On August 16, 2021 Vyant Bio, Inc. ("Vyant Bio", "Company") (Nasdaq: VYNT), an emerging global drug discovery company, reported that it is rapidly identifying small and large molecule therapeutics to treat central nervous system (CNS) and oncology-related diseases (Press release, Cancer Genetics, AUG 16, 2021, View Source [SID1234586632]). Today, Vyant Bio reports its Second Quarter 2021 strategic and business updates in a conference call scheduled for 4:30 p.m. ET.

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"We have achieved a tremendous amount of momentum in the first 90 days since launching the Vyant Bio brand and completing the merger we announced at the end of March 2021. Vyant Bio is committed to transforming the way drugs are discovered by quickly adapting to exciting new technologies and combining capabilities in ways that leverage their strengths," stated Jay Roberts, CEO of Vyant Bio. "Our internal teams of scientists, data scientists and engineers, coupled with the capabilities of select strategic partners that are now integrated into our platform, allow us all to work together to design and develop superior therapeutics and position us to build a robust pipeline of novel therapeutics targeting degenerative and developmental neurological disorders and cancers with high unmet needs."

Vyant Bio’s drug discovery platform uses both human-induced pluripotent stem cell-derived (hiPSC) and primary human cell organoids as proprietary disease models combined with analysis of human genetics and the use of machine learning algorithms for the identification of new targets, validation of known targets, and high-throughput screening for drug discovery. Vyant Bio’s drug discovery platform is intended to overcome the shortcomings of traditional drug discovery efforts that rely more heavily on insights from animal models to identify targets and to develop therapies intended for human disease. The Company is currently focused on the specific utility for the identification of targets and therapies in CNS and Oncology.

The Company filed its quarterly report for the Second Quarter 2021 on Form 10-Q today with the Securities and Exchange Commission. Please refer to our Form 10-Q for more detailed information with respect to our financial results for the three and six months ended June 30, 2021.

SECOND QUARTER 2021 FINANCIAL RESULTS1

As StemoniX, Inc. was deemed to have acquired Cancer Genetics, Inc. for accounting purposes and the Merger closed on March 30, 2021, the Company’s Second Quarter 2021 financial results include the post-merger results of the combined companies, now known as Vyant Bio. The analysis below excludes the Second Quarter 2020 results as they are based solely on StemoniX’s historical stand-alone operations and therefore do not reflect the post-merger enterprise.

Cash and cash equivalents totaled $26.5 million as of June 30, 2021.

Total revenues were $1.9 million for the three months ended June 30, 2021. Cost of goods sold – service aggregated to $1.0 million for the three months ended June 30, 2021 resulting in a cost of goods sold of 56% of service revenues. Cost of goods sold – product aggregated to $345 thousand for the three months ended June 30, 2021 resulting in a cost of goods sold gross margin deficit of $229 thousand. Our product manufacturing capabilities currently have excess capacity to support future growth. Research and development expenses were $910 thousand for the three months ended June 30, 2021. Selling, general and administrative expenses, which include public company costs and non-cash expenses of $620 thousand, were $3.7 million for the three months ended June 30, 2021.

While the Company executes its drug development strategy for long-term growth, the Company currently generates revenue from its vivoPharm and StemoniX subsidiaries. On a pro forma basis, assuming the Merger occurred on January 1, 2020, revenues for the three and six-month ended June 30, 2021 were $1.9 million and $3.8 million, respectively, as compared with $1.5 million and $3.1 million for the respective prior-year periods. On a pro forma basis, revenues increased by 26% and 21% in the current-year three and six-month periods as compared with the same prior-year periods.

1Pro forma information gives effect to the Merger between Cancer Genetics, Inc. and StemoniX, Inc. as if the Merger had occurred as of January 1, 2020. The pro forma information is presented solely for informational purposes and is not necessarily indicative of the combined results of operations or financial position that might have been achieved for the periods or dates indicated, nor is it necessarily indicative of the future results of the Company.

