On August 12, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that the U.S. Food and Drug Administration (FDA) has approved its Guardant360 CDx liquid biopsy test as a companion diagnostic (CDx) to select patients with unresectable or metastatic HER2-mutant non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations for treatment with ENHERTU (fam-trastuzumab deruxtecan-nxki), a HER2-directed antibody drug conjugate (ADC) jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (Press release, Guardant Health, AUG 12, 2022, https://www.businesswire.com/news/home/20220811005816/en/Guardant-Health-Receives-FDA-Approval-for-Guardant360%C2%AE-CDx-as-Companion-Diagnostic-for-Daiichi-Sankyo-and-AstraZeneca%E2%80%99s-ENHERTU%C2%AE-for-Treatment-of-NSCLC-Patients-With-Activating-HER2-Mutations [SID1234618269]).

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The approval means that Guardant360 CDx, a next generation sequencing (NGS)-based assay that detects genomic alterations using circulating tumor DNA from blood, is validated as a CDx assay to identify NSCLC patients who have an activating HER2 mutation (SNVs and exon 20 insertions) and may benefit from treatment with ENHERTU. Mutations in the HER2 gene, also called ERBB2, drive approximately 2-4% of non-squamous NSCLC.1 Non-small cell lung cancer represents about 82% of all lung cancer,2 which is the leading cause of cancer death in the U.S.3

"This is great news for metastatic NSCLC patients with activating HER2 mutations, who now have, for the first time, an approved treatment for their cancer, but also the first blood-based companion diagnostic in Guardant360 CDx," said Helmy Eltoukhy, Guardant Health co-CEO. "We are proud to offer our Guardant360 CDx liquid biopsy as a companion diagnostic so that patients can access comprehensive genomic profiling to see if they are eligible to receive this therapy."

Guardant360 CDx

For oncologists, the FDA-approved Guardant360 CDx test provides comprehensive genomic results from a simple blood draw in seven days, helping them move beyond the limitations of tissue biopsies to rapidly obtain clinically relevant information in time to match patients to the optimal personalized treatment. Guardant360 CDx covers all genes recommended by the National Comprehensive Cancer Network, including those most relevant to clinical care and NSCLC treatment guidelines.

Since being introduced as a laboratory developed test (LDT), the Guardant360 test has become widely accepted for blood-based comprehensive genomic profiling with more than 300 peer-reviewed publications. It has been trusted by more than 12,000 oncologists, with more than 300,000 tests performed to date, and is broadly covered by Medicare and many private payers, representing over 200 million lives.

On August 12, 2022 Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on developing lenzilumab (LENZ), a first-in class antibody that neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF), reported financial results for the second quarter and six months ended June 30, 2022 (Press release, Humanigen, AUG 12, 2022, View Source [SID1234618268]).

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"We have made excellent progress on the strategic realignment announced in July. We have increased the number of sites for the PREACH-M study in Australia of lenzilumab in chronic myelomonocytic leukemia (‘CMML’), a rare blood cancer, and have interest from top oncology centers in the United States. We are on track to enroll the first patient in the RATinG study in the UK of lenzilumab in acute graft versus host disease (‘aGvHD’) and expect dosing soon," stated Cameron Durrant, Chairman and Chief Executive Officer, Humanigen. "Given the positive results from the company’s LIVE-AIR study and the survival trend observed in the ACTIV-5/BET-B study, we have interest from a global group of leading institutions and research networks to include lenzilumab in their large-scale, multinational studies of COVID-19. Tocilizumab and baricitinib demonstrated mortality benefit following inclusion in such studies despite having failed to do so in smaller studies. We are exploring the requirements for inclusion in these studies and plan to provide an update before the end of 2022. In addition, we are currently assessing requests for investigator-initiated trials (‘IIT’s’) of lenzilumab in combination with CAR-T therapies and plan to continue the development of ifabotuzumab (‘iFab’), an EpAh-3 targeted monoclonal antibody currently in Phase 1 development, as part of an antibody drug conjugate (‘ADC’), for certain solid tumors in Australia."

