On October 7, 2020, Cumberland Pharmaceuticals Inc. (the "Company" or "Cumberland") reported that it entered into a Third Amendment to the Revolving Credit Note and Fourth Amendment ("Fourth Amendment") to the Revolving Credit Loan Agreement with Pinnacle Bank (the "Pinnacle Agreement") (Filing, 8-K, Cumberland Pharmaceuticals, OCT 7, 2020, View Source [SID1234568266]). The original Pinnacle Agreement was dated July 31, 2017. The Fourth Amendment provides for a principal available for borrowing of up to $15 million and Cumberland has the ability to request an increase of up to an additional $5 million, upon the satisfaction of certain conditions and approval by Pinnacle Bank. If fully expanded, the Fourth Amendment would provide a maximum principal available for borrowing of up to $20 million, which was also the maximum aggregate principal available for borrowing under the previously amended Pinnacle Agreement.

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The Fourth Amendment extends the maturity date of the Pinnacle Agreement through October 1, 2022.
The interest rate on the Pinnacle Agreement, as amended, is based on LIBOR plus an interest rate spread. The pricing provides for an interest rate spread of 1.75% to 2.75% above LIBOR with a minimum LIBOR of 0.90%. Cumberland is subject to a financial covenant, maintenance of either the Funded Debt Ratio or a Tangible Capital Ratio, as defined, determined on a quarterly basis. Borrowings under the line of credit are collateralized by substantially all of the Company’s assets.

On October 7, 2020 Brainlab, the digital medical technology company, reported the planned delivery of 10 new ExacTrac Dynamic systems to GenesisCare, offering US cancer patients and physicians access to the latest treatment technologies on the market (Press release, GenesisCare, OCT 7, 2020, View Source [SID1234568198]). This follows GenesisCare’s acquisition of major integrated cancer care provider, 21st Century Oncology, increasing access to advanced cancer care for patients across US communities.

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ExacTrac Dynamic, a patient positioning and position monitoring device, received FDA 510(k) clearance in July 2020 and supports the delivery of precision radiotherapy with surface and thermal tracking combined with real-time X-Ray monitoring. ExacTrac Dynamic will allow GenesisCare physicians to deliver stereotactic radiosurgery, a non-invasive form of radiation therapy which delivers precisely targeted radiation in fewer high-dose treatments than traditional therapies.

Australian-headquartered GenesisCare is one of the largest networks of integrated oncology care in the world, with treatment centers and clinics across Australia, the UK, Spain and now the US. ExacTrac Dynamic systems have already been rolled out in Australia and the UK, providing patients access to the latest advancements in radiation therapy, including stereotactic radiosurgery and tattoo-free treatment.

"During COVID-19, we have remained steadfastly committed to ensuring all cancer patients in local communities across the United States and globally receive rapid access to world-class cancer care. Our investment in these cutting-edge ExacTrac Dynamic systems will help us deliver on our vision to ensure as many cancer patients as possible are able to receive the right treatment, at the right time, closer to home. Our partnership with Brainlab will allow our physicians in the US to automate precise patient monitoring during the delivery of faster, more personalized radiotherapy treatments in our 290 centers across the country," said Dan Collins, Founder and Global Chief Executive Officer, GenesisCare."

Building upon the first generation ExacTrac X-Ray, the new ExacTrac Dynamic system expands clinical workflows beyond traditional stereotactic capabilities with new surface-guided and thermal technology. These high-precision tracking and verification capabilities enable the delivery of effective prescription target doses, with less radiation to normal healthy tissues, for a wide range of treatment locations in the body. The system allows for:

Surface guided patient setup without tattoos or markings
Submillimetric patient monitoring using integrated surface, thermal, and X-Ray imaging at all couch angles
Real-time motion management with automatic beam-hold enabling future applications such as Deep Inspiration Breath Hold (DIBH) gated treatments*
"It’s exciting for Brainlab to continue to work with GenesisCare as they expand their presence in the United States," said Stefan Vilsmeier, President and CEO, Brainlab. "We have long partnered with GenesisCare in Australia and the UK and share their vision to make precision radiotherapy more accessible on a global scale."

