On August 4, 2022 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported financial results and business highlights for the second quarter 2022 (Press release, Sana Biotechnology, AUG 4, 2022, View Source [SID1234617548]).

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"We are pleased with the continued progress this quarter both across our platforms and with our product candidates. We made executive hires in critical operational roles, executed on key pre-IND activities for both SC291 and SG295, made business decisions that extend our cash runway to allow more potential clinical data readouts across multiple drug candidates with our current balance sheet, and presented important preclinical data across multiple platforms at various scientific conferences," said Steve Harr, Sana’s President and Chief Executive Officer. "We are well-positioned with our current resources to file INDs across several platforms with multiple drug products in both 2022 and 2023, and our team is enthusiastic to understand the potential of these medicines to improve outcomes for patients."

Continued progress in building Sana’s hypoimmune ex vivo platform and in vivo fusogen platform with presentations at AACR (Free AACR Whitepaper), ASGCT (Free ASGCT Whitepaper), ADA, and ISSCR

Ex vivo hypoimmune platform (HIP): Sana’s HIP platform makes multiple genomic modifications to cells with the goal of preventing allogeneic transplant rejection, and importantly includes modifications to prevent both adaptive and innate immune recognition and rejection. Presented data showed survival of transplanted allogeneic HIP cells of several different types – including pancreatic islet cells, cardiomyocytes, and retinal pigment epithelial (RPE) cells – in a variety of locations in non-human primates. Sana also presented data showing that HIP allogeneic regulatory T cells function and are able to evade immune detection in preclinical models. These cells have the potential to treat a variety of autoimmune disorders. Finally, Sana scientists presented in vitro and in vivo data showing that exposure to an anti-CD47 antibody leads to elimination of HIP induced pluripotent stem cells (iPSCs) as well as HIP pancreatic islet cells. These data provide a path for a potential safety strategy as well as validation of the mechanism of immune protection. Sana’s pipeline includes HIP-modified cells to replace damaged or missing cells in the body in a number of different diseases, including, among others, cancer, type 1 diabetes, cardiac disease, and various neurologic conditions.
HIP pancreatic islet cells: Type 1 diabetes is a disease where a person’s immune system destroys one’s own pancreatic beta cells, which are a key component in pancreatic islets. Presented data showed that transplanted HIP pancreatic islet cells evade allogeneic immune response and autoimmune response in a type 1 diabetes mouse model. These data build upon previous in vitro data showing that HIP pancreatic islet cells are not recognized by serum from type 1 diabetic patients, including no T cell or antibody recognition. HIP technology is incorporated in SC451, Sana’s islet cell product candidate, which has a goal of filing an IND in 2023 for the treatment of type 1 diabetes.
In vivo fusogen platform: Presented additional preclinical data utilizing retargeted fusosomes for in vivo delivery of genetic payloads to various cells, including CD8+ T cells, CD4+ T cells, and human hepatocytes. This technology is the backbone of Sana’s in vivo delivery platform and is incorporated into various product candidates, including SG295.
Announced expected cash runway into 2025 to enable multiple data readouts across the platforms; largest part of cash savings from plans to relocate manufacturing facility to Bothell, Washington

Expect cash runway into 2025 enabling multiple data readouts across the platforms based on current timelines for lead programs. The extension includes a slowed pace of investment for multiple programs with INDs expected in 2024 and beyond.
Announced decision to move Sana’s manufacturing plant from Fremont, CA to Bothell, WA, resulting in approximately $100 million in expected cost savings over the next three years. As part of this decision, Sana signed a lease agreement to develop an approximately 80,000 square foot manufacturing facility in Bothell, WA. The facility will be designed to support the late-stage clinical and early commercial manufacturing of multiple product candidates across the portfolio.
Announced key executive hires and appointments, building on the company’s scientific excellence and operational capabilities

Strengthened the leadership team with the appointments of Snehal Patel to lead internal and external manufacturing and Julie Lepin to lead regulatory affairs.
Second Quarter 2022 Financial Results

