On August 9, 2022 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") reported its financial and operating results for the second quarter ended June 30, 2022 and provided an update on its full year 2022 financial guidance and recent corporate activities (Press release, Halozyme, AUG 9, 2022, View Source [SID1234617991]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"As we report our strong second quarter results and execute our plans to continue to deliver sustained high growth, I have never been more excited about the future and potential of Halozyme. We see strong ENHANZE momentum with our Wave 2 products DARZALEX SC and Phesgo and with recent positive Phase III study results for efgartigimod SC and Tecentriq SC, two of our four Wave 3 launch products with the potential for launch 2023-2025. As planned, we project at least six Phase 2 or Phase 3 study starts in 2022," said Dr. Helen Torley, president and chief executive officer of Halozyme. "The acquisition of Antares Pharma enhances our revenue growth and durability, adding a commercialized, broadly licensable autoinjector platform and two innovative commercial products in the large and growing testosterone replacement therapy market."

Recent Partner Highlights:

In August 2022, Roche announced that the Phase III IMscin001 study evaluating a subcutaneous (SC) formulation of Tecentriq (atezolizumab) with ENHANZE met its co-primary endpoints. The study showed non-inferior levels of Tecentriq in the blood (pharmacokinetics), when injected subcutaneously, compared with intravenous (IV) infusion, in cancer immunotherapy-naïve patients with advanced or metastatic non-small cell lung cancer for whom prior platinum therapy has failed. The safety profile of the SC formulation was consistent with IV Tecentriq.
In July 2022, Takeda announced positive topline results from pivotal Phase 3 trial evaluating HYQVIA (Immunoglobulin infusion 10% (Human) with rHuPH20), for maintenance treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
In June 2022, Bristol Myers Squibb nominated an undisclosed target resulting in a $5 million milestone payment.
In June 2022, ViiV initiated enrollment of a Phase 1 single dose escalation study in subjects with HIV to evaluate pharmacokinetics, safety and tolerability of long-acting cabotegravir administered subcutaneously with ENHANZE.
In June 2022, argenx initiated a Phase 2 study evaluating efgartigimod with ENHANZE in subjects with bullous pemphigoid.
In May 2022, Chugai initiated a Phase 1 study to evaluate the pharmacokinetics, pharmacodynamics, and safety of targeted antibody administered subcutaneously with ENHANZE.
In April 2022, Roche initiated a Phase 3 study evaluating OCREVUS (ocrelizumab) with ENHANZE in subjects with multiple sclerosis.
Recent Corporate Highlights:

In May 2022, we completed the acquisition of Antares Pharma, Inc. resulting in an expansion of our commercial portfolio of proprietary and partnered products and the potential for future growth through new partnership agreements.
In June 2022, we announced the commercial launch of TLANDO, an oral treatment indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (primary or hypogonadotropic hypogonadism). TLANDO was approved by the U.S. Food and Drug Administration (FDA) on March 28, 2022.
In June 2022, we completed the $150 million Accelerated Stock Repurchase that was initiated in December of 2021, resulting in the total repurchase of 3.9 million shares at an average price of $38.51 per share.
Second Quarter Financial Highlights

Revenue for the second quarter was $152.4 million compared to $136.5 million for the second quarter of 2021. The 12% year-over-year increase was driven by an increase in royalty revenue primarily attributable to subcutaneous DARZALEX (daratumumab) and the addition of product sales as a result of the Antares Pharma acquisition, partially offset by a decrease in revenues under collaborative agreements due to a $40 million upfront payment associated with entering into the ViiV collaboration in the prior year period. Revenue for the quarter included $85.3 million in royalties, an increase of 86% compared to $45.8 million in the prior year period.
Cost of sales for the second quarter was $33.9 million, compared to $23.0 million for the second quarter of 2021. The year-over-year increase was driven by an increase in product sales as a result of the Antares Pharma acquisition.
Amortization of intangibles expense in the second quarter was $11.4 million, an increase from no expense in the second quarter of 2021 due to the Antares Pharma acquisition, in which we acquired intangible assets that are amortized over a useful life related to the auto injector technology platform, XYOSTED and TLANDO.
Research and development expenses for the second quarter were $15.5 million, compared to $8.1 million for the second quarter of 2021. The increase is primarily due to planned investments in ENHANZE and one-time compensation costs related to the Antares Pharma acquisition.
Selling, general and administrative expenses for the second quarter were $57.5 million, compared to $12.3 million for the second quarter of 2021. The increase was primarily due to one-time transaction and compensation costs related to the Antares Pharma acquisition and an increase in compensation expense related to the ongoing combined workforce.
Operating Income in the second quarter of 2022 was $34.1 million, compared to an operating income of $93.0 million in the second quarter of 2021.
Net Income: On a GAAP basis in the second quarter of 2022, net income was $22.7 million, compared with net income of $91.5 million in the second quarter of 2021. Non-GAAP net income was $75.7 million in the second quarter of 2022, compared with non-GAAP net income of $97.8 million in the second quarter of 2021.1 The Company notes that 2022 is the first year in which Halozyme will record income tax expense as part of its income statement.
Earnings per Share: On a GAAP basis in the second quarter of 2022, diluted earnings per share was $0.16, compared with $0.62 in the second quarter of 2021. On a non-GAAP basis diluted earnings per share was $0.53, compared with diluted earnings per share of $0.66 in the second quarter of 2021.1
Cash, cash equivalents and marketable securities were $209.4 million on June 30, 2022, compared to $740.9 million on December 31, 2021.
Financial Outlook for 2022

