BMEA Biomea Fusion Inc.

11.98
+0.08  (+1%)
Previous Close 11.9
Open 11.91
52 Week Low 9.72
52 Week High 22.22
Market Cap $347,956,512
Shares 29,044,784
Float 15,264,529
Enterprise Value $159,212,929
Volume 59,972
Av. Daily Volume 139,507
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Drug Pipeline

Drug Stage Notes
BMF-219
Acute myeloid leukemia (AML) / acute lymphocytic leukemia (ALL)
Phase 1
Phase 1
Phase 1 IND cleared by FDA. September 16, 2021.

Latest News

  1. REDWOOD CITY, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible small molecules to treat and improve the lives of patients with genetically defined cancers, today announced that Thomas Butler, Chief Executive Officer and Chairman of the Board, will participate in two upcoming virtual conferences.

    Jefferies London Healthcare Conference
    Fireside chat on Thursday, November 18th at 3:00am ET

    Piper Sandler 33rd Annual Virtual Healthcare Conference
    Fireside chat on Monday, November 22nd at 10:00am ET

    Biomea Fusion will participate in 1x1 investor meetings during the conferences hosted by Jefferies and…

    REDWOOD CITY, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible small molecules to treat and improve the lives of patients with genetically defined cancers, today announced that Thomas Butler, Chief Executive Officer and Chairman of the Board, will participate in two upcoming virtual conferences.

    Jefferies London Healthcare Conference

    Fireside chat on Thursday, November 18th at 3:00am ET

    Piper Sandler 33rd Annual Virtual Healthcare Conference

    Fireside chat on Monday, November 22nd at 10:00am ET

    Biomea Fusion will participate in 1x1 investor meetings during the conferences hosted by Jefferies and Piper Sandler, respectively. Video webcasts will be available for viewing on the News & Events section of biomeafusion.com. Archived webcasts will be available for viewing for 30 and 90 days, respectively, following the webcasts.

    About BMF-219

    BMF-219 is an irreversibly binding inhibitor of menin, a protein that is known to play an essential role in oncogenic signaling in genetically defined leukemias. Preclinically, BMF-219 has demonstrated robust downregulation of key leukemogenic genes in addition to menin itself (via MEN1) in well-established menin dependent cell lines. Additionally, BMF-219 has shown efficacy in multiple in vivo and in vitro models of acute leukemias and lymphomas. BMF-219 will be evaluated in a first-in-human trial in patients with relapsed or refractory acute leukemia with MLL/KMT2A gene rearrangement or NPM1 mutation.

    About Biomea Fusion

    Biomea Fusion is a biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers. An irreversible small molecule is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional reversible drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response. The company is utilizing its proprietary FUSION™ discovery platform to advance a pipeline of irreversible treatments against key oncogenic drivers of cancer. Biomea Fusion's goal is to utilize its capabilities and platform to become a leader in developing irreversible small molecules in order to maximize the clinical benefit when treating various cancers.

    Contact:

    Van Sandwick

    Director, Investor Relations & Corporate Development



    (650) 460-7759 



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    • BMF-219 displays global disruption of menin, highlighting ‘219's novel mechanism of action
    • Molecule elicits broad impact on the complexes surrounding menin, resulting in strong modulation of MYC expression, highlighting potential in multiple cancer types
    • BMF-219 demonstrated potent preclinical efficacy in diffuse large B cell lymphoma (DLBCL) cell lines as a single agent

    REDWOOD CITY, Calif., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible small molecules to treat and improve the lives of patients with genetically defined cancers, today announced that an abstract containing preclinical data for BMF-219…

    • BMF-219 displays global disruption of menin, highlighting ‘219's novel mechanism of action

    • Molecule elicits broad impact on the complexes surrounding menin, resulting in strong modulation of MYC expression, highlighting potential in multiple cancer types
    • BMF-219 demonstrated potent preclinical efficacy in diffuse large B cell lymphoma (DLBCL) cell lines as a single agent

    REDWOOD CITY, Calif., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible small molecules to treat and improve the lives of patients with genetically defined cancers, today announced that an abstract containing preclinical data for BMF-219 has been published in Blood, the journal of the American Society of Hematology.

    The study, as published in Blood, analyzed how Biomea's irreversible menin inhibitor, BMF-219, is impacting acute myeloid leukemia cells against the background of transcription factors in the GEO dataset. Menin is involved in many protein-protein interactions as part of a larger complex, with Menin and MLL/KMT2A being an example of one of those interactions. Here we investigated how ‘219 disrupts menin globally (selective disruption of global menin co-factors in addition to KMT2A).