GAAP Results

Cash Position: Cash, cash equivalents, and marketable securities as of June 30, 2022 were $579.6 million compared to $746.9 million as of December 31, 2021. The decrease of $167.3 million was primarily driven by cash used in operations of $149.2 million and cash used for the purchase of property and equipment of $11.9 million. Cash used in operations includes $6.2 million of upfront payments related to licensing technology for our CD22 and BCMA programs, $3.2 million of costs incurred related to the previously planned manufacturing facility in Fremont, CA (the Fremont facility) which will be replaced by the Bothell, WA site (the Bothell facility), as well as multiple cash payments that will not recur this year.

Research and Development Expenses: For the three and six months ended June 30, 2022, research and development expenses, inclusive of non-cash expenses, were $72.5 million and $145.2 million, respectively, compared to $45.0 million and $86.9 million for the same periods in 2021. The increases of $27.5 million and $58.3 million were due to increases in personnel expenses related to increased headcount to expand Sana’s research and development capabilities, increased third-party manufacturing costs for contract development and manufacturing organizations including pass-through costs for materials, facility and other allocated costs, research and laboratory costs, and costs to acquire technology complementary to our own. Research and development expenses for the three and six months ended June 30, 2022 include non-cash stock-based compensation of $7.4 million and $13.1 million, respectively, and $3.1 million and $5.8 million for the same periods in 2021.

Research and Development Related Success Payments and Contingent Consideration: For the three and six months ended June 30, 2022, we recognized non-cash gains of $17.9 million and $73.4 million, respectively, in connection with the change in the estimated fair value of the success payment liabilities and contingent consideration in aggregate, compared to a gain of $76.0 million and an expense of $51.0 million for the same periods in 2021. The value of these potential liabilities can fluctuate significantly with changes in our market capitalization and stock price.

General and Administrative Expenses: General and administrative expenses for the three and six months ended June 30, 2022, inclusive of non-cash expenses, were $18.3 million and $32.7 million, respectively, compared to $12.5 million and $24.3 million for the same periods in 2021. The increases of $5.8 million and $8.4 million, respectively, were primarily due to the write-off of construction in progress costs incurred in connection with the previously planned Fremont facility which will be replaced by the Bothell facility. The increases were also due to personnel-related expenses attributable to an increase in headcount to support our continued research and development activities, increased facility and information technology costs, including rent. These increases were partially offset by a decrease in legal fees. General and administrative expenses for the three and six months ended June 30, 2022 include stock-based compensation of $2.5 million and $4.5 million, respectively, and $1.8 million and $3.3 million for the same periods in 2021.

Net Loss: Net loss for the three and six months ended June 30, 2022 was $72.5 million, or $0.39 per share, and $103.9 million, or $0.56 per share, respectively, compared to net income of $18.7 million, or $0.10 per share, and net loss of $161.9 million, or $1.08 per share for the same periods in 2021.
Non-GAAP Measures

Non-GAAP Operating Cash Burn: Non-GAAP operating cash burn for the six months ended June 30, 2022 was $155.4 million compared to $89.8 million for the same period in 2021. Non-GAAP operating cash burn is the decrease in cash, cash equivalents, and marketable securities, excluding cash inflows from financing activities, cash outflows from business development activities, and the purchase of property and equipment.

Non-GAAP General and Administrative Expense: Non-GAAP general and administrative expense for the three and six months ended June 30, 2022 was $13.8 million and $28.3 million, respectively, compared to $12.5 million and $24.3 million for the same periods in 2021. Non-GAAP general and administrative expense excludes the write-off of construction in progress costs incurred in connection with the previously planned Fremont facility, which will be replaced by the Bothell facility.

