On September 6, 2022 bioAffinity Technologies, Inc. ("bioAffinity" or the "Company") (NASDAQ: BIAF, BIAFW), a cancer diagnostics company that develops noninvasive, early-stage diagnostics to detect cancer and diseases of the lung and is researching targeted therapies to treat cancer, reported it has completed its previously announced initial public offering ("IPO") of 1,282,600 units, each consisting of one share of common stock, one tradeable warrant to purchase one share of common stock at an exercise price of $7.35 per share, and one non-tradeable warrant to purchase one share of common stock at an exercise price of $7.656 per share, for aggregate gross proceeds of approximately $7.8 million, prior to deducting underwriting discounts, commissions, and other offering expenses (Press release, BioAffinity Technologies, SEP 6, 2022, View Source [SID1234619090]). In addition, bioAffinity has granted the underwriters a 45-day option to purchase up to 192,390 shares of common stock, and/or 192,390 tradeable warrants, and/or 192,390 non-tradeable warrants, or any combination of additional shares of common stock and warrants representing, in the aggregate, up to 15% of the number of the units sold in this offering to cover over-allotments in this offering.

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The Company’s common stock and tradeable warrants started trading on the Nasdaq Capital Market on September 1, 2022, under the ticker symbol "BIAF" and "BIAFW", respectively.

WallachBeth Capital, LLC and Craft Capital Management, LLC are co-managers and co-book running managers for the offering.

The Company intends to use the proceeds from the offering to expand existing operations and the commercialization of CyPath Lung. Proceeds may also be used in the Company’s pursuit of regulatory approvals and research and development of additional diagnostics, cancer therapeutics, and for working capital and general corporate purposes.

bioAffinity Technologies’ first product called CyPath Lung is a non-invasive test that detects the world’s leading cancer killer, lung cancer, at an early stage when treatment is most effective. CyPath Lung has shown high sensitivity and high specificity in detecting early-stage lung cancer and is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Services in San Antonio, Texas.

bioAffinity Technologies Chief Executive Officer Maria Zannes said, "We are pleased to have concluded the IPO process and are excited about opportunities that this funding and a presence on NASDAQ will bring. bioAffinity has the utmost confidence in the success of its business. The hard-working scientists and other professionals at bioAffinity are committed to bringing to market products that give people longer, healthier lives by the early detection of cancer and other lung diseases and by advancing therapeutic discoveries that treat cancer at the cellular level."

A registration statement on Form S-1, as amended (File No. 333- 264463) was filed with the Securities and Exchange Commission ("SEC") and was declared effective on August 29, 2022. A final prospectus relating to the offering was filed with the SEC and is available on the SEC’s website at View Source Electronic copies of the final prospectus relating to this offering may be obtained from WallachBeth Capital, LLC, Attention: Capital Markets, 185 Hudson Street, Jersey City, NJ 07311, by telephone at 646-998-7608, or by email at [email protected].

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

About CyPath Lung

CyPath Lung is a noninvasive test for the early detection of lung cancer which uses flow cytometry to count and characterize cells in a person’s sputum, or phlegm. The test’s automated analysis of the flow cytometry data detects cell populations that indicate cancer is present. CyPath Lung has the potential to increase overall diagnostic accuracy of lung cancer diagnosis leading to increased survival while lowering the number of unnecessary invasive procedures, reducing patient anxiety, and lowering medical costs. CyPath Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Services.

On September 6, 2022 NaNotics LLC, a biopharmaceutical company developing NaNots, novel subtractive nanoparticles that treat disease by capturing and clearing pathogenic molecules from blood, reported a research collaboration with Mass General Cancer Center, a program of Massachusetts General Hospital (MGH) in Boston, to develop NaNots that target the soluble forms of Tumor Necrosis Factor Receptors, which are tumor-generated immune inhibitors, with the goal of initiating human trials by mid-2024 (Press release, NaNotics, SEP 6, 2022, View Source [SID1234619088]).

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Tumor necrosis factor-alpha (TNF-α) is an essential immune signaling molecule which, as the name implies, is toxic to cancer and other abnormal cells. Immune cells kill bad cells by delivering TNF-α to TNF receptors on the target cell membrane, inducing apoptosis (cell death). However, most if not all malignant tumors inhibit TNF-α by cleaving off the extracellular domains of their TNF receptors, producing a soluble receptor form called "sTNF-Rs". sTNF-Rs neutralize TNF-α molecules secreted by immune cells, preventing them from inducing apoptosis in cancer cells, thereby enabling immune evasion. This bioanimation by the Company illustrates the process.

sTNF-Rs have been undruggable targets. Functional membrane TNF receptors (mTNF-Rs) are essential for a broad range of normal immune functions. A drug that neutralizes sTNF-Rs would also block mTNF-Rs, given that the binding sites of both forms are identical. Instead, NaNots deplete soluble targets – in this case sTNF-Rs – without blocking membrane forms of the same target – in this case mTNF-Rs. NaNots represent a novel form of immunotherapy, targeting an important new immunosuppressive pathway. NaNots have been tested for safety in rodents at up to 100x the planned human dose, with no observed toxicity.

The MGCC team is led by Keith Flaherty, M.D., Director of Clinical Research and a Professor of Medicine at Harvard Medical School. Dr. Flaherty is also a co-founder of multiple cancer therapeutics companies, including Loxo Oncology. Dr. Flaherty’s team includes Justin Gainor, MD, Director of Targeted Immunotherapy at MGCC.