    Figure 1: Menin and various co-factors 

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/210950de-0c6c-4204-9c99-a7ab3eb4a54c

    The study demonstrates further the ability of BMF-219 to modulate MYC expression in leukemia cells, offering the foundation for exploring its activity in DLBCL cells. Transcription factor (TF) activity inference was calculated by analysis of TF-binding sites established by chromatin immunoprecipitation sequencing (ChIP-seq) GEO datasets that overlap with BMF-219 mediated differentially expressed genes in MOLM-13 cells using a published statistical framework and algorithm. This analysis revealed MYC, and its co-factor MAX, as top TFs regulating this subset of differentially expressed genes by BMF-219, as TF activity inference was highly enriched for both proteins. Established menin co-factors (KMT2A, JUND) also emerged as top candidates in this dataset. These results strongly point toward altered MYC-activity mediated by BMF-219 in leukemia cells, prompting additional exploration in MYC-dependent lymphoid malignancies.

    Figure 2: Transcription factor (TF) activity inference using ChIP-seq of differentially expressed genes in MOLM-13 cells incubated with 500 nM BMF-219 at 24 hours. Each bar represents a study in the GEO repository using the specified TF antibody. TFs with more than one bar represent multiple study sets in GEO that overlap with BMF-219 mediated differentially expressed genes. MYC and MAX are top TFs regulating this subset of differentially expressed genes (p=10-49.5). Established menin co-factors (KMT2A, JUND) also emerged as top candidates in this dataset. 

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/982b0dd0-91ce-482b-bd8a-fa06e9c01dd9

    Using these results as the basis for further investigation, we explored BMF-219 and menin reversible inhibitors' impact on cell viability in two different DLBCL double hit lymphoma (DHL) cell lines (DB and Toledo). Single-agent BMF-219 reduced >90% of cell viability in DB and Toledo cells, at 1.0μM and 0.36 μM, respectively. The IC50 values of BMF-219 were calculated near 0.3 mM for both DB and Toledo cells; however, the two reversible menin inhibitors tested were significantly less effective. One of the reversible inhibitors exhibited IC50 values at multi-fold higher drug concentrations than BMF-219 in both cell lines tested and the other reversible compound tested did not show sensitivity to either cell line.

    "With this study, we gained valuable understanding and expanded our knowledge into the mechanism of action of our irreversible menin inhibitor, BMF-219. Besides its targeted selectivity profile, we also recognize the broad impact BMF-219 has on the complexes surrounding menin," said Alex Cacovean, M.D., Biomea Fusion's Executive Medical Director. "At low dosage levels, by targeting menin, we were able to inhibit MYC gene expression and demonstrated potent cell killing in two very aggressive cell lines, representative of underserved DLBCL subpopulations. We are very excited about these preclinical findings and we are hopeful to now clinically validate the effects of our irreversible menin inhibitor in MYC-positive, double expressor, and double hit DLBCL patients."

    Abstract Details

    Title: Novel Irreversible Menin Inhibitor, BMF-219, Shows Potent Single Agent Activity in Clinically Relevant DLBCL Cells

    Abstract Number: 148045

    About Diffuse Large B Cell Lymphoma (DLBCL)

    Diffuse large B cell lymphoma (DLBCL) is the most common subtype of Non-Hodgkin Lymphoma. DLBCL starts in white blood cells called lymphocytes and grows in lymph nodes. Every year, there are ~18,000 people in the United States that are diagnosed with DLBCL. Following initial treatment with standard chemotherapy, ~70% of people have a complete response and ~50% of patients are cured. For patients with relapsed or refractory DLBCL, median overall survival is between 6-7 months. Double Hit Lymphomas (DHL) and Double Expressor Lymphomas (DEL) are high grade B cell lymphomas (HGBLs) that have high MYC and BCL2 dependency.

    About BMF-219

    BMF-219 is an irreversibly binding inhibitor of menin, a protein that is known to play an essential role in oncogenic signaling in genetically defined leukemias. Preclinically, BMF-219 has demonstrated robust downregulation of key leukemogenic genes in addition to menin itself (via MEN1) in well-established MLLr AML cell lines. Additionally, BMF-219 has shown efficacy in multiple in vivo and in vitro models of acute leukemias. BMF-219 will be evaluated in a first-in-human trial in patients with relapsed or refractory acute leukemia with MLL/KMT2A gene rearrangement or NPM1 mutation.

