On October 9, 2018 Immune Pharmaceuticals, Inc. (OTCQB: IMNP) ("Immune" or the "Company"), a biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases, reported that it has entered into a Securities Purchase Agreement with an institutional investor pursuant to which it has sold $5.5 million in principal amount of Senior Secured Redeemable Convertible Debentures (the "Debentures") for $2 million in cash, and a $3 million promissory note to be funded upon the earlier of the effectiveness of a registration statement covering the resale of the shares issuable or conversion of the Debentures (Press release, Immune Pharmaceuticals, OCT 9, 2018, View Source [SID1234530276]).

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Tony Fiorino MD, PhD, Immune’s interim Chief Executive Officer, said "This financing gives us the means to continue the recent forward momentum we have achieved with bertilimumab, with the goal of building what we believe will be substantial additional value. We expect the proceeds from this transaction to fund our operations into the second quarter of 2019. Over that time, we expect to achieve previously disclosed milestones that include the release of additional results from the BP-01 study, obtaining important regulatory feedback, advancing our new manufacturing process and unblinding the ulcerative colitis study, which has now completed recruiting subjects."

Dr. Fiorino went on to say, "I accepted the role of interim Chief Executive Officer because I believe that bertilimumab is a strategically attractive asset, and this funding provides us with runway to pursue that option. Given the challenging financing environment faced by the company, we have decided to accelerate our plan to seek a development partner for bertilimumab. We will initiate the bertilimumab partnering process this quarter, rather than waiting to complete these important milestones prior to formally launching a process."

The Debentures bear compounded interest at a rate of 10% per annum, subject to adjustment as specified in the Debentures, and mature five years from the issuance date. The debt is convertible into shares of Immune common stock at a conversion price of $0.075 per share, subject to certain adjustments in the event of future financings. The Company also issued to the investor 50 million three-year warrants exercisable at $0.10 per share, also subject to adjustment in the event of future financings. The Debentures are secured by the Company’s assets, other than those associated with Ceplene (histamine dihydrochloride).

The Company does not currently have sufficient common shares authorized if the Debentures are converted in full and the Warrants are exercised, and plans to call a special meeting of stockholders within 90 days to obtain approval for an increase in the authorized common stock to enable us to satisfy those obligations.

In connection with this financing, the holders of the Company’s Original Issue Discount Convertible Debentures agreed to waive the outstanding event of default resulting from the suspension of the trading of the Company’s common stock on the Nasdaq Capital Market (other than the required increase in the principal amount of the OID Debentures) and to amend the OID Debentures to enable the Company to consummate the financing, in exchange for an aggregate amendment fee of $49,220.

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

On October 9, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, reported the closing of the first $8 million tranche of its $15 million investment from Alpha Holdings, Inc. (KOSDAQ: 117670) (Press release, OncoSec Medical, OCT 9, 2018, View Source [SID1234529816]). This value-focused, fundamental strategic investment is centered on the clinical development of OncoSec’s lead immunotherapy product candidate, TAVO (tavokinogene telseplasmid). TAVO enables the intratumoral delivery of DNA-based interleukin-12 (IL-12), a naturally occurring protein with powerful immune-stimulating functions.

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Alpha Holdings is a leading Korean technology company engaged in the design, development, service and manufacture of system semiconductors, as well as the development of biotechnologies and thermal compound materials. Since 2002, Alpha Holdings has successfully carried out many projects as a major partner of Samsung Advanced Foundry Eco-system (SAFE) of Samsung Electronics. Alpha Holdings, a listed company in the KOSDAQ Market, was founded in 2002 and is headquartered in Seongnam, South Korea.

Under the terms of the agreement, Alpha Holdings has committed to purchase a total of $15 million worth of shares of common stock from OncoSec in two tranches at $1.50 per share. The two tranches are each subject to a six-month holding requirement from date of funding. As stated above, Alpha has funded the first tranche of $8 million. The closing of the second tranche is subject to the satisfaction of certain closing conditions. Further details of the transaction can be found in the Form 8-K filed by the Company describing the agreement.

On October 9, 2018 Veracyte, Inc. (Nasdaq: VCYT) reported that new interim data from a three-year, "real world," prospective clinical utility study show that use of the Percepta Bronchial Genomic Classifier to evaluate patients with potentially cancerous lung nodules reduced invasive procedures during 12 months of patient follow-up (Press release, Veracyte, OCT 9, 2018, View Source [SID1234530238]). The early findings were presented in an oral session at CHEST 2018, the annual meeting of the American College of Chest Physicians, being held October 6-10 in San Antonio, Texas.

