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 8, 2023, Beam Therapeutics Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended September 30, 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. |
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Description |
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99.1 |
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Press Release Issued by Beam Therapeutics Inc. on November 8, 2023 |
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 8, 2023 |
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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 Reports Pipeline and Business Updates and Third Quarter 2023 Financial Results
Recent Portfolio Prioritization Focuses Business on Key Near-term Value Drivers and Long-term Growth of Precision Genetic Medicines Pipeline
Lilly Acquires Beam’s Opt-In Rights to Verve Therapeutics’ Base Editing Cardiovascular Programs for up to $600 Million in Combined Upfront Payment, Equity Investment and Potential Future Development-Stage Payments
GMP Operations Initiated at Beam's North Carolina Manufacturing Facility
Strong Balance Sheet Provides Anticipated Operating Runway into the Second Half of 2026
CAMBRIDGE, Mass., November 8, 2023 – Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today reported third quarter 2023 financial results and provided an update on the business and its clinical and pipeline progress.
“This year, Beam has established an exceptional foundation for future growth, with significant financial strength, a broad portfolio of differentiated base editing programs in large addressable markets driving toward clinical milestones, and a fully operational suite of research, development, and manufacturing capabilities for precision genetic medicines,” said John Evans, chief executive officer of Beam. “We have made critical decisions on where to focus and how to prioritize our investments over the coming years, creating significant momentum in our business and portfolio. In the BEACON trial, patient enrollment, mobilization, and manufacturing are progressing well, and we remain on track to treat the first trial patient with BEAM-101 this year and report clinical trial data on multiple patients next year. We’re also advancing our first in vivo program, BEAM-302, for patients with alpha-1 anti-trypsin deficiency with a regulatory filing expected in the first quarter of next year, followed by our planned IND submission for BEAM-301 shortly thereafter. External interest in our base editing technology continues to grow, illustrated most recently by our transaction with Lilly. With a strong balance sheet, a focused team, and leading capabilities, we are well positioned to advance our base editing programs and platform, which we believe have transformative potential for patients.”
Pipeline Updates and Key 2023-2024 Anticipated Milestones
Beam recently announced portfolio priorities and plans to streamline its business operations to support potential near-term value drivers and long-term growth and, as such, is now focusing its efforts as follows:
Hematology Portfolio
Genetic Disease (in vivo) Portfolio
Immunology/Oncology Portfolio
Research Portfolio
Corporate Updates
Third Quarter 2023 Financial Results
Cash Runway
Beam expects that its cash, cash equivalents and marketable securities as of September 30, 2023, together with upfront and equity investment proceeds received from Lilly, will enable the company to fund its anticipated operating expenses and capital expenditure requirements into the second half of 2026. This expectation assumes anticipated cost savings related to the company’s portfolio prioritization and streamlining of operations and includes funding directed toward reaching each of the key anticipated milestones for BEAM-101, BEAM-201, 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 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 preclinical development plans; the therapeutic applications and potential of our technology, including with respect to SCD, beta-thalassemia, GSDIa, T-ALL/T-LL, and AATD; our plans, and anticipated timing, to advance our clinical trials and programs, including our 2023-2024 anticipated milestones; our estimated cash, cash equivalents and marketable securities as of September 30, 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; any future payments we may receive under our agreement with Lilly; the potential impact of the portfolio prioritization and strategic restructuring on our operations and development timelines; our ability to seek, establish and maintain a collaboration or partnership to develop our programs with a collaborator or partner; 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 the portfolio prioritization and strategic restructuring, including our ability to seek, establish and maintain partners for certain of our programs; 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 pandemics and other health emergencies, including their 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 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, 2022, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, our Quarterly Report on Form 10-Q that we will file for the quarter ended September 30, 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.
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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$ |
1,015,457 |
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$ |
1,078,134 |
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Total assets |
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1,290,534 |
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1,341,714 |
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Total liabilities |
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511,593 |
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608,240 |
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Total stockholders’ equity |
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778,941 |
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733,474 |
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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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2023 |
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2022 |
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2023 |
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2022 |
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License and collaboration revenue |
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$ |
17,193 |
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$ |
15,799 |
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$ |
61,517 |
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$ |
40,883 |
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Operating expenses: |
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0 |
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Research and development |
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100,050 |
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85,287 |
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297,304 |
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225,253 |
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General and administrative |
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25,410 |
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21,815 |
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73,556 |
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65,124 |
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Total operating expenses |
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125,460 |
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107,102 |
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370,860 |
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290,377 |
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Loss from operations |
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(108,267 |
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(91,303 |
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(309,343 |
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(249,494 |
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Other income (expense): |
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0 |
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Change in fair value of derivative liabilities |
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4,700 |
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(4,900 |
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9,400 |
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20,900 |
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Change in fair value of non-controlling equity investments |
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(11,221 |
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10,431 |
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(17,870 |
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(1,378 |
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Change in fair value of contingent consideration liabilities |
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6,002 |
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(875 |
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7,877 |
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(543 |
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Interest and other income (expense), net |
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12,698 |
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4,982 |
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34,612 |
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7,686 |
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Total other income (expense) |
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12,179 |
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9,638 |
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34,019 |
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26,665 |
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Net loss before income taxes |
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(96,088 |
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(81,665 |
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(275,324 |
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(222,829 |
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Provision for income taxes |
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— |
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(2,410 |
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— |
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(2,410 |
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Loss from equity method investment |
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— |
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(25,500 |
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— |
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(25,500 |
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Net loss |
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$ |
(96,088 |
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$ |
(109,575 |
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$ |
(275,324 |
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$ |
(250,739 |
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Unrealized gain (loss) on marketable securities |
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(9 |
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(484 |
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406 |
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(4,624 |
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Comprehensive loss |
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$ |
(96,097 |
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$ |
(110,059 |
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$ |
(274,918 |
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$ |
(255,363 |
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Net loss per common share, basic and diluted |
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$ |
(1.22 |
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$ |
(1.56 |
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$ |
(3.63 |
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$ |
(3.59 |
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Weighted-average common shares outstanding, basic and diluted |
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79,024,647 |
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70,343,196 |
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75,902,612 |
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69,758,434 |
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