    About Biomea Fusion

    Biomea Fusion is a biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers. An irreversible small molecule is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional reversible drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response. The company is utilizing its proprietary FUSION™ discovery platform to advance a pipeline of irreversible treatments against key oncogenic drivers of cancer. Biomea Fusion's goal is to utilize its capabilities and platform to become a leader in developing irreversible small molecules in order to maximize the depth and durability of clinical benefit when treating various cancers.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the potential safety, efficacy, and continued development of BMF-219, the timing for initiating clinical development, the timing of pre-clinical and clinical data announcement, the timing of nominating additional product candidates, the building out of our proprietary irreversible platform and progress made in early-stage small pipeline molecules through their preclinical development, including the timing for nominating development candidates in each program. These statements often include words such as "believe," "expect," "anticipate," "intend," "plan," "estimate," "seek," "will," "may," or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company's control. Any forward-looking statements in this statement are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of the Company's product candidate development activities and planned IND-enabling and clinical trials, the Company's ability to execute on its strategy, regulatory developments in the United States, the Company's ability to fund operations, and the impact that the current COVID-19 pandemic will have on the Company's clinical trials and pre-clinical studies, supply chain, and operations, as well as those risks and uncertainties set forth in the Company's filings with the United States Securities and Exchange Commission. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Contact:



    Van Sandwick

    Director, Investor Relations & Corporate Development



    (650) 460-7759



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    • Announced FDA clearance of Investigational New Drug Application (IND) for BMF-219, the company's first development candidate from the FUSION platform
    • Phase I trial to enroll adult patients with relapsed or refractory acute leukemia, including those with an MLL/KMT2A gene rearrangement or NPM1 mutation
    • Scientific rationale for irreversible menin inhibition in diffuse large B cell lymphoma (DLBCL) now expected in Q4 2021
    • Pathway validation in diabetes anticipated in Q1 2022
    • Opened Biomea Innovation Research Center, to enable the Research & Development (R&D) team to rapidly discover and develop novel irreversible covalent small molecules by leveraging the FUSION platform to build a broad portfolio of therapeutics

    REDWOOD CITY, Calif., Nov. 03, 2021…

    • Announced FDA clearance of Investigational New Drug Application (IND) for BMF-219, the company's first development candidate from the FUSION platform
    • Phase I trial to enroll adult patients with relapsed or refractory acute leukemia, including those with an MLL/KMT2A gene rearrangement or NPM1 mutation
    • Scientific rationale for irreversible menin inhibition in diffuse large B cell lymphoma (DLBCL) now expected in Q4 2021
    • Pathway validation in diabetes anticipated in Q1 2022
    • Opened Biomea Innovation Research Center, to enable the Research & Development (R&D) team to rapidly discover and develop novel irreversible covalent small molecules by leveraging the FUSION platform to build a broad portfolio of therapeutics

    REDWOOD CITY, Calif., Nov. 03, 2021 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel small molecules to treat and improve the lives of patients with genetically defined cancers, reported financial results for the third quarter of 2021.

    "The Third Quarter was a historic one for the company as it advanced its first investigational drug into a clinical stage program. BMF-219, our internally discovered and developed small molecule, has shown broad anti-cancer activity pre-clinically and we now have the opportunity to explore this potential in patients in need." said Thomas Butler, Biomea's CEO and Chairman of the Board. "In September, we received FDA clearance of our IND for BMF-219, and we are now working diligently to initiate a Phase I study for the treatment of relapsed or refractory acute leukemia. We look forward to providing clinical development updates as we deepen our understanding of menin's role in various cancers and the potential impact of irreversible inhibition for these patient populations. Our vision for this company has always been to develop a suite of novel covalent inhibitors that can act as single agent therapies or in combination, together, to build best-in-class medicine for patients. We have executed on this promise by hiring world-class drug hunters, and developers, and by custom designing and opening a state-of-the-art Research Center. We now have our first molecule ready for the clinic, and a number of exciting programs advancing through pre-clinical development."

    Mr. Butler continued, "As we move BMF-219 into the clinic, we intend to also focus on leveraging our novel chemistry across multiple indications. To that end, we anticipate announcing our next pipeline candidate in the first half of 2022."

