On April 16, 2020 Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, reported that it has entered into definitive agreements with several institutional and accredited investors for the purchase and sale of 4,787,553 shares of the Company’s common stock, at a purchase price of $1.671 per share, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Pulmatrix, APR 16, 2020, View Source [SID1234556389]). Pulmatrix has also agreed to issue to the investors unregistered warrants to purchase up to an aggregate of 4,787,553 shares of common stock. The closing of the offering is expected to occur on or about April 20, 2020, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants have an exercise price of $1.55 per share of common stock, will be exercisable immediately following the date of issuance and will expire two (2) years following the date of issuance.

The gross proceeds to Pulmatrix from this offering are expected to be approximately $8.0 million, before deducting the placement agent’s fees and other offering expenses. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) are being offered by Pulmatrix pursuant to a "shelf" registration statement on Form S-3 (File No. 333-230225) previously filed with the Securities and Exchange Commission (the "SEC") on March 12, 2019 and declared effective by the SEC on March 15, 2019. The offering of the securities will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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 April 16, 2020 Beijing Mabworks Biotech reported that it raised $160 million in a Series C1/C2 funding to support its biologic drug development efforts (Press release, Mabworks Biotech, APR 16, 2020, View Source [SID1234556410]). Founded in 2011, Mabworks has more than 15 candidates being tested in China and US trials targeting diseases that include lung, breast and colorectal cancers, leukemia and infectious diseases. The company has partnered with InnoCare Pharma to develop a novel therapy for B-cell lymphoma, and it also collaborates with China’s Betta Pharma, an oncology company. The funding was led by CICC Qide Innovative Biopharma Equity Investment Fund, CITIC Securities, Lyzz Capital and Huge Capital.

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On April 16, 2020 Elicio Therapeutics, a next generation immuno-oncology company, reported that it has established a collaboration with the National Cancer Institute (NCI) to characterize T cell responses to ELI-002 in animals (Press release, Elicio Therapeutics, APR 16, 2020, View Source [SID1234556374]). The collaboration will be led by Dr. James Yang, Senior Investigator, Surgery Branch, Center for Cancer Research, NCI.

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Elicio has demonstrated in multiple tumor models that improving the targeting of immunogens and cell-therapy activators to lymph nodes, where resident immune cells potently orchestrate immunity, can substantially amplify their ability to induce effective tumor-killing immune responses. ELI-002 is an "AMP KRAS-vaccine" containing seven Amphiphile mKRAS peptides and a proprietary Amphiphile adjuvant, administered subcutaneously.

KRAS mutations are present in 90% of pancreatic cancers, 40% of colorectal cancers, 30% of non-small cell lung, 30% of bile duct, 14% of endometrial, and 14% of ovarian cancers. ELI-002has completed preclinical validation, IND-enabling GLP toxicology studies, and a pre-IND meeting with the FDA. P1/2 trials will be multi-site, starting with an open label dose escalation, progression to expansion cohorts in KRAS mutated solid tumors, and seamlessly progressing into a randomized, controlled cohort.

"This research investigates the mechanism of action of ELI-002 in mice that have key human HLA genes important for immune response," said Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer. "Dr. Yang is a pioneer of T cell therapy for solid tumors, and we are excited to collaborate in the study, which may help monitor patient responses in the planned clinical study of ELI-002, and would set the stage for clinical trials combining ELI-002 with KRAS targeting T cells."

The Elicio Amphiphile platform enables precise targeting and delivery of immunogens and cell-therapy activators directly to the lymphatic system, the "brain center" of the immune response, to significantly amplify and enhance the body’s own system of defenses, defeat solid and hematologic cancers, and prevent their recurrence. Elicio’s ELI-002 targets seven position 12 and 13 KRAS mutations, present in approximately 25% of all human solid tumors. ELI-002 has the potential to become a multi-targeted mKRAS therapy with the ability to treat and prevent disease recurrence for hundreds of thousands of patients with mKRAS-driven cancers, including pancreatic, colorectal, lung, bile duct, endometrial, and ovarian.

