On July 11, 2021 Alpha Tau reported that proprietary Alpha DaRT is designed to deliver uniquely potent alpha radiation to destroy solid tumors with localized precision, sparing surrounding healthy tissue, thereby maintaining cancer patients’ quality of life (Press release, Alpha Tau Medical, JUL 11, 2021, View Source [SID1234584768]). Alpha DaRT has recently received FDA’s Breakthrough Device Designation for the indication of Squamous Cell Carcinoma of the skin and oral cavity without curative standard of care, and preclinical studies support evaluation across various cancer indications (skin, pancreas, breast and GBM, among others).

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– The transaction represents an implied pro forma equity value of approximately $1 billion and is expected to provide up to $367 million in gross proceeds, including up to $275 million of cash held in the trust account of Healthcare Capital Corp. (Nasdaq: HCCC) and a $92 million PIPE.

– The $92 million fully-committed PIPE is anchored by a combination of Healthcare-focused financial and strategic investors including Yozma Investment Co. (part of Yozma Group Korea), Grand Decade Developments (an affiliate of China Grand Pharmaceutical and Healthcare Holdings), as well as other leading technology investors including OurCrowd, Regah Ventures and the co-founders of Apax Partners, Alan Patricof and Sir Ronald Cohen. Medison Group, an early supporter of Alpha Tau and global pharma company that provides access to highly innovative therapies to patients in international markets, is also an investor in the PIPE.

– After giving effect to the transaction (and assuming no redemptions by public shareholders), Alpha Tau is expected to have approximately $362 million of cash on the balance sheet.

– Net proceeds are to be used for further expansion of Alpha Tau’s clinical strategy including the pursuit of FDA marketing authorization, a broad array of R&D activities, expanding manufacturing capacity and preparing for commercialization, and are expected to provide cash runway at least into 2024.

– All Alpha Tau shareholders will retain 100% of their equity holdings in the public company.

– Alpha Tau will continue to be led by its current management team, and upon closing, it is expected that HCC Chairman Dr. David M. Milch will be appointed to the Alpha Tau Board of Directors.

– The proposed business combination is expected to be completed by the end of 2021, upon which Alpha Tau is expected to be listed on Nasdaq.

JERUSALEM and WILMINGTON, Del., July 8, 2021 /PRNewswire/ — Alpha Tau Medical Limited ("Alpha Tau"), the developer of the pioneering alpha-radiation cancer therapy Alpha DaRT, and Healthcare Capital Corp. ("HCC") (Nasdaq: HCCC), a special purpose acquisition company, reported they have entered into a definitive business combination agreement (the "Business Combination"). Upon closing of the Business Combination, Alpha Tau is expected to be listed on the Nasdaq.

Alpha Tau’s proprietary Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) enables highly potent and conformal alpha-irradiation of solid tumors through the intra-tumoral insertion of radium-224 impregnated sources mainly affecting the tumor, sparing the healthy tissue around it. In the company’s first-in-human clinical trial for Squamous Cell Carcinoma ("SCC") tumors of the skin & oral cavity exhibited 100% overall response rate and approximately 78% complete response rate. In June 2021, Alpha Tau received FDA Breakthrough Device Designation for the use of Alpha DaRT in the treatment of SCC of the skin and oral cavity without curative standard of care.

Alpha Tau has developed a robust clinical trial strategy with leading global centers, including its flagship US multi-center feasibility study currently ongoing, led at Memorial Sloan Kettering Cancer Center in New York, which recently enrolled its first patient.

A group of Healthcare-focused financial and strategic investors have committed to participate in the transaction through a fully committed ordinary share PIPE of approximately $92 million at $10.00 per share. Investors in the PIPE include Yozma Investment Co. (part of Yozma Group Korea) and Grand Decade Developments (an affiliate of China Grand Pharmaceutical and Healthcare Holdings) as well as other leading technology investors including OurCrowd, Regah Ventures and the co-founders of Apax Partners, Alan Patricof and Sir Ronald Cohen. Medison Group, an early supporter of Alpha Tau and global pharma company that provides access to highly innovative therapies to patients in international markets, is also an investor in the PIPE.