First deliveries are planned for November 2020.

On October 7, 2020 Sensei Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing personalized yet off the shelf immunotherapies for cancer and infectious diseases, reported the completion of a $28.5 million equity financing (Press release, Sensei Biotherapeutics, OCT 7, 2020, View Source [SID1234568267]). The financing was co-led by Cambrian Biopharma and H&S Ventures, along with participation from new investors Future Ventures, Christian Angermayer’s Apeiron Investment Group, and Presight Ventures, Apeiron’s U.S. arm.

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Sensei is currently advancing multiple clinical and pre-clinical studies with their lead Immunophage program, SNS-301, a bacteriophage engineered to express aspartate β-hydroxylase (ASPH), a tumor associated antigen. The proceeds from the Series AA financing will enable the further development of SNS-301 and enable the advancement of Sensei’s pipeline of novel immunotherapies based on its Immunophage platform, which combines a vaccine’s ability to generate antigen-specific B- and T-cells with payloads of immunomodulatory nanobodies. Sensei Bio is building an extensive R&D infrastructure for the discovery of Immunophage, including GMP manufacturing, and is creating libraries of Immunophage that will be combined to create personalized yet off the shelf cocktails based on the genetic profile of each patient’s tumor.

"With this new funding, we advance our vision for establishing a new and disruptive class of immunotherapies called Immunophage, based on engineered bacteriophage," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "We are poised for significant progress as this funding enables us to expand our clinical programs for SNS-301 and operate our Immunophage platform at scale. We are grateful for the support from both new and existing investors and I look forward to further realizing Sensei’s potential and building out this new class of immunotherapies."

"Sensei’s phage platform represents a transformative leap in immuno-oncology, with a cancer vaccine that can induce all the elements of a robust anti-tumor immune response. With experienced management and scientific teams, Sensei is well positioned to become a leader in next generation of immune-oncology therapeutics," said James Peyer, CEO of Cambrian Biopharma. "We are pleased to support their highly unique platform approach and advance these therapies clinically."

In its next stage of growth, Sensei Bio will employ its proprietary platform to discover novel classes of cancer immunotherapies and advance lead candidates toward the clinic. These approaches include the following:

The development of select immunomodulatory nanobodies, camelid-based antibodies, that can be deployed as Immunophage payloads or stand-alone therapeutics.
The expansion of Sensei’s library based approach by engineering Immunophage targeting additional tumor associated antigens.
The deployment of customized yet off-the-shelf Immunophage cocktail therapies targeting tumor associated antigens, neoantigens, and virally-based cancer antigens.
A novel antibody-based approach to novel checkpoint inhibition and other methods of altering the tumor microenvironment toward anti-tumor immunity.
Potential expansion of its therapeutic area focus into infectious diseases based on partnerships with Pharma companies and government entities.

On October 7, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that the Company will be participating in the BIO Investor Forum Digital, which is taking place virtually from October 13-15, 2020 (Press release, Oncolytics Biotech, OCT 7, 2020, View Source [SID1234568182]).

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The Company’s profile for the forum is available here. Registered attendees will be able to view an on-demand corporate overview provided by President and Chief Executive Officer Dr. Matt Coffey. Company management will also be participating in one-on-one investor meetings at the forum. To schedule a meeting, please submit a meeting request on the forum website, or email [email protected].

On October 7, 2020 Pulse Biosciences, Inc. (Nasdaq: PLSE) a novel bioelectric medicine company progressing Nano-Pulse Stimulation (NPS) technology, reported that clinical results from studies spanning the Company’s dermatologic application portfolio will be presented at the American Society for Dermatologic Surgery (ASDS) virtual annual meeting on October 9-11, 2020 (Press release, Pulse Biosciences, OCT 7, 2020, View Source [SID1234568199]). Positive study results generated using the Company’s innovative cellular-specific Nano-Pulse Stimulation mechanism performed with its CellFX System for the treatment of sebaceous hyperplasia lesions, cutaneous non-genital warts, plantar warts, and basal cell carcinoma will be presented in two oral presentations and two e-posters.

