On August 12, 2021 Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, reported consolidated financial results for the three and nine months ended June 30, 2021 (Press release, Applied DNA Sciences, AUG 12, 2021, View Source [SID1234586439]).

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"We delivered excellent year-over-year revenue growth in the fiscal third quarter while laying the groundwork to secure a recently awarded COVID-19 testing services contract that has potential to be the largest contract in the Company’s history," said Dr. James A. Hayward, president and CEO of Applied DNA. "Demand for safeCircle, our pooled COVID-19 testing program, experienced a seasonal decline from the fiscal second quarter, reflecting the start of the summer recess months for our academic clients and progressively higher vaccination rates and lower positivity rates in our operating area. Our recent award from the City University of New York for large-scale turnkey COVID-19 testing services should continue to drive strong year-over-year revenue growth over the period of the contract."

Continued Dr. Hayward, "Our operating activities during the quarter were distinguished by an expansion of our COVID-19 offerings to drive incremental revenue and to drive adoption of LinearDNA as an alternative to plasmids for nucleic acid-based therapies. Following constructive interactions with the U.S. Food and Drug Administration (FDA) as part of a preliminary Emergency Use Authorization application process and the evolving nature of the pandemic, we revised our Linea SARS-CoV-2 Mutation (the "Linea Mutation Panel") (formerly SGS Mutation Panel) to target three SARS-CoV-2 mutations (E48K, L452R, N501Y) that have been designated substitutions (mutations) of therapeutic concern by the Centers for Disease Control and Prevention.

"Should the FDA grant an EUA for the Linea Mutation Panel, we believe that it will offer clinical utility to healthcare systems by enabling precision COVID-19 treatment and commercial utility to monoclonal antibody manufacturers by better characterizing patients before treatments. In recent months, several monoclonal antibody treatments have had their EUA revoked or have demonstrated a reduction in efficacy on a standalone or in combination with other treatments due to mutational impact. Use of the Linea Mutation Panel is tied to our Linea COVID-19 Assay Kit to determine positivity in clinical samples that would drive additional Assay demand if the EUA is granted for our Mutation Panel. We believe that an EUA-authorized Linea Mutation Panel will also provide additional value to our existing COVID-19 testing customers and, when combined with our Whole Genome Sequencing assets, provide data of interest to epidemiologists.

"Concurrently, the launch of our veterinary LinearDNA COVID-19 vaccine trial and the subsequently reported strong immune response that the vaccine candidate elicited, further reinforce the value proposition of LinearDNA, and, longer-term, generates invaluable preclinical data supporting the eventual application of LinearDNA to nucleic acid-based therapies in humans."

Concluded Dr. Hayward, "Looking ahead, the confluence of increasing positivity rates due to the Delta variant, the commingling of vaccinated, partially vaccinated, and unvaccinated individuals, and new mandatory testing requirements for local and state-level employees in our operating area affirm the need for ongoing and consistent COVID-19 screening available through safeCircle. Subject to FDA’s evolving EUA request review priorities, we expect to file shortly our formal request for EUA for our Linea Mutation Panel. In addition, in the coming weeks we intend to launch our COVID-19 veterinary vaccine candidate challenge trial in furtherance of a commercial animal health opportunity.

"Regarding our supply chain security business, we have cautious optimism within the cotton supply chains we serve as we approach the start of the cotton ginning season in the U.S. However, with Asia-Pacific beset by the Delta variant, man-made fiber opportunities remain static. With the tailwind of COVID-19 testing at our back supplemented by continued execution on business development initiatives, we believe we are laying the foundation for sustainable growth."

