On April 21, 2020 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported the pricing of a public offering with expected total gross proceeds of approximately $20 million, before deducting placement agent fees and other offering expenses payable by the Company (Press release, Cyclacel, APR 21, 2020, View Source [SID1234556584]).

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Roth Capital Partners is acting as the lead placement agent for the offering. Ladenburg Thalmann and Brookline Capital Markets, a division of Arcadia Securities, LLC are acting as co-placement agents for the offering.

The securities offered by the Company consist of (i) 4,000,000 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and (ii) common warrants to purchase up to 4,000,000 shares of common stock. Each share of common stock and, as applicable, each pre-funded warrant, is being sold together with a common warrant to purchase one share of common stock at a combined effective price to the public of $5.00 per share and accompanying common warrant, and/or $4.999 per pre-funded warrant and accompanying common warrant. For each pre-funded warrant the Company sells, the number of shares of common stock the Company is offering will be decreased on a one-for-one basis. The common warrants will be immediately exercisable at a price of $5.00 per share of common stock and will expire five years from the date of issuance. The shares of common stock and/or the pre-funded warrants, and the accompanying common warrants, can only be purchased together in the offering but will be issued separately and will be immediately separable upon issuance. The offering is expected to close on April 23, 2020, subject to customary closing conditions.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission (the "SEC") and was declared effective on April 20, 2020. A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. Copies of the final prospectus relating to this offering may be obtained, when available, by contacting Roth Capital Partners, LLC, Attention: Equity Capital Markets, 888 San Clemente Drive, Suite 400, Newport Beach, California 92660, by telephone at (800) 678-9147 or e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy 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.

On April 21, 2020 Nymox Pharmaceutical Corporation (NASDAQ: NYMX) reported the recent allowances of 4 new different US and international patents concerning the Company’s prostate enlargement and prostate cancer treatments (Press release, Nymox, APR 21, 2020, View Source [SID1234556462]). The new US and international patents that have been allowed are further expansions of Nymox’s intellectual property covering the Company’s prostate treatment technologies.

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Nymox CEO, Dr Paul Averback stated, "Intellectual property is one of the backbones of the biopharmaceutical industry. We are therefore very pleased to report that another 4 patents have recently been allowed. During the past year a total of 10 new patents have been allowed which adds to the Company’s very strong intellectual property position for the future. Nymox continues with intensive work to maximize our IP portfolio for the long-term value and strength of the Company’s proprietary foundations."

Dr. Averback added, "Operationally at the present time, our employees are doing very well and are following the prescribed guidelines in their area, including working remotely, where necessary. On a different note, we are also extremely pleased with the reactions and feedback we are receiving from multiple sources with regard to the recent (Feb 2020) peer review journal article in the World Journal of Urology (View Source) documenting the very promising clinical results of Fexapotide Triflutate in treating men with early prostate cancer. We look forward to advancing this program into pivotal registrational trials."

The recent peer review publication is entitled "Prospective Evaluation of Fexapotide Triflutate Injection Treatment of Grade Group 1 Prostate Cancer: Four Year Results". The authors are Neal Shore, Myrtle Beach, SC; Steven A. Kaplan, New York, NY; Ronald Tutrone, Baltimore, MD; Richard Levin, Towson, MD; James Bailen, Louisville, KY; Alan Hay, Salem, OR; Susan Kalota, Tucson, AZ; Mohamed Bidair, San Diego, CA; Sheldon Freedman, Las Vegas, NV; Kenneth Goldberg, Lewisville, TX; Frederick Snoy, Albuquerque, NM; Jonathan I. Epstein, Baltimore, MD.

