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Gamida Cell Reports Third Quarter 2022 Financial Results and Provides Company Update

On November 14, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, reported financial results for the quarter ended September 30, 2022 (Press release, Gamida Cell, NOV 14, 2022, View Source [SID1234624042]). Net loss for the third quarter of 2022 was $17.8 million, compared to a net loss of $23.2 million in the third quarter of 2021. As of September 30, 2022, Gamida Cell had total cash, cash equivalents and investments of $61.3 million.

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Recently, Gamida Cell:

Advanced commercial readiness activities to support the potential launch of omidubicel in preparation for the target action date of January 30, 2023 under Prescription Drug User Fee Act (PDUFA).
Presented new data supporting the potential of omidubicel for the treatment of patients with blood cancers in need of allogeneic hematopoietic stem cell transplant at the Tenth Annual Meeting of the Society of Hematologic Oncology (SOHO) and the 2022 Cord Blood Connect Meeting (CBC). Data presented included new three-year follow-up data from the Phase 3 study that demonstrated that patients treated with omidubicel had an overall and disease-free survival rate of 63% and 56% at three years, respectively. Additional data presentations demonstrated that treatment with omidubicel led to higher health-related quality of life scores, and that, if approved, omidubicel is projected to meaningfully improve patient outcomes among racial and ethnic minorities by extending access and reducing time to transplant for patients who may not be able to currently find a donor source.
Appointed Abigail "Abbey" Jenkins as President and CEO as part of a planned succession.
Executed an underwritten public offering in September 2022 that raised $20 million before deducting underwriting discounts, commissions and offering expenses. The company also announced a commitment letter for a $25 million senior secured convertible loan in September 2022 with Highbridge Capital Management, LLC.
Continued pre-clinical development of the company’s proprietary NAM-enabled NK cell pipeline, including genetically modified product candidates GDA-301, GDA-401, GDA-501 and GDA-601, which aim to treat solid-tumor and hematological cancers. These cell therapy candidates utilize CAR, membrane bound- and CRISPR-mediated technologies to increase the NK cell targeting, potency and persistence against hematologic malignancies and solid tumors. At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 37th Annual Meeting (SITC) (Free SITC Whitepaper), Gamida Cell announced encouraging preclinical data on GDA-501, supporting its continued pre-clinical development. "Gamida Cell is entering a pivotal time of growth as we prepare to transition from being a clinical stage to commercial stage company upon the potential approval of omidubicel. The January 30, 2023 PDUFA date for omidubicel is rapidly approaching and, if approved, omidubicel will offer a transformative new option to patients in need of an allogeneic stem cell transplant," said Abbey Jenkins, president and CEO of Gamida Cell. "The Gamida Cell team has utilized robust market insights to understand the important role that omidubicel can play for transplanters, if approved, in terms of both improving patients outcomes and increasing access for patients who cannot currently find a donor source. We have now accelerated launch preparations across our commercial, operations and medical affairs teams to ensure we can begin making omidubicel available upon potential approval in January. Beyond omidubicel, we are enrolling patients in our company-sponsored Phase 1/2 study of GDA-201 and are continuing to develop our genetically modified NK cell immunotherapy programs that leverage CAR- and CRISPR-mediated technologies. We are excited about the progress across our pipeline as we advance on our mission to deliver potentially curative therapies to patients with cancer and other serious diseases."
Third Quarter and Recent Developments

