On August 12, 2021 Lyell Immunopharma, Inc. (Lyell), (Nasdaq: LYEL), a T cell reprogramming company dedicated to the mastery of T cells to cure patients with solid tumors, reported financial results for the second quarter and first six months of 2021 and provided business highlights (Press release, Lyell Immunopharma, AUG 12, 2021, View Source [SID1234586446]).

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"Lyell is steadily progressing our two T cell reprogramming platforms, Gen-R and Epi-R, to address what we believe are the primary barriers that limit consistent, reliable and curative responses to cell therapy in solid tumors," said Liz Homans, Chief Executive Officer of Lyell. "Over the past six months we have expanded our development and executive teams and achieved important operational advances that keep us on track to submit four INDs and begin generating clinical data in 2022. With the completion of our initial public offering in June, we have a strong capital position to execute our vision of curing patients with solid tumors."

Recent Business Highlights

Achieved operational readiness of state-of-the-art manufacturing capabilities to produce cell products for multiple upcoming planned clinical trials. The LyFE Manufacturing Center integrates innovations that enable real-time monitoring and analysis of data and insights into the manufacturing processes. LyFE is operational and the Company has successfully completed engineering runs at scale to supply product for its upcoming planned clinical trials.

Expanded Board of Directors with industry and medical leaders Otis Brawley, M.D., Elizabeth Nabel, M.D. and Lynn Seely, M.D.
Dr. Brawley is a Bloomberg Distinguished Professor of Oncology and Epidemiology at Johns Hopkins University and is a member of the board of directors of PDS Biotechnology Corporation. He was formerly the Chief Medical and Scientific Officer of American Cancer Society and director of the Georgia Cancer Center at Grady Memorial Hospital.

Dr. Nabel is Executive Vice President for Strategy at ModeX Therapeutics and a member of the board of directors of Moderna, Inc., Medtronic, and Accolade. She is the former President of Brigham Health, which includes Brigham and Women’s Hospital, Brigham and Women’s Faulkner Hospital, and the Brigham and Women’s Physician Organization. Dr. Nabel was also a Professor of Medicine at Harvard Medical School.

Dr. Seely is a member of the board of directors of Blueprint Medicines, Corp. She previously served as President, Chief Executive Officer and member of the board of directors of Myovant Sciences and Senior Vice President and Chief Medical Officer of Medivation.

Further strengthened its balance sheet with net proceeds of $391.8 million from the sale of 25 million shares of common stock in the Company’s initial public offering, bringing cash, cash equivalents and marketable securities to $974.8 million as of June 30, 2021.
Second Quarter and First Six Months of 2021 Financial Results

GAAP Results

Cash Position: Cash, cash equivalents and marketable securities were $974.8 million as of June 30, 2021, compared to $692.6 million as of December 31, 2020, an increase of $282.2 million. Lyell successfully completed its initial public offering in June 2021 in which it issued 25 million shares of common stock, at a price of $17.00 per share, for net proceeds of $391.8 million, after deducting underwriting discounts and commissions and offering expenses.
Research and Development (R&D) Expenses: R&D expenses, were $46.4 million and $88.0 million for the three and six months ended June 30, 2021, respectively, as compared to $97.2 million and $122.7 million for the three and six months ended June 30, 2020, respectively. The decrease in R&D expense for the three and six months ended June 30, 2021, compared to the same periods in the prior year was primarily due to a decrease in collaborations and licensing costs, offset by an increase in success payments expenses.
General and Administrative (G&A) Expenses: G&A expenses were $19.1 million and $35.9 million for the three and six months ended June 30, 2021, respectively, as compared to $9.6 million and $18.4 million for the three and six months ended June 30, 2020, respectively. The increase in G&A expense for the three and six months ended June 30, 2021 compared to the same periods in the prior year was primarily due to an increase in stock-based compensation expense.
Net Loss: Net loss was $62.6 million and $117.6 million for the three and six months ended June 30, 2021, respectively, as compared to $100.7 million and $129.9 million for the three and six months ended June 30, 2020, respectively.
Non-GAAP Measures

