BEAM 8-K
Beam Therapeutics Inc. (BEAM)
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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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 August 8, 2023, Beam Therapeutics Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended June 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 August 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: August 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 Updates and Second Quarter 2023 Financial Results
BEACON Trial of BEAM-101 in Sickle Cell Disease Progressing with Consented Patients Projected to Fill Sentinel Cohort and to Initiate Expansion Cohort
First Patient Consented in Phase 1/2 Trial of BEAM-201 in T-ALL/T-LL and Expected to be Dosed in The Third Quarter of 2023
Company to Accelerate Development of BEAM-302 for Treatment of AATD; Program Now Expected to be First In Vivo Liver Regulatory Filing in First Quarter of 2024
Well-Capitalized with $1.1B in Cash, Cash Equivalents and Marketable Securities at the End of the Second Quarter of 2023
CAMBRIDGE, Mass., August 8, 2023 – Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today reported second quarter 2023 financial results and provided an update on its clinical and pipeline progress.
“The first half of 2023 has been marked by focused execution across the business, with the singular goal of making an impact on the lives of people suffering from serious diseases,” said John Evans, chief executive officer of Beam. “We are very pleased with the continued enrollment progress in the BEACON trial, having now consented enough patients projected to both fill the sentinel cohort and initiate the expansion cohort. In addition, the BEAM-201 trial is now open for enrollment at multiple clinical sites, with the first patient having been consented and dosing expected this quarter. We have also continued to accelerate development of BEAM-302, a potential best-in-class product candidate for patients with alpha-1 anti-trypsin deficiency, and are now prioritizing a BEAM-302 regulatory filing in the first quarter of 2024 as our first in vivo program, with a regulatory filing for BEAM-301 expected to follow shortly thereafter. Our critical manufacturing capability in North Carolina is anticipated to be cGMP ready for both cell manufacturing and LNP manufacturing this year. Finally, Beam is well capitalized to pursue the next wave of growth in its innovative research platform, from non-genotoxic conditioning with ESCAPE in hematology, to next-generation allogeneic cell therapies in cancer and immunology, to a growing number of wholly owned and partnered base editing programs targeting the liver. We believe we are well positioned to establish an industry-leading platform in precision genetic medicine.”
Second Quarter 2023 Business Updates and Key 2023-2024 Anticipated Milestones
Hematology Portfolio
Immunology/Oncology Portfolio
Genetic Disease (in vivo) Portfolio
Manufacturing Updates
Recent Nature Genetics Preclinical Publication Suggests Base Editing Enables More Uniform HbF Upregulation than Nuclease Editing
Second Quarter 2023 Financial Results
Cash Runway
Beam expects that its cash, cash equivalents and marketable securities as of June 30, 2023, will enable the company to fund its anticipated operating expenses and capital expenditure requirements at least into 2025. This expectation 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: the therapeutic applications and potential of our technology, including with respect to SCD, GSDIa, T-ALL/TLL, 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 June 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; our anticipated timing for initiating current good manufacturing practice compliant operations at our North Carolina manufacturing facility; 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 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 that we will file for the quarter ended June 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
Media:
Dan Budwick
1AB
Condensed Consolidated Balance Sheet Data (unaudited) |
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(in thousands) |
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June 30, |
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December 31, |
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Cash, cash equivalents, and marketable securities |
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$ |
1,073,016 |
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$ |
1,078,134 |
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Total assets |
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1,353,887 |
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1,341,714 |
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Total liabilities |
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542,244 |
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608,240 |
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Total stockholders’ equity |
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811,643 |
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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 June 30, |
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Six Months Ended June 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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$ |
20,116 |
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$ |
16,652 |
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$ |
44,324 |
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$ |
25,084 |
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Operating expenses: |
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Research and development |
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97,608 |
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74,556 |
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197,254 |
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139,966 |
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General and administrative |
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24,656 |
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24,062 |
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48,146 |
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43,309 |
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Total operating expenses |
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122,264 |
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98,618 |
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245,400 |
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183,275 |
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Loss from operations |
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(102,148 |
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(81,966 |
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(201,076 |
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(158,191 |
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Other income (expense): |
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Change in fair value of derivative liabilities |
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(900 |
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12,200 |
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4,700 |
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25,800 |
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Change in fair value of non-controlling equity investments |
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6,148 |
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(4,124 |
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(6,649 |
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(11,809 |
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Change in fair value of contingent consideration liabilities |
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2,171 |
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(120 |
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1,875 |
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332 |
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Interest and other income (expense), net |
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11,953 |
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2,060 |
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21,914 |
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2,704 |
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Total other income (expense) |
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19,372 |
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10,016 |
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21,840 |
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17,027 |
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Net loss |
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$ |
(82,776 |
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$ |
(71,950 |
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$ |
(179,236 |
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$ |
(141,164 |
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Unrealized gain (loss) on marketable securities |
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(1,250 |
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(1,481 |
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415 |
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(4,140 |
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Comprehensive loss |
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$ |
(84,026 |
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$ |
(73,431 |
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$ |
(178,821 |
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$ |
(145,304 |
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Net loss per common share, basic and diluted |
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$ |
(1.08 |
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$ |
(1.02 |
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$ |
(2.41 |
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$ |
(2.03 |
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Weighted-average common shares outstanding, basic and diluted |
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76,335,175 |
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70,210,227 |
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74,315,721 |
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69,461,207 |
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