On August 11, 2021 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the second quarter and year-to-date for the period ended June 30, 2021 (Press release, Navidea Biopharmaceuticals, AUG 11, 2021, View Source [SID1234586336]).

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"The Company is prepared and looking forward to our meeting with the U.S. Food and Drug Administration ("FDA") on September 1," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "We remain laser focused on a positive meeting and a successful launch to the NAV3-33 trial. Navidea is also extremely excited to now have a full 7-member board with the appointments of Amit Bhalla, Alex Cappello and John K. Scott, Jr. to the board."

Second Quarter 2021 Highlights and Subsequent Events

Scheduled an End-of-Phase 2 Type B meeting with the FDA to discuss its ongoing program in Rheumatoid Arthritis ("RA") and advancement to the pivotal Phase 3 trial. The meeting will take place on September 1, 2021, via conference call.
Achieved study closeout in the Company’s NAV3-31 Phase 2b study.
Opened the first U.S. site, Northwestern University, as well as the primary U.K. site, Queen Mary University of London, for enrollment in the Company’s NAV3-32 Phase 2b trial comparing Tc99m tilmanocept imaging to histopathology of joints of patients with active RA. A second U.S. site, Attune Health Research, will be opened on August 13, 2021.
Enrolled over 115 subjects in the Company’s NAV3-35 Phase 2b study, "Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging with Tc99m Tilmanocept." Expected total enrollment for this two-arm trial will be 135 participants.
Completed enrollment in the investigator-initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals.
Announced the granting of a National Institutes of Health ("NIH") award to the University of California San Diego School of Medicine for the proposal entitled, "Renal Molecular Imaging of Mesangial Cell Function with Tc-99m-Tilmanocept." The award (Project Number: 1R01DK127201-01), from the National Institute of Diabetes and Digestive and Kidney Diseases of the NIH, was granted to Co-Principal Investigators UC San Diego faculty Carl Hoh, MD and David Vera, PhD, of the Department of Radiology, and Charles Ginsberg, MD, MAS, of the Department of Medicine, Division of Nephrology.
Results from the Company’s preclinical studies of its targeted cancer immunotherapeutic agent were presented as a poster at the New York Academy of Science’s ("NYAS") Frontiers in Cancer Immunotherapy Symposium 2021. The poster is titled, "Targeted Delivery of Doxorubicin (DOX) to Tumor Associated Macrophages (TAMs) Beneficially Alters the Tumor Immune Microenvironment and Synergizes the Activity of Anti-CTLA4."
Announced that the U.S. Patent and Trademark Office ("USPTO") issued to Navidea U.S. patent 11,007,272, entitled "Compounds and Methods for Diagnosis and Treatment of Viral Infections," with protection to October 7, 2037.
Converted the provisional patent application "Synthesis of Uniformly Defined Molecular Weight Mannosylated Dextrans and Derivatives Thereof" to an A1 application on July 9, 2021.
Appointed Amit Bhalla to the Company’s Board of Directors. Mr. Bhalla brings a wealth of financial experience and over 20 years of pharmaceutical experience to the board.
Appointed John K. Scott, Jr. and Alex Cappello to the Board of Directors. Mr. Scott is the Company’s largest shareholder and Mr. Cappello brings over 30 years of banking and public board experience to the Company.
Announced that on June 23, 2021, Vice Chancellor Joseph Slights of the Court of Chancery of the State of Delaware (the "Court") ruled in favor of Navidea’s wholly-owned subsidiary, Macrophage Therapeutics, Inc. ("MT") and against its former CEO, Dr. Michael Goldberg, finding that Dr. Goldberg breached his fiduciary duties to MT. In addition, the Court denied Dr. Goldberg’s motion to hold MT’s directors and CEO in contempt, denied Dr. Goldberg’s motion to dismiss the lawsuit against him, and granted MT’s motion to dismiss Dr. Goldberg’s petition to remove MT’s board members.
Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, "The clinical research team continues to work diligently to advance the technology in key disease areas, with an emphasis on our RA program. We are preparing for our September discussion with the FDA over the results of the completed NAV3-31 Phase 2b trial as well as our proposed plan for the Phase 3 study. We continue to prepare for initiation of the Phase 3 and have opened up key sites for enrollment into the NAV3-32 Phase 2b trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients. Concurrent with all of this, we continue to make exciting progress in our therapeutics pipeline, and we expect to continue to advance these towards the clinic."

