On August 15, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the second quarter and year-to-date for the period ended June 30, 2022 (Press release, Navidea Biopharmaceuticals, AUG 15, 2022, View Source [SID1234618377]).

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Second Quarter 2022 Highlights and Subsequent Events

Continued enrollment into the Company’s NAV3-33 Phase 3 trial in rheumatoid arthritis ("RA") titled "Evaluation of Tc 99m Tilmanocept Imaging for the Early Prediction of Anti-TNFα Therapy Response in Patients with Moderate to Severe Active Rheumatoid Arthritis." Enrollment is ongoing across the three currently opened sites.
Announced positive preliminary results from the Company’s ongoing NAV3-32 Phase 2b trial comparing Tc99m tilmanocept imaging to histopathology of joints of patients with active RA. Two non-overlapping classes that align with the fibroid and non-fibroid histological pathotypes were identified, supporting the hypothesis that these classes can be identified by Tc99m tilmanocept imaging.
Received $800,000 from a strategic partner as reimbursement for certain manufacturing and research and development expenses.
The Company’s abstract titled "TAM Targeted Imaging Agents Binding CD206 and Selective Blocking of Off Target Liver Localization" was presented at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting on June 11, 2022 in Vancouver, British Columbia.
The Company’s abstract titled "CD206 Targeted Delivery of Bisphosphonate Payloads Alter Human Macrophage Phenotypes Towards M1-like" was presented at the Tumor Myeloid-Directed Therapies Summit on June 14, 2022 in Boston, MA.
Announced publication of a manuscript titled "Increased Macrophage Specific Arterial Inflammation Relates Uniquely to Non-calcified Plaque and Specific Immune Activation Pathways in People with HIV: A Targeted Molecular Imaging Approach," based on work performed at the Massachusetts General Hospital ("MGH") and Harvard Medical School, Boston MA, and sponsored by the Company. The research, appearing in The Journal of Infectious Diseases (PMID: 35856671), was led by Principal Investigator Steven Grinspoon, MD, Chief of the Metabolism Unit at MGH and Professor of Medicine at Harvard Medical School.
Announced publication of a manuscript titled "Tilmanocept as a novel tracer for lymphatic mapping and sentinel lymph node biopsy in melanoma and oral cancer," based on work performed at the Crown Princess Mary Cancer Centre ("CPMCC") at the University of Sydney, in Sydney, Australia. The research, appearing in the ANZ Journal of Surgery (PMID: 35848587), was led by Principal Investigator Dr. Muzib Abdul-Razak, MBBS, FRACS, FRCSE, MCh., of the Faculty of Medicine, Department of Surgical Oncology and Head and Neck Surgery in the CPMCC at the University of Sydney.
Received notification of issuance of patent from the USPTO for the application titled, "Compounds And Compositions For Treating Leishmaniasis And Methods Of Diagnosis And Treating Using Same" (Patent No. US 11,369,680 B2).
Filed a provisional patent application describing a new degradable linker for dexamethasone and paclitaxel containing Manocept therapeutic constructs. These constructs are being evaluated preclinically for effects on macrophages and in animal models of oncology and inflammatory indications.
Received a Decision of Grant for patent application in Japan for claims related to targeted delivery of a wide range of therapeutic payloads attached to Manocept platform-based constructs using a degradable hydrazone linker.
Closed on a $2.5 million bridge loan from the Company’s Vice Chair of the Board of Directors, John K. Scott, Jr.
Adopted a plan designed to protect the Company’s net operating loss and tax credit carryforwards.
Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, "The company continues to work diligently to advance the technology in key disease areas, with an emphasis on our RA program. The NAV3-33 Phase 3 and NAV3-32 Phase 2b trials continue to enroll. We are pleased with the preliminary positive results from the NAV3-32 study that thus far support our hypothesis that we can distinguish between fibroid and non-fibroid pathotypes of RA with a single scan." Dr. Rosol continued, "Concurrent with all of this, we continue to make progress in our therapeutics pipeline, and we expect to keep advancing these towards the clinic."