"Following the recent enrollment of the first patient in our flagship US feasibility study and receipt of FDA Breakthrough Device Designation, this transaction represents another significant milestone on Alpha Tau’s journey to transform the treatment of solid tumors through the precision delivery of alpha radiation. We are grateful to the outstanding team at HCC, whose cadre of experienced and well-regarded professionals have provided superb execution and continued support for Alpha Tau, and we are excited for Dr. David M. Milch to join as our newest member of the Board of Directors upon the closing of the business combination. We thank our investors, both new joiners as well as those who have supported us for years, who continue to demonstrate their faith in the company and its leadership," said Uzi Sofer, CEO and Chairman of Alpha Tau.

"The completion of this transaction will allow the company to realize its vision and implement the clinical development plans and construction of our manufacturing plants around the world, in order to bring hope to millions of patients around the world."

"This transaction ensures that we are well capitalized to accelerate our ambitious plans across multiple fronts," said Raphi Levy, CFO of Alpha Tau. "We look forward to delivering continued clinical momentum and hope for patients as we evolve into a public company."

"We are excited about Alpha Tau’s unique therapy, which has generated a response observed across a wide array of solid tumors in pre-clinical studies, with minimal side effects, positioning it to potentially become a vital weapon in the battle against cancer," said Dr. David M. Milch. "After evaluating many opportunities in the healthcare industry, we believe that Alpha Tau stands out as the best choice for a business combination due to its proprietary technology, rapid clinical and product development and easy to administer treatment solution for the great number of cancer patients worldwide."

"It was a pleasure to work with the team at HCC as their due diligence advisor following my departure as Commissioner of the FDA in January 2021," said Dr. Stephen M. Hahn. "My background as a medical and radiation oncologist helped me immediately appreciate the potential of Alpha Tau’s therapy in providing a solution for a potentially significant number of patients, including those with untreatable or difficult to treat tumors, whether alone or in combination with other therapies such as immunotherapies. I would expect the product to be well received by the clinical community because of the potential applications, modest side effect profile, and demonstrated potency of the Alpha DaRT"

Proceeds of the business combination and the PIPE will be primarily used to:

advance ongoing, and launch, new clinical trials;

continue existing, and initiate additional, clinical and research collaborations;

develop and expand global manufacturing capacity;

develop KOL centers of excellence; and

prepare for commercialization efforts.

Key Transaction Terms

The Business Combination values Alpha Tau at an implied pre-money equity value of $600 million, and is expected to add approximately $337 million of cash to its balance sheet upon closing, inclusive of $275 million in HCC’s trust (assuming no redemptions by public shareholders) and $92 million in PIPE proceeds, net of transaction expenses.

All existing Alpha Tau shareholders will retain 100% of their current equity holdings and are expected to hold approximately 59% of the pro forma company immediately following the closing. Following the closing of the business combination, Alpha Tau is expected to be listed on the Nasdaq.

The Business Combination was unanimously approved by each of Alpha Tau’s and HCC’s Boards of Directors, and HCC Chairman Dr. David M. Milch is expected to join the Board of Directors after closing. The transaction is expected to be completed by the end of 2021, and is subject to obtaining necessary regulatory approvals, the fulfillment of customary closing conditions, as well as the approval of both Alpha Tau’s and HCC’s shareholders.

Additional information about the proposed business combination, including a copy of the definitive agreement and investor presentation, will be provided in a Current Report on Form 8-K to be filed by HCC with the Securities and Exchange Commission and available at www.sec.gov.

Advisors

Citigroup is acting as financial advisor to Alpha Tau. Citigroup, Piper Sandler, and Cantor Fitzgerald are acting as joint placement agents on the PIPE. Cantor Fitzgerald is acting as a capital markets advisor to HCC. Value Base M&A Ltd. is also acting as financial advisor on the transaction.

Latham & Watkins LLP and Meitar | Law Offices are acting as legal advisors to Alpha Tau. Ellenoff Grossman & Schole LLP and FBC & Co. are acting as legal advisors to HCC. Winston & Strawn LLP is acting as legal advisor to the placement agents.

Management Presentation

A link to a presentation by management of Alpha Tau and HCC discussing the business and the proposed transaction can be found at www.netroadshow.com/nrs/home/#!/?show=d422ce03

The investor presentation is being filed by Alpha Tau and HCC with the Securities and Exchange Commission ("SEC") and will be available on the SEC’s website at www.sec.gov.

On July 11, 2021 Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported data from two abstracts featuring its Bladder EpiCheck test at the 36th Annual European Association of Urology (EAU) Virtual Congress (Press release, Nucleix, JUL 11, 2021, View Source [SID1234584771]).

