On August 11, 2021 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, 2021 (Press release, Navidea Biopharmaceuticals, AUG 11, 2021, View Source [SID1234586336]).

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"The Company is prepared and looking forward to our meeting with the U.S. Food and Drug Administration ("FDA") on September 1," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "We remain laser focused on a positive meeting and a successful launch to the NAV3-33 trial. Navidea is also extremely excited to now have a full 7-member board with the appointments of Amit Bhalla, Alex Cappello and John K. Scott, Jr. to the board."

Second Quarter 2021 Highlights and Subsequent Events

Scheduled an End-of-Phase 2 Type B meeting with the FDA to discuss its ongoing program in Rheumatoid Arthritis ("RA") and advancement to the pivotal Phase 3 trial. The meeting will take place on September 1, 2021, via conference call.
Achieved study closeout in the Company’s NAV3-31 Phase 2b study.
Opened the first U.S. site, Northwestern University, as well as the primary U.K. site, Queen Mary University of London, for enrollment in the Company’s NAV3-32 Phase 2b trial comparing Tc99m tilmanocept imaging to histopathology of joints of patients with active RA. A second U.S. site, Attune Health Research, will be opened on August 13, 2021.
Enrolled over 115 subjects in the Company’s NAV3-35 Phase 2b study, "Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging with Tc99m Tilmanocept." Expected total enrollment for this two-arm trial will be 135 participants.
Completed enrollment in the investigator-initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals.
Announced the granting of a National Institutes of Health ("NIH") award to the University of California San Diego School of Medicine for the proposal entitled, "Renal Molecular Imaging of Mesangial Cell Function with Tc-99m-Tilmanocept." The award (Project Number: 1R01DK127201-01), from the National Institute of Diabetes and Digestive and Kidney Diseases of the NIH, was granted to Co-Principal Investigators UC San Diego faculty Carl Hoh, MD and David Vera, PhD, of the Department of Radiology, and Charles Ginsberg, MD, MAS, of the Department of Medicine, Division of Nephrology.
Results from the Company’s preclinical studies of its targeted cancer immunotherapeutic agent were presented as a poster at the New York Academy of Science’s ("NYAS") Frontiers in Cancer Immunotherapy Symposium 2021. The poster is titled, "Targeted Delivery of Doxorubicin (DOX) to Tumor Associated Macrophages (TAMs) Beneficially Alters the Tumor Immune Microenvironment and Synergizes the Activity of Anti-CTLA4."
Announced that the U.S. Patent and Trademark Office ("USPTO") issued to Navidea U.S. patent 11,007,272, entitled "Compounds and Methods for Diagnosis and Treatment of Viral Infections," with protection to October 7, 2037.
Converted the provisional patent application "Synthesis of Uniformly Defined Molecular Weight Mannosylated Dextrans and Derivatives Thereof" to an A1 application on July 9, 2021.
Appointed Amit Bhalla to the Company’s Board of Directors. Mr. Bhalla brings a wealth of financial experience and over 20 years of pharmaceutical experience to the board.
Appointed John K. Scott, Jr. and Alex Cappello to the Board of Directors. Mr. Scott is the Company’s largest shareholder and Mr. Cappello brings over 30 years of banking and public board experience to the Company.
Announced that on June 23, 2021, Vice Chancellor Joseph Slights of the Court of Chancery of the State of Delaware (the "Court") ruled in favor of Navidea’s wholly-owned subsidiary, Macrophage Therapeutics, Inc. ("MT") and against its former CEO, Dr. Michael Goldberg, finding that Dr. Goldberg breached his fiduciary duties to MT. In addition, the Court denied Dr. Goldberg’s motion to hold MT’s directors and CEO in contempt, denied Dr. Goldberg’s motion to dismiss the lawsuit against him, and granted MT’s motion to dismiss Dr. Goldberg’s petition to remove MT’s board members.
Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, "The clinical research team continues to work diligently to advance the technology in key disease areas, with an emphasis on our RA program. We are preparing for our September discussion with the FDA over the results of the completed NAV3-31 Phase 2b trial as well as our proposed plan for the Phase 3 study. We continue to prepare for initiation of the Phase 3 and have opened up key sites for enrollment into the NAV3-32 Phase 2b trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients. Concurrent with all of this, we continue to make exciting progress in our therapeutics pipeline, and we expect to continue to advance these towards the clinic."