Financial Results

Total net revenues for the second quarter of 2021 were $261,000, compared to $271,000 for the same period in 2020. Total net revenues for the first six months of 2021 were $385,000, compared to $427,000 for the same period in 2020. The decrease was primarily due to decreased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development, offset by receipt of reimbursement from Cardinal Health 414, LLC of certain research and development ("R&D") costs and the partial recovery of debts previously written off in 2015.
R&D expenses for the second quarter of 2021 were $1.5 million, compared to $1.3 million in the same period in 2020. R&D expenses for the first six months of 2021 were $2.7 million, compared to $2.3 million in the same period in 2020. The increase was primarily due to net increases in drug project expenses, including increased Manocept diagnostic and therapeutic development costs. The net increase in research and development expenses also included increased regulatory consulting expenses offset by decreased employee compensation including incentive-based awards.
Selling, general and administrative ("SG&A") expenses for the second quarter of 2021 were $1.4 million, compared to $1.3 million in the same period in 2020. SG&A expenses for the first six months of 2021 were $3.7 million, compared to $3.2 million in the same period in 2020. The net increase was primarily due increased consulting services related to preparing for European distribution of Tc99m tilmanocept, increased employee compensation including incentive-based awards, increased insurance cost, increased director fees related to additional board members, increased general office expenses, increased travel costs and increased European license fees, offset by decreased legal and professional services and decreased investor relations costs.
Navidea’s net loss attributable to common stockholders for the second quarter of 2021 was $2.7 million, or $0.09 per share, compared to $2.4 million, or $0.11 per share, for the same period in 2020. Navidea’s net loss attributable to common stockholders for the first six months of 2021 was $5.6 million, or $0.20 per share, compared to $5.1 million, or $0.24 per share, for the same period in 2020.
Navidea ended the second quarter of 2021 with $7.1 million in cash and cash equivalents.
Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Participants who would like to ask questions during the question and answer session will be prompted by the moderator, who will provide instructions.

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On August 11, 2021 Aileron Therapeutics (NASDAQ:ALRN), a chemoprotection oncology company focused on fundamentally transforming the experience of chemotherapy for cancer patients, reported business highlights and financial results for the second quarter ended June 30, 2021 (Press release, Aileron Therapeutics, AUG 11, 2021, View Source [SID1234586335]).

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"Bolstered by a strong balance sheet and a healthy cash runway, we continue to execute against our clinical development strategy to advance selective chemoprotection for patients with p53-mutated cancer, including our initiation in the second quarter of our first randomized, double-blind, placebo-controlled clinical trial of ALRN-6924 for patients with p53-mutated non-small cell lung cancer (NSCLC)," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron.

Dr. Aivado continued, "The findings from this NSCLC trial will inform our late-stage clinical development strategy for ALRN-6924. Nearly 1 million cancer patients across all cancer types each year are diagnosed with p53-mutated cancer in the United States alone, and chemotherapy continues to be a cornerstone of cancer treatment for nearly every patient. As such, we believe that ALRN-6924 has the potential to protect many patients from chemotherapy-induced effects, thereby transforming their quality of life while they undergo chemotherapy and without reducing the effects of chemotherapy against cancer."

Aileron is developing ALRN-6924 to selectively protect healthy cells in patients with cancers that harbor p53 mutations, which are present in over half of all cancer patients, to reduce or eliminate chemotherapy-induced side effects while not interfering with chemotherapy’s attack on cancer cells. This novel concept is known as chemoprotection. By reducing or eliminating multiple chemotherapy-induced side effects, ALRN-6924 may improve patients’ quality of life and help them better tolerate chemotherapy. Enhanced tolerability may lead to fewer dose reductions or delays of chemotherapy, which could result in an improved efficacy of chemotherapy. Given Aileron’s p53 biomarker approach, designed to ensure selective chemoprotection only of healthy cells, coupled with the prevalence of p53-mutated cancers, the company’s strategy is to ultimately pursue a tumor-agnostic label for ALRN-6924 as a chemoprotective agent in p53-mutated cancers.

