On August 12, 2021 Brooklyn ImmunoTherapeutics, Inc. (NYSE American: BTX) ("Brooklyn"), a biopharmaceutical company focused on exploring the role that gene editing/cell and cytokine therapy can have in treating patients with cancer, blood disorders, and monogenic diseases, reported financial results for the quarter ended June 30, 2021 (Press release, Brooklyn ImmunoTherapeutics, AUG 12, 2021, View Source [SID1234591393]).

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Financial and corporate highlights for the quarter ended June 30, 2021 and subsequently include the following:

Completed the acquisition of Novellus Therapeutics Limited ("Novellus") in July 2021. Novellus is developing next‑generation engineered mesenchymal stem cell ("MSC") therapies using patented mRNA-based cell reprogramming and gene editing technologies licensed from Factor Bioscience ("Factor").

Raised nearly $51 million through equity line sales of common stock for general corporate purposes, including working capital to be used to enhance the development of the mRNA gene editing and cell therapies technology recently licensed from Factor.

Appointed Jay Sial as chief administrative officer and Kevin D’Amour, Ph.D. as chief scientific officer.

Established a research and development center in Cambridge, Massachusetts, to pursue its mRNA-based gene editing and cellular therapies, co-locating with Factor.

Howard Federoff, M.D., Ph.D., Brooklyn’s President and Chief Executive Officer, commented, "The second quarter advanced the evolution of Brooklyn ImmunoTherapeutics from being a cytokine-focused immunotherapeutics company to a platform company with a pipeline of next-generation engineered cellular, gene editing and cytokine products. This was in no small measure due to the acquisition of Novellus, which enables us to utilize the full range of the MSCs they have developed with no restriction on fields of use. By combining these with our licensed mRNA-based cell reprogramming and gene editing technology from Factor Bioscience, we believe we can create a platform technology that will lead to a family of product candidates in varying stages of development from target selection to research and preclinical, including one in the respiratory area that is in the IND-enabling stage."

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"Further, we believe we are positioned to develop a variety of gene-modified products using this platform, which ultimately could help solve problems of treating certain conditions that to date have confounded science, including potential treatments for a set of solid tumors, autoimmune disorders where inflammation is a prominent feature, and addressing multiple issues in the liver, the brain and the eye, as well as applying that technology again to iPSCs for a multitude of applications," continued Dr. Federoff.

"The quarter also resulted in creating a strong balance sheet and a growing in-licensed intellectual property portfolio," said Dr. Federoff. "Following the Novellus acquisition, we had approximately $25 million of cash on hand, which we estimate will fund our operations and expansion through the end of 2023," Dr. Federoff continued. "We are awaiting the readout of our Phase 2b trial for neoadjuvant head and neck cancer with our original asset, IRX-2 human-derived cytokines, during the first half of 2022. Additionally, we have multiple investigator-driven trials in a number of additional cancer types, and additional planned studies in 2022 and 2023."

"We have made a considerable investment in ensuring that we have the right people in place, and with the addition of our new chief scientific officer Dr. Kevin D’Amour and new chief administrative officer Jay Sial. Now it’s time for us to begin to execute on these ambitious plans that this next-generation version of Brooklyn ImmunoTherapeutics promises," concluded Dr. Federoff.

Financial Results for Quarter Ended June 30, 2021

Operating expenses for the quarter ended June 30, 2021 were $10.1 million, as compared to operating expenses for the quarter ended June 30, 2020 of $2.0 million.

Research and development expenses increased to $5.4 million for the quarter ended June 30, 2021 compared to $1.0 million in the quarter ended June 30, 2020. Research and development expenses increased due to upfront payments associated with licensed technology, increased clinical trial expenses, and stock-based compensation for the issuance of equity awards. Brooklyn expects research and development expenses to continue to grow as it expands its clinical trial activities.

General and administrative expenses increased to $4.6 million in the second quarter of 2021 compared to $1.0 million during the same period in 2020. The quarter-over-quarter increase in general and administrative expense was primarily related to increased legal, accounting and consulting fees associated with merger and acquisition activity, costs associated with being a publicly traded company, and increased stock-based compensation resulting from the issuance of equity awards. Brooklyn expects general and administrative expenses to continue to increase in future periods as it increases its business activities and incurs costs associated with being a publicly traded company.

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Net loss for the quarter ended June 30, 2021 was $(27.8) million, as compared to $(3.1) million for the quarter ended June 30, 2020.

As of June 30, 2021, Brooklyn ImmunoTherapeutics had $50.2 million in cash, of which approximately $23.0 million was paid as partial consideration for the acquisition of Novellus on July 16, 2021.

On August 12, 2021 A Buffalo-based biotechnology company reported that it has received a $2.2 million federal grant to begin clinical trials on a treatment for brain cancer using light therapy (Press release, Photolitec, AUG 12, 2021, View Source [SID1234587063]).

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Photolitec LLC, which spun off from Roswell Park Comprehensive Cancer Center in 2010, received the three-year grant from the National Institutes for Health through the Small Business Innovation Research (SBIR) program, along with approvals from the Food & Drug Administration to begin phase one human trials.

The trials will allow the company to use its Photobac compound in combination with photodynamic therapy (PDT) to treat glioblastoma, a type of brain cancer.

This next step in the drug development process follows orphan drug status approval for Photobac by the FDA in late 2017; and an initial SBIR grant of $1.9 million awarded earlier that year.

