On May 12, 2022 Pulmatrix, Inc. (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 [SID1234614313]).

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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 LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, LianBio, MAY 12, 2022, View Source [SID1234614312]).

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"LianBio continues to solidify our standing as the partner of choice to bring clinically validated therapeutic candidates to Greater China and other Asian markets," said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. "Several of our partners have recently reached significant global milestones, including a U.S. FDA approval, positive pivotal trial results, and an acquisition. We congratulate our development partners on these important achievements. In China, we are committed to accelerating patient access to potentially transformative therapeutics, and we remain on track to complete enrollment in our ongoing Phase 3 EXPLORER-CN trial of mavacamten and to initiate three additional pivotal studies this year."

Recent Business Highlights and Clinical Development Updates

BMS receives FDA approval for mavacamten and presents additional positive Phase 3 clinical trial results

In April 2022, LianBio’s partner Bristol Myers Squibb (BMS) presented data from two clinical trials of mavacamten at the American College of Cardiology 71st Annual Scientific Session. Data from the EXPLORER-LTE clinical trial demonstrated sustained improvements in clinically meaningful cardiovascular outcomes at weeks 48 and 84 in patients with symptomatic oHCM receiving mavacamten. Data from the Phase 3 VALOR-HCM clinical trial demonstrated the addition of mavacamten significantly reduced the need for septal reduction therapy (SRT) in patients with severely symptomatic oHCM who had been appropriate for SRT at baseline.

In April 2022, BMS announced the U.S. Food and Drug Administration (FDA) approval of mavacamten for the treatment of adults with symptomatic New York Heart Association Class II-III oHCM to improve functional capacity and symptoms.
Mavacamten development progress continues in China

In January 2022, LianBio initiated the Phase 3 EXPLORER-CN clinical trial of mavacamten in Chinese patients with symptomatic oHCM. Patient enrollment is ongoing.

In February 2022, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation in China for mavacamten for the treatment of patients with oHCM.

In May 2022, LianBio announced topline results from the Phase 1 pharmacokinetic (PK) study of mavacamten in healthy Chinese volunteers. A single oral administration of mavacamten in Chinese healthy adult subjects showed no new safety signals. The data demonstrated a favorable PK, safety and tolerability profile comparable to that observed in the Phase 1 pharmacokinetic study of mavacamten conducted by LianBio’s partner, MyoKardia, now a wholly owned subsidiary of BMS, in healthy volunteers in the United States.
TP-03 met all primary and secondary endpoints in Tarsus’s second U.S. pivotal trial

In May 2022, Tarsus announced positive topline data from the Phase 3 Saturn-2 clinical trial of TP-03 in Demodex blepharitis (DB) patients. The clinical trial met all primary and secondary endpoints and TP-03 was well-tolerated.

Based on these data, Tarsus announced that it will submit a New Drug Application to the U.S. FDA in the second half of 2022.
Development partner ReViral Ltd. entered into definitive agreement to be acquired by Pfizer Inc.

In April 2022, Pfizer and ReViral entered into a definitive agreement under which Pfizer will acquire ReViral and its respiratory syncytial virus therapeutic candidates, including sisunatovir.
Formation of Scientific Advisory Board

In April 2022, LianBio formed a Scientific Advisory Board (SAB). The LianBio SAB is comprised of industry leaders in global drug development who are serving as strategic advisors to the Company.
Appointment to the Board of Directors

In April 2022, LianBio appointed Wei Wei Chen to the Board of Directors. Ms. Chen brings over 17 years of experience serving as chief financial officer of companies in the consumer, retail and healthcare sectors.
Business is well-positioned to achieve anticipated milestones

Current cash runway is projected to extend through mid-2024.
Key Milestones Anticipated in 2022

Mavacamten

Enrollment is ongoing in the EXPLORER-CN Phase 3 clinical trial of mavacamten in Chinese patients with oHCM. LianBio expects to complete enrollment in the second half of 2022.
TP-03

LianBio remains on track to initiate a Phase 3 clinical trial of TP-03 in Chinese patients with DB in the second half of 2022 to support regulatory approval in China.
NBTXR3

LianBio expects to begin dosing Chinese patients in Nanobiotix’s ongoing global pivotal Phase 3 NANORAY-312 clinical trial of NBTXR3 for the treatment of locally advanced head and neck squamous cell carcinoma in elderly patients ineligible for cisplatin in the second half of 2022.
Infigratinib

Enrollment is ongoing in LianBio’s Phase 2a clinical trial of infigratinib in locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with fibroblast growth factor receptor-2 (FGFR2) gene amplification and other advanced solid tumors with FGFR genomic alterations.

LianBio expects to begin dosing Chinese patients in QED’s ongoing global pivotal Phase 3 PROOF-301 clinical trial of infigratinib in first-line cholangiocarcinoma (CCA) patients with FGFR2 gene fusions/translocations in the second half of 2022.
First Quarter 2022 Financial Results

Research & Development Expenses
Research and development expenses were $12.3 million for the first quarter of 2022 compared to $53.4 million for the first quarter of 2021. The decrease was primarily attributable to increased milestone payments in 2021, and was offset by higher development activities to support clinical trials and personnel-related expenses in 2022.

General & Administrative Expenses
General and administrative expenses were $16.1 million for the first quarter of 2022 compared to $7.1 million for the first quarter of 2021. The increase was primarily attributable to increases in payroll and personnel-related expenses (including share-based compensation expense) for increased employee headcount and higher expense for legal, consulting and accounting services.

