On September 8, 2021 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported a clinical trial collaboration and supply agreement with Pfizer Inc. (NYSE: PFE) for the BRAF inhibitor encorafenib (BRAFTOVI) (Press release, Erasca, SEP 8, 2021, View Source [SID1234639384]).

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This agreement will support a clinical proof-of-concept study evaluating ERAS-007, an oral ERK1/2 inhibitor, in combination with encorafenib and the EGFR inhibitor cetuximab for the treatment of patients with BRAF V600E-mutant mCRC. This combination will be investigated as part of the Phase 1b/2 HERKULES-3 trial expected to initiate in the second half of 2021. Erasca will sponsor the study, and Pfizer will supply encorafenib. The two companies will form a Joint Development Committee to review the clinical trial results.

"We are excited to work with Pfizer to explore this promising combination in colorectal cancer," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "MAPK signaling is constitutively activated in patients with BRAF V600E mutations, who often have a poor prognosis. Combining upstream EGFR inhibition, midstream BRAF inhibition, and downstream ERK inhibition fits squarely within Erasca’s strategies to erase cancer and has potential to limit pathway reactivation, offering the therapeutic potential to comprehensively shut down the RAS/MAPK pathway in this tumor type."

Worldwide, approximately 1.8 million cases of CRC are diagnosed annually, with BRAF V600E mutations occurring in approximately 10% of these patients. The combination of encorafenib and cetuximab was approved in April 2020 for previously treated patients with BRAF V600E-mutant mCRC. The combination demonstrated improved overall survival compared to the chemotherapy control arm; however, only 20% of patients experienced an objective response, and the progression-free survival was approximately four months. Therefore, emergence of resistance is a major therapeutic barrier to long-term clinical benefit. Erasca is exploring whether ERK inhibition with ERAS-007 in combination with encorafenib plus cetuximab can reduce the emergence of resistance and further improve treatment benefit for patients with BRAF V600E-mutant mCRC.

About ERAS-007
ERAS-007 is a potential best-in-class ERK1/2 inhibitor being investigated alone or in combination with different inhibitors targeting upstream nodes of the MAPK pathway as part of Erasca’s MAPKlamp strategy. The extracellular signal-regulated kinases (ERK), ERK1 and ERK2, belong to a family of serine-threonine kinases that regulate cellular signaling and comprise the terminal node of the RAS/MAPK pathway. ERAS-007 is being investigated across a series of four HERKULES clinical trials that span multiple tumor types and includes both monotherapy and combinations with approved and investigational agents, such as RTK, SHP2, RAS, RAF, and/or cell cycle inhibitors. HERKULES-1 is a Phase 1b/2 clinical trial for ERAS-007 as a single agent and in combination with the SHP2 inhibitor ERAS-601 (together, Erasca’s first MAPKlamp) in advanced solid tumors. HERKULES-2 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with non-small cell lung cancer. HERKULES-3 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with gastrointestinal cancers. HERKULES-4 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with hematologic malignancies.

On September 8, 2021 A-Alpha Bio, a biotechnology company that works with pharmaceutical industry partners to accelerate drug discovery with massively multiplexed measurements of protein interactions, reported that it has closed a $20M Series A Financing Round to dramatically expand capabilities and throughput (Press release, A-Alpha Bio, SEP 8, 2021, View Source [SID1234636941]). The round was led by Madrona Venture Group with participation from Perceptive Advisors’ Perceptive Xontogeny Venture Fund (PXV Fund) and Lux Capital. Madrona Venture Group’s Matt McIlwain and Xontogeny’s Ben Askew, Ph.D. have joined A-Alpha Bio’s Board of Directors as part of the financing.

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A-Alpha Bio is building a high-resolution model of biology by measuring millions of protein-protein interactions, leveraging the intersection of synthetic biology, protein engineering, and machine learning. Compared to traditional technologies for screening protein interactions, including biophysical and display platforms, A-Alpha Bio’s proprietary AlphaSeq platform is able to measure protein interactions at a scale and to a degree of precision that is otherwise inaccessible. The quantity and quality of AlphaSeq data is ideal for drug discovery and also critical for training highly predictive ML-models for protein-protein binding.

