On May 12, 2022 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported corporate updates and financial results for the first quarter ended March 31, 2022 (Press release, CymaBay Therapeutics, MAY 12, 2022, View Source [SID1234614345]).

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Sujal Shah, President and CEO of CymaBay, stated, "Despite facing ongoing external challenges, we have made steady progress over the past few months enrolling patients in RESPONSE, our second, global phase 3 registration study of seladelpar for patients with primary biliary cholangitis (PBC). We now have over 150 clinical sites activated across 26 countries where we have continued to increase our direct site engagement initiatives. As we approach what we project to be the final months of screening, we have greater visibility into monthly metrics and forecast completion of enrollment in the third quarter. We were also excited to have the results of our 52-week, open-label, Phase 2 study of seladelpar in patients with PBC published in the Journal of Hepatology last month. The opportunity to have these data featured in one of the world’s preeminent medical journals for liver diseases elevates seladelpar’s visibility as a differentiated drug candidate for patients with PBC. Finally, we have continued to navigate the difficult market environment with a focus on diligent expense management leaving us with a strong balance sheet after completing two successful financings in 2021. In the first quarter, we received the third $25 million funding tranche from our non-dilutive, clinical funding agreement with Abingworth and ended the quarter with $193 million of cash, cash equivalents and investments."

Recent Corporate Highlights

Moving towards completion of enrollment in RESPONSE, a 52-week, placebo-controlled, randomized, global, Phase 3 registrational study evaluating the safety and efficacy of seladelpar in patients with PBC. This study is targeting enrollment of 180 patients who have an inadequate response to, or intolerance to, ursodeoxycholic acid, in a 2:1 randomization to oral, once daily seladelpar 10 mg or placebo. The primary outcome measure is the responder rate at 52 weeks. A responder is defined as a patient who achieves an alkaline phosphatase level < 1.67 times the upper limit of normal with at least a 15% decrease from baseline and has a normal level of total bilirubin. Additional key outcomes of efficacy will compare the rate of normalization of alkaline phosphatase at 52 weeks and the level of pruritus at 6-months for patients with moderate to severe pruritus at baseline assessed by a numerical rating scale recorded with an electronic diary. To date we have over 150 sites activated across 26 countries.
Continued strong enrollment in ASSURE, an open-label, long-term study of seladelpar in patients with PBC intended to collect additional long-term safety data to support registration. In April, we successfully rolled over patients completing RESPONSE into ASSURE. Together with patients that entered into ASSURE from prior studies with seladelpar, there are now approximately 140 patients in this study taking daily seladelpar.
Supported enrollment efforts in a Phase 2a proof-of-pharmacology study to evaluate the potential for MBX-2982, a GPR119 agonist, to prevent hypoglycemia in patients with type 1 diabetes. The study is being conducted by the AdventHealth Translational Research Institute in Orlando, Florida and fully funded by The Leona M. and Harry B. Helmsley Charitable Trust with CymaBay retaining full rights to MBX-2982.

Published results from Phase 2, 52-week study of seladelpar in patients with primary biliary cholangitis (PBC) in the Journal of Hepatology. This 52-week, phase 2, dose-ranging, open-label study examined the efficacy and safety of seladelpar in PBC patients who were receiving or intolerant to first-line therapy with ursodeoxycholic acid., The results included:

An interim primary efficacy analysis of ALP change from baseline at Week 8 found that seladelpar treatment provided 26%, 33%, and 41% reductions for the 2 mg, 5 mg and 10 mg doses, respectively (all p<0.005).
Responses were maintained or improved at Week 52, which included dose escalation in 91% and 80% of the 2 mg and 5 mg cohorts, respectively.
At Week 52, the composite biochemical response (ALP <1.67×ULN, ≥15% ALP decrease from baseline, and normal total bilirubin) rates were 64%, 53%, and 67%, and ALP normalization rates were 9%, 13%, and 33% in the 2 mg, 5 mg, and 10 mg cohorts, respectively.
The pruritus visual analog scale score decreased in the 5 mg and 10 mg cohorts.
There were no treatment-related serious adverse events (AEs), and 4 patients discontinued due to AEs.
Expanded the Board of Directors to include Dr. Éric Lefebvre, the Chief Medical Officer of Pliant Therapeutics. Prior to joining Pliant, Dr. Lefebvre served as the Vice President of Research and Development of Allergan plc and before that was Chief Medical Officer of Tobira Therapeutics, Inc. Dr. Lefebvre also led global clinical development and global medical affairs at Janssen Pharmaceuticals for 10 years prior to starting his pharmaceutical career at GlaxoSmithKline Canada.
Received $25 million of funding in January 2022 from Abingworth through a non-dilutive financing agreement for the development of seladelpar, which was executed in July 2021. $75 million has been received to date through the financing agreement. CymaBay also has an option to receive an additional $25 million after the completion of enrollment of the RESPONSE clinical trial.
Held $193.4 million in cash, cash equivalents and investments as of March 31, 2022. We believe that cash and investments on hand, together with committed capital available through the development financing agreement with Abingworth, is sufficient to fund CymaBay’s operating plan through 2023.
First Quarter Ended March 31, 2022 Financial Results