The Fexapotide (FT) prostate cancer study was started in 2012 and enrolled 147 men with localized Gleason Grade 6 T1c prostate cancer at 28 U.S. clinical investigation sites. Patients were followed with clinical and laboratory evaluations and regular periodic prostate biopsies for up to 5 years. Patients randomized to FT were treated with a single one-time targeted injection of FT, either 2.5mg or 15mg. Statistical comparisons were made over time of the proportions of subjects and untreated controls who progressed to higher Gleason grade and/or invasive treatments instituted with prostatectomy, radiotherapy, or chemotherapy. Important clinical highlights from the study include:

FT treatment reduced cancer progression (-67.7%) compared to controls (3 years, FT 15mg, p<.02, pooled FT p=.0265).
FT treatment group had reduced (-54.7%) incidence of surgery, radiotherapy or chemotherapy (4 years, FT 15mg p<.02; pooled FT p=.0374).
At 4 years the incidence of surgery, radiotherapy or chemotherapy with increased Gleason grade was significantly reduced (FT 15mg -73.3% p=.0059, pooled FT p=.0064).
Results for the high dose (FT 15mg) were superior to the lower dose (FT 2.5mg). Safety data showed no serious adverse events related to FT during the study.
FT is a pro-apoptotic proprietary drug which promotes natural programmed cell death (apoptosis) in prostatic glandular cells which compose the prostate cancer. FT has been safely administered to men in clinical trials in the U.S. involving over 1700 patients and controls treated for BPH or prostate cancer. FT has completed Phase 3 studies for BPH and further studies of FT for prostate cancer are planned in the near future.

On April 21, 2020 OncoSec Medical Incorporated ("OncoSec") (Nasdaq: ONCS), a company developing late-stage intratumoral cancer immunotherapies, reported pre-clinical data from a feasibility study of its visceral lesion applicator (VLA) electroporation device and APOLLO generator which were presented online at the Annual Meeting of the Society of Interventional Radiology (SIR) (Press release, OncoSec Medical, APR 21, 2020, View Source [SID1234556479]). The feasibility study demonstrated the capability of a rigid, trocar-like VLA applicator to safely deliver and electroporate DNA-based immunotherapy directly into target organs in a large animal model using a CT-guided approach and OncoSec’s new, lower voltage APOLLO generator.

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In a study titled, "Can an Intratumoral DNA-Encoded Immunotherapeutic Device Platform Currently Used in the Management of Cutaneous Lesions Be Scaled in Size to Function in the Treatment of Visceral Tumors Through Image-Guided Techniques?", investigators built upon data presented at the Annual Meeting of the Society of Interventional Oncology (SIO) demonstrating the VLA’s ability to reach deep visceral organs using laparoscopic/ultrasound and bronchoscope/steerable catheter methods in live large animal models.

In the study presented online at the Annual Meeting of the SIR, OncoSec demonstrated the ability to guide and deploy the VLA under a different guidance method and electroporate with the APOLLO generator. Using CT-guidance, investigators were able to reach high value targets including liver, lung, bone, and pancreas in a live large animal model. Additionally, TAVO was safely delivered and electroporated directly into the liver. Importantly, data also showed that it had no significant effects on hemodynamics, as indicated by consistent heart rate and arterial blood pressure. Animals were survived for at least 24 hours and no adverse events were observed.

"The potential opportunities that this technology represents are very promising. Interventional radiologists are eager to find treatment solutions that extend beyond standard of care. The possibility of delivering potent immunotherapy directly to visceral tumors in radiology suites could shift the paradigm of how we treat certain tumors, particularly in the liver, lung and bone," said Dr. Daniel Simon, Board Certified Interventional Radiologist at Vascular Management Associates of New Jersey and Maryland Cardiology Associates, and scientific advisor to OncoSec, who performed these large animal studies presented at SIR.

