On September 27, 2022 Nemaura Medical, Inc.(NASDAQ: NMRD)("Nemaura" or the "Company"), a medical technology company focused on developing and commercialising noninvasive wearable diagnostic devices and supporting personalized lifestyle coaching programs, reported that it has entered into a preliminary agreement with EVERSANA, a pioneer of next-generation commercial services to the global life sciences industry (Press release, EVERSANA, SEP 27, 2022, View Source [SID1234621442]).

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The agreement covers the U.S. and all global sales and marketing of Nemaura’s Diabetes Management Solution, BEATdiabetes. The BEATdiabetes program is based on Nemaura’s noninvasive glucose monitoring solution, proBEAT. Nemaura and EVERSANA will work together to develop the optimal launch strategy for large-scale adoption of the diabetes management program, including franchising and direct sales to self-insured corporate clients and healthcare insurers.

In early pilot trials conducted over the last 12 months, the BEATdiabetes program yielded overall positive outcomes, demonstrating that sustainable, long-term weight loss and, therefore, improvement in the management of Type 2 diabetes is achievable. Incumbents in the space have also demonstrated clinically significant outcomes when such diabetes management programs are used in conjunction with continuous glucose monitors. Nemaura, however, has the advantage of its own proprietary noninvasive sensor technology which significantly reduces sensor costs, as the sensors are only worn a few days each month.

EVERSANA is widely regarded as the leader in digital therapeutic commercialization. Across the life sciences industry, the fully integrated commercialization provider works with more than 670 organizations, including innovative start-ups and established pharmaceutical companies.

Dr. Faz Chowdhury, Nemaura Medical’s Chief Executive Officer stated, "We are excited to be working with EVERSANA to bring our diabetes management solution to market. This is a culmination of several months of negotiations with EVERSANA following the encouraging outcome of the pilot studies. Diabetes management is an area of huge unmet need, and we anticipate that our solution will be very easy, simple to administer, and highly cost-effective, all elements supporting large-scale adoption"

Jim Lang, CEO at EVERSANA, added, "Nemaura’s innovative programs and sensor technology potentially represent a major change in the way in which diabetes is addressed and how patients may be supported. We look forward to leveraging our full suite of commercialization services to support a successful U.S. launch."

On September 27, 2022 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") and Enalare Therapeutics Inc. ("Enalare") reported that Enalare has secured a contract for up to $50.3 million from the Biomedical Advanced Research and Development Authority ("BARDA"), part of the Administration for Strategic Preparedness and Response in the U.S. Department of Health and Human Services (contract number 75A50122C00072) (Press release, Eagle Pharmaceuticals, SEP 27, 2022, View Source [SID1234621441]). In partnership with BARDA, ENA-001 is being developed in an intramuscular ("IM") formulation for potential use in patients experiencing community drug overdose and as a potential medical countermeasure for mass casualty events.

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The contract is awarded in stages based on the achievement of established milestones and deliverables and provides funding for Enalare to perform pre-clinical toxicology studies, human clinical studies, drug and device manufacturing, and submission of the regulatory file to the U.S. Food and Drug Administration ("FDA") for a formulation of ENA-001 suitable for community use. The first phase of the contract, which provides approximately $6.0 million to complete activities through the initial Phase 1 study, coincides with grant support from the National Institute on Drug Abuse ("NIDA"), part of the National Institutes of Health.

"Respiratory depression can be life threatening. This award provides critical non-dilutive funding to Enalare to accelerate the development of an IM formulation for ENA-001, which could potentially enable more rapid deployment in emergency situations. The pre-clinical work is going very well, and the BARDA contract provides support along the development and regulatory pathway toward FDA approval of ENA-001 for use in the United States. We believe this is a promising opportunity to address a serious, unmet issue in our society, and adds further to our enthusiasm for our agreement with Enalare," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

"We are pleased to expand our partnership with BARDA on the development of ENA-001 – a novel compound with a unique mechanism of action as an agnostic respiratory stimulant," said Herm Cukier, President and CEO of Enalare Therapeutics. "ENA-001’s rapid and proven ventilatory stimulation, irrespective of the cause of the respiratory depression, is critical for effective post-exposure therapy given the urgency for treatment and the unknowns associated with many chemical threats. Drug overdoses continue to ravage our communities, and with this new contract, we can accelerate our efforts to achieve our mutual goal of developing an innovative and rapid treatment for respiratory depression in a variety of settings," concluded Cukier.