Non-GAAP R&D Expenses: Non-GAAP R&D Expenses were $32.1 million and $58.8 million for the three and six months ended June 30, 2021, respectively, as compared to $91.6 million and $113.0 million for the three and six months ended June 30, 2020, respectively. Non-GAAP R&D expenses excludes non-cash stock-based compensation expense and non-cash expenses related to the change in the estimated fair value of success payment liabilities.
Non-GAAP G&A Expenses: Non-GAAP G&A Expenses were $9.0 million and $17.9 million for the three and six months ended June 30, 2021, respectively, as compared to $7.3 million and $15.0 million for the three and six months ended June 30, 2020, respectively. Non-GAAP G&A expenses exclude non-cash stock-based compensation expense.
Non-GAAP Net Loss: Non-GAAP Net loss was $38.1 million and $70.4 million for the three and six months ended June 30, 2021, respectively, as compared to $92.9 million and $116.8 million for the three and six months ended June 30, 2020, respectively. Non-GAAP net loss excludes non-cash stock-based compensation expense and non-cash expenses related to the change in the estimated fair value of success payment liabilities.
A discussion of these non-GAAP financial measures, including reconciliations of GAAP to non-GAAP financial measures, is presented below under "Non-GAAP Financial Measures."

On August 12, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, reported financial results for the second quarter ended June 30, 2021 and provided a business update (Press release, Silverback Therapeutics, AUG 12, 2021, View Source [SID1234586445]).

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"The second quarter was notable for the significant progress we made across our entire pipeline of tissue-targeted therapies, with SBT6050, our HER2-TLR8 ImmunoTAC leading the way with continued robust enrollment in our Phase 1/1b study," said Laura Shawver, Ph.D., chief executive officer of Silverback. "We are deeply appreciative of the patients, their families, and our clinical investigators who continue to contribute to the SBT6050-101 clinical trial, and we look forward to providing the first update of the clinical data at the ESMO (Free ESMO Whitepaper) conference in September."

Recent Highlights

SBT6050 (HER2-TL8 ImmunoTAC) clinical abstract accepted for poster presentation at the European Society for Medical Oncology ("ESMO") 2021 Annual Meeting. The presentation will provide an update on the monotherapy dose-escalation arm (Part 1) and the pembrolizumab combination dose-escalation arm (Part 3) of the SBT6050-101 Phase 1/1b study. Details of the upcoming ESMO (Free ESMO Whitepaper) poster presentation are as follows:

Title: "Interim results of a Phase 1/1b study of SBT6050 monotherapy and pembrolizumab combination in patients with advanced HER2-expressing or amplified solid tumors" Klempner, S., et al.
Poster Number: 209P
Session Date and Time: The ePoster will be released virtually on Thursday, September 16th at 8:30 AM Central European Summer Time / 2:30 AM Eastern Standard Time
Announced a clinical supply agreement with Regeneron to evaluate SBT6050 in combination with Libtayo (cemiplimab), a PD-1 inhibitor. Under the terms of the agreement, Silverback will expand the ongoing Phase 1/1b trial to evaluate the combination of SBT6050 and Libtayo in tumor-specific dose expansion cohorts, initially in HER2-expressing non-small cell lung and gastric cancers.
GLP toxicology study for SBT6290 (Nectin4-TLR8 ImmunoTAC) is nearing completion, with IND filing on track for the fourth quarter of 2021. Dosing was initiated in the GLP toxicology study in the second quarter and cGMP manufacturing of the drug product for Phase 1 clinical supply has been completed, with release testing in progress.
SBT8230 (ASGR1-TLR8 ImmunoTAC for chronic HBV) continues to advance through preclinical development with early CMC activities initiated including selection of the clone and creation of a master cell bank. The GLP toxicology study is expected to commence in the first quarter of 2022.
Second Quarter Financial Results

For the second quarter ended June 30, 2021, Silverback reported a net loss of $24.5 million, compared to a net loss of $6.5 million for the comparable period in 2020. For the six months ended June 30, 2021, Silverback reported a net loss of $43.4 million, compared to a net loss of $11.7 million for the comparable period in 2020. Included in the net losses for the three and six months ended June 30, 2021 were $4.7 million and $9.0 million of non-cash stock-based compensation compared to $128,000 and $175,000 for the same periods in 2020.