    Business Highlights

    • FDA clearance of IND for First-in-Human Phase I Clinical Trial of BMF-219. In September 2021, Biomea received FDA clearance of its IND for BMF-219, an irreversible menin inhibitor for the treatment of relapsed or refractory acute leukemias including those with an MLL/KMT2A gene rearrangement or NPM1 mutation.
    • Preclinical studies underway for DLBCL and multiple myeloma (MM) as potential indications for BMF-219. Biomea is conducting preclinical studies to demonstrate the potential for BMF-219 in genetically defined patient subsets of DLBCL and MM.
    • Pathway validation studies of irreversible menin inhibition in diabetes. Biomea is continuing preclinical studies to explore the potential of its irreversible menin inhibitor approach for the treatment of type 2 diabetes. The company plans to report findings from these studies in the fourth quarter of 2021.
    • Launch of Biomea Innovation Center; scale-up of R&D organization. Biomea recently opened the Biomea Innovation Center with laboratory space and a dedicated R&D team focused on leveraging the company's FUSION platform to generate a broad portfolio of next generation covalent inhibitors.

    "Our CEO's vision for the company is to build a fully sustainable, world-class R&D organization, which mines the deep potential of our FUSION platform and irreversible binding small molecule approach. With our recently opened Biomea Innovation Research Center and our continued scale-up of an extremely talented, forward-and creative-thinking scientific team, we will aggressively interrogate our irreversible binding approach against known and validated biological targets with the goal of rapidly advancing a broad portfolio of therapies designed to deliver enhanced efficacy and safety for patients. Thanks to our successful IPO and considering our current programs' quarterly expenses, we expect our cash balance to sustain our operations well into 2024," concluded Ramses Erdtmann, Biomea's COO and President.

    Financial Highlights

    Third Quarter 2021 Year to Date Financial Results

    • Biomea reported a net loss attributable to common stockholders of $26.9 million for the first nine months of 2021, compared to a net loss of $1.8 million for the same period in 2020.
    • Research and development expenses were $16.9 million for the first nine months of 2021, compared to $1.3 million for the same period in 2020. The increase of $15.6 million was primarily due to an increase in personnel-related expenses, as well as an increase in pre-clinical development costs, including manufacturing and external consulting, related to the IND-enabling studies for BMF-219.
    • General and administrative expenses were $10.0 million for the first nine months of 2021, compared to $0.5 million for the same period in 2020. The increase of $9.5 million was primarily due to higher personnel-related expenses and other corporate costs to support the Company's public company status.
    • As of September 30, 2021, the Company had cash, cash equivalents, restricted cash, and investments of $191.9 million.

    About Acute Myeloid Leukemia (AML)

    AML is the most common form of acute leukemia in adults and represents the largest number of annual leukemia deaths in the U.S. and Europe. AML originates within the white blood cells in the bone marrow and can rapidly move to the blood and other parts of the body, including the lymph nodes, spleen, and central nervous system. Approximately 30,000 people in the U.S. and Europe are diagnosed with AML each year, and the five-year overall survival rate in adults roughly 29%. Among patients with relapsed/refractory disease, the need is greatest, as the overall survival is approximately 3 to 9 months. It is estimated that upwards of 45% of AML patients have menin dependent genetic drivers (MML-r or NPM1).

    About BMF-219

    BMF-219 is an irreversibly binding inhibitor of menin, a protein that is known to play an essential role in oncogenic signaling in genetically defined leukemias. Preclinically, BMF-219 has demonstrated robust downregulation of key leukemogenic genes in addition to menin itself (via MEN1) in well-established MLLr AML cell lines. Additionally, BMF-219 has shown efficacy in multiple in vivo and in vitro models of acute leukemias. BMF-219 will be evaluated in a first-in-human trial in patients with relapsed or refractory acute leukemia with MLL/KMT2A gene rearrangement or NPM1 mutation.

    About Biomea Fusion

    Biomea Fusion is a biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers. An irreversible small molecule is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional reversible drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response. The company is utilizing its proprietary FUSION™ System discovery platform to advance a pipeline of irreversible treatments against key oncogenic drivers of cancer. Biomea Fusion's goal is to utilize its capabilities and platform to become a leader in developing irreversible small molecules in order to maximize the depth and durability of clinical benefit when treating various cancers.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the potential safety, efficacy, and continued development of BMF-219, the timing for initiating clinical development, the timing of pre-clinical and clinical data announcement, the timing of nominating additional product candidates, the building out our proprietary irreversible platform and progress made in early-stage small pipeline molecules through their preclinical development, including the timing for nominating development candidates in each program, and the sufficiency of our cash resources to fund our operations. These statements often include words such as "believe," "expect," "anticipate," "intend," "plan," "estimate," "seek," "will," "may," or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company's control. Any forward-looking statements in this statement are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of the Company's product candidate development activities and planned IND-enabling and clinical trials, the Company's ability to execute on its strategy, regulatory developments in the United States, the Company's ability to fund operations, and the impact that the current COVID-19 pandemic will have on the Company's clinical trials and pre-clinical studies, supply chain, and operations, as well as those risks and uncertainties set forth in the Company's filings with the United States Securities and Exchange Commission. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



    Contact:

    Van Sandwick

    Director, Investor Relations & Corporate Development



    (650) 460-7759

    - See attached for financial tables -



    BIOMEA FUSION, INC.

