On August 10, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported its financial and operating results for the second quarter ended June 30, 2021 and provided a corporate update (Press release, Biodesix, AUG 10, 2021, View Source [SID1234586258]).

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"It was a productive quarter with 180% year over year growth in total revenue. Our first four blood-based tests which make up our core lung diagnostic testing, grew 109% year over year and 20% over the prior quarter," said Scott Hutton, CEO of Biodesix. "We expect growth in core lung diagnostic testing to continue through 2021 driven by the U.S.’s emergence from the pandemic, productivity from our growing salesforce, and our efforts to build on the body of evidence supporting the use of our tests. Beyond our currently marketed products, we also continue to develop our Diagnostic Cortex Artificial Intelligence (AI) platform and expand our pipeline of products capable of providing broad lung diagnostics to address patients’ needs over the course of their disease. The launch of our 72-hour liquid NGS test is now projected for the first quarter of 2022 and will supplement our 36-hour VeriStrat and GeneStrat tests. With this accelerated launch and multiple studies underway for our Risk of Recurrence (ROR) and Primary Immune Response (PIR) tests as well as our ALTITUDE, BEACON, INSIGHT, and ORACLE prospective studies actively enrolling or following patients, we look forward to a productive and exciting second half of the year."

Second Quarter 2021 Financial Results

For the three-month period ended June 30, 2021, as compared to the same period of 2020 (where applicable):

Total revenue of $11.9 million, an increase of 180%;

Core lung diagnostic revenue of $4.8 million, an increase of 109%;
Continued sequential recovery from initial rapid uptake of COVID-19 immunizations.
Growth driven primarily by Nodify XL2 and Nodify CDT.
Nodify XL2 growth triggered the previously disclosed milestone resulting in a $37 million obligation payable by us over six quarterly installments of approximately $4.6 million beginning January 2022 and a final payment of approximately $9.3 million in July 2023.
COVID-19 testing revenue of $6.1 million, an increase of 345%;
Sequential quarter over quarter decline commensurate with our prior commentary as US immunizations accelerated in second quarter.
Services revenue of $1.0 million, an increase of 76%;
Clinical trial services showed improvement and we expect further recovery in clinical trial enrollments in second half of 2021.

Gross profit of $4.8 million, an increase of 103%, and gross margin percentage of 40% as compared to 56% representing a decline primarily attributable to the lower gross margin COVID-19 testing;

Operating expenses (excluding direct costs and expenses) of $15.4 million, which includes an investment in the planned expansion of our sales force, increased 93% over second quarter 2020;
On track to double size of lung focused direct and dedicated sales force in 2021.
Non-cash stock compensation expense of $0.5 million as compared to $0.1 million.
Non-cash expense for change in fair value of contingent consideration of $0.6 million as compared to a gain of $1.0 million.

Net loss of $11.4 million, an increase of 38% over second quarter of 2020; and

Maintained fiscal discipline and strong liquidity with cash and cash equivalents of $56.3 million as of June 30, 2021 and expect to qualify for PPP loan forgiveness of $3.1 million later in 2021.
For a full list of Biodesix’s press releases and webinars, please visit Biodesix.com.

Conference call and webcast information

Management will host an investor conference call and webcast today, August 10, 2021 at 4:30 p.m. Eastern Time.

On August 10, 2021 Indapta Therapeutics, Inc., a biotechnology company developing and commercializing an NK (natural killer) cell therapy platform for the treatment of blood cancers and solid tumors, reported the publication of new preclinical data in Blood Advances demonstrating Indapta’s proprietary allogeneic FcεRIγ-deficient G-NK cells in combination with an FDA-approved monoclonal antibody (mAb) resulted in greater than 99.9% tumor reduction in a preclinical cancer regression model of multiple myeloma compared to conventional NK cells (Press release, Indapta Therapeutics, AUG 10, 2021, View Source [SID1234586257]). G-NK cells are a naturally occurring subset of NK cells that when expanded and "turbocharged" using Indapta’s proprietary manufacturing process, boost the efficacy of mAbs and can overcome the cost, inconsistency, and possible toxicities associated with autologous T-cell therapies commonly used in the treatment of multiple myeloma.

