Beam Therapeutics Inc 8-K, filed Nov 8, 2021
Beam Therapeutics Inc. (BEAM)
About this 8-K
Beam Therapeutics Inc filed this 8-K on November 8, 2021, reporting on events of November 5, 2021.
Items reported
- Item 2.02: Financial results
- Item 5.02: Director or officer change, or executive pay
- 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
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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):
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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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: |
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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, 2021, Beam Therapeutics Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended September 30, 2021. 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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
(d)
On November 5, 2021, the Board of Directors (the “Board”) of the Company, upon recommendation from the Nominating and Corporate Governance Committee of the Board, expanded the size of the Board from six to seven members and elected John Maraganore, Ph.D., as a member of the Board. Dr. Maraganore will serve as a Class III director with a term expiring at the Company’s 2023 annual meeting of stockholders and thereafter until his successor has been duly elected and qualified or until his earlier death, resignation or removal in accordance with the Amended and Restated Bylaws of the Company.
Dr. Maraganore will receive compensation for his service as a non-employee director in accordance with the Company’s Amended and Restated Non-Employee Director Compensation Policy dated June 10, 2021, which was described in the Company’s Quarterly Report on Form 10-Q and filed with the Securities and Exchange Commission on August 10, 2021. Dr. Maraganore will also enter into a standard indemnification agreement in the form previously approved by the Board.
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, 2021 |
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, 2021 |
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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 Provides Business and Pipeline Updates and Reports Third Quarter 2021 Financial Results
BEAM-101 IND Cleared by FDA for Evaluation as a Treatment for Sickle Cell Disease
BEAM-102 IND-Enabling Studies Also Underway
CAMBRIDGE, Mass., Nov. 8, 2021 -Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today reported recent business and pipeline updates, as well as third quarter 2021 financial results.
As part of today’s update, Beam announced that its Investigational New Drug (IND) application for BEAM-101 for the treatment of sickle cell disease was cleared by the U.S. Food and Drug Administration (FDA). BEAM-101, the company’s lead ex vivo base editing product candidate, is a patient-specific, autologous hematopoietic investigational cell therapy which incorporates base edits that mimic single nucleotide polymorphisms seen in individuals with hereditary persistence of fetal hemoglobin (HPFH) to potentially alleviate the effects of mutations causing sickle cell disease or beta thalassemia. This is the first open IND for base editing technology, a next-generation form of CRISPR capable of making single base changes without creating double strand breaks in the DNA. Beam is preparing to initiate a Phase 1/2 clinical trial designed to assess the safety and efficacy of BEAM-101 for the treatment of sickle cell disease, which Beam refers to as the BEACON-101 trial.
“We are thrilled to share that the FDA has cleared our first IND. BEAM-101 has the potential to offer a one-time treatment for patients with sickle cell disease, and this clearance enables the important transition from a preclinical to a clinical-stage company, bringing us closer to our ultimate goal of helping patients,” said John Evans, chief executive officer of Beam. “As leaders in the field of base editing, this milestone underscores the expertise of our team and the significant potential of our technology. We are grateful to the team members who have dedicated countless hours to this effort, and we look forward to this program’s continued evaluation in the clinic. As we look toward 2022, we believe we are well-positioned both financially and organizationally to execute on our vision.”
“In addition to the clearance of our IND for BEAM-101, we are pleased to announce that we have initiated IND-enabling studies for BEAM-102, our Makassar base editing approach for the treatment of sickle cell disease,” said Giuseppe Ciaramella, Ph.D., president and chief scientific officer of Beam. “We have also made continued progress on BEAM-201, our multiplexed base editing approach for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic leukemia as well as continued advancement across our robust portfolio, as showcased by a number of recent and upcoming data presentations demonstrating our leadership in base editing as well as optimized delivery technologies for our programs. Importantly, we also expect to nominate our first development candidate for in vivo base editing in the liver using LNP delivery for the treatment of patients with glycogen storage disease type Ia (R83C mutation) by the end of the year. We’ve made extraordinary progress as a company this year and remain committed to advancing novel science so that we may reach as many patients as possible.”
