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Chengdu Kanghong Pharma buys Israel's IOPtima for $56m
21 Nov, 2017 17:15
Gali Weinreb
The acquisition of the ophthalmology products company will generate $23-27.3 million in cash flow for BioLight, IOPtima's controlling shareholder.
BioLight Israeli Life Sciences Investments Ltd. (TASE:BOLT; Bulletin Board: BLGTY), which develops various ophthalmology products, has announced the completion of a deal to sell its IOPtime subsidiary. BioLight reported in April a memorandum of understanding for an initial investment in the company with an option for acquisition, and the option is now being exercised. IOPtima manufactures and markets a surgical device for treatment of glaucoma. BioLight's share price soared today by over 10%, pushing its market cap up to almost NIS 60 million.
The acquiring company is Chengdu Kanghong Pharmaceutical Group, which is listed on the Shenzhen stock exchange at a $6 billion market cap. The company works in the ophthalmology field, from R&D to marketing. BioLight reported that it would obtain $23.27.3 million in net cash flow from the deal, starting in late 2018. The deal will take place in four stages, with Chengdu Kanghong investing $7 million at a company value of $30 million, before money, in the first stage.
In the next stage, it will buy shares from IOPtima's existing shareholders, including BioLight, which has a 70% stake. If all of the stages are exercised, IOPtima will be sold at a $56 million value, to be paid gradually by 2021.
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Chengdu Kanghong will distribute IOPtima's products in China
Even before the deal is completed, Chengdu Kanghong will become a distributor of IOPtima's products in China. The terms for distributing the products are not known.
IOPtima is responsible for BioLight's only current commercial product. BioLight's revenue in 2016 totaled NIS 2.1 million, mostly from IOPtima's activity, and it lost NIS 21.8 million. The company had only NIS 544,000 in revenue in the first half of 2017, 33% less than in the corresponding period last year. IOPtima had NIS 25 million in cash as of the end of the first half of this year.
BioLight CEO Suzana Nahum-Zilberberg today remarked, "China is an important target market for the product. Cooperation with Chengdu Kanghong, which is active in ophthalmology inside and outside China, is the first step in future cooperation."
IOPtima CEO Ronen Castro said, "This is an important step for IOPtima that will enable it to deepen its penetration of the market in China and throughout the world, and to promote the unique solution that the company offers for glaucoma patients."
Israel Makov acquired BioLight in 2011 in order to realize his vision of assembling a group of companies in medical fields with synergy between them. Makov now owns 14% of BioLight, while Hong Kong investor Lau Ngai Cheung owns 18.8% and Indian investor Dilip Shanghvi owns 14%. IOPtima's product belonged to BioLight before Makov invested in the company, which has since added other products, including an intraocular eye implant for treatment of glaucoma, a product for diagnosing and guiding treatment of dry eye syndrome, and a platform for delivering drugs within the eye. These products are currently in development.
Published by Globes [online], Israel Business News - www.globes-
BioLight Reports Successful Results in Phase 1/2a Clinical Trial for Glaucoma Insert
TEL-AVIV, Israel, July 24, 2017 /PRNewswire/ --
BioLight Life Sciences Ltd. (TASE: BOLT) ("BioLight"), an emerging global ophthalmic company focused on the discovery, development and commercialization of ophthalmic products and product candidates, announced today successful results from its glaucoma insert VS101 ("Eye-D latanoprost insert") Phase 1/2a clinical trial, which demonstrated its ability to lower intraocular pressure ("IOP") for a 12-week period, with a favorable safety profile.
The Eye-D latanoprost insert is designed to provide sustained IOP-lowering for patients who have difficulty taking their prescribed eye drops for the treatment of glaucoma on a continuous daily basis.
BioLight's first-in-human study, this randomized, controlled, exploratory Phase 1/2a clinical trial was designed to compare three doses of its Eye-D latanoprost inserts to once-daily latanoprost eye drops. Following a simple, in-office procedure, the sustained release Eye-D latanoprost inserts were tested for 12 weeks and compared to once-daily latanoprost eye drops for the same period.