Vyant Bio’s Conference Call and Webcast and Information

Vyant Bio’s management will host a conference call on Monday, August 16, 2021 at 4:30pm ET to discuss the Second Quarter 2021 results and provide strategic business updates, as well as answer questions. Event information is below:

On August 16, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, reported recent presentations on two of its skin cancer gene expression profile tests at the 2021 American Academy of Dermatology (AAD) Summer Meeting, held Aug. 5-8, 2021 (Press release, Castle Biosciences, AUG 16, 2021, View Source [SID1234586648]).

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DecisionDx-Melanoma:

DecisionDx-Melanoma is Castle’s gene expression profile test that uses an individual patient’s tumor biology to predict the risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node (SLN) positivity, independent of traditional staging factors.

"Integrating 31-gene expression profiling with clinicopathologic features improves prognostication of recurrence and metastasis in patients with stage I-III cutaneous melanoma" was presented by Nicholas Taylor, M.D., Ph.D., Zitelli and Brodland, P.C., Pittsburgh and Central Dermatology Center, Chapel Hill, N.C. in the Frontiers in Research, Science and Technology (FiRST) session on Saturday, Aug. 7.

"The study demonstrated that DecisionDx-Melanoma added significant prognostic value for a patient beyond traditional staging," said Taylor. "The study further showed that the ability to integrate a patient’s unique tumor biology with their personal clinical and pathologic risk factors helped both patients and clinicians."

Study methods and findings:

DecisionDx-Melanoma’s 31-gene expression profile (31-GEP) has been validated to both identify patients at low risk of sentinel lymph node positivity and refine risk of recurrence prognosis.
A new integrated algorithm (i31-GEP ROR (risk of recurrence) for outcomes prediction) was developed (n=1581) and validated (n=523) using Cox regression and 10×4-fold cross-validation on patients with stage I-III cutaneous melanoma from multiple centers.
The final integrated outcomes prediction algorithm combined DecisionDx-Melanoma’s continuous 31-GEP score and patient-specific clinicopathologic risk factors, including Breslow thickness, ulceration, mitotic rate, age, tumor location, sentinel lymph node (SLN) status and/or the presence of microsatellites.
Compared to American Joint Committee on Cancer Eighth Edition (AJCC8) staging, the i31-GEP ROR algorithm for outcomes prediction significantly improved the classification of overall risk for five-year recurrence-free survival (RFS), distant metastasis-free survival (DMFS) and melanoma-specific survival (MSS).
Integrating DecisionDx-Melanoma’s continuous 31-GEP score with clinicopathologic features improves risk stratification over staging guidelines alone.
Overall, the study demonstrated that DecisionDx-Melanoma’s i31-GEP ROR integrated test result was an independent, significant predictor of five-year RFS, DMFS and MSS, and that the i31-GEP ROR outcomes prediction algorithm provided an individualized risk estimate rather than an average, population-based risk estimate that can help personalize patient management decisions and overall risk assessments beyond standard melanoma staging.
DecisionDx-SCC:

DecisionDx-SCC is Castle’s prognostic 40-gene expression profile (GEP) test for patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC), designed to use a patient’s tumor biology to predict individual risk of metastasis for patients with SCC and one or more risk factors.

"Risk assessment by the 40-gene expression profile (40-GEP) test further stratifies risk of metastasis in a subset of high-risk cutaneous squamous cell carcinoma (cSCC) patients meeting T1 staging criteria​" was presented by Aaron Farberg, M.D., Baylor University Medical Center, Dallas in the Frontiers in Research, Science and Technology (FiRST) session on Saturday, Aug. 7.

"As a physician, it is important that I leverage all of the information available to me to make the best decisions for the care of each patient," said Farberg. "This study demonstrated that by incorporating DecisionDx-SCC into their clinical practice, physicians can more confidently identify patients with a higher risk of metastasis, who may have otherwise been considered low-risk using traditional staging systems alone, which provides the ability to adjust their treatment plans for improved patient outcomes."

