On February 14, 2024 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, reported financial results for its fiscal third quarter ended December 31, 2023 and provided an update on recent developments (Press release, Aethlon Medical, FEB 14, 2024, View Source [SID1234640108]).

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Company Updates

Aethlon Medical is continuing the research and clinical development of its Hemopurifier, a therapeutic blood filtration system designed to bind and remove harmful exosomes and life-threatening viruses from blood and other biological fluids. These qualities of the Hemopurifier have potential applications in oncology, where cancer associated exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases. Aethlon is also investigating the use of the Hemopurifier in the organ transplant setting, initially focusing on the potential removal of viruses and exosomes with harmful cargo from recovered kidneys.

In October 2023, Aethlon received clearance from the Drug Controller General of India (DCGI), the country’s central drug authority, to conduct a phase 1 safety, feasibility and dose-finding trial of the Hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda or Opdivo. The trial is expected to begin following completion of an in vitro binding study of relevant targets, and subsequent approval by the respective Ethics Boards of interested sites in India.

"In addition to an interested initial site in India, we have two interested sites in Australia that are also awaiting the data from our in vitro binding study," stated James Frakes, Interim Chief Executive Officer and Chief Financial Officer. "Our in vitro binding study of relevant oncology targets is complex and stands on the cutting edge of extracellular vesicle science. Our goal is to quantify the potential impact of our Hemopurifier on plasma from cancer patients that have been treated with anti-PD-1 monotherapy treatment in order to provide pre-clinical evidence to support our trial design.

"While our research and development team has started to quantify our internal data, the results, to date, are inconclusive. Therefore, while our internal team continues to finetune their work, in parallel we have engaged several third-party laboratories to independently perform assays on the samples.

"We are also maintaining a position in the use of our Hemopurifier as a treatment against life-threatening viral infections through our COVID-19 trial in India. We have two participating sites for this trial — the Medanta Medicity Hospital and Maulana Azad Medical College, or MAMC. One patient has been treated thus far, however, we have been informed by our contract research organization that a new COVID-19 subvariant was recently detected in India. Our COVID-19 trial in India remains open in the event that there are COVID-19 admissions to the intensive care units at our two participating sites.

"Finally, since being named interim Chief Executive Officer three months ago, I have focused our efforts on our oncology program, as well as on reducing our expenses. As previously reported, we disclosed some interesting pre-clinical proof on concept data of the Hemopurifier in organ transplantation. As a result, we plan to submit one or more articles for publication on our pre-clinical data," concluded Mr. Frakes.

Financial Results for the Third Quarter Ended December 31, 2023

As of December 31, 2023, Aethlon Medical had a cash balance of approximately $8.0 million.

Consolidated operating expenses for the three months ended December 31, 2023 were approximately $3.6 million, compared to $2.8 million for the three months ended December 31, 2022. This increase of approximately $717,000, or 25.2%, in the 2023 period was due to increase in payroll and related expenses of approximately $871,000, offset by decreases in general and administrative expenses of approximately $92,000 and in professional fees of approximately $61,000.

The $871,000 increase in payroll and related expenses was primarily due to separation expenses for our former chief executive officer of $873,000 and an increase in salary expense of $81,000 associated with an increase in average headcount, offset by a decrease in stock-based compensation of $83,000.

The $92,000 decrease in general and administrative expenses was primarily due to a decrease in clinical trial expense of approximately $399,000 and a $33,000 decrease in travel and conferences expenses. Decreases were offset by a $284,000 increase in supplies for manufacturing and research and development expense, a $31,000 increase in insurance expense, a $13,000 increase in depreciation expense and a $12,000 increase in outside services and repairs. The increase in insurance expense included $16,000 of health insurance related to the separation agreement with our former chief executive officer.

The $61,000 decrease in professional fees was due to a $54,000 decrease in scientific consulting, a $22,000 decrease in marketing, a $21,000 decrease in recruiting and a net $33,000 decrease in contract labor related to general research and development. These decreases were offset by an increase of $44,000 in legal expenses relating to the reverse stock split, an $11,000 increase in director fees associated with the addition of a new director and a $14,000 increase in investor relations and accounting fees.

As a result of the changes in expenses noted above, the company’s net loss increased to $3.6 million for the three months ended December 31, 2023, from $2.8 million in the three months ended December 31, 2022.

The condensed consolidated balance sheet for December 31, 2023, and the condensed consolidated statements of operations for the three- and nine-month periods ended December 31, 2023 and 2022 follow at the end of this release.

Conference Call

Aethlon Medical will hold a conference call today, Wednesday, February 14, 2023, at 4:30 p.m. ET to review its financial results for its fiscal third quarter ended December 31, 2023 and recent corporate developments. 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.

