- 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
“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
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
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
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
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
Contact:
Director, Investor Relations & Corporate Development
vsandwick@biomeafusion.com
(650) 460-7759
- See attached for financial tables -
Condensed Statement of Operations
(Unaudited)
(in thousands, except share and per share amounts)
Three Months Ended | Nine Months Ended | |||||||||||||||
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 | |||||||||||||||
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 | $ | — |
Condensed Balance Sheet Data
(Unaudited)
(in thousands)
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 |
Source:
2021 GlobeNewswire, Inc., source