About the Amphiphile Platform

The Elicio Amphiphile platform enables precise targeting and delivery of immunogens and cell-therapy activators directly to the lymphatic system, the "brain center" of the immune response, to significantly amplify and enhance the body’s own system of defenses, defeat solid and hematologic cancers, and prevent their recurrence. Once in the lymph nodes, Amphiphile immunotherapies are taken up by antigen presenting cells (APC’s) to orchestrate signaling to natural or engineered immune cells in order to maximize therapeutic immune responses to disease. This strategy has been used to improve the activity of immunostimulatory agents, antigens, adjuvants, and cell-therapies that generate little to no response when used in the conventional forms. By precisely targeting these immunotherapies to the lymph nodes, Amphiphiles can unlock their full potential to generate and amplify anti-tumor immune responses. This substantially enhanced anti-tumor functionality and long-term protective memory may someday unlock the full potential of the immune response to eliminate cancer.

On April 16, 2020 CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, reported that 2020 first quarter financial results will be released on Thursday, April 30, 2020 after the market closes (Press release, CryoLife, APR 16, 2020, View Source [SID1234556390]). On that day, the Company will hold a teleconference call and live webcast at 4:30 p.m. ET to discuss the results, followed by a question and answer session hosted by Pat Mackin, Chairman, President and Chief Executive Officer of CryoLife, Inc.

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To listen to the live teleconference, please dial 201-689-8261 a few minutes prior to 4:30 p.m. ET. A replay of the teleconference will be available April 30 through May 7, 2020 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415. The conference number for the replay is 13702193.

The live webcast and replay can be accessed in the Investor Relations section of the CryoLife website at www.cryolife.com and selecting Webcasts & Presentations. In addition, a copy of the earnings press release, which will contain financial and statistical information for the completed quarter and full year, can be accessed in the Investor Relations section of the CryoLife website.

On April 16, 2020 Cofactor Genomics reported the peer-reviewed publication of an analytical validation study demonstrating the performance of its novel RNA-based immune profiling assay, ImmunoPrism, in the April 2020 issue of the Journal of Molecular Diagnostics (Press release, Cofactor Genomics, APR 16, 2020, View Source [SID1234556375]). The paper is the first public disclosure of the company’s proprietary methods used for quantifying immune cells in the tumor microenvironment (TME).

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Accurate quantification of immune cells from small amounts of tumor tissue has become increasingly important as the role of the immune system in cancer is illuminated. The number of clinical trials under the umbrella of immune-oncology has exploded since 2014, with more than five times the number of trials now starting each year worldwide, and a total of more than 1,000 trials underway in 2018 alone, according to Kantar Health. Cofactor’s technology affords a number of advantages over other approaches, using less tissue and achieving higher sensitivity and specificity in detecting even difficult-to-quantify cell types, such as M2 macrophages.

Technical validation of the ImmunoPrism assay represents a key step in Cofactor’s efforts towards developing predictive diagnostics. The ImmunoPrism platform is the underlying technology used in recently presented data that showed improved performance over the on-label PD-L1 immunohistochemistry (IHC) assay in predicting response to anti-PD-1 therapy in recurrent and metastatic squamous cell carcinoma of the head and neck (RM-SCCHN).

"Analytical validation is a requirement for any assay to be used in routine clinical care or in clinical trials leading up to routine clinical care," stated Andrew Aijian, Partner at DeciBio, a strategy consulting and market research firm focused on precision medicine. "A robust assay that has already been rigorously validated significantly lowers the barriers to adoption and makes sophisticated biomarkers, such as immune gene expression models, more broadly accessible."

The analytical validation study utilized a series of increasingly more complex control mixtures to demonstrate performance of Cofactor’s RNA models, starting first with known cell mixtures from purified peripheral blood mononuclear cells (PBMCs), then adding interfering substances such as non-immune cells, genomic DNA, and ribosomal RNA. Importantly, the study also leveraged viable dissociated tumor tissue for orthogonal validation compared to the gold standard, flow cytometry, which showed immune cell models in the assay maintain their performance in the tumor microenvironment. Finally, formalin-fixed and paraffin embedded (FFPE) tissue, which represents the most common clinical sample format, was used for orthogonal comparison to immunohistochemistry (IHC). In the publication, metrics including limit of detection, reportable range, and intra- and inter-operator reproducibility were reported for the assay.

"The results of this validation study demonstrate that our expectations of improved performance for multidimensional RNA models over single-analyte approaches are not hypothetical – they are real and quantifiable," stated Jon Armstrong, Cofactor Genomics Chief Scientific Officer and one of the first authors on the paper. "ImmunoPrism represents the ability to bring the positive attributes of flow cytometry to commonly available FFPE materials."

The ImmunoPrism assay may be ordered through Cofactor’s CAP/CLIA accredited laboratory. It is also available as a reagent kit and cloud-based informatics that may be validated in any laboratory with Illumina sequencing capabilities.