    Condensed Statement of Operations

    (Unaudited)

    (in thousands, except share and per share amounts)

      Three Months Ended  Nine Months Ended 
      September 30,  September 30, 
      2021  2020  2021  2020 
    Operating expenses:                
    Research and development $7,886  $789  $16,908  $1,339 
    General and administrative  4,752   346   10,022   489 
    Total operating expenses  12,638   1,135   26,930   1,828 
    Loss from operations  (12,638)  (1,135)  (26,930)  (1,828)
    Interest and other income, net  32      73   2 
    Net loss $(12,606) $(1,135) $(26,857) $(1,826)
    Other comprehensive loss:                
    Unrealized gain on investments, net        2    
    Comprehensive loss $(12,606) $(1,135) $(26,855) $(1,826)
    Net loss per common share, basic and diluted  (0.43)  (0.10)  (1.21)  (0.18)
    Weighted-average number of common shares used to compute basic and diluted net loss per common share  29,001,213   11,724,100   22,105,321   10,082,667 



    Includes stock-based compensation as follows:                
                     
      Three Months Ended  Nine Months Ended 
      September 30,  September 30, 
      2021  2020  2021  2020 
    Research and development $766  $  $1,690  $ 
    General and administrative  1,155      2,613    
    Total stock-based compensation expense $1,921  $  $4,303  $ 





    BIOMEA FUSION, INC.

    Condensed Balance Sheet Data

    (Unaudited)

    (in thousands)

      September 30,  December 31, 
      2021  2020 
             
    Cash, cash equivalents, investments, and restricted cash $191,859  $61,695 
    Working capital  185,462   60,604 
    Total assets  199,403   62,526 
    Stockholders' equity  191,331   5,169 

     



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    • Biomea Fusion to transform to a Clinical Stage Company with First in Human (FIH) Clinical Trial
    • BMF-219 advances as the first clinical stage therapeutic from the company's deep pipeline of covalent irreversible small molecules
    • BMF-219 is a novel, first-in-class, irreversible menin inhibitor designed to control menin's negative impact across several indications
    • FIH Study will initially enroll patients with relapsed/refractory acute leukemia, with additional indications planned
    • Despite novel agents in the clinic and commercial settings, acute leukemia remains a significant unmet need due to the aggressive, heterogenous nature of the disease

    REDWOOD CITY, Calif., Sept. 16, 2021 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a…

    • Biomea Fusion to transform to a Clinical Stage Company with First in Human (FIH) Clinical Trial

    • BMF-219 advances as the first clinical stage therapeutic from the company's deep pipeline of covalent irreversible small molecules
    • BMF-219 is a novel, first-in-class, irreversible menin inhibitor designed to control menin's negative impact across several indications
    • FIH Study will initially enroll patients with relapsed/refractory acute leukemia, with additional indications planned
    • Despite novel agents in the clinic and commercial settings, acute leukemia remains a significant unmet need due to the aggressive, heterogenous nature of the disease

    REDWOOD CITY, Calif., Sept. 16, 2021 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug application to begin a Phase I trial of BMF-219, a selective irreversible menin inhibitor, in adult patients with relapsed or refractory acute leukemia including those with an MLL/KM2TA gene rearrangement or NPM1 mutation.

    "First of all, I would like to take this opportunity to thank the FDA, the Contract Research Organizations, our consultants, our investors, and of course TEAM FUSION for the commitment, guidance, support, and tireless effort in getting BMF-219, an investigational new drug, in the hands of patients in need. It was a true community effort, and we are so blessed here at Biomea to be in position to provide an impactful therapy against aggressive cancers," said Thomas Butler, Biomea's CEO and Chairman of the Board. "This is just the beginning for BMF-219 as we are planning to pursue multiple indications with our novel molecule. This is also just the beginning for the company, as we continue to make significant progress with our pipeline programs. We are in a strong position to continue to bring novel small molecules into the clinic and help the many patients with life threatening and life altering diseases."