Non-GAAP Net Loss: Non-GAAP net loss for the three and six months ended June 30, 2022 was $85.9 million, or $0.47 per share, and $172.8 million, or $0.93 per share, respectively, compared to $57.3 million, or $0.32 per share, and $110.9 million, or $0.74 per share for the same periods in 2021. Non-GAAP net loss excludes certain one-time costs to acquire technology, non-cash expenses related to the change in the estimated fair value of contingent consideration and success payment liabilities, and the write-off of construction in progress costs incurred in connection with the previously planned Fremont facility, which will be replaced by the Bothell facility.
A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under "Non-GAAP Financial Measures."

On August 4, 2022 Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, reported financial results for the second quarter of 2022 (Press release, Schrodinger, AUG 4, 2022, View Source [SID1234617547]).

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"We are very pleased with our performance for the quarter and for the first six months of 2022, with both software and drug discovery revenue contributing to strong growth, and our cash position is strong," stated Ramy Farid, Ph.D., chief executive officer at Schrödinger. "Additionally, we are seeing continued progress across our collaborative and internal drug discovery pipeline. In the second quarter, our investigational new drug application for our MALT1 inhibitor, SGR-1505, was cleared to proceed to Phase 1 clinical development. We are on track to initiate our Phase 1 study of SGR-1505 in patients with relapsed or refractory B-cell lymphoma in the fourth quarter of 2022."

At June 30, 2022, Schrödinger had cash, cash equivalents, restricted cash and marketable securities of approximately $513 million, compared to approximately $529 million at March 31, 2022.

Recent Company Highlights

Collaborative Programs and Internal Pipeline

In June, Schrödinger announced that its investigational new drug (IND) application for its MALT1 inhibitor, SGR-1505, was cleared to proceed to Phase 1 clinical development. Schrödinger expects to initiate a Phase 1 trial of SGR-1505 in patients with relapsed or refractory B-cell lymphoma in the fourth quarter of 2022. The planned multi-center, dose-escalation study will be conducted in patients with relapsed or refractory B-cell lymphoma to evaluate the safety, pharmacokinetics, pharmacodynamics, and early signals of clinical activity of SGR-1505 as a monotherapy. Once the recommended dose is determined, an expansion cohort is planned to evaluate SGR-1505 in combination with other anti-cancer agents, such as BTK and BCL-2 inhibitors, in patients with specific B-cell malignancies.
Schrödinger continues to optimize multiple lead series within its Wee1 program and expects to select a Wee1 development candidate with a differentiated profile by the end of this year and to submit an IND at the end of 2023. Wee1 is emerging as a potentially important therapeutic target for a range of solid tumors, including ovarian and uterine cancer.
Schrödinger continues to advance its CDC7 inhibitor, SGR-2921, through IND-enabling studies. The company expects to submit an IND to the U.S. Food and Drug Administration (FDA) in the first half of 2023 and to initiate a Phase 1 clinical study in the second half of 2023, subject to regulatory clearance. Targeting proteins such as CDC7 that play important roles in DNA replication and replication stress is gaining momentum as a new therapeutic approach based on the proliferative capacity of cancer cells to bypass DNA damage responses.
Schrödinger is progressing multiple undisclosed research programs in the areas of oncology and immunology. In the first half of this year, the company added four new programs to its wholly-owned pipeline, for a total of six early discovery programs, including targets with first-in-class potential.
The company’s collaborative programs continue to progress through discovery, preclinical and clinical development. A total of eight collaborative programs are in the clinic, which underscores the impact of its platform.
Underlying Science

Schrödinger continues to make scientific advances underlying the predictive power of the company’s computational platform. Schrödinger scientists were authors on seven recent publications in peer-reviewed life sciences and materials science journals, including the publication of data validating the use of the company’s recently developed next-generation induced fit docking methods to optimize homology models to enable predictive modeling of targets where experimental structures have been unavailable, broadening the applicability of Schrödinger’s platform. Additionally, Nimbus Therapeutics and Schrödinger scientists co-authored a manuscript based on data from the companies’ ongoing collaboration describing how Schrödinger’s predictive computational methods accelerated Nimbus’s discovery of potent, selective Tyk2 inhibitors with activity in preclinical models of psoriasis.
In June, Schrödinger hosted its second annual Educator’s Day, which brought together educators from across the globe to discuss the growing opportunity for incorporating computational tools in the classroom. Schrödinger is committed to empowering and training the next generation of computational scientists, and Educator’s Day is one component of Schrödinger’s ongoing educational initiatives.
2022 Financial Outlook