The new award builds on an existing partnership between Enalare and the BARDA DRIVe ReDIRECT (Repurposing Drugs in Response to Chemical Threats) program. During that project, Enalare performed work to develop a formulation of ENA-001 that is suitable for intramuscular administration, which is much preferred for emergency use in the community.

The funding is provided via Biomedical Advanced Research and Development Authority to support the advanced research and development of medical countermeasures (MCM) for chemical, biological, radiological and nuclear (CBRN) agents, pandemic influenza, and emerging infectious diseases that threaten the U.S. civilian population.

In August 2022, Eagle made an equity investment of $12.5 million in Enalare, with a commitment to invest another $12.5 million six months later 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 also has the option to acquire the 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 development of ENA-001 is also supported by the National Institute on Drug Abuse ("NIDA") of the National Institutes of Health ("NIH") under award number R44DA057133. The content of this document is the responsibility of its authors and does not necessarily represent the official views of the National Institutes of Health.

About ENA-001

Enalare’s lead compound, ENA-001, is a one-of-a-kind new chemical entity (NCE) designed as an agnostic respiratory stimulant. The compound has a novel mechanism of action that affects ventilation via the peripheral chemoreceptor pathways in the carotid body. It utilizes the body’s own ventilation control system to beneficially influence breathing and has been shown to be effective and well tolerated in five human studies to date. 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. ENA-001 is an investigational compound and is not approved for use by the FDA.

On September 27, 2022 Alentis Therapeutics ("Alentis" or "the Company"), the biotechnology company developing breakthrough treatments for organ fibrosis and fibrotic-associated cancers, reported the Swiss Innovation Agency, Innosuisse, will co-fund a research collaboration with the FHNW School of Life Sciences to accelerate the discovery of Claudin-1-associated biomarkers for fibrosis (Press release, Alentis Therapeutics, SEP 27, 2022, View Source [SID1234621439]).

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Claudin-1 (CLDN1) is a novel, previously unexploited target with a unique mechanism of action that plays a key role in the pathology of organ fibrosis and fibrotic tumors. Alentis’ lead therapeutic candidate, ALE.F02, is currently in Phase 1 clinical studies for the treatment of advanced kidney, liver and lung fibrosis which are expected to read out in Q1 2023. The Company is also developing ALE.C04 for solid tumors that is currently in pre-clinical development.

Alentis Therapeutics will partner with the School of Life Sciences to test anti-CLDN1 antibodies in established 3D-multicellular liver co-culture systems, developed and validated by Prof. Dr. Laura Suter-Dick’s lab at the FHNW Campus Muttenz, Basel-Landschaft, Switzerland, and published recently in the International Journal of Molecular Science. The goal is to identify translational biomarkers of CLDN1 target engagement that be deployed in future Alentis trials. The total project cost of CHF 720,000 will be supported by the grant from Innosuisse and contributions from Alentis Therapeutics.

Dr. Geoffrey Teixeira, Head of Fibrosis at Alentis Therapeutics, commented: "With the support of Innosuisse, we look forward to continuing our close collaboration with Prof. Dr. Laura Suter-Dick’s group to provide further validation and monitoring of the therapeutic effect of CLDN1 inhibition in fibrotic disorders. This is another important step in our goal to develop breakthrough treatments for organ fibrosis and fibrotic-associated cancers."

Prof. Dr. Laura Suter-Dick, Professor of Cell Biology and In Vitro Toxicology at FHNW, added: "We are grateful to Innosuisse for its support in promoting science-based innovation in Switzerland. Through our continued collaboration with the Alentis team, we aim to identify translational biomarkers of CLDN1 target engagement for use in future clinical trials."

On September 27, 2022 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company focused on advanced therapies for autoimmune and inflammatory diseases, reported financial results for the quarter ended June 30, 2022, as well as pre-clinical and clinical progress on nomacopan and long-acting PAS-nomacopan (Press release, Akari Therapeutics, SEP 27, 2022, View Source [SID1234621438]). Investigational nomacopan is a bispecific recombinant inhibitor of complement C5 and leukotriene B4 (LTB4) currently being investigated in a Phase 3 clinical trial for use in severe pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA) and a pre-clinical program is developing long-acting PASylated nomacopan in geographic atrophy (GA) in dry age-related macular degeneration (dAMD).