Financial Results

Total net revenues for the second quarter of 2021 were $261,000, compared to $271,000 for the same period in 2020. Total net revenues for the first six months of 2021 were $385,000, compared to $427,000 for the same period in 2020. The decrease was primarily due to decreased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development, offset by receipt of reimbursement from Cardinal Health 414, LLC of certain research and development ("R&D") costs and the partial recovery of debts previously written off in 2015.
R&D expenses for the second quarter of 2021 were $1.5 million, compared to $1.3 million in the same period in 2020. R&D expenses for the first six months of 2021 were $2.7 million, compared to $2.3 million in the same period in 2020. The increase was primarily due to net increases in drug project expenses, including increased Manocept diagnostic and therapeutic development costs. The net increase in research and development expenses also included increased regulatory consulting expenses offset by decreased employee compensation including incentive-based awards.
Selling, general and administrative ("SG&A") expenses for the second quarter of 2021 were $1.4 million, compared to $1.3 million in the same period in 2020. SG&A expenses for the first six months of 2021 were $3.7 million, compared to $3.2 million in the same period in 2020. The net increase was primarily due increased consulting services related to preparing for European distribution of Tc99m tilmanocept, increased employee compensation including incentive-based awards, increased insurance cost, increased director fees related to additional board members, increased general office expenses, increased travel costs and increased European license fees, offset by decreased legal and professional services and decreased investor relations costs.
Navidea’s net loss attributable to common stockholders for the second quarter of 2021 was $2.7 million, or $0.09 per share, compared to $2.4 million, or $0.11 per share, for the same period in 2020. Navidea’s net loss attributable to common stockholders for the first six months of 2021 was $5.6 million, or $0.20 per share, compared to $5.1 million, or $0.24 per share, for the same period in 2020.
Navidea ended the second quarter of 2021 with $7.1 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. Participants who would like to ask questions during the question and answer session will be prompted by the moderator, who will provide instructions.

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On August 11, 2021 Advanced Chemotherapy Technologies (ACT), Inc., a clinical-stage drug delivery company, reported that it has been awarded a Phase IIb Small Business Innovation research (SBIR) grant expected to total $4 million over two years from the National Cancer Institute, part of the National Institutes of Health (Press release, Advanced Chemotherapy Technologies, AUG 11, 2021, View Source [SID1234586353]). The grant, in combination with prior financing, supports development of the company’s ACT-IOP-003 local drug delivery system for the treatment of locally advanced non-resectable and borderline resectable pancreatic cancer.

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Pancreatic cancer is a devastating disease with 5-year survival rates of only 10%. New treatment modalities are desperately needed and ACT is developing the ACT-IOP-003 system for the targeted delivery of the FDA-approved chemotherapy treatment gemcitabine. ACT-IOP-003 enables the delivery of significantly higher concentrations directly to the tumor than achievable in systemic delivery, while also minimizing the systemic exposure and toxicity. This approach offers three major advantages over traditional systemic chemotherapy: (1) superior delivery of chemotherapy to the targeted tumor cells that are often shrouded in stroma within growing tumors, greatly increasing the amount of drug to treat the growing tumor, (2) tumor shrinkage that can enable surgical resection, the only curative treatment for pancreatic cancer, and (3) greatly decreased systemic toxicity so that the patient can better tolerate conventional approaches to their treatment.

William Daunch PhD., ACT’s Chief Technology Officer will serve as the Principal Investigator on the grant. Dr. Daunch says, "We are thrilled and encouraged that NCI has chosen to award us this highly competitive Phase IIb grant. It demonstrates the NIH’s positive recognition of the work we completed in our earlier phases, as well as their continued confidence in our program to accelerate this potentially life extending treatment to patients."

NIH sponsored grant programs are an integral source of capital for early-stage U.S. small businesses that are creating innovative technologies to improve human health. These programs help small businesses break into the federal research and development arena, create life-saving technologies, and stimulate economic growth. ACT is honored to be a recipient of this competitive award from the NIH/NCI and looks forward to advancing treatment for pancreatic cancer patients and expanding its local drug delivery technology in new indications

On August 10, 2021 Verrica Pharmaceuticals Inc. ("Verrica") (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, reported financial results for the second quarter ended June 30, 2021 (Press release, Verrica Pharmaceuticals, AUG 10, 2021, View Source [SID1234586203]).