Financial Results

Total net revenues for the second quarter of 2022 were $57,000, compared to $261,000 for the same period in 2021. Total net revenues for the first half of 2022 were $57,000, compared to $385,000 for the same period in 2021. The decrease was primarily due to the 2021 partial recovery of debts previously written off in 2015, the 2021 receipt of reimbursement from Cardinal Health 414, LLC of certain research and development ("R&D") costs, decreased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development, and decreased license revenue from transitional sales of Tc99m tilmanocept in Europe.
Research and development expenses for the second quarter of 2022 were $1.7 million, compared to $1.5 million for the same period in 2021. R&D expenses for the first half of 2022 were $2.9 million, compared to $2.7 million for the same period in 2021. The increase was primarily due to increased employee compensation including incentive-based awards and increased recruiting fees, offset by decreases in drug project expenses and regulatory consulting expenses.
Selling, general and administrative ("SG&A") expenses for the second quarter of 2022 were $1.3 million, compared to $1.4 million for the same period in 2021. SG&A expenses for the first half of 2022 were $3.1 million, compared to $3.7 million for the same period in 2021. Decreases in employee compensation including fringe benefits and incentive-based awards, travel, investor relations, general office expenses, facilities costs and franchise taxes were offset by increases in insurance, director fees, losses on the abandonment of certain intellectual property and legal and professional services.
Navidea’s net loss attributable to common stockholders for the second quarter of 2022 was $3.0 million, or $0.10 per share, compared to $2.7 million, or $0.09 per share, for the same period in 2021. Navidea’s net loss attributable to common stockholders for the first half of 2022 was $6.0 million, or $0.20 per share, compared to $5.6 million, or $0.20 per share, for the same period in 2021.
Navidea ended the second quarter of 2022 with $328,000 million in cash and cash equivalents.
The Company’s registration statement on Form S-1 (Registration No. 333-262691) relative to the Company’s current rights offering was declared effective by the Securities and Exchange Commission ("SEC") on August 3, 2022. The prospectus relating to and describing the terms of the rights offering has been filed with the SEC as a part of the registration statement and is available on the SEC’s web site at View Source Copies of the final prospectus for the rights offering may be obtained, when available, from Maxim Group LLC, 300 Park Avenue, New York, NY 10022, Attention Syndicate Department, email: [email protected] or telephone (212) 895-3745.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

In light of the Company’s pending rights offering, the Company will host a second quarter earnings conference call and business update following the conclusion of the rights offering. The Company will issue a press release announcing the date and time of the earnings conference call.

On August 15, 2022 Q32 Bio, a clinical stage biotechnology company developing biologic therapeutics to restore immune homeostasis, and Horizon Therapeutics plc (Nasdaq: HZNP), reported that they have entered into a collaboration and option agreement to develop ADX-914 for the treatment of autoimmune diseases (Press release, Horizon Therapeutics, AUG 15, 2022, View Source [SID1234618376]).

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ADX-914 is a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function by blocking signaling mediated by both IL-7 and TSLP. Q32 has recently completed a biomarker-enabled Phase 1 study characterizing pharmacokinetics, pharmacodynamics and safety of ADX-914 that demonstrated pharmacological effect on T cells in healthy volunteers. Q32 expects to initiate a Phase 2 trial in atopic dermatitis later this year and is planning to initiate a Phase 2 trial in a second autoimmune disease next year.

"Horizon is a leader in the autoimmune and inflammatory disease space and brings to this collaboration both the resources and experience of a pharmaceutical company and the speed and agility of a biotech," said Michael Broxson, chief executive officer of Q32 Bio. "We’re very excited to combine our strengths and expertise to continue to advance ADX-914 for autoimmune diseases, an area that is underserved by existing therapeutics and one where we hope to deliver life-changing medicines for patients in need."

Under the terms of the agreement, Horizon will fund development through completion of the two Phase 2 trials of ADX-914, with Q32 being operationally responsible for the conduct of all program-related activities. Horizon will receive an option to acquire the ADX-914 program, exercisable through a period following completion of the Phase 2 trials. During the option period, Q32 will receive $55 million in the form of initial consideration and staged development funding, of which Horizon expects to recognize as R&D expenses approximately $32.5 million in the third quarter of 2022, and the remainder in 2023.

These payments will be included in Horizon’s non-GAAP financial measures, including adjusted EBITDA. If Horizon exercises the option, Q32 may be eligible to receive up to an additional $645 million in closing and milestone payments, as well as tiered royalties on net sales, less certain amounts payable under a pre-existing license agreement.