Research and development expenses for the second quarter ended June 30, 2021 were $17.7 million, compared to $5.1 million for the same period in 2020. Research and development expenses for the six months ended June 30, 2021 were $30.0 million compared to $9.5 million for the same period in 2020. The increases in the Company’s research and development expenses in 2021 were primarily attributable to the advancement of pipeline programs, including SBT6290 and SBT8230, through preclinical development and the continued clinical development of SBT6050. Silverback also incurred additional personnel-related expenses as operations grew in support of program advancements.

General and administrative expenses for the second quarter ended June 30, 2021 were $6.8 million, compared to $1.3 million for the same period in 2020. General and administrative expenses for the six months ended June 30, 2021 were $13.4 million, compared to $2.2 million for the same period in 2020. The increases in general and administrative expenses were primarily attributable to an increase in personnel-related expenses due to increased headcount in 2021, including new executives, as well as increases in salaries, bonuses, and stock-based compensation. The increases in general and administrative expenses were also due to an increase in legal fees, professional fees, and other various general and administrative expenses as we now operate as a public company.

As of June 30, 2021, Silverback reported cash and cash equivalents of $359.7 million, compared to $386.6 million at December 31, 2020, which is expected to fund operating expenses and capital expenditure requirements for at least the next 24 months.

On August 12, 2021 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading edge computational and experimental technologies, reported second quarter 2021 financial results and announced a collaboration with EQRx (Press release, Relay Therapeutics, AUG 12, 2021, View Source [SID1234586444]).

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"PI3Kα mutations have been a known oncogene for the past 20 years but this has been a very difficult drug discovery challenge to solve using conventional approaches. Leveraging our Dynamo platform, the Relay Therapeutics team has been able to create what we believe to be the first ever mutant selective inhibitor of PI3Kα, which offers the potential to address a significant unmet medical need," said Sanjiv Patel, M.D., president and chief executive officer. "Other programs in our pipeline continue to progress as anticipated, with RLY-4008, our FGFR2 inhibitor on track for an initial data disclosure later this year. We hope to demonstrate that our platform has achieved another breakthrough by potentially creating the first ever selective small molecule inhibitor of FGFR2. Finally, our new collaboration with EQRx announced today opens yet another avenue for our Dynamo platform to potentially impact the lives of more patients and generate value for our shareholders. This partnership allows us to utilize the scale and efficiencies of our machine learning and artificial intelligence capabilities against an expanded target landscape. We look forward to a productive remainder of 2021."

PI3Kα Mutant Selective Program Update

Phosphoinositide 3-kinase alpha (PI3Kα) is the most frequently mutated kinase in solid tumors. Approximately 60%-70% of the mutations in PI3Kα cluster at three amino acids (H1047, E542, and E545). Traditionally, the development of PI3Kα inhibitors has focused on the active, or orthosteric site. The therapeutic index of orthosteric inhibitors is limited by the lack of clinically meaningful selectivity for mutant versus wild-type PI3Kα and off-isoform activity. Toxicity related to inhibition of wild-type PI3Kα and other PI3K isoforms results in sub-optimal inhibition of mutant PI3Kα with reductions in dose intensity and frequent discontinuation. RLY-2608, the first allosteric, pan-mutant (H1047X, E542X and E545X), and isoform-selective PI3Kα inhibitor was designed to overcome these limitations.

Relay Therapeutics solved the full-length cryo-EM structure of PI3Kα, performed computational long time-scale molecular dynamic simulations to elucidate conformational differences between wild-type and mutant PI3Kα, and leveraged these insights to enable the design of RLY-2608. In biochemical assays, RLY-2608 inhibits H1047R, E542K, and E545K mutant PI3Kα activity with <10nM potency and 8-12x selectivity relative to wild-type PI3Kα. RLY-2608 is > 1000-fold selective over the β, δ, and γ PI3K isoforms in biochemical assays and demonstrates exquisite selectivity across a panel of 322 kinases.

This progress puts RLY-2608 on path to initiate a first-in-human clinical study in the first half of 2022. RLY-2608 is the lead program of multiple preclinical efforts to discover and develop mutant selective inhibitors of PI3Kα.