As recently announced, the company has strategically realigned its pipeline and resources with plans to accelerate the development of lenzilumab in CMML, for which the "PREcision Approach to Chronic Myelomonocytic Leukemia," or "PREACH-M" study, is already underway and to continue the "Risk Adapted Therapy in Acute GvHD," or " RATinG" study, in patients undergoing bone marrow transplant, that is expected to enroll its first patient in the third quarter of 2022. These studies are majority funded by the company’s partners. Under the realignment plan, the company will deemphasize the deployment of certain resources for the development of lenzilumab for COVID-19. The preliminary topline results from the Accelerating COVID-19 Therapeutic Interventions and Vaccines-5 ("ACTIV-5") and Big Effect Trial, in the "B" arm of the trial ("BET-B"), referred to as the ACTIV-5/BET-B trial did indicate that lenzilumab demonstrated a positive trend in mortality. The company continues to support National Institutes of Health’s ("NIH’s") further analysis of the data.

Second Quarter and Six Months Ended June 30, 2022 Financial Results

Net loss for the quarter ended June 30, 2022 was $30.1 million, or $0.43 per share, as compared to $70.8 million, or $1.20 per share, for the quarter ended June 30, 2021. The net loss for the six months ended June 30, 2022 was $51.4 million or $0.75 per share, as compared to $136.4 million or $2.45 per share for the six months ended June 30, 2021. The decrease in net loss for both periods was largely due to a decrease in expenses, mainly Research and Development ("R&D") expense. R&D expense decreased $36.6 million from $63.0 million for the three months ended June 30, 2021, to $26.4 million for the three months ended June 30, 2022 and decreased $79.2 million from $122.9 million for the six months ended June 30, 2021 to $43.7 million for the six months ended June 30, 2022. The decrease in R&D expense is primarily due to decreased lenzilumab manufacturing costs for the quarter ended June 30, 2022 of $34.6 million, and for the six months ended June 30, 2022 of $70.3 million.

Cash and Cash Equivalents

Net cash used in operating activities, net of balance sheet changes, was $44.8 million for the six months ended June 30, 2022. During the first half of 2022, the company sold shares of its common stock under its At-the-Market or "ATM" facility, raising net proceeds of approximately $21.8 million. As of June 30, 2022, the company had cash and cash equivalents of approximately $47.0 million. Subsequent to end of the quarter and through August 10, 2022, the company raised an additional $15.9 million under the ATM.

In July 2022, the company repaid the Term Loan with Hercules by prepaying $25.0 million of outstanding principal, together with approximately $1.7 million of accrued interest, fees and other amounts, due under the loan, terminating all obligations, liens and security interests thereunder. By retiring the Term Loan, the company reduced future cash payments for interest and enhanced its ability to generate additional liquidity from its intellectual property by removing the loan’s collateral requirements.

A summary of key financial highlights as of and for the three and six months ended June 30, 2022 and 2021 is as follows ($ in thousands):

About Lenzilumab

Lenzilumab is a proprietary Humaneered first-in-class monoclonal antibody that has been proven to neutralize GM-CSF, a cytokine of critical importance in the hyperinflammatory cascade, sometimes referred to as cytokine release syndrome, or cytokine storm. Humanigen believes that GM-CSF neutralization with lenzilumab also has the potential to treat patients with CMML and to reduce the hyper-inflammatory cascade known as cytokine release syndrome common to aGvHD. A study of lenzilumab is underway for patients with CMML exhibiting RAS pathway mutations. This study builds on evidence from a Phase 1 study, conducted by Humanigen, that showed RAS mutations are associated with hyper-proliferative features, which may be sensitive to GM-CSF neutralization. Lenzilumab will also be tested to assess its ability to prevent and/or treat aGvHD in patients undergoing allogeneic hematopoietic stem cell transplantation.