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"These results suggest Indapta’s G-NK cells have the potential to be a potent off-the-shelf NK cell therapy that could enhance the efficacy of most mAbs," said Guy DiPierro, founder and chief executive officer of Indapta. "The promising results showed G-NK cells, compared to conventional NK cells, significantly enhanced anti-tumor cell activity of two FDA-approved mAbs for multiple myeloma and were able to maintain this augmented activity, expand in vivo, and have greater persistence even after cryopreservation. Together with a simplified and consistent, high-yield commercial-scale manufacturing platform at Lonza, we have the potential to produce an NK cell therapy with outstanding efficacy at a lower cost than other engineered cell therapies."

Austin Bigley, Indapta’s vice president, research and development, said, "This data suggests our G-NK cell therapy, which has been optimized with a donor phenotyping and genotyping selection process and our propriety expansion method produces a highly functional, anti-tumor NK cell product when coupled with a therapeutic antibody."

This preclinical study examined the ability of G-NK cells to improve the efficacy of mAbs in multiple myeloma. Results from in vitro assays showed G-NK cells had six-fold higher anti-myeloma cell-killing activity compared with conventional NK cells when combined with the mAb daratumumab or elotuzumab (p<0.001). Separately, in a murine persistence study, cryopreserved G-NK cells showed more than 10 times greater persistence in peripheral blood (p<0.001) and spleen (p<0.001) compared with conventional NK cells at Day 31 post-infusion. Persistence in bone marrow was also higher (p<0.05). Additionally, in a mouse model of multiple myeloma that investigated tumor regression, the combination of G-NK cells and daratumumab led to a greater than 99.9% reduction in tumor burden compared with the combination of conventional NK cells and daratumumab (p<0.001). At Day 57 post-tumor inoculation, all seven mice treated with the G-NK cells in combination with daratumumab were alive, and the myeloma tumor burden was eliminated in five of seven mice. In contrast, no mice treated with conventional NK cells and daratumumab survived to Day 57. Further, Indapta allowed the cancer to grow for two weeks post-inoculation until therapy was started, resulting in a cancer regression model as opposed to a cancer suppression model, as is often seen in other pre-clinical NK cell models.

"We believe these findings underscore the promise of Indapta’s naturally occurring G-NK cell therapy to augment the effects of therapeutic antibodies more than conventional NK cells," said Nina Shah, M.D., study investigator and professor, Department of Medicine, University of California, San Francisco. "The data suggest that Indapta’s G-NK cell therapy have the potential to be a much needed, universal allogeneic cell source that could amplify the effect of therapeutic antibodies in patients, such as those with relapsing or refractory multiple myeloma."

Indapta plans to file an Investigational New Drug (IND) application for its G-NK cell therapy in combination with a mAb in multiple myeloma by the end of 2021 and expects to initiate clinical trials in early 2022.

About Indapta’s G-NK Cell Therapy

Indapta Therapeutics is developing a universal, allogeneic G-NK cell therapy designed to substantially improve the cytotoxicity of monoclonal antibody (mAb) therapy in multiple cancers. G-NK cells are a specific and potent subset of NK (natural killer) cells with specialized anti-tumor activity resulting from an epigenetic change rather than engineering. Indapta has further enhanced G-NK cells via specific G-NK cell subset selection and its proprietary manufacturing process, which, when combined, produce a G-NK cell therapy that demonstrates higher efficacy, persistence and enhanced cryopreservation.

When a mAb binds to the tumor target and Indapta’s G-NK cell therapy, it initiates the release of dramatically more cancer-killing compounds than conventional NK cells, allowing for increased efficacy and potentially less frequent dosing. Indapta’s off-the-shelf G-NK cell therapy is further differentiated from other NK cell therapies in that it is a cell banked product with low variability. In vivo studies have demonstrated the safety and efficacy of Indapta’s G-NK cell therapy.