The Phase 1/2a results comprise data from 77 glaucoma patients that were collected from 19 clinical centers across the United States. The data demonstrated that a single placement of the Eye-D latanoprost insert of one of the three doses provided the best sustained reduction in IOP throughout the 12 weeks follow up, with a positive safety profile.
Highlights of the clinical trial results include:
Most adverse events were found to be mild and transient. No unanticipated adverse events were observed.
Mean diurnal IOP before treatment of patients that were treated with the effective dosed insert and completed the trial was 23.5 mmHg. A sustained reduction in IOP was observed with average diurnal IOP 17.9 mmHg at the primary endpoint of 12 weeks (5.6 mmHg, 24% reduction).
During the study, the company has gathered additional information about the procedure as well as the insert size, structure and location, which were used to improve retention rates in patient eyes.
"Ophthalmologists today continue to struggle with finding effective solutions to the significant problem of non-adherence to the pharmaceutical treatment of patients with glaucoma," said Dr. Howard Barnebey, MD, who served as a Principle Investigator in the study. "Non-adherence is a complex problem to solve. Several therapeutic approaches that aimed to address the lack of therapy compliance and persistence have either failed or are still in development."
Dr. Barnebey continued, "The Eye-D latanoprost insert has now successfully demonstrated effective intra-ocular pressure lowering for three months after subconjunctival placement of the insert in human eyes, and was well tolerated. This innovative insert presents a promising approach to improving therapeutic compliance, bypassing the issues of patients remembering to take medication as well as instilling it in their eyes. I am excited to participate in further development of Eye-D latanoprost insert."
Suzana Nahum Zilberberg, BioLight's CEO, commented, "We are very happy with the success of this clinical trial which demonstrated that the Eye-D latanoprost insert is safe and efficacious, and intend to continue our discussions with potential strategic partners, aiming to advance the development and approval process for the Eye-D latanoprost insert, while, at the same time, promoting additional steps that will assist in optimizing the treatment for glaucoma patients. This novel technology and its first indication, have the potential of becoming an important advance in the treatment of glaucoma patients".
About BioLight Life Sciences Ltd.
BioLight addresses a number of significant unmet medical needs with a pipeline of ophthalmic products and product candidates, which are in various commercial and clinical stages, including: IOPtiMate™, a laser-based non-invasive surgical treatment for glaucoma; TeaRx™, a diagnostic solution that provides a multi-assay analysis of tear film constituents in order to identify one or more underlying causes of dry eye syndrome, or DES; Eye-D, an in-office insertable platform that provides for controlled release of ophthalmic medications over time; OphRx's lyotropic liquid crystals, or LLC, a non-invasive drug delivery technology administered through eye drops as an alternative to current ocular delivery modalities; and LIPITEAR™, a microemulsion consisting of Phospholipidis and Triglycerides, which forms a tear-like elastic lipid shield which is indicated for use in DES, post-operative ocular surgery (e.g. refractive surgery, cataract surgery and corneal transplant) and corneal erosions. BioLight has also invested, through Micromedic, in innovations in cancer diagnostics.
Leading key investors are Mr. Israel Makov, Chairman of Sun Pharmaceuticals, former CEO and President of Teva Pharmaceuticals and former Chairman of Given Imaging, Mr. Dilip Shanghvi, founder of Sun Pharmaceuticals, India's largest pharmaceutical company, Mr. Dan Oren, founder and CEO of Dexcel Pharma, the second-largest pharmaceutical manufacturer in Israel and Rock-One, a Hong Kong-based investment company.
For more information please visit the Company's website at http://www.bio-light.co.il
Biolight Life Sciences: Raise Up To Nis12m In Rights Offering
By Edison Stock Markets
BioLight Life Sciences Ltd (TA:BOLT) is engaging in a shareholder rights offering of up to NIS12m (if fully subscribed) to strengthen its balance sheet. While BioLight had NIS20.2m net cash at Q117, most was held at subsidiaries, and only NIS4.7m was directly available to the parent firm; hence the imminent funding need. The four largest shareholders (representing 55%) will participate to some degree in the rights offering. If fully subscribed, we estimate the rights offering can provide funding into at least Q417. Our model, which does not yet include the rights offering or the potential IOPtima sale to a Chinese investor, derives an rNPV valuation of NIS92.9-103.4m.