Interested parties without internet access or who are unable to pre-register, may dial in as follows:

Participant Dial In (Toll Free): 1-844-836-8741
Participant International Dial In: 1-412-317-5442

All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through March 14, 2024. 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 7691190.

On February 14, 2024 Numab Therapeutics AG ("Numab") and Ono Pharmaceutical Co., Ltd. ("Ono") reported a global research, development and commercialization collaboration for NM49, a multi-specific antibody designed to activate tumor associated macrophage phagocytosis for the treatment of cancers and identified through Numab’s proprietary discovery and engineering technology platform (Press release, Numab, FEB 14, 2024, View Source [SID1234640106]).

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Under the terms of the agreement, Ono has obtained an option to in-license NM49 from Numab for global development and commercialization, with Numab retaining an option to co-develop and commercialize in the United States. The option can be exercised prior to the start of a Phase 3 clinical trial and, if exercised, Numab will be eligible for co-promotion and a 50/50 profit split arrangement in the United States. Numab will be responsible for conducting preclinical studies and CMC activities with Ono covering the related expenses and being responsible for development and associated costs if the program enters clinical development. Numab will receive an undisclosed upfront payment and is eligible for additional payments based upon the achievement of certain development, regulatory and sales milestones as well as tiered royalties on net sales.

"This important partnership marks our third collaboration with Ono and the first one where Numab has the option to co-develop and commercialize in the United States. We are thrilled to continue working with Ono on developing new high impact multi-specific therapeutics for cancer patients," said David Urech, Ph.D., Founder and Chief Executive Officer of Numab Therapeutics. "The collaboration will further expand Numab’s product pipeline and improve the productivity of our R&D activities."

"We are very pleased to strengthen the partnership with Numab through the development and commercialization of NM49 generated through Numab’s unique multi-specific antibody platform," said Toichi Takino, Senior Executive Officer / Executive Director, Discovery & Research of Ono. "We are committed to the development and commercialization of NM49 to deliver it as a new therapeutic option to patients as soon as possible by maximally utilizing Ono’s deep immuno-oncology expertise."

On February 14, 2024 VBI Vaccines Inc. (Nasdaq: VBIV) ("VBI" or the "Company"), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported agreements whereby Brii Biosciences ("Brii Bio"), subject to certain activities, is expected to: (i) acquire the intellectual property for VBI-2601, VBI’s HBV immunotherapeutic development program, and eliminate payment obligations from the July 2023 agreements between VBI and Brii Bio, (ii) acquire manufacturing capabilities and certain related assets at VBI’s Rehovot, Israel manufacturing facility, and (iii) enter into an exclusive license to develop and commercialize VBI-1901, VBI’s glioblastoma (GBM) immunotherapeutic candidate, in the Asia Pacific region (APAC), excluding Japan (Press release, VBI Vaccines, FEB 14, 2024, View Source [SID1234640102]). Additionally, subject to certain approvals, VBI and Brii Bio will work together to transfer the manufacturing technologies of VBI-2601 to a site designated by Brii Bio. VBI received $2.5 million of consideration upon signing of definitive documents and is expected to receive up to an additional $30.5 million of consideration, subject to achievement of certain activities, with a target completion date of June 30, 2024.

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Jeff Baxter, President and CEO of VBI, stated: "We believe that this transaction improves the financial stability of VBI and balances the potential value creation within our development and commercial portfolio with a streamlined and focused resource deployment. Upon successful completion of all transactions, we anticipate that we will have reduced the long-term burn of the company, and reduced our debt overhang by about 70%. We remain steadfast in our belief that our pipeline can have a meaningful impact on patients, providers, and public health, and we believe this deal better positions us to deliver on this mission."

The proceeds from these agreements will be used for reduction of debt under the Company’s current facility with K2 HealthVentures.

On February 14, 2024 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported a shareholder update with a projected outlook for the current year (Press release, TC Biopharm, FEB 14, 2024, View Source [SID1234640101]).

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"The previous year was a time of significant operational achievement for TC BioPharm," said Bryan Kobel, Chief Executive Officer. "Despite strong headwinds throughout financial markets, we announced capital infusions of [approximately] $11.6 million while streamlining efficiencies, successfully dosing the final patient our ACHIEVE Study safety cohort and receiving FDA clearance of the Company’s investigational new drug (IND) application for a Phase 1B study in relapse/refractory Acute Myeloid Leukemia (AML). Additionally, we announced a new collaboration with Queen Mary University of London to expand TCB-008 into anti-fungal and anti-bacterial diseases, including non-dilutive funding to advance the project at lesser/lessened cost to the Company. Our team remains confident in TCB-008 as a therapeutic both as a monotherapy and in combination with other cell and immune system focused therapeutics, and looks forward to receiving interim data for the ACHIEVE trial in 2024. In March of 2023, we gave the investment community a roadmap of milestones we looked to complete in the subsequent 9 months of 2023, and it’s a great credit to the team that the Company was able to successfully achieve each of these milestones. We look forward/expect to continue this pattern of execution in 2024 and hitting our key milestones as laid out."

