On August 26, 2020 Biotech Prescient Therapeutics (ASX: PTX) reported that it has successfully raised $7 million to fund an expanded pipeline of innovative cancer treatments (Press release, Prescient Therapeutics, AUG 26, 2020, View Source;utm_medium=rss&utm_campaign=prescient-therapeutics-raises-7-million-to-fund-cancer-treatment-pipeline [SID1234565484]).

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The clinical stage oncology company reported it has received firm commitments from professional and sophisticated investors for the placement of 128.1 million shares priced at $0.055 each to raise over $7 million before costs.

The placement immediately follows a recently completed oversubscribed $6.5 million share purchase plan, bringing the total funds raised to $13.5 million. Following settlement of the placement, Prescient confirmed it will have more than $20.3 million cash on hand.

Prescient chief executive officer and managing director Steven Yatomi-Clarke said the strong response for the placement partly reflected the excess demand for the share purchase plan.

"Both existing and new shareholders have shown that they share Prescient’s enthusiasm for its expanded pipeline of innovative cancer treatments," he said.

The placement shares are expected to be issued this Friday.

Use of funds
The company has assigned some of the funds for the development of targeted therapies and cell therapy enhancement programs.

"These funds will also be applied towards the development of OmniCAR, a next generation CAR-T platform that aims to significantly broaden CAR-T’s addressable market, while overcoming many limitations of existing CAR-T therapies," Mr Yatomi-Clarke said.

"These represent tremendous market opportunities. We welcome new shareholders as they join us on our journey to develop innovative and personalised cancer therapies," he added.

The placement funds will also be used for working capital and to pay the costs of the offer.

CAR-T technology
CAR-T technology is a type of cellular therapy that reprograms a cancer patient’s immune cells to recognise and destroy cancer.

Mr Yatomi-Clarke joined Small Caps last week in a podcast talking about Prescient’s next-generation CAR-T platform, OmniCAR.

"For the very first time, thanks to this brand new approach (CAR-T therapy) we’re seeing responses that we’ve not yet seen in cancer before that are akin to cures…Some are calling it the beginning of the end which is incredibly exciting to contemplate," he said.

"The problem with cancer is that it’s mutated at surface just enough to avoid surveillance from the immune system, so the T-cells – the frontline soldiers of the immune system – don’t recognise the cancer anymore."

Mr Yatomi-Clarke said Prescient’s technology modifies and trains the receptor of the T-cells in a patient’s own immune system so they can detect cancer again.

"We are seeing unparalleled cancer-killing capabilities with this type of therapy that has caused durable remissions in patients that have failed everything else… it’s a remarkably exciting new frontier of cancer [treatment] that we’re in," he said.

Targeted therapies
Prescient’s other approach to cancer is targeted therapies and it is developing two drug candidates, PTX-100 and PTX-200.

Mr Yatomi-Clarke described targeted therapies as injectable medicines that "finds the mutations or drivers of the cancer and switches them off – so the things that make it divide in an uncontrolled manner".

PTX-100 is currently in a pharmacokinetics/pharmacodynamics (PK/PD) basket study of hematological and solid malignancies, focusing on cancers with Ras and RhoA gene mutations. It is believed to be the only RhoA inhibitor in the world in clinical development, according to Prescient.

PTX-200 is a novel PH domain inhibitor that inhibits the Akt tumour survival pathway, which plays a role in the development of breast and ovarian cancers, as well as leukemia. It achieved encouraging results from a Phase 2a study on HER2-negative breast cancer, Phase 1b/2 in relapsed and refractory acute myeloid leukemia and Phase 1b in recurrent or persistent platinum resistant ovarian cancer.

Prescient also recently announced two of its assets are being assessed by the Doherty Institute in Melbourne for antiviral activity against SARS-CoV-2, the virus that causes COVID-19.

On August 26, 2020 Phosplatin Therapeutics LLC, a clinical stage pharmaceutical company focused on oncology therapeutics, reported the completion of an oversubscribed $18.4 million private financing round (Press release, Phosplatin, AUG 26, 2020, View Source [SID1234564995]). Participation included new and existing investors, inclusive of family offices from the US, Europe and Asia-Pacific, and high net worth individuals.

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Robert Fallon, President and Chief Executive Officer of Phosplatin Therapeutics, commented, "The success of the financing underscores the breadth of our data from three different Phase I trials and the broad potential of our lead compound, PT-112, which is advancing through clinical development as a monotherapy, including in mCRPC and multiple myeloma, and in combination with PD-L1 immune checkpoint inhibition. We plan to utilize the proceeds of this capital raise to complete Phase 2 development of PT-112, and our continued planning prior to launching intended pivotal trials."

Phosplatin Therapeutics has raised $56 million in equity capital since inception, and receives milestone fees from its sub-licensee for Greater China.