    "Over the past 6 months, we have brought together a first-class team of biotech professionals to tackle our next phase of growth, which will include clinical development of BMF-219 in not only liquid but also solid tumors," said Ramses Erdtmann, Biomea's COO and President. "BMF-219 is a very special compound, with a unique effect on menin which we believe will lead to improved outcomes for patients with specific gene arrangement and mutations."

    An irreversible small molecule, such as BMF-219, is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional reversible drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response.

    The Phase 1, first-in-human, open-label, dose-escalation and dose-expansion clinical trial of BMF-219 will assess the safety, pharmacokinetic (PK) and pharmacodynamic (PD) profile of BMF-219 in adult patients with relapsed or refractory acute leukemia including those with an MLL/KM2TA gene rearrangement or NPM1 mutation.

    About Acute Myeloid Leukemia (AML)

    AML is the most common form of acute leukemia in adults and represents the largest number of annual leukemia deaths in the U.S. and Europe. AML originates within the white blood cells in the bone marrow and can rapidly move to the blood and other parts of the body, including the lymph nodes, spleen, and central nervous system. Approximately 30,000 people in the U.S. and Europe are diagnosed with AML each year, and the five-year overall survival rate in adults roughly 29%. Among patients with relapsed/refractory disease, the need is greatest, as the overall survival is approximately 3 to 9 months. It is estimated that upwards of 45% of AML patients have menin dependent genetic drivers (MML-r or NPM1).

    About BMF-219

    BMF-219 is an irreversibly binding inhibitor of menin, a protein that is known to play an essential role in oncogenic signaling in genetically defined leukemias. Preclinically, BMF-219 has demonstrated robust downregulation of key leukemogenic genes in addition to menin itself (via MEN1) in well-established MLLr AML cell lines. Additionally, BMF-219 has shown efficacy in multiple in vivo and in vitro models of acute leukemias. BMF-219 will be evaluated in a first-in-human trial in patients with relapsed or refractory acute leukemia with MLL/KM2TA gene rearrangement or NPM1 mutation.

    About Biomea Fusion

    Biomea Fusion is a biopharmaceutical company focused on the discovery, development and commercialization of irreversible small molecules to treat patients with genetically defined cancers. An irreversible small molecule is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional reversible drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response. The company is utilizing its proprietary FUSION™ System discovery platform to advance a pipeline of irreversible treatments against key oncogenic drivers of cancer. Biomea Fusion's goal is to utilize its capabilities and platform to become a leader in developing irreversible small molecules in order to maximize the depth and durability of clinical benefit when treating various cancers.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the potential safety, efficacy, and continued development of BMF-219, the timing for commencing the first in human clinical trial, the potential therapeutic indications of the Company's products candidates, including BMF-219, the building out our proprietary irreversible platform and progress made in early-stage small pipeline molecules through their preclinical development. These statements often include words such as "believe," "expect," "anticipate," "intend," "plan," "estimate," "seek," "will," "may," or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company's control. Any forward-looking statements in this statement are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of the Company's product candidate development activities and pre-clinical studies and clinical trials, the Company's ability to execute on its strategy, regulatory developments in the United States, the Company's ability to fund operations, and the impact that the current COVID-19 pandemic will have on the Company's clinical trials and pre-clinical studies, supply chain, and operations, as well as those risks and uncertainties set forth in the Company's Quarterly Report on Form Q for the quarter ended June 30, 2021, filed with the Securities and Exchange Commission on August 11, 2021, and its other filings filed with the United States Securities and Exchange Commission filed from time. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



    Contact:

    Van Sandwick

    Director, Investor Relations & Corporate Development



    (650) 460-7759 



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    • Completed investigational new drug ("IND") enabling studies for lead program, BMF-219, an irreversibly binding menin inhibitor. On track to complete IND submission for Phase I/II study of BMF-219 as treatment for patients with menin-dependent acute myeloid leukemia ("AML") and acute lymphocytic leukemia ("ALL") during the second half of this year
    • Continued to advance ongoing preclinical studies of BMF-219 in a number of menin-dependent liquid and solid tumors, including Diffuse Large B Cell Lymphoma ("DLBCL"), to expand potential impact of novel drug   
    • Initiated pathway validation studies in type 2 diabetes
    • Continued to expand team and laboratory facilities to support long-term growth and clinical and preclinical development plans
    • Strengthened…
    • Completed investigational new drug ("IND") enabling studies for lead program, BMF-219, an irreversibly binding menin inhibitor. On track to complete IND submission for Phase I/II study of BMF-219 as treatment for patients with menin-dependent acute myeloid leukemia ("AML") and acute lymphocytic leukemia ("ALL") during the second half of this year

    • Continued to advance ongoing preclinical studies of BMF-219 in a number of menin-dependent liquid and solid tumors, including Diffuse Large B Cell Lymphoma ("DLBCL"), to expand potential impact of novel drug   
    • Initiated pathway validation studies in type 2 diabetes
    • Continued to expand team and laboratory facilities to support long-term growth and clinical and preclinical development plans
    • Strengthened Board of Directors with appointment of Sumita Ray, J.D., Chief Legal and Administrative Officer at Calithera Biosciences, Inc.