Study methods and findings:

Previous validation of the DecisionDx-SCC test in a high-risk SCC cohort (n=420, all high-risk or very- high risk by the National Comprehensive Cancer Network (NCCN) guidelines v1.2021 or meeting Appropriate Use Criteria for Mohs Micrographic Surgery) demonstrated independent prognostic value when the result was incorporated into existing risk assessment methods.
Using this validation cohort, the objective of this study was to determine whether DecisionDx-SCC could identify biologically risky tumors within a subset of NCCN high-risk tumors comprehensively staged as T1 by either American Joint Committee on Cancer Eighth Edition (AJCC8) or Brigham and Women’s Hospital (BWH) staging (AJCC8 cohort n=222; BWH cohort n=200).
Kaplan-Meier analysis demonstrated a statistically significant difference in three-year metastasis-free survival rates between DecisionDx-SCC risk groups:
AJCC8 T1 cases – Class 1: 95.2%, Class 2A: 81.4%, Class 2B: 50%; p<0.001
BWH T1 cases – Class 1: 96.6%, Class 2A: 84.9%, Class 2B: 55.6%; p<0.001
Within these T1 subsets, DecisionDx-SCC accurately identified metastatic cases in approximately 80% of the cases:
AJCC8 T1 cases: 78.6% ​of metastatic cases ​received a Class 2A (moderate biological risk of metastasis) or 2B (high biological risk of metastasis) DecisionDx-SCC result
BWH T1 cases: 78.9%​ of metastatic cases ​received a Class 2A or 2B DecisionDx-SCC result
Overall, the study demonstrated that DecisionDx-SCC accurately identified tumors at risk of metastasis and can be incorporated into clinical assessments with traditional clinicopathological risk factors to help inform patient surveillance and treatment decisions.
About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. To predict likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithm, i31-GEP, to produce an integrated test result. i31-GEP is an artificial intelligence-based neural network algorithm (independently validated in a cohort of 1,674 prospective, consecutively tested patients with T1-T4 cutaneous melanoma) that integrates the DecisionDx-Melanoma test result with the patient’s traditional clinicopathologic features. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through June 30, 2021, DecisionDx-Melanoma has been ordered 78,277 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.CastleTestInfo.com.

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), 2A (moderate) or 2B (high) risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

More information about the test and disease can be found at www.CastleTestInfo.com.

On August 16, 2021 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring, developing and commercializing or monetizing promising biopharmaceutical products and product candidates cost-effectively, reported financial results and recent corporate highlights for the second quarter ended June 30, 2021 (Press release, Fortress Biotech, AUG 16, 2021, View Source [SID1234586672]).

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Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, "We generated significant sales momentum in the second quarter, recording quarterly record net revenues of $17.8 million, an 89% increase year-over-year. We also successfully acquired and recently launched QBREXZA to further expand our portfolio of marketed products, as well as in-licensed Dotinurad, DFD-29, and a novel CAR T technology, which enhance our robust pipeline of drug candidates. In addition, we presented compelling clinical data for CAEL-101 for the treatment of AL amyloidosis and MB-106 for relapsed or refractory B-cell non-Hodgkin lymphomas ("B-NHL") and chronic lymphocytic leukemia ("CLL") at the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Virtual Congress ("EHA2021"). Looking ahead, we anticipate several additional regulatory and clinical catalysts throughout the remainder of 2021, including the availability of pivotal data from cosibelimab for the treatment of metastatic cutaneous squamous cell carcinoma. We also expect to begin the rolling New Drug Application ("NDA") submission for CUTX-101 for the treatment of Menkes disease in the second half of 2021."

Dr. Rosenwald continued, "We have an expanding portfolio of seven marketed dermatology products and more than 25 product candidates across our partner companies, including 18 clinical programs and 24 clinical trials, of which four are pivotal clinical trials, and up to four more could potentially be pivotal soon. Our diversified business model is supported by a world-class business development team. Fortress and our partner companies are well-positioned to achieve an array of milestones over the next year and into the future with the objective of providing new treatment options to patients in need, while creating significant long-term value for our shareholders."

