On August 9, 2021 Prescient Therapeutics’ (ASX: PTX) reported that strong cash position will enable it to advance its multiple cancer programs, with work to follow on from what managing director Steven Yatomi-Clarke describes as "tremendous" FY 2021 (Press release, Prescient Therapeutics, AUG 9, 2021, View Source;utm_medium=rss&utm_campaign=after-tremendous-fy-2021-prescient-therapeutics-well-funded-to-advance-cancer-fighting-therapies [SID1234586069]).

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The company develops personalised medicinal approaches to cancer, including targeted and cellular therapies.

Its targeted therapy candidates PTX-100 and PTX-200 are designed to inhibit cancer growth and tumour survival, while OmniCAR is a universal immune receptor platform being developed for next-generation CAR-T therapies for acute myeloid leukemia, HER2-positive solid tumours including breast, ovarian and gastric cancers, and glioblastoma multiforme (brain cancer).

Prescient ended the June quarter with $16.1 million cash in the bank after spending $280,000 on research and development activities in Australia and the United States, particularly related to the development of OmniCAR and cell therapy enhancements, and the ongoing clinical studies of PTX-100 and PTX-200.

Recent accomplishments include successful results from a phase 1b trial of PTX-100, announced after 30 June, which has led to an expanded study of the drug candidate to treat T cell lymphoma, and trial and manufacturing milestones achieved in the development of the OmniCAR platform.

PTX-100 trial progress
At the end of July, Prescient reported results from the PTX-100 phase 1b basket trial in solid and hematological cancers that demonstrated the drug was very well tolerated at all dose levels.

Early clinical activity was also observed in two patients with aggressive disease, in which prior therapies had failed to stop its progression. One of the patients experienced a partial response (a reduction in cancer burden) from the therapy with no disease progression for 17 months so far, while the other patient experienced a reduction in cancerous lesions and symptomatic .

"In both cases, such patients with refractory T cell lymphoma on standard-of-care therapies would typically be expected to have disease progression within four months, highlighting the encouraging nature of these responses," Prescient reported.

Owing to these encouraging phase 1b results, the company is now progressing development of PTX-100 as a monotherapy in an expansion cohort study in relapsed and refractory T cell lymphoma.

If the expansion cohort is successful, Prescient could advance directly to a separate registration study which may only require small trials compared to typical phase three trials.

Prescient’s other targeted therapy, PTX-200 is currently undergoing a phase 1b clinical trial in patients with acute myeloid leukemia. Updates from this study is expected in coming months.

OmniCAR milestones
To expedite its OmniCAR milestones, Prescient expanded its research partnership with the world-renowned Peter MacCallum Cancer Centre during the June quarter.

The partnership will fast-track development of Prescient’s next generation CAR-T therapy using the OmniCAR platform.

also recently announced "excellent" results from independent in silico immunogenicity testing of OmniCAR’s key binding components, SpyTag and SpyCatcher.

According to the company, this is a key milestone that substantially de-risks the entire platform and is important for progressing Prescient’s in-house programs and external collaborations.

Immunogenicity testing evaluates the immune response against a new therapy. In the case of CAR-T cell therapies, high levels of immunogenicity can adversely impact CAR-T cell expansion and persistence, which can impact the overall safety and clinical response of the treatment.

OmniCAR’s binding system components SpyTag and SpyCatcher were independently tested by a US research provider with results demonstrating that both components have very low immunogenicity – on par with circulating human antibodies.

Prescient chief executive officer and managing director Steven Yatomi-Clarke said the results "could not have been better".

"It gives us confidence that if these therapies are ultimately delivered to patients, their immune systems will not impair the therapy itself."

"This is essential not only for Prescient’s three in-house OmniCAR programs, but also for potential external collaborators, who consider immunogenicity very stringently," he added.

The development followed the successful completion of manufacturing and delivery of critical components of the OmniCAR platform including cell binders for several cancer targets and lentiviral vectors used to produce CAR-T cells.

