On August 11, 2021 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, reported financial results for the second quarter ended June 30, 2021 and provided recent business highlights (Press release, Shattuck Labs, AUG 11, 2021, View Source [SID1234586338]).

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"Over the past quarter we have begun to compare and contrast the immunological effects of CD40 and OX40 stimulation in cancer patients treated with SL-172154 and SL-279252. We believe the emerging data validate the hypothesis that the ARC platform can uniquely activate the TNF superfamily and indicate that the effects of OX40 stimulation are far more subtle than innate immune stimulation of CD40. We are excited to share this data in just a few months’ time at the SITC (Free SITC Whitepaper) Annual Meeting," said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. "Discharging the perceived safety risks associated with dose-escalating a CD40 agonist has enabled us to broaden our clinical development strategy, including an expected IND application for expansion into both Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndrome in the fourth quarter of this year."

Second Quarter 2021 Recent Business Highlights and Other Recent Developments

ARC Clinical-Stage Pipeline

Continued Enrollment of SL-172154 Phase 1 Clinical Trial in Ovarian Cancer with Encouraging Safety Profile: The phase 1 trial is an open label, multi-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 administered intravenously in patients with platinum resistant ovarian cancer. SL-172154 is a dual CD47/SIRPα inhibitor and CD40 agonist. Today, Shattuck reported continued enrollment at the fourth dose level, 3.0 mg/kg, and plans to advance to the next dose level, 10.0 mg/kg. To date, no evidence of anemia, thrombocytopenia, cytokine release syndrome or liver dysfunction, nor other dose-limiting toxicities have been observed. Prior CD40 agonist antibodies have encountered dose limiting toxicities at doses of greater than 0.3 mg/kg. Initial dose-escalation data from the trial have been submitted for presentation at the SITC (Free SITC Whitepaper) Annual Meeting, to be held in November 2021.
Anticipated IND Application for SL-172154 in AML and HR-MDS: Shattuck plans to submit to the U.S. Food and Drug Administration an investigational new drug application for a phase 1A/B clinical trial for SL-172154 in patients with AML and HR-MDS, anticipated in the fourth quarter of 2021. The trial will evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154, as both monotherapy and in combination. In AML, Shattuck plans to evaluate SL-172154 in combination with both azacitidine and venetoclax. In both HR-MDS and TP53 mutant AML, Shattuck plans to evaluate SL-172154 in combination with azacitidine.
Continued Enrollment of SL-172154 Phase 1 Clinical Trial in Squamous Cell Carcinoma of the Head and Neck or Skin: Shattuck continues to enroll patients in a Phase 1 clinical trial for SL-172154, administered intratumorally, in patients with squamous cell carcinoma of the head and neck or skin. The Phase 1 trial will evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 as monotherapy. Initial dose-escalation data from the trial are expected in the first half of 2022.
Additional Dose Escalation Cohorts Added to the SL-279252 Phase 1 Clinical Trial: An analysis of data collected across a dose range of 0.0001 through 6.0 mg/kg, on two dosing schedules, demonstrated dose dependent OX40 receptor engagement of OX40 expressing T cells, and a primary pharmacodynamic effect showing rapid egress of these target cells from circulation. This effect has not been reported for prior OX40 agonist antibodies. No dose-limiting toxicities have been observed to date. Based on these data Shattuck plans to enroll additional patients at dose levels of 12.0 and 24.0 mg/kg. Because very few of the patients treated to date are known to express PD-L1 within the tumor, Shattuck plans to enroll patients with known PD-L1 positive tumors in the additional dose level cohorts. The Phase 1 trial is an open label, multi-center, dose escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-279252 as monotherapy in patients with advanced solid tumors. SL-279252 is currently being developed in collaboration with Takeda Pharmaceuticals. An abstract containing data from the dose-escalation cohorts through 6.0 mg/kg has been submitted to the SITC (Free SITC Whitepaper) Annual Meeting, to be held in November 2021.
Corporate

