical data from the Phase 1 trial at medical meetings in the second half of 2021.

•

Preclinical Data to be Featured at the 2021 AACR Annual Meeting. Three preclinical presentations on PRT543 will be featured at the upcoming American Association for Cancer Research (AACR) Annual Meeting being held April 10-15, 2021 in a virtual setting. A copy of the posters, titled “PRMT5 inhibition downregulates MYB and NOTCH1 signaling, key molecular drivers of adenoid cystic carcinoma”, “PRMT5 inhibition epigenetically regulates DNA damage response pathways in cancer cells and sensitizes to chemotherapy and PARP inhibition”, and “PRMT5 inhibition regulates alternative splicing and DNA damage repair pathways in SF3B1 R625C expressing uveal melanoma cells”, will be available in the Publications section of the Prelude Therapeutics website following the conclusion of the meeting.

•

Phase 1 Dose Expansion Cohorts Expected to Commence in Mid-2021. The dose escalation portion of the Company’s Phase 1 trial of its second clinical product candidate, PRT811, which is designed to be a potent, selective, and brain penetrant PRMT5 inhibitor, in patients with advanced solid tumors, including glioblastoma multiforme (GBM), remains ongoing. As previously reported, the trial has demonstrated early signs of clinical activity and tolerability. Prelude remains on track to establish the recommended expansion dose and commence the dose expansion portion of the trial in mid-2021 in patients with central nervous system cancers including GBM, with initial clinical data expected by the end of 2021.

•

Oral Formulation: Dose Expansion and Combination Cohorts Expected to be Added to Ongoing Phase 1 Trial in the Second Half of 2021. The dose escalation portion of the Company’s first-in-human Phase 1 open-label, multicenter, dose-escalation study of oral PRT1419 in patients with relapsed/refractory hematologic malignancies, including acute myeloid leukemia and high-risk myelodysplastic syndromes, remains ongoing. PRT1419, which is the Company’s third clinical candidate, is designed to be an orally available, potent, and selective MCL1 inhibitor. The Company expects to add dose expansion and combination cohorts to the Phase 1 clinical trial in the second half of 2021.

•

IV Formulation: IND Application Cleared. Prelude today announced the recent U.S. Food and Drug Administration (FDA) clearance of the Company’s Investigational New Drug (IND) application for an intravenous (IV) formulation of PRT1419. A Phase 1 trial of the IV formulation, which leverages the optimized physicochemical properties of PRT1419, is expected to commence in the first half of 2021 in patients with solid tumors.

•

Data on Preclinical Characterization to be Featured at the 2021 AACR Annual Meeting. Data on the preclinical characterization of PRT1419 will be featured during a poster session at the 2021 AACR Annual Meeting. A copy of the poster, titled “Preclinical characterization of PRT1419, a potent, selective and orally available inhibitor of MCL1”, will be available in the Publication section of the Prelude Therapeutics website following the conclusion of the meeting.

•

Advancement of Earlier-Stage Candidates Expected in 2021. Prelude remains on track to submit an IND application for PRT2527, which is designed to be a potent and selective CDK9 inhibitor, in 2021. The Company also continues to expect to initiate IND-enabling studies for PRT-SCA2, which is designed to be a SMARCA2 protein degrader, in 2021.

•

Preclinical Data on SMARCA2 Protein Degradation to be Featured at the 2021 AACR Annual Meeting. A poster presentation on Prelude’s SMARCA2 protein degradation program, titled “Potent SMARCA2 targeted degraders induce genetic synthetic lethality in SMARCA4 deleted cancer”, will be presented at the 2021 AACR Annual Meeting. A copy of the poster will be available in the Publications section of the Prelude Therapeutics website following the conclusion of the meeting.

•

Completed Successful Upsized Public Offering of $172.5 Million. In January 2021, the Company announced the closing of its upsized public offering of 2,583,334 shares of its voting common stock and 291,666 shares of its non-voting common stock, each at a public offering price of $60.00 per share, which includes the exercise in full of the underwriters’ option to purchase an additional 375,000 shares of its voting common stock. The aggregate gross proceeds from this offering were $172.5 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Prelude.

