8-K
false000174599900017459992024-02-272024-02-27

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 27, 2024

 

BEAM THERAPEUTICS INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

001-39208

 

81-5238376

(State or other jurisdiction

 

(Commission

 

(IRS Employer

of incorporation)

 

File Number)

 

Identification No.)

 

 

 

 

 

238 Main Street

 

 

 

 

Cambridge, MA

 

 

 

02142

(Address of principal executive offices)

 

 

 

(Zip Code)

 

(Registrant’s telephone number, including area code): (857) 327-8775

Not Applicable

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

Trading

Symbol(s)

Name of each exchange

on which registered

Common Stock, par value $0.01 per share

BEAM

Nasdaq Global Select Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 


 

Item 2.02 Results of Operations and Financial Condition.

On February 27, 2024, Beam Therapeutics Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended December 31, 2023. A copy of this press release is furnished as Exhibit 99.1 and is incorporated herein by reference.

The information in this Item 2.02 as well as in the accompanying Exhibit 99.1 attached hereto is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing by the Company, under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release Issued by Beam Therapeutics Inc. on February 27, 2024

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

BEAM THERAPEUTICS INC.

 

 

 

 

Date: February 27, 2024

 

By:

/s/ John Evans

 

 

Name:

John Evans

 

 

Title:

Chief Executive Officer

 

 


EX-99.1

Exhibit 99.1

 

https://cdn.kscope.io/63e60c6aca3f0374fbe57dbcdfbe8776-img55885398_0.jpg 

 

 

 

Beam Therapeutics Reports Fourth Quarter and Year-End 2023 Financial Results and Reiterates Anticipated Milestones

Patient Dosing and Enrollment Continue to Progress in Beacon Phase 1/2 Study of BEAM-101 in Severe Sickle Cell Disease; First Clinical Data Anticipated in Second Half of 2024

Phase 1 Trial Initiation for BEAM-302 in Alpha-1 Antitrypsin Deficiency on Track for First Half of 2024 Pending European Clinical Trial Application (CTA) Acceptance

Ended Fourth Quarter 2023 with $1.2 Billion in Cash, Cash Equivalents and Marketable Securities; Cash Runway Expected to Support Operating Plans into 2027

 

CAMBRIDGE, Mass., February 27, 2024 Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today reported fourth quarter and full year 2023 financial results and reiterated anticipated milestones across the company’s sickle cell disease and genetic disease portfolios.

“This year has the potential to be transformative for Beam as we work to advance multiple base editing programs in the clinic, anchoring key high-value franchises through near-term catalysts – all backed by a strong balance sheet,” said John Evans, chief executive officer of Beam. “In 2024, we expect to initiate our first in vivo clinical studies and report the first in-human data from our ex vivo base editing clinical programs. Operationally, we’ve made significant progress in the BEACON study of BEAM-101 in sickle cell disease, and we’re on track to complete the sentinel cohort and initiate dosing in the expansion cohort in the first half of the year. In addition, we filed our CTA for BEAM-302 in alpha-1 anti-trypsin deficiency ahead of schedule and remain on track to initiate that study in the first half of 2024. We are convinced that base editing has the potential to provide new options and meaningful advantages over existing therapies for patients suffering from serious diseases.”

Key 2024 Anticipated Milestones

Sickle Cell Disease (SCD) Franchise

In the BEACON Phase 1/2 clinical trial of BEAM-101 in adults with severe SCD, Beam anticipates completing dosing in patients in the sentinel cohort and initiating dosing in patients in the expansion cohort in the first half of 2024.
The company is on track to report initial data on multiple patients from the BEACON trial in the second half of 2024.
Beam continues to advance and invest in its Engineered Stem Cell Antibody Paired Evasion (ESCAPE) conditioning platform and anticipates initiating Phase 1-enabling preclinical studies for the program in 2024.

Genetic Disease Franchise

Beam has filed a European clinical trial application (CTA) for BEAM-302, the company’s priority genetic disease program for the treatment for alpha-1 antitrypsin deficiency (AATD), and, assuming CTA acceptance, plans to initiate a Phase 1 clinical trial for BEAM-302 in the first half of 2024.
Beam expects to submit an investigational new drug (IND) application in the U.S. for BEAM-301 for the potential treatment of glycogen storage disease type 1a (GSD1a) in the first half of 2024.

 

 


 

Fourth Quarter and Full Year 2023 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $1.2 billion as of December 31, 2023, compared to $1.1 billion as of December 31, 2022.
Research & Development (R&D) Expenses: R&D expenses were $140.1 million for the fourth quarter of 2023 and $437.4 million for the full year ended December 31, 2023, compared to $86.3 million for the fourth quarter of 2022 and $311.6 million for the full year ended December 31, 2022.
General & Administrative (G&A) Expenses: G&A expenses were $43.3 million for the fourth quarter of 2023 and $116.8 million for the full year ended December 31, 2023, compared to $22.7 million for the fourth quarter of 2022 and $87.8 million for the full year ended December 31, 2022.
Net Income (Loss): Net income attributable to common stockholders was $142.8 million, or $1.77 per basic share and $1.73 per diluted share, for the fourth quarter of 2023 and net loss attributable to common stockholders was $132.5 million, or $1.72 per share, for the year ended December 31, 2023, compared to net losses of $38.3 million, or $0.54 per share, for the fourth quarter of 2022 and $289.1 million, or $4.13 per share, for the full year ended December 31, 2022.