Fiscal Third Quarter 2021 Financial Highlights:

Revenues increased 294% for the third quarter of fiscal 2021 to $1.7 million, compared with $432 thousand reported in the same period of the prior fiscal year and decreased 36% from $2.7 million for the second quarter of fiscal 2021. The increase in revenues year over year was due primarily to an increase in service revenues of approximately $686 thousand and an increase of $583 thousand in product revenues. The increase in service revenue was primarily from revenues derived from our safeCircle COVID-19 surveillance testing. The increase in product revenue was mainly attributable to an increase in sales of our Linea COVID-19 Assay Kit. The decrease in revenues compared to the second quarter of fiscal 2021 was due to a decline in our safeCircle COVID-19 surveillance testing.
Total operating expenses increased to $4.5 million for the third fiscal quarter of 2021, compared with $3.5 million in the prior fiscal year’s third quarter and decreased from $4.6 million for the second quarter of fiscal 2021. The year-over-year increase is primarily attributable to an increase in total payroll of $535 thousand, of which $325 thousand was for staffing of Applied DNA Clinical Labs, LLC (ADCL). The increase in operating expenses was also the result of an increase of $148 thousand for supplies and equipment to operate the ADCL laboratory. The increase also relates to increases in research and development expenses of $215 thousand and depreciation and amortization of $186 thousand.
Net loss applicable to common stockholders for the quarter ended June 30, 2021, was $3.5 million, or $0.46 per share, compared with a net loss of $3.3 million, or $0.72 per share, for the quarter ended June 30, 2020.
Excluding non-cash expenses, Adjusted EBITDA was negative $2.8 million for both the quarters ended June 30, 2021, and 2020. See below for information regarding non-GAAP measures.
Cash and cash equivalents stood at $12.2 million on June 30, 2021, compared to $7.8 million as of September 30, 2020.
Nine-Month Financial Highlights:

Revenues increased 270% for the first nine-months of fiscal 2021 to $6.0 million, compared with $1.6 million reported in the same period of the prior fiscal year. The increase in revenues year over year was due primarily to an increase in service revenues of approximately $2.7 million and an increase of $1.7 million in product revenues. The increase in service revenue was primarily from revenues derived from our safeCircle COVID-19 surveillance testing. The increase in product revenue was mainly attributable to an increase in sales of our Linea Assay Kit.
Total operating expenses increased to $13.5 million for the first nine-months of fiscal 2021, compared with $9.5 million in the same period of the prior fiscal year. This increase is primarily attributable to an increase in payroll of $790 thousand relating to additional headcount to staff at ADCL. The increase in operating expenses also related to an increase in stock-based compensation expense of $834 thousand primarily relating to officer stock option grants that vested immediately. The increase also relates to increases in research and development expenses of $570 thousand and depreciation and amortization of $341 thousand.
Net loss applicable to common stockholders for the nine-months ended June 30, 2021, was $9.8 million, or $1.45 per share, compared with a net loss of $8.9 million, or $2.54 per share, for the first six months of fiscal 2020.
Excluding non-cash expenses, Adjusted EBITDA was negative $6.7 million for the first nine months of fiscal 2021, compared to negative $7.8 million for the same period in the prior fiscal year. See below for information regarding non-GAAP measures.
Fiscal Third Quarter 2021 Conference Call Information

The Company will hold a conference call and webcast to discuss its fiscal third quarter-end 2021 results on Thursday, August 12, 2021, at 4:30 PM ET. To participate on the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, not all questions may be answered.

To Participate:

Participant Toll Free:1-844-887-9402
Participant Toll: 1-412-317-6798
Please ask to be joined to the Applied DNA Sciences call
Live webcast: View Source

Telephonic replay (available 1 hour following the conclusion of the live call through August 19, 2021):

Participant Toll Free: 1-877-344-7529
Participant Toll: 1-412-317-0088
Participant Passcode: 10158254
The webcast and accompanying PowerPoint presentation will be archived on the ‘IR Calendar and Corporate Presentations’ page listed under the Investor Relations drop-down menu on the Company’s website.

About safeCircle

ADCL’s high throughput pooled testing program, known as safeCircle, utilizes frequent, high-sensitivity pooled testing to help prevent virus spread by quickly identifying infections within a community, school, or workplace. safeCircle provides rapid results using real-time PCR (RT-PCR) testing.

