Profound Pharma AS

Antibody-drug conjugates have been behind some of the biggest pharma deals in recent months. With Big Pharmas heading into 2024 with a renewed interest in antibody-drug conjugates (ADCs), it’s no surprise that ProfoundBio managed to assemble a who’s who of biotech investors for an oversubscribed series B round. The likes of Lilly Asia Ventures, RA Capital Management, OrbiMed, Medicxi and LifeSci Venture Partners all featured in the $112 million round, which was led by Ally Bridge Group. As part of the financing, ProfoundBio’s board will be embiggened by Andrew Lam, managing director and head of biotech private equity at Ally Bridge, as well as Eric Dobmeier and Enoch Kariuki. “We are excited to welcome this premier group of life science investors,” Profound’s chief operating officer and chief financial officer Erin Lavelle said in the Feb. 13 release. “This investment boosts our momentum, especially with three clinical-stage candidates in our portfolio and another poised for clinical trials. It's a pivotal step in achieving significant milestones and delivering key data readouts this year and through 2025.” Those three clinical-stage ADCs are headed up by Rina-S, which is targeted at folate receptor-alpha (FRα) and is in phase 2 trials for ovarian and endometrial cancers, with pivotal studies in ovarian cancer in the works for later this year. Eli Lilly, the Asia VC arm of which is a returning investor for today’s funding round, has an interest in FRα courtesy of its acquisition of Mablink Bioscience last fall. That deal saw the Big Pharma get its hands on MBK-103, an ADC designed to deliver a topoisomerase I inhibitor to cells that express FRα. It’s not the only player in that field, with ImmunoGen receiving accelerated FDA approval for an ADC aimed at the folate receptor in 2022. Bristol Myers Squibb paid Eisai $650 million for its own candidate a year earlier. Profound, which has operations in both Seattle and Suzhou, China, has two ADCs in phase 1 trials. An initial readout from a study of a CD70-targeted ADC called PRO1160 is due later in 2024, to be followed next year by results from PRO1107, a protein tyrosine kinase 7-targeted therapy. This year may also see a bispecific ADC called PRO1286 enter the clinic, Profound said in today’s release. ADCs have been behind some of the biggest pharma deals in recent months, including Merck & Co.’s $22 billion partnership with Daiichi Sankyo, Bristol Myers Squibb’s $8.4 billion agreement with SystImmune, AbbVie’s $10 billion acquisition of Immunogen and Johnson & Johnson’s $2 billion Ambrx buy, to name a few.

TORONTO, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Profound Medical Corp. (TSX:PRN; NASDAQ:PROF) ("Profound" or the "Company") is pleased to announce that the Company has entered into subscription agreements, dated as of January 16, 2024, with certain existing Canadian institutional investors, in connection with a non-brokered private placement (the "Private Placement") for aggregate gross proceeds of approximately US$2,937,502. In connection with the closing of the Private Placement, the Company is expected to issue an aggregate of 391,667 common shares in the capital of the Company ("Common Shares") at a price of US$7.50 per Common Share. All of the Common Shares issued in connection with the Private Placement will be subject to a four-month and one day statutory hold period. The Company expects to use the proceeds from the closing to fund the continued commercialization of the TULSA-PRO® system in the United States, the continued development and commercialization of the TULSA-PRO® system and the Sonalleve® system globally and for working capital and general corporate purposes. The closing of the Private Placement is expected to occur on or about January 17, 2024, subject to customary closing conditions. The Company is offering the Common Shares in Canada only. The Common Shares have not been, and will not be, registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act") or any U.S. state securities laws and may not be offered or sold in the United States absent registration or an available exemption from the registration requirements of the U.S. Securities Act and applicable U.S. state securities laws. 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 the securities referenced in this press release, in any jurisdiction in which such offer, solicitation or sale would be unlawful. About Profound Medical Corp. Profound is a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue. Profound is commercializing TULSA-PRO®, a technology that combines real-time MRI, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. TULSA-PRO® is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting the urethra and rectum to help preserve the patient’s natural functional abilities. TULSA-PRO® has the potential to be a flexible technology in customizable prostate ablation, including intermediate stage cancer, localized radio-recurrent cancer, retention and hematuria palliation in locally advanced prostate cancer, and the transition zone in large volume benign prostatic hyperplasia ("BPH"). TULSA-PRO® is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration ("FDA"). Profound is also commercializing Sonalleve®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. Sonalleve® has also been approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids and has FDA approval under a Humanitarian Device Exemption for the treatment of osteoid osteoma. The Company is in the early stages of exploring additional potential treatment markets for Sonalleve® where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy. Forward-Looking Statements This release includes forward-looking statements regarding Profound and its business which may include, but are not limited to, statements with respect to the Private Placement (including size, pricing and closing date) and the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, BPH, uterine fibroids, palliative pain treatment and osteoid osteoma and the expected use of proceeds from the Private Placement. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the Private Placement (including that the Private Placement may not close and/or that the Company’s use of proceeds of the Private Placement may differ from those indicated), the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. In addition, there is uncertainty about the spread of the COVID-19 virus and the impact it will have on Profound’s operations, the demand for its products, global supply chains and economic activity in general. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law. For further information, please contact: Stephen KilmerInvestor Relationsskilmer@profoundmedical.com T: 647.872.4849