As of August 4, 2022, Schrödinger maintained the following expectations for the fiscal year ending December 31, 2022:

Total revenue expected to range from $161 million to $181 million, representing 17 percent to 31 percent growth over 2021
Total software revenue expected to range from $126 million to $136 million, representing 11 percent to 20 percent growth over 2021
Total drug discovery revenue expected to range from $35 million to $45 million, representing 42 to 82 percent growth over 2021
Operating expense growth is expected to be slightly lower than the 42 percent reported for the year ended December 31, 2021
Software gross margin percentage is expected to be in the mid-70s
For the third quarter of 2022, software revenue is expected to range from $23 million to $25 million.

Webcast and Conference Call Information

Schrödinger will host a conference call to discuss its second quarter 2022 financial results on Thursday, August 4, 2022, at 4:30 p.m. ET. The live webcast can be accessed under "News & Events" in the investors section of Schrödinger’s website, View Source To participate in the live call, please register for the call here. It is recommended that participants register at least 15 minutes in advance of the call. Once registered, participants will receive the dial-in information. The archived webcast will be available on Schrödinger’s website for approximately 90 days following the event.

On August 4, 2022 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, reported second quarter 2022 financial results and provided a business update (Press release, NextCure, AUG 4, 2022, View Source [SID1234617546]).

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"We have set the stage for multiple clinical data updates in the second half of this year for our NC318, NC410, and NC762 programs as well as an IND filing for NC525," said Michael Richman, NextCure’s president and chief executive officer. "We expect our strong cash position of $185.5 million as of June 30, 2022 will fund our operations into the first quarter of 2024."

Business Highlights

NC318

Announced the publication of a paper titled "Development of an Immunohistochemical Assay for Siglec-15" in Laboratory Investigation. The publication outlines data from a study, conducted in collaboration with researchers in the Department of Pathology at Yale School of Medicine, utilizing a newly developed antibody to Siglec-15 (S15) and an immunohistochemical (IHC) assay to investigate S15 expression in solid tumors.
NC410

Presented in vivo data at the 2022 Extracellular Matrix (ECM) Pharmacology Congress in Copenhagen that demonstrated NC410 remodels tumor ECM, enhances immune cell infiltration, alleviates immunosuppression, and reduces tumor growth in a humanized mouse tumor model.
Announced that collaborator Brahm Segal, M.D., of Roswell Park Comprehensive Cancer Center shared nonclinical data from a research study that models the ability of NC410 to block neutrophil-mediated suppression of T cells in a tumor microenvironment (TME) at the 24th Translational Research Cancer Centers Consortium Annual Meeting. In addition, NextCure appointed Dr. Segal to its Scientific Advisory Board (SAB).
Expected Upcoming Milestones

The company remains on track for the following 2022 milestones:

NC318 (S15 mAb) Phase 2 update: fourth quarter of 2022 (Amended Phase 2 with patient selection and increased dosing).
NC318 (S15 mAb) anti-PD-1 combo initial data: second half of 2022 (Yale University Investigator-Initiated trial).
NC410 (LAIR-2 fusion) Phase 1 update: second half of 2022.
NC762 (B7-H4 mAb) Phase 1 initial data: second half of 2022.
NC525 (LAIR-1 mAb) Investigational New Drug (IND) Application filing: fourth quarter of 2022.
Financial Guidance

Based on its current research and development plans, NextCure expects its existing cash, cash equivalents and marketable securities will enable it to fund operating expenses and capital expenditures into the first quarter of 2024.