Ravindra Pandey, founder and chief scientific officer, is director of pharmaceutical chemistry at Roswell Park and first developed the compounds there in his lab. They were later licensed back to the company and have been further developed in collaboration with global partners AMI-Organics in India and HISUN Pharma in China.

With no approved treatments yet for these types of brain tumors and the recurrence rates, the orphan drug status will definitely help speed up the process, Pandey said. The process helps surgeons be more precise in attacking tumors with better specificity, he said.

"No treatment works except PDT and this compound can treat tumors not only with the margins that you want, but deep-seated tumors. So the chances are we’ll have a much better response," he said.

Scott Friedman, general counsel at Photolitec and chairman at Lippes Mathias Wexler Friedman LLP, said though the process is taking longer than initially projected, the company is making great progress.

"Ravi is continuing to make great progress," he said. "There are hoops that early-stage companies without necessarily hundreds of millions or billions of dollars are being asked to jump through, so it’s a challenging environment to succeed in and it does occasionally take more time than might be expected. But I believe great companies figure out how to move forward."

Though PDT is not new, Photolitec’s approach applies light to a photosensitizer, which destroys tumor cells when combined with the oxygen present in the cancer. The company’s Photobac allows for deeper penetration into the tumor, which also limits the impact on surrounding tissue and reduces long-term skin phototoxicity.

Plans call for submitting clinical protocols to Roswell Park’s review board for approval, with a goal of beginning trials soon thereafter. Pandey is hopeful that process will be hastened with the FDA approval already in hand.

"Generally what happens is we send it for IRB first and then FDA but in this case it was the other way around," he said. "We hope that will make it faster. We already have the drug formulations and we’re all ready to go."

Pandey said the new funding from NIH, plus a score of "outstanding" on the research by peer reviewers also helps boost the chances the drug will attract lots of attention from big pharma when it comes time to manufacture and market Photobac. Whether investors will keep manufacturing here in Western New York is another question.

"We’re waiting on phase one data first, and that could take a couple of years," he said.

Pfizer has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On August 12, 2021 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, reported that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its clinical trial evaluating eprenetapopt with acalabrutinib or with venetoclax and rituximab in lymphoid malignancies (Press release, Aprea, AUG 12, 2021, View Source [SID1234586583]). No additional patients can be enrolled until the clinical hold is resolved, though patients on study deriving clinical benefit can continue to receive study treatment.

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Subsequent to receiving notification of a partial clinical hold on its myeloid malignancies program, Aprea was informed by FDA of a clinical hold on its lymphoid malignancy study. The FDA’s concerns referred to the safety and efficacy data from the Phase 3 MDS clinical trial. One CLL patient is currently on study treatment receiving eprenetapopt in combination with venetoclax and rituximab and has achieved complete remission (CR). Aprea intends to work closely with the FDA to address the specific questions raised, and seek to resolve the clinical hold as soon as possible.

On August 12, 2021 Labcorp (NYSE: LH), a leading global life sciences company, reported that it has acquired Ovia Health, a digital health platform used by millions of women seeking information and support with family planning, pregnancy and parenting (Press release, LabCorp, AUG 12, 2021, View Source [SID1234586581]).

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The transaction extends Labcorp’s position as a leading, go-to source for women’s health insights, opens new avenues for personalized care experiences and fosters better dialogue between health care providers and their patients.

"Patients, doctors and health systems are increasingly using digital health solutions to inform health care and treatment options," said Dr. Brian Caveney, chief medical officer and president, Labcorp Diagnostics. "We’re excited to expand our leadership in women’s health solutions by bringing Ovia Health’s trusted health content and easy-to-use digital platforms to our patients and customers. We welcome Ovia Health’s innovative and dedicated team to Labcorp and look forward to bringing the combination of our strengths in women’s health to our customers."

Labcorp, through its wide-ranging specialty testing services and deep diagnostics and genetics expertise, is a leader in women’s health. The company supports OB-GYNs and primary care doctors by providing essential testing, screening, educational support and clinical trial options for women including expectant mothers. This creates a better understanding of a patient’s health and potential risks and enables that patient to become more engaged in her wellbeing and pregnancy.

"Joining Labcorp enables us to broaden our impact and improve every woman’s opportunity to have a healthy pregnancy and access necessary care and resources," said Paris Wallace, Ovia Health’s CEO and co-founder. "Our combined capability will enable us to significantly expand our reach, enrich our content and explore new methods of promoting a holistic approach to improving women’s health. We’re particularly excited about developing new products and services with Labcorp that fulfill the unmet needs of individuals with reproductive health conditions."

The acquisition marks Labcorp’s continued investment in its women’s health capabilities and represents the next step in a collaborative relationship developed during the past year. The two companies began exploring ways of leveraging their shared commitment to improving patient outcomes following a strategic investment from Labcorp’s Venture Fund in August 2020. Labcorp and Ovia Health are uniquely positioned to harness the power of science and data, positioning Labcorp as the preeminent choice for providers and health plans looking to enhance their patients’ experience.

Ovia Health, one of the first "femtech" companies, has supported more than 15 million family journeys through its suite of interactive, experience-focused platforms. The company has about $20 million in annual revenues and maintains key partnerships with leading universities and research groups, generating a wealth of personal health data and patient insights. Additionally, Ovia Health furnishes numerous employers and health plans with valuable clinical, health and wellness programs to enhance their existing offerings.

Kilpatrick Townsend & Stockton LLP served as legal advisor to Labcorp. Raymond James & Associates, Inc. served as exclusive financial advisor and Foley Hoag LLP served as legal advisor to Ovia Health.

Specific terms of the transaction were not disclosed.