"Despite the profound benefits of PD-1/PD-L1 antibody-based immunotherapy for approximately 10% of cancer patients, it is clear that we have not yet overcome the primary basis for immune evasion in the vast majority of cancer patients," said Dr. Flaherty. "TNF-α has been on the very short list of desired mechanisms to leverage for decades, but has been largely forgotten because there has been no feasible way of selectively delivering TNF-α to tumor cells. The NaNotics approach overcomes this barrier by depleting the molecules that tumor cells produce and shed in order to intercept TNF-α produced by immune cells."

"NaNotics is delighted to be collaborating with the Mass General Cancer Center in the study of NaNots against sTNF-Rs," said Lou Hawthorne, CEO of NaNotics and the inventor of NaNots. "We’re especially excited to be working with Dr. Flaherty – a brilliant scientist and clinician with a record of innovation and success – and his colleagues at MGCC, including Dr. Gainor, an expert in immunotherapy. They bring deep scientific insight and a wealth of clinical trial experience to our collaboration, enabling translation of the NaNot platform from novel science into therapeutics of potential benefit to millions of patients suffering deadly cancers."

As part of the collaboration, NaNotics will produce pre-clinical and then clinical NaNots against sTNF-Rs. MGCC will provide patient samples for preclinical validation of NaNots, following which the teams will work together on clinical trial design, leading to a study of NaNots against sTNF-Rs in cancer patients, centered at MGCC in 2024.

On September 6, 2022 Nucleai, a leader in AI-powered spatial biology transforming precision medicine by unlocking the power of pathology data, reported new data showing that the deep learning capabilities of the Nucleai platform accurately analyzed and classified the spatial arrangement of immune cells in the tumor microenvironment (TME) to identify metastatic non-small cell lung cancer (mNSCLC) patients who are likely to benefit from pembrolizumab, an immune checkpoint inhibitor (ICI) therapy (Press release, Nucleai, SEP 6, 2022, View Source [SID1234619087]). This work is part of several ongoing studies examining the spatial arrangement of immune cells in the TME and the significance of this research is its potential to identify new predictive spatial immune signatures in a large-scale, multi-site patient dataset.

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Nucleai will present the new data in a poster presentation at ESMO (Free ESMO Whitepaper) Congress 2022 in Paris on Monday, September 12.

Lung cancer is among the leading causes of cancer death for men and women worldwide, as well as the second most commonly diagnosed cancer. NSCLC is the most common type of lung cancer in the United States, accounting for 82% of all lung cancer diagnoses, according to the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).

While ICI is the standard treatment for mNSCLC, only a small proportion of patients derive durable clinical benefit. PD-L1 has been shown to be limited as a predictive indicator. However, spatial arrangements of immune cells in the TME have emerged as a potential biomarker for ICI efficacy. The new data from Nucleai’s spatial biology-centric study of lung cancer patients directly addresses the medical community’s need for better predictive biomarkers for improving clinical decision-making. Nucleai teamed up with the Hospital of the University of Pennsylvania, Thomas Jefferson University Hospital, Sheba Medical Center and Rabin Medical Center for the study.

"Identifying NSCLC patients who are exceptionally sensitive to immune checkpoint inhibitor therapy as monotherapy may improve clinical decision making," said Ori Zelichov, MD, VP of Clinical Development at Nucleai. "The results of our NSCLC study can help pharma companies select patients for clinical trials based on the likelihood of response to an ICI therapy and support physicians in planning the optimal treatment for their patients."

Overview of the Study

Nucleai evaluated this predictive role by utilizing deep learning models to extract TME features from digitalized H&E whole slide images. mNSCLC patients treated with first line single-agent pembrolizumab in four medical centers in Israel and the US were identified. Patients were randomly assigned into training and test sets.

Pre-treatment H&E WSI were analyzed using a deep learning model to identify and classify tumor, immune and fibroblast cells as well as tumor, necrotic and stromal areas and dozens of spatial features were calculated per patient. Baseline patient characteristics and PD-L1 scores were similar between the positive and negative groups. Details will be shown at the medical oncology-focused ESMO (Free ESMO Whitepaper) conference.

Poster Presentation

Nucleai will present the scientific poster on Monday, September 12 during the NSCLC session at the ESMO (Free ESMO Whitepaper) Congress in France. The poster number is 1068P.

On September 6, 2022 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a leading late-stage, clinical biotechnology company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders with high unmet need, reported that Gaurav Shah, M.D., Chief Executive Officer, will participate in a fireside chat at the Morgan Stanley 20th Annual Global Healthcare Conference on Monday, Sept. 13, at 3:30 p.m. ET (Press release, Rocket Pharmaceuticals, SEP 6, 2022, View Source [SID1234619086]).

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A live audio webcast of the presentation will be available under "Events" in the Investors section of the Company’s website at View Source The webcast replay will be available on the Company’s website following the conference.

On September 6, 2022 ADC Therapeutics SA (NYSE: ADCT) reported that Ameet Mallik, Chief Executive Officer, will participate in a fireside chat at Morgan Stanley’s 20th Annual Global Healthcare Conference on Tuesday, September 13th at 11:45 a.m. ET (Press release, ADC Therapeutics, SEP 6, 2022, View Source [SID1234619085]).

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A live webcast of the presentation will be available via the Events & Presentations page in the Investors section of ADC Therapeutics’ website, ir.adctherapeutics.com. A replay of the webcast will be available for approximately 30 days.