Recent Corporate Highlights1:

Marketed Dermatology Products and Product Candidates

Our seven dermatology products are marketed by our partner company, Journey Medical Corporation ("Journey").
Our products generated net revenues of $15.3 million for the second quarter of 2021, compared to second quarter 2020 net revenues of $9.4 million.
In July 2021, Journey completed its final closing under the Cumulative Convertible Class A Preferred Stock Offering (the "Preferred Offering"). In connection with the Preferred Offering, Journey issued an aggregate of 750,680 preferred shares at a price of $25.00 per share, and after deducting commissions, fees and expenses, for a total of approximately $16.8 million in net proceeds across the various closings.
In June 2021, Journey entered into a definitive agreement with Dr. Reddy’s Laboratories Ltd. to develop and commercialize DFD-29 (modified release minocycline capsules) for the treatment of rosacea. Journey and Dr. Reddy’s Laboratories Ltd. intend to conduct two Phase 3 clinical trials to assess the efficacy, safety and tolerability of DFD-29 for regulatory approval.
In May 2021, Journey acquired and recently launched its seventh prescription dermatology product, QBREXZA.
In April 2021, Journey entered into an agreement with East West Bank ("EWB") in which EWB provided a $7.5 million working capital line of credit.
Journey intends to launch one additional prescription product in the second half of this year.
CUTX-101 (Copper Histidinate for Menkes disease)

We intend to begin the rolling submission of the NDA for CUTX-101 to the U.S. Food and Drug Administration ("FDA") in the second half of 2021.
CUTX-101 was sourced by Fortress and is currently in development at our partner company, Cyprium Therapeutics, Inc.
CAEL-101 (Light Chain Fibril-reactive Monoclonal Antibody for AL Amyloidosis)

Caelum Biosciences, Inc. ("Caelum") has two ongoing Phase 3 studies of CAEL-101 for AL amyloidosis.
Caelum formed a collaboration with Alexion Pharmaceuticals, Inc. ("Alexion") in 2019, which included an option to acquire Caelum. AstraZeneca completed its acquisition of Alexion on July 21, 2021. The period during which AstraZeneca/Alexion must now decide whether or not to exercise their option to purchase Caelum expires in January 2022. Fortress would receive approximately 43 percent of the proceeds from a potential AstraZeneca transaction.
In June 2021, we announced that CAEL-101 clinical data were presented at EHA (Free EHA Whitepaper)2021. The data, presented in two e-posters, strengthen the safety and tolerability profile of CAEL-101 to further support the dose selection for the ongoing Phase 3 study, and suggest possible cardiac and renal response.
Also in June 2021, the FDA granted Fast Track designation to CAEL-101 for the treatment of light chain AL amyloidosis.
CAEL-101 was sourced by Fortress and is currently in development at Caelum Biosciences, Inc., a company founded by Fortress in 2017 and in which Fortress maintains a minority position.
Cosibelimab (formerly CK-301, an anti-PD-L1 antibody)

The registration-enabling study in metastatic cutaneous squamous cell carcinoma is fully enrolled and we are on track to report top-line results by year-end 2021. Upon a successful outcome, Checkpoint Therapeutics, Inc. ("Checkpoint") intends to submit a Biologics License Application ("BLA") for cosibelimab in 2022, followed shortly thereafter by a Marketing Authorization Application submission in Europe. With a potentially favorable safety profile versus anti-PD-1 therapy and a plan to commercialize at a substantially lower price, we believe cosibelimab has the potential to be a market disruptive product in the $25 billion and growing PD-(L)1 class.
A Phase 3 registration-enabling trial is planned to begin in first-line metastatic non-small cell lung cancer ("NSCLC") in the second half of 2021.
Cosibelimab was sourced by Fortress and is currently in development at our partner company, Checkpoint.
Olafertinib (formerly CK-101, a third-generation epidermal growth factor receptor ("EGFR") inhibitor)

During the second quarter, we had productive interactions with the FDA regarding our development program for olafertinib (formerly CK-101), our third-generation EGFR inhibitor being evaluated by our partner in an ongoing double-blind, randomized Phase 3 study in China. We intend to utilize the Phase 3 study, if successful, to support an NDA submission for olafertinib as a potential first-line treatment for patients with NSCLC whose tumors have certain types of EGFR mutations.
Olafertinib was sourced by Fortress and is currently in development at our partner company, Checkpoint.
MB-106 (CD20-targeted CAR T Cell Therapy)