Appointed Chief Technical Officer: In June 2021, Abhinav A. Shukla was appointed Chief Technical Officer. Prior to joining Shattuck, Dr. Shukla was the Chief Technical Operations Officer at Redpin Therapeutics and was responsible for all aspects of process, analytical and formulation development, and cGMP manufacturing. Previously he held several senior leadership positions, including Vice President of Manufacturing at CRISPR Therapeutics, Vice President and Head of Biologics Process Development at Shire, and Senior Vice President of Process Development and Manufacturing at KBI Biopharma. Shukla received his doctorate in Chemical and Biochemical Engineering from Rensselaer Polytechnic Institute and his undergraduate degree from the Indian Institute of Technology, Delhi.
Second Quarter 2021 Financial Results

Cash Position: As of June 30, 2021, cash and cash equivalents and short-term investments were $304.8 million, as compared to $335.4 million as of December 31, 2020.
Collaboration Revenue: Revenue for the second quarter ended June 30, 2021 was $(4.2) million, as compared to $3.2 million for the second quarter ended June 30, 2020. The negative revenue was driven by increased expected costs required to complete the performance obligation contained in the Collaboration Agreement with Takeda as a result of changes to the SL-279252 clinical development plan.
Research and Development (R&D) Expenses: R&D expenses for the second quarter ended June 30, 2021 were $14.9 million, as compared to $7.8 million for the second quarter ended June 30, 2020. The increase was primarily driven by increases in clinical development, manufacturing, personnel-related costs, and laboratory capabilities.
General and Administrative (G&A) Expenses: G&A expenses for the second quarter ended June 30, 2021, were $5.4 million, as compared to $1.7 million for the second quarter ended June 30, 2020. The increase was primarily driven by an increase in personnel related costs to support the operational expansion and costs associated with being a public company.
Net Loss: Net loss was $23.6 million for the second quarter ended June 30, 2021, or $0.56 per basic and diluted share, as compared to a net loss of $6.2 million for the second quarter ended June 30, 2020, or $0.81 per basic and diluted share.
2021 Financial Guidance

Shattuck believes its cash and cash equivalents and short-term investments will be sufficient to fund its operations through 2024, which is beyond results from its Phase 1 clinical trials of SL-172154 and SL-279252. This cash runway guidance is based on the Company’s current operational plans and excludes any additional funding that may be received or business development or additional clinical development activities that may be undertaken.

About SL-172154

SL-172154 is an investigational bi-functional fusion protein designed to block the CD47 immune checkpoint and simultaneously agonize the CD40 pathway. SL-172154 is currently being evaluated in Phase 1 clinical trials for the treatment of patients with ovarian and head and neck or skin squamous cell carcinoma.

In preclinical studies, SL-172154, demonstrated evidence of bridging the innate and adaptive immunity, antigen cross-priming to CD8+ T cells, and durable receptor occupancy, leading to superior anti-tumor activity over anti-CD47 antibodies, and anti-CD40 antibodies, both alone or in combination. Additionally, SL-172154 preclinically demonstrated a favorable safety profile with no evidence of hematologic toxicities observed with other CD47 inhibitors.

About SL-279252

SL-279252 is an investigational bi-functional fusion protein designed to block the PD-1 immune checkpoint and simultaneously agonize the OX40 pathway. SL-279252 is currently being evaluated in a Phase 1 clinical trial for the treatment of patients with advanced solid tumors and lymphoma. SL-279252 is part of a collaboration with Takeda Pharmaceuticals.

In preclinical studies, SL-279252, demonstrated evidence of high monotherapy activity, potent stimulation of OX40+ T Cells and superior anti-tumor activity over Anti-PD1/L-1 antibodies and Anti-OX40 antibodies, both alone or in combination.

On August 11, 2021 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, reported a business update and financial results for the quarter ended June 30, 2021 (Press release, DiaMedica, AUG 11, 2021, View Source [SID1234586337]). DiaMedica will host a conference call Thursday, August 12, 2021, at 7:00AM Central Time/8:00AM Eastern Time to discuss its business update and second quarter financial results.

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Pivotal Phase 2/3 ReMEDy Trial on Track for Summer 2021 Initiation; Prevention of Stroke Recurrence is being Added as Independent Co-Primary Endpoint

DiaMedica’s Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for an adaptive Phase 2/3 clinical trial of DM199 was accepted by the FDA in mid-May 2021, and the Company expects to formally initiate the study by the end of this summer.

