On June 30, 2022 X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a leader in the discovery and development of novel CXCR4-targeted small molecule therapeutics to benefit people with rare immune system disorders, reported that it has agreed to sell an aggregate of 50,925,365 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase an aggregate of 50,925,365 shares of common stock, to certain institutional accredited investors in a private investment in public equity (PIPE) financing (Press release, X4 Pharmaceuticals, JUN 30, 2022, View Source [SID1234616452]). X4 anticipates that gross proceeds from the PIPE will be approximately $55 million, before deducting fees to the placement agent and other estimated offering expenses payable by the Company. The closing of the financing is expected to occur on or about July 6, 2022, subject to customary closing conditions.

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In addition, on June 30, 2022, contemporaneous with the execution of the PIPE, X4 entered into an amendment to its loan and security agreement with Hercules Capital Inc. to extend the interest-only period of its loan facility by up to twelve months (into 2024), subject to achieving certain financial and business milestones. This amendment results in a potential reduction of X4’s cash burn by $20 million over the interest-only period.

Pursuant to the terms of the securities purchase agreement, at the closing of the PIPE, X4 will issue an aggregate of 50,925,365 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase an aggregate of 50,925,365 shares of common stock. The purchase price per share and accompanying warrant is $1.095 (or $1.094 per pre-funded warrant and accompanying warrant). The warrants will have a per share exercise price of $1.095 and may be exercised at any time on or after the closing date and through the fifth anniversary of the closing date. The price per share and accompanying warrant was based in part upon the last reported sale price of the common stock on the Nasdaq Capital Market. If exercised for cash, the warrants would result in additional gross proceeds to X4 of up to approximately $55 million.

X4 expects to use these funds for continued clinical development and commercial readiness of its lead candidate, mavorixafor, and for business development activities, working capital, and general corporate purposes.

The PIPE financing included participation from new investors including co-lead investor New Enterprise Associates (NEA), Acorn Bioventures and Lumira Ventures, as well as existing investors including co-lead investor Bain Capital Life Sciences, OrbiMed, AXA Investment Managers and Hercules Capital, Inc (NYSE: HTGC). Stifel served as sole placement agent for the financing. B. Riley Securities and H.C. Wainwright & Co. acted as financial advisors to X4 in the financing.

The securities sold in this financing are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended, and 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. X4 has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock and the shares of its common stock underlying the pre-funded warrants and accompanying warrants sold in this financing. In connection with the PIPE, the Company has agreed to convene a special meeting of its stockholders no later than 90 days
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following the closing to seek approval of an increase in the number of its authorized shares of common stock.

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 June 30, 2022 Provectus (OTCQB: PVCT) reported that updated data from the Company’s initial expansion cohort of patients with uveal melanoma metastatic to the liver (mUM) in its cancers-of-the-liver Phase 1 trial of investigational immunocatalyst PV-10 (NCT00986661) were part of two oral presentations at the 20th Congress of the International Society of Ocular Oncology (ISOO), held June 17-21, 2022 in Leiden, The Netherlands (Press release, Provectus Biopharmaceuticals, JUN 30, 2022, View Source [SID1234616443]).

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The first presentation, given by Krysta McVay, Research Nurse, Department of Melanoma Medical Oncology, Division of Cancer Medicine at MD Anderson Cancer Center (MDACC), was entitled "A phase 1 study of percutaneous autolytic rose bengal disodium for metastatic uveal melanoma patients with hepatic metastases." A copy of her presentation is available on Provectus’ website at: View Source

Sapna Patel, MD, Associate Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine and Director of the Uveal Melanoma Program at MDACC and Chair, Melanoma Committee, SWOG Cancer Research Network, made the second presentation entitled "Metabolic complete responses (mCR) in metastatic uveal melanoma (mUM) patients treated with image-guided injection of PV-10." A copy of her presentation is available on the Company’s website at: View Source

This ongoing single-center mUM study at MDACC has been led since inception by Dr. Patel. Up to three hepatic mUM tumors can be injected per PV-10 treatment cycle. Response assessments are performed at Day 28, and then every three months. Patients with additional, injectable, visceral hepatic mUM disease may receive additional cycles of PV-10 after Day 28. Eligible patients may also receive standard of care immune checkpoint blockade during and after PV-10 treatment.