Research and development expenses for the three months ended March 31, 2022 and 2021 were $18.4 million and $12.4 million, respectively. Research and development expenses in the three months ended March 31, 2022 were higher than the corresponding period in 2021 primarily due to an increase in clinical trial activities associated with the ongoing late-stage development of seladelpar in PBC. In particular, cost increases were primarily driven by an expansion of our site activation, patient enrollment, and other clinical trial activities associated with RESPONSE and ASSURE, our two active global late-stage clinical trials in PBC.

General and administrative expenses for the three months ended March 31, 2022 and 2021 were $6.1 million and $5.2 million, respectively. General and administrative expenses in the three months ended March 31, 2022 were higher than the corresponding period in 2021 due to higher employee compensation associated with the hiring of additional personnel and an increase in consulting and other expenses to support our late-stage development of seladelpar in PBC.

Net loss for the three months ended March 31, 2022 and 2021 was $27.8 million and $17.6 million, or ($0.32) and ($0.25) per diluted share, respectively. Net loss was higher largely due to increases in clinical operating expenses, as clinical activity related to our late-stage development of seladelpar in PBC continued to expand and accretion of interest expense related to the Abingworth development financing arrangement. We expect our operating expenses to increase in the future as we continue to execute on our clinical development plans.
Conference Call Details

CymaBay will host a conference call today at 4:30 p.m. ET to discuss fourth quarter and fiscal year end 2021 financial results and provide a business update. To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13728967. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

On May 12, 2022 Day One Biopharmaceuticals (Nasdaq: DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported financial results for the first quarter of 2022 and highlighted recent corporate achievements (Press release, Day One, MAY 12, 2022, View Source [SID1234614363]).

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"We continue to make excellent progress across our clinical programs and look forward to reporting initial data from our pivotal Phase 2 FIREFLY-1 trial in relapsed pLGG next month," said Jeremy Bender, Ph.D., chief executive officer of Day One. "These initial data will provide preliminary insights into the potential of tovorafenib to transform patient care for the most common childhood brain cancer, which currently has no approved therapies. Beyond FIREFLY-1, we are preparing to initiate a pivotal Phase 3 study, FIREFLY-2, for the first-line treatment of pLGG patients and recently initiated the combination portion of our Phase 2 FIRELIGHT-1 study with tovorafenib and our investigational oral MEK inhibitor, pimasertib. As our clinical programs advance, we continue to accelerate planning for our first potential regulatory submission for tovorafenib in 2023 and execute on our business strategy to make an impact for patients of all ages with life threatening diseases."

Program Highlights

Initial data from FIREFLY-1, a pivotal Phase 2 clinical trial of tovorafenib in relapsed pLGG, is expected in June 2022.

Day One anticipates releasing topline results from the fully-enrolled pivotal study in the first quarter of 2023. Pending positive results from FIREFLY-1, Day One anticipates filing a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) in 2023.

Day One has expanded the FIREFLY-1 study to include two additional study arms:

An expanded access arm that enables treatment for eligible patients once the primary cohort has completed enrollment; and
An advanced solid tumor arm to evaluate the preliminary efficacy of tovorafenib in patients aged 6 months to 25 years with a relapsed or progressive extracranial solid tumors with activating RAF fusion.

Day One plans to initiate a pivotal Phase 3 clinical trial (FIREFLY-2) evaluating tovorafenib as a front-line therapy in pLGG in the second quarter of 2022.