"Understanding and characterizing protein-protein interactions is fundamental to the future of drug discovery and development and we are excited to back this impressive team that is at the intersection of innovation – bringing together life and computer sciences to uncover previously inaccessible discoveries," said Matt McIlwain, Managing Director, Madrona Ventures Group. "We have been impressed by the traction David and the team have made since we invested in the seed round and believe they are well on their way to helping to develop treatments for diseases and create a data advantage that could change the future of antibody and small molecule discovery."

A-Alpha Bio will deploy the new capital announced today to build a new production laboratory, generate the largest ever database of protein interaction measurements, and fill key roles in their rapidly growing team. These investments will enhance the company’s partnerships with leading pharmaceutical companies to discover new drugs – with a focus on antibodies and molecular glues. With a massive and ever-growing protein interaction data asset, A-Alpha Bio also plans to expand their machine-learning capabilities to uncover the complex rules of protein binding and enable in silico modeling of complex protein interaction networks.

"Our mission is to improve human health by accelerating drug discovery with synthetic biology and machine learning. I’m incredibly proud of the phenomenal team we’ve built and the impactful work we’ve already accomplished with leading pharma and biotech partners," said Dr. David Younger, Co-Founder and CEO of A-Alpha Bio. "Our Series A investors share our vision and optimism for the future of medicine. I’m especially delighted to welcome Matt McIlwain and Ben Askew as Board Members who bring decades of experience building high-impact companies across the technology and pharmaceutical industries."

Protein interactions are central to antibody and small-molecule drugs, and AlphaSeq represents the first high-throughput and quantitative approach for measuring protein-protein binding. By leveraging AlphaSeq, partners have been able to accelerate antibody discovery by measuring millions of interactions between antibodies and antigens for high-throughput determination of properties like affinity, specificity, cross-reactivity, and epitope. Instead of narrowly funnelling an antibody library and characterizing the few strongest binders, AlphaSeq allows partners to maintain a wide funnel with thousands of antibodies to avoid missing therapeutic candidates with unique and desirable properties. AlphaSeq is also leveraged for molecular glue target discovery by measuring weak and likely druggable interactions between a library of E3 ubiquitin ligases and a library of neo-substrates.

"When it comes to measuring protein-protein interactions and assisting pharma in the discovery of antibodies and molecular-glue targets, AlphaSeq is unmatched," said Ben Askew Ph.D., Partner, PXV Fund. "AlphaSeq is enabling pharma companies to find the high-value needles in the haystack, a process so prohibitively expensive, rare, or slow that these opportunities might have never been found. We’re thrilled to support A-Alpha Bio’s next phase of growth as they continue to set new standards for protein and molecular glue research."

To date, A-Alpha Bio has worked with a number of partners across the pharmaceutical and biotech industry to advance drug discovery, ranging from mid-sized biotechs to top-ten pharma. Additionally, A-Alpha Bio has ongoing awards from the Bill & Melinda Gates Foundation to support the discovery of therapeutics for infectious diseases and the National Science Foundation to support molecular-glue target discovery and ML-guided antibody discovery.

On September 8, 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 that it has entered into a clinical collaboration and supply agreement with Bristol Myers Squibb (NYSE: BMY) to investigate Bolt Biotherapeutics’ BDC-1001 in combination with Bristol Myers Squibb’s PD-1 checkpoint inhibitor Opdivo (nivolumab) (Press release, Bolt Biotherapeutics, SEP 8, 2021, View Source [SID1234618695]). BDC-1001 is a HER2-targeting Boltbody immune-stimulating antibody conjugate (ISAC) in development for the treatment of patients with HER2-expressing solid tumors .

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"We look forward to working with BMS in our continued development of BDC-1001, which has shown promising results in preclinical and early clinical studies," said Randall Schatzman, CEO of Bolt Biotherapeutics. "Our unique ISAC approach initiates an innate and an adaptive immune response that may be synergistic with BMS’ innovative PD-1 inhibitor Opdivo. The combination of BDC-1001 and Opdivo holds potential as a treatment for cancer patients, and we welcome the opportunity to investigate this in a clinical setting." He added, "We remain grateful to all of the healthcare professionals, scientists, patients, and families involved with Bolt’s clinical studies."