On August 10, 2021 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported that presentations at the upcoming 2021 Society of Neuro-Oncology (SNO) Conference on Brain Metastases, to be held in a virtual format from August 19 to 20, 2021 (Press release, Blue Earth Diagnostics, AUG 10, 2021, View Source [SID1234586256]). The conference, the Third Annual Conference on Brain Metastases, is conducted by SNO and the American Association of Neurological Surgeons (AANS)/CNS Section on Tumors. Details of the presentations to be given by Blue Earth Diagnostics and its collaborators are listed below.

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Note: 18F-fluciclovine, under the tradename Axumin (fluciclovine F 18) injection, is an FDA-approved and commercially available molecular imaging radiopharmaceutical for use in PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. The safety and efficacy of 18F-fluciclovine PET imaging for the detection of recurrent brain metastases has not been established.

Highlighted 18F-Fluciclovine Scientific Presentations

All 2021 SNO Conference on Brain Metastases presentations are available beginning 11:00 a.m. ET, Thursday, August 19, 2021.

Title:

Trial in Progress: A Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine PET in Detecting Recurrent Brain Metastases after Radiation Therapy (PURSUE)
Presenter: Rupesh Kotecha, MD, Baptist Health South Florida, Miami, FL, USA
Abstract:

TRLS-01

Title:

Trial in Progress: A Multicenter Phase 3 Study to Establish the Diagnostic Performance of 18F-Fluciclovine PET in Detecting Recurrent Brain Metastases after Radiation Therapy (REVELATE)
Presenter: Alain Chaglassian, MD, Blue Earth Diagnostics Inc., Burlington, MA
Abstract:

TRLS-02
Blue Earth Diagnostics invites participants at the SNO Conference on Brain Metastases 2021 to attend the presentations above. For more information about the meeting, please see the online program here.

Blue Earth Diagnostics has two clinical studies underway to investigate the use of 18F-fluciclovine PET in the detection of recurrent brain metastases. The Phase 2 PURSUE trial is designed to establish image interpretation criteria for 18F-fluciclovine PET in detecting recurrent brain metastases. REVELATE is a Phase 3 study designed to evaluate its diagnostic performance in the detection of recurrent brain metastases in patients previously treated with radiation therapy. Further information about these trials, including a current list of clinical trial sites, can be found on www.clinicaltrials.gov (PURSUE, NCT04410367; REVELATE, NCT04410133).

About 18F-Fluciclovine PET

18F-Fluciclovine PET is a novel diagnostic imaging radiopharmaceutical for PET imaging to visualize the increased amino transport that occurs in malignant tumors. It consists of a synthetic amino acid that is preferentially taken up by cancer cells compared with surrounding normal tissues and is labeled with the radioisotope 18F for PET imaging. 18F-Fluciclovine is under investigation by Blue Earth Diagnostics for potential use for the detection of recurrent brain metastases in adult patients who have previously undergone radiation therapy. 18F-Fluciclovine was invented at Emory University, in Atlanta, Ga., with much of the fundamental clinical development carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Blue Earth Diagnostics licensed 18F-fluciclovine from GE Healthcare and is investigating the molecule for other potential cancer indications, including in neuro-oncology.

U.S. Indication and Important Safety Information About Axumin

INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

On August 10, 2021 TYME Technologies, Inc. (Nasdaq: TYME) (the "Company" or "TYME"), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported financial and operating results for its fiscal first quarter ended June 30, 2021 (Press release, TYME, AUG 10, 2021, View Source [SID1234586255]).

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Fiscal First Quarter 2022 Business and Recent Highlights:

Completed strategic review and identified clinical priorities with a focus on metastatic hormone receptor positive, human epidermal growth factor receptor 2 negative ("HR+/HER2-") breast cancer, second-line pancreatic cancer and sarcomas as well as biomarker and mechanism of action ("MOA") studies.
Granted U.S. patent claims covering use of tyrosine-based drug delivery method to treat cancer. This early-stage technology, if proven, could provide TYME an opportunity to expand its current cancer-metabolism based approach with a drug delivery platform that aims to deliver toxic therapies in a targeted manner to offer improved safety and efficacy for a range of anticancer drugs.
Commenced a comprehensive biomarker initiative across several leading institutions, including Mayo Clinic and Georgetown University and the global drug development company Evotec. These studies have the potential to provide valuable information to help guide our future clinical development. In April 2021, Mayo Clinic established multiple human pancreatic organoid models.
Presented interim clinical data from the Phase II HopES Sarcoma trial at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") General Meeting. The Company expects enrollment of this trial to be completed this fiscal year.
Strengthened leadership team with the appointments of biopharmaceutical veterans, Dr. Jan M. Van Tornout as Acting Chief Medical Officer, and Frank Porfido as Chief Financial Officer.
"It was an active and productive fiscal first quarter at TYME. Having completed our comprehensive strategic review, we believe we are now better positioned with a more diversified pipeline and larger addressable market opportunities. We welcomed Dr. Van Tornout and Mr. Porfido to the leadership team and look forward to their contributions as we embark on a host of promising clinical initiatives. Importantly, we have been able to implement these strategies without increasing our projected clinical spend," stated Richie Cunningham, Chief Executive Officer of TYME.

"Looking ahead, we believe the recently granted patent on our drug delivery technology and the announcement of the Phase II OASIS breast cancer trial with Georgetown University are exciting opportunities for TYME that help position us for meaningful achievements ahead," concluded Cunningham.

First Quarter Fiscal 2022 Financial Results

As of the first quarter ended June 30, 2021, the Company had approximately $101.5 million in cash and marketable securities, compared to $107.5 million as of the fourth quarter ended March 31, 2021. In the first quarter, the Company invested approximately $74.1 million in a portfolio of highly liquid investments and marketable securities with the primary objectives of preserving capital and diversifying risk, while maintaining sufficient liquidity to meet cash flow requirements.

TYME’s operational cash burn rate for the first quarter of fiscal year 2022 was $6.0 million compared to $5.2 million for the fourth quarter of fiscal year 2021 and $6.7 million for the first quarter of fiscal 2021. The burn rate was below the Company’s previous projections and reflects expenses associated with ongoing clinical trials in pancreatic cancer (Precision Promise) and sarcoma cancers (HopES), as well as reduced costs associated with our discontinued pancreatic cancer trial, TYME-88-Panc Part II.

Based on the Company’s active clinical trials including OASIS, our new investigator-initiated open-label Phase II breast cancer trial, ongoing and close out costs related to our discontinued pancreatic cancer study, the upcoming pre-clinical studies in biomarker and mechanism of action research of SM-88 and TYME-19 pre-clinical studies; TYME continues to anticipate that its quarterly cash usage or "cash burn rate" will range from $6.0 to $8.0 million per quarter for the remainder of fiscal year 2022.

Net loss was $5.9 million for the first quarter ended June 30, 2021, or a net loss per basic and diluted share of ($0.03), as compared to a net loss of $8.8 million for the first quarter ended June 30, 2020, or a net loss per basic and diluted share of ($0.07). The decrease was substantially due to the year over year variance in the change in value of the warrant liability compared to prior years’ gain on the warrant exchange and decreased operating costs. The reduction in operating costs primarily reflected lower ongoing trial costs and employee related expenses. Adjusted net loss for the three months ended June 30, 2021, was $6.0 million, or an adjusted net loss per share of ($0.03), compared to adjusted net loss of $6.7 million, or an adjusted net loss per share of ($0.05), for the three months ended June 30, 2020, after adjusting for the change in fair value of warrant liability, amortization of employees, directors and consultants stock options, and the prior year’s gain on warrant exchange. Adjusted net loss and adjusted net loss per share are non-GAAP measures. See "Use of Non-GAAP Measures" below for a reconciliation to the comparable GAAP measures.

TYME has reported its full financial results for the quarter ended June 30, 2021 in the Company’s Form 10-Q filed with the Securities and Exchange Commission ("SEC"). TYME’s 10-Q is located in the SEC filings section of the Company’s website.

The webcast will be accessible on the Events & Presentations page of the Investors section of the TYME website, tymeinc.com, and will be archived for 90 days following the event.