Click through to learn more about how safeCircle can help your community, school, and workplace: safeCircle

About Linea COVID-19 Assay Kit and Linea SARS-CoV-2 Mutation Panel

The Linea COVID-19 Assay Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens including anterior nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider (HCP). The test is also intended for use with anterior nasal swab specimens that are self-collected in the presence of an HCP from individuals without symptoms or other reasons to suspect COVID-19 when tested at least weekly and with no more than 168 hours between serially collected specimens.

The scope of the Linea COVID-19 Assay Kit EUA, as amended, is expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated or until the EUA’s prior termination or revocation. The diagnostic kit has not been FDA cleared or approved, and the EUA’s limited authorization is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

The Linea SARS-CoV-2 Mutation Panel (formally SGS Mutation Panel) (the "Linea Mutation Panel") is for Research Use Only (RUO) and shall not be used for clinical diagnostic purposes. The Linea Mutation Panel has not been approved or authorized to diagnose, ameliorate and/or detect any disease by any U.S. or international regulatory authority.

On August 12, 2021 ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF) ("ProMIS or the Company"), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported its operational and financial results for the three and six months ended June 30, 2021 (Press release, ProMIS Neurosciences, AUG 12, 2021, View Source [SID1234586457]).

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ProMIS Neurosciences is applying its patented technology platform to build a portfolio of antibody therapies, therapeutic vaccines, and diagnostics in neurodegenerative diseases, including Alzheimer’s disease (AD) and other dementias, Parkinson’s Disease (PD), and amyotrophic lateral sclerosis (ALS).

These diseases share a common biologic cause – misfolded versions of proteins, that otherwise perform a normal function, kill neurons and produce disease.

ProMIS’ technology platform is an example of the advances in drug discovery enabled by computational power, in silico discovery, and/or artificial intelligence. This platform provides an advantage in either selectively targeting the toxic misfolded proteins with therapeutics or detecting them with diagnostics. This capability has given ProMIS a growing portfolio of potential "best in class" monoclonal antibodies (or corresponding therapeutic vaccines), including our lead program PMN310, targeting toxic oligomers of amyloid in AD.

Corporate Highlights

On May 21, 2021, we re-initiated the path to Investigational New Drug application for PMN310 in AD with the start of producer cell line development. This key first step in the manufacturing of antibody therapeutics is being carried out by Selexis, SA, using Selexis’ proprietary SUREtechnology Platform.
On June 3, 2021, the Company announced that it had filed a preliminary Prospectus with the securities regulators in each of the provinces and territories of Canada, except Quebec. The Prospectus will allow the Company to make offerings of common shares, warrants, units, debt securities, subscription receipts, convertible securities or any combination thereof for up to an aggregate total of US$50 million during the 25-month period that the Prospectus is effective.
On July 8, 2021, the Company announced that it had filed, and obtained a receipt for the Prospectus with the securities regulators in each of the provinces and territories of Canada, except Quebec.
On July 2, 2021, the Company announced the voting results of the Company’s annual meeting of shareholders held on June 30, 2021, in Vancouver, British Columbia, Canada. All resolutions described in the Management Proxy Circular and placed before the meeting were approved by the shareholders.
People

On May 12, 2021, Dr. Rudolph Tanzi, Ph.D., was appointed as the Chair of the Company’s Scientific Advisory Board. Dr. Tanzi is the Joseph P. and Rose F. Kennedy Professor of Neurology at Harvard University and Vice-Chair of Neurology, Director of the Genetics and Aging Research Unit, and Co-Director of the Henry and Allison McCance Center for Brain Health at Massachusetts General Hospital.
On May 13, 2021, we appointed Neil K. Warma, to the Company’s Board of Directors. Neil Warma has been a healthcare entrepreneur for over 25 years having managed and advised numerous biotechnology and pharmaceutical companies.
On May 25, 2021, the Company appointed Owen Dempsey to lead the commercialization program for its COVID-19 serology assay.
On May 27, 2021, Dr. David Wishart, Distinguished University Professor in the Departments of Biological Sciences and Computing Science at the University of Alberta, was appointed as Chief Physics Officer at ProMIS.
Financial Results

Results of Operations – Three months ended June 30, 2021 and 2020

Net Loss for the three months ended June 30, 2021 were $297,346 compared to $1,650,218 for the three months ended June 30, 2020. Included in the net loss amount for the three months ended June 30, 2021, was non-cash expenses/(income) of ($1,049,745) representing the change in the fair value of the embedded derivative of ($1,245,388), share-based compensation of $180,392, amortization of property and equipment and an intangible asset of $12,252 compared to $76,310 for the three months ended June 30, 2020, consisting of share-based compensation of $74,642 and amortization of an intangible asset of $1,668.