In May 2021, we announced that the FDA approved Mustang Bio Inc.’s ("Mustang Bio") Investigational New Drug ("IND") application to initiate a multicenter Phase 1/2 clinical trial investigating the safety and efficacy of MB-106, a CD20-targeted CAR T for relapsed or refractory B-NHL and CLL.
In June 2021, we announced that MB-106 CD20-targeted CAR T data were presented at EHA (Free EHA Whitepaper)2021. Dr. Mazyar Shadman of Fred Hutchinson Cancer Research Center presented updated interim data from the ongoing Phase 1/2 clinical trial for B-NHL and CLL, which showed a favorable safety profile and compelling clinical activity, with a 93% overall response rate and 67% complete response rate in patients treated with the modified cell manufacturing process.
Also in June 2021, we hosted a key opinion leader webinar featuring a presentation from Dr. Shadman, who discussed interim results from the ongoing Phase 1/2 clinical trial investigating the safety and efficacy of MB-106 CD20-targeted CAR T for B-NHL and CLL. A replay of the webinar can be found here.
MB-106 was sourced by Fortress and is currently in development at our partner company, Mustang Bio.
MB-107 and MB-207 (Lentiviral Gene Therapies for X-linked Severe Combined Immunodeficiency ("XSCID"))

Earlier this month, we announced that the European Medicines Agency ("EMA") granted Priority Medicines ("PRIME") designation to MB-107, a lentiviral gene therapy for the treatment of XSCID in newly diagnosed infants, also known as bubble boy disease.
Later this quarter, we expect to enroll the first patient in the MB-107 pivotal multicenter Phase 2 clinical trial under Mustang Bio’s IND and to file an IND for our pivotal multicenter Phase 2 clinical trial of MB-207.
MB-107 and MB-207 were sourced by Fortress and are currently in development at our partner company, Mustang Bio.
MB-101 (IL13Rα2-targeted CAR T Cell Therapy)

In May 2021, we announced that the first patient was dosed at City of Hope in a clinical trial to establish the safety and feasibility of administering MB-101 (autologous IL13Rα2-targeted CAR T cells) to patients with leptomeningeal brain tumors (e.g., glioblastoma, ependymoma or medulloblastoma).
MB-101 was sourced by Fortress and is currently in development at our partner company, Mustang Bio.
Novel CAR T Technology

In August 2021, we announced an exclusive license agreement with Mayo Clinic for a novel technology that may be able to transform the administration of CAR T therapies and has the potential to be used as an off-the-shelf therapy.
The novel CAR T technology was sourced by Fortress and is currently in development at our partner company, Mustang Bio.
Dotinurad (Urate Transporter (URAT1) Inhibitor)

In May 2021, we announced an exclusive license agreement with Fuji Yakuhin Co. Ltd. to develop Dotinurad in North America, Europe, United Kingdom and Canada. Dotinurad is a potential best-in-class urate transporter (URAT1) inhibitor for gout and possibly other hyperuricemic indications, including chronic kidney disease and heart failure. Dotinurad (URECE tablet) was approved in Japan in 2020 as a once-daily oral therapy for gout and hyperuricemia. Dotinurad was efficacious and well-tolerated in more than 500 Japanese patients treated for up to 58 weeks in Phase 3 clinical trials.
Dotinurad was sourced by Fortress and is currently in development at our partner company, FBIO Acquisition Corp. VIII.
Financial Results:

To assist our stockholders in understanding our company, we have prepared non-GAAP financial results for the three months ended June 30, 2021 and 2020. These results exclude the operations of our three public partner companies: Avenue, Checkpoint and Mustang Bio. The goal in providing these non-GAAP financial metrics is to highlight the financial results of Fortress’ core operations, which are comprised of our commercial-stage business, our privately held development-stage entities, as well as our business development and finance functions.

