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
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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):
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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 November 7, 2022, Beam Therapeutics Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended September 30, 2022. 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. |
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Description |
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99.1 |
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Press Release Issued by Beam Therapeutics Inc. on November 7, 2022 |
104 |
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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.
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BEAM THERAPEUTICS INC. |
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Date: November 7, 2022 |
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By: |
/s/ John Evans |
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Name: |
John Evans |
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Title: |
Chief Executive Officer |
Exhibit 99.1
Beam Therapeutics Announces Portfolio Progress and Reports Third Quarter 2022 Financial Results
Patient Recruitment Underway in BEACON Clinical Trial of BEAM-101 for Treatment of Sickle Cell Disease as Part of Wave 1 Strategy Execution
IND-enabling Studies Underway for BEAM-301 for Treatment of GSDIa
BEAM-302 Nominated as Development Candidate for Treatment of Alpha-1 Antitrypsin Deficiency; Targeting Durable Gene Correction Designed to Address Both Lung and Liver Disease
New Data Highlighting Enhanced Conditioning Approach for Hematologic Transplant (ESCAPE) to be Presented at ASH
Ended Third Quarter 2022 with $1.1 Billion in Cash, Cash Equivalents and Marketable Securities
CAMBRIDGE, Mass., November 7, 2022 – Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today provided portfolio updates and reported financial results for the third quarter, ended September 30, 2022.
“As pioneers in base editing, Beam has been at the forefront of advancing a broad pipeline across a range of therapeutic areas and delivery strategies, and today we report significant progress and updates in each of these areas,” said John Evans, chief executive officer of Beam. “Our top priority is executing the BEACON trial for BEAM-101. Bringing a novel transplant-based medicine into clinical development in the U.S. has been a tremendous effort, and we are laser-focused on screening and site activation efforts to enroll our first sickle cell patient by year-end. We are also accelerating our overall BEAM-101 development program, where we see an opportunity to potentially seek regulatory approval on data generated from the BEACON trial. Given those priorities, we have elected not to file an IND in 2022 for BEAM-102. Instead, we will take the opportunity to streamline the BEACON trial while focusing the next phase of our investment in sickle cell disease on our Wave 2 programs for non-genotoxic conditioning, as well as our Wave 3 strategy for in vivo lipid nanoparticle delivery of base editors, continuing to leverage both HbF and Makassar editing strategies.”
Evans added, “Beyond hematology, the Beam team has also executed on the rest of our ambitious goals for advancing and expanding our pipeline. In immune cell therapies, we have submitted our response to the FDA clinical hold for BEAM-201, and we continue our research toward a potential best-in-class platform for allogeneic cell therapies leveraging the strength of multiplex base editing, which may be the key to delivering deeper and more durable responses. In the liver portfolio, we have initiated IND-enabling studies for BEAM-301, to our knowledge the first gene editing program to target direct in vivo correction of a genetic mutation. Finally, we are very pleased to announce the selection of our second in vivo development candidate, BEAM-302, for alpha-1 antitrypsin deficiency (AATD). BEAM-302 is a first-in-kind program targeting direct in vivo DNA correction of the disease-causing E342K mutation in patients with severe AATD, which could address both the lung and liver manifestations of the disease with a potentially one-time treatment. I am so proud of the entire Beam team for advancing the science and medicine of base editing across such a diverse portfolio, and we are excited about the near-term opportunity to bring each of these potential medicines to patients.”
Portfolio Updates & Anticipated Milestones
Ex Vivo Hematopoietic Stem Cell (HSC) Pipeline
To accelerate development of BEAM-101, Beam is currently working to amend the BEACON trial protocol to enable clinical trial modifications designed to streamline and expedite patient enrollment and trial conduct based on the recent regulatory landscape in SCD trials. The company also plans to make investments required to finalize its commercial manufacturing process for BEAM-101.
Ex Vivo T Cell Pipeline
In Vivo LNP Liver-targeting Pipeline
Third Quarter 2022 Financial Results
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 upcoming presentation at the ASH annual meeting; our plans, and anticipated timing, to advance our programs; our expectations for transitioning to a multi-program clinical stage company; the therapeutic applications and potential of our technology, including with respect to SCD and our conditioning regimens, GSDIa, AATD, HBV, and CAR-T cells; the expected timing of enrolling the first subject in our BEACON Phase 1/2 clinical trial of BEAM-101; the sufficiency of our capital resources to fund operating expenses and capital expenditure requirements; 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 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 potential impact of the COVID-19 pandemic, including its impact on the global supply chain; 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 enrollment and initiation of 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, 2021, 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.
This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.
Contacts:
Investors:
Chelcie Lister
THRUST Strategic Communications
chelcie@thrustsc.com
Media:
Dan Budwick
1AB
dan@1abmedia.com
Condensed Consolidated Balance Sheet Data (unaudited) |
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(in thousands) |
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September 30, |
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December 31, |
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Cash, cash equivalents, and marketable securities |
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$ |
1,094,554 |
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$ |
965,647 |
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Total assets |
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1,350,250 |
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1,474,453 |
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Total liabilities |
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635,773 |
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647,715 |
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Total stockholders’ equity |
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714,477 |
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826,738 |
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Condensed Consolidated Statement of Operations (unaudited) |
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(in thousands, except share and per share data) |
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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$ |
15,799 |
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$ |
763 |
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$ |
40,883 |
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$ |
775 |
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Operating expenses: |
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Research and development |
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85,287 |
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54,623 |
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225,253 |
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290,306 |
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General and administrative |
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21,815 |
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15,774 |
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65,124 |
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39,450 |
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Total operating expenses |
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107,102 |
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70,397 |
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290,377 |
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329,756 |
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Loss from operations |
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(91,303 |
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(69,634 |
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(249,494 |
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(328,981 |
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Other income (expense): |
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Change in fair value of derivative liabilities |
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(4,900 |
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35,800 |
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20,900 |
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(8,400 |
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Change in fair value of non-controlling equity investments |
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10,431 |
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(4,892 |
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(1,378 |
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21,960 |
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Change in fair value of contingent consideration liabilities |
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(875 |
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10,599 |
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(543 |
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9,553 |
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Interest and other income (expense), net |
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4,982 |
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9 |
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7,686 |
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(63 |
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Total other income (expense) |
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9,638 |
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41,516 |
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26,665 |
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23,050 |
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Net loss before income taxes |
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(81,665 |
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(28,118 |
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(222,829 |
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(305,931 |
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Provision for income taxes |
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(2,410 |
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— |
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(2,410 |
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— |
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Loss from equity method investment |
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(25,500 |
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— |
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(25,500 |
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— |
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Net loss |
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$ |
(109,575 |
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$ |
(28,118 |
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$ |
(250,739 |
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$ |
(305,931 |
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Unrealized gain (loss) on marketable securities |
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(484 |
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(12 |
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(4,624 |
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28 |
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Comprehensive loss |
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$ |
(110,059 |
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$ |
(28,130 |
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$ |
(255,363 |
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$ |
(305,903 |
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Net loss per common share, basic and diluted |
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$ |
(1.56 |
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$ |
(0.42 |
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$ |
(3.59 |
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$ |
(4.86 |
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Weighted-average common shares outstanding, basic and diluted |
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70,343,196 |
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66,377,611 |
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69,758,434 |
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62,960,219 |
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