Operating loss for the three months ended June 30, 2021 was $1,378,603, as compared to $1,650,218 in the three months ended June 30, 2020. The decrease in the operating loss for the three months ended June 30, 2021, reflects decreased contracted salaries and associated costs of $350,622 due to reduction in compensation to management and attrition of contract staff, decreased investor relations of $203,971 due to scale down of investor relations activities and consultants and foreign exchange gains of $233,874 due to the foreign exchange on US denominated assets and liabilities offset by increased costs associated with external contract research organizations for internal programs of $172,518 as the company restarts the internal programs, share-based compensation of $105,749 due to the grant of share options, increased patent expense of $40,162 due to increased maintenance fees, increased legal expense of $45,752, increased consulting expense of $137,522, increase in amortization of property and equipment and intangible asset of $13,584 and decreased revenue of $1,565.

Research and development expenses for the three months ended June 30, 2021 were $1,065,197, as compared to $898,887 in the three months ended June 30, 2020. The increase in research and development expense for the three months ended June 30, 2021, compared to the same period ended June 30, 2020, is primarily attributed to increased costs associated with external contract research organizations for internal programs of $172,518 as the company restarts the internal programs, increased share-based compensation of $28,579 due to the grant of share options, increased patent expense of $40,162 due to increased maintenance fees ,increased outside consultants of $137,706 and increase in amortization of property and equipment and intangible asset of $13,584 offset by decreased contracted research salaries and associated costs of $226,238 due to reduction in compensation to management and attrition of contract staff.

General and administrative expenses for the three months ended June 30, 2021 were $313,406, as compared to $752,896 in the three months ended June 30, 2020. The decrease for the three months ended June 30, 2021, compared to the same period in 2020, is primarily attributable to a reduction in contracted corporate salaries and associated costs of $124,383 due to reduction in compensation to management and attrition of contracted staff, decreased investor relations of $203,971 due to scale down of investor relations activities and consultants and foreign exchange gains of $233,874 due to the foreign exchange on US denominated assets and liabilities offset by share-based compensation of $77,171 due to the grant of share options, and increased legal expense of $45,752.

Results of Operations – Six months ended June 30, 2021 and 2020

Net loss for the six months ended June 30, 2021 were $7,896,763 compared to $3,412,137 for the six months ended June 30, 2020. Included in the net loss amount for the six months ended June 30, 2021, was non-cash expense $5,909,542, representing the change in the fair value of the embedded derivative of $5,766,915, share-based compensation of $112,123, amortization of property and equipment and an intangible asset of $30,504 for the six months ended June 30, 2021, compared to $290,048 for the six months ended June 30, 2020, consisting of share-based compensation of $286,712 and amortization of an intangible asset of $3,336.

Operating loss for the six months ended June 30, 2021 was $1,960,934, as compared to $3,412,137 in the six months ended June 30, 2020. The decrease in the operating loss for the six months ended June 30, 2021, reflects decreased contract salaries and associated costs of $924,565 due to reduction in compensation to management and attrition of contracted staff, decreased investor relations of $380,959 due to scale down of investor relation activities and consultants, decreased share-based compensation of $174,589 due to forfeiture of unvested/vested share options due to termination of consulting arrangement and foreign exchange gains of $293,012 due to the foreign exchange on US denominated offset by increased costs associated with external contract research organizations for internal programs of $88,673 as the company restarts the internal programs, increased patent expense of $3,617 due to increased maintenance fees, increased legal expense of $99,572, increased consulting expense of $101,315, increase in amortization of property and equipment and intangible asset of $27,168 and decreased revenue of $1,578.