Cash Runway

Beam expects that its cash, cash equivalents and marketable securities as of December 31, 2023, will enable the company to fund its anticipated operating expenses and capital expenditure requirements into 2027. This expectation includes funding directed toward reaching each of the key anticipated milestones for BEAM-101, ESCAPE, BEAM-301 and BEAM-302 described above, as well as continued investments in platform advancements and manufacturing capabilities.

 

 


 

About Beam Therapeutics

Beam Therapeutics (Nasdaq: BEAM) is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Investors are cautioned not to place undue reliance on these forward-looking statements, including, but not limited to, statements related to: our expectations for transitioning to a multi-program clinical stage company; the therapeutic applications and potential of our technology, including with respect to SCD, AATD, GSD1a, and ESCAPE; our plans, and anticipated timing, to advance our programs, the clinical trial designs and expectations for BEAM-101, BEAM-301, BEAM-302 and ESCAPE; our estimated cash, cash equivalents and marketable securities as of December 31, 2023 and our expectations related thereto; the sufficiency of our capital resources to fund operating expenses and capital expenditure requirements and the period in which such resources are expected to be available; and our ability to develop life-long, curative, precision genetic medicines for patients through base editing. Each forward-looking statement is subject to important risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement, including, without limitation, risks and uncertainties related to: our ability to successfully achieve the benefits of our portfolio prioritization and strategic restructuring; our ability to develop, obtain regulatory approval for, and commercialize our product candidates, which may take longer or cost more than planned; our ability to raise additional funding, which may not be available; our ability to obtain, maintain and enforce patent and other intellectual property protection for our product candidates; the uncertainty that our product candidates will receive regulatory approval necessary to initiate human clinical studies; that preclinical testing of our product candidates and preliminary or interim data from preclinical studies and clinical trials may not be predictive of the results or success of ongoing or later clinical trials; that initiation and enrollment of, and anticipated timing to advance, our clinical trials may take longer than expected; that our product candidates may experience manufacturing or supply interruptions or failures; risks related to competitive products; whether our actual audited results will be consistent with our estimated cash, cash equivalents and marketable securities as of December 31, 2023; and the other risks and uncertainties identified under the headings “Risk Factors Summary” and “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, and in any subsequent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law.

Contacts:

Investors:

Holly Manning

THRUST Strategic Communications

holly@thrustsc.com

Media:

Dan Budwick

1AB

dan@1abmedia.com

 

 


 

Condensed Consolidated Balance Sheet Data (unaudited)

 

(in thousands)

 

 

 

 

 

 

 

 

 

 

December 31,
2023

 

 

December 31,
2022

 

Cash, cash equivalents, and marketable securities

 

$

1,189,876

 

 

$

1,078,134

 

Total assets

 

 

1,459,714

 

 

 

1,341,714

 

Total liabilities

 

 

478,385

 

 

 

608,240

 

Total stockholders’ equity

 

 

981,329

 

 

 

733,474

 

 

Condensed Consolidated Statement of Operations (unaudited)

 

(in thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended December 31,

 

 

Years Ended December 31,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

License and collaboration revenue

 

$

316,192

 

 

$

20,037

 

 

$

377,709

 

 

$

60,920

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

140,077

 

 

 

86,341

 

 

 

437,381

 

 

 

311,594

 

General and administrative

 

 

43,257

 

 

 

22,681

 

 

 

116,813

 

 

 

87,805

 

Total operating expenses

 

 

183,334

 

 

 

109,022

 

 

 

554,194

 

 

 

399,399

 

Income (loss) from operations

 

 

132,858

 

 

 

(88,985

)

 

 

(176,485

)

 

 

(338,479

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Change in fair value of derivative liabilities

 

 

(1,900

)

 

 

3,000

 

 

 

7,500

 

 

 

23,900

 

Change in fair value of non-controlling equity investments

 

 

(722

)

 

 

21,578

 

 

 

(18,592

)

 

 

20,200

 

Change in fair value of contingent consideration liabilities

 

 

1,863

 

 

 

19,447

 

 

 

9,740

 

 

 

18,904

 

Interest and other income (expense), net

 

 

12,064

 

 

 

7,611

 

 

 

46,676

 

 

 

15,297

 

Total other income (expense)

 

 

11,305

 

 

 

51,636

 

 

 

45,324

 

 

 

78,301

 

Net income (loss) before income taxes

 

 

144,163

 

 

 

(37,349

)

 

 

(131,161

)

 

 

(260,178

)

Provision for income taxes

 

 

(1,366

)

 

 

(1,000

)

 

 

(1,366

)

 

 

(3,410

)

Loss from equity method investment

 

 

 

 

 

 

 

 

 

 

 

(25,500

)

Net income (loss)

 

$

142,797

 

 

$

(38,349

)

 

$

(132,527

)

 

$

(289,088

)

Unrealized gain (loss) on marketable securities

 

 

2,628

 

 

 

2,244

 

 

 

3,034

 

 

 

(2,380

)

Comprehensive income (loss)

 

$

145,425

 

 

$

(36,105

)

 

$

(129,493

)

 

$

(291,468

)

Net income (loss) per common share - basic

 

$

1.77

 

 

$

(0.54

)

 

$

(1.72

)

 

$

(4.13

)

Basic weighted-average common shares outstanding

 

 

80,858,517

 

 

 

70,777,452

 

 

 

77,151,771

 

 

 

70,015,305

 

Net income (loss) per common share - diluted

 

$

1.73

 

 

$

(0.54

)

 

$

(1.72

)

 

$

(4.13

)

Diluted weighted-average common shares outstanding

 

 

82,702,302

 

 

 

70,777,452

 

 

 

77,151,771

 

 

 

70,015,305