    REDWOOD CITY, Calif., Aug. 11, 2021 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a preclinical-stage biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers, reported financial results for the second quarter of 2021.

    "We continue to make notable progress as we rapidly advance BMF-219 toward a planned entry into the clinic and continue to grow our company and pipeline," said Thomas Butler, Biomea's CEO and Chairman of the Board. "In the second quarter, we successfully completed IND-enabling studies for BMF-219 and are now in the final stages of completing our IND submission to the FDA to advance BMF-219 to a Phase I study for the treatment of patients with menin-dependent AML and ALL. We also continued to make important progress pursuing our broad, ambitious, preclinical strategy focused on exploring the potential of this novel irreversible small molecule across a number of menin-dependent liquid and solid tumors, including DLBCL."

    Mr. Butler continued, "While our primary focus is oncology drug development, there are multiple diseases where the menin pathway is implicated and where an irreversibly binding small molecule approach may have an important impact, including for patients with type 2 diabetes. At our core, we feel a profound responsibility to help patients with our novel chemistry. To that end, we look forward to seeing the results of our exploratory pathway validation in type 2 diabetes next year."

    Business Highlights

    • Completed IND-enabling studies with irreversibly binding menin inhibitor BMF-219. Biomea successfully conducted IND-enabling studies with BMF-219, an irreversible menin inhibitor for the treatment of patients with menin-dependent AML and ALL. Biomea anticipates submitting the IND during the second half of 2021.



    • Continued preclinical studies of BMF-219 in DLBCL. Biomea continues to explore the potential of BMF-219 for a number of menin-dependent liquid and solid tumor cancers, including a subset of DLBCL, with a number of preclinical studies currently underway. The Company plans to report its findings in DLBCL in the first quarter of 2022. Despite the high dependency of several cancers on menin, Biomea Fusion is not aware of any menin inhibitors currently in clinical development for these cancer types.



    • Initiated pathway validation studies in diabetes. Based on a growing body of internal and external scientific evidence, Biomea has initiated key preclinical studies to explore the potential of its irreversible menin inhibitors as a treatment for type 2 diabetes. The Company plans to report its findings in the first quarter of 2022. Biomea Fusion is not aware of any menin inhibitors currently in clinical development for diabetes.
    • Expanded team and in-house research capabilities to support long-term growth and clinical and preclinical development plans. Biomea strengthened its executive team with the appointments of Franco Valle as Chief Financial Officer, Alex Cacovean, M.D. as Executive Medical Director and Sasha Blaug Ph.D. as Senior VP of Corporate Development. Biomea has successfully grown its headcount this year to date by 29 for a total of 41 current team members. The Company has also completed the buildout of its own laboratory facilities to further support the research and preclinical pipeline development of its irreversible platform.
    • Strengthened the Company's Board of Directors. In the second quarter Biomea appointed Sumita Ray J.D., Chief Legal and Administrative Officer at Calithera Biosciences, Inc., to its Board. Ms. Ray is an industry veteran with over 20 years of expertise in FDA regulatory law, global health care law and compliance, brand support, product launches, collaborations and alliances.

    Financial Highlights

    Second Quarter 2021 Year to Date Financial Results

    • Biomea reported a net loss attributable to common stockholders of $14.3 million for the first six months of 2021, compared to a net loss of $0.7 million for the same period in 2020.



    • Research and development expenses were $9.0 million for the first six months of 2021, compared to $0.6 million for the same period in 2020. The increase of $8.4 million was primarily due to an increase in personnel-related expenses, as well as an increase in pre-clinical development costs, including manufacturing and external consulting, related to the IND-enabling studies for BMF-219.



    • General and administrative expenses were $5.3 million for the first six months of 2021, compared to $0.1 million for the same period in 2020. The increase of $5.2 million was primarily due to higher personnel-related expenses and other corporate costs to support the Company's expanding operations, including legal and accounting.