Omidubicel: Advanced Cell Therapy Candidate

Data presentations at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting: In November, Gamida Cell announced it will present new real-world analysis data comparing the safety and efficacy of omidubicel to alloHCT donor sources used in clinical practice from the Center for International Blood and Marrow Transplant Research (CIBMTR) database at the December ASH (Free ASH Whitepaper) annual meeting. The analysis demonstrated that omidubicel was associated with more rapid neutrophil recovery (median: 10 days) than all other donor sources (median 15-20 days; p-value <0.001) and evaluated other outcomes comparing omidubicel Phase 3 results and those from the CIBMTR database. Overall survival (OS) was comparable across donor sources.
Presented new long-term data from Phase 3 trial at SOHO: In September, at SOHO, Gamida Cell presented new long term follow-up data and health-related quality of life scores of patients treated with omidubicel. In an analysis of 105 patients transplanted with omidubicel between 2006 and 2020 (median follow-up of 22 months), the data demonstrated an overall and disease-free survival rate of 63% (95% CI, 53%-73%) and 56% (95% CI, 47%-67%) at three years, respectively. A second presentation featured an analysis of 108 patients that completed validated health-related quality of life (HRQL) surveys on screening and days 42, 100, 180, and 365 post-transplant. Measures of physical and functional well-being and other HRQL scores were more favorable with omidubicel and suggest clinically meaningful and sustained improvements in physical, functional and overall well-being compared to umbilical cord blood (UCB) transplantation.
Presented data demonstrating the impact of transplantation with omidubicel for patients with hematologic malignancies at CBC: In September, at CBC, Gamida Cell presented data supporting the potential of omidubicel for the treatment of patients with blood cancers in need of an allogeneic hematopoietic stem cell transplant. The data suggest during the first-year post-transplant, patients receiving omidubicel had meaningfully greater preservation or improvement of important HRQL domains compared to UCB recipients. A second poster featured an analysis of the projected impact of allogeneic hematopoietic cell transplant on clinical outcomes and potential access for patients who currently cannot find a donor source, with the greatest improvements among the racial and ethnic groups underserved by the current standard of care. In a third poster, results of a translational sub-study from the Phase 3 trial showed that patients transplanted with omidubicel had more rapid and robust immune reconstitution than controls, including higher numbers of Recent Thymic Emigrants in peripheral blood at one year post transplant compared to transplantation with UCB, which suggest faster thymopoiesis and provide a mechanistic rational for the lower infection rates in these patients.
Continued launch preparations in preparation for January 30, 2023 PDUFA date: The company’s Biologics License Application (BLA) for omidubicel is under review with the U.S. Food and Drug Administration (FDA) with a target action PDUFA date of January 30, 2023. Gamida Cell continues to advance readiness activities throughout the organization to support the potential launch of omidubicel.
GDA-201: NAM-Enabled NK Cell Therapy

Continued advancement of Phase 1/2 study of cryopreserved formulation of GDA-201: Gamida Cell continues to advance its company-sponsored Phase 1/2 study evaluating a cryopreserved formulation of GDA-201 for the treatment of follicular and diffuse B-cell lymphomas.
NAM-Enabled NK Cell Pipeline Development

Presented preclinical data on GDA-501: At the SITC (Free SITC Whitepaper) Annual Meeting, Gamida Cell announced new preclinical data on GDA-501, a genetically modified HER2-CAR NAM-NK cell therapy candidate, that provide support for its continued preclinical development. GDA-501 displayed significantly enhanced in vitro cytotoxicity when cultured with HER2+ targeted cancer cells, as well as increased potency based on elevated levels of proinflammatory cytokines and biomarkers compared with control cells. Importantly, increased cytotoxicity and potency were persistent. These preclinical data demonstrate potent antitumor activity.
Continued the development of NAM-enabled genetically modified NK pipeline: Gamida Cell continues to progress its NAM-enabled genetically modified NK pipeline, which utilizes CAR, membrane bound- and CRISPR-mediated technologies to increase targeting, potency and persistence against hematologic malignancies and solid tumors. In order to both prioritize resources to the commercialization of omidubicel and advancement of GDA-201, as well as enable development activities to progress further, the company will hold on selecting an IND candidate and will continue to conduct in vitro and in vivo preclinical proof-of-concept studies for these genetically modified NK therapeutic targets.
Corporate Updates

Appointed Abigail Jenkins as President and CEO: As part of a CEO succession plan, Julian Adams retired as CEO and Abigail "Abbey" Jenkins was appointed as President and CEO. Ms. Jenkins has also been appointed to Gamida Cell’s Board of Directors. Ms. Jenkins brings over 25 years of leadership experience in the biopharmaceutical industry developing life-enhancing therapies from research to commercialization. Julian Adams will remain on the company’s Board of Directors.
Strengthened financial position: In September 2022, Gamida Cell executed an underwritten public offering raising approximately $20 million, before deducting underwriting discounts, commissions and offering expenses. Also, in September 2022, the company announced it entered into a commitment letter with Highbridge Capital Management, LLC for a $25 million senior secured, convertible term loan. These capital commitments will be used to fund the commercial readiness activities to support the potential launch of omidubicel, if approved, and to further the clinical development of its NK product candidates, including GDA-201.
Third Quarter 2022 Financial Results