Strategic Collaboration with EQRx

Relay Therapeutics and EQRx entered a worldwide strategic collaboration to discover, develop, and commercialize novel medicines against validated oncology targets. Under the terms of the agreement, Relay Therapeutics will be responsible for the discovery phase through to Investigational New Drug application filing, while EQRx will be responsible for clinical development, regulatory and commercialization efforts of the product candidates developed pursuant to the collaboration. Relay Therapeutics and EQRx will equally share in the discovery, development and commercialization costs and the net profits from sales of any collaboration medicines, if approved. The collaboration will start with one program, but the companies can mutually agree to add additional programs to the collaboration in the future. Relay Therapeutics retains the right to develop any collaboration medicines in combination with its wholly-owned pipeline.

Other Recent Corporate Highlights

RLY-4008, a potent, selective and oral small molecule inhibitor of FGFR2, remains on track to report initial safety, tolerability and pharmacokinetics data across multiple dose levels before the end of 2021. Most patients to be reported on will be FGFR2 altered cholangiocarcinoma (CCA) patients with prior exposure to pan-FGFR inhibitor therapies. The disclosure will also include preliminary efficacy data focusing on FGFR2 fusion CCA pan-FGFR treatment naïve patients.

In July 2021, Genentech initiated the cohort of RLY-1971/GDC-1971, an inhibitor of SHP2, in combination with GDC-6036, an inhibitor of KRAS G12C, in a Phase 1b trial.
Second Quarter 2021 Financial Results

Cash, Cash Equivalents and Investments: As of June 30, 2021, cash, cash equivalents and investments totaled approximately $671.2 million, compared to $678.1 million as of December 31, 2020. The change in cash reflects the receipt of Genentech’s $75 million upfront payment in the first quarter, partially offset by $25.1 million in net cash paid for the acquisition of ZebiAI and cash used to fund our operations. The Company expects its current cash and cash equivalents will be sufficient to fund its current operating plan into 2024.

R&D Expenses: Research and development expenses were $180.0 million for the second quarter of 2021, as compared to $21.7 million for the second quarter of 2020. $134.9 million was due to the acquisition of ZebiAI in April 2021. The additional increase of $23.5 million was primarily due to $12.3 million of additional employee related costs, including an increase in stock-based compensation of $8.2 million, $7.3 million related to our pre-clinical candidates and $2.5 million related to increased clinical trial expenses associated with RLY-1971 and RLY-4008.

G&A Expenses: General and administrative expenses were $14.4 million for the second quarter of 2021, as compared to $6.1 million for the second quarter of 2020. The increase of $8.4 million was primarily due to $5.8 million of increased personnel costs, including increased stock-based compensation of $3.9 million, to support our infrastructure and $2.6 million related to increases in other general and administrative expenses primarily attributed to an increase in insurance expense.

Net Loss: Net loss was $193.4 million for the second quarter of 2021, or a net loss per share of $2.10, as compared to a net loss of $26.7 million for the second quarter of 2020, or a net loss per share of $6.06.

On August 12, 2021 HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, reported its financial results for the quarter ended June 30, 2021 (Press release, HTG Molecular Diagnostics, AUG 12, 2021, View Source [SID1234586443]).