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"This quarter, we continued to ramp up commercial preparations for the potential FDA approval of VP-102, our lead product candidate for the treatment of molluscum contagiosum, including strengthening our senior leadership team and ensuring patient access to VP-102 through productive dialogue with medical providers and payors," said Ted White, Verrica’s President and Chief Executive Officer. "With a strong financial position, and a PDUFA goal date of September 23, 2021, we continue to invest in our commercial capabilities and, if approved, we look forward to the opportunity to launch VP-102 in the fourth quarter of 2021."

Business Highlights and Recent Developments

In May 2021, the Company announced that the U.S. Food and Drug Administration (FDA) extended the Prescription Drug User Fee Act (PDUFA) goal date for the New Drug Application (NDA) for VP-102 (cantharidin 0.7% Topical Solution) for the treatment of molluscum contagiosum by three months to September 23, 2021 to allow the Agency additional time to review information requested and submitted regarding the Company’s training program and distribution model.
The Company continued to expand its U.S. commercial operations during the quarter in preparation for the potential FDA approval of VP-102, and has made key hires in marketing, sales and payor functions to support product launch and commercialization. The Company will be focusing its sales efforts in Dermatology, Pediatric Dermatology and key academic centers and health systems.
The Company strengthened its management team in anticipation of the potential commercial launch of VP-102 with the appointment of Terry Kohler as Chief Financial Officer, effective July 16, 2021. Mr. Kohler is a strategic and operational finance leader with over 20 years of commercial business experience, most recently at a global pharmaceutical company with annual revenues over $2 billion.
The Company continues to prepare to submit an Investigational New Drug Application for LTX-315 in the second half of 2021 for use in all malignant and pre-malignant dermatological indications, other than metastatic melanoma and metastatic merkel cell carcinoma.
Financial Results

Second Quarter 2021 Financial Results

Research and development expenses were $3.4 million in the second quarter of 2021, compared to $3.5 million for the same period in 2020. The decrease was primarily attributable to lower clinical costs related to Verrica’s development of VP-102 for external genital warts and common warts.
General and administrative expenses were $7.3 million in the second quarter of 2021, compared to $5.1 million for the same period in 2020. The increase was primarily driven by increased headcount and other expenses related to pre-commercial activities for VP-102, as well as an increase in insurance, professional fees and other operating expenses.
For the second quarter of 2021, net loss on a GAAP basis was $11.8 million, or $0.43 per share, compared to a net loss of $9.4 million, or $0.38 per share, for the same period in 2020.
For the second quarter of 2021, non-GAAP net loss was $9.6 million, or $0.35 per share, compared to a non-GAAP net loss of $7.9 million, or $0.32 per share, for the same period in 2020.
Year-to-Date June 2021 Financial Results

Verrica recognized license revenues of $12.0 million for the six months ended June 30, 2021 related to the Collaboration and License Agreement (the "Torii Agreement") with Torii Pharmaceutical Co., Ltd ("Torii"). There were no license revenues recognized in 2020.
Research and development expenses were $8.8 million for the six months ended June 30, 2021, compared to $8.4 million for the same period in 2020. The increase was primarily attributable to a one-time $2.3 million milestone payment to Lytix Biopharma AS upon the achievement of a regulatory milestone for LTX-315, partially offset by decreased Chemistry, Manufacturing and Controls ("CMC") and clinical costs related to Verrica’s development of VP-102 for molluscum contagiosum, external genital warts, and common warts.
General and administrative expenses were $13.9 million for the six months ended June 30, 2021, compared to $10.1 million for the same period in 2020. The increase was primarily driven by increased headcount and other expenses related to pre-commercial activities for VP-102, as well as an increase in insurance, professional fees and other operating expenses.
For six months ended June 30, 2021, net loss on a GAAP basis was $12.7 million, or $0.46 per share, compared to a net loss of $19.2 million, or $0.77 per share, for the same period in 2020.
For the six months ended June 30, 2021, non-GAAP net loss was $8.8 million, or $0.32 per share, compared to a non-GAAP net loss of $16.7 million, or $0.67 per share, for the same period in 2020.
As of June 30, 2021, Verrica had aggregate cash, cash equivalents, and marketable securities of $90.1 million. The Company believes that its existing cash, cash equivalents, and marketable securities as of June 30, 2021 will be sufficient to support planned operations at least into the first quarter of 2023.
Non-GAAP Financial Measures

In evaluating the operating performance of its business, Verrica’s management considers non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share. These non-GAAP financial measures exclude stock-based compensation charges and non-cash interest expense that are required by GAAP. Verrica believes that non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share provides useful information to both management and investors by excluding the effect of certain non-cash expenses and items that Verrica believes may not be indicative of its operating performance, because either they are unusual and Verrica does not expect them to recur in the ordinary course of its business, or they are unrelated to the ongoing operation of the business in the ordinary course. non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. Non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share have been reconciled to the nearest GAAP measure in the tables following the financial statements in this press release.