"We are very pleased to begin our collaboration with Q32 to advance ADX-914 through the next phase of clinical development," said Elizabeth H.Z. Thompson, Ph.D., executive vice president, research and development, Horizon. "By targeting the IL-7 and TSLP pathways, which are biologically and genetically implicated as central mediators of T cell-mediated pathologies, ADX-914 represents a novel approach to targeting a number of autoimmune diseases with the potential to restore healthy immune regulation."

On August 15, 2022 Novartis reported that the Phase III CANOPY-A study evaluating adjuvant treatment with canakinumab (ACZ885), an inhibitor of interleukin-1beta (IL-1β), in adult patients with stages II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC) did not meet its primary endpoint of disease-free survival (DFS) versus placebo1 (Press release, Novartis, AUG 15, 2022, View Source [SID1234618375]). No unexpected safety signals were observed.1 Findings from the trial will be presented at an upcoming medical meeting.

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"We made an investment in the CANOPY program based on signals of reduced lung cancer incidence and mortality observed in the CANTOS study. These positive signals supported the study of canakinumab as adjuvant treatment for early lung cancer," said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development, Novartis. "While we are disappointed CANOPY-A did not show the benefit we hoped for, every trial generates scientific evidence that supports future research and development, and we look forward to continuing to pursue new therapeutic options for people living with lung cancer, whose needs remain urgent and significant. We thank the patients and clinical investigators whose time and commitment made this research possible."

CANOPY-A is a Phase III, multicenter, randomized, double blind study that is evaluating the efficacy and safety of canakinumab as adjuvant treatment in patients with NSCLC stages II-IIIA and IIIB (T>5cm N2), per American Joint Committee on Cancer/The Union for International Cancer Control (AJCC/UICC) 8th edition staging, whose margins are free of cancer following surgery2. In the trial, 1,382 patients were randomized 1:1 to canakinumab, 200 mg subcutaneously every three weeks, or matching placebo for up to one year2. Patients completed standard-of-care adjuvant cisplatin-based chemotherapy and radiation therapy, if applicable, prior to randomization2.

About canakinumab (ACZ885)
Canakinumab is a human monoclonal antibody that binds with high affinity and selectivity to human IL-1β and inhibits IL-1β activity by blocking its interaction with its receptors3-5. By inhibiting IL-1β, preliminary evidence suggests that canakinumab may suppress Pro-Tumor Inflammation to 1) enhance anti-tumor immune response; 2) reduce tumor cell proliferation, survival and invasiveness; and 3) impair angiogenesis5. Pro-Tumor Inflammation enables tumor development by driving cancer-causing processes and suppressing anti-tumor immune responses6,7.

About the CANOPY program
Novartis launched the CANOPY study program after observing significantly lower than expected rates of lung cancer mortality among patients in the Phase III cardiovascular CANTOS trial. The CANTOS trial evaluated canakinumab as a secondary prevention measure for cardiovascular events in patients following a heart attack5,8. Patients in the CANTOS trial also were at high risk for inflammatory cancers like lung cancer due to advanced age, smoking history, and other clinical risk factors5,8. Based on these findings, Novartis launched three large-scale, randomized, Phase III clinical trials and a Phase II clinical trial to investigate canakinumab as a potential treatment option in NSCLC.

Novartis and lung cancer
Lung cancer is one of the most common cancers worldwide, accounting for more than 2 million new cases diagnosed each year9. More people die of lung cancer every year than any other cancer9. There are two main types of lung cancer—small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC)10. NSCLC accounts for approximately 85% of lung cancer diagnoses11, and 30-55% of patients with early NSCLC develop recurrence despite resection12.

Novartis is committed to working with the scientific and medical communities to reimagine the treatment of lung cancer and pursue advances in medicine that could extend the survival of people living with lung cancer. Novartis is developing experimental therapies that block cancer growth; learning more about ways to activate the body’s immune system; increasing understanding of the relationship between chronic inflammation and tumor growth and progression; and exploring the potential for advanced nuclear medicine to fight the disease.