Upcoming Base Editing Data Presentations
Recent Base Editing Progress & Data Updates
Business Highlights
Third Quarter 2021 Financial Results
About Sickle Cell Disease and Beta-Thalassemia
Sickle cell disease, a severe inherited blood disease, is caused by a single point mutation, E6V, in the beta globin gene. This mutation causes the mutated form of sickle hemoglobin (HbS) to aggregate into long, rigid molecules that bend red blood cells into a sickle shape under conditions of low oxygen. Sickled cells obstruct blood vessels and die prematurely, ultimately resulting in anemia, severe pain (crises), infections, stroke, organ failure, and early death. Sickle cell disease is the most common inherited blood disorder in the United States, affecting an estimated 100,000 individuals, of which a significant proportion are of African-American descent. Beta-thalassemia is another inherited blood disorder characterized by severe anemia caused by reduced production of functional hemoglobin due to insufficient expression of the beta globin protein. Transfusion-dependent beta-thalassemia (TDBT) is the most severe form of this disease, often requiring multiple transfusions per year. Patients with TDBT suffer from failure to thrive, persistent infections, and life-threatening anemia.
About BEAM-101
BEAM-101 is a patient-specific, autologous hematopoietic cell therapy under investigation for the treatment of sickle cell disease. BEAM-101 incorporates ex vivo base edits that mimic single nucleotide polymorphisms seen in individuals with hereditary persistence of fetal hemoglobin (HPFH) to potentially alleviate the effects of mutations causing sickle cell disease or beta thalassemia by increasing the levels of fetal hemoglobin (HbF).
About Beam Therapeutics
Beam Therapeutics Inc. (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 enables precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This enables 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 potentially 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 commencement of clinical trials for BEAM-101, including our BEACON-101 trial; our expectation that we will nominate our first development candidate for in vivo base editing in the liver using LNP delivery for the treatment of patients with GSDIa disease (R83C mutation) by the end of the year; any future payments we may receive under our agreement with Sana; our planned base editing data presentations at upcoming scientific conferences; and the therapeutic applications and potential of our technology, including 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; 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 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, 2020, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, our Quarterly Report on Form 10-Q that we will file for the quarter ended September 30, 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.
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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$ |
933,405 |
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$ |
299,671 |
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Total assets |
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1,156,555 |
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451,677 |
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Total liabilities |
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302,741 |
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206,116 |
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Total stockholders’ equity |
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853,814 |
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245,561 |
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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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2021 |
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2020 |
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2021 |
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2020 |
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License and collaboration revenue |
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$ |
763 |
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$ |
6 |
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$ |
775 |
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$ |
18 |
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Operating expenses: |
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Research and development |
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54,623 |
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29,825 |
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290,306 |
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70,728 |
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General and administrative |
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15,774 |
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7,502 |
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39,450 |
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21,251 |
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Total operating expenses |
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70,397 |
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37,327 |
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329,756 |
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91,979 |
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Loss from operations |
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(69,634 |
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(37,321 |
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(328,981 |
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(91,961 |
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Other income (expense): |
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Change in fair value of derivative liabilities |
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35,800 |
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2,700 |
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(8,400 |
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(8,700 |
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Change in fair value of long-term investments |
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(4,892 |
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— |
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21,960 |
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517 |
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Change in fair value of contingent consideration liabilities |
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10,599 |
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— |
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9,553 |
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— |
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Interest and other income (expense), net |
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9 |
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169 |
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(63 |
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1,016 |
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Total other income (expense) |
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41,516 |
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2,869 |
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23,050 |
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(7,167 |
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Net loss |
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$ |
(28,118 |
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$ |
(34,452 |
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$ |
(305,931 |
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$ |
(99,128 |
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Accretion of redeemable convertible preferred stock to redemption value, including dividends on preferred stock |
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— |
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— |
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— |
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(1,277 |
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Net loss attributable to common stockholders |
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$ |
(28,118 |
) |
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$ |
(34,452 |
) |
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$ |
(305,931 |
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$ |
(100,405 |
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Net loss per common share attributable to common stockholders, basic and diluted |
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$ |
(0.42 |
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$ |
(0.69 |
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$ |
(4.86 |
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$ |
(2.31 |
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Weighted-average common shares used in net loss per share attributable to common stockholders, basic and diluted |
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66,377,611 |
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50,087,747 |
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62,960,219 |
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43,438,919 |
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