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The first abstract titled, "Real world evidence of alternating cystoscopy/cytology with Bladder EpiCheck in NMIBC surveillance," shows the results of a pilot performed at Radboud University Medical Center evaluating the feasibility and clinical outcomes of alternating between cystoscopy/cytology and Bladder EpiCheck in non-muscle invasive bladder cancer (NMIBC) surveillance. To alleviate the burden of invasive and costly standard surveillance methods on patients, urine collection was performed at home and shipped to a central lab to perform the Bladder EpiCheck test. In the pilot analysis, patients with follow-up showed Bladder EpiCheck achieved 100% sensitivity for high-grade disease, with specificity of 88%, thereby avoiding 76% of unnecessary cystoscopies. Authors concluded this modified surveillance schedule was both safe and cost-effective due to Bladder EpiCheck’s high sensitivity for high-grade disease and high specificity.

"This is the first published evidence for using an alternating schedule of a urine marker, such as Bladder EpiCheck, and cystoscopy or cytology. Due to Bladder EpiCheck’s high sensitivity for high-grade disease and high specificity, and a well-planned infrastructure, all high-grade tumors, including muscle invasive tumors, were detected while avoiding 76% of unnecessary cystoscopies," said Fred Witjes, M.D., Professor of Medical Sciences at Radboud University Medical Center. "As a result of the pilot, Radboud University hospital has implemented this monitoring schedule as a routine for all NMIBC patients."

The second abstract titled, "DNA methylation urine biomarkers test (EpiCheck assay) in the diagnosis of upper tract urothelial carcinoma: results from a single-center prospective study," evaluated the performance of Bladder EpiCheck in the detection of upper urinary tract urothelial carcinoma (UTUC) among 80 consecutive patients undergoing ureteroscopy for the diagnosis, treatment or follow-up of UTUC. The study found that Bladder EpiCheck achieved a high-grade sensitivity of 95.8%; a high-grade negative predictive value of 97.2%; and a specificity of 80.6% in urine collected from the ureter-bladder junction, compared to 80.0%, 90.0% and 91.7% for cytology, respectively.

"It is very challenging to stage a UTUC with a biopsy, as we know that up to 30% of UTUC are understaged with this technique. This can be detrimental to the patient as high-grade UTUC, if missed, can progress to metastases very quickly. Alternatively, if a patient with a low-grade tumor is mistaken for high-grade, or high-grade disease can’t be ruled-out, they might undergo unnecessary procedures such as removal of the ureter and kidney of that side," said Dr. Alberto Breda, head of the oncological urology unit and the kidney transplant team in Fundació Puigvert, Barcelona, Spain. "The results of this study show that Bladder EpiCheck can be a useful tool in the UTUC setting and could play a crucial role in the diagnosis and follow-up of the disease, particularly in ruling-out high-grade disease."

About Bladder EpiCheck

Bladder EpiCheck provides patients and clinicians with a simple, objective urine test to detect recurrence of bladder tumors. The test analyzes subtle disease-specific changes in DNA methylation markers, allowing for the detection of 92% of the high-risk (non Ta-LG) cancers. Bladder EpiCheck demonstrated negative predictive value (NPV) of 99% for high-risk cancer, meaning that when receiving a negative Bladder EpiCheck result, there is 99% chance that no high-risk cancer is present1. Bladder EpiCheck is intended for use as a noninvasive method for monitoring of tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer. Bladder EpiCheck is CE-marked and available in Europe. The test is not available for sale in the United States.

On July 9, 2021 ABL Bio, Inc. (KOSDAQ: 298380), a clinical-stage biotech developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, reported the publication of pre-clinical data highlighting the safety and anti-tumor efficacy of ABL503/TJ-L14B in the Journal for ImmunoTherapy of Cancer(JITC) (Press release, ABL Bio, JUL 9, 2021, View Source [SID1234584756]).

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Jointly developed with I-Mab (NASDAQ: IMAB), ABL503 is a bispecific antibody combining PD-L1 checkpoint pathway with 4-1BB agonistic activity to overcome the current limitation of PD-(L)1 therapy and 4-1BB related toxicity. Using ABL’s Grabody-T bispecific antibody platform technology, ABL503 induces 4-1BB activation only in the presence of PD-L1 expressing tumors to minimize the risk of 4-1BB related peripheral toxicity. ABL503 is currently being evaluated in a Phase 1 study in the U.S. in patients with locally advanced or metastatic solid tumors (NCT04762641).