About PT-112

PT-112 is the first small molecule conjugate of pyrophosphate developed in oncology therapeutics. PT-112 promotes immunogenic cell death (ICD), or the release of damage associated molecular patterns (DAMPs) that lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 represents a potential best-in-class small molecule inducer of this immunological form of cancer cell death, and is under Phase 2 development. The first-in-human study of PT-112 demonstrated an attractive safety profile and evidence of long-lasting responses among heavily pre-treated patients, and won "Best Poster" at the ESMO (Free ESMO Whitepaper) 2018 Annual Congress within the Developmental Therapeutics category. The novelty of its pyrophosphate moiety also results in osteotropism, or the propensity of the drug to reach the mineralized bone. This property is of interest in cancer types that originate in bone, or frequently lead to metastatic bone involvement, such as metastatic castrate-resistant prostate cancer (mCRPC). The first human clinical results in mCRPC were presented at the 2020 Genitourinary Cancers Symposium.

On August 26th, 2020, Bonnie J Addario Lung Cancer Foundation reported that the Food and Drug Administration (FDA) approved the FoundationOne Liquid CDx for comprehensive liquid biopsy biomarker testing for patients with any solid tumor (Press release, Bonnie J Addario Lung Cancer Foundation, AUG 26, 2020, View Source [SID1234564229]). The FDA based their approval on analysis from multiple clinical validation studies which showed that FoundationOne Liquid CDx is very sensitive and specific in finding mutations.

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This approval gives patients more options for comprehensive liquid biopsy biomarker testing that were not previously available.

On August 26, 2020 Fortress Biotech, Inc. (Common Stock: Nasdaq: FBIO) (Preferred Stock: Nasdaq: FBIOP) ("Fortress"), an innovative biopharmaceutical company, reported that it has priced an underwritten public offering of 666,666 shares of its 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock ("Series A Preferred Stock") at a price of $18.00 per share, with expected gross proceeds to Fortress of approximately $12 million (Press release, Fortress Biotech, AUG 26, 2020, View Source [SID1234564099]). In addition, Fortress has granted the underwriters a 45-day option to purchase up to 66,666 additional shares of its Series A Preferred Stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about August 31, 2020, subject to customary closing conditions.

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The Benchmark Company, LLC and ThinkEquity, a division of Fordham Financial Management, Inc. are acting as joint bookrunning managers for the offering.

Fortress intends to use the net proceeds from the public offering for its operations, including, but not limited to, general corporate purposes, which may include research and development expenditures, clinical trial expenditures, manufacture and supply of product, and working capital.

This offering is being made only by means of a written prospectus and related prospectus supplement that form a part of the registration statement. A copy of the final prospectus supplement and accompanying prospectus related to this offering may be obtained from any of the underwriters, including the offices of The Benchmark Company, LLC, Attn: Prospectus Department, 150 E 58th Street, 17th floor, New York, NY 10155, 212-312-6700, Email: [email protected], and the offices of ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673 or by email at [email protected]. You may also obtain these documents for free when they are available by visiting the Securities Exchange Commission’s ("SEC") website at www.sec.gov.

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

On August 26, 2020 EDAP TMS SA (Nasdaq: EDAP) (the "Company"), the global leader in robotic energy based therapies, reported financial results for the second quarter of 2020 and provided an update on strategic and operational developments (Press release, EDAP TMS, AUG 26, 2020, View Source [SID1234564097]).

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Marc Oczachowski, EDAP’s Chairman and Chief Executive Officer, said: "Notwithstanding the significant physician and hospital outreach challenges posed by the COVID-19 pandemic during the second quarter, we continued to advance late-stage discussions, resulting in the completion of several notable deals toward the end of the period. Of particular note, our recent sales momentum, which carried into the current quarter, was characterized by a healthy mix of stand-alone Focal One sales, stand-alone Exact-Vu sales, and bundled sales of both complementary technologies that represent the industry’s first true ‘end-to-end’ solution for the urology suite. These are exactly the types of sales synergies that we envisioned when we announced our worldwide distribution agreement with Exact Imaging in May, and the traction we are seeing continues to exceed our internal forecasts. In parallel with these recent sales announcements, we continue to build our pipeline, assisted by highly regarded reference hospitals that were early adopters of Ablatherm and continue to champion our Focal One HIFU technology.

"Regarding our financial results, as with the first quarter, we did see an impact on revenue, driven mostly by lower procedure volumes as hospitals focused on treating COVID patients. This was in line with our expectations. However, because of the essential nature of timely prostate cancer screenings and treatments, it is anticipated these procedures must ultimately resume and continue, and we do see signs that our key markets in the U.S. and elsewhere are returning to a more normalized environment. We are optimistic that a gradual return to pre-pandemic procedure volumes, coupled with continued sales successes, will set the stage for improved financial results in the back half of the year and a strong 2021," Mr. Oczachowski concluded.