The clinical trial design is a double blinded, placebo controlled, randomized study of approximately 350 participants, based on a 90% powering for statistical significance on the primary endpoint of modified Rankin Scale (mRS) at day 90 with 24-hour treatment window from onset of stroke symptoms. The prevention of stroke recurrence is being added as an independent co-primary endpoint for this study based on the statistically significant 13% absolute reduction in severe recurrent strokes observed in the ReMEDy Phase 2 study. Secondary endpoints will include mRS shift, NIHSS and Barthel Index scores, deaths, safety and tolerability measures, and biomarkers relating to KLK1.

The trial population includes acute ischemic stroke (AIS) patients who are not eligible for and/or who do not receive tissue plasminogen activator (tPA) and do not have large vessel occlusions. This group represents up to 80% of all AIS patients, for whom there is no treatment option other than supportive care. DiaMedica believes that the proposed trial has the potential to serve as a pivotal registration study of DM199 in this patient population.

DM199 for the Treatment of Chronic Kidney Disease (CKD)

Interim data from the Phase 2 REDUX trial was announced in June 2021. The Company highlights that DM199 demonstrated clinically meaningful improvements in kidney function in IgA Nephropathy as measured by simultaneously stabilizing estimated glomerular filtration rate (eGFR) and decreasing urinary albumin-to-creatinine ratio (UACR). Interim data from 11 subjects with moderate to severe albuminuria (baseline UACR>500) showed an average decrease in UACR of -33% (P=0.002) with stable eGFR.

Additionally, DM199 was well tolerated across all cohorts, with no DM199 related severe adverse events or discontinuations due to drug-related adverse events (AEs). The AEs observed were generally mild to moderate in severity, with the most common being local injection site irritation that resolved without medical intervention.

DiaMedica is preparing to provide a more complete update on the interim study results to be presented at the American Society of Nephrology Annual Meeting in November 2021.

As of July 31, 2021, DiaMedica had enrolled 75 subjects, including 20 African American subjects into Cohort I, 22 subjects with IgAN into Cohort II and completed enrollment with 33 subjects with Type 2 diabetes, hypertension and albuminuria into Cohort III. The Company has continued to experience slower than expected enrollment in the first two Cohorts of the REDUX study and believes this is due to continued concerns of potential study subjects related to visiting clinical study sites. DiaMedica is evaluating the effects of the recent surge in COVID-19 infections related to the Delta variant and will provide an update on the anticipated completion of Cohort I and Cohort II when the Company is able to reasonably estimate timing.

Two Pharma Industry Veterans Added to DiaMedica Board of Directors

In July 2021, the Company announced the election of two experienced executives to its Board of Directors. Joining the Board are:

Amy Burroughs, has held senior leadership and advisory roles with a broad range of public and private biopharmaceutical companies over the last 20 years. She is currently president and chief executive officer of Cleave Therapeutics, a clinical stage, venture backed oncology company. Previously, she served as executive in residence at 5AM Ventures, a leading venture capital firm focused on building next-generation life science companies, and a senior advisor to Crinetics (NASDAQ: CRNX). She began her biopharmaceutical career at Genentech, where she held key roles in commercial strategy and planning across the portfolio and led the neurology commercial team.
Charles Semba, M/D., has over 20 years of drug development experience in public and private biotechnology companies and is a recognized expert in endovascular therapy, thrombolysis, mechanical thrombectomy, and endovascular surgery. He is Chief Medical Officer (CMO) at Eluminex Biosciences and has served as CMO for SARcode Bioscience (acquired by Shire/Takeda), ForSight VISION5 (acquired by Allergan), and Graybug Vision (NASDAQ: GRAY). He has held senior leadership roles as Vice President Ophthalmic Medicine at Shire/Takeda and Ophthalmology Group Head at Genentech. Dr. Semba led the clinical development of ranibizumab (LUCENTIS) and lifitegrast (XIIDRA). He also led FDA approval for CathFlo Activase (Alteplase) for ischemic stroke.
Financial Results

Research and development (R&D) expenses increased to $2.2 million for the three months ended June 30, 2021, up from $1.6 million for the three months ended June 30, 2020, an increase of $0.6 million. R&D expenses increased to $4.6 million for the six months ended June 30, 2021, compared to $2.9 million for the six months ended June 30, 2020, an increase of $1.7 million. The increase for the six-month comparison was primarily due to a number of factors including costs incurred for the pivotal ReMEDy2 clinical study, increased year-over-year costs related to manufacturing process development and the REDUX Phase 2 CKD study, as well as increased personnel costs associated with additional staff added to support R&D operations. These increases were partially offset by decreased costs incurred for the ReMEDy Phase 2 stroke study which completed in the prior year.