Research and development expenses were $9.9 million in the third quarter of 2022, compared to $11.7 million in the same quarter in 2021. The decrease was attributable mainly to a $1.6 million decrease in clinical activities relating to the conclusion of the Phase 3 clinical trial and a decrease of $0.2 million in GDA-201 clinical program.
Commercial expenses were $2.8 million in the third quarter of 2022, compared to $5.8 million in the third quarter of 2021. The decrease was attributable mainly to an $2.5 million decrease in launch readiness activities, and $0.6 million decrease in headcount related expenses.
General and administrative expenses were $4.4 million in the third quarter of 2022, compared to $5.0 million in the same period in 2021. The decrease was mainly due to a $0.3 million decrease in professional services expenses and $0.3 million decrease in headcount related expenses.
Finance expenses, net, were $0.7 million in the third quarters of 2022 and 2021, with no material changes.
Net loss was $17.8 million in the third quarter of 2022, compared to a net loss of $23.2 million in the third quarter of 2021.
2022 Financial Guidance

Gamida Cell expects that its current total cash position, together with recent financing, will support the company’s ongoing operating activities into mid-2023, excluding the cost of commercializing omidubicel beyond the initial launch. This cash runaway guidance is based on the company’s current operational plans and excludes any additional funding and any business development activities that may be undertaken. Gamida Cell continues to assess all financing options that support its corporate strategy.

Expected Milestones in 2023

Omidubicel

PDUFA target action date of January 30, 2023.
Conference Call Information

Gamida Cell will host a conference call today, November 14, 2022, at 8:00 a.m. ET to discuss these financial results and company updates. To access the conference call, please register here and be advised to do so at least 10 minutes prior to joining the call. A live webcast of the conference call can be accessed in the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.

About NAM Technology
Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.

About Omidubicel
Omidubicel is an advanced cell therapy candidate developed as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment in comparison to standard umbilical cord blood in an international, multi-center, randomized Phase 3 study (NCT0273029) in patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The Phase 3 study also showed reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. One-year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by significant reduction in infectious complications as well as reduced non-relapse mortality and no significant increase in relapse rates nor increases in graft-versus-host-disease (GvHD) rates. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the US and EU.

The BLA for omidubicel has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2023. If approved, omidubicel will be the first allogeneic advanced stem cell therapy donor source for patients with blood cancers in need of a stem cell transplant.

Omidubicel is an investigational stem cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. For more information about omidubicel, please visit View Source

About GDA-201
Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy candidate for the potential treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical study data. Preclinical studies have shown that GDA-201 may address key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, these data suggest GDA-201 may improve antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. There are approximately 40,000 patients with relapsed/refractory lymphoma in the US and EU, which is the patient population that will be studied in the currently ongoing GDA-201 Phase 1/2 clinical trial.

Rakovina Therapeutics Announces Publication Highlighting Activity of Novel Bi-functional PARP-HDAC Inhibitor in Preclinical Models of Ewing Sarcoma

On November 14, 2022 Rakovina Therapeutics Inc. (TSX-V: RKV) ("the Company"), reported publication of a scientific article on the anti-cancer activity of the Company’s novel dual PARP-HDAC inhibitor in models of Ewing sarcoma (Press release, Rakovina Therapeutics, NOV 14, 2022, View Source [SID1234624041]).

The manuscript entitled "A bi-functional PARP-HDAC inhibitor with activity in Ewing sarcoma", indicate a benefit of dual PARP and HDAC inhibition and provide proof-of-concept for a bi-functional single-molecule therapeutic strategy in the treatment of Ewing sarcoma.

Ewing sarcoma is a highly aggressive bone and soft tissue tumor affecting mainly children and young adults, with a dismal 5-year survival rate of 15-30% for metastatic disease. Previous studies have demonstrated that Ewing sarcoma cells are sensitive to FDA-approved PARP inhibitors, but clinical trials have failed to produce a durable treatment response.

PARP inhibitors have been demonstrated to impact tumors that harbor BRCA mutations or other defects in homologous repair (HR). This concept is commonly referred to as "BRCAness".

Ewing sarcoma is characterized by the presence of a genetic fusion involving the EWSR1 gene. This fusion has been shown to impair HR activity indicating a level of "BRCAness" in Ewing sarcoma. The lack of clinical response in Ewing sarcoma to treatment with single-agent PARP inhibitors supports employing combination therapy strategies that further inhibit HR and increase BRCAness in Ewing sarcoma.