Day One is enrolling patients in the Phase 2 FIRELIGHT-1 trial evaluating tovorafenib monotherapy in adults with recurrent, progressive, or refractory solid tumors harboring MAPK pathway aberrations. Day One recently expanded FIRELIGHT-1 to include a Phase 1b/2 portion to evaluate tovorafenib in combination with pimasertib, Day One’s investigational MEK inhibitor.
First Quarter 2022 Financial Highlights

Cash Position: Cash and cash equivalents totaled $262.7 million on March 31, 2022. Based on Day One’s current operating plan, management believes it has sufficient capital resources to fund anticipated operations into 2024.

R&D Expenses: Research and development expenses were $15.0 million for the first quarter of 2022 compared to $12.6 million for the first quarter of 2021. The increase was primarily due to additional employee compensation costs, clinical trial and product development expenses which were offset by a decrease in milestone payments for licensing agreements.

G&A Expenses: General and administrative expenses were $12.7 million for the first quarter of 2022 compared to $3.5 million for the first quarter of 2021. The increase was primarily due to additional employee compensation costs, initial commercial buildout, and professional expenses to support company growth.

Net Loss: Net loss totaled $27.7 million for the first quarter of 2022 compared to $16.1 million for the first quarter of 2021 with non-cash stock compensation expense of $6.2 million and $0.5 million for the first quarters of 2022 and 2021, respectively.
Upcoming Events

2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
A trial-in-progress poster on Day One’s FIREFLY-1 pivotal study, abstract number TPS10062, will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting on Monday, June 6, 2022, from 8 to 11 a.m. CST.

The 20th International Symposium on Pediatric Neuro-Oncology (ISPNO) Annual Meeting
An educational exhibit on Day One’s pipeline will be displayed at Booth #F.05, at ISPNO’s Annual Meeting, which is being held June 12-15, 2022.
About Tovorafenib
Tovorafenib is an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway, which is being investigated in primary brain tumors or brain metastases of solid tumors. Tovorafenib has been studied in over 250 patients to date. Currently tovorafenib is under evaluation in a pivotal Phase 2 clinical trial (FIREFLY-1) among pediatric, adolescent and young adult patients with pediatric low-grade glioma (pLGG), which is an area of considerable unmet need with no approved therapies. Tovorafenib is also being evaluated alone or as a combination therapy for adolescent and adult patient populations with recurrent or progressive solid tumors with MAPK pathway aberrations (FIRELIGHT-1). Tovorafenib has been granted Breakthrough Therapy and Rare Pediatric Disease designations by the U.S. Food and Drug Administration (FDA) for the treatment of patients with pLGG harboring an activating RAF alteration. Tovorafenib has also received Orphan Drug designation from the FDA for the treatment of malignant glioma, and from the European Commission (EC) for the treatment of glioma.

About Pimasertib
Pimasertib is an investigational, oral, highly selective, small molecule inhibitor of mitogen‐activated protein kinases 1 and 2 (MEK-1/-2) within the MAPK signaling pathway. Pimasertib has been dosed in over 850 patients to date for various tumor types. Preclinical data indicates that the combination of a MEK inhibitor, such as pimasertib, and a type II RAF inhibitor, such as tovorafenib, has synergistic anti-tumor activity.

Day One is conducting a Phase 1b/2 study (FIRELIGHT-1) to evaluate the safety, tolerability, and preliminary efficacy of combining pimasertib with tovorafenib in adolescent and adult patients (≥12 years of age) with recurrent, progressive, or refractory solid tumors with MAPK pathway aberrations.

On May 12, 2022 Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, reported financial results for the first quarter ended March 31, 2022 and provided an update on pipeline programs (Press release, Synlogic, MAY 12, 2022, View Source [SID1234614379]).

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"We are pleased to share this progress as we seek to advance our novel phenylketonuria (PKU) program towards Phase 3 initiation," said Synlogic President and Chief Executive Officer Aoife Brennan, M.B. Ch.B. "We believe that we have a unique opportunity to advance a potential treatment for the 55,000 people around the globe with PKU, of whom more than 75% remain in need of additional treatment options – either monotherapy or adjunctive. We are pleased with the progress across our additional programs with expected milestones in 2022, including our homocystinuria (HCU) and enteric hyperoxaluria programs, as well as research progress including our ongoing collaborations with Ginkgo Bioworks and Roche."