BDC-1001 is a human epidermal growth factor receptor 2 (HER2) ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated to one of Bolt’s proprietary TLR7/8 agonists with an intervening non-cleavable linker, for the treatment of patients with HER2-expressing solid tumors. It is currently being investigated in a Phase 1/2 clinical trial (NCT04278144) in patients with solid tumors, including breast, gastroesophageal and colorectal, that are HER2+ or HER2-low, for which Bolt recently presented preliminary data detailing safety, tolerability, and signs of activity at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The trial is being conducted in four parts, with dose-escalation and dose-expansion parts exploring both monotherapy and combination with a PD-1 checkpoint inhibitor. BMS will provide Opdivo for the combination dose escalation and combination dose expansion portions of the trial. Bolt Biotherapeutics is the study sponsor and will be responsible for costs associated with the trial execution. The combination dose escalation is expected to start later in 2021.

Opdivo is a trademark of Bristol-Myers Squibb Company.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
ISACs are a new category of immunotherapy that combines the precision of antibody targeting with the strength of the innate and adaptive immune systems. Boltbody ISACs are comprised of three primary components: a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant to activate the patient’s innate immune system. By initially targeting a single marker on the surface of a patient’s tumor cells, an ISAC can create a new immune response by activating and recruiting myeloid cells. The activated myeloid cells start a feed-forward loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This reprograms the tumor microenvironment and invokes an adaptive immune response that targets the tumor, with the goal of durable responses for patients with cancer.

On September 8, 2021 AstraZeneca PLC ("AstraZeneca") (LSE/STO/Nasdaq:AZN) reported that they have initiated SANOVO, a China Phase III study of ORPATHYS (savolitinib), an oral, potent, and highly selective MET tyrosine kinase inhibitor ("TKI"), in combination with AstraZeneca’s third-generation, irreversible epidermal growth factor receptor ("EGFR") TKI, TAGRISSO (osimertinib) as a first-line treatment in certain non-small cell lung cancer ("NSCLC") patients whose tumors harbor EGFR mutation and overexpress MET (Press release, Hutchison China MediTech, SEP 8, 2021, View Source [SID1234590537]). The first patient was dosed on September 7, 2021.

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The Phase III trial is a blinded, randomized, controlled study in previously untreated patients with locally advanced or metastatic NSCLC with activating EGFR mutations and MET overexpression. The study will evaluate the efficacy and safety of TAGRISSO in combination with ORPATHYS comparing to TAGRISSO alone, a standard-of-care treatment option for these patients. The primary endpoint of the study is median progression free survival ("PFS") as assessed by investigators. Other endpoints include median PFS assessed by an independent review committee, median overall survival ("OS"), objective response rate ("ORR"), duration of response ("DoR"), disease control rate ("DCR"), time to response (TTR), and safety. Additional details may be found at clinicaltrials.gov, using identifier NCT05009836.

About NSCLC, EGFR and MET Aberrations
Lung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths.[1] More than a third of the world’s lung cancer patients are in China.[2] Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.[3] The majority of NSCLC patients are diagnosed with advanced disease while approximately 25-30% present with resectable disease at diagnosis.[4],[5] For patients with resectable tumors, the majority of patients eventually develop recurrence despite complete tumor resection and adjuvant chemotherapy.[6]

Approximately 10-25% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFR-mutated NSCLC.[7],[8],[9] These patients are particularly sensitive to treatment with an EGFR TKI which blocks the cell-signaling pathways that drive the growth of tumor cells.[10]

MET is a tyrosine kinase receptor.[11] Aberration of MET (amplification or overexpression) is present in both treatment naïve patients as well as being one of the primary mechanisms of acquired resistance to EGFR TKIs for metastatic EGFR-mutated NSCLC. [12],[13]

About Savolitinib (ORPATHYS in China)
Savolitinib is an oral, potent, and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations) or gene amplification.

Savolitinib is marketed in China under the brand name ORPATHYS for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers, as a single treatment and in combination with other medicines.

In 2011, following its discovery and initial development by HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing agreement to jointly develop and commercialize savolitinib. Joint development in China is led by HUTCHMED, while AstraZeneca leads development outside of China. HUTCHMED is responsible for the marketing authorization, manufacturing and supply of savolitinib in China. AstraZeneca is responsible for the commercialization of savolitinib in China and worldwide. Sales of savolitinib are recognized by AstraZeneca.