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Recent Business Highlights

Total revenue increased by approximately 45% from the first quarter to the second quarter of 2021.
Commercially launched the HTG Transcriptome Panel for sale in the U.S. and Europe in kit form or as a service in HTG’s VERI/O laboratory. The HTG Transcriptome Panel, designed to measure approximately 20,000 mRNA targets using the HTG EdgeSeq technology, is currently available for use with the Illumina sequencing platforms. Through its work with Early Adopter Program collaborators in the first half of 2021, the company received its first revenue-generating commercial orders for the HTG Transcriptome Panel in the second quarter of 2021.
Announced the release of HTG EdgeSeq Reveal version 4.0.0, adding additional features and software functionalities to support, among other things, data analysis for the HTG Transcriptome Panel.
Formed a new drug discovery business unit, HTG Therapeutics, in July 2021. This business unit is expected to leverage the company’s existing capabilities and expand upon the utility of the HTG EdgeSeq platform technology in the discovery of early-stage drug candidates. By leveraging these profiling technologies earlier in the drug discovery process, HTG Therapeutics is expected to generate lead compounds faster, and with superior efficacy and toxicity profiles.
"We believe our sequential growth this quarter over the first quarter of 2021 indicates our core business is recovering. Increased sample processing activity in our VERI/O laboratory and consumable product orders from existing and new customers were the driving factors in the growth of our product and product-related services revenue. I commend our commercial team, whose commitment with existing and new customers has never wavered despite the challenges we faced since 2020," said John Lubniewski, President and CEO of HTG. "The focus of our research and development teams on development milestones and opportunities to improve upon our existing technology and expand into other RNA-related applications has resulted in significant progress this quarter. We again successfully completed our development milestones in the second quarter, which enabled us to commercially launch our HTG Transcriptome Panel on August 5th. In addition, our vision to further advance precision medicine into drug discovery is quickly coming into place, and we are excited to be building an even stronger technology platform foundation with which we can continue to grow."

Second Quarter 2021 Financial Highlights:

Total revenue for the quarter ended June 30, 2021 was $2.1 million, compared with $2.0 million for the same period in 2020.

Product and product-related services revenue for the quarter ended June 30, 2021 was $2.1 million, compared with $1.7 million for the same period in 2020 and $1.4 million for the first quarter ended March 31, 2021. This increase is due primarily to RUO sample processing services and the sale of RUO consumables products for which demand has begun to recover to pre-COVID-19 levels as customers have resumed development activities. Revenue for the quarter ended June 30, 2020 included $0.2 million of collaborative development services revenue for which the remaining contracted development tasks on our existing programs have been completed.

Net loss from operations for the quarter ended June 30, 2021 was $4.1 million, compared with $5.0 million for the same period in 2020. Net loss per share was $(0.39) for the quarter ended June 30, 2021 compared with $(1.30) for the second quarter of 2020.

Cash, cash equivalents and short-term available-for-sale securities totaled $29.8 million as of June 30, 2021, with current liabilities of approximately $7.1 million and non-current liabilities of $11.7 million.

Conference Call and Webcast:

HTG will host a conference call for the investment community today beginning at 4:30 p.m. Eastern Time. Conference call and webcast details are as follows:

On August 12, 2021 Bolt Biotherapeutics, Inc. (NASDAQ: BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, reported financial results for the second quarter ended June 30, 2021 and provided an update on recent business highlights (Press release, Bolt Biotherapeutics, AUG 12, 2021, View Source [SID1234586442]).

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"We continue to build strong momentum with our business strategy and remain on target for a BDC-1001 Phase 1/2 clinical data update later this year," said Randall C. Schatzman, Ph.D., Chief Executive Officer of Bolt. "Our recently announced Genmab collaboration expands our proprietary Boltbody platform into novel bispecific ISAC applications, while fortifying our strong cash position. Furthermore, our CEA-targeted candidate BDC-2034 made steady progress towards an IND filing that is expected next year. I am proud of the passionate and experienced team we have assembled at Bolt, including recent additions to our leadership, who share our commitment to advancing targeted immuno-oncology therapies that will benefit patients with cancer."

Recent Business Highlights and Anticipated Milestones

Lead program BDC-1001 on track for anticipated Phase 1/2 trial data update in 2H21 – In June 2021, Bolt presented a poster at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting that expanded on the preliminary data, as of January 29, 2021, from the first 20 patients in an ongoing BDC-1001 Phase 1/2 clinical trial. The monotherapy dose-escalation portion of the trial is proceeding on plan, with a further data update expected in the second half of 2021. This Phase 1/2 trial is being conducted in four parts: [1] Phase 1 monotherapy dose escalation, [2] Phase 1 dose escalation in combination with PD-1 checkpoint inhibitor, [3] Phase 2 monotherapy expansion cohorts, and [4] Phase 2 expansion cohorts in combination with a PD-1 checkpoint inhibitor. Bolt also remains on track to initiate the monotherapy Phase 2 dose-expansion cohorts and the dose-escalation of BDC-1001 in combination with an anti-PD-1 antibody in the second half of 2021.