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The ongoing 40-site registry trial aims to measure the impact of the Percepta test on lung nodule management in "real world" clinical practice and to monitor clinical outcomes of patients managed with the test. Reviewing results from the first 258 evaluable patients, researchers found that patients who had a negative Percepta result following an inconclusive bronchoscopy had lower rates of subsequent invasive procedures at all evaluation time points (immediately post-test, 3 months, 6 months and 12 months), compared to physicians’ plans for these patients prior to Percepta testing. At 12 months of follow-up, researchers observed a 20 percent relative reduction in invasive procedures as compared to physicians’ initial plans.

The findings also showed that Percepta classifier results changed how physicians managed patients with lung nodules. The researchers found that patients with negative Percepta test results were significantly less likely to undergo invasive procedures at all time points over the 12-month post-test period, as compared to patients with positive genomic test results.

"Physicians often use bronchoscopy to evaluate potentially cancerous lung nodules, but the results from this procedure are often inconclusive, which can lead to unnecessary, invasive follow-up procedures for a diagnosis," said Giulia C. Kennedy, Ph.D., chief scientific and medical officer at Veracyte. "These early data show that use of the Percepta test following an inconclusive bronchoscopy result can reduce the number of unnecessary procedures and that this trend is durable over 12 months of follow-up."

The Percepta classifier uses proprietary "field of injury"-based technology to detect genomic changes associated with lung cancer in the main lung airway of current and former smokers. Percepta detects these genomic changes to determine the likelihood that a nodule is cancerous without the need to sample the nodule directly. Clinical validation data published in The New England Journal of Medicine demonstrated the Percepta test’s high accuracy in identifying patients at low risk of lung cancer (negative predictive value of 91 percent), suggesting that these patients may safely avoid further invasive procedures.

"These new data reinforce the value that the Percepta classifier brings to lung cancer diagnosis by reducing, over the long term, the number of invasive procedures among patients being evaluated for suspicious lung nodules," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "We believe these findings support physicians’ use of the Percepta classifier as a complement to diagnostic bronchoscopy and look forward to sharing future findings from our ongoing registry trial."

The Percepta multicenter registry study has enrolled over 655 patients who were former or current smokers without prior active cancer and who were deemed eligible for bronchoscopy following identification of a pulmonary lesion on CT scan. Physicians captured a bronchial brushing at the time of the bronchoscopy to enable genomic diagnostic evaluation by the Percepta classifier if the bronchoscopy result was inconclusive.

Lung cancer is the leading cause of cancer-related deaths in the United States, killing over 154,000 Americans each year, according to the American Cancer Society. Early detection and diagnosis can significantly improve survival, but currently very few lung cancer cases (just 16 percent) are diagnosed at an early stage when the disease is most treatable. The identification of a lung nodule or lesion on a CT scan – either through screening or incidentally – is often the first sign that an individual may have lung cancer. Determining whether lung nodules or lesions identified on CT scans – either through screening or incidentally – are cancerous is often difficult, which can lead to patients undergoing invasive, risky and expensive procedures that are frequently unnecessary.

About Percepta

The Percepta Bronchial Genomic Classifier uses advanced genomic and machine learning technology to improve lung cancer diagnosis for patients while reducing the need for invasive procedures. The classifier is run when bronchoscopy results are inconclusive, and helps physicians determine which patients are at low or very low risk for cancer and may therefore be monitored with CT scans instead of undergoing further, invasive diagnostic procedures. The Percepta classifier uses proprietary "field of injury"-based technology to detect molecular changes in the main lung airway of current or former smokers. Percepta detects these genomic changes to determine the likelihood that a nodule is cancerous without the need to sample the nodule directly. The classifier’s performance has been validated in multiple, rigorous clinical studies, including clinical validation data published in The New England Journal of Medicine.

On October 9, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that it intends to offer, subject to market and other conditions, $150 million aggregate principal amount of convertible senior notes due 2025 (the "Notes") in a private offering to qualified institutional buyers in reliance on Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Karyopharm, OCT 9, 2018, View Source [SID1234530277]). Karyopharm also expects to grant to the initial purchasers of the Notes a 13-day option to purchase up to an additional $22.5 million aggregate principal amount of the Notes.