Savolitinib development in NSCLC
Phase II study of savolitinib monotherapy in MET Exon 14 skipping alteration NSCLC (NCT02897479) – In June 2021, savolitinib was granted drug registration conditional approval by the National Medical Products Administration of China (NMPA) for MET Exon 14 skipping alteration NSCLC. The approval was based on the results of a Phase II study in China; results of this study were published in The Lancet Respiratory Medicine[14]. At a median follow up of 17.6 months, savolitinib demonstrated an ORR of 42.9% (95% confidence interval [CI] 31.1-55.3) and median PFS of 6.8 months (95% CI 4.2-9.6) in the overall trial population. DCR in the overall trial population was 82.9% (95% CI 72.0-90.8). The safety and tolerability profile of savolitinib was consistent with previous trials, and no new safety signals were identified. Continued approval is contingent upon the successful completion of a confirmatory trial in this patient population (NCT04923945).

TATTON Phase Ib/II expansion studies of savolitinib in combination with TAGRISSO in patients who have progressed following EGFR TKI treatment due to MET amplification (NCT02143466) – This global exploratory study in over 220 EGFR mutation positive NSCLC patients with MET amplified tumors following progression after treatment with any EGFR TKI. Results were published in Lancet Oncology[15] and final analysis was presented at the World Conference on Lung Cancer[16]. Three cohorts with patients treated following progression on first- or second-generation EGFR TKI demonstrated an ORR of 64.7-66.7% and a median PFS of 9.0-11.1 months. The cohort of patients treated following progression on a third-generation EGFR TKI demonstrated an ORR of 33.3% (95% CI 22.4-45.7), with a median PFS of 5.5 months (95% CI 4.1-7.7). The combination demonstrated encouraging anti-tumor activity and an acceptable risk-benefit profile.

SAVANNAH Phase II study of savolitinib in combination with TAGRISSO in patients who have progressed following TAGRISSO due to MET amplification or overexpression (NCT03778229) – This is a single-arm, open-label, global study in epidermal growth factor receptor ("EGFR") mutation positive NSCLC patients with MET amplified/overexpressed tumors following progression after treatment with TAGRISSO, an EGFR TKI owned by AstraZeneca.

SACHI Phase III study of savolitinib in combination with TAGRISSO in patients who have progressed following EGFR TKI treatment due to MET amplification (NCT05015608) – This is a randomized, open-label study in China in EGFR mutation positive NSCLC patients with MET amplified tumors following progression after treatment with any EGFR TKI.

SANOVO Phase III study of savolitinib in combination with TAGRISSO in treatment-naïve patients with EGFR mutant positive NSCLC with MET overexpression (NCT05009836) – This is a randomized, blinded study in China in untreated, unresectable or metastatic patients with EGFR mutation positive NSCLC with MET positive tumors.

Savolitinib development in kidney cancer
SAVOIR randomized, controlled study of ORPATHYS monotherapy in MET-driven papillary renal cell carcinoma ("RCC") (NCT03091192) – In May 2020, data from 60 patients in this global study of savolitinib monotherapy compared with sunitinib monotherapy in MET-driven papillary RCC was presented at the ASCO (Free ASCO Whitepaper) 2020 Program and published simultaneously in JAMA Oncology[17]. Savolitinib demonstrated encouraging activity, including an ORR of 27% versus 7% for sunitinib, with no savolitinib responding patients experiencing disease progression at data cut-off, and an encouraging OS hazard ratio of 0.51 (95% CI: 0.21–1.17; p=0.110) with median not reached at data cut-off.

CALYPSO Phase I/II study of savolitinib in combination with IMFINZI PD-L1 inhibitor in RCC (NCT02819596) – The CALYPSO study is an investigator initiated open-label Phase I/II study of savolitinib in combination with IMFINZI, a PD-L1 antibody owned by AstraZeneca. The study is evaluating the safety and efficacy of the savolitinib /IMFINZI combination in patients with papillary RCC and clear cell RCC. An analysis of 41 patients enrolled in the PRCC cohort of in this study was presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting[18], showing a confirmed response rate in 8 out of 14 MET-driven patients, or 57%, with a median DoR of 9.4 months, median PFS of 10.5 months and median OS of 27.4 months. No new safety signals were seen.