On August 15, 2022 Nuvo Pharmaceuticals Inc. (TSX:MRV; OTCQX:MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian-focused healthcare company with global reach and a diversified portfolio of commercial products, reported its financial and operational results for the three and six months ended June 30, 2022 (Press release, Nuvo Pharmaceuticals, AUG 15, 2022, View Source [SID1234618374]). For further details on the results, please refer to Miravo’s Management, Discussion and Analysis (MD&A) and Condensed Consolidated Interim Financial Statements for the three and six months ended June 30, 2022, which are available on the Company’s website (www.miravohealthcare.com). All figures are in Canadian dollars, unless otherwise noted.

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Key Developments

Three months ended June 30, 2022 include the following:

Total revenue was $20.9 million, an increase of 6% compared to $19.8 million for the three months ended June 30, 2021. Adjusted total revenue(1) was $23.3 million, an increase of 17% compared to $19.9 million for the three months ended June 30, 2021.
Net income was $18.3 million compared to net income of $9.1 million for the three months ended June 30, 2021. Adjusted EBITDA(1) was $10.3 million, an increase of 40% compared to $7.4 million for the three months ended June 30, 2021.
Revenue related to the Blexten franchise, Cambia and Suvexx was $12.8 million, an increase of 34% compared to revenue of $9.5 million for the three months ended June 30, 2021. Total Canadian prescriptions of Blexten, Cambia and Suvexx increased by 17%, 6% and 85%, respectively compared to the three months ended June 30, 2021.
The Company repaid $3.2 million (US$2.5 million) of the Amortization Loan to Deerfield Management Company, L.P. (Deerfield).
As at June 30, 2022, cash and cash equivalents were $28.6 million.
Six months ended June 30, 2022 include the following:

Total revenue was $36.6 million, an increase of 7% compared to $34.2 million for the six months ended June 30, 2021. Adjusted total revenue(1) was $39.1 million, an increase of 13% compared to $34.4 million for the six months ended June 30, 2021.
Net income was $20.3 million compared to net loss of $8.8 million for the six months ended June 30, 2021. Adjusted EBITDA(1) was $13.4 million, an increase of 15% compared to $11.7 million for the six months ended June 30, 2021.
Revenue related to the Blexten franchise, Cambia and Suvexx was $20.9 million, an increase of 36% compared to revenue of $15.4 million for the six months ended June 30, 2021. Total Canadian prescriptions of Blexten, Cambia and Suvexx increased by 18%, 4% and 100%, respectively compared to the six months ended June 30, 2021.
The Company repaid $6.7 million (US$5.3 million) of the Amortization Loan to Deerfield.
(1)

Non-IFRS financial measure. These measures are not recognized under IFRS and do not have standardized meanings prescribed by IFRS. See the Non-IFRS Measures section for definitions, reconciliations and the basis of presentation of the Company’s non-IFRS measures.