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"We sharpened our pipeline focus on two programs that have the potential to address areas of significant unmet need for patients, including our Phase 3 clinical trial in severe pediatric HSCT-TMA that we believe is the shortest path to value creation for our investors," said Rachelle Jacques, President and CEO of Akari Therapeutics. "The recently announced financing provides us with the cash needed to bring our HSCT-TMA program to our next important milestone, which is the Part A data readout we expect in the first half of 2023, and to advance our promising pre-clinical program investigating PAS-nomacopan in geographic atrophy."

Akari Recent Progress and Highlights

Amidst a very challenging capital markets environment, Akari successfully closed a registered direct offering with healthcare-focused institutional and accredited investors, including participation of certain existing investors for the issuance of an aggregate 15,100,000 American Depositary Shares (ADSs) at $0.85 per ADS and a concurrent private placement of series A warrants to purchase 15,100,000 ADSs and series B warrants to purchase 15,100,000 ADSs for aggregate gross proceeds of approximately $12.8 million
Proceeds from the offering will support Akari’s narrowed pipeline focus, including the Phase 3 Part A clinical trial of nomacopan in severe pediatric HSCT-TMA and the promising pre-clinical program developing long-acting PAS-nomacopan in GA
The Phase 3 Part A clinical trial of nomacopan in severe pediatric HSCT-TMA remains on track for a data readout in the first half of 2023
Akari continues to participate in the U.S. Food and Drug Administration (FDA) Model Informed Drug Development (MIDD) program that, along with a robust PK/PD model, supported dose selection and rapid advancement into the Phase 3 Part A clinical trial of nomacopan in severe pediatric HSCT-TMA
Akari clinical data from 38 subjects in previous nomacopan clinical studies and healthy volunteers supported a PK/PD model and model simulations of 10,000 virtual patients that were used to inform FDA MIDD interactions that confirmed PK/PD model suitability and dosing selected for the Phase 3 Part A clinical trial of nomacopan in severe pediatric HSCT-TMA
Positive results from recent pre-clinical studies support the advancement of long-acting PAS-nomacopan toward IND/IMPD for clinical trials in GA as well as the potential for the investigational treatment to address areas of unmet patient needs
PK measurements have indicated the half-life of early generation PAS-nomacopan in a standard ophthalmic pre-clinical model can be accurately predicted, which supports work to develop new generation PAS-nomacopan that may enable dosing intervals of more than three months between intravitreal injections with the potential of an acceptable low dose volume
Pivotal data recently released on a late-stage complement-only inhibitor (not nomacopan) further reinforce the efficacy of C5 inhibition in GA. Pre-clinical PAS-nomacopan is a bispecific inhibitor of both complement C5 and LTB4, which is important because previously presented data show LTB4 inhibition by PAS-nomacopan may also reduce the risk of sight-threatening choroidal neovascularization (CNV), a safety risk associated with current late-stage complement-only inhibitors.
Second Quarter 2022 Financial Results

As of June 30, 2022, the Company had cash of approximately $8.2 million, compared to cash of approximately $9.4 million as of December 31, 2021. Following the end of the second quarter, Akari closed a registered direct offering of 15,100,000 ADSs along with a concurrent private placement of series A warrants to purchase 15,100,000 ADSs and series B warrants to purchase 15,100,000 ADSs, resulting in approximately $12.8 million in gross proceeds.

Research and development expenses for the second quarter 2022 were approximately $2.9 million, as compared to approximately $2.2 million in the same quarter the prior year. This increase of 31% or $0.7 million was primarily due to increased expenses due to the timing of manufacturing of nomacopan to support ongoing clinical trials.

General and administrative expenses for the second quarter 2022 were approximately $3.0 million, as compared to approximately $2.1 million in the same quarter the prior year. This increase of 43% or $0.9 million was primarily due to increased consulting fees for services such as strategic advisory, investor relations, and other activities.

For the second quarter 2022, total other income was approximately $136,000 as compared to total other expense of approximately $16,000 in the second quarter of 2021. This $152,000 increase was primarily attributed to foreign currency exchange gains in the current period as compared to foreign currency exchange losses in the prior period.