Anticipated Upcoming Milestones

Report additional Phase 2 data and final candidate selection for PKU program in H2 2022

Initiate the Phase 3 trial for the PKU program in H1 2023 with Phase 3 readiness activities currently underway

Share data from the Phase 1 trial in healthy volunteers for SYNB1353 in H2 2022

Share proof of concept data for SYNB8802 for enteric hyperoxaluria in H2 2022
Recent Business Highlights

Michael Jensen joined Synlogic as CFO in March 2022

Participation and data presentations at scientific congresses described below:

PKU and HCU program data were presented at inborn errors of metabolism congresses including the Society for Inherited Metabolic Disorders (SIMD) Annual Meeting, the Genetic Metabolic Dietitians International (GMDI) 2022 Conference, and the Garrod Symposium 2022

From Synlogic’s Research team, five different programs were represented at the 2022 Synthetic Biology: Engineering, Evolution & Design (SEED) Conference covering preclinical and clinical work in PKU, HCU, enteric hyperoxaluria, inflammatory bowel disease (IBD), and gout

From Process Development & Manufacturing Sciences (PDMS) at Synlogic, a presentation at the 2022 18th Annual Protein Engineering & Cell Therapy Summit (PEGS) Boston Conference & Expo
First Quarter 2022 Financial Results

As of March 31, 2022, Synlogic had cash, cash equivalents and short-term investments of $120.5 million.

Revenue was $0.2 million for the three months ended March 31, 2022. Revenue in 2022 was associated with the ongoing research collaboration with Roche for the discovery of a novel Synthetic Biotic for the treatment of IBD. There was no revenue for the three months ended March 31, 2021.

For the three months ended March 31, 2022, Synlogic reported a consolidated net loss of $15.7 million, or $0.22 per share, compared to a consolidated net loss of $15.0 million, or $0.36 per share, for the corresponding period in 2021.

Research and development expenses were $11.7 million for the three months ended March 31, 2022 compared to $11.2 million for the corresponding period in 2021.

General and administrative expenses were $4.3 million for the three months ended March 31, 2022 compared to $3.9 million for the corresponding period in 2021.

Financial Outlook

Based upon its current operating plan and balance sheet as of March 31, 2022, Synlogic expects to have sufficient cash to be able to fund operations into 2024.

Investor & Industry Conference Participation

Synlogic will participate in the following upcoming investor and industry conferences:

RBC Capital Markets Global Healthcare Conference. Dr. Brennan will provide a Company presentation on Wednesday, May 18, 2022 at 8:30 am ET during the RBC Capital Markets Global Healthcare Conference to be held in New York City from May 17-18, 2022.

The H.C. Wainwright Global Investment Conference. Chief Financial Officer Michael Jensen and Chief Business Officer Molly Harper will provide a company presentation on Wednesday, May 25, 2022 at 10:30 am ET during the H.C. Wainwright Global Investment Conference taking place from May 23- 26, 2022 in Miami, Florida.

BIO International Convention. Synlogic will participate in the BIO International Convention taking place from June 13-16, 2022 in San Diego, California, including a company presentation by Ms. Harper.
Live webcasts of the presentations, if available, will be accessible under the "Event Calendar" in the Investors & Media section of the Synlogic website. Archived versions will be available afterwards at the same location.

Conference Call & Webcast Information

Synlogic will host a conference call and live webcast at 8:30 a.m. ET today, May 12, 2022. To access the live webcast, please visit the "Event Calendar" page within the Investors and Media section of the Synlogic website. Investors may listen to the call by dialing +1 (844) 815-2882 from locations in the United States or (213) 660-0926 from outside the United States. The conference ID number is 5149412. A replay will be available for 30 days on the Investors and Media section of the Synlogic website.

On May 12, 2022 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported its financial results for the quarter ended March 31, 2022 (Press release, Moleculin, MAY 12, 2022, View Source [SID1234614396]). The Company also provided an update on its portfolio of oncology drug candidates for the treatment of highly resistant tumors and viruses.

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"We have continued to make excellent progress across our entire pipeline since the start of 2022, paving the way for important data readouts throughout this year," commented Walter Klemp, Chairman and CEO of Moleculin. "Importantly, our clinical and regulatory strategies have expanded significantly outside of the U.S. and we recently bolstered the expertise of our leadership team to drive our EU clinical trials forward. Our development programs for Annamycin in STS lung mets and AML, as well as WP1122 for COVID-19 and GBM continue to advance. With the progress we’ve made and the milestones ahead, 2022 is poised to be an important year for not only providing more clarity for each clinical program’s path towards registration, but also an opportunity to unlock value for all stakeholders, and importantly, addressing unmet needs for people with highly resistant tumors and viruses."