Research and development expenses for the six months ended June 30, 2021 were $1,259,120, as compared to $1,872,473 in the six months ended June 30, 2020. The decrease in research and development expense for the six months ended June 30, 2021, compared to the same period ended June 30, 2020, reflects the conservation of cash resources and decreased contract salaries and associated costs of $673,785 due to reduction in compensation to management and attrition of contracted staff and decreased share-based compensation of $145,459 due to forfeiture of unvested/vested share options due to termination of consulting arrangement offset by increased costs associated with external contract research organizations for internal programs of $88,673 as the company restarts the internal programs, increased patent expense of $3,617 due to increased maintenance fees, increased consulting expense of $86,435 and increase in amortization of property and equipment and intangible asset of $27,168.

General and administrative expenses for the six months ended June 30, 2021 were $701,814, as compared to $1,541,242 in the six months ended June 30, 2020. The decrease for the six months ended June 30, 2021, compared to the same period in 2020, is primarily attributable to a reduction in contract salaries and associated costs of $250,780 due to reduction in compensation to management and attrition of contracted staff, decreased investor relations of $380,959 due to scale down of investor relation activities and consultants, decreased share-based compensation of $29,129 due to forfeiture of unvested/vested share options due to termination of consulting arrangement and foreign exchange gains of $293,012 due to the foreign exchange on US-denominated offset by the increased legal expense of $99,572 and increased consulting expense of $14,880.

Outlook

Going forward ProMIS will focus on accelerating or re-initiating programs in our core business area, best-in-class therapeutics for neurodegenerative diseases. In addition, we will continue to expand the application of our unique discovery platform, with which we can "rationally design" antibodies or vaccines to be selective for only mis-folded, pathogenic proteins involved in disease.

In Alzheimer’s we will restart IND enabling work for PMN310, our antibody highly selective for toxic oligomers of amyloid. That selectivity may prove to give PMN310 significant competitive advantages in safety and efficacy over products from Biogen, Lilly, and Eisai that appear to provide benefit slowing the progression of Alzheimer’s disease. In addition, starting with the same proprietary technology that creates selective antibodies ("passive" immunotherapy), we are moving forward our program to create therapeutic vaccines ("active" immunotherapy) targeting toxic oligomers of amyloid. Therapeutic vaccines may be a preferred therapy for Alzheimer’s prevention; the ultimate goal in Alzheimer’s treatment is to detect disease in the ~20 year window before symptoms arise and treat to prevent symptoms of cognitive decline.

In ALS we will advance our program targeting toxic TDP-43 with further in vitro and in vivo validation, and we will build on the significant scientific advances we have made targeting RACK1 (Receptor for A Activated C Kinase 1). We will also further advance our alpha-synuclein program with further in vivo and in vitro validation, targeting diseases like Parkinson’s disease and Multiple System Atrophy.

On August 12, 2021 PharmaCyte Biotech, Inc. (NASDAQ: PMCB) (PharmaCyte or Company), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported the closing of its previously announced underwritten public offering of approximately $15 million (Press release, PharmaCyte Biotech, AUG 12, 2021, View Source [SID1234586474]).

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The public offering includes 3,529,412 shares of the Company’s common stock (or pre-funded warrants to purchase common stock in lieu of common stock) and warrants to purchase up to an aggregate of 3,529,412 shares of common stock. In addition, PharmaCyte granted the underwriter a 30-day option to purchase up to an additional 529,411 shares of its common stock and/or accompanying warrants to purchase an aggregate of up to 529,411 shares of its common stock, which the underwriter has partially exercised for warrants to purchase an aggregate of up to 499,116 shares of common stock. At closing, PharmaCyte received net proceeds from the offering of approximately $13.6 million, after deducting underwriting discounts and commissions and estimated offering expenses. All of the securities in the offering were sold by PharmaCyte.

H.C. Wainwright acted as sole book-running manager for the offering.