Net loss for the second quarter 2022 was approximately $5.7 million, as compared to approximately $4.3 million for the period of 2021. This increase was primarily due to the aforementioned higher research and development expenses as well as higher general and administrative expenses.

Net cash used in operating activities for the six months ended June 30, 2022 was approximately $13.6 million, as compared to approximately $12.3 million for the six months ended June 30, 2021. This increase was primarily due to the aforementioned higher net loss as well as an increase in prepaid expenses and other current assets.

On 26 September 2022 Arovella Therapeutics Ltd, a biotechnology company focused on developing its invariant Natural Killer T (iNKT) cell platform for cancer treatment, reported it collaborate with clinical stage immune-oncology company Imugene Limited (ASX: IMU), using its onCARlytics platform (Press release, Imugene, SEP 26, 2022, View Source [SID1234629026]). This will test Arovella’s CAR19-iNKT (ALA-101) cell therapy with Imugene’s onCARlytics platform to seek and destroy solid tumours. The read out from the preclinical studies performed through the collaboration is expected in H1 2023.

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Arovella’s lead iNKT product, ALA-101, contains a Chimeric Antigen Receptor (CAR) that targets tumour cells producing CD19 on their surface. Typically, CD19 expression is on the cell surface of blood cancers. Imugene’s onCARlytics platform enables solid tumour cancers to express CD19 on their surface, which creates the opportunity to use ALA-101 to seek and destroy the solid tumour cells. Currently, ALA-101 is being developed for CD19-producing blood cancers. Working with Imugene raises the possibility of using ALA-101 to treat solid tumour cancers.

Imugene is evaluating a range of CD19 targeting therapies in combination with onCARlytics of which Arovella’s ALA-101 will be included, allowing Arovella to benchmark its iNKT therapy for the treatment of solid tumours. Initial pre-clinical data from Arovella demonstrates that ALA-101 cells outperform conventional T cells in haematological malignancies that produce CD19 and CD1d. Achieving compelling data in this study would open up a new therapeutic area of potential indications in solid tumours for Arovella’s iNKT cell therapy products.

Solid tumours represent 90% of diagnosed cancer cases1, and as of 2021, the solid tumour market was valued at US$209.61 billion2.

Imugene’s CEO and MD, Leslie Chong, commented, "Our onCARlytics platform opens up the possibility to treat solid tumours with existing CD19 targeting drugs. Solid tumours account for more than 90% of cancers diagnosed, and our technology has the potential to change the outcomes for these patients. We are excited to see how Arovella’s iNKT cell platform and other drugs in our trial perform on the back of our platform. We are delighted to work with another Australian-based biotechnology company focussing on cancer treatment."

Arovella’s CEO and MD, Dr Michael Baker, commented, "We are excited to collaborate with Imugene to evaluate potential of our iNKT product in combination with their onCARlytics product for treatment of solid tumours. Imugene’s onCARlytics is one of the most promising products to be developed for solid tumours. We believe strongly in the unique capability of our iNKT program and look forward to seeing how ALA-101 performs in these models. Arovella is excited by the prospect of expanding its use of its iNKT cell therapy platform to treat solid tumours."

The research partnership is material to Arovella as it includes development of Arovella’s iNKT cell therapy platform licensed from Imperial College London (see ASX announcement dated 18 June 2021) with Arovella’s onCARlytics CD19 oncolytic virus licensed from the City of Hope. The combination has the potential to be a novel approach to treating certain solid tumour cancers.

The research collaboration agreement is effective as of 26 September 2022 and has an initial term of twelve months. The strategic collaboration may be terminated upon completion of the research, or by mutual agreement. Arovella will fund the preclinical studies from its planned research budget, and no further funding is required for the initial research completed through the partnership. Currently each party has full intellectual property (IP) rights (patents) to their individual background technology. In the event new IP is generated from the research collaboration (each a "Combination Invention"), the parties shall discuss in good faith the filing, prosecution, maintenance, enforcement, defense of any patent applications thereto, as well as each party’s right to use, such Combination Invention. After the results from this research agreement are known and can be quantified, the parties will negotiate in good faith (and without obligation) whether to jointly develop or commercialise on the outcomes of the strategic collaboration on commercially reasonable terms.