The Company is raising its financial guidance for 2022 which was last provided on May 10, 2022, as a result of the recent close of the Antares Pharma transaction and strong year-to-date results. For the full year 2022, the Company expects:

Total revenue of $655 million to $685 million, an increase from our prior guidance range of $530 million to $560 million, representing growth of 48% to 55% over 2021 total revenue primarily driven by projected revenue contribution from the Antares business of $115 million to $125 million. The Company expects revenue from royalties to increase greater than 65% over revenue from royalties in 2021 to approximately $340 million to $350 million.
Operating income of $240 million to $265 million, a decrease from our prior guidance range of $350 million to $380 million, representing a decline of 4% to 13% over 2021 operating income. Our 2022 guidance includes one-time transaction costs related to the Antares Pharma acquisition, including amortization of intangible assets, as well as an incremental $20 million operating expense investment to maximize ENHANZE and to extend royalty revenue durability.
GAAP net income of $170 million to $195 million, a decrease from our prior guidance range of $270 million to $295 million; and non-GAAP net income of $295 million to $320 million, an increase from our prior guidance range of $290 million to $315 million.1 The Company notes that 2022 will be the first full fiscal year in which Halozyme will record income tax expense as part of its income statement.
GAAP diluted earnings per share of $1.20 to $1.35, a decrease from our prior guidance of $1.90 to $2.05, due to acquisition related costs in 2022.
Non-GAAP diluted earnings per share are expected to be $2.10 to $2.25, an increase from our prior guidance range of $2.05 to $2.20,1 reflective of the projected accretion from the Antares Pharma acquisition.
The Company’s earnings per share guidance does not consider the impact of potential future share repurchases.

Webcast and Conference Call
Halozyme will host its Quarterly Update Conference Call for the second quarter ended June 30, 2022 today, Tuesday, August 9, 2022 at 4:30 p.m. ET/1:30 p.m. PT. The call will be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit the "Investors" section of www.halozyme.com.

On August 9, 2022 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company"), and Enalare Therapeutics Inc ("Enalare") reported an agreement for Eagle to make an equity investment of $25 million in Enalare, a clinical-stage privately held biopharmaceutical company dedicated to developing novel therapies for patients suffering from life-threatening acute respiratory and critical care conditions (Press release, Eagle Pharmaceuticals, AUG 9, 2022, View Source [SID1234617990]). The investment also includes an exclusive option for Eagle to acquire all remaining issued and outstanding Enalare stock upon the achievement of development milestones as set forth in the agreement.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As part of the transaction, Eagle will invest up to approximately $55 million, which is expected to occur over the next two years subject to the achievement by Enalare of certain milestones on an agreed upon timeline. The investment consists of an upfront investment of $25 million, $12.5 million now and $12.5 to be paid in six months, and two potential follow-on equity investments of $15 million each contingent upon (i) the commencement of the ENA-001 Phase 2 clinical trial, and (ii) the ENA-001 Phase 2 clinical trial reaching 50% enrollment. Eagle and Enalare have also entered into an agreement providing Eagle the option to acquire the all remaining Enalare shares for an aggregate purchase price ranging from $100-$175 million plus royalty rights ranging from 9%-12% on all future global net sales of any Enalare product, paid to the ex-Eagle holders of Enalare shares at the time of acquisition.