As of June 30, 2021, Fortress’ consolidated cash, cash equivalents and restricted cash totaled $276.6 million, compared to $235.0 million as of December 31, 2020, an increase of $41.6 million year-to-date.
On a GAAP basis, Fortress’ net revenue totaled $17.8 million for the second quarter of 2021, which included $15.3 million in net revenue generated from our marketed dermatology products. This compares to net revenue totaling $9.5 million for the second quarter of 2020, which included $9.4 million in net revenue generated from our marketed dermatology products.
On a GAAP basis, consolidated research and development expenses, including license acquisitions of $11.0 million, were $33.8 million for the second quarter of 2021, compared to consolidated research and development expenses, including license acquisitions of $1.6 million, totaling $17.3 million for the second quarter of 2020. On a non-GAAP basis, research and development expenses including license acquisitions of $10.0 million, were $14.5 million for the second quarter of 2021, compared to research and development expenses, including license acquisitions of $0.3 million, totaling $4.8 million for second quarter of 2020.
On a GAAP basis, consolidated selling, general and administrative expenses were $19.4 million for the second quarter of 2021, compared to $14.5 million for the second quarter of 2020. On a non-GAAP basis, consolidated selling, general and administrative expenses were $14.9 million, of which $7.6 million is attributed to Journey, for the second quarter of 2021, compared to $10.4 million, of which $4.7 million is attributed to Journey, for the second quarter of 2020.
On a GAAP basis, consolidated net loss attributable to common stockholders was $3.5 million, or $0.04 per share, for the second quarter of 2021, compared to consolidated net loss attributable to common stockholders of $13.3 million, or $0.19 per share for the second quarter of 2020.
Fortress’ non-GAAP loss attributable to common stockholders was $14.1 million, which includes $10 million related to Journey’s acquisition of DFD-29 and excludes the change in fair value of Fortress’ investment in Caelum, or $0.17 per share, for the second quarter of 2021, compared to Fortress’ non-GAAP loss attributable to common stockholders of $3.7 million, or $0.05 per share, for the second quarter of 2020.
The tables below have more information.
Use of Non-GAAP Measures:

In addition to the GAAP financial measures as presented in our Form 10-Q that will be filed with the Securities and Exchange Commission ("SEC") on August 16, 2021, the Company has, in this press release, included certain non-GAAP measurements. The non-GAAP net income (loss) attributable to common stockholders is defined by the Company as GAAP net income (loss) attributable to common stockholders, less net losses attributable to common stockholders from our public partner companies Avenue, Checkpoint and Mustang Bio. In addition, the Company has also provided a Fortress non-GAAP loss attributable to common stockholders which is a modified EBITDA calculation that starts with the non-GAAP income (loss) attributable to common stockholders and removes stock-based compensation expense, non-cash interest expense, amortization of licenses and debt discount, changes in fair values of investment, changes in fair value of derivative liability, Qbrexza inventory step-up and depreciation expense.

Management believes use of these non-GAAP measures provide meaningful supplemental information regarding the Company’s performance because (i) it allows for greater transparency with respect to key measures used by management in its financial and operational decision-making, (ii) it excludes the impact of non-cash or, when specified, non-recurring items that are not directly attributable to the Company’s core operating performance and that may obscure trends in the Company’s core operating performance and (iii) it is used by institutional investors and the analyst community to help analyze the Company’s results. However, non-GAAP income (loss) attributable to common stockholders and any other non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Further, non-GAAP financial measures used by the Company and the manner in which they are calculated may differ from the non-GAAP financial measures or the calculations of the same non-GAAP financial measures used by other companies, including the Company’s competitors.