Recent studies in leukemia, breast cancer, liver cancer, glioblastoma, prostate cancer and anaplastic thyroid models demonstrated suppression of HR following treatment with HDAC inhibitors, supporting the synergistic potential of dual HDAC and PARP inhibition.

Rakovina Therapeutics researchers characterized and tested kt-3283, a novel dual-function single molecule of PARP and HDAC in Ewing sarcoma model systems. In these studies, kt-3283 demonstrated higher efficacy than treatment with single-agent PARP or HDAC inhibitors. These data indicate the dual activity of kt-3283 is 30- to 80-times more potent in Ewing sarcoma models than an FDA-approved PARP inhibitor, and 30- to 60-times more potent than an FDA-approved HDAC inhibitor. In an Ewing sarcoma metastasis model, kt-3283 prevented metastatic cancer growth in the lungs of mice inoculated with an aggressive Ewing sarcoma cell line.

"These results provide proof-of-concept for a novel single-molecule PARP-HDAC inhibitor in the treatment of Ewing sarcoma," stated Prof. Mads Daugaard Rakovina Therapeutics’ president and chief scientific officer. "This concept will likely be relevant in other cancer indications beyond Ewing sarcoma and potentially offer an opportunity to suppress therapeutic resistance to PARP-inhibitor treatment."

Development of Rakovina Therapeutics’ novel kt-3000 DNA-damage response inhibitors is supported, in part, by the St. Baldrick’s Foundation Martha’s BEST Grant for All, which is aimed at developing new treatments for Ewing sarcoma, an aggressive bone and soft tissue cancer in children and young adults.

Agenus Data at SITC 2022 Highlight Durable Responses of Botensilimab / Balstilimab Combination in Nine Different Treatment-Resistant Cancers

On November 14, 2022 Agenus (Nasdaq: AGEN), an immuno-oncology company with a broad pipeline targeting cancer and infectious disease, reported expanded data from the Company’s Phase 1 study of botensilimab (Fc-enhanced anti-CTLA-4) and balstilimab (anti-PD-1) in patients with treatment-resistant tumors, including MSS-CRC, ovarian, sarcoma and NSCLC (Press release, Agenus, NOV 14, 2022, View Source [SID1234624040]). The data presented represents four of the most mature data sets from the nine cancer types where responses have been observed to date. The data was presented at a plenary session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting and a company-hosted R&D event.

"This expanded dataset demonstrates the tremendous potential of botensilimab and balstilimab to treat a wide range of immunotherapy-resistant tumors," said Steven O’Day, M.D., Chief Medical Officer of Agenus. "Importantly, the superior efficacy we observed in our MSS-CRC presentation at GI ESMO (Free ESMO Whitepaper) earlier this year has remained consistent across a larger dataset. Further, we are seeing a strong signal with higher response rates than has been reported with other immunotherapies in multiple tumor types, including anti-PD-(L)1 relapsed/refractory NSCLC. These data provide compelling support for our ongoing Phase 2 botensilimab development program and highlight the broad therapeutic potential of botensilimab across solid tumors."

Study Design and Highlights

Out of over 250 enrolled patients, data on 125 patients has matured to efficacy and safety evaluation. These include four primary expansion cohorts in MSS CRC, recurrent platinum refractory/resistant ovarian, sarcoma and PD-(L)1 relapsed/refractory NSCLC. Patients in these cohorts received either 1 or 2 mg/kg botensilimab every 6 weeks and 3 mg/kg balstilimab every 2 weeks, with imaging assessments every six weeks. Fixed dosing was also permitted whereby patients received botensilimab 150 mg every 6 weeks, and balstilimab 450 mg every 3 weeks. Trial enrollees were heavily pre-treated with the majority receiving at least 3 prior lines of therapy.