Business Update

In August 2022, Miravo announced the appointment of Anthony Snow to its Board of Directors. Mr. Snow has over twenty years of experience investing in and advising public and private companies. Mr. Snow is currently the President and Co-Portfolio Manager of Red Oak Partners, LLC. He also serves as President and a director of CBA Florida, Inc. (previously known as Cord Blood America, Inc.). Prior to joining Red Oak Partners, Mr. Snow worked at Soros Fund Management where he was part of a two-person team that managed a global long/short equity portfolio. Prior to Soros, he also focused on global equities at both Ardea Capital Management, as part of the founding team, and Wyper Capital Management. Previously, Mr. Snow was an Associate at private equity firm Lindsay Goldberg. Mr. Snow began his career at Merrill Lynch & Co. as an Analyst in the Mergers & Acquisitions group. Mr. Snow received a B.B.A. with high distinction from the University of Michigan, concentrating in finance and accounting, and an M.B.A. from Harvard Business School.
In August 2022, Miravo’s U.S. partner for Pennsaid 2% announced it would be winding down the business segment that currently promotes and sells Pennsaid 2% in the U.S. in response to the market erosion resulting from an at-risk launch of a generic version of Pennsaid 2% in May 2022. The Company has conducted a thorough evaluation of its manufacturing operations based in Varennes, Québec, where it manufactures Pennsaid 2%, and has determined that its continued operation of its manufacturing facility is no longer viable as a result of this lost revenue stream. Miravo is exploring strategic alternatives to monetize its manufacturing facility and related intellectual property, while winding down its manufacturing operations. Miravo estimates that prior to any recoveries, its restructuring charges related to the wind-down of its manufacturing operations will be $2.0 million – $2.5 million. The Company anticipates that a wind-down of its manufacturing operations may take 9 – 12 months, depending on various factors, some of which are beyond the Company’s control.
In June 2022, Miravo’s European partner, Orion Corporation (Orion) received marketing authorization for Suvexx packaged in bottles in Denmark, Estonia, Finland, Hungary, Lithuania, Latvia and Sweden (collectively the EU Markets). Orion intends to launch Suvexx in the EU Markets throughout 2023 once marketing authorization for a blister pack format has been obtained in each jurisdiction.
In May 2022, Miravo filed U.S., Canadian, European and PCT patent applications for a reformulated and improved version of Resultz. This new formulation maintains the original treatment claims, but is now enhanced with a 100% effectiveness claim for killing nits (the lice eggs) in addition to head lice. The Company believes this enhanced efficacy against nits adds value to existing Resultz partners, as well as other companies active in the head lice category globally who may be interested in licensing the technology. The Company commenced its partnering process for this new intellectual property during Q2 2022. Additional basic development work is anticipated to be conducted to support the new product.
"Our second quarter was marked by a number of notable events. First, this was the first time our Adjusted EBITDA was more than $10 million in a quarter. This financial milestone was driven by the continued growth of our Commercial Business segment and the continued prescription and sales growth of our promoted products Blexten, Cambia and Suvexx. Second, our European partner, Orion, received marketing authorizations for Suvexx in 7 of the 9 territories they have licensed, and we anticipate the final two authorizations to be obtained in the coming months. This marks the first ex-North American approvals for Suvexx and is a testament to the strength of the regulatory submission prepared by our scientific affairs team. We look forward to a commercial launch of Suvexx in Europe during the first half of 2023," said Jesse Ledger, Miravo’s President & CEO.

Mr. Ledger went on to state, "We remain committed to enhancing profitability and cash flow generation while advancing our strategic growth objectives. After careful review of the cost structure and contribution provided by operating an under-utilized manufacturing facility and considering the recent entry of generic Pennsaid 2% in the U.S., we concluded that the continued operation of our manufacturing facility does not align with our strategic growth objectives. Exiting our involvement with direct manufacturing will improve our gross profit margins and better focus the Company’s efforts and resources on advancing the key growth engines of our business: our Commercial Business and our international Licensing and Royalty Business segments. On behalf of our entire Company, I would like to thank all the employees involved in our manufacturing operations for their significant contributions over the years. The in-house development of both the Pennsaid 1.5% and Pennsaid 2% products and the launch of these products in various territories around the world would not have been possible without the hard work of this very resourceful and resilient team."

Second Quarter 2022 Financial Results
Adjusted total revenue was $23.3 million and $39.1 million for the three and six months ended June 30, 2022 compared to $19.9 million and $34.5 million for the three and six months ended June 30, 2021. The $3.4 million increase in adjusted total revenue in the current quarter was primarily attributable to a $2.4 million increase in revenue from the Commercial Business segment and an increase of $2.3 million (US$1.8 million) for Yosprala-related milestone revenue billed to the Company’s Japanese licensee, offset by a decrease of $1.3 million of revenue from the Production and Service Business segment.

Revenue attributable to the Commercial Business segment increased during the three months ended June 30, 2022 due to a $3.3 million increase in sales of the Company’s promoted products (Blexten, Cambia, Suvexx and Neovisc), offset by a $0.8 million decrease in sales of the Company’s mature products. Revenue attributable to the Commercial Business segment increased during the six months ended June 30, 2022 due to a $5.5 million increase in sales of the Company’s promoted products, slightly offset by a decrease in sales of the segment’s mature products.

The Production and Service Business segment revenue decreased during the three and six months ended June 30, 2022, primarily due to a decrease in the Company’s Pennsaid 2% product sales.

For the three months ended June 30, 2022, the $2.3 million increase in adjusted total revenue in the Licensing and Royalty Business segment was the result of an increase of $2.3 million (US$1.8 million) for Yosprala-related milestone revenue billed to the Company’s Japanese licensee.