Avenue net loss from their external SEC report for the three months ended June 30, 2021 and 2020 of $0.9 million and $1.9 million, respectively, net of non-controlling interest of $0.7 million and $1.4 million, respectively. Avenue net loss from their external SEC report for the six months ended June 30, 2021 and 2020 of $2.0 million and $3.1 million, respectively, net of non-controlling interest of $1.5 million and $2.4 million, respectively.
Checkpoint net loss from their external SEC report of $9.1 million net of non-controlling interest of $7.1 million, MSA fee to Fortress of $0.1 million and financing fee to Fortress of $0.3 million for the quarter ended June 30, 2021; and net loss of $4.6 million net of non-controlling interest of $3.4 million, less MSA fee to Fortress of $0.1 million and financing fee to Fortress of $0.1 million for the quarter ended June 30, 2020. Checkpoint net loss from their external SEC report of $15.6 million net of non-controlling interest of $11.6 million, MSA fee to Fortress of $0.1 million and financing fee to Fortress of $0.9 million for the six months ended June 30, 2021; and net loss of $7.9 million net of non-controlling interest of $5.8 million, less MSA fee to Fortress of $0.3 million and financing fee to Fortress of $0.1 million for the six months ended June 30, 2020.
Mustang Bio net loss from their external SEC report of $14.4 million net of non-controlling interest of $11.3 million, MSA fee to Fortress of $0.1 million and financing fee to Fortress of $0.4 million for the quarter ended June 30, 2021; and net loss of $14.6 million net of non-controlling interest of $9.7 million, MSA fee to Fortress of $0.1 million and financing fee to Fortress of $1.0 million for the quarter ended June 30, 2020. Mustang Bio net loss from their external SEC report of $29.3 million net of non-controlling interest of $22.1 million, MSA fee to Fortress of $0.3 million and financing fee to Fortress of $1.6 million for the six months ended June 30, 2021; and net loss of $26.5 million net of non-controlling interest of $17.7 million, MSA fee to Fortress of $0.3 million and financing fee to Fortress of $1.1 million for the six months ended June 30, 2020.
Increase in fair value of investment in Caelum Biosciences for the quarter and six months ended June 30, 2021.
Increase in fair value of derivative liabilities of Journey Medical Corporation for the quarter and six months ended June 30, 2021.
Step-up related to FV of Qbrexza inventory sold and recorded in COGS for the quarter and six months ended June 30, 2021.
Reconciliation to non-GAAP research and development and selling, general and administrative costs:

Includes Research and development expense and Research and development – licenses acquired expense for the quarter and six month ended June 30, 2021 and 2020, respectively.

Excludes $0.1 million and $0.1 million of Fortress MSA expense for the quarter ended June 30, 2021 and 2020, respectively and $0.1 million and $0.1 million for the six months ended June 30, 2021 and 2020, respectively.

Excludes $0.1 million of Fortress MSA expense and $0.3 million Fortress financing fee for the quarter ended June 30, 2021; and $0.1 million of Fortress MSA expense and $0.1 million Fortress financing fee for the quarter ended June 30, 2020. Excludes $0.3 million of Fortress MSA expense and $0.9 million Fortress financing fee for the six months ended June 30, 2021; and $0.3 million of Fortress MSA expense and $0.1 million Fortress financing fee for the six months ended June 30, 2020.

Excludes $0.1 million of Fortress MSA expense and $0.4 million Fortress financing fee for the quarter ended June 30, 2021; and $0.1 million of Fortress MSA expense and $1.0 million Fortress financing fee for the quarter ended June 30, 2020. Excludes $0.1 million of Fortress MSA expense and $1.6 million Fortress financing fee for the six months ended June 30, 2021; and $0.1 million of Fortress MSA expense and $1.1 million Fortress financing fee for the six months ended June 30, 2020.

On August 16, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved the Oncotype DX Breast Recurrence Score Program (Press release, Exact Sciences, AUG 16, 2021, View Source [SID1234586599]). The test helps guide chemotherapy treatment recommendations and provides risk of distant recurrence in patients with hormone receptor-positive, HER2-negative early-stage breast cancer with up to three positive lymph nodes. MHLW approval is a critical step in making Oncotype DX accessible to breast cancer patients in Japan.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

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Breast cancer is the most common cancer in Japanese women, and more than 90,000 new breast cancer cases were diagnosed in Japan in 2020.i The Oncotype DX Breast Recurrence Score Program approved in Japan combines the Oncotype DX Breast Recurrence Score test and software developed for the Japanese market. Exact Sciences plans to pursue coverage under Japan’s universal healthcare insurance system and launch the test through its Japanese affiliate, Exact Sciences K.K.

"MHLW’s approval of Oncotype DX is great news for breast cancer patients in Japan and reflects the powerful evidence backing the Oncotype DX test," said Kevin Conroy, chairman and CEO. "Our international team is enabling new areas of growth for our current advanced cancer tests and will accelerate access to future innovative tests for patients around the world."