The transaction is expected to provide Eagle with products protected by intellectual property rights, including composition of matter patents, which potentially provide patent term into the mid-2030s to the early 2040s. The Company believes these products have the potential to address significant unmet medical needs for millions of patients worldwide suffering from acute respiratory depression, including those in the hospital post-operative care setting, those experiencing community drug overdose, and preterm infants suffering a common condition known as Apnea of Prematurity.

Enalare’s lead compound, ENA-001, is an investigational, one-of-a-kind NCE designed as an agnostic respiratory stimulant.
It has been shown to be well tolerated in restoring breathing drive and responsiveness in five Phase 1 human studies.
Recent topline results of Enalare’s Phase 1 Study 108 indicate that ENA-001 successfully achieved the study’s primary endpoint. It was shown to be safe and well-tolerated and was able to reverse propofol-induced dampening of ventilatory responsiveness in the population studied.
Enalare is planning to initiate a Phase 2 clinical study for use in this patient population in the near term.
Approval for post-operative respiratory depression expected in 2026, and community drug overdose thereafter.
ENA-001 is also being developed in an Intramuscular ("IM") Formulation in partnership with the Biomedical Advanced Research and Development Authority ("BARDA") (contract number 75A50121C00044) for the potential use in patients experiencing drug overdose in a community setting and as a potential medical countermeasure for mass casualty events. This effort is also supported via a grant from the National Institute on Drug Abuse (NIDA: award number R44DA057133), a division of the National Institutes of Health. Enalare is planning to complete the required preclinical activities with the IM formulation in the near term and to begin human clinical studies in the first half of next year.
In addition, Enalare is developing ENA-001 for the treatment of Apnea of Prematurity ("AoP"), a condition commonly affecting infants born preterm in which they experience shallow or intermittent stoppage of breathing. Persistent AoP can cause near- and long- term neurological development risks to the infant. ENA-001 has received Rare Pediatric Disease designation from the U.S. Food and Drug Administration ("FDA") in the treatment of AoP, which potentially provides for a priority review voucher if the product is approved for this indication. Enalare is currently executing an animal proof-of-concept study with ENA-001 in the treatment of AoP and expects to further pursue orphan drug designation and initiate human clinical trials.
"By adding Enalare’s highly differentiated and complementary NCE to our portfolio, we immediately expand Eagle’s long-term growth possibilities. We believe ENA-001 has enormous potential to address important unmet medical needs. It is an agnostic respiratory stimulant with what we view as compelling clinical and health economic value propositions. It is also an ideal fit within our current hospital critical care portfolio, comprised of four approved and two investigational products. BARHEMSYS, the only proven antiemetic for the treatment of post-operative nausea and vomiting ("PONV"), BYFAVO5, the first new drug approved for procedural sedation in decades, RYANODEX, and vasopressin are all in market. If approved, landiolol, an ultra-short acting cardio-selective IV beta-blocker, and CAL02, a first-in-class anti-infective agent to treat severe bacterial pneumonia will join our currently approved products to create a formidable hospital/anesthesia product portfolio," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

"We plan to leverage our strong balance sheet and usher ENA-001 toward a potential 2026 launch. This is a great opportunity for Eagle and one that furthers our transformation into a diversified, branded pharmaceutical company with long-duration assets in acute care," concluded Tarriff.

"This partnership is an exciting step forward in the development of ENA-001 and for the millions of patients worldwide that can benefit from such a novel agnostic respiratory stimulant," stated Herm Cukier, President and CEO of Enalare Therapeutics. "Our partnership with Eagle provides us access to capital and a robust infrastructure and commercial platform to develop and potentially launch our product. Without added headcount or expense, Eagle will be able to rely on our experienced and highly regarded team as we move onto Phase 2 and 3 trials, which we believe will successfully demonstrate ENA-001’s ability to improve patient respiratory capacity. We look forward to a close and productive working relationship and supporting Eagle in the successful development of Enalare’s products," concluded Cukier.