About VP-102

Verrica’s lead product candidate, VP-102, is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator that allows for precise topical dosing and targeted administration. VP-102 is currently under U.S. Food and Drug Administration (FDA) review, with a PDUFA goal date of September 23, 2021, and could potentially be the first product approved by the FDA to treat molluscum contagiosum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. If approved, VP-102 will be marketed in the United States under the conditionally accepted brand name YCANTH. In addition, Verrica has successfully completed a Phase 2 study of VP-102 for the treatment of common warts and a Phase 2 study of VP-102 for the treatment of external genital warts.

About Molluscum Contagiosum (Molluscum)

There are currently no FDA-approved treatments for molluscum, a highly contagious viral skin disease that affects approximately six million people — primarily children — in the United States. Molluscum is caused by a pox virus that produces distinctive raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching and bacterial infection. It is easily transmitted through direct skin-to-skin contact or through fomites (objects that carry the disease like toys, towels or wet surfaces) and can spread to other parts of the body or to other people, including siblings. The lesions can be found on most areas of the body and may carry substantial social stigma. Without treatment, molluscum can last for an average of 13 months, and in some cases, up to several years.

On August 10, 2021 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology," Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported second quarter financial results for the period ended June 30, 2021 (Press release, Olema Oncology, AUG 10, 2021, View Source [SID1234586231]).

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"We made important progress in the second quarter of 2021 as we advanced the clinical development of our lead candidate, OP-1250, an investigational complete estrogen receptor (ER) antagonist (CERAN), and strengthened our corporate foundation to ensure that we have the talent and resources in place to support our future success," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We have seen robust enrollment in the ongoing Phase 1/2 clinical trial of OP-1250 and look forward to sharing interim dose-escalation data at a medical meeting in the fourth quarter of this year."

Corporate Highlights and Anticipated Milestones

Significant progress advancing the Phase 1/2 clinical trial of OP-1250 in patients with metastatic, ER+ / HER2- breast cancer. As of June 4, 2021, 28 patients have been enrolled across five dose-escalation cohorts. OP-1250 has demonstrated oral bioavailability and a dose-proportional pharmacokinetic profile consistent with predictions from Olema nonclinical models. A maximum tolerated dose has not been identified. The Company plans to present interim safety, tolerability, pharmacokinetic and initial efficacy data at a medical meeting in the fourth quarter of 2021, pending abstract acceptance.
Advance into monotherapy dose expansion in the second half of 2021.
Initiate a Phase 1b clinical trial of OP-1250 in combination with a CDK4/6 inhibitor in the first quarter of 2022.
Second Quarter 2021 Financial Highlights

Cash, cash equivalents and marketable securities as of June 30, 2021 were $318.1 million. Olema anticipates that this cash balance will be sufficient to fund operations through the end of 2023.
Research and development (R&D) expenses were $11.9 million for the quarter ended June 30, 2021, compared to $1.9 million for the same period of the prior year. The increase in R&D expenses was primarily due to increased expenditures to advance the Phase 1/2 clinical trial of OP-1250, the increase in nonclinical development activities, higher personnel-related expenses as headcount grew to support the advancement of the clinical and nonclinical programs, and higher non-cash stock-based compensation expenses.
General and administrative (G&A) expenses were $4.6 million for the quarter ended June 30, 2021, compared to $0.5 million for the same period of the prior year. The increase in G&A expenses was primarily due to higher personnel-related expenses associated with increases in the number of G&A personnel supporting the growth of the organization, public company-related expenses and other corporate costs, and non-cash share-based compensation expenses.
Net loss for the quarter ended June 30, 2021 was $16.4 million, compared to $2.5 million for the same period of the prior year.