General and administrative (G&A) expenses were $1.2 million for the three months ended June 30, 2021, up from $1.1 million for the three months ended June 30, 2020. G&A expenses increased to $2.4 million for the six months ended June 30, 2021, up $0.2 million from $2.2 million for the six months ended June 30, 2020. The increase for the six-month comparison was primarily due to increased professional services costs and increased personnel costs to support the Company’s expanding clinical programs.

Balance Sheet and Cash Flow

The Company had cash, cash equivalents and marketable securities of $21.3 million, current liabilities of $1.4 million and working capital of $20.2 million as of June 30, 2021, compared to $27.5 million in cash, cash equivalents and marketable securities, $2.0 million in current liabilities and $25.9 million in working capital as of December 31, 2020. The decreases in combined cash, cash equivalents and marketable securities and in working capital are due primarily to increased clinical study costs associated with preparing for the ReMEDy2 Phase 2/3 stroke study, costs related to the REDUX Phase 2 CKD study and increased costs related manufacturing development.

Net cash used in operating activities for the six months ended June 30, 2021 was $6.4 million compared to $3.8 million for the six months ended June 30, 2020. This increase relates primarily to the increase in the net loss, partially offset by non-cash share-based compensation and the effects of the changes in operating assets and liabilities.

Conference Call and Webcast Information

DiaMedica Management will host a conference call and webcast to discuss its business update and second quarter 2021 financial results on Thursday, August 12, 2021, at 7:00AM Central Time:

Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on DiaMedica’s website, under investor relations – events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until August 19, 2021, by dialing (800) 585-8367 (US Toll Free), (416) 621-4642 (International), and entering the replay passcode: 4148874.

About DM199

DM199 is a recombinant (synthetic) form of human tissue kallikrein-1 (KLK1). KLK1 is a serine protease (protein) that plays an important role in the regulation of diverse physiological processes including blood flow, inflammation, fibrosis, oxidative stress and neurogenesis via a molecular mechanism that increases production of nitric oxide and prostaglandin. KLK1 deficiency may play a role in multiple vascular and fibrotic diseases such as chronic kidney disease, retinopathy, stroke, vascular dementia, and resistant hypertension where current treatment options are limited or ineffective. DiaMedica is the first company to have developed a recombinant form of the KLK1 protein. The KLK1 protein, produced from porcine pancreas and human urine, has been used to treat patients in Japan, China and South Korea for decades. DM199 is currently being studied in patients with acute ischemic stroke and patients with chronic kidney disease.

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 Aileron Therapeutics (NASDAQ:ALRN), a chemoprotection oncology company focused on fundamentally transforming the experience of chemotherapy for cancer patients, reported business highlights and financial results for the second quarter ended June 30, 2021 (Press release, Aileron Therapeutics, AUG 11, 2021, View Source [SID1234586335]).

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"Bolstered by a strong balance sheet and a healthy cash runway, we continue to execute against our clinical development strategy to advance selective chemoprotection for patients with p53-mutated cancer, including our initiation in the second quarter of our first randomized, double-blind, placebo-controlled clinical trial of ALRN-6924 for patients with p53-mutated non-small cell lung cancer (NSCLC)," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron.

Dr. Aivado continued, "The findings from this NSCLC trial will inform our late-stage clinical development strategy for ALRN-6924. Nearly 1 million cancer patients across all cancer types each year are diagnosed with p53-mutated cancer in the United States alone, and chemotherapy continues to be a cornerstone of cancer treatment for nearly every patient. As such, we believe that ALRN-6924 has the potential to protect many patients from chemotherapy-induced effects, thereby transforming their quality of life while they undergo chemotherapy and without reducing the effects of chemotherapy against cancer."