As a result of the company’s recent strategic shift toward current and emerging opportunities in HIFU, as well as its recently announced exclusive worldwide distribution agreement with Exact Imaging, beginning with the second quarter of 2020, EDAP is reporting its financial results in three segments: (1) HIFU, which includes sales of Focal One, Ablatherm and related consumables and services, (2) Lithotripsy, which includes revenue generated from the existing Sonolith range, and (3) Distribution, which includes the sale of complementary products such as lasers and micro-ultrasound systems and products from third parties.
EDAP’s new reporting segments align with organizational changes implemented within the company to better support the expansion of its HIFU development and sales activities as well as to maximize the potential of its distribution activities. This improved reporting format will allow for an unbiased comparative analysis of our past, current and future operational results.

Second Quarter 2020 Results

Total revenue for the second quarter 2020 was EUR 9.3 million (USD 10.3 million), a decrease of 26% compared to total revenue of EUR 12.5 million (USD 14.0 million) for the same period in 2019. Second quarter 2020 revenue reflects the impact of the ongoing COVID-19 pandemic on both procedure volumes and equipment sales.

Total revenue in the HIFU business for the second quarter 2020 was EUR 2.6 million (USD 2.8 million), a 44.2% decrease compared to EUR 4.6 million (USD 5.1 million) for the second quarter of 2019.

Total revenue in the LITHO business for the second quarter 2020 was EUR 2.9 million (USD 3.3 million), a 22.8% decrease compared to EUR 3.8 million (USD 4.3 million) for the second quarter of 2019

Total revenue in the Distribution business for the second quarter 2020 was EUR 3.8 million (USD 4.2 million), a 8.3% decrease compared to EUR 4.1 million (USD 4.6 million) for the second quarter of 2019.

Gross profit for the second quarter 2020 was EUR 4.3 million (USD 4.8 million), compared to EUR 6.3 million (USD 7.1 million) for the year-ago period. Gross profit margin on net sales was 46.8% in the second quarter of 2020, compared to 50.7% in the year-ago period. The decline in gross profit year-over-year was due to in part to lower sales in HIFU business as compared to the year-ago period driven primary by COVID-19.

Operating expenses were EUR 4.0 million (USD 4.5 million) for the second quarter of 2020, compared to EUR 4.7 million (USD 5.3 million) for the same period in 2019.

Operating profit for the second quarter of 2020 was EUR 0.3 million (USD 0.3 million), compared to an operating profit of EUR 1.7 million (USD 1.9 million) in the second quarter of 2019.

Net loss for the second quarter of 2020 was EUR 0.2 million (USD 0.2 million), or EUR (0.01) per diluted share, as compared to net income of EUR 1.4 million (USD 1.6 million), or EUR 0.05 per diluted share in the year-ago period.

For the first six months 2020 Results

Total revenue for the first half of 2020 was EUR 16.9 million (USD 18.7 million), a decrease of 25% compared to total revenue of EUR 22.6 million (USD 25.6 million) for the same period in 2019. As mentioned, first half 2020 revenue reflects the impact of the ongoing COVID-19 pandemic on the company’s activities.

Total revenue in the HIFU business for the first six months of 2020 was EUR 4.5 million (USD 5.0 million), a 47.0% decrease compared to EUR 8.4 million (USD 9.5 million) for the first six months of 2019.

Total revenue in the LITHO business for the first six months of 2020 was EUR 5.9 million (USD 6.5 million), a 13.0% decrease compared to EUR 6.7 million (USD 7.6 million) for the first six months of 2019.

Total revenue in the Distribution business for the first six month of 2020 was EUR 6.5 million (USD 7.2 million), a 12.3% decrease compared to EUR 7.4 million (USD 8.4 million) for the first six month of 2019.

Gross profit for the first six months of 2020 was EUR 7.4 million (USD 8.2 million), compared to EUR 11.2 million (USD 12.6 million) for the year-ago period. Gross profit margin on net sales was 43.9% for the first six months of 2020, compared to 49.5% in the year-ago period. The decline in gross profit year-over-year was due in part to lower sales in the HIFU business driven by COVID-19.

Operating expenses were EUR 8.5 million (USD 9.5 million) for the first six months of 2020, compared to EUR 9.3 million (USD 10.5 million) for the same period in 2019.

Operating loss for the first six months of 2020 was EUR 1.2 million (USD 1.3 million), compared to an operating profit of EUR 1.9 million (USD 2.1 million) for the same period of 2019.

Net loss for the first six months of 2020 was EUR 1.5 million (USD 1.6 million), or EUR (0.05) per diluted share, as compared to a net income of EUR 1.7 million (USD 1.9 million), or EUR 0.06 per diluted share in the year-ago period.

As of June 30, 2020, the Company recorded a strong cash position of EUR 15.7 million (USD 17.6 million).

Conference Call

An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30am EDT on Thursday, August 27, 2020. Please refer to the information below for conference call dial-in information and webcast registration.

Following the live call, a replay will be available on the Company’s website, www.edap-tms.com under "Investors Information."