Second Quarter 2021 Highlights and Recent Updates

Initiated randomized, double-blind, placebo-controlled Phase 1b clinical trial of ALRN-6924 in patients with advanced NSCLC undergoing chemotherapy. Aileron anticipates enrolling a total of 60 patients with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed with or without immune checkpoint inhibitors. Patients enrolled in the NSCLC trial will be randomized 1:1 to receive carboplatin/pemetrexed plus 0.3 mg/kg ALRN-6924 or placebo for at least four 21-day treatment cycles. Components of the primary endpoint are the proportion of treatment cycles free of severe hematological and other toxicities, including Grade ≥ 3 neutropenia, Grade ≥ 3 thrombocytopenia, Grade ≥ 3 anemia, Grade 4 neutropenia and febrile neutropenia, as well as duration of Grade 4 neutropenia. An additional component of the primary endpoint is the proportion of completed treatment cycles without chemotherapy dose reduction or without the use of growth factors or transfusions. Other endpoints include the proportion of patients with National Cancer Institute Common Terminology Criteria Adverse Events Grade 3/4 treatment-emergent adverse events, quality of life, overall response rate, and progression-free survival.

Aileron anticipates reporting first interim safety data from the trial late in the fourth quarter of 2021 and topline results in mid-2022.
Company to present final data from ALRN-6924 SCLC study and initial data from Healthy Volunteer Study at two upcoming scientific congresses. Aileron has had abstracts accepted for presentation at the International Society for Experimental Hematology (ISEH) 2021 Virtual Scientific Meeting, being held August 25-28, 2021, and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021, being held September 16-21, 2021. At these congresses, Aileron will present final data from its Phase 1b study of ALRN-6924 in patients with SCLC undergoing chemotherapy with second-line topotecan. This presentation follows Aileron’s October 2020 presentation of data from its Phase 1b clinical trial of ALRN-6924 in SCLC demonstrating clinical proof-of-concept that treatment with ALRN-6924 resulted in a protective effect against neutropenia, thrombocytopenia and anemia in patients with p53-mutated SCLC treated with topotecan. A link to the SCLC presentation from October 2020 can be found here.

Aileron will also present initial data at both meetings from its ongoing Healthy Volunteer Study, which is evaluating ALRN-6924’s induction of p21-induced cell cycle arrest in healthy, normal bone marrow cells and other cell types in healthy volunteers receiving ALRN-6924. p53 upregulates the expression of p21, a known inhibitor of cell cycle. The Healthy Volunteer Study, therefore, is designed to characterize the time to onset, magnitude and duration of p21-induced cell cycle arrest in human bone marrow relative to ALRN-6924. The ultimate aim of the study is to develop a universal dosing regimen for ALRN-6924 for use as a chemoprotection agent across a range of chemotherapies and p53-mutated tumor indications.
Presented poster at 2021 ASCO (Free ASCO Whitepaper) Annual Meeting, co-authored by Foundation Medicine, Inc., demonstrating rarity of longitudinal changes in p53 mutation status. In June 2021, Aileron presented a poster co-authored by Foundation Medicine, Inc., entitled, "Frequency of longitudinal changes in TP53 mutation status from gene sequencing of serial tumor biopsies from a large cohort of cancer patients," at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting. The companies examined approximately 16,500 samples arising from repeat biopsies from more than 7,800 patients across a spectrum of cancer types and over an average interval of 11 months and up to 23 months between biopsies. The analysis found that in nearly all of the biopsies evaluated (97%), an initial p53-mutant diagnosis was maintained in subsequent biopsies, regardless of cancer type, primary tumor versus metastases, or time period between subsequent biopsies.
Second Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and investments on June 30, 2021 were $59.5 million, compared to $13.8 million at December 31, 2020. The company expects, based on its current operating plan, that its existing cash, cash equivalents and investments will fund operations into the second half of 2023.

Research and Development (R&D) Expenses: R&D expenses for the quarter ended June 30, 2021 were $3.9 million, compared to $2.5 million for the quarter ended June 30, 2020. The increase of $1.4 million primarily results from increased spending for clinical development of ALRN-6924 for the company’s Phase 1b clinical trial in patients with advanced NSCLC and the study of ALRN-6924 in healthy volunteers. The company also increased its spending on ALRN-6924 manufacturing costs, employee-related costs and non-clinical research costs while decreasing facility-related spending.