On August 9, 2021 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that it is offering to sell $200 million of its common stock and, in lieu of common stock, to offer and sell to certain investors pre-funded warrants to purchase shares of its common stock in an underwritten public offering. As part of this offering, BioCryst intends to grant the underwriters a 30-day option to purchase additional shares of common stock in an amount equal to up to 15% of the securities offered in the public offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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J.P. Morgan, Evercore ISI and Piper Sandler are acting as joint book-running managers for the offering.

All of the shares to be sold in the offering are being sold by BioCryst, with the proceeds to be used for general corporate purposes, which may include, but are not limited to, worldwide development, manufacturing, regulatory and commercial activities for ORLADEYO; advancement of the worldwide development, manufacturing, regulatory and clinical activities for BCX9930 for complement-mediated diseases; discovery, manufacturing, development and clinical activities for other pipeline molecules in rare diseases; and capital expenditures and other general working capital needs.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 filed by BioCryst with the U.S. Securities and Exchange Commission (SEC) and only by means of a prospectus supplement and related prospectus. A preliminary prospectus supplement relating to the offering will be filed with the SEC and will be available on its website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at [email protected], or by telephone at (866) 803-9204; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, by telephone at (888) 474-0200, or by email at [email protected]; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at (800) 747-3924, or by email at [email protected].

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

On August 9, 2021 Inhibrx, Inc. (Nasdaq: INBX), a biotechnology company with four clinical programs in development, reported financial results for the second quarter of 2021 (Press release, Inhibrx, AUG 9, 2021, View Source [SID1234586125]).

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Financial Results

Cash and Cash Equivalents. As of June 30, 2021, Inhibrx had cash and cash equivalents of $125.7 million, compared to $128.7 million as of December 31, 2020.

R&D Expense. Research and development expenses were $17.9 million during the second quarter of 2021, compared to $19.0 million during the second quarter of 2020. This overall decrease was primarily due to the timing of work performed by Inhibrx’s contract development and manufacturing organization partners for the formulation and manufacturing of certain of its therapeutic candidates, offset in part by an increase in headcount and personnel-related costs due to the continued expansion of its organization.

G&A Expense. General and administrative expenses were $2.9 million during the second quarter of 2021, compared to $1.5 million during the second quarter of 2020. This increase was primarily due to an increase in personnel-related costs and other expenses associated with operating as a public company following its initial public offering in August 2020.

Net Loss. Net loss was $20.7 million during the second quarter of 2021, or $0.55 per share, compared to $17.9 million during the second quarter of 2020, or $0.99 per share.
About the Inhibrx sdAb Platform

Inhibrx utilizes diverse methods of protein engineering in the construction of therapeutic candidates that can address the specific requirements of complex target and disease biology. A key tool for this effort is the Inhibrx proprietary sdAb platform, which enables the development of therapeutic candidates with attributes superior to other monoclonal antibody and fusion protein approaches. This platform allows the combination of multiple binding units in a single molecule, enabling the creation of therapeutic candidates with defined valency or multiple specificities that can achieve enhanced cell signaling or conditional activation. An additional benefit of this platform is that these optimized, multi-functional entities can be manufactured using the established processes that are commonly used to produce therapeutic proteins.

On August 9, 2021 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (the "Company") reported that members of the executive management team will participate in a fireside chat during the Virtual BTIG Annual Biotech Conference on Tuesday, August 10, 2021 at 2:50 p.m. ET (Press release, Aurinia Pharmaceuticals, AUG 9, 2021, View Source [SID1234586141]).

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In order to participate in the audio webcast, interested parties can access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

On August 9, 2021 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical technology company focused on developing products to diagnose and treat life and organ threatening diseases, reported financial results for its first quarter ended June 30, 2021 and provided an update on recent developments (Press release, Aethlon Medical, AUG 9, 2021, View Source [SID1234586158]).