SAMETA Phase III study in combination with IMFINZI PD-L1 inhibitor in MET-driven, unresectable and locally advanced or metastatic PRCC (in planning) – Based on the encouraging results of the SAVOIR and CALYPSO studies, we are planning to initiate SAMETA, a global Phase III, open-label, randomized, controlled study of savolitinib plus IMFINZI versus sunitinib monotherapy versus IMFINZI monotherapy in patients with MET-driven, unresectable and locally advanced or metastatic PRCC.

Savolitinib development in gastric cancer
Phase II study of savolitinib monotherapy in advanced or metastatic MET amplified gastric cancer ("GC") or adenocarcinoma of the gastroesophageal junction ("GEJ") (NCT04923932) – This is an open-label, two-cohort, multi-center study to evaluate the efficacy, safety and pharmacokinetics (PK) of savolitinib in locally advanced or metastatic GC or GEJ patients whose disease progressed after at least one line of standard therapy.

Savolitinib development in other cancer indications
Savolitinib opportunities are also continuing to be explored in multiple other MET-driven tumor settings via investigator-initiated studies including colorectal cancer.

About TAGRISSO
TAGRISSO is a third-generation, irreversible EGFR TKI with clinical activity against central nervous system metastases. TAGRISSO (40mg and 80mg once-daily oral tablets) has been used to treat more than 325,000 patients across indications worldwide and AstraZeneca continues to explore TAGRISSO as a treatment for patients across multiple stages of EGFR-mutated NSCLC.

In Phase III trials, TAGRISSO is being tested in the neoadjuvant resectable setting (NeoADAURA), in the Stage III locally advanced unresectable setting (LAURA) and, in combination with chemotherapy, in the Stage III locally advanced or Stage IV metastatic settings (FLAURA2). AstraZeneca is also researching ways to address tumor mechanisms of resistance through the SACHI and SANOVO Phase III trials, as well as the SAVANNAH and ORCHARD Phase II trials, which test TAGRISSO given concomitantly with savolitinib, as well as other potential new medicines.

On September 8, 2021 Candel Therapeutics, Inc. ("the Company") (Nasdaq: CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported financial results for the second quarter ended June 30, 2021 and provided a corporate update (Press release, Candel Therapeutics, SEP 8, 2021, View Source [SID1234587591]).

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"This has been a transformational year for Candel Therapeutics as we continue to execute on our corporate strategy by advancing the development of our lead product candidate from our adenovirus platform, CAN-2409, and our lead product candidate from our HSV platform, CAN-3110, both in areas of significant unmet need," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel Therapeutics. "With the completion of our IPO in August and multiple data readouts across our broad pipeline over the next 12 months, we are in a strong position to advance our strategy and well-capitalized to support achievement of important milestones toward bringing novel immunotherapies to patients with cancer."

Second Quarter 2021 & Recent Highlights

On April 13, the Company announced formation of its new Research Advisory Board that included 2018 Nobel Laureate, James Allison, Ph.D. (MD Anderson Cancer Center), Henry Brem, M.D. (Johns Hopkins University), Roy S. Herbst, M.D., Ph.D. (Yale Cancer Center), Elizabeth Jaffee, M.D. (Johns Hopkins University), Philip Kantoff, M.D. (formerly Memorial Sloan Kettering Cancer Center), and Padmanee Sharma, M.D., Ph.D. (MD Anderson Cancer Center).
On April 22, the Company announced it completed enrollment in a phase 1 clinical trial in patients with newly diagnosed high-grade glioma to evaluate the safety and efficacy of CAN-2409 in combination with Opdivo (nivolumab) and standard of care radiation therapy, as well as temozolomide for patients who have a methylated MGMT promoter.
On June 4, the Company reported data from an ongoing phase 1 clinical trial of its oncolytic virus, CAN-3110, in patients with high-grade glioma that has recurred after initial treatment. The data presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) demonstrated a favorable safety and tolerability profile and durable responses in a number of patients.
On June 22, the U.S. Food and Drug Administration granted Fast Track designation for CAN-2409 in combination with standard-of-care surgery and chemoradiation to improve survival in adults with newly diagnosed high-grade glioma.
On July 15, the Company announced the appointment of Diem Nguyen, Ph.D., M.B.A. to its Board of Directors.
On August 17, the Company announced the completion of its Initial Public Offering, raising gross proceeds of $79.1 million, before deducting underwriting discounts and commissions and offering expenses, to support ongoing research and development efforts.
On September 7, the Company announced it completed enrollment in its phase 3 clinical trial of CAN-2409 in combination with valacyclovir for the treatment of intermediate- to high-risk localized prostate cancer.
Key Upcoming Milestones