OncoSec has developed a short mechanism of action video that illustrates the way the VLA system is designed to target and treat tumors in humans. The video can be accessed on the Company’s website via View Source

In the previous feasibility study originally reported at SIO, large live healthy animal subjects were placed under general anesthesia while investigators safely and successfully accessed and deployed the VLA in the lungs with a flexible, catheter-based applicator using a bronchoscope and a steerable catheter, and liver using ultrasound-guided laparoscopy with a rigid-trocar-based applicator. Following deployment of the VLA, electroporation was performed in the liver using the company’s proprietary APOLLO generator. No adverse effects were recorded during or after electroporation. Additionally, initial data from the APOLLO generator’s built-in feedback system embedded within the platform detected and recorded trends in impedance values between different tissue types, as well as between the presence and absence of DNA. The APOLLO generator was also able to indicate when the applicator tip was not effectively placed within the tissue. These data highlight the safety mechanisms as well as the future possibility of differentiating between healthy tissue and a local tumor. Data from both SIR and SIO can be accessed via the two respective posters at View Source

"This study of our VLA device demonstrates the feasibility of reaching critical tissue targets, delivering a drug — in this case our lead product, TAVO, and electroporating in a large-animal model," said John Rodriguez, Vice President, Product Engineering at OncoSec. "We are very encouraged by these data, as they support our belief that electroporation combined with delivering drug intratumorally may be possible in tumors located within internal organs. These results allow us to move forward with a preclinical safety study in the near term, followed by the potential filing of an Investigational New Drug application and initiation of a phase 1 human clinical trial using the VLA platform in combination with TAVO."

On April 21, 2020 Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported that the Company will release its financial results for the first quarter ended March 31, 2020 after the market closes on May 5, 2020 (Press release, Nevro, APR 21, 2020, View Source [SID1234556480]).

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Investors interested in listening to the conference call may do so by dialing (833) 968-2321 in the U.S. or (778) 560-2840 internationally, using Conference ID: 8129245. In addition, a live webcast, as well as an archived recording, will be available on the "Investors" section of the Company’s website at: www.nevro.com.

On April 21, 2020 ArcherDX, Inc. and Premier Inc., a leading healthcare improvement company, reported that they have signed a two-part agreement, kicking off a multi-year program. Premier Applied Sciences will identify eight to 10 member institutions that will implement STRATAFIDE – in a research use only (RUO) capacity – to participate in a retrospective study to evaluate its sequencing performance in comparison to other diagnostic tests (Press release, ArcherDX, APR 21, 2020, View Source [SID1234556481]). ArcherDX plans to seek approval from the U.S. Food and Drug Administration (FDA) for STRATAFIDE as a genomic sequencing in vitro diagnostic (IVD) cancer assay capable of analyzing both tissue and blood samples. The ultimate goal of the partnership is to help solve for the underutilization of targeted therapies in late-stage cancer patients.

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"Genomic testing has resulted in clear benefit at multiple stages in the fight against cancer. However, there remains a stark need for a kitted IVD solution designed for broader use in any hospital’s molecular diagnostic laboratory," said Jason Myers, Chief Executive Officer and co-founder, ArcherDX. "Premier shares our commitment to providing actionable, accurate information to patients and healthcare providers in a community setting, where clinicians are empowered to control the sample, data and economics. This agreement provides for both a clinical and commercial collaboration, and we are pleased to partner with such a forward-thinking healthcare enterprise dedicated to serving more than 4,000 U.S. hospitals and health systems and approximately 175,000 other providers."

ArcherDX and Premier’s research team will identify retrospective samples from patients with lung, thyroid and colorectal cancer to be analyzed by Archer Clinical Services. The study aims first to evaluate STRATAFIDE as a composite test to identify genomic alterations associated with cancer. The expanded collaboration intends to further understand best practices to implement and utilize a distributed IVD in community hospital settings, which may currently lack advanced molecular genomics tools.

"Our partnership with ArcherDX demonstrates the expanse of Premier’s research portfolio so that it is now engaged in next-generation sequencing for multiple forms of cancer in various provider settings," said Stella A. Safo, M.D., MPH, Chief Clinical Transformation Officer and Vice President for Premier Applied Sciences. "We hope this research will help accelerate appropriate cancer care for hard to reach populations and are thrilled to be working with an innovative team that has the potential to bring accurate and actionable genomic data to patients and their caregivers everywhere. This represents a critical unmet need since so many cancer patients lack access to genomic testing and therapy selection tools in their communities."