On June 30, 2022 (the "Effective Date"), Geron Corporation (the "Company") reported that it entered into a second amendment (the "second amendment") to the Loan and Security Agreement dated September 30, 2020, as amended (the "Loan Agreement") with Hercules Capital, Inc., as administrative agent and collateral agent (in such capacity, the "Agent") and a lender, and Silicon Valley Bank, as a lender (collectively with Hercules Capital, Inc., the "Lenders") (Filing, 8-K, Geron, JUN 30, 2022, View Source [SID1234616426]). Under the second amendment, the aggregate principal amount available to the Company increased from $75 million to $125 million (the "Term Loan"), with such principal being available in a series of tranches, subject to certain terms and conditions. As of June 30, 2022, the total outstanding principal amount under the Loan Agreement is $50 million.

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The tranches for the remaining $75 million of the Term Loan (the "Remaining Tranches") available to the Company are as follows: a) the first remaining tranche of $20 million (the "First Tranche") is available within 30 days of the achievement of certain clinical and financial milestones until September 15, 2023, subject to the achievement of such milestones; b) the second remaining tranche of $10 million is available from January 1, 2023 until December 15, 2023, subject to the achievement of certain clinical and regulatory milestones, and satisfaction of certain other requirements; c) the third remaining tranche of $20 million is available from September 15, 2023 until September 15, 2024, subject to the achievement of certain clinical and regulatory milestones, and satisfaction of certain capitalization requirements; and d) the final tranche of $25 million is available through December 31, 2024, subject to the Lenders’ approval. With the exception of the final tranche, and subject to achievement of the applicable milestones and other requirements with respect to each tranche, utilization of the Remaining Tranches under the Term Loan is at the Company’s election.

Under the second amendment, the Company is required to pay 1.0% facility charge for each of the remaining tranches that is drawn down by the Company after the Effective Date, including 0.5% of facility charge with respect to the First Tranche paid at the Effective Date. If the Company chooses to prepay the principal with respect to any Remaining Tranche drawn down after the Effective Date, any such prepayment within the first 36 months after the Effective Date will be subject to a prepayment charge equal to 1.5% of the principal amount prepaid. No prepayment charge will be assessed for any prepayment occurring more than 36 months after the Effective Date.

The maturity date, interest only payment dates, end of term charges, collateral, events of default, representations, warranties and covenants remain consistent with the terms of the original Loan Agreement, except as follows:

●Beginning June 1, 2022 and prior to the potential achievement by the Company of regulatory approval for imetelstat (the "potential Regulatory Approval"), if any, the Company is required to maintain a minimum cash balance in an amount equal to the greater of: 50% of the outstanding principal amount under the Loan Agreement or $30 million.

●After the potential Regulatory Approval, if any, the minimum cash requirement may be satisfied through one of the following three options, as elected by the Company: a) maintaining a cash balance in an amount not less than 40% of the outstanding principal amount under the Loan Agreement; b) maintaining a cash balance in an amount not less than 25% of the outstanding principal amount under the Loan Agreement, if the Company’s market cap is or exceeds $750 million; or c) maintaining six month net product revenues of at least 70% of net product revenues forecasted by the Company, should any potential Regulatory Approval for imetelstat be obtained.

The descriptions of the second amendment to the Loan Agreement contained herein do not purport to be complete and are qualified in their entirety by reference to the complete text of the second amendment to the Loan Agreement, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending June 30, 2022.

On June 30, 2022 Nanostics Inc., a precision health diagnostics company, reported that positive data from a pre-biopsy clinical validation study of its ClarityDX Prostate test designed to improve the accuracy of detecting clinically significant prostate cancer in men that are at risk of the disease (Press release, Nanostics, JUN 30, 2022, View Source [SID1234616423]).