•

Cash and Cash Equivalents: Cash and cash equivalents as of December 31, 2020 were $218.3 million.

•

Research and Development (R&D) Expenses: For the fourth quarter of 2020, R&D expense increased to $14.6 million from $8.8 million for the prior year period, and for the full year increased to $48.2 million compared to $24.3 million for 2019. The fourth quarter and full year increases were primarily due to increased clinical research costs for the PRT543 and PRT811 clinical trials and increased costs associated with the initiation of the clinical trial for PRT1419, which began in the third quarter of 2020. The Company also incurred an increase in chemistry, manufacturing, and other costs for those trials.

•

General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2020 increased to $4.9 million from $1.2 million for the prior year period, and for the full year increased to $10.6 million compared to $3.8 million for 2019. The fourth quarter and full year increases were primarily due to an increase in personnel related expense due to increased employee headcount and an increase in professional fees as the Company expanded its operations to support R&D efforts and incurred additional costs associated with operating as a public company.

•

Net Loss: For the fourth quarter of 2020, net loss was $19.3 million, or $0.45 per share, compared with a net loss of $10.0 million, or $5.56 per share, for the same period in 2019. Net loss for the year ended December 31, 2020 was $56.9 million, or $4.56 per share, compared with a net loss of $27.6 million, or $16.52 per share, for the year ended December 31, 2019.

•

Financial Guidance: The Company believes that its current cash and cash equivalents will be sufficient to fund operating expenses and capital expenditure requirements into 2023.

Year ended December 31,

(in thousands, except share and per share data)

2020

2019

Operating expenses:

Research and development

$

48,177

$

24,279

General and administrative

10,586

3,830

Total operating expenses

58,763

28,109

Loss from operations

(58,763

)

(28,109

)

Other income, net

1,834

539

Net loss

$

(56,929

)

$

(27,570

)

Per share information:

Net loss per share of common stock, basic and diluted

$

(4.56

)

$

(16.52

)

Weighted average common shares outstanding, basic and diluted

12,478,463

1,668,549

December 31,

(in thousands, except share and per share data)

2020

2019

Assets

Current assets:

Cash and cash equivalents

$

218,309

$

18,879

Prepaid expenses and other current assets

2,500

1,345

Total current assets

220,809

20,224

Property and equipment, net

2,480

1,647

Deferred offering costs

301

—

Total assets

$

223,590

$

21,871

Liabilities, convertible preferred stock and stockholders’ equity (deficit)

Current liabilities:

Capital lease obligation

$

—

$

258

Accounts payable

3,920

1,974

Accrued expenses and other current liabilities

7,455

2,603

Total current liabilities

11,375

4,835

Other liabilities

32

5

Total liabilities

11,407

4,840

Convertible preferred stock, $0.0001 par value:

Series A convertible preferred stock: No shares and 13,574,008 shares authorized at December 31, 2020 and 2019, respectively; No shares and 11,736,119 shares issued and outstanding at December 31, 2020 and 2019, respectively

—

36,595

Series B convertible preferred stock: No shares and 18,500,000 shares authorized at December 31, 2020 and 2019, respectively; No shares and 7,628,846 shares issued and outstanding at December 31, 2020 and 2019, respectively

—

29,848

Series C convertible preferred stock: No shares authorized, issued or outstanding at December 31, 2020 and 2019

—

—

Total convertible preferred stock

—

66,443

Stockholders’ equity:

Voting common stock, $0.0001 par value: 487,149,741 and 42,000,000 shares authorized at December 31, 2020 and 2019, respectively; 32,595,301and 3,161,653 shares issued and outstanding at December 31, 2020 and 2019, respectively

3

—

Non-voting common stock, $0.0001 par value: 12,850,259 and no shares

authorized at December 31, 2020 and 2019, respectively; 11,110,371

and no shares issued and outstanding at December 31, 2020

and 2019, respectively

1

—

Additional paid-in capital

319,605

1,085

Accumulated deficit

(107,426

)

(50,497

)

Total stockholders’ equity (deficit)

212,183

(49,412

)

Total liabilities, convertible preferred stock and stockholders’ equity (deficit)

$

223,590

$

21,871