Beam Therapeutics Inc 8-K, filed May 7, 2024
Beam Therapeutics Inc. (BEAM)
About this 8-K
Beam Therapeutics Inc filed this 8-K on May 7, 2024.
Items reported
- Item 2.02: Financial results
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
|
|
|||
(State or other jurisdiction |
|
(Commission |
|
(IRS Employer |
of incorporation) |
|
File Number) |
|
Identification No.) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||
(Address of principal executive offices) |
|
|
|
(Zip Code) |
(Registrant’s telephone number, including area code): (
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 |
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 May 7, 2024, Beam Therapeutics Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended March 31, 2024. 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 May 7, 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: May 7, 2024 |
|
By: |
/s/ John Evans |
|
|
Name: |
John Evans |
|
|
Title: |
Chief Executive Officer |
Exhibit 99.1
Beam Therapeutics Reports Pipeline Updates and First Quarter 2024 Financial Results
Dosing Completed for Sentinel Cohort of BEACON Phase 1/2 Trial of BEAM-101 in Severe Sickle Cell Disease; Expansion Cohort Initiated
Clinical Trial Authorisation (CTA) Application Cleared for the Phase 1/2 Trial of BEAM-302 in Alpha-1 Antitrypsin Deficiency; Study to Initiate in First Half of 2024
BEAM-301 On Track for Submission of U.S. Investigational New Drug Application (IND) in First Half 2024
Ended First Quarter 2024 with $1.1 Billion in Cash, Cash Equivalents and Marketable Securities; Cash Runway Expected to Support Operating Plans into 2027
CAMBRIDGE, Mass., May 7, 2024 – Beam Therapeutics Inc.(Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today reported first quarter 2024 financial results and provided updates across the company’s hematology and genetic disease franchises.
“We’re pleased to share progress across our high-priority programs that exemplify our commitment to rapid, focused execution and a dedication to developing differentiated, one-time medicines for serious genetic diseases,” said John Evans, chief executive officer of Beam. “We have successfully completed dosing and engraftment for three sickle cell disease patients in the sentinel cohort of the BEAM-101 BEACON trial allowing us to now move forward with expansion phase dosing. We look forward to sharing data for multiple patients treated with BEAM-101 later this year. In addition, our team has done an incredible job executing our ex-U.S. clinical strategy for BEAM-302, securing CTA clearance in the UK and rapidly working toward the initiation of our Phase 1/2 trial in patients with alpha-1 antitrypsin deficiency. This study is designed to demonstrate proof-of-concept for correction of the disease-causing mutation that could potentially help patients with both lung and liver disease manifestations. These updates, supported by our robust balance sheet, mark a significant stride toward our goal of establishing base editing as a potentially transformative and differentiated therapeutic option for patients in need.”
First Quarter 2024 and Recent Progress
Key 2024 Anticipated Milestones
Hematology Franchise
Genetic Disease Franchise
First Quarter 2024 Financial Results
Cash Runway
Beam expects that its cash, cash equivalents and marketable securities as of March 31, 2024, 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: the therapeutic applications and potential of our technology, including with respect to sickle cell disease, 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 March 31, 2024 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; 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) |
|
|||||||
|
|
|
|
|
|
|
||
|
|
March 31, |
|
|
December 31, |
|
||
Cash, cash equivalents, and marketable securities |
|
$ |
1,094,554 |
|
|
$ |
1,189,876 |
|
Total assets |
|
|
1,359,796 |
|
|
|
1,459,714 |
|
Total liabilities |
|
|
446,306 |
|
|
|
478,385 |
|
Total stockholders’ equity |
|
|
913,490 |
|
|
|
981,329 |
|
Condensed Consolidated Statement of Operations (unaudited) |
|
|||||||
(in thousands, except share and per share data) |
|
|||||||
|
|
|
|
|
|
|
||
|
|
Three Months Ended March 31, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
License and collaboration revenue |
|
$ |
7,410 |
|
|
$ |
24,208 |
|
Operating expenses: |
|
|
|
|
|
|
||
Research and development |
|
|
84,818 |
|
|
|
99,646 |
|
General and administrative |
|
|
26,724 |
|
|
|
23,490 |
|
Total operating expenses |
|
|
111,542 |
|
|
|
123,136 |
|
Loss from operations |
|
|
(104,132 |
) |
|
|
(98,928 |
) |
Other income (expense): |
|
|
|
|
|
|
||
Change in fair value of derivative liabilities |
|
|
(2,900 |
) |
|
|
5,600 |
|
Change in fair value of non-controlling equity investments |
|
|
(3,353 |
) |
|
|
(12,797 |
) |
Change in fair value of contingent consideration liabilities |
|
|
(133 |
) |
|
|
(296 |
) |
Interest and other income (expense), net |
|
|
11,849 |
|
|
|
9,961 |
|
Total other income (expense) |
|
|
5,463 |
|
|
|
2,468 |
|
Net loss |
|
$ |
(98,669 |
) |
|
$ |
(96,460 |
) |
Unrealized gain (loss) on marketable securities |
|
|
(1,525 |
) |
|
|
1,665 |
|
Comprehensive loss |
|
$ |
(100,194 |
) |
|
$ |
(94,795 |
) |
Net loss per common share, basic and diluted |
|
$ |
(1.21 |
) |
|
$ |
(1.33 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
|
81,698,633 |
|
|
|
72,273,829 |
|