Announced oncology research and development (R&D) collaboration with Genmab to develop multiple bispecific ISACs – In June 2021, Bolt announced an oncology R&D collaboration with Genmab to discover and evaluate novel bispecific immune-stimulating antibody conjugate (ISAC) products for the treatment of multiple types of cancer. The collaboration will combine Bolt’s BoltBody ISAC platform with Genmab’s proprietary antibodies and bispecific technology, and Genmab will fully fund three programs through initial clinical proof-of-concept. Bolt received a $10 million USD upfront payment and a $15 million USD equity investment from Genmab, is eligible to receive up to $285 million USD for each program exclusively developed and commercialized by Genmab, and has the option to participate in the development and commercialization of one candidate after seeing clinical proof-of-concept data.

Expanded leadership team, adding expertise across research, clinical development, regulatory, quality and technical operations over the last year.
Amreen Husain, M.D., Vice President, Clinical Development and Translational Medicine. Dr. Husain brings more than a decade of experience in oncology drug development with a focus on breast and gynecological cancers and immuno-oncology. Dr. Husain joined Bolt from Roche/Genentech. Prior, Dr. Husain was as a practicing oncologist and clinical researcher at Stanford University Medical Center.
Bruce Hug, M.D., Ph.D., Vice President, Early Development and Research Collaborations. Dr. Hug joins Bolt from GlaxoSmithKline, bringing more than 16 years of oncology, hematology and immunotherapy experience, with a focus on early development.
Karen L. Bergman, Vice President, Communications and Investor Relations. Ms. Bergman has more than two decades of experience in biopharma communications, spanning corporate roles at companies such as ALZA and FibroGen, and 15 years heading a life science practice specializing in strategy, positioning, communications, and investor relations.
Liang Fang, Ph.D., Vice President, Biometrics and Bioinformatics. Dr. Fang brings more than 15 years of experience in developing and applying statistical methods and data sciences to drug development in oncology and the biotechnology industry from MyoKardia, Gilead Sciences, Genentech, and Amgen.
Triona O’Hanlon, Vice President, Program Management. Ms. O’Hanlon joined Bolt from Gilead, where she led program and portfolio management for hematology/oncology and cell therapy. Ms. O’Hanlon brings more than 20 years of experience in program and alliance management from Gilead Sciences, Kite Pharma, Elan Pharmaceuticals, and Ambit Biosciences.
Wesley Burwell, Vice President, Head of Human Resources. Mr. Burwell most recently worked at Global Blood Therapeutics and brings more than 20 years of experience building and driving HR strategy for biopharma companies.

Cash, cash equivalents, and marketable securities were $310.9 million as of June 30, 2021, which is expected to fund operations and the advancement of its oncology product pipeline to achieve multiple key milestones through the end of 2023.
Upcoming Events

Bolt Biotherapeutics will be attending the following conferences in September 2021:
Citi’s 16th Annual Biopharma Virtual Conference, September 8-10
Wells Fargo Virtual Healthcare Conference, September 9-10
Morgan Stanley Global Healthcare Conference, September 9-15
Cantor Fitzgerald Global Healthcare Conference, September 27-30
Second Quarter 2021 Financial Results

Cash Position – Cash, cash equivalents, and marketable securities were $310.9 million as of June 30, 2021, compared to $302.9 million as of March 31, 2021. Bolt expects its cash balance to fund operations through the end of 2023.

Research and Development Expenses – R&D expenses were $19.7 million for the quarter ended June 30, 2021, compared to $9.2 million for the same quarter in 2020, primarily due to increases in manufacturing expenses related to BDC-1001 and BDC-2034, increased personnel expenses relating to an increase in headcount, increased facility-related expenses, and increased clinical trial expenses.

General and Administrative (G&A) Expenses – G&A expenses were $4.1 million for the quarter ended June 30, 2021, compared to $2.0 million for the same quarter in 2020, primarily due to increased personnel expenses relating to an increase in headcount and increased professional services expenses related to consulting services, legal fees and other professional services.

Loss from Operations – Loss from operations was $23.8 million for the quarter ended June 30, 2021 compared to $11.1 million for the same quarter in 2020.