Recent Company Updates

● FDA clearance of investigational new drug (IND) application for a Phase 1B study in relapse/refractory Acute Myeloid Leukemia (AML)
● The Company streamlined efficiencies and reduced overhead on several fronts
● Formed a third-party manufacturing partnership in US with Excellos
● Entered into a collaboration agreement with Queen Mary University of London (QMUL) to expand the platform into non-oncology indications. The QMUL project received grant funding from The Impact Fund arm of QMUL, to research the therapeutic potential of gamma-delta T cells for the treatment of mucosal infections.
● Completed ACHIEVE Safety Cohort and received positive review from the Data Safety Monitoring Board (DSMB).

2024 Potential Milestones

● Interim data review for ACHIEVE trial studying TCB-008 in Acute Myeloid Leukemia
● Management is focused on leveraging existing strategic relationships in order to execute partnerships and or collaborations in combination with TCB-008.
● Platform expansion with Proof of Concept and preclinical work completed for its anti-fungal/anti-bacterial program
● Expected budget savings of approximately $11.6M after eliminating redundancies and asset prioritization efforts.

Filing of Preliminary Proxy Statement

On February 9, 2024 the Company filed a preliminary proxy statement with the Securities and Exchange Commission which included a proposal to obtain shareholder approval, in accordance with Nasdaq Marketplace Rule 5635(d), regarding the proposed sale, issuance, or potential issuance by the Company of Ordinary Shares or ADSs, in connection with certain non-public offerings, of the Ordinary Shares or ADSs (and/or securities convertible into or exercisable for Ordinary Shares or ADSs) equal to 20% or more outstanding immediately prior to the issuance of such securities at a price less than the lower of: (i) the closing price immediately preceding the signing of the binding agreement, or (ii) the average closing price of the ADSs for the five trading days immediately preceding the signing of the binding agreement for the transaction, subject to certain limitations. The Board of Directors of the Company has not yet determined the terms and conditions of any potential financing(s). This filing is not a registration statement and no shares have been issued or registered with the Securities and Exchange Commission (SEC). TC BioPharm has taken this step in light of converting from foreign filer status to a domestic filer status, and in order to comply with NASDAQ marketplace rules that are applicable to domestic filers.

Kobel continued, "In 2024, our goal is to make additional strides throughout our pipeline of differentiated gamma delta T cell therapies via a strategic and disciplined approach. Receiving clearance on our IND from the U.S. FDA of TCB-008 in Acute Myeloid Leukemia marks an important milestone in maximizing our lead therapeutics’ opportunity in the category of blood cancers that we believe it is ideally suited to address. Additionally, last week the Company filed a preliminary proxy statement relating to the Nasdaq stock exchange’s requirement of obtaining shareholder approval for the potential issuance of more than 20% of the shares outstanding. This relates to being positioned to effectively execute our business strategy over the coming 90 days, both in the M&A arena and access to capital, and is a function of timing as we shift from foreign filer status to domestic filer status for SEC reporting and NASDAQ compliance purposes."

On February 14, 2024 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapeutic drugs for cancer, reported its financial results for the three months ended December 31, 2023 and provided a business update (Press release, Sonnet BioTherapeutics, FEB 14, 2024, View Source [SID1234640100]).

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"This last quarter set the stage for an exciting year across Sonnet’s pipeline, highlighted by the progress of the combination study of SON-1010 and atezolizumab in platinum-resistant ovarian cancer (PROC), where we continue to expect safety data during the first half of 2024." commented Pankaj Mohan, Ph.D., Founder and CEO. "Additionally, enrollment of the Phase 1b portion of the SON-080 study in patients with CIPN is now finished. We believe this trial will yield important safety data that could help position the asset for a potential partnering opportunity in this indication, as well as in diabetic peripheral neuropathy (DPN), both indications of high unmet medical need. On the operations side, we continue the work to optimize our cash usage and runway, including leveraging tax credits. From the sale of the New Jersey NOLs, we expect to receive net proceeds of $4.3 million, after deducting expected fees, during February 2024. Pending the completion of this sale, we believe it will extend the funding of our projected operations into the third calendar quarter of 2024. Taken together, we are pleased with the progress of our clinical programs and look forward to updating the market on our continued progress over the balance of 2024."