________________________
5 View Source

Transaction Rationale

Enalare’s intellectual property with potential patent duration through the mid 2030s to early 2040s offers Eagle access to complementary and diversified revenue streams;
Eagle believes there is a compelling commercial opportunity for Enalare’s lead drug candidate, ENA-001:
Agnostic respiratory stimulant with first-in-class mechanism of action;
Studied in more than 100 human subjects to date;
Differentiated product that significantly expands long-term sales potential and durability of Eagle’s hospital business;
Synergistic fit with Eagle’s current and expanding portfolio of hospital products, with overlap of customer channel and decision makers;
Timing of launch, if approved, aligns with anticipated Eagle commercial capacity;
Provides the opportunity for strategic expansion into adjacent therapeutic and customer channels.
About ENA-001

ENA-001 is an investigational new chemical entity ("NCE") being developed by Enalare for multiple potential indications, including the prevention and treatment of post-operative respiratory depression. With its novel mechanism-of-action and based on findings to date, it could potentially improve the lives of those impacted by several life-threatening conditions including community drug overdose, post-operative respiratory depression, and apnea of prematurity. If approved, ENA-001 would offer new treatment options for physicians, emergency responders, and caregivers addressing acute respiratory depression across multiple patient populations in multiple settings.

On August 9, 2022 Celularity Inc. (Nasdaq: CELU) ("Celularity"), a clinical-stage biotechnology company developing placental-derived allogeneic cell therapies, reported financial results for the second quarter ended June 30, 2022, and provided a corporate update (Press release, Celularity, AUG 9, 2022, View Source;utm_medium=rss&utm_campaign=celularity-reports-second-quarter-2022-financial-results-and-corporate-update [SID1234617989]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We achieved another exciting milestone during the second quarter with the treatment of our first gastric cancer patient with CYNK-101, which we are evaluating as an add-on therapy to the current standard of care that we believe could extend progression free survival for patients," said Robert J. Hariri, M.D., Ph.D., Founder, Chairman and Chief Executive Officer of Celularity. "We continue to make good progress with all three of our ongoing Phase 1 clinical trials, which includes the CYNK-101 gastric cancer trial and CYNK-001 trials in AML and glioblastoma multiforme. We look forward with anticipation to the second half of the year, during which we plan to report multiple data readouts. Celularity remains committed to demonstrating the potential clinical advantages of our unique approach and leading the next evolution of cellular therapies for the treatment of cancer, infectious and degenerative diseases using our proprietary placental-derived cell therapy platform."

Second Quarter Clinical and Regulatory Highlights

CYNK-001 for the Treatment of Acute Myeloid Leukemia (AML) and Glioblastoma Multiforme (GBM):

CYNK-001 is Celularity’s unmodified cryopreserved natural killer (NK) cell therapy candidate that is derived and expanded from human placental CD34+ cells. CYNK-001 is currently being investigated in a Phase 1 clinical trial in AML and in a Phase 1/2a clinical trial in GBM, with data readouts expected in the second half of 2022.
Celularity continues to enroll new cohorts in both the minimal residual disease (MRD) and relapsed/refractory (R/R) arms of the Phase 1 AML study with clinical trial protocol adjustments communicated in December 2021, including a fourth dose on day 21 that increases the overall dosage of NK cells.
In June 2022, Celularity presented a Trials in Progress poster at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting for the ongoing Phase 1/2a clinical trial to assess the safety and efficacy of CYNK-001 in combination with recombinant interleukin 2 (IL-2) in adults with resection eligible IDH1 wild-type glioblastoma.
CYNK-101 for the Treatment of G/GEJ Cancers:

CYNK-101 is a novel allogeneic off-the-shelf human placental CD34+-derived NK cell therapy candidate that is genetically modified to express high-affinity and cleavage-resistant CD16 (FCGRIIIA) variant to drive antibody-dependent cell-mediated cytotoxicity. CYNK-101 is currently being investigated in the Phase 1 portion of a Phase 1/2a clinical trial in advanced HER2 positive G/GEJ cancers.
In July 2022, Celularity announced that the first patient had been treated with CYNK-101 in the Phase 1 portion of the Phase 1/2a clinical trial in G/GEJ cancers.
Earlier this year, the U.S. Food and Drug Administration (FDA) granted both a Fast Track designation and an Orphan Drug Designation to CYNK-101 for the treatment of G/GEJ cancers.
CYCART-19 for the Treatment of B-Cell Malignancies:

CYCART-19 is an allogeneic Chimeric Antigen Receptor (CAR) engineered human placental-derived T cell therapy candidate in B-cell malignancies.
Celularity submitted an investigational new drug application (IND) for CYCART-19 in the first quarter of 2022 and in May 2022, the FDA requested additional information before Celularity can proceed with the planned first-in-human Phase 1/2 clinical trial of CYCART-19. Celularity is in the process of working with the FDA to resolve the agency’s questions as promptly as possible, and, if the IND is cleared, plans to commence a Phase 1/2 clinical trial of CYCART-19 in B-cell malignancies in 2023.
Second Quarter Corporate Highlights

Entered into a preclinical research collaboration with Antengene to evaluate the potential therapeutic synergy of combining Antengene’s bispecific antibody with Celularity’s cryopreserved human placental hematopoietic stem cell-derived NK cell therapy platform.
Named industry leader Diane Parks to its Board of Directors, bringing to the company experience with commercialization of novel immuno-oncology therapies. Ms. Parks has led the successful launch of numerous hematology and cancer therapies at large pharmaceutical and biotech companies, including Kite Pharma, Inc. (now part of Gilead Sciences, Inc.), Amgen Inc., and Genentech, Inc. (now part of Roche Holdings, Inc.).
Closed a private placement priced at-the-market under Nasdaq rules, resulting in net proceeds of approximately $27.5 million after deducting placement agent commissions and other offering expenses.
Added to the Russell 3000 Index and the Small-Cap Russell 2000, effective after the U.S. market opened on June 27, 2022.
Second Quarter and Year to Date 2022 Financial Results

Cash and Cash Equivalents

Cash and cash equivalents were $38.0 million as of June 30, 2022, compared to $37.2 million as of December 31, 2021. In May 2022, we received net cash proceeds of approximately $27.5 million from a private placement of 4,054,055 shares of our Class A common stock and warrants to purchase up to 4,054,055 shares of our Class A common stock.

Net revenues

Net revenues for the three months ended June 30, 2022 increased by approximately $0.6 million compared to the prior year period. The increase was primarily driven by an increase in license, royalty and other revenues driven by increased product sales to our distribution partners.
Net revenues for the six months ended June 30, 2022 increased by approximately $3.9 million, compared to the prior year period. The increase was primarily driven by an increase of $4.1 million in license, royalty and other revenues driven by increased product sales to our distribution partners.
Research and Development

Research and development expenses for the three months ended June 30, 2022 increased by $2.4 million compared to the prior year period. The increase was driven by higher clinical trial costs and higher personnel costs as we continue to enroll new cohorts in both arms of the Phase 1 AML study for CYNK-001 and continue advancing the Phase 1 portion of a Phase 1/2a clinical trial in advanced HER2 positive G/GEJ cancers for CYNK-101.
Research and development expenses for the six months ended June 30, 2022 increased by $7.1 million, compared to the prior year period. The increase was primarily driven by technology platform fees, higher personnel costs, and laboratory supplies to support cell therapy process development.
Selling, General and Administrative

Selling, general and administrative expenses for the three months ended June 30, 2022 decreased by $13.3 million compared to the prior year period. The decrease was primarily driven by a reduction in stock-based compensation expense of $24.3 million related to prior year awards granted to our board of directors and senior management, a portion of which was allocated to research and development expense, offset by higher personnel, professional services and, insurance costs to support operations of a public company.
Selling, general and administrative expenses for the six months ended June 30, 2022 decreased by $4.5 million compared to the prior year period. The decrease was primarily driven by a reduction in stock-based compensation expense of $22.8 million related to prior year awards granted to our board of directors and senior management, a portion of which was allocated to research and development expense, offset by higher personnel, professional services and, insurance costs to support operations of a public company.
Net Income (Loss)

Net income for the three months ended June 30, 2022 was $47.8 million, or $0.34 per share (basic) and $0.32 per share (diluted). Net loss for the three months ended June 30, 2021 was $64.5 million, or $(2.69) per share (basic and diluted). The increase to net income was primarily related to gain recognized from the change in the fair value of the warrant liabilities and contingent liability.
Net loss for the six months ended June 30, 2022 was $15.0 million, or ($0.11) per share (basic and diluted). Net loss for the six months ended June 30, 2021 was $146.0 million, or $(6.09) per share (basic and diluted). The decrease in net loss was primarily related to gain recognized from the change in the fair value of the warrant liabilities and contingent liability.