    • As of June 30, 2021, the Company had cash, cash equivalents, restricted cash, and investments of $203.0 million.

    About Biomea Fusion

    Biomea Fusion is a preclinical-stage biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers. An irreversible small molecule drug is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional reversible drugs, including greater target selectivity, lower drug exposure and the ability to drive a deeper, more durable response. Leveraging its extensive expertise in irreversible binding chemistry and development, the Company built its proprietary FUSION System discovery platform to advance a pipeline of novel irreversible, small molecule therapies. The lead product candidate, BMF-219, is an orally bioavailable, potent and selective irreversible inhibitor of menin, an important transcriptional regulator known to play a direct role in oncogenic signaling in multiple cancers. In preclinical studies, administration of BMF-219 has resulted in robust anti-tumor responses across a range of liquid and solid tumor models and has been well-tolerated in animal studies. Biomea Fusion is developing BMF-219 for the treatment of liquid and solid tumors that are highly dependent on menin, including leukemias containing the mixed lineage leukemia ("MLL") fusion protein. The Company is currently completing investigational new drug enabling studies and expects to file an IND application with the U.S. Food and Drug Administration in the second half of 2021. Additionally, literature has implicated menin inhibition as a potential therapeutic strategy for the treatment of various forms of diabetes, including type 2 diabetes. Biomea Fusion has initiated preclinical work to assess the potential of the menin pathway in type 2 diabetes and will report findings in the first quarter of 2022. Beyond BMF-219, the Company is utilizing its novel platform to develop irreversible treatments against other high-value oncogenic drivers of cancer and expects to nominate its second development candidate in the first half of 2022. Biomea Fusion's goal is to utilize its capabilities and platform to become a leader in developing irreversible small molecules in order to maximize the depth and durability of clinical benefit when treating various cancers.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the potential safety, efficacy, and continued development of BMF-219, the timing for completing the IND filing or starting the clinical development, the building out our proprietary irreversible platform and progress made in early-stage small pipeline molecules through their preclinical development, including the timing for nominating development candidates in each program. These statements often include words such as "believe," "expect," "anticipate," "intend," "plan," "estimate," "seek," "will," "may," or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company's control. Any forward-looking statements in this statement are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of the Company's product candidate development activities and planned IND-enabling and clinical trials, the Company's ability to execute on its strategy, regulatory developments in the United States, the Company's ability to fund operations, and the impact that the current COVID-19 pandemic will have on the Company's clinical trials and pre-clinical studies, supply chain, and operations, as well as those risks and uncertainties set forth in the Company's Quarterly Report on Form Q for the quarter ended June 30, 2021, filed with the Securities and Exchange Commission on August 11, 2021, and its other filings filed with the United States Securities and Exchange Commission filed from time. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



    Contact:



    Van Sandwick

    Director, Investor Relations & Corporate Development

     

    (650) 460-7759

    BIOMEA FUSION, INC.

    Condensed Statement of Operations

    (Unaudited)

    (in thousands, except share and per share amounts)

     Three Months Ended  Six Months Ended 
     June 30,  June 30, 
     2021  2020  2021  2020 
    Operating expenses:               
    Research and development$5,224  $216  $9,022  $550 
    General and administrative 3,211   79   5,270   143 
    Total operating expenses 8,435   295   14,292   693 
    Loss from operations (8,435)  (295)  (14,292)  (693)
    Interest and other income, net 36   2   41   2 
    Net loss$(8,399) $(293) $(14,251) $(691)
    Other comprehensive loss:               
    Changes in unrealized gain on short term investments, net 17      2    
    Comprehensive loss$(8,382) $(293) $(14,249) $(691)
    Net loss per common share, basic and diluted (0.33)  (0.03)  (0.77)  (0.07)
    Weighted-average number of common shares used to

    compute basic and diluted net loss per common share
     25,161,038   9,746,868   18,598,521   9,252,931 



    Includes stock-based compensation as follows:           
                
     Three Months Ended Six Months Ended
     June 30, June 30,
     2021 2020 2021 2020
    Research and development$611 $- $924 $-
    General and administrative 852  -  1,458  -
    Total stock-based compensation expense$1,463 $- $2,382 $-



    BIOMEA FUSION, INC.


    Condensed Balance Sheet Data

    (Unaudited)

    (in thousands)

     June 30, December 31,
     2021 2020
          
    Cash, cash equivalents, investments, and restricted cash$203,044 $61,695
    Working capital 195,579  60,604
    Total assets 209,533  62,526
    Stockholders' equity 202,016  5,169


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