Initial efficacy and safety data from a phase 1 clinical trial of CAN-2409 in combination with Opdivo (nivolumab) in patients with high-grade glioma are expected to be presented in the fourth quarter of 2021.
Blinded safety data from a phase 2 clinical trial of CAN-2409 in patients undergoing active surveillance for prostate cancer are expected to be presented in the third quarter of 2021.
Biomarker results from a phase 1 clinical trial of CAN-3110 in patients with recurrent high-grade glioma are expected to be presented in the fourth quarter of 2021.
Financial Results for the Second Quarter Ended June 30, 2021

Cash Position: Cash and cash equivalents as of June 30, 2021, were $24.3 million, as compared to $35.1 million as of December 31, 2020. In August 2021, Candel completed its initial public offering in which the Company issued 9,887,994 shares of common stock at a price of $8.00 per share, including the partial exercise of the underwriters’ overallotment option, for net proceeds of $71.5 million after deducting underwriting discounts and commissions and offering expenses. Based on current plans and assumptions, the Company expects its existing cash and cash equivalents, including the net proceeds of the IPO, will be sufficient to fund its operations into the second quarter of 2023.

Research & Development Expenses: Research and development expenses were $3.3 million and $6.0 million for the three and six months ended June 30, 2021, respectively, as compared to $1.8 million and $3.4 million for the comparable periods of 2020. The increases were primarily due to increased personnel-related costs for additional headcount to support the ongoing clinical trials for Candel’s product candidates as well as increased clinical development costs. Excluding stock-based compensation expense of $0.4 million for the three months ended June 30, 2021, and $0.5 million for the six months ended June 30, 2021, research and development expenses for the three and six months ended June 30, 2021, were $2.9 million and $5.5 million, respectively.

General and Administrative Expenses: General and administrative expenses were $2.0 million and $4.0 million for the three and six months ended June 30, 2021, respectively, as compared to $0.9 million and $1.6 million for the comparable periods of 2020. The increases were primarily due to increased personnel-related costs, including stock-based compensation, additional headcount required to support the growth of the Company, and an increase in professional fees associated with Candel’s preparation for the IPO completed in August 2021. Excluding stock-based compensation expense of $0.7 million for the three months ended June 30, 2021, and $ 1.0 million for the six months ended June 30, 2021, general and administrative expenses for the three and six months ended June 30, 2021, were $1.3 million and $3.0 million, respectively.

Total Operating Expenses: Total operating expenses were $5.3 million and $10.0 million for the three and six months ended June 30, 2021, respectively, as compared to $2.7 million and $5.0 million for the comparable periods of 2020. The increases were primarily due to increased personnel-related costs, including stock-based compensation, for additional headcount required to support the growth of the Company, an increase in professional fees associated with Candel’s preparation for the IPO completed in August 2021 and increased clinical development costs. Excluding stock-based compensation expense of $1.1 million for the three months ended June 30, 2021, and $1.5 million for the six months ended June 30, 2021, total operating expenses for the three and six months ended June 30, 2021, were $4.2 million and $8.5 million, respectively.

Net Loss: Net loss was $17.1 million and $21.6 million for the three and six months ended June 30, 2021, respectively, as compared to $2.9 million and $4.6 million for the comparable periods of 2020. The net loss for the three and six months ended June 30, 2021, includes a noncash charge of $12.4 million for the change in the fair value of the Company’s warrant liability and stock-based compensation of $1.1 million and $1.5 million, respectively. Excluding the noncash charges for the change in the warrant liability and stock-based compensation, the net loss for the three and six months ended June 30, 2021, was $3.6 million and $7.7 million, respectively.