Continuing to work towards completing IOPtima sale
In April 2017, BioLight’s IOPtima subsidiary (of which BioLight holds a 70% ownership stake) signed a non-binding term sheet, calling for it to be sold to Chengdu Kanghong Pharma. Chengdu had a 60-day exclusivity clause restricting IOPtima from entering potential sale discussions with other prospective buyers. While this window should expire imminently (mid-June 2017), BioLight management remains involved with ongoing discussions to finalise a sale transaction with Chengdu, and suggests the expiry of the exclusivity period should not diminish the likelihood of the completion or finalisation of the Chengdu deal.
BioLight will sell its stake in IOPtima in installments at a company value of $30-56 million.
BioLight Israeli Life Sciences Investments Ltd. (TASE:BOLT; Bulletin Board: BLGTY), chaired by Israel Makov and managed by CEO Suzana Nahum-Zilberberg, has signed a memorandum of understanding for the sale of its leading product, the only one directly generating revenue for the company, to a Chinese company. BioLight's share was up 8% today, pushing the company's market cap up to NIS 280 million.
IOPtima, a company that was part of BioLight's historical portfolio before Makov's involvement with the company, developed laser surgery technology for treatment of glaucoma. BioLight holds 70% of IOPtima. Under the memorandum of understanding, which for the present is non-binding, the Chinese company, Chengdu Kanghong Pharma will invest $7 million in IOPtima for 19% of that company's shares at a $30 million company value. The Chinese company will receive an exclusive license to market IOPtima's product in China. After six months, the Chinese company will acquire additional shares in IOPtima from the existing shareholders, including BioLight, thereby increasing Chengdu Kanghong Pharma's IOPtima stake to 60%, for $17.2 million, reflected a $42 million company value.
In two further stages scheduled for 2019 and 2021, the Chinese company will acquire the remaining shares in IOPtima at a price determined by IOPtima's profits, reflected a company value of $40-56 million.
BioLight's system for treatment of glaucoma is approved for marketing in China, Europe, Israel, Mexico, Peru, and Canada. IOPtima already has a Chinese subsidiary founded in order to market its products in this country.
Two months ago BioLight announced that a Chinese company was investing in BioLight itself, but this investment was called off when the Chinese government imposed restrictions on funds leaving the country.
BioLight needs money
BioLight's revenue totaled NIS 2.1 million in 2016, mostly from IOPtima, and the company lost NIS 21.8 million. The company burned NIS 27 million on current activities, leaving it with NIS 25 million.
If and when it receives revenue from the sale, BioLight will invest it in other products it is developing that have yet to reach the sales stage. These include a intra-eye implant for treatment of glaucoma, a product for diagnosing and guiding treatment for dry eye disease, and a product designed as a platform for transporting drugs within the eye. BioLight also owns 35% of Micromedic Technologies Ltd. (TASE:MCTC), a company developing cancer diagnostic tests.
It appears that although BioLight's vision is to found a collection of companies in a specific area enjoying synergy with each other, IOPtima is currently unsuitable for such an ophthalmology group, and will not become the marketing channel for the company's other products. This is probably because the company has not managed to generate substantial revenue, and also because unlike BioLight's other drugs, IOPtima's product is a surgical device, not a drug, test, or tool for guiding drugs. BioLight also needs the money that the IOPtima exit can provide.