General and Administrative (G&A) Expenses: G&A expenses for the quarter ended June 30, 2021 were $2.2 million compared to $1.9 million for the quarter ended June 30, 2020. Increased G&A expenses were primarily the result of higher employee-related costs partially offset by lower facility costs.

Net Loss: Net loss for the quarter ended June 30, 2021 was $5.7 million, compared to $4.4 million for the corresponding quarter in 2020. The basic and diluted net loss per share for the second quarter of 2021 was $0.06 compared to $0.14 for the second quarter of 2020. The change in basic and diluted net loss per share is primarily a result of increased shares outstanding in connection with sales of common stock during the first quarter of 2021.

On August 11, 2021 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported that financial, clinical and operational updates for the second quarter ended June 30, 2021 (Press release, Heat Biologics, AUG 11, 2021, View Source [SID1234586334]).

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Jeff Wolf, Chief Executive Officer of Heat, commented, "This quarter we achieved several meaningful clinical, research and business milestones. First, we presented favorable survival data of HS-110 in previously treated non-small cell lung cancer (NSCLC) patients at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Based on these results, we believe HS-110, in combination with a checkpoint inhibitor (CPI), holds significant potential to improve survival benefit for patients with non-small cell lung cancer. We are continuing to evaluate possible Phase 3 registration pathways with the FDA and potential partners. At the same time, we are exploring a variety of paths forward related to our infectious disease efforts. We look forward to providing further near-term updates."

"This quarter we also announced the groundbreaking for our biomanufacturing/bioanalytic facility in San Antonio, TX and the expansion of our current research and development (R&D) facilities at our corporate headquarters in Morrisville, NC. This expansion will support enhanced R&D capabilities including in-house synthesis and production of antibodies and other drugs/reagents, as well as an expanded vivarium for onsite pre-clinical studies. We believe that this expansion will allow us to accelerate R&D timelines and generate cost savings on research and development by bringing more of our development activities in-house."

"Moreover, we have maintained a strong balance sheet with approximately $122.5 million of cash, cash equivalents and short-term investments which should allow us to augment our clinical programs as well as enhance and expand our therapeutic pipeline."

Second Quarter 2021 Financial Results

●Recognized $0.5 million of grant revenue for qualified expenditures under the CPRIT grant compared to $0.6 million for the quarter ended June 30, 2020. The decrease in grant revenue in the current-year period primarily reflects the expected timing of completion of deliveries under the current phase of the contracts. As of June 30, 2021, we had a grant receivable balance of $0.4 million for CPRIT proceeds not yet received but for which the costs had been incurred or the conditions of the award had been met. We continue our efforts to secure future non-dilutive grant funding to subsidize ongoing research and development costs.
●Research and development expense was $4.2 million and $2.8 million for the three months ended June 30, 2021 and 2020, respectively.
●General and administrative expense was $2.9 million and $1.8 million for the three months ended June 30, 2021 and 2020. The increase was primarily due to an increase in stock-based compensation expense.
●Net loss attributable to Heat Biologics was approximately $6.5 million, or ($0.26) per basic and diluted share for the quarter ended June 30, 2021 compared to a net loss of approximately of $4.5 million, or ($0.35) per basic and diluted share for the quarter ended June 30, 2020.
●As of June 30, 2021, the Company had approximately $122.5 million in cash, cash equivalents and short investments.

On August 11, 2021 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported its financial results for the second quarter 2021 (Press release, Cyclacel, AUG 11, 2021, View Source [SID1234586333]). The quarter’s business highlights included an update on the Company’s progress with fadraciclib and CYC140, Cyclacel’s novel CDK2/9 and PLK1 inhibitors, respectively.