On August 12, 2022 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, reported financial results for the second quarter ended June 30, 2022 and provided an update on business highlights (Press release, Point Biopharma, AUG 12, 2022, View Source [SID1234618267]).

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"We continue to execute across our pipeline and platform," said Dr. Joe McCann, CEO of POINT Biopharma. "The Phase 3 SPLASH trial in pre-chemotherapy mCRPC began European randomization in the second quarter, and I look forward to the release of further data from the 27-patient lead-in of the SPLASH trial this fall."

"One of the achievements from this past quarter I am most proud of is the commencement of the FRONTIER trial – the Phase 1 trial for PNT2004, our pan-cancer fibroblast activation protein targeted program," Dr. McCann continued. "This program is a true cross-functional collaboration highlighting POINT’s strengths in chemistry, radiochemistry, biology, clinical development and regulatory to enable the acceleration of radioligand discovery, progressing from in-license of a non-radiopharmaceutical molecule to a Phase 1 trial for both an imaging agent and a therapeutic agent in just 2 years. 68Ga-PNT6555 and 177Lu-PNT6555, the leads of the PNT2004 program, have now advanced into the clinic, a significant step forward in the development of a pan-cancer theranostic."

Recent Developments and Upcoming Milestones

Pipeline Updates

PNT2002: 177Lu-based PSMA targeted radiopharmaceutical

In April 2022, the Company dosed its first European Union patient in the SPLASH trial. The SPLASH trial is currently enrolling patients across 53 sites in North America, Europe, and UK, and site activations remain ongoing to expedite accrual. The Company continues to expect to report top line data from SPLASH mid-2023.

PNT2004: fibroblast activation protein-alpha (FAP-alpha) targeted radiopharmaceutical

The Company filed a clinical trial application (CTA) with Health Canada at the end of the first quarter of 2022 for PNT6555, the lead of the pan-cancer PNT2004 fibroblast activation protein-alpha (FAP-alpha) targeted program, and a No Objection Letter was received from Health Canada in May 2022. The first patient was dosed in FRONTIER in July 2022.

The Company also presented posters on PNT6555 at two recent academic conferences including the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting in April 2022, and the Society for Nuclear Medicine and Molecular Imaging (SNMMI) 2022 Annual Meeting in June 2022. Both posters are accessible at View Source

Management Updates:

In June 2022, the Company appointed Chris Horvath as Executive Vice President, Commercial. Mr. Horvath brings almost twenty years of experience in the pharmaceutical industry, having led or worked on the launch of a number of key oncology products, including Pluvicto (lutetium 177Lu vipivotide tetraxetan), Locametz (gallium 68Ga gozetotide), Nubeqa (darolutamide), and Zytiga (abiraterone acetate). In his new role at POINT, Mr. Horvath will lead the commercial strategy for POINT’s pipeline.

Mr. Horvath began his career as a scientist, working at both DuPont and Novartis Institutes for BioMedical Research. He then transitioned to commercial roles of increasing responsibility at Janssen, Dendreon, Merck, Bayer, and most recently Advanced Accelerator Applications (Novartis). Mr. Horvath holds a BSc in Chemistry & Biology from Wilfrid Laurier University, a MSc in Analytical Science from the University of Guelph, and an MBA from Rutgers Business School.

Three Months and Six Months Ended 2022 Financial Results

Cash, Cash Equivalents and Investments: As of June 30, 2022, POINT had approximately $204.3 million in cash, cash equivalents and investments, which is anticipated to fund operations into the first quarter of 2024.

Net Loss: Net loss was $24.6 million, or $0.27 net loss per share, for the three months ended June 30, 2022, as compared to a net loss of $8.8 million, or $0.15 net loss per share, for the same period in 2021. Net loss was $41.0 million, or $0.45 net loss per share, for the six months ended June 30, 2022, as compared to a net loss of $14.6 million, or $0.26 net loss per share, for the same period in 2021.