Published by Globes [online], Israel Business News - www.globes-online.com - on April 19, 2017
BioLight's TeaRx Multi-Parameter Diagnostic Assays to be Used in Dry Eye Syndrome Drug Trial
TEL-AVIV, Israel, February 23, 2017 /PRNewswire/ --
BioLight Life Sciences Ltd. (BOLT.TA) ("BioLight"), an emerging global ophthalmic company focused on the discovery, development and commercialization of products and product candidates which address ophthalmic conditions, announced today that, DiagnosTear Ltd. ("DiagnosTear"), one of BioLight's subsidiaries, has signed a services agreement (the "Agreement") with a pharmaceuticals company, pursuant to which DiagnosTear will provide analysis services through its TeaRx™ multi-parameter diagnostic assays for use in an clinical trial for dry eye syndrome ("DES").
This Agreement marks the first time TeaRx™ will be used in a drug trial. The TeaRx™ assays will be used in order to characterize sub populations of responders and non-responders to the new DES drug treatment. Assuming the TeaRx™ analysis will result with a differentiation between responders and non-responders, the parties will, in good faith, extend their collaboration to a joint-development project of a potential companion diagnostics solution.
"DES is a multifactorial condition and, as such, requires a personalized approach to therapy," commented Suzana Nahum Zilberbeg, BioLight's Chief Executive Officer. "Indeed, the recent launch of a second FDA-approved drug for the treatment of DES clearly demonstrates that significant unmet medical need remains for the personalized treatment of patients suffering from this condition. With that in mind, we are thrilled to be involved in this clinical trial, and are optimistic about the role that TeaRx™ may play in the development of the next generation of DES therapeutics."
About Dry Eye Syndrome
DES is a common disorder of the ocular surface in which the eye produces insufficient tears or tears with abnormal composition. In its mild to moderate forms, DES causes pain and discomfort, and can impact vision quality and the ability to go about daily activities. In its more severe forms, DES can lead to the permanent loss of vision. DES affects approximately 40 million people in the U.S. and 100 million people worldwide. A change in any of the multiple parameters in the tear film could indicate a problem that might cause DES.
About TeaRx™
TeaRx™ is a diagnostic solution that provides a multi-assay analysis of tear film constituents in order to identify one or more underlying causes of DES.
Chinese fund in talks to buy BioLight
29 Dec, 2016 15:09
Gali Weinreb
If a deal takes place, the fund will initially buy the public's 45% holding in ophthalmic company BioLight, resulting in it being delisted.
Ophthalmic company BioLight Israeli Life Sciences Investments Ltd. (TASE:BOLT), run by Suzana Nahum-Zilberberg, announced today that it had signed a non-binding memorandum of understanding with a Chinese investment fund whereby the fund will buy the public's holdings in the company and delist it. If the acquisition goes ahead, it will be at a price of NIS 16.5 per share, representing a premium of 83% on the company's base share price this morning. The share price is currently up 45%, giving BioLight a market cap of NIS 13.6 million.
It should be pointed out that there is no binding agreement. The price, and the entire deal, are subject to due diligence. BioLight said that it estimated that the negotiations could continue for several more weeks.
BioLight has been seeking to commercialize some of its products in the past year, but it was asked to desist from contacts with third parties during the negotiations with the fund, which began in November. The company said today that this condition would shortly expire, perhaps indicating that it is still not certain that the deal with the fund will go ahead, and that it is going back to examining alternatives.
If a deal does take place, the fund will hold 45% of BioLight, for a payment of $5.1 million. The fund will then invest $5-7 million on the same terms and will become the controlling shareholder, but by then BiolIght will be a privately held company and the additional investment will not affect the investing public.
"Product cluster" vision
Former Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) CEO Israel Makov became the controlling shareholder in the stagnating biomed company in 2011. He wanted to use BioLight to realize his vision of "product clusters". According to this vision, Israeli biomed startups can best develop if synergy between them is built in at all stages of the development process: product development, regulation, finance, market research, and marketing. Makov (together with CEO Susana Nahum Zilberberg) assembled two such clusters. He leveraged a glaucoma surgery product, one of BioLight's long-standing technologies, and assembled a cluster of ophthalmology drugs around it. BioLight also acquired a 48% controlling share in Micromedic, a listed diagnostic company, which formerly served as a cluster in cancer diagnosis. The experiment was partly successful. BioLight's products have not yet been commercialized, and have therefore also not attained a value that the shareholders in Tel Aviv could relate to. Perhaps for this reason, the company share has gradually faded in recent years, and lost 72% of its value over the past year. BioLight sought to make an offering to the public last March, but could not complete it at the prices it wanted. That was also one of the reasons why its share price plummeted.