Adjusted EBITDA was $10.3 million for the three months ended June 30, 2022 compared to $7.4 million for the comparative quarter. During the three months ended June 30, 2022, a $2.1 million increase in gross profit from the Commercial Business segment and a $2.2 million increase in amounts billed to customers for existing contract assets was offset by a $0.5 million increase in sales and marketing expenses and a $0.8 million decrease in gross profit contribution from the Company’s Production and Service Business segment.

Adjusted EBITDA was $13.4 million for the six months ended June 30, 2022 compared to $11.7 million for the six months ended June 30, 2021. During the six months ended June 30, 2022, a $3.0 million increase in gross profit from the Commercial Business segment and a $2.2 million increase in amounts billed to customers for existing contract assets was offset by a $0.3 million decrease in the contribution from the License and Royalty Business segment, a $1.6 million decrease in gross profit contribution from the Production and Service Business segment, a $0.5 million increase in sales and marketing expenses and a $1.0 million increase in general and administrative expenses.

Non-IFRS Measures
The Company discloses non-IFRS financial measures (adjusted total revenue, adjusted EBITDA, and cash value of loans) and non-IFRS ratios (adjusted EBITDA per share and net debt leverage ratio) that are not recognized under and do not have standardized meanings prescribed by IFRS. Accordingly, such measures are not necessarily comparable and may not have been calculated in the same way as similarly named financial measures presented by other companies. These measures should be considered as supplemental in nature and not as a substitute for related financial information prepared in accordance with IFRS. The Company believes that shareholders, investment analysts and other readers find such measures and ratios helpful in understanding and assessing the Company’s financial performance. We utilize these measures in managing our business, including as means of performance measurement, cash management, debt compliance and assessing leverage and borrowing capacity. Because non-IFRS financial measures and non-IFRS ratios do not have standardized meanings prescribed under IFRS, securities regulations require that such measures be clearly defined, identified, and for non-IFRS financial measures, reconciled to their nearest IFRS measure. The applicable definition, calculation and reconciliation of each such measure used in this press release is provided below.

Adjusted Total Revenue
The Company defines adjusted total revenue as total revenue, plus amounts billed to customers for existing contract assets, less revenue recognized upon recognition of a contract asset. Management believes adjusted total revenue is a useful supplemental measure to determine the Company’s ability to generate cash from its customer contracts used to fund its operations.

The following is a summary of how adjusted total revenue is calculated, reconciled to the nearest IFRS measure

Adjusted EBITDA
EBITDA refers to net income (loss) determined in accordance with IFRS, before depreciation and amortization, net interest expense (income) and income tax expense (recovery). The Company defines adjusted EBITDA as EBITDA, plus amounts billed to customers for existing contract assets, inventory step-up expenses, stock-based compensation expense, loss on fair value of derivative liabilities, loss on fair value of contingent and variable consideration, impairment loss, foreign currency loss, other losses less revenue recognized upon recognition of a contract asset, stock-based compensation recovery, gain on fair value of derivative liabilities, gain on fair value of contingent and variable consideration, impairment recovery, foreign currency gain and other income. Management believes adjusted EBITDA is a useful supplemental measure to determine the Company’s ability to generate cash available for working capital, capital expenditures, debt repayments, interest expense and income taxes.

(1) Income tax expense for the three and six months ended June 30, 2022, includes $1.7 million and $2.0 million for deferred income tax due to the utilization of loss carry forwards that were previously recognized [$1.1 million and $1.4 million for the three and six months ended June 30, 2021]

(2) The Company’s derivative liabilities are measured at fair value through profit or loss at each reporting date. As a result of the decrease in the share price in the current quarter and a decrease in the volatility of the Company’s shares, amongst other inputs, the value of the Company’s derivative liabilities decreased and the Company recognized net non-cash gains of $19.3 million on the change in fair value of derivative liabilities for the three months ended June 30, 2022 [$6.9 million net non-cash gains for the three months ended June 30, 2021]. During the six months ended June 30, 2022 as a result of the decrease in the share price and a decrease in the volatility of the Company’s shares, amongst other inputs, the value of the Company’s derivative liabilities decreased and the Company recognized net non-cash gains of $22.6 million on the change in fair value of derivative liabilities [$11.5 million net non-cash loss for the six months ended June 30, 2021].