Aileron is developing ALRN-6924 to selectively protect healthy cells in patients with cancers that harbor p53 mutations, which are present in over half of all cancer patients, to reduce or eliminate chemotherapy-induced side effects while not interfering with chemotherapy’s attack on cancer cells. This novel concept is known as chemoprotection. By reducing or eliminating multiple chemotherapy-induced side effects, ALRN-6924 may improve patients’ quality of life and help them better tolerate chemotherapy. Enhanced tolerability may lead to fewer dose reductions or delays of chemotherapy, which could result in an improved efficacy of chemotherapy. Given Aileron’s p53 biomarker approach, designed to ensure selective chemoprotection only of healthy cells, coupled with the prevalence of p53-mutated cancers, the company’s strategy is to ultimately pursue a tumor-agnostic label for ALRN-6924 as a chemoprotective agent in p53-mutated cancers.

Second Quarter 2021 Highlights and Recent Updates

Initiated randomized, double-blind, placebo-controlled Phase 1b clinical trial of ALRN-6924 in patients with advanced NSCLC undergoing chemotherapy. Aileron anticipates enrolling a total of 60 patients with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed with or without immune checkpoint inhibitors. Patients enrolled in the NSCLC trial will be randomized 1:1 to receive carboplatin/pemetrexed plus 0.3 mg/kg ALRN-6924 or placebo for at least four 21-day treatment cycles. Components of the primary endpoint are the proportion of treatment cycles free of severe hematological and other toxicities, including Grade ≥ 3 neutropenia, Grade ≥ 3 thrombocytopenia, Grade ≥ 3 anemia, Grade 4 neutropenia and febrile neutropenia, as well as duration of Grade 4 neutropenia. An additional component of the primary endpoint is the proportion of completed treatment cycles without chemotherapy dose reduction or without the use of growth factors or transfusions. Other endpoints include the proportion of patients with National Cancer Institute Common Terminology Criteria Adverse Events Grade 3/4 treatment-emergent adverse events, quality of life, overall response rate, and progression-free survival.

Aileron anticipates reporting first interim safety data from the trial late in the fourth quarter of 2021 and topline results in mid-2022.
Company to present final data from ALRN-6924 SCLC study and initial data from Healthy Volunteer Study at two upcoming scientific congresses. Aileron has had abstracts accepted for presentation at the International Society for Experimental Hematology (ISEH) 2021 Virtual Scientific Meeting, being held August 25-28, 2021, and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021, being held September 16-21, 2021. At these congresses, Aileron will present final data from its Phase 1b study of ALRN-6924 in patients with SCLC undergoing chemotherapy with second-line topotecan. This presentation follows Aileron’s October 2020 presentation of data from its Phase 1b clinical trial of ALRN-6924 in SCLC demonstrating clinical proof-of-concept that treatment with ALRN-6924 resulted in a protective effect against neutropenia, thrombocytopenia and anemia in patients with p53-mutated SCLC treated with topotecan. A link to the SCLC presentation from October 2020 can be found here.

Aileron will also present initial data at both meetings from its ongoing Healthy Volunteer Study, which is evaluating ALRN-6924’s induction of p21-induced cell cycle arrest in healthy, normal bone marrow cells and other cell types in healthy volunteers receiving ALRN-6924. p53 upregulates the expression of p21, a known inhibitor of cell cycle. The Healthy Volunteer Study, therefore, is designed to characterize the time to onset, magnitude and duration of p21-induced cell cycle arrest in human bone marrow relative to ALRN-6924. The ultimate aim of the study is to develop a universal dosing regimen for ALRN-6924 for use as a chemoprotection agent across a range of chemotherapies and p53-mutated tumor indications.
Presented poster at 2021 ASCO (Free ASCO Whitepaper) Annual Meeting, co-authored by Foundation Medicine, Inc., demonstrating rarity of longitudinal changes in p53 mutation status. In June 2021, Aileron presented a poster co-authored by Foundation Medicine, Inc., entitled, "Frequency of longitudinal changes in TP53 mutation status from gene sequencing of serial tumor biopsies from a large cohort of cancer patients," at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting. The companies examined approximately 16,500 samples arising from repeat biopsies from more than 7,800 patients across a spectrum of cancer types and over an average interval of 11 months and up to 23 months between biopsies. The analysis found that in nearly all of the biopsies evaluated (97%), an initial p53-mutant diagnosis was maintained in subsequent biopsies, regardless of cancer type, primary tumor versus metastases, or time period between subsequent biopsies.
Second Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and investments on June 30, 2021 were $59.5 million, compared to $13.8 million at December 31, 2020. The company expects, based on its current operating plan, that its existing cash, cash equivalents and investments will fund operations into the second half of 2023.