Nahum Zilberberg said, "The stock exchange was good to us for many years, but at the current valuation, it is logical to consider an investment like the one proposed to us. The product cluster vision is working in the company on a day-to-day basis. There is no connection between the vision and its reflection in the share price."
Published by Globes [online], Israel business news - www.globes-online.com - on December 29, 2016
BioLight Reports Successful Feasibility Clinical Study Results for the Detection of Prostate Cancer with CellDetect® Non-Invasive Test
TEL-AVIV, Israel, July 26, 2016 /PRNewswire/ --
BioLight Life Sciences Ltd. (BOLT.TA) ("BioLight" or the "Company"), an emerging global ophthalmic company focused on the discovery, development and commercialization of products and product candidates which address ophthalmic conditions and also in innovations in cancer diagnostics, announced promising results from a feasibility clinical study designed to detect prostate cancer cells in urine specimens using its CellDetect® technology. The study successfully demonstrated the feasibility of detecting intact cells originating in the prostate from urine samples following prostate massage.
The CellDetect® technology is being developed by Micromedic Technologies (MCTC.TA), BioLight's cancer diagnostics subsidiary, and allows an accurate diagnosis of cancerous and precancerous cells, based on a unique combination of color and morphology, by utilizing a proprietary kit containing unique extract and dyes. These study results represent a significant milestone in the commercial development of a third diagnostic product based on the CellDetect® platform technology for different cancers, and paves the way for the detection of prostate cancer through a simple urine test.
"We are very pleased with the results from this clinical study, which validates the potential we see in the CellDetect® technology to dramatically improve prostate cancer diagnostics," commented Susana Nahum Zilberberg, BioLight's Chief Executive Officer. "While prostate cancer is the second most common cancer in men worldwide, the currently available diagnostic testing is known to be unreliable or invasive and expensive. With the results that we have announced today, we are confident that CellDetect® has the potential to transform prostate cancer diagnostics, offering patients a non-invasive, accurate and reliable test, and one that could improve the healthcare system through considerable cost savings."
The feasibility clinical study was conducted in the Kaplan Medical Center in Israel. Using the CellDetect® technology, urine samples derived from prostate cancer patients and healthy subjects were examined for the existence of cancerous and precancerous cells using a unique color marker. Of the 18 samples tested, Micromedic's research team correctly diagnosed each case in the study. Assessment of the samples by an external reviewer produced encouraging results, correctly identifying most cases of prostate cancer and most of the healthy subjects as well.
"These results add momentum to what has already been a strong year for BioLight's CellDetect® platform," continued Ms. Zilberberg. "Overall, we believe this technology fills a key void in cancer diagnostics, not only for prostate cancer, but other cancer indications as well."
Last year, BioLight announced that a blinded, multi-center clinical study of CellDetect® had successfully achieved the study's primary endpoint for effectively detecting the recurrence of bladder cancer in subjects with a history of the disease. Since then, BioLight has obtained CE Marking for the use of CellDetect® testing for the detection of bladder cancer in urine, which allows the product to be marketed and sold in Europe and other territories. The Company also recently announced a partnership agreement with Axella Research LLC to advance commercialization of the bladder cancer product in the United States.
About Prostate Cancer
Prostate cancer is the second most common cancer among men worldwide. The incidence of prostate cancer in the U.S. is the highest in the world and it represents the second most common cause of cancer-related death in men. In 2014, 233,000 new cases of prostate cancer were diagnosed in the U.S., and nearly 30,000 patients died of the disease.