Use of Non-GAAP Measures

Adjusted net loss and adjusted net loss per share as presented in this report are non-GAAP measures. The adjustments relate to the change in fair value of warrant liability, amortization of employees, directors and consultants stock options and gain on warrant exchange. These financial measures are presented on a basis other than in accordance with U.S. generally accepted accounting principles ("Non-GAAP Measures"). In the reconciliation tables that follow, we present adjusted net loss and adjusted net loss per share, reconciled to their comparable GAAP measures, net loss and net loss per share. These items are adjusted because they are not operational or because they are significant noncash charges and management believes these adjustments are meaningful to understanding the Company’s performance during the periods presented. These Non-GAAP Measures should be considered a supplement to, not a substitute for, or superior to, the corresponding financial measures calculated in accordance with GAAP. Our definitions of adjusted net loss and adjusted loss per share may not be comparable to similar measures reported by other companies.

On August 10, 2021 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 its second quarter 2021 financial results and provides a business update (Press release, Pulmatrix, AUG 10, 2021, View Source [SID1234586254]).

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"We have made steady progress across our pipeline in the second quarter," said Ted Raad, Chief Executive Officer of Pulmatrix. "Recent toxicology data from PUR1800 suggests the potential to expand into indications that require chronic dosing. We look forward to presenting topline data from the fully enrolled, ongoing Phase 1b study of PUR1800 in Q1 2022. We are also rapidly advancing towards the clinic with PUR3100 in acute migraine. We believe that our strong cash position allows us to advance our pipeline through major data milestones into 2023."

Second Quarter and Recent Highlights:

PUR1800

Completed enrollment in ongoing Phase 1b clinical study of PUR1800 in acute exacerbations in COPD (AECOPD). Study endpoints include safety, tolerability, and exploratory biomarkers to demonstrate target engagement and anti-inflammatory effect.
PUR1800 Phase 1b top-line data is expected in Q1 2022.
Results from 6-month rat and 9-month dog toxicology results demonstrate no progression of 28-day findings, suggesting potential for chronic dosing of PUR1800 in indications beyond AECOPD including, but not limited to, steroid resistant asthma, chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF).
The Company estimates an approximate peak net revenue opportunity of $2.4B in AECOPD1, due to the significant unmet need beyond standard of care oral steroids and/or antibiotic therapy. Expansion to chronic indications should further broaden the market potential of PUR1800.
PUR3100

14-day toxicology results for PUR3100, Pulmatrix’s dry powder iSPERSE formulation of dihydroergotamine (DHE) for pulmonary delivery to treat acute migraine are expected in Q3 2021.
IND filing planned in Q4 2021, with a Phase 1/ Phase 2 clinical study start date anticipated in Q1 2022. Data from this proof-of-concept study are expected in Q4 2022.
Pulmazole

Pulmatrix notified Cipla Technologies LLC (Cipla) that it is in material breach of the Development and Commercialization Agreement (the Cipla Agreement) in May 2021. The Company continues to seek Cipla’s reaffirmation of all of its obligations under the Cipla Agreement and, in the absence of such reaffirmation, to pursue all available remedies.
1 Market research and analysis from ClearView Healthcare Partners

Financials

As of June 30, 2021, Pulmatrix had $56.9 million in cash and cash equivalents, compared to $31.7 million for the year ended December 31, 2020.

Revenue for the second quarter of 2021 was $2.2 million, compared to $3.5 million for the same period in 2020. The revenue for the second quarter of 2021 was the result of the collaboration and licensing agreements with Cipla and JJEI.

Research and development expense was $4.5 million in the second quarter of 2021 compared to $3.2 million for the same period in 2020. The increase year–over-year was primarily attributable to increased preclinical and manufacturing costs related to the PUR3100 project partially offset by decreased spend on the Pulmazole clinical trial.

General and administrative expense was $1.6 million for the second quarter of 2021 compared to $1.5 million for the same period in 2020. The increase year–over-year was primarily attributable to increase legal, patent, ad public company costs partially offset by decreased employment costs.

Net loss was $3.9 million for the second quarter of 2021 compared to a net loss of $1.2 million for the same period of 2020. The $2.7 million increase in net loss year-over-year was due to increased spend for preclinical and manufacturing expenses on the PUR3100 program and reduced revenue recognized that related to the Pulmazole program.