On August 9, 2022, Asieris Pharmaceuticals, a global biopharmaceutical company specializing in the discovery and development of innovative drugs for the treatment of genitourinary tumors and other major diseases, reported that the multinational Phase III Clinical Trial of APL-1702 (Cevira), a novel non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL), has successfully enrolled 402 patients in the study two months ahead of schedule (Press release, PhotoCure, AUG 9, 2022, View Source [SID1234617971]). Additionally, Photocure received a $1 million milestone payment from Asieris related to the ongoing clinical development of Cevira.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

APRICITY is a multicenter, prospective, double-blind, randomized controlled Phase III study further evaluating the efficacy and safety of the integrated drug-and light-delivery device Cevira in the treatment of HSIL. The clinical trial was approved by the National Medical Products Administration (NMPA) in July 2020 and was conducted simultaneously at 65 sites in 8 countries including China, Germany, Hungary and the Netherlands. The first patient was dosed in November 2020.

Cervical cancer is the fourth most common cancer in women worldwide1. In 2020, 604,000 new cases and 342,000 deaths worldwide were attributed to cervical cancer.1,2 Current treatments of HSIL of the cervix are based on invasive surgical interventions, compromising cervical competence and functionality. Currently, no non-surgical approach is available for the treatment of precancerous cervical lesions.

Read Asieris’ full press release here: View Source

1. Cervical cancer. Available from: View Source

2. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209-49

Note to editors:

All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA

About Cevira:

Cevira is a breakthrough photodynamic drug-device combination product that is being developed for non-surgical treatment of high-grade precancerous lesions of the cervix. Cevira holds the potential to serve the high unmet medical need for non-invasive treatment options for patients with HSIL in an outpatient setting, especially for young women of reproductive age. Asieris Pharmaceuticals entered into a license agreement with Photocure ASA (Photocure, PHO: OSE) to obtain the worldwide development and commercialization of Cevira in July 2019. Cevira is a registered trademark of Photocure ASA, based in Oslo, Norway.

On August 9, 2022 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to diagnose and treat cancer and life threatening infectious diseases, reported financial results for its first quarter ended June 30, 2022 and provided an update on recent developments (Press release, Aethlon Medical, AUG 9, 2022, View Source [SID1234617969]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Company Updates

Aethlon Medical is continuing the research and clinical development of its Hemopurifier, a therapeutic blood filtration system that can bind and remove life-threatening viruses and harmful exosomes from blood. This action has potential applications in cancer, where cancer associated exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases, including removal of COVID-19 virus, associated variants, and related exosomes.

We recently published a peer-reviewed manuscript demonstrating that Aethlon’s proprietary GNA affinity resin, a key component of the Hemopurifier, was able to bind seven clinically relevant SARS-CoV-2 variants in vitro, including the Delta and Omicron variants. Viral capture efficiency with the GNA affinity resin ranged from 53% to 89% for all variants tested. The findings from this paper suggest that the Hemopurifier should be able to bind any future SARS-CoV-2 variants that may potentially arise. The manuscript is titled "Removal of Clinically Relevant SARS-CoV-2 Variants by An Affinity Resin Containing Galanthus Nivalis Agglutinin" and was published in PLOS ONE on July 28, 2022.

We continue to advance our severe COVID-19 clinical trial for the Hemopurifier under our open Investigational Device Exemption (IDE) for life-threatening viral infections. Since our last update, the first patient has completed the study. Our active sites continue to actively screen patients along with our contract research organization (CRO), PPD, Inc. On July 6, 2022, the U.S. Food and Drug Administration (FDA) approved a supplement to our COVID-19 trial. The newly approved protocol supplement eliminates the inclusion criteria that patients must have a dialysis catheter in place and have tolerated dialysis at the time of screening. This change should improve the feasibility of enrolling new patients into our study. The active sites are currently submitting this supplement to their IRBs, and we expect to have their approvals in August and September 2022.

Medanta Medicity Hospital, a multi-specialty hospital in Delhi NCR, India, has enrolled one patient in our COVID-19 trial in India and continues to actively screen patients. Our CRO, Qualtran LLC, has identified additional potential sites for the trial in India and is currently assessing feasibility.

In addition to our work with COVID-19, we continue to screen patients for our IDE clinical trial in head and neck cancer. We have submitted a protocol supplement to the FDA to request the inclusion of patients who have failed platinum chemotherapy in the trial. If accepted by the FDA, this change would increase the eligible population for the study. We are currently drafting a protocol for a new clinical trial to allow us to examine the effects of the Hemopurifier in multiple tumor types where the cancer has progressed, following a two-month period of checkpoint inhibitor therapy.