Recent Highlights
Received required authorizations for an amendment to commence a Phase 1a clinical trial of WP1122 in the United Kingdom (UK) for the treatment of COVID-19.
Received allowance from the Polish Department of Registration of Medicinal Products (URPL), as well as the requisite Ethics Committee approval, to proceed with its Phase 1/2 clinical trial in Poland of Annamycin (L-ANN) in combination with Cytarabine (Ara-C) in the treatment of subjects with acute myeloid leukemia (AML) who are refractory to or relapsed after induction therapy.
Engaged Wolfram C. M. Dempke, MD, PhD, MBA as its European Chief Medical Officer and part-time contractor for its European clinical trials.
Received IND clearance to conduct Phase 1 study of WP1066 for the treatment of recurrent malignant glioma.
Presented preclinical data at the AACR (Free AACR Whitepaper) 2022 Annual Meeting demonstrating Annamycin exhibited robust antitumor activity in experimental colorectal cancer liver and lung metastasis models.
Launched new corporate branding and website.
Programs Update
Next Generation Anthracycline – Annamycin
Annamycin is the Company’s next-generation anthracycline that has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin, as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines. Importantly, Annamycin has also demonstrated a lack of cardiotoxicity in multiple human clinical trials, including ongoing trials for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases, and the Company believes that the use of Annamycin may not face the same usage limitations imposed on doxorubicin, one of the most common currently prescribed anthracyclines. Annamycin is currently in development for the treatment of AML and STS lung metastases and the Company believes it may have the potential to treat a number of additional indications.

Annamycin currently has Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of STS lung metastases, in addition to Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia.

For more information about the Phase 1b/2 study evaluating Annamycin for the treatment of STS lung metastases, please visit clinicaltrials.gov and reference identifier NCT04887298.

Upcoming Milestones Expectations
Q2 2022: Commence Phase 1/2 study in Europe for the treatment of AML evaluating combination therapy of Annamycin + Ara-C.
Q2 2022: Commencement of an investigator-funded, second Phase 1b/2 clinical trial of Annamycin in sarcoma lung metastases in Europe.
Q2 2022: Report topline data from Phase 1b portion of ongoing Phase 1b/2 study of Annamycin for the treatment of sarcoma lung metastases in the US.
Metabolism/Glycosylation Inhibitor – WP1122
WP1122, the Company’s lead metabolism/glycosylation inhibitor, is a prodrug of a well-known glucose decoy called 2-deoxy-D-glucose (2-DG), currently being developed by an unrelated third party in India for inhibition of viral replication and disease manifestations in humans infected with SARS-CoV-2, the virus responsible for COVID-19. The Company is also evaluating WP1122 for the treatment of Glioblastoma Multiforme (GBM). The mechanism of action of 2-DG includes both the inhibition of glycolysis and the disruption of glycosylation, two processes that are important to both viral activity and tumor development. WP1122 was developed as a 2-DG prodrug to provide a more favorable pharmacological profile, and was found to have greater potency than 2-DG alone in preclinical models where tumor cells require higher glycolytic activity than normal cells. WP1122 has also been shown to have a more potent antiviral effect than 2-DG against SARS-CoV-2 in MRC-5 cells (one of the most common human-derived cell lines used for antiviral research) in culture.

COVID-19

The Company has received authorization from the Medicines and Healthcare Products Regulatory Agency (MHRA) to commence a Phase 1a clinical trial of WP1122 in the United Kingdom (UK). The Company also received a favorable opinion from the London – Riverside Research Ethics Committee in the UK to begin the study, which is expected to be conducted at the Medicines Evaluation Unit in Manchester, United Kingdom. In May 2022, the Company received approval from both the Riverside Ethics Committee and the MHRA for its amended study protocol to update the dilution of the oral solution to achieve full dissolution of WP1122. No risk/benefit to the study was affected because of this change. The Phase 1a study in healthy human volunteers will investigate the effects of a single ascending dose (SAD) and multiple days of ascending dosing (MAD) of WP1122 administered as an oral solution. Dose escalation will take place in sequential SAD cohorts, and MAD will start as soon as SAD has completed at least 3 dosing cohorts in which WP1122 is found to be safe and well-tolerated. This study in healthy volunteers will explore safety and pharmacokinetics (PK), and subsequent clinical development will be in patients infected with SARS-CoV-2 to further evaluate safety and establish a favorable risk/benefit profile. The Company expects to enroll approximately 80 healthy volunteers in the United Kingdom.