Research and Development Expenses: Research and development expenses were $20.8 million for the three months ended June 30, 2022, as compared to $6.7 million for the same period in 2021. Research and development expenses were $33.3 million for the six months ended June 30, 2022, as compared to $11.0 million for the same period in 2021.

General and Administrative Expenses: General and administrative expenses were $4.1 million for the three months ended June 30, 2022, as compared to $1.9 million for the same period in 2021. General and administrative expenses were $7.9 million for the six months ended June 30, 2022, as compared to $3.4 million for the same period in 2021.

On August 12, 2022 Beyond Air, Inc. (NASDAQ: XAIR), a medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, reported financial results for its first fiscal quarter ended June 30, 2022 (Press release, Beyond Air, AUG 12, 2022, View Source [SID1234618266]).

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"Our sales team has quickly ramped up the initial phase of the commercial launch for the LungFit PH, which received FDA approval in late-June. This initial activity includes conducting product demonstrations at numerous U.S. hospitals, which we are pleased to report have generated positive feedback from the participating hospital staff. We are also highly encouraged by the feedback received during the medical conferences our team has attended since approval. The early success of this program and initial feedback received is expected to put us on schedule to equip the first small group of hospitals with LungFit PH systems over the next several months. We look forward to the upcoming American Association for Respiratory Care (AARC) in November and encourage investors to come see us in New Orleans," commented Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. "We continue to expect to receive CE Mark for LungFit PH in Europe during the second half of calendar year 2022. In addition, we are planning to submit a PMA supplement for an expanded cardiac label for the LungFit PH system to the U.S. FDA."

Recent Highlights and Upcoming Milestones

LungFit PH
Received U.S. FDA approval on June 28, 2022 to treat term and near-term neonates with hypoxic respiratory failure
Initiated limited release phase of commercial launch, making it the first and only nitric oxide generator, delivery and monitoring system available in the U.S.; and already conducted numerous on-site demonstrations
CE Mark anticipated to be received in the second half of calendar year 2022, which is expected to be followed by an international commercial partnership
Expect to submit a PMA supplement for an expanded cardiac label for the LungFit PH to the U.S. FDA prior to year-end 2022
LungFit PRO
Planning to initiate a U.S. trial for patients hospitalized with viral community-acquired pneumonia (VCAP), including COVID-19, in the fourth quarter of calendar year 2023, pending discussion with FDA
Will present data in a poster session at an upcoming conference this Fall from the Company’s recently completed VCAP study
LungFit GO
Will present data from the pilot study of at-home LungFit GO for nontuberculous mycobacterial (NTM) lung infection at CHEST 2022 in Nashville on October 17, 2022
Expect to initiate a pilot study in COPD patients who are hospitalized due to an exacerbation in the fourth quarter of calendar 2023
Beyond Cancer’s Solid Tumor Program
Anticipate dosing the first patient in a first-in-human Phase 1 study to assess the safety and efficacy of ultra-high concentration nitric oxide for the treatment of solid tumors in the current quarter
Financial Results for the fiscal quarter ended June 30, 2022

Research and development expenses for the fiscal quarter ended June 30, 2022 were $3.2 million, compared with $2.7 million for the fiscal quarter ended June 30, 2021.

General and administrative expenses for the fiscal quarter ended June 30, 2022 increased to $8.2 million, compared with $3.9 million for the fiscal quarter ended June 30, 2021. The increase is mainly attributable to the staffing and scaling up of Beyond Cancer in both the U.S. and Israel, as well as continued investments necessary to support the commercial launch of LungFit PH in the U.S.

Other income and expense for the fiscal quarter ended June 30, 2022 was a loss of $0.2 million, compared with a loss of $0.2 million for the fiscal quarter ended June 30, 2021.