TORONTO, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, today announced preliminary unaudited revenues for the fourth quarter and full year 2023, and provided an update on the progress it is making with the commercialization of TULSA-PRO® in the United States. Profound is providing this information due to the significant lag time between planned investment community meetings to be held in connection with, among other investor events, the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, and its expected reporting of final 2023 results in March 2024. Profound anticipates total revenues for the fourth quarter of 2023 to be in the approximate range of $1.9 million to $2.0 million, with the full amount coming from recurring revenue, which consists of the sale of TULSA-PRO® consumables, lease of medical devices, procedures and services associated with extended warranties. This represents recurring revenue growth of between 51% and 59% year-over-year, and between 10% and 16% sequentially over the 2023 third quarter. For the full year 2023, Profound anticipates total revenues to be in the approximate range of $7.1 million to $7.2 million. These figures are preliminary and unaudited, and actual revenues may differ. “Our focus on early adopters and teaching hospitals resulted in the adoption of TULSA-PRO® continuing to increase throughout 2023, both in terms of installed base growth and existing system utilization,” said Arun Menawat, Profound’s CEO and Chairman. “Q4-2023 marked the seventh consecutive quarter of recurring revenue growth; and TULSA-PRO® is now installed at, or contracted with, 10 of the top 20 cancer hospitals in the United States as ranked by U.S. News and World Report, including prestigious institutions such as MD Anderson, Mayo Clinic-Rochester, UCLA Medical Center, Brigham and Women's Hospital, Johns Hopkins Hospital, and Cleveland Clinic, among others. The growth capital raised through our recent financing, which closed yesterday, puts us in a stronger position to make the requisite investments, particularly in our commercial organization, to maximize the exciting opportunity for TULSA that we see ahead. In preparation for the permanent CPT® Category 1 codes for TULSA going into effect at the beginning of 2025 -– an anticipated major revenue inflection point for our business – our top priorities for 2024 will be to further increase our TULSA-PRO® installed base, support increased system utilization, complete our ongoing Level 1 CAPTAIN trial comparing the TULSA procedure to radical prostatectomy for the treatment of prostate cancer, and advance additional TULSA AI modules designed to increase both the ease and speed of prostate disease treatment. We look forward to updating investors as we progress.” About Profound Medical Corp. Profound is a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue. Profound is commercializing TULSA-PRO®, a technology that combines real-time MRI, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. TULSA-PRO® is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting the urethra and rectum to help preserve the patient’s natural functional abilities. TULSA-PRO® has the potential to be a flexible technology in customizable prostate ablation, including intermediate stage cancer, localized radio-recurrent cancer, retention and hematuria palliation in locally advanced prostate cancer, and the transition zone in large volume benign prostatic hyperplasia (“BPH”). TULSA-PRO® is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration (“FDA”). Profound is also commercializing Sonalleve®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. Sonalleve® has also been approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids and has FDA approval under a Humanitarian Device Exemption for the treatment of osteoid osteoma. The Company is in the early stages of exploring additional potential treatment markets for Sonalleve® where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy. Forward-Looking Statements This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, BPH, uterine fibroids, palliative pain treatment and osteoid osteoma; Profound’s preliminary unaudited fourth quarter and full year 2023 revenues; and the success of Profound’s U.S. commercialization strategy and activities for TULSA-PRO®. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. In addition, there is uncertainty about the spread of the COVID-19 virus and the impact it will have on Profound’s operations, the demand for its products, global supply chains and economic activity in general. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law. For further information, please contact: Stephen KilmerInvestor Relationsskilmer@profoundmedical.com T: 647.872.4849