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"After announcing In July that the first patient had been dosed with oral fadraciclib, two additional patients with advanced solid tumors have been treated, completing enrolment of the first dose level," said Spiro Rombotis, President and Chief Executive Officer. "We are encouraged by investigator interest in our fadraciclib 065-101 solid tumor study. In earlier clinical studies fadraciclib has demonstrated single-agent activity, including durable PR. We believe that fadraciclib is a leading, transcriptionally-active CDK inhibitor with a differentiated product profile. Pipeline momentum will continue to build with the planned opening of protocol 065-102, an oral fadraciclib study in patients with hematological malignancies, and later with the initiation of two similar protocols in solid tumors and hematological malignancies for our novel PLK1 inhibitor, CYC140. The second half of 2021 is an exciting period for Cyclacel, as we expand our clinical programs and increase our visibility as an oncology leader focused on cell cycle inhibition for the treatment of cancer. We look forward to reporting further updates as data from these studies become available."

Key Corporate Highlights

Oral fadraciclib – First three patients with advanced solid tumors dosed in the 065-101 Phase 1/2, registration-directed trial. The study includes multiple cohorts defined by histology thought to be sensitive to the drug’s mechanism of action and informed by the clinical activity of fadraciclib in MCL1, MYC and/or cyclin E amplified cancers. The cohorts include breast (metastatic, hormone receptor positive, post-CDK4/6 inhibitor; HER-2 refractory; or triple negative), cholangiocarcinoma, colorectal (including KRAS mutant), endometrial, hepatocellular, ovarian cancers and certain lymphomas. The study design also includes a basket cohort which will enroll patients with relevant biomarkers to the drug’s mechanism regardless of histology. Previously single agent, intravenous fadraciclib has demonstrated durable suppression of MCL1 and other mechanistically-related proteins, including cyclin E and MYC, at tolerated doses.

Oral CYC140 – continued progress with IND-directed activities and manufacturing of clinical trial supplies. Initial data in preclinical models show that KRAS mutant cancers are sensitive to oral CYC140 inhibition. The Company expects to begin a study in patients with solid tumors in the second half of 2021. Similar to the fadraciclib clinical program, the CYC140 Phase 1/2 study will be a registration-directed trial using a streamlined design that will first determine the recommended Phase 2 dose (RP2D) for single-agent CYC140. Once the RP2D has been established, the trial will immediately enter into a proof-of-concept, cohort stage, using a Simon 2-stage design, where single agent CYC140 will be administered to patients across multiple cohorts based upon those histologies thought to be sensitive to the drug’s mechanism of action.
Key Near-Term Business Objectives and Expected Timeline

2H 2021

First patient to be dosed with oral fadraciclib in 065-102 Phase 1/2 leukemia study
FDA clearance of IND filing; begin oral CYC140 Phase 1/2 advanced solid tumor study
1H 2022

First patient to be dosed with oral CYC140 in Phase 1/2 leukemia study
Phase 1 data with oral fadraciclib in advanced solid tumor 065-101 study
Financial Highlights

As of June 30, 2021, cash and cash equivalents totaled $43.6 million, compared to $47.8 million as of March 31, 2021. The decrease of $4.2 million was primarily due to net cash used in operating activities. The Company estimates that the cash resources will fund currently planned programs through early 2023.

Research and development expenses were $4.1 million for the three months ended June 30, 2021 as compared to $1.2 million for the same period in 2020. Research and development (R&D) expenses relating to fadraciclib increased by approximately $1.9 million for the three months ended June 30, 2021 with the start of the CYC065-101 study of fadraciclib in solid tumors and preparations for opening the 065-102 study of fadraciclib in leukemias. Additionally, R&D expenses related to CYC140 increased $1.0 million for the quarter as IND-directed activities are approaching completion and clinical trial supplies are being manufactured.

General and administrative expenses for the three months ended June 30, 2021 were $2.0 million, compared to $1.3 million for the same period of the previous year due to costs of approximately $0.4 million related to exiting a long-term facility lease, increased legal and professional expenses and recruitment costs.

United Kingdom research & development tax credits were $1.0 million for the three months ended June 30, 2021, as compared to $0.3 million for the same period in 2020 due to the increase in R&D expenditure.

Net loss for the three months ended June 30, 2021 was $5.1 million, compared to $2.2 million for the same period in 2020.

On August 11, 2021 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 (Press release, Biomea Fusion, AUG 11, 2021, View Source [SID1234586332]).

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"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.