The offering was made only by means of a written prospectus and related prospectus supplement forming part of PharmaCyte’s shelf registration statement on Form S-3 (File No. 333-255044) that was previously filed with and subsequently declared effective by the U.S. Securities and Exchange Commission (SEC) on April 14, 2021. The final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting H.C. Wainwright & Co., LLC, at 430 Park Ave., New York, New York 10022, by telephone at (212) 856-5711, or by email at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On August 12, 2021 Century Therapeutics, (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, reported financial results and business highlights for the second quarter ended June 30, 2021 (Press release, Century Therapeutics, AUG 12, 2021, View Source [SID1234586513]).

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"With the proceeds raised from our IPO in June, we are well positioned to advance our lead candidate CNTY-101 toward clinical development, targeting IND filing in mid-2022," said Lalo Flores, Chief Executive Officer, Century Therapeutics. "We continue our investment in our iPSC platforms and are pleased with the progress achieved in developing iPSC-derived cell product candidates for the treatment of cancers with high unmet clinical need. We look forward to providing scientific updates on our programs and platform in the second half of 2021."

Recent Highlights

Raised $221 million in public offering of common stock: In June 2021, the company announced a public offering of 10,550,000 shares of its common stock at a price of $20 per share. The underwriters also exercised their option to purchase an additional 1,582,500 shares of common stock for total offering net proceeds of $221 million.
Expanded our Board of Directors: The Company appointed pharmaceutical industry veterans Alessandro Riva, M.D. and Kimberly Blackwell, M.D., as new Independent Directors.
Continued manufacturing and technical operations investment: Our US manufacturing facility is expected to be operational by end of 2021.
Second Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $440.0 million as of June 30, 2021, as compared to $246.1 million as of March 31, 2021. This includes $221.2 million in net proceeds from the company’s public offering in June 2021.

Research and Development (R&D) expenses: R&D expenses were $18.9 million for the three months ended June 30, 2021, compared to $8.5 million for the same period in 2020.

General and Administrative (G&A) expenses: G&A expenses were $4.1 million for the three months ended June 30, 2021, compared to $2.3 million for the same period in 2020.
Net loss: Net loss was $23.3 million for the three months ended June 30, 2021, compared to $15.3 million for the same period in 2020.

On August 12, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that the company has executed an exclusive license agreement with Mayo Clinic for a novel technology that may be able to transform the administration of chimeric antigen receptor engineered T cell ("CAR T") therapies and potentially be used as an off-the-shelf therapy.

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The technology, developed by Larry R. Pease, Ph.D., principal investigator and former director of the Center for Immunology and Immune Therapies at Mayo Clinic, is a new platform to administer CAR T therapy using a two-step approach. First, a peptide is administered to the patient to drive the proliferation of the patient’s resident T cells. This is followed by the administration of a viral CAR construct directly into the lymph nodes of the patient. In turn, the viral construct infects the activated T cells and effectively forms CAR T cells in vivo in the patient. Successful implementation may lead to an off-the-shelf product with no need to isolate and expand patient T cells ex vivo.

"We are excited by the possibilities that this novel technology has to offer given our ongoing development of CAR T cell therapies in hematologic and solid tumor cancers," said Manuel Litchman, M.D., President and Chief Executive Officer of Mustang. "The potential use of this technology to facilitate how these treatments are delivered to patients can lead to earlier treatment post diagnosis, and using an off-the-shelf therapy may reduce the cost of care, all of which would help bring more innovative treatments to a broader base of patients in need."

Preclinical proof-of-concept has been established and the ongoing development of this technology will take place at Mayo Clinic.

"The immune cells are activated in vivo using the natural methods employed by the body to deal with infection rather than the artificial activation used to manufacture traditional CAR T cells ex vivo," said Dr. Pease. "This could potentially reduce the substantial toxicities that are characteristic of traditional CAR T therapy."

Mustang plans to file an Investigational New Drug ("IND") application for a multicenter Phase 1 clinical trial once a lead construct has been identified.

Mayo Clinic and Dr. Pease have financial interest in the technology referenced in this announcement. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.