Research and Development (R&D) Expenses: R&D expenses for the quarter ended June 30, 2021 were $3.9 million, compared to $2.5 million for the quarter ended June 30, 2020. The increase of $1.4 million primarily results from increased spending for clinical development of ALRN-6924 for the company’s Phase 1b clinical trial in patients with advanced NSCLC and the study of ALRN-6924 in healthy volunteers. The company also increased its spending on ALRN-6924 manufacturing costs, employee-related costs and non-clinical research costs while decreasing facility-related spending.

General and Administrative (G&A) Expenses: G&A expenses for the quarter ended June 30, 2021 were $2.2 million compared to $1.9 million for the quarter ended June 30, 2020. Increased G&A expenses were primarily the result of higher employee-related costs partially offset by lower facility costs.

Net Loss: Net loss for the quarter ended June 30, 2021 was $5.7 million, compared to $4.4 million for the corresponding quarter in 2020. The basic and diluted net loss per share for the second quarter of 2021 was $0.06 compared to $0.14 for the second quarter of 2020. The change in basic and diluted net loss per share is primarily a result of increased shares outstanding in connection with sales of common stock during the first quarter of 2021.

On August 11, 2021 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported that financial, clinical and operational updates for the second quarter ended June 30, 2021 (Press release, Heat Biologics, AUG 11, 2021, View Source [SID1234586334]).

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Jeff Wolf, Chief Executive Officer of Heat, commented, "This quarter we achieved several meaningful clinical, research and business milestones. First, we presented favorable survival data of HS-110 in previously treated non-small cell lung cancer (NSCLC) patients at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Based on these results, we believe HS-110, in combination with a checkpoint inhibitor (CPI), holds significant potential to improve survival benefit for patients with non-small cell lung cancer. We are continuing to evaluate possible Phase 3 registration pathways with the FDA and potential partners. At the same time, we are exploring a variety of paths forward related to our infectious disease efforts. We look forward to providing further near-term updates."

"This quarter we also announced the groundbreaking for our biomanufacturing/bioanalytic facility in San Antonio, TX and the expansion of our current research and development (R&D) facilities at our corporate headquarters in Morrisville, NC. This expansion will support enhanced R&D capabilities including in-house synthesis and production of antibodies and other drugs/reagents, as well as an expanded vivarium for onsite pre-clinical studies. We believe that this expansion will allow us to accelerate R&D timelines and generate cost savings on research and development by bringing more of our development activities in-house."

"Moreover, we have maintained a strong balance sheet with approximately $122.5 million of cash, cash equivalents and short-term investments which should allow us to augment our clinical programs as well as enhance and expand our therapeutic pipeline."

Second Quarter 2021 Financial Results

●Recognized $0.5 million of grant revenue for qualified expenditures under the CPRIT grant compared to $0.6 million for the quarter ended June 30, 2020. The decrease in grant revenue in the current-year period primarily reflects the expected timing of completion of deliveries under the current phase of the contracts. As of June 30, 2021, we had a grant receivable balance of $0.4 million for CPRIT proceeds not yet received but for which the costs had been incurred or the conditions of the award had been met. We continue our efforts to secure future non-dilutive grant funding to subsidize ongoing research and development costs.
●Research and development expense was $4.2 million and $2.8 million for the three months ended June 30, 2021 and 2020, respectively.
●General and administrative expense was $2.9 million and $1.8 million for the three months ended June 30, 2021 and 2020. The increase was primarily due to an increase in stock-based compensation expense.
●Net loss attributable to Heat Biologics was approximately $6.5 million, or ($0.26) per basic and diluted share for the quarter ended June 30, 2021 compared to a net loss of approximately of $4.5 million, or ($0.35) per basic and diluted share for the quarter ended June 30, 2020.
●As of June 30, 2021, the Company had approximately $122.5 million in cash, cash equivalents and short investments.