Given the ongoing outbreak of monkeypox virus (MPXV), Aethlon is commissioning a new in vitro binding experiment to confirm that the Hemopurifier effectively captures the current strain of that virus. In 2008, we conducted an in vitro study that demonstrated that the Hemopurifier effectively bound and removed MPXV. We believe that the Hemopurifier’s ability to bind the current MPXV strain should not be affected because the mutations present in this strain do not change the mannose sugar in the viral envelope, which is recognized by the GNA within the Hemopurifier resin.

For more context regarding the 2008 study, we commissioned Battelle Memorial Institute to run an MPXV in vitro study using a miniature version of our Hemopurifier. This study demonstrated that high concentrations of MPXV, approximately 35,000s GPUs per mil, were rapidly depleted from cell culture fluids when circulated through the Hemopurifier. The study indicated that the Hemopurifier removed 44% of monkeypox virus in the first hour of testing, 82% after six hours, and 98% after 20 hours. The studies were conducted in triplicate and data verification was provided by real time polymerase chain reaction (PCR).

We continue to monitor MPXV caseload and disease severity. We have contacted the FDA and confirmed the process by which we could provide the Hemopurifier to requesting physicians for single patient emergency use. On August 4, 2022, the U.S. Department of Health and Human Services (DHHS) officially declared Monkeypox a health emergency. An Emergency Use Authorization (EUA) declaration has not yet been made. We plan to submit a pre-EUA package to the FDA so as to be prepared in the event this declaration occurs.

Financial Results for the First Quarter Ended June 30, 2022

As of June 30, 2022, Aethlon Medical had a cash balance of approximately $14.9 million.

Consolidated operating expenses for the three months ended June 30, 2022, were approximately $2.91 million, compared to $2.23 million for the three months ended June 30, 2021. This increase of approximately $680,000, or 30%, in the 2022 period was due to increases in our general and administrative expenses of approximately $402,000, in our professional fees of approximately $261,000 and in our payroll and related expenses of approximately $13,000.

The $402,000 increase in our general and administrative expenses in the June 30, 2022, quarter was primarily due to the combination of a $161,000 increase in our clinical trial expenses, a $97,000 increase in supplies, a $91,000 increase in our rent expense and a $27,000 increase in our insurance expense.

The $261,000 increase in our professional fees was primarily due to the combination of a $154,000 increase in our contract labor expense associated with product development and analytical services and a $95,000 increase in professional fees associated with regulatory strategy services

The $13,000 increase in our payroll and related expenses was due to an increase in our stock-based compensation expense of $95,000. Our cash-based compensation expense decreased by $82,000 because our CEO received a $215,000 bonus in the June 2021 period for achieving certain contractual milestones in his employment agreement and there were no bonuses paid out in the June 2022 period.

Aethlon did not record any revenue related to our government contracts with the NIH in the three months ended June 30, 2022, compared to approximately $132,000 in the three months ended June 30, 2021. As of June 30, 2022, the Company had approximately $459,000 of deferred revenue related to those contracts as a result of not achieving certain milestones in those contracts.

As a result of the changes in revenues and expenses noted above, Aethlon’s net loss before noncontrolling interests increased to approximately $2.9 million for the three months ended June 30, 2022, from approximately $2.1 million for the three months ended June 30, 2021.

During the three months ended June 30, 2022, the Company raised approximately $619,000 in net proceeds under our ATM agreement with H.C. Wainwright & Co., pursuant to sales of our common stock. In July and August 2022 to date, the Company raised approximately $8.3 million under our ATM agreement through sales of our common stock.

The unaudited condensed consolidated balance sheet for June 30, 2022, and the unaudited condensed consolidated statements of operations for the three months ended June 30, 2022 and 2021 follow at the end of this release.

Conference Call

The Company will hold a conference call today, Tuesday, Aug. 9, 2022, at 4:30 p.m. EDT to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question-and-answer session.

Interested parties can register for the conference by navigating to View Source

Please note that registered participants will receive their dial in number upon registration.

A replay of the call will be available approximately one hour after the end of the call through July 28, 2022. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada Toll Free at 1-855-669-9658. The replay conference ID number is 2740523.