Glioblastoma Multiforme

Additionally, Moleculin recently received IND clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 open label, single arm, dose escalation study of the safety, pharmacokinetics and efficacy of oral WP1122 in adult patients with GBM, which the Company expects to commence in 2022.

Upcoming Milestones Expectations
Q2 2022: Commence recruitment in Phase 1a study of WP1122 for the treatment of COVID-19 in the UK.
H2 2022: Potential to launch Phase 2 study of WP1122 for the treatment of COVID-19 outside of the US.
2022: Identify investigators interested in initiating a Phase 1 open label, single arm, dose escalation study of the safety, pharmacokinetics and efficacy of oral WP1122 in adult patients with GBM.
Ongoing preclinical development work in additional anti-viral indications such as HIV, Zika, and Dengue. Collaborations targeted for 2022.
Summary of Financial Results for the First Quarter 2022
Research and development (R&D) expense was $4.6 million and $4.1 million for the three months ended March 31, 2022 and 2021, respectively. The increase of $0.5 million is mainly related to increased clinical trial activity as described above, a license termination fee, and costs related to manufacturing of additional drug product.

General and administrative expense was $2.4 million and $1.9 million for the three months ended March 31, 2022 and 2021, respectively. The increase of $0.5 million is mainly related to an increase in regulatory legal services, consulting and advisory fees.

For the three months ended March 31, 2022 and 2021, the Company reported a net loss of $6.9 million and $4.4 million, respectively, and had net cash flows used in operating activities of $4.8 million and $3.6 million, respectively.

The Company ended the quarter with $66.1 million of cash. The Company believes that this cash is sufficient to meet its projected operating requirements, which include a forecasted increase over its current R&D rate of expenditures, into 2024.

On May 12, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported new clinical utility data highlighting the impact of the Nodify XL2 Risk Assessment Test on clinical management decisions in patients with lung nodules will be presented at the American Thoracic Society (ATS) 2022 International Conference (Press release, Biodesix, MAY 12, 2022, View Source [SID1234614416]). The meeting will take place May 13-18, 2022, in San Francisco, California.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Data from the abstract titled, The Impact of Plasma Proteomics Biomarker on Clinical Management Decision in Lung Nodules, presented by Dr. J. P. Uribe of Deaconess Medical Center, Boston, Massachusetts, United States, will highlight data that show the impact of the Nodify XL2 integrated proteomic classifier on management decisions in a "real world" clinical setting. Conclusions show that when used in patients with lung nodules with a nodule probability of malignancy (pCA) of ≤ 50%, the blood-based lung nodule risk assessment test was able to support a decrease in chest imaging, outpatient clinic visits and additional invasive procedures without misclassifying benign lung nodules.

An additional presentation titled, ALTITUDE trial design: A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Classifier in Incidentally Discovered Low to Moderate Risk Lung Nodules, will review the ALTITUDE study, a first-in-class biomarker study which aligned with the recommendations from the official 2018 American Thoracic Society (ATS) policy statement on the early detection of lung cancer. The abstract, authored by Michael N. Kammer, Ph.D. of Vanderbilt University Medical Center, Nashville, Tennessee, Steve Springmeyer, MD, Biodesix, Boulder, Colorado and Gerard Silvestri, MD of Medical University of South Carolina, Charleston, South Carolina will be presented at ATS by Dr. Michael Kammer.

Both poster presentations will occur during ATS discussion Session B30 – THE QUEST FOR THE HOLY GRAIL: MODELING AND BIOMARKERS FOR NODULES AND LUNG CANCER. The session, moderated by Edwin Ostrin, MD, PhD. from MD Anderson Cancer Center, Houston, Texas and Adam Fox, MD, from Medical University of South Carolina, Charleston, South Carolina, will occur at the ATS meeting on May 16th, 2022, from 9:30-11:00AM PT, Room 203-204 (South Building, Level 2), Moscone Center.