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The ClarityDX Prostate test uses a proprietary machine-learning algorithm that combines data from two biological biomarkers and three clinical biomarkers to generate a risk score for clinically significant prostate cancer. The ClarityDX Prostate test is intended to be used as a reflex test for men with elevated levels of PSA, the current prostate cancer screening test, and is designed to help physicians and patients make a more informed decision to proceed with biopsy or not.

"We are extremely excited to announce positive results from the clinical validation study of the ClarityDX Prostate test in Alberta", John Lewis, CEO of Nanostics said, "Implementing ClarityDX Prostate as a reflex test for men with elevated PSA levels will improve decision-making for men and their families, while providing substantial savings for healthcare systems and resulting in better health outcomes for men with prostate cancer."

A total of 1,437 men between 40-75 years of age, with elevated PSA levels, no prior prostate cancer diagnosis, and who were referred for prostate biopsy, were recruited for this clinical study. Algorithmic risk models to predict prostate cancer or clinically significant (grade group ≥2) prostate cancer were generated using data from 1036 men recruited at the Kipnes Urology Center in Edmonton, AB, and a site in Baltimore, USA. These models were then tested in a validation cohort of 401 men recruited at the Prostate Cancer Center in Calgary, AB.

The ClarityDX Prostate test provided 94% sensitivity, 37% specificity, 49% positive predictive value, and 90% negative predictive value for predicting clinically significant (grade group ≥2) prostate cancer. The potential impact of the ClarityDX Prostate test is considerable; implementation could eliminate up to 37% of unnecessary biopsies and significantly reduce the number of unnecessary treatments for prostate cancer. The results from the study are being submitted for peer-reviewed publication. Beyond the immediate cost savings to the healthcare system, the launch of the ClarityDX Prostate test will positively impact the overall healthcare experience and quality of life for men with prostate cancer.

The study was conducted in partnership with DynaLIFE Medical Labs and the Alberta Prostate Cancer Research Initiative (APCaRI) at the University of Alberta. Funding for the clinical study comes in part from The Bird Dogs, Motorcycle Ride for Dad, Alberta Cancer Foundation, Alberta Innovates, the University Hospital Foundation Kaye Fund, and the Frank and Carla Sojonky Chair in Prostate Cancer Research funded by the Alberta Cancer Foundation, held by Dr. John Lewis from 2012 to 2022.

On June 30, 2022 Inceptor Bio, a biotechnology company advancing cell therapies for difficult-to-treat cancers, reported a collaboration with University of Minnesota (Press release, Inceptor Bio, JUN 30, 2022, View Source [SID1234616422]). The aim of this collaboration is to build a novel induced pluripotent stem cells (iPSC) platform that will accelerate Inceptor Bio’s best-in-class next-generation cell therapies platforms. Under the terms of the agreement, Inceptor Bio will receive an exclusive license to the technology developed under this collaboration.

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Inceptor Bio plans to advance multiple cell therapy products into clinical studies incorporating the iPSC platform into its proprietary K62 platform for CAR-M therapy, which increases the phagocytic capabilities of macrophages and supports an M1 anti-tumor phenotype, as well as its novel co-stimulatory domain, M83, for CAR-NK therapies.

"iPSC-derived cell therapies have the potential to enable the next frontier of cell therapies. We are excited to work with Dr. Beau Webber at University of Minnesota and his team to develop this unique platform," said Mike Nicholson, Ph.D., President and Chief Operating Officer at Inceptor Bio.

"The team at University of Minnesota is confident that Inceptor Bio is the right partner for building a differentiated iPSC platform to advance novel cell therapies," said Beau Webber, Ph.D., Assistant Professor in the Department of Pediatrics, Division of Hematology and Oncology. "We are deeply encouraged by Inceptor Bio’s progress in the cell therapy arena, and we look forward to being part of future developments to help cure difficult-to-treat cancers."

"This partnership is an important step in continuing to execute on our strategy of advancing cell therapies to bring a more positive prognosis and quality of life to patients with difficult-to-treat cancers," said Abe Maingi, Vice President, Business Development at Inceptor Bio. "We are thrilled to be able to develop and deliver on the promise of iPSC-derived cell therapies."