MSS-CRC:

59 evaluable patients
76% failed on ≥3 prior lines of therapy
34% did not respond to prior experimental I-O
22% overall response rate: 1 complete response (CR), 12 partial responses (PR)
Other PD-(L)1 + CTLA-4 combination regimens in comparable patient populations achieved only 1-5% response rates1,2
73% disease control rate
Median duration of response not reached
69% of responses are ongoing
31% of responses have already exceeded 1 year
Median Progression Free Survival (mPFS) of 4.1 months; 12 month Overall Survival (OS) of 60.4%; median Overall Survival (mOS) has not been reached
Other PD-(L)1 + CTLA-4 combination regimens in comparable patient populations achieved a 1.8 mPFS and 6.6 mOS
Ovarian:

19 evaluable patients
71% received ≥3 prior lines of therapy
26% overall response rate: 1 CR, 4 PRs
Other PD-(L)1 + CTLA-4 combination regimens in comparable patient populations achieved only 3-10% response rates3,4
63% disease control rate
Median duration of response not reached
Sarcoma:

12 evaluable patients
73% received ≥3 prior lines of therapy
42% overall response rate: 1 CR, 4 PRs
Other PD-(L)1 + CTLA-4 combination regimens in comparable patient populations achieved only 12-16% response rates5,6
50% response rate in angiosarcoma, including 3 of 4 patients with visceral angiosarcoma
Other PD-(L)1 + CTLA-4 combinations achieved only 20-25% response rates with no reported responses in 7 treated patients with visceral angiosarcoma6,7
67% disease control rate
Median duration of response not reached
60% of responses have already exceeded 1 year and are ongoing
Anti-PD-(L)1 Relapsed/Refractory NSCLC:

5 evaluable patients (including 1 evaluable patient dosed after the data cut-off)
60% overall response rate
Other PD-(L)1 + CTLA-4 combination regimens in comparable patient populations achieved only 6-13% response rates8,9
80% disease control rate
Median duration of response not reached
67% of responses are ongoing
Tolerability:

Botensilimab was well tolerated, with no new immune-mediated safety signals outside of those observed in the class. Rates of gastrointestinal and skin toxicities were comparable to those reported with first-generation CTLA-4 inhibitors, while other immune mediated toxicities were less frequent than expected, consistent with botensilimab’s design to reduce complement binding.

"There is an urgent need to develop new therapies for patients suffering with cold and refractory tumors as current standards of care typically offer only single-digit response rates, "said Breelyn Wilky, M.D., Principal Investigator and Director of Sarcoma Medical Oncology at the University of Colorado School of Medicine. "The robust and durable clinical responses demonstrated by botensilimab and balstilimab in this study across a wide spectrum of refractory tumor types, coupled with its well-tolerated safety profile, provide strong support for the further development of this combination in a broad range of patients."

Presentation Details:

Abstract Number: 778

Abstract Title: Botensilimab, a novel innate/adaptive immune activator, plus or minus balstilimab (anti-PD-1) in ‘cold’ and I-O refractory metastatic solid tumors

Presenting Author: Breelyn A. Wilky, M.D., Director of Sarcoma Medical Oncology, Deputy Associate Director for Clinical Research University of Colorado School of Medicine

The data were presented on Saturday, November 12 at both the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) and "The Road Taken" R&D event hosted offsite by Agenus. An archived version of each presentation will be available on the Agenus website.

Cue Biopharma Announces $30 Million Private Investment in Public Equity (PIPE) Financing

On November 14, 2022 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate tumor-specific T cells directly within the patient’s body, reported that it has entered into securities purchase agreements with certain accredited investors for a $30 million private investment in public equity (PIPE) financing (Press release, Cue Biopharma, NOV 14, 2022, View Source [SID1234624039]).

The PIPE financing included a life sciences-focused investment fund that is a new investor in the company as well as participation from other new and existing investors.

Piper Sandler & Co. acted as lead placement agent and Public Ventures LLC acted as co-placement agent to Cue Biopharma for the PIPE financing.

In the PIPE financing, Cue Biopharma agreed to sell 7,656,966 shares of its common stock and, in lieu of shares of common stock to certain investors, pre-funded warrants ("Pre-Funded Warrants") to purchase an aggregate of 1,531,440 shares of common stock, and, in each case, accompanying warrants ("Warrants") to purchase an aggregate of up to 9,188,406 additional shares of common stock (or Pre-Funded Warrants in lieu thereof) at a price of $3.265 per share and accompanying Warrant (or $3.2649 per Pre-Funded Warrant and accompanying Warrant). The exercise price of the Warrants is $3.93 per share, or if exercised for a Pre-Funded Warrant in lieu thereof, $3.9299 per Pre-Funded Warrant. The Warrants are exercisable at any time after they are issued and ending on the fifth anniversary of the closing. The Pre-Funded Warrants are exercisable at any time after they are issued and will not expire.