Financial Results for Quarter Ended June 30, 2022

Cash, cash equivalents, and marketable securities, excluding restricted cash as of June 30, 2022, were $185.5 million as compared to $219.6 million as of December 31, 2021. The decrease of $34.1 million primarily related to cash used to fund operations, cash used to purchase fixed assets, and changes in the fair value of our marketable securities.
Research and development expenses were $12.8 million for the quarter ended June 30, 2022, as compared to $11.9 million for the quarter ended June 30, 2021. The increase of $0.9 million was driven primarily by additional clinical and lab-related costs.
General and administrative expenses were $5.3 million for the quarter ended June 30, 2022, as compared to $6.0 million for the quarter ended June 30, 2021. The decrease of $0.7 million was primarily related to reduced professional services and personnel-related costs.
Net loss was $17.9 million for the quarter ended June 30, 2022, as compared with a net loss of $18.0 million for the quarter ended June 30, 2021. The changes in net loss from the previous year’s quarter was primarily due to higher interest income and lower general administrative expenses offset by increased research and development expenses.

On August 4, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune and Infectimune T cell activating technologies, reported that its independent Data Monitoring Committee (DMC) met for its scheduled review of PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) for the potential treatment of recurrent or metastatic HPV16-positive head and neck cancer (Press release, PDS Biotechnology, AUG 4, 2022, View Source [SID1234617545]).

Data from the 43 patients included both Stage 1 and Stage 2 checkpoint inhibitor (CPI) naïve subjects and Stage 1 CPI refractory subjects in the safety analysis. Assessment of clinical efficacy was not a focus of the DMC meeting review. Based on their review of patients with available safety data, PDS0101 in combination with KEYTRUDA continues to appear safe and well tolerated. Specifically, there were no drug discontinuations related to toxicity as of the DMC review. In addition, there were no Grade 3 or greater treatment-related adverse events attributed to the combination. The DMC recommended continuing the trial with no modifications.

"The safety profile of PDS0101 in combination with KEYTRUDA was consistent with previously reported studies of KEYTRUDA alone." mentioned Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "The safety data in patients with recurrent or metastatic HPV16-positive head and neck cancer continues to appear to be well tolerated. We look forward to evaluating this further in the VERSATILE-002 trial."

VERSATILE-002 enrollment has progressed to Stage 2 for the checkpoint inhibitor (CPI) naive cohort and is ongoing in Stage 1 for the CPI refractory cohort. The DMC is comprised of an independent group of clinical and scientific leaders in the field of immuno-oncology and is responsible for reviewing and evaluating patient safety and efficacy data in the Phase 2 VERSATILE-002 trial.

KEYTRUDA is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About VERSATILE-002

VERSATILE-002 is a single-arm Phase 2 trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech’s proprietary Versamune technology, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab). The combination is being evaluated in CPI-naïve and CPI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.

In June 2022, preliminary efficacy and safety data were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting for CPI-naïve patients (PR link). Preliminary data from the first 19 patients demonstrated that 77% of the patients with available imaging (17 of 19) had either disease stabilization or tumor shrinkage. Additionally, the overall survival rate of these patients at 9-months was 87%.

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On August 4, 2022 Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, reported recent business progress and financial results for the second quarter June 30, 2022 (Press release, Aligos Therapeutics, AUG 4, 2022, View Source [SID1234617544]).

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"In the second quarter, we continued to make strong progress in advancing our drug candidates and discovery programs," said Lawrence Blatt, PhD, MBA, CEO and Chairman of the Board at Aligos. "We completed enrollment in multiple cohorts across our Phase 1 CAM-2 and NASH studies and presented posters for these and other drug candidates and discovery programs at the recent International Liver Congress meeting hosted by the European Association for the Study of the Liver (EASL). We are similarly off to a strong start in Q3, where we have initiated enrollment in a 12-week cohort evaluating the safety and chronic suppressive activity of ALG-000184 in chronic hepatitis B (CHB) patients. We also remain on track to submit a clinical trial application (CTA) this quarter to evaluate our siRNA drug candidate, ALG-125755, in healthy volunteers and CHB patients. We believe our siRNA, which is designed to lower HBsAg levels, is an important addition to our clinical portfolio and has the potential to be a cornerstone of our functional cure strategy."