The paper, "Novel anti-4-1BB X PD-L1 bispecific antibody augments anti-tumor immunity through tumor-directed T-cell activation and checkpoint blockade," was published in collaboration with Su-Hyung Park, PhD, Professor at the KAIST Graduate School of Medical Science and Engineering. The paper highlights key in vitro and in vivo research that demonstrate ABL503’s potential as a promising immunotherapeutic agent against cancer.

In the study, ABL503 induced complete tumor regression in humanized mice, which was superior to anti-PD-L1 or anti-4-1BB monotherapy. Moreover, no tumor growth was observed in these mice when they were rechallenged at 40 days after their first ABL503 treatment, demonstrating that ABL503 treatment yields a prolonged anti-tumor response despite a short-term administration schedule.

In addition, ABL503 was well-tolerated following a repeated high dose administration of ABL503 in monkeys. Monkeys treated with ABL503 exhibited overall good tolerance with normal liver functions.

"These published data validate our Grabody-T platform technology to achieve anti-tumor efficacy with a low risk of off-tumor liver toxicity and support the therapeutic value of ABL503 as a potential best-in-class treatment for cancer," said Sang Hoon Lee, PhD, CEO of ABL Bio. "We have great expectations for the program and look forward to further evaluating ABL503 in our Phase 1 study with I-Mab."

On July 9, 2021 RhoVac AB ("RhoVac"), a Swedish cancer immunotherapy company, reported on July 9th 2021, that its Safety Monitoring Committee has conducted a planned interim safety review of its clinical phase IIb trial in prostate cancer, known as BRaVac (Press release, RhoVac, JUL 9, 2021, View Source [SID1234584757]). The safety profile of RV001 was excellent and the Safety Monitoring Committee concluded the trial can continue without modifications.

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RhoVac started the clinical phase IIb trial (BRaVac) with the company’s drug candidate, RV001, late 2019, in prostate cancer patients with a biochemical recurrence (a rise in PSA) after curative intent therapy. In November of 2020, RhoVac was awarded Fast Track Designation by the FDA for RV001 in this cancer indication. RhoVac currently estimates finalizing the patient recruitment for the study no later than September this year, and after that the study will run to completion, which is estimated to take 9-12 months after the closing of the recruitment. The objective of the study is to show that RV001 can significantly prevent or delay disease progression in these patients, something for which no standard therapy is available today. As planned, an interim safety review was conducted today by the Safety Monitoring Committee, and no unexpected adverse events have been identified, confirming excellent safety, in concurrence with the previous clinical phase I/II findings.

RhoVac CEO, Anders Månsson, comments: "We had never anticipated anything but a clean safety review. Nevertheless, it is great to get further confirmation that our drug has a safety profile that makes it suitable for treating symptomless cancer patients who have already undergone local curative intent therapy, with an aim to prevent cancer recurrence. Also, the fact that we have excellent patient compliance in the study in spite of the pandemic circumstances, is a sign of how motivated these patients are to receive the treatment. This will add to the interest we already experience in our drug candidate".

This disclosure contains information that RhoVac is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 09-07-2021 14:20 CET.

On July 9, 2021 HAMLET Pharma reported that All required milestones and deliverables to date are without any significant deviations (Press release, HAMLET Pharma, JUL 9, 2021, View Source;utm_medium=rss&utm_campaign=hamlet-pharmas-achievements-are-emphasized-after-eu-evaluation-the-company-has-fully-achieved-its-milestones-and-secured-the-second-payment [SID1234584810]). This is particularly impressive in light of the global Corona virus pandemic.

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To date, the beneficiary has succeeded in manufacturing the Investigational Medicinal Product (IMP) Alpa1H. The company has demonstrated non-clinical improvement of therapeutic efficacy of other cancer drugs like Mitomycin C and Epirubicin, when combined with Alpa1H and successfully continued with the Phase I/II study of Alpha1H in bladder cancer patients.

There is evidence of good financial management in this project. The amount of financial resources utilized to date is proportionate to the achievements of the project to date".

Hamlet Pharma will now receive the second payment from the EIC Accelerator Horizon 2020 fund of approximately 6,7 million SEK. The third payment is expected at the end of the program.

This disclosure contains information that Hamlet is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 09-07-2021 09:47 CET.