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These newest published results from NPS clinical studies provide further evidence of the unique CellFX cellular mechanism of action for multiple applications across the lesion treatment spectrum. These recent findings were also the basis for the recently initiated multicenter clinical study to compare NPS technology to RF electrodessication in clearing sebaceous hyperplasia lesions. Treatment of the first study patient was previously announced by the Company on October 1, 2020.

"The positive results being shared at this year’s ASDS meeting add to the growing body of evidence in support of using Nano-Pulse Stimulation technology delivered by the CellFX System to treat a broad range of dermatology applications for which targeted clearance of cellular lesions or structures is medically or cosmetically desirable," said Darrin Uecker, President and CEO of Pulse Biosciences. "These data underscore our persistent dedication to providing dermatologists a highly differentiated non-thermal solution with vast opportunity."

Highlights from this meeting of leading dermatologic surgeons demonstrate:

Successful use of lower NPS energy levels to maintain high levels of effectiveness in clearing sebaceous hyperplasia lesions with greatly improved cosmesis and high subject satisfaction
Favorable clearance rate for warts on the hands, leg, knee, neck; no plume detected in a subset of NPS procedures
Encouraging findings of biopsy-confirmed elimination of residual BCC in the known NPS treatment zone for 8 nodular BCCs and 21 superficial BCCs, indicating promising potential for NPS treatment of both BCC-subtypes
Strong clearance rate of difficult-to-treat, recalcitrant plantar warts in a single treatment session
Dr. Ted Lain, author of the non-genital cutaneous wart study, said: "We are pleased to present conclusive evidence of consistently high rates of clearance across a variety of anatomical areas in one to two NPS treatments. Compared to today’s standard wart treatments, which typically require two to four visits to clear common cutaneous warts, these NPS results represent a much more convenient approach for the patient and the physician." Dr. Lain is Chief Medical Officer of Sanova Dermatology in Austin, TX.

Members of the dermatologic surgery community who have registered for the virtual meeting can gain access to accepted video presentations and posters at the ASDS meeting portal. The listed dates and times below are subject to change.

Title

Lead Author Session Information
A Prospective, Non-Randomized, Multicenter Pivotal Study of Nano-Pulse Stimulation (NPS) for Treatment of Cutaneous Non-Genital Warts

Edward (Ted) Lain, MD,
Chief Medical Officer of Sanova Dermatology, Austin, TX

Oral Presentation
(narrated video slide set)

Friday, October 9th at

11:15am ET

General Derm Track

Nano-Pulse Stimulation (NPS) Procedure to Treat Sebaceous Hyperplasia – A Dose-Ranging, Multi-Center, Pivotal Study

Girish (Gilly) Munavalli, MD,
Medical Director of Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte, NC.

Oral Presentation
(narrated video slide set)

Saturday, October 10th at

11:00 to 11:45am ET

Cosmetic Track

A Prospective, Non-Randomized, Multicenter Pivotal Study of Nano-Pulse Stimulation (NPS) Technology for Cutaneous Warts on the Feet

Brenda LaTowsky, MD,
Clear Dermatology& Aesthetics Center, Scottsdale, AZ

Poster Presentation
A first human feasibility study of Nano-Pulse Stimulation (NPS) to evaluate the potential elimination of a biopsy-confirmed nodular or superficial BCC in a short-term treat and resect study design

Christopher B. Harmon, MD,
Mohs surgeon and founder of Surgical Dermatology Group, Birmingham, AL

Poster Presentation
"We are thrilled to showcase our latest research and congratulate the American Society for Dermatology Surgery for hosting this important scientific exchange with aesthetic and surgical dermatology professionals as we work toward commercial introduction of our CellFX System powered by Nano-Pulse Stimulation technology," said Ed Ebbers, Pulse’s Executive Vice President and General Manager, Dermatology.