About CellDetect®
Micromedic's CellDetect® technology allows an accurate diagnosis of cancerous and precancerous cells, based on unique combination of color and morphology. The technology may be implemented in screening tests and monitoring tests of disease recurrence in cancer patients after being treated. Micromedic has proven the product's efficacy in diagnosing cervical cancer and bladder cancer in the framework of clinical trials, and estimates that the technology underlying the products may be implemented for use in additional cancer indications. Both the cervical cancer detection screening diagnostic test kit and detection of bladder cancer recurrence in urine are in the initial commercial stage.
BioLight Expands Its Product Portfolio With Eye Drops for Dry Eye Syndrome
TEL AVIV, Israel, May 19, 2016 /PRNewswire/ --
BioLight Life Sciences Ltd. (BOLT.TA), ("BioLight" or the "Company"), an emerging global ophthalmic company focused on the discovery, development and commercialization of products and product candidates which address ophthalmic conditions, announced today that it has obtained the worldwide rights (excluding Israel and Italy) for the manufacturing, distribution, marketing and sales of a groundbreaking new eye drop product for the treatment of dry eye syndrome (DES) and other ophthalmic indications. The product was in-licensed by BioLight from Fischer Pharmaceuticals Ltd. and RAMOT, the technology transfer arm of the Tel Aviv University. The product has CE Mark marketing approval in Europe, and BioLight is currently evaluating the clinical and regulatory efforts required to commercialize it in other territories around the world.
BioLight was also granted exclusive global rights (excluding Italy) by RAMOT to develop, manufacture and commercialize additional new ophthalmic therapies based on the product's underlying technology. The technology, which protects the ocular surface and enhances the corneal re-epithelization process, was originally developed in the Tel-Aviv University.
"This global in-licensing agreement adds a fifth major ophthalmic product to our pipeline," commented commented BioLight's Chief Executive Officer, Suzana Nahum Zilberberg. "While there have been a number of advances in the understanding and treatment of DES over the past few years, there is no question that significant unmet medical need remains. The potential synergies of pairing the new DES therapeutic product with our TeaRx™ multi-parameter diagnostic test for DES are both obvious and exciting. We look forward to updating our stakeholders as we progress."
About Dry Eye Syndrome
DES is a common disorder of the ocular surface in which the eye produces insufficient tears or tears with abnormal composition. In its mild to moderate forms, DES causes pain and discomfort, and can impact vision quality and the ability to go about daily activities. In its more severe forms, DES can lead to the permanent loss of vision. DES affects approximately 40 million people in the U.S. and 100 million people worldwide.
BioLight Reports 2015 Financial Results
TEL AVIV, Israel, April 4, 2016 /PRNewswire/ --
BioLight Life Sciences (BOLT.TA) ("BioLight" or the "Company"), an emerging global ophthalmic company focused on the discovery, development and commercialization of products and product candidates which address ophthalmic conditions, reported operational and financial results for the year ended December 31, 2015. Results were characterized by continued development and commercial progress in multiple markets, and the achievement of all previously announced 2015 milestones.
Operational Highlights:
Completed an upsized private investment and signed a strategic partnership with Rock-One International Holdings Ltd. designed to help BioLight maximize its presence within China, the second largest healthcare market in the world after the United States.
Reported first IOPtiMate™ System sales and procedures for a total of 1.4 million NIS (or approx. $360,000) in selected markets, enhanced worldwide marketing platform, and increased installed based, focusing on KOLs as the basis for expanding product sales going forward.
Completed a joint equity financing agreement pursuant to which two Asia-based venture capital firms invested in BioLight subsidiary, IOPtima, for an aggregate amount of US$6.0 million, representing an approx. US$21 million post-money valuation for IOPtima, primarily to enhance IOPtiMate™ sales and marketing efforts, as well as to initiate a regulatory approval pathway process for the IOPtimate™ system with the U.S. FDA.
Signed a collaboration agreement with Ora, Inc., a world-leading independent, full-service ophthalmic contract research organization and product development firm, pursuant to which the Company and Ora will work together to advance the clinical, regulatory and commercial development of BioLight's novel TeaRx™ multi-assay diagnostic test for dry eye syndrome ("DES").