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Company Updates

Aethlon Medical is continuing the research and clinical development of our Hemopurifier to bind and remove COVID-19 viral particles, including many variant COVID-19 particles of interest and related exosomes.

As disclosed in our last earnings release on June 24, 2021, the Aethlon Hemopurifier has demonstrated binding of SARS-CoV-2 spike protein and binding and removal from circulation of SARS-CoV-2 virus from a human patient. This is in addition to the Hemopurifier’s previously demonstrated binding of numerous pathogenic viruses. This new information has stimulated clinical researchers to express interest in joining our ongoing clinical trial investigating the Hemopurifier for the treatment of patients with SARS-CoV-2/COVID-19 infection. This trial is being conducted under the open Investigational Device Exemption (IDE) for the Hemopurifier in life threatening viral infections. This trial will allow for up to 40 of these patients to be treated under a new Early Feasibility Study (EFS) protocol at up to 20 clinical sites in the U.S. During the quarter, Cooper Medical Center, located in Camden, N.J., joined the trial. Additionally, the Company is in late-stage clinical trial agreement discussions to bring on board other key U.S. medical centers and interested international medical centers. The Company anticipates finalizing our selection of a Contract Research Organization to supervise these clinical trials in the near future.

Financial Results for the First Quarter Ended June 30, 2021

At June 30, 2021, Aethlon Medical had a cash balance of approximately $25.2 million.

During the three months ended June 30, 2021, we raised approximately $17.5 million in net proceeds from the issuance of common stock in a combination of a registered direct financing and ATM sales.

Aethlon recorded approximately $115,000 of government contract revenue on its Phase 2 Melanoma Cancer Contract in the three months ended June 30, 2021. We also recorded approximately $17,000 of revenue related to our cost reimbursable subaward arrangement with the University of Pittsburgh in connection with an NIH contract entitled "Depleting Exosomes to Improve Responses to Immune Therapy in HNNCC." As a result, the Company recorded total government contract revenue of approximately $132,000 in the three months ended June 30, 2021. Aethlon did not record any government contract revenue in the three months ended June 30, 2020.

Consolidated operating expenses for the three months ended June 30, 2021 were approximately $2.2 million, compared to $1.4 million for the three months ended June 30, 2020. This increase of approximately $800,000, or 58%, in the 2021 period was due to increases in payroll and related expenses of approximately $580,000, in general and administrative expenses of approximately $221,000, and in professional fees of approximately $19,000.

The $580,000 increase in payroll and related expenses was primarily due to the combination of a $234,000 increase in R&D payroll as the result of hiring additional scientists, a $210,000 bonus payment to our CEO as the result of achieving certain milestones in his employment contract, a $64,000 increase in general and administrative payroll expense as the result of additional headcount and a $36,000 increase in stock-based compensation.

The $221,000 increase in general and administrative expenses was primarily due to a $133,000 increase in our subcontractor expenses related to our government contracts and a $74,000 increase in insurance expenses.

The $19,000 increase in professional fees was primarily due to a $50,000 increase in legal fees which was partially offset by a $22,000 decrease in scientific consulting expenses and a $6,000 decrease in accounting expenses.

Other expense was nominal during the first quarter ended June 30, 2021.

As a result of the changes in revenues and expenses noted above, the Company’s net loss before noncontrolling interests increased to approximately $2.1 million for the three months ended June 30, 2021, from approximately $1.4 million for the three months ended June 30, 2020.

The unaudited condensed consolidated balance sheet for June 30, 2021 and the unaudited condensed consolidated statements of operations for the three month periods ended June 30, 2021 and 2020 follow at the end of this release.

Conference Call

The Company will hold a conference call today, Monday, August 9, 2021 at 4:30 p.m. Eastern Time 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.

Interested parties without internet access or unable to pre-register may dial in by calling:
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 September 9, 2021. 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 10159282.