Net Loss
Net loss was $27.7 million for the first quarter of 2022 compared to net loss of $61.6 million for the first quarter of 2021.

Cash Balance
Cash, cash equivalents, marketable securities and restricted cash at March 31, 2022 totaled $389.1 million compared to $403.2 million as of December 31, 2021. LianBio projects its current cash, cash equivalents, marketable securities, and restricted cash will be sufficient to fund its current operating plan through mid-2024.

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 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a late clinical stage biopharmaceutical company focused on helping patients fight cancer with oncolytic viral immunotherapies, reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, Candel Therapeutics, MAY 12, 2022, View Source [SID1234614282]).

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"2022 is off to a great start as we continue to advance our late-stage pipeline of novel oncolytic viral immunotherapies for cancer," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "Today, we are well positioned for major catalysts over the next 12 months, namely multiple clinical data readouts across our product candidates and advancement of our pipeline of promising therapeutics with potential to treat various solid tumors including lung, brain, pancreatic and prostate cancer. We look forward to delivering on our mission to develop oncolytic viral immunotherapies aimed at tipping the balance in favor of the patient’s immune system to fight cancer."

First Quarter 2022 & Recent Highlights

•Enhanced executive leadership with the promotion of Francesca Barone, MD, PhD to Chief Scientific Officer and appointment of Seshu Tyagarajan, PhD, RAC as Chief Technical and Development Officer.
•Strengthened cash position with a $20.0 million non-dilutive debt financing with Silicon Valley Bank (SVB) in February 2022.

Key Upcoming Milestones

•To present initial data from an ongoing Phase 2 clinical trial of CAN-2409 and valacyclovir combined with PD-1 or PD-L1 targeting agents in patients with stage III/IV non-small cell lung cancer at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held in-person June 3-7, 2022 at the McCormick Place Convention Center in Chicago, Illinois.
•In the fourth quarter of 2022, the Company expects to present data from two high grade glioma clinical trials – a Phase 1b clinical trial of CAN-2409 in combination with

nivolumab (Opdivo) combined with standard of care first line treatment and a Phase 1 clinical trial of CAN-3110 in recurrent high-grade glioma.

Financial Results for the Quarter Ended March 31, 2022

Cash Position: Cash and cash equivalents as of March 31, 2022 were $94.3 million compared to $82.6 million as of December 31, 2021. The net increase was due to receipt of $20.0 million from a term loan with SVB and the use of $8.0 million in cash to fund operating activities. Based on current plans and assumptions, the Company expects that its existing cash and cash equivalents will be sufficient to fund its operations into the fourth quarter of 2023.

Research and Development Expenses: Research and development expenses were $5.4 million for the three-month period ended March 31, 2022 compared to $2.8 million for the comparable period in 2021. The increase was primarily due to increased personnel-related costs, including stock-based compensation, for additional headcount to support the ongoing clinical trials for Candel’s product candidates and $1.0 million of severance in the first quarter of 2022, as well as increased clinical development costs related to our clinical trial sites and the cost of treatment and follow-up on patients. Excluding stock-based compensation expense of $142,000 for the three-month period ended March 31, 2022, research and development expenses for the three-month period ended March 31, 2022 were $5.3 million.

General and Administrative Expenses: General and administrative expenses were $3.6 million for the three-month period ended March 31, 2022 compared to $1.9 million for the comparable period in 2021. The increase was primarily due to increased insurance costs, personnel-related costs including stock-based compensation for additional headcount required to support the growth of the Company and operate as a public company, and professional and consulting fees associated with public relations consultants, legal firms, and accounting firms associated with operating as a public company. Excluding stock-based compensation expense of $350,000 for the three-month period ended March 31, 2022, general and administrative expenses for the three-month period ended March 31, 2022 were $3.3 million.

Total Operating Expenses: Total operating expenses were $9.0 million for the three-month period ended March 31, 2022 compared to $4.7 million for the comparable period in 2021.The increase was primarily due to increased personnel-related costs including stock-based compensation for additional headcount required to support the growth of the Company and to operate as a public company, severance costs, insurance costs, and professional and consulting fees associated with operating as a public company. Excluding stock-based compensation expense of $492,000 for the three-month period ended March 31, 2022, total operating expenses for the three-month period ended March 31, 2022, were $8.5 million.

Net Loss: Net loss was $874,000 for the three-month period ended March 31, 2022 compared to a net loss of $4.5 million for the comparable period in 2021. The net loss for the three-month period ended March 31, 2022 includes a non-cash credit of $8.3 million for the change in the fair value of the Company’s warrant liability and stock-based compensation expense of $492,000. Excluding the non-cash credit for the change in the warrant liability and the charge for stock-based compensation, the net loss for the three-month period ended March 31, 2022 was $8.7 million.

On May 12, 2022 ArcticZymes Technologies reported that it is attending the ASGCT (Free ASGCT Whitepaper) 25th Annual Meeting in Washington, D.C. from – May 16-19 (Press release, Biotec Pharmacon, MAY 12, 2022, View Source [SID1234614281]).

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Mr. Scott Frayo is looking forward to meeting you at booth 241 for a discussion on how our SAN HQ, SAN HQ 2.0 and M-SAN HQ can improve the efficiency of your viral bioprocessing process.

Our salt active nuclease (SAN) enzymes have been validated for AV, AAV and LV purification. ArcticZymes Technologies therefore supplies different nucleases for the purification of viral gene vectors or oncolytic virus that you may need for your manufacturing process.