On August 10, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a clinical stage biotherapeutics company, reported that the company has expanded its research collaboration with The Ohio State University (OSU) to deepen the understanding of the immune mechanisms of sarcoid granuloma formation and identify potential biomarkers of efficacy for the company’s lead therapeutic candidate, ATYR1923, which is currently in clinical development for the treatment of pulmonary sarcoidosis (Press release, aTyr Pharma, AUG 10, 2021, View Source [SID1234586253]). The research will be conducted in the laboratory of Elliott Crouser, M.D., Professor of Pulmonology, Critical Care and Sleep Medicine at OSU. Dr. Crouser specializes in sarcoidosis research and treatment and will serve as the principal investigator.

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The collaboration, which expands upon a successful pilot proof-of-concept study, will assess the effect of ATYR1923 on sarcoid granuloma formation in vitro in blood samples taken from sarcoidosis patients. The study will focus on identifying the relevant immune mechanisms triggered in granuloma formation and analyze promising biomarkers predictive of strong granuloma formation in order to assess whether they could be used as predictive biomarkers for treatment selection or treatment response to ATYR1923.

"We look forward to working with aTyr on this important initiative to expand the current understanding of the underlying mechanisms involved in pulmonary sarcoidosis, particularly the formation of granulomas. This work has the potential to identify promising biomarkers that may be used to predict treatment response, including to ATYR1923. Current treatment options for pulmonary sarcoidosis are limited, and the ability to determine a patient population that may benefit from a potential treatment such as ATYR1923 presents the opportunity to take a much-needed step forward in managing this disease," said Dr. Crouser.

"We are very pleased to expand this research collaboration with OSU and Dr. Crouser. This collaboration will build upon the successful findings from research conducted with Dr. Crouser that were recently accepted to be presented at the upcoming European Respiratory Society International Congress in September, which demonstrate the ability of a splice variant of histidyl-tRNA synthetase, the active portion of ATYR1923, to disrupt sarcoid granuloma formation in vitro — a hallmark of this debilitating disease," said Sanjay Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "The research generated from this collaboration may help direct us to biomarkers indicative of a population that may be sensitive to treatment with ATYR1923, which could lead to improved patient outcomes."

Sarcoidosis is an inflammatory disease characterized by the formulation of granulomas, clumps of inflammatory cells, in one or more organs of the body. Sarcoidosis in the lungs is called pulmonary sarcoidosis and occurs in more than 90% of all sarcoidosis patients. Approximately 150,000 to 200,000 Americans live with pulmonary sarcoidosis and the prognosis ranges from benign and self-limiting to chronic, debilitating disease, permanent loss of lung function and death. Current treatment options include corticosteroids and other immunosuppressive therapies, which have limited efficacy and are associated with serious side-effects when used long-term that many patients cannot tolerate.

Dr. Crouser received his medical degree from the Medical College of Ohio at Toledo, OH. He completed an internship, residency and fellowship at The Ohio State University Wexner Medical Center in Columbus, OH. He is board certified in Internal Medicine with subspecialty certifications in Pulmonary Disease and Critical Care. He is a leader in sarcoidosis research and treatment and currently serves as the Chair of the Foundation for Sarcoidosis Research’s Scientific Advisory Board. In 25 years, his laboratory has contributed to the publication of more than 100 peer-reviewed manuscripts, including the first clinical practice guidelines for sarcoidosis, which were endorsed by the American Thoracic Society in 2020. Ohio State’s Sarcoidosis Specialty Clinic was named a Center of Excellence in 2020 by the World Association of Sarcoidosis and Other Granulomatous Disorders.

About ATYR1923

aTyr is developing ATYR1923 as a potential therapeutic for patients with severe inflammatory lung diseases. ATYR1923, a fusion protein comprised of the immuno-modulatory domain of histidyl-tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of neuropilin-2 that downregulates the innate and adaptive immune response in inflammatory disease states. aTyr has completed enrollment in a proof-of-concept Phase 1b/2a trial evaluating ATYR1923 in patients with pulmonary sarcoidosis. This Phase 1b/2a study is a multi-ascending dose, placebo-controlled, first-in-patient study of ATYR1923 that has been designed to evaluate the safety, tolerability, steroid sparing effect, immunogenicity and pharmacokinetic profile of multiple doses of ATYR1923. Proof-of-mechanism for ATYR1923 was established in a Phase 2 clinical trial in COVID-19 patients with severe respiratory complications, which demonstrated that ATYR1923 reduced inflammatory cytokine levels in patients consistent with preclinical models, including cytokines that are implicated in sarcoidosis and other forms of interstitial lung disease.