For the fiscal quarter ended June 30, 2022, the Company had a net loss of $11.7 million, of which $10.9 million, or ($0.37) per share, was attributable to the shareholders of Beyond Air, compared with a net loss of $6.7 million, or ($0.31) per share, for the fiscal quarter ended June 30, 2021.

As of June 30, 2022, the Company reported cash and cash equivalents of $72.8 million.

Net cash used in operations, including Beyond Cancer, was $6.8 million in the fiscal quarter ended June 30, 2022. This is below the quarterly cash burn guidance of $8.0 – 10.0 million. The Company expects to see the quarterly average cash burn during the fiscal year 2023 to fall within this range.

On August 12, 2022 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), reported financial results for the second quarter ended June 30, 2022 (Press release, Crinetics Pharmaceuticals, AUG 12, 2022, View Source [SID1234618263]).

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"Enrollment is on-track in our Phase 3 PATHFNDR program for paltusotine in acromegaly and our Phase 2 study in carcinoid syndrome, with results from these studies expected in 2023," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "We continue to validate the unique early de-risking efficiency of our endocrine drug development paradigm. CRN04894 is now our third program to successfully demonstrate pharmacologic proof-of-concept in Phase 1. We are now working with global regulators to align on clinical plans for both CRN04777 and CRN04894 with the goal of initiating clinical studies in congenital HI, Cushing’s disease, and CAH."

SECOND QUARTER 2022 AND RECENT HIGHLIGHTS

Reported positive top-line results from multiple-ascending dose (MAD) cohorts of the CRN04894 Phase 1 study. In May 2022, Crinetics announced positive data from the MAD cohorts of a Phase 1 healthy volunteer study of CRN04894, the company’s adrenocorticotropic hormone (ACTH) antagonist being developed as a treatment for Cushing’s disease, congenital adrenal hyperplasia (CAH) and other conditions of ACTH excess. Pharmacodynamic data from the trial demonstrated pharmacologic proof-of-concept for CRN04894, while pharmacokinetic data demonstrated its oral bioavailability and support a once-daily dosing schedule. No serious adverse events nor study drug discontinuations due to treatment-related adverse events were observed.
Presented clinical and research results at the ENDO 2022 Annual Conference. Presentations included an oral presentation featuring results from the Phase 1 study of CRN04894, a poster presentation featuring results from a Phase 1 study of CRN04777, the company’s somatostatin receptor type 5 (SST5) agonist being developed as a treatment for congenital hyperinsulinism (HI), and a late-breaking poster presentation on the company’s preclinical parathyroid hormone (PTH) receptor antagonist program.
Strengthened balance sheet with successful $125 million common stock offering. In April 2022, Crinetics successfully completed an underwritten follow-on offering of its common stock raising gross proceeds of $125 million. Based on its current plans, the company expects that current cash, cash equivalents and short-term investments will fund its current operating plan into the second half of 2024.

SECOND QUARTER 2022 FINANCIAL RESULTS

Research and development expenses were $33.0 million for the three months ended June 30, 2022, compared to $20.5 million for the same period in 2021. The increase was primarily attributable to an increase spending on manufacturing and development activities of $7.6 million associated with clinical and nonclinical activities for paltusotine, CRN04777, CRN04894 and other preclinical programs, and an increase in personnel costs of $3.9 million.
General and administrative expenses were $10.5 million for the three months ended June 30, 2022, compared to $5.6 million for the same period in 2021. The increase was primarily attributable to an increase in personnel costs of $3.1 million.
Net loss for the three months ended June 30, 2022, was $42.4 million, compared to a net loss of $26.1 million for the same period in 2021.
Revenues were $0.4 million for the three months ended June 30, 2022, consisting of license revenue recognized from the license agreement entered into with Sanwa Kagaku Kenkyusho Co., Ltd. in February 2022.
Unrestricted cash, cash equivalents and investments totaled $408.5 million as of June 30, 2022, compared to $333.7 million as of December 31, 2021.
The company had 53,752,778 common shares outstanding as of August 9, 2022.