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 May 10, 2023, Beam Therapeutics Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended March 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. |
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Description |
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99.1 |
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Press Release Issued by Beam Therapeutics Inc. on May 10, 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: May 10, 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 First Quarter 2023 Financial Results
Focused on Executing Three Strategic Pillars – Hematology, Immunology/Oncology and Genetic Diseases – Potential for Long-Term Pipeline Growth and Sustained Impact on Patient Lives
Multiple Sites Activated and Additional Patients Enrolled in BEACON Clinical Trial of BEAM-101 for Patients with Sickle Cell Disease
Twenty-Year Industry Veteran, Gopi Shanker, Ph.D., Appointed as Chief Scientific Officer
Well-Capitalized with $1.1 Billion in Cash, Cash Equivalents and Marketable Securities at the End of the First Quarter of 2023
CAMBRIDGE, Mass., May 10, 2023 – Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today reported first quarter 2023 financial results and provided an update on its BEACON clinical trial and pipeline progress.
“As we work through the sentinel cohort process with our investigators, we are encouraged by the overall momentum of the BEACON trial, with multiple new sites activated, a growing number of patients on the wait list for future enrollment, and continuing progress preparing for internal GMP manufacturing in our North Carolina facility,” said John Evans, chief executive officer of Beam. “In parallel to BEACON, we are preparing to initiate our second clinical trial this year, evaluating BEAM-201 in patients with a devastating form of blood cancer, while advancing our in vivo programs, BEAM-301 and BEAM-302, all of which remain on track. As leaders in the field of base editing, we have spent the last several years building a deep platform and pipeline and securing meaningful funding to support this ambitious set of goals. We plan to continue to follow the science, maintain a disciplined investment strategy, and preserve optionality in our portfolio, so that we can maximize our potential to create medicines that provide life-long cures for patients in need.”
Hematology Program Updates
Immunology/Oncology Program Updates
Genetic Disease (in vivo) Program Updates
Manufacturing Updates
Leadership Addition
Upcoming Presentations at ASGCT
Beam plans to present new in vivo data from its Engineered Stem Cell Antibody Paired Evasion (ESCAPE) platform, which it continues to advance in an effort to enable utility of its base editing investigational medicines in as many patients as possible, and from its base editing program for the treatment of Stargardt disease at the American Society of Cell and Gene Therapy 26th Annual meeting. The meeting is being held May 16-20, 2023, in Los Angeles.
Details of the presentations are as follows:
Title: Paired HSC Epitope Engineering of CD117 (Ckit) for Antibody-Mediated Autologous Hematopoietic Stem Cell Therapy Conditioning for the Potential Treatment of Hemoglobinopathies
Date & Time: Friday, May 19, 2023 12:00 pm – 2:00 pm PT
Session Title: Friday Poster Session
Title: (308) In Vivo Genetic Eye Disease Correction Using Split AAV-Mediated Adenine Base Editing
Date & Time: Friday May 19, 2023, 4:30 pm - 4:45 pm PT
Session Title: Gene Targeting and Gene Correction: Hemoglobin, Muscle, and Eye
First Quarter 2023 Financial Results
Cash Runway
Beam expects that its cash, cash equivalents and marketable securities as of March 31, 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 March 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; our anticipated timing for initiating current good manufacturing practice compliant operations at our North Carolina manufacturing facility; our upcoming presentations; 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, 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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March 31, |
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December 31, |
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Cash, cash equivalents, and marketable securities |
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$ |
1,059,471 |
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$ |
1,078,134 |
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Total assets |
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1,332,352 |
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1,341,714 |
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Total liabilities |
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570,846 |
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608,240 |
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Total stockholders’ equity |
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761,506 |
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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 March 31, |
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2023 |
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2022 |
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License and collaboration revenue |
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$ |
24,208 |
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$ |
8,432 |
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Operating expenses: |
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Research and development |
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99,646 |
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65,410 |
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General and administrative |
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23,490 |
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19,247 |
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Total operating expenses |
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123,136 |
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84,657 |
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Loss from operations |
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(98,928 |
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(76,225 |
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Other income (expense): |
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Change in fair value of derivative liabilities |
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5,600 |
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13,600 |
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Change in fair value of non-controlling equity investments |
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(12,797 |
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(7,685 |
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Change in fair value of contingent consideration liabilities |
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(296 |
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452 |
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Interest and other income (expense), net |
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9,961 |
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644 |
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Total other income (expense) |
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2,468 |
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7,011 |
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Net loss |
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$ |
(96,460 |
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$ |
(69,214 |
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Unrealized gain (loss) on marketable securities |
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1,665 |
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(2,659 |
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Comprehensive loss |
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$ |
(94,795 |
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$ |
(71,873 |
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Net loss per common share, basic and diluted |
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$ |
(1.33 |
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$ |
(1.01 |
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Weighted-average common shares outstanding, basic and diluted |
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72,273,829 |
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68,703,864 |
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