(3) In the three and six months ended June 30, 2022, the impairment loss of $0.9 million represented a $46 write-down of certain mature intangible assets and $0.3 million for Resultz goodwill in the Commercial Business segment and a $0.6 million write-down of certain intangible assets in the Licensing and Royalty Business segment.

Management to Host Conference Call/Webcast
Management will host a conference call to discuss the results today (Monday, August 15, 2022) at 11:00 a.m. ET. To participate in the conference call, please dial (416) 764-8646 or 1 (888) 396-8049 / Conference ID: 64633261. Please call in 15 minutes prior to the call to secure a line. You will be put on hold until the conference call begins.

A live audio webcast and replay webcast of the conference call will be available through:

View Source

On August 15, 2022 RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of difficult-to-treat solid tumors through its proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMPTM) therapy platform, reported its financial results for the quarter ended June 30, 2022 (Press release, Renovorx, AUG 15, 2022, View Source [SID1234618373]).

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"Over the past decade, our team has developed and refined a unique therapy platform for difficult-to-treat solid tumors by localizing and targeting chemotherapy to minimize systemic side-effects, improve quality of life, and potentially extend life. We started with one of the most aggressive tumor types – pancreatic cancer," said Shaun Bagai, CEO of RenovoRx. "Innovation and success in treatment options for pancreatic cancer are sparse. Through our Phase 3 TIGeR-PaC clinical study, we have the potential to revolutionize the treatment of pancreatic cancer, shifting patients’ focus from coping with the treatment and its side-effects, to enjoying more time with their family and loved ones."

Mr. Bagai continued, "The most significant milestone to date for our therapy platform is expected during the fourth quarter of this year: the first prospective interim analysis for this pivotal Phase 3 study. This data will provide us with important insight into the potential for RenovoTAMP at a juncture in the trial equivalent to a robust Phase 2 oncology study, with the rigor of having it randomized. We have also submitted a protocol for a Phase 2/3 clinical trial in extrahepatic (or outside the liver) cholangiocarcinoma to FDA – advancing our therapy platform to other indications. We plan to commence the study and enroll the first patient during the fourth quarter of 2022, assuming the protocol is acceptable to FDA."

"To support our growth and infrastructure, in July, we added James Ahlers, an accomplished life sciences finance leader, as Chief Financial Officer, and expanded our finance team with the addition of Ron Kocak, a seasoned financial reporting and accounting professional, as Vice President & Controller," said Mr. Bagai. "With the addition of James and Ron, we continue to build the foundation to support the evolution of our clinical pipeline."

Financial Highlights for the Quarter Ended June 30, 2022

As of June 30, 2022, the Company had cash and cash equivalents and short-term marketable securities of $10.8 million.
Research and development expenses were $1.4 million for the quarter ended June 30, 2022, compared to $0.5 million for the quarter ended June 30, 2021. The $0.9 million increase was primarily due to a $0.5 million increase in preclinical research and development and regulatory expenses, and a $0.2 million increase in clinical consulting to support the ongoing Phase 3 trial.
General and administrative expenses were $1.2 million for the quarter ended June 30, 2022, compared to $0.3 million for the quarter ended June 30, 2021. This $0.9 million increase was primarily due to a $0.4 million increase in professional and consulting services related to post-IPO support, and a $0.2 million increase for higher personnel related costs.
Net loss was $2.6 million for the quarter ended June 30, 2022, compared to net loss of $1.3 million for quarter ended June 30, 2021.
As of June 30, 2022, the Company had 9,066,863 common shares outstanding.
About the Phase 3 TIGeR-PaC Clinical Trial

TIGeR-PaC is a randomized multi-center Phase 3 study using RenovoRx’s innovative therapy platform, RenovoTAMPTM (RenovoRx Trans-Arterial Micro-Perfusion). The study is evaluating the Company’s first product candidate, RenovoGemTM, to treat locally advanced pancreatic cancer (LAPC) through the intra-arterial delivery of gemcitabine (FDA-approved chemotherapy). The study has a primary endpoint of overall survival and several secondary endpoints, including quality of life.

TIGeR-PaC is currently enrolling unresectable LAPC patients at several sites across the US. To learn more about the study and the participating clinical trial sites, visit View Source