On May 12, 2022 Pulmatrix (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, reported first quarter financial results for 2022 and provided a corporate update (Press release, Pulmatrix, MAY 12, 2022, View Source [SID1234614311]).

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Ted Raad, Chief Executive Officer of Pulmatrix commented, "We have prioritized capital towards extending our cash runway through the Pulmazole Phase 2b top-line data anticipated in Q2 2024. We anticipate dosing for the Phase 2b study to begin in Q1 2023. Also in 2022, we will further analyze the PUR1800 Phase 1b data to finalize a potential Phase 2 study design while we execute to deliver PUR3100 Phase 1 top-line data in Q4 2022."

First Quarter 2022 and Recent Program Highlights

Pulmazole (PUR1900)

The Pulmazole Phase 2b efficacy study will include a 16-week dosing regimen with potential registration efficacy endpoints, is on track to begin dosing patients in Q1 2023. With a focus on capital conservation, we have extended our projected cash runway through the anticipated top-line data readout in Q2 2024.
PUR3100

On January 25, 2022, the Company conducted a Type C meeting with the FDA to add additional clarification around some of the written pre-IND responses in relation to the overall non-clinical and clinical program. Management concluded that conducting the Phase 1 study in Australia should allow the Company to generate the most comprehensive dataset for inclusion in an IND for Phase 2 in the United States, while also providing the most time efficient path to Phase 1 data in 2022.
PUR1800

On March 21, 2022, the Company announced top-line data from a Phase 1b clinical study of PUR1800 assessing the safety, tolerability and pharmacokinetics of PUR1800 in patients with stable COPD after dosing the first patient in February 2021. We are analyzing the Phase 1b clinical study data for future publication and to finalize design of a potential Phase 2 efficacy study in treatment of AECOPD.
First Quarter Corporate Highlights

On February 28, the Company completed a reverse stock-split at a ratio of 1-for-20 which reduced the number of outstanding shares of the Company’s common stock from approximately 65.9 million shares to 3.3 million shares.

On March 1, the Company announced the hiring of Dr. Margaret Wasilewski as the Company’s Chief Medical Officer. Dr. Wasilewski leverages over 25 years of experience in pharmaceutical drug development.

On March 17, the Company announced that it regained compliance for its listing on Nasdaq, allowing continued access to capital markets and liquidity for its investors.
First Quarter 2022 Financial Results

Revenue was $1.2 million for the first quarter ended March 31, 2022, compared to $1.4 million for the same period in 2021, a decrease of $0.2 million. Revenue for 2022 from the collaboration and license agreement with Cipla on the Company’s Pulmazole program increased, offset by no revenues from a previous JJEI License Agreement for the Company’s PUR1800 kinase inhibitor.

For the three months ended March 31, 2022, research and development expenses were $4.1 million compared to $3.9 million for the same period in 2021, an increase of $0.3 million. The increase was primarily due to increased spend of $0.7 million in employment costs and $0.1 million in rent costs, partially offset by decreased spend of $0.3 million on preclinical costs related to our PUR1800 program and $0.2 million on clinical and manufacturing costs related to the Pulmazole program.

General and administrative expenses were $2.0 million for the three months ended March 31, 2022, compared to $1.6 million for the three months ended March 31, 2021, an increase of $0.4 million. The increase was primarily due to increased spend of $0.1 million in employment costs, $0.3 million on consulting and legal, and $0.1 million on audit, tax and public company expense, partially offset by decreased patent expense of $0.1 million.

Our total cash and cash equivalents balance as of March 31, 2022 was $47.5 million. We expect that our existing cash and cash equivalents as of March 31, 2022 will enable us to fund our projected operating expenses and capital expenditures into Q2 2024.

On May 12, 2022 Paige, a global leader in clinical AI applications in pathology, reported it received CE-IVD and UKCA marks for the Paige Prostate Biomarker Suite, an AI software that is designed to detect the presence of four prostate cancer biomarkers on digitized tissue images stained with hematoxylin and eosin (H&E)* (Press release, Paige AI, MAY 12, 2022, View Source [SID1234614328]). This is the first European regulatory certification of image-based biomarker detection on H&E-stained tissue samples for Paige, potentially expanding the utility of AI to analyze tissues prepared with the most frequently used stain in histology.

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In contrast to traditional molecular biomarker testing, image-based biomarkers can enable faster turnaround time for results, provide new information at the point of diagnosis and reduces the need for unnecessary and expensive testing on definite negatives, while protecting the integrity of the tissue sample. Specifically, the Paige Prostate Biomarker Suite can detect biomarkers from H&E-stained samples and can inform the need for confirmatory tests such as immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH).

The Paige Prostate Biomarker Suite is designed to assist in the detection of Androgen Receptor (AR), TP53, RB1 and PTEN biomarkers that are associated with the development and progression of prostate cancer. The biomarkers can help physicians stratify patients into treatment paradigms and direct targeted enrollment into clinical trials. The Paige Prostate Biomarker Suite was developed using the same underlying technology from Paige Prostate Detect, which was developed with histology image data from tens of thousands of patients and is already CE-IVD and UKCA marked, in addition to being approved by the FDA in the U.S.

"By employing Paige Prostate Biomarker Suite, clinicians can rapidly reduce laboratory turnaround time while providing a broader range of data at the point of diagnosis," said Jill Stefanelli, Ph.D., President and Chief Business Officer at Paige. "We’re excited by this regulatory milestone of our biomarker capabilities built on our robust AI technology platform, which can rapidly screen and develop proof-of-concept biomarkers. As we expand our biomarker portfolio, we also look forward to developing novel biomarkers across indications to identify patients that should receive genomic testing or could potentially respond to targeted therapies. This opens the door to a whole new range of biomarker applications and, in turn, new opportunities for industry collaboration."

For more information about the Paige Prostate Biomarker Suite, contact [email protected].

*In the United States, Paige Prostate Biomarker Suite is available for Research Use Only and not for use in diagnostic procedures.

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.