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The Notes will be unsecured, senior obligations of Karyopharm and will bear interest payable semi-annually in arrears on April 15 and October 15 of each year, beginning on April 15, 2019. The Notes will mature on October 15, 2025, unless earlier repurchased, redeemed or converted in accordance with their terms. Subject to certain conditions, on or after October 15, 2022, Karyopharm may redeem for cash all or a portion of the Notes. The Notes will be convertible at the option of holders of the Notes, upon satisfaction of certain conditions and during certain periods, into cash, shares of Karyopharm’s common stock, or a combination of cash and shares of Karyopharm’s common stock, at Karyopharm’s option. The interest rate, conversion rate, conversion price and certain other terms of the Notes will be determined at the time of pricing of the offering.

Karyopharm intends to use the net proceeds from the sale of the Notes: to continue establishing the infrastructure to support the potential commercial launch of selinexor; to support continued clinical development of selinexor in hematologic malignancies and solid tumors; to conduct ongoing activities to support regulatory submissions for oral selinexor as a new treatment for patients with penta-refractory multiple myeloma and, if the results of Karyopharm’s SADAL trial are positive, as a new treatment for patients with relapsed/refractory diffuse large B-cell lymphoma; for clinical trials of two of Karyopharm’s pipeline drug candidates in oncology, eltanexor and KPT-9274; and for working capital and other general corporate purposes.

The Notes will be offered and sold to qualified institutional buyers pursuant to Rule 144A under the Securities Act. The offer and sale of the Notes and the shares of common stock issuable upon conversion of the Notes, if any, have not been and will not be registered under the Securities Act or the securities laws of any other jurisdiction, and the Notes and any such shares may not be offered or sold in the United States absent registration or an applicable exemption from such registration requirements. Any offer of the Notes will be made only by means of a private offering memorandum.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the Notes or any other securities, nor shall there be any offer, solicitation or sale of the Notes or any other securities (including the shares of Karyopharm’s common stock issuable upon conversion of the Notes, if any) in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful.

On October 9, 2018 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that its PCT patent application covering a targeted therapy to treat solid cancerous tumors was published on September 27, 2018 (Publication No. WO 2018/175576) (Press release, PharmaCyte Biotech, OCT 9, 2018, View Source [SID1234529817]). It was titled "Encapsulated Cells Producing Cytochrome P450 and Methods of Use Thereof." This PCT application allows PharmaCyte to file patent applications and seek protection in most major market countries throughout the world. These patent applications, if granted, will provide protection for PharmaCyte’s technology for 20 years without a gap in patent protection – until March 2038.

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Kenneth L. Waggoner, PharmaCyte Biotech’s Chief Executive Officer, commented "The publication of this PCT patent application is a significant step in being able to protect our unique cancer therapy for many years to come. It is particularly important now as we get closer to beginning our clinical trial in patients with locally advanced pancreatic cancer (LAPC). However, in addition to pancreatic cancer, the Cell-in-a-Box live cell encapsulation technology also gives us opportunities to develop unique therapies for other forms of cancer where new treatment modalities are needed."

The PCT application also specifically includes methods of treating other cancerous tumors, such as those of the liver, breast and colon, using the live-cell encapsulation of genetically modified human cells that overexpress a form of the cytochrome P450 enzyme system normally found in the liver. These cells are encapsulated using the proprietary Cell-in-a-Box technology. Together with low doses of a drug of the oxazaphosphorine class, ifosfamide, the encapsulated cells comprise PharmaCyte’s therapy for pancreatic cancer. The patent application also includes using PharmaCyte’s platform technology with cyclophosphamide, another chemotherapy drug of the oxazaphosphorine class that is activated by the cytochrome P450 enzyme system. In the case of pancreatic cancer, it is hoped that the Cell-in-a-Box plus low dose ifosfamide combination will be beneficial to patients whose pancreatic tumors become resistant to standard chemotherapies such as the combination of the anticancer drugs gemcitabine and Abraxane or FOLFIRINOX. The use of Cell-in-a-Box encapsulation with other drugs against other forms of cancer remains to be investigated.

The PCT patent application originated from a provisional patent application by the same title that was filed with the U.S. Patent and Trademark Office (USPTO) on March 21, 2017 and a patent application by the same title that was filed with the USPTO on March 21, 2018.