The transaction is expected to close on or about November 16, 2022, subject to the satisfaction of customary closing conditions.

Net proceeds from the PIPE financing are expected to be used to advance the clinical development of CUE-101, Cue Biopharma’s lead interleukin 2 (IL-2)-based Immuno-STAT biologic, business development activities, working capital and other general corporate purposes.

The securities to be sold in the PIPE financing have not been registered under the Securities Act of 1933, as amended ("Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Cue Biopharma has agreed to file a registration statement with the SEC registering the resale of the shares of common stock issued in the PIPE financing and the shares of common stock issuable upon the exercise of the Pre-Funded Warrants and Warrants issued in the PIPE financing.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

NAVIDEA BIOPHARMACEUTICALS REPORTS THIRD QUARTER 2022 FINANCIAL RESULTS

On November 14, 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 three-month and nine-month periods ended September 30, 2022 (Press release, Navidea Biopharmaceuticals, NOV 14, 2022, View Source [SID1234624038]).

Third 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."
Announced the opening of nine additional sites for recruitment into the Company’s pivotal NAV3-33 Phase 3 clinical trial, for a total of 12 sites now open and recruiting.
Presented positive results from the Company’s completed NAV3-31 Phase 2B clinical study as well as the positive preliminary results of its ongoing NAV3-32 Phase 2B study at the Annual Meeting of the American College of Rheumatology held November 10-14, 2022 in Philadelphia, PA.
Presented results from the Company’s ongoing preclinical studies evaluating targeted immunotherapy for cancer based on the Manocept platform at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) held November 8-12, 2022 in Boston, MA. Results demonstrate efficacy of new constructs at macrophage phenotype change and in a mouse tumor model.
Received gross cash proceeds of $6.2 million in connection with the Rights Offering.
Received $800,000 from a strategic partner as reimbursement for certain manufacturing and research and development expenses.
Received an additional $1.0 million under a bridge loan from the Company’s Vice Chair of the Board of Directors, John K. Scott, Jr.
Appointed Joshua M. Wilson, a seasoned banking and finance executive with more than 23 years of financial services and family office experience, to the Company’s Board of Directors.
Received notification of issuance of patent from the USPTO and the state of Israel 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; State of Israel Patent Office No. 265830).
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.
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.
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 IND filing and clinical trials. The promising results to date of our RA trials and the preclinical studies of our therapeutics demonstrate the significant potential of our macrophage-targeting Manocept platform."

Financial Results

Total revenues for the three-month period ended September 30, 2022 were approximately $8,000, compared to $96,000 for the same period in 2021. Total revenues for the nine-month period ended September 30, 2022 were $65,000, compared to $481,000 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 three-month period ended September 30, 2022 were $1.2 million, compared to $1.0 million for the same period in 2021. R&D expenses for the nine-month period ended September 30, 2022 were $4.1 million, compared to $3.8 million for the same period in 2021. The increase was primarily due to increased employee compensation including incentive-based awards offset by decreases in drug project expenses and regulatory consulting expenses.
Selling, general and administrative ("SG&A") expenses for the three-month period ended September 30, 2022 were $3.6 million, compared to $1.5 million for the same period in 2021. SG&A expenses for the nine-month period ended September 30, 2022 were $6.7 million, compared to $5.1 million for the same period in 2021. Following the ruling by the Texas Court in August 2022, the Company recorded $2.6 million in legal fees in SG&A pursuant to the CRG judgment. Increases in legal and professional services, insurance, director fees, losses on the abandonment of certain intellectual property, and depreciation and amortization were partially offset by decreases in employee compensation including fringe benefits and incentive-based awards, expenses related to European operations, investor relations and shareholder services, travel, facilities costs, general office expenses and franchise taxes.
Navidea’s net loss attributable to common stockholders for the three-month period ended September 30, 2022 was $7.7 million, or $0.25 per share, compared to $2.4 million, or $0.08 per share, for the same period in 2021. Navidea’s net loss attributable to common stockholders for the nine-month period ended September 30, 2022 was $13.7 million, or $0.45 per share, compared to $8.1 million, or $0.28 per share, for the same period in 2021.
Navidea ended the third quarter of 2022 with $4.6 million in cash and cash equivalents.
Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.