Recent Business Progress

Aligos Portfolio of Drug Candidates

HBV Programs

ALG-000184 (CAM-2): Enrollment of HBeAg positive subjects in 28-day and 12-week cohorts evaluating various dose levels is ongoing. We plan to share data from HBeAg positive cohorts at a scientific conference in Q4 2022.
ALG-125755 (siRNA): Phase 1 enabling nonclinical studies are nearly complete. We are on track to file a CTA in Q3 2022 to enable the evaluation of the safety, tolerability, pharmacokinetics, and antiviral activity of ALG-125755. Dosing is planned to begin in healthy volunteers in Q4 2022 and in CHB subjects
in Q1 2023.
NASH

ALG-055009: Enrollment of hyperlipidemic subjects in all 4 cohorts of the multiple ascending dose portion of our Phase 1 study is now complete. We are currently analyzing these data and remain on track to share top line data from the single and multiple ascending dose portions of this study in Q3 2022.

COVID-19 3CL Protease Inhibitor (PI) Program

ALG-097558: Evaluation of ALG-097558 in the hamster SARS-CoV-2 infection model indicates that when dosed prior to infection or up to 24 hours post-infection, the compound causes a significant reduction in the levels of infectious virus in the lungs.
Phase 1 enabling nonclinical studies are on track to be initiated in H2 2022. A subsequent CTA filing for a Phase 1 study evaluating the safety and pharmacokinetics of ALG-097558 in healthy volunteers is planned for Q1 2023.
COVID-19 3CL Protease Inhibitor Resistance Profiling

The potential for the emergence of viral resistance to 3CL protease inhibitors used to treat COVID-19 is of considerable concern. Together with our collaborators at KU Leuven, including its Centre for Drug Design and Discovery (CD3), a drug discovery unit and investment fund of KU Leuven, and the Rega Institute for Medical Research, we have begun to investigate the viral resistance profile of our 3CL protease inhibitors. A resistant mutant was derived by incubating SARS-CoV-2 infected cells with an early lead compound, ALG-097161. We identified a combination of 3 amino acid substitutions in the 3CL protease (L50F E166A L167F) that are associated with a greater than 50-fold increase in the EC50 values for ALG-097161 and PF-07321332 (nirmatrelvir) when assessed in a biochemical assay. In contrast, when ALG-097558 was profiled against the L50F E166A L167F resistant mutant, only a 3-fold shift in the EC50 value was observed. Experiments to further evaluate the viral resistance profile of ALG-097558 are currently ongoing.

Financial Results for the Second Quarter 2022

Cash, cash equivalents and investments totaled $159.3 million as of June 30, 2022, compared with $205.8 million as of December 31, 2021. We continue to believe our cash balance provides sufficient cash to fund planned operations into the first half of 2024.

Net losses for the three months ended June 30, 2022, were $19.9 million or basic and diluted net loss per common share of ($0.47), compared to net losses of $29.8 million or basic and diluted net loss per common share of $(0.79) for the three months ended June 30, 2021.

Research and development (R&D) expenses for the three months ended June 30, 2022, were $16.5 million compared with $24.6 million for the same period of 2021. The decrease in R&D expenses for this comparative period is primarily attributable to our continued wind-down related to the discontinuation of our STOPS and ASO programs offset by our expenditures related to the ongoing development and manufacturing activities associated with our CAM and NASH clinical program activities. Total R&D stock-based compensation expense incurred for the three months ended June 30, 2022, was $2.2 million compared with $2.0 million for the same period of 2021.

General and administrative (G&A) expenses for the three months ended June 30, 2022, were $7.6 million compared with $6.6 million for the same period of 2021. The increase in G&A expenses for this comparative period is primarily attributable to routine employee and facility related costs. Total G&A stock-based compensation expense incurred for the three months ended June 30, 2022, was $1.8 million compared with $1.5 million for the same period of 2021.