Fiscal Year 2024 First Quarter and Recent Corporate Updates

Sonnet provided the following corporate updates:

● On October 17, 2023, announced that interim data from the SB101 clinical trial of the company’s proprietary Fully Human Albumin Binding (FHAB) candidate, SON-1010 (IL12- FHAB), would be presented by Dr. Sant Chawla, a key opinion leader in the field of sarcoma research, at the Connective Tissue Oncology Society Annual Meeting 2023, held November 1-4, 2023, in Dublin, Ireland.
● On October 25, 2023, announced the pricing of an underwritten public offering of 2,843,750 shares of common stock (or pre-funded warrants to purchase shares of common stock in lieu of shares of common stock) and investor warrants to purchase up to an aggregate of 5,687,500 shares of common stock. Each share of common stock (or pre-funded warrant in lieu thereof) was sold together with two investor warrants at a combined offering price of $1.60, for total gross proceeds of approximately $4.55 million (final net proceeds were $3.9 million), before underwriting discounts and commissions and offering expenses payable by Sonnet.

● On December 21, 2023, announced the publication of extensive preclinical data on SON-1210 in Frontiers in Immunology. SON-1210, Sonnet’s lead proprietary bifunctional compound, combines the company’s FHAB construct with a novel single-chain Interleukin 12 (IL-12) and fully human Interleukin 15 (IL-15). The paper, entitled "SON-1210 – a novel bifunctional IL-12 / IL-15 fusion protein that improves cytokine half-life, targets tumors, and enhances therapeutic efficacy", demonstrated the robust binding affinity of SON-1210 to albumin and the anticipated in vitro activity and tumor model efficacy that might be expected from the body of research on native IL-12 and IL-15. In the B16F10 melanoma model, a single dose resulted in a marked reduction of tumor growth that was concomitant with increased IFNγ and augmented immune cell numbers and activity in the tumor microenvironment. Repeat doses in non-human primates displayed excellent safety and tolerability and were similarly accompanied by increased IFNγ levels.
● In December 2023, Sonnet received preliminary approval of its application to sell up to $4.8 million of its New Jersey state net operating losses (NOLs) through the Technology Business Tax Certificate Transfer Program. On January 24, 2024, the Company executed an agreement pursuant to the program whereby a buyer has agreed to purchase, and the Company agreed to sell, such NOLs. Sonnet expects to receive net proceeds of $4.3 million, after deducting expected fees, during February 2024. Pending the completion of the sale of the New Jersey NOLs, Sonnet believes it will extend the funding of its projected operations into the third calendar quarter of 2024.
● Also during December 2023, Sonnet received a $0.8 million net cash refund from the research and development tax incentive program in Australia.
● Safety was recently reviewed for the 2nd dose-escalation cohort in the SB221 Phase 1b combination study (NCT05756907) in patients with platinum-resistant ovarian cancer (PROC) and enrollment has begun in the 3rd cohort. Enrollment continues in the final dose-escalation cohort with SON-1010 monotherapy in SB101 (NCT05352750) cancer patients. Safety updates for both studies are expected during the first half of 2024.
● Enrollment has finished in the Phase 1b safety portion of the SB211 study of SON-080 (NCT05435742) in patients with persistent CIPN. A safety update from this trial is expected during the first quarter of 2024.
● Regarding the agreement with Janssen, the parties have completed two combination studies in a prostate tumor model. A review of the resulting data remains ongoing.

"As our pipeline continues to advance, we remain focused on areas for further operating expense reductions." said Jay Cross, CFO. "Furthermore, we are diligently working to expand on our business development accomplishments, in an otherwise highly competitive environment."

FY 2024 First Quarter Ended December 31, 2023, Financial Results

● As of December 31, 2023, Sonnet had $3.0 million cash on hand and no debt.
● Research and development expenses were $0.6 million for the three months ended December 31, 2023, compared to $3.7 million for the three months ended December 31, 2022. The decrease of $3.1 million was primarily due to the cancellation of accrued but unpaid bonuses that had been awarded for fiscal years 2022 and 2023 in the amount of $1.0 million, as well as due to cost saving initiatives, as we are managing expenses for liquidity purposes and are tightening our focus on the research and development projects we have assessed to have the greatest near-term potential. In addition to transitioning product development activities to cost advantaged locations such as India and Australia, we have reduced expenditures on tertiary programs and suspended antiviral development related to SON-1010.
● General and administrative expenses were $0.7 million for the three months ended December 31, 2023, compared to $1.9 million for the three months ended December 31, 2022. The decrease of $1.3 million relates primarily to the cancellation of accrued but unpaid bonuses that had been awarded for fiscal years 2022 and 2023 in the amount of $0.9 million, and due to cost saving initiatives, as we are managing expenses for liquidity purposes.