The Oncotype DX test provides information allowing doctors and patients to personalize treatment plans with greater confidence.ii While chemotherapy is routinely offered, research shows that only a minority of patients with early-stage breast cancer will actually benefit.iii Oncotype DX is the only test validated to determine which patients will benefit from chemotherapy and provides critical information beyond traditional prognostic factors.iv-viii The test is supported by prospective outcomes data from the TAILORxvii and RxPONDERviii studies, which show that most patients with either node-negative or node-positive disease can be spared chemotherapy when decisions are guided by Oncotype DX.

About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Exact Sciences. The Oncotype MAP Pan-Cancer Tissue test is a rapid, comprehensive tumor profiling panel that aids therapy selection for patients with advanced, metastatic, refractory, or recurrent cancer. With more than 1 million patients tested in more than 90 countries, the Oncotype tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.

On August 16, 2021 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported financial results for the quarter ended June 30, 2021 (Press release, Kinnate Biopharma, AUG 16, 2021, View Source [SID1234586633]). The company also announced that the first patient has commenced treatment in its Phase 1 KN-8701 clinical trial evaluating its lead RAF product candidate, KIN-2787, a pan-RAF inhibitor being developed for the treatment of patients with lung cancer, melanoma and other solid tumors.

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"2021 continues to be a year of progress for Kinnate. Initiating our first in-human trial for KIN-2787 and dosing our first patient were important steps forward toward expanding options for cancer patients who are not benefiting from currently approved RAF inhibitors," said Nima Farzan, Chief Executive Officer of Kinnate. "As we enter the second half of the year, our expanding team of clinical and business leaders are well positioned to drive further progress in our KIN-2787 program and advance our pipeline of targeted precision oncology therapies, including our lead FGFR inhibitor candidate for which we anticipate filing an IND in the first half of 2022."

The KN-8701 trial is a multi-center, open-label, two-part study of approximately 115 patients to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with Class I, Class II, or Class III BRAF-mutated advanced or metastatic solid tumors.

"Successfully targeting patients with Class II and Class III BRAF mutations remains a substantial unmet need in cancer care. KIN-2787 brings a unique approach to potentially address the shortcomings of existing therapies by inhibiting dimer signaling in specific patient populations with BRAF mutations while also minimizing MAPK paradoxical activation," said Meredith McKean, MD, MPH, Associate Director, Melanoma and Skin Cancer Research Program, Sarah Cannon Research Institute at Tennessee Oncology. "We are proud to be the first site to treat a patient with KIN-2787 and look forward to working with Kinnate to continue enrollment in this important Phase 1 trial."

Other Recent Business Highlights and Corporate Update:

In May 2021, we closed a $35 million Series A preferred stock financing of a China joint venture ("China JV"), of which Kinnate is the majority shareholder. Established with OrbiMed Asia Partners, OrbiMed Private Investments and Foresite Capital, the China JV will be headquartered in Shanghai and the financing will enable the potential development and commercialization by the China JV of certain Kinnate targeted oncology product candidates across Greater China (PRC, Hong Kong, Taiwan, and Macau).
We appointed Neha Krishnamohan as our Chief Financial Officer and Executive Vice President, Corporate Development, and we continued to expand our leadership team, including with the appointment of Ken Kobayashi, M.D., our Senior Vice President, Clinical Development.
Helen Sabzevari, Ph.D. was appointed to our Board of Directors, and Stephen Kaldor, Ph.D., one of our founders, was not nominated for re-election to our Board of Directors when his term expired at our 2021 annual meeting of shareholders.
We expanded our organization to 52 full-time employees at June 30, 2021, of which 39 were engaged in research and development activities.
During a virtual poster session at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), we presented results from preclinical studies evaluating the efficacy and tolerability of KIN-2787, in vitro and in vivo in BRAF mutation-driven human cancer models.
Second Quarter 2021 Financial Results

Second quarter net loss for 2021 was $21.4 million, compared to $7.6 million for the same period in 2020.
Second quarter research and development expenses for 2021 were $16.2 million, compared to $5.6 million for the same period in 2020.
Second quarter general and administrative expenses for 2021 were $5.3 million, compared to $2.0 million for the same period in 2020.
As of June 30, 2021, the total of cash and cash equivalents and investments was $365.1 million, exclusive of $35.0 million in the China JV.