Completed two positive U.S. clinical studies which assessed the TeaRx™' test's effectiveness in assessing tears of healthy subjects as well as patients with DES, providing the basis for regulatory submissions in the U.S and Europe in 2016.
Progressed with patient enrollment into an ongoing U.S. Phase 1/2a clinical study of Eye-D™ VS-101, BioLight's latanoprost insert product based on its ground-breaking in-office insertable platform that provides for controlled release of ophthalmic medications over time, the results of which are expected to be obtained in the second half of 2016.
Expanded BioLight's balanced and diverse pipeline of ophthalmic products and product candidates with OphRx, a joint-venture that is developing a non-invasive, eye-drop-based ophthalmic drug delivery technology as an alternative to current delivery modalities, such as intravitreal injections.
Reported positive clinical studies results for its CellDetect™ and BRONJ cancer diagnostics, and obtained CE Mark for the CellDetect™ bladder cancer test, enabling the product to be marketed and sold in Europe and other territories.
Financial Results:
All dollar amounts are expressed in New Israeli Shekels ("NIS"), with a convenience U.S. dollar translation of NIS amounts provided using the rate of NIS 3.902 to US$1.00, the representative rate of exchange as of December 31, 2015, and results are reported in accordance with International Financial Reporting Standards.
For the year ended December 31, 2015, BioLight's revenues were NIS 1.4 million (US$ 360,000). The net loss for 2015 was approximately NIS 27.6 million (US$ 7.1 million), or NIS 7.98 loss per share, as compared to a net loss of approximately NIS 36 million (US$ 9.2 million), or NIS 11.96 loss per share, for 2014.
BioLight ended 2015 in a strong financial position. As at December 31, 2015, the Company had approximately NIS 51 million (US$ 13.1 million) in cash and short-term deposits.
About BioLight Life Sciences Ltd.
BioLight address ophthalmic significant unmet medical needs with a pipeline of products and product candidates, which are in various commercial and clinical stages, including: IOPtiMate™, a laser-based non-invasive surgical treatment for glaucoma; TeaRx™, a diagnostic solution that provides a multi-assay analysis of tear film constituents in order to identify one or more underlying causes of DES; Eye-D™, an in-office insertable platform that provides for controlled release of ophthalmic medications over time and OphRx's lyotropic liquid crystals, or LLC, a non-invasive drug delivery technology administered through eye drops as an alternative to current ocular delivery modalities. BioLight has also invested, through Micromedic, in innovations in cancer diagnostics, including proprietary tests that are designated for bladder, cervical, multiple myeloma and other cancers.
Leading key investors are Mr. Israel Makov, Chairman of Sun Pharmaceuticals, former CEO and President of Teva Pharmaceuticals and former Chairman of Given Imaging, Mr. Dilip Shanghvi, founder of Sun Pharmaceuticals, India's largest pharmaceutical company, Mr. Dan Oren, founder and CEO of Dexcel Pharma, the second-largest pharmaceutical manufacturer in Israel and Rock-One, a Hong Kong-based investment company.
For more information please visit the Company's website at http://www.bio-light.co.il
CONTACTS:
Israel Investor Contact:
Itai Bar-Natan, CFO
Email: itai@bio-light.co.il
Tel: +972-73-2753400
U.S. Investor Contact:
Stephen Kilmer, IR
Email: steve@bio-light.co.il
Tel: +1-646-274-3580
Bio Light's IOPtiMate System Receives Regulatory Approval in Canada
PR Newswire Bio Light Israeli Life Sciences Investments Ltd.
TEL AVIV, Israel, December 21, 2015 /PRNewswire/ --
Bio Light Israeli Life Sciences Investments Ltd. (TASE: BOLT, OTCQX: BLGTY) ("Bio Light" or the "Company"), an emerging global ophthalmic company focused on the discovery, development and commercialization of products and product candidates which address ophthalmic conditions, announced today that its IOPtiMate™ system for the treatment of glaucoma has been approved by the Canadian Medical Devices Bureau, allowing the Company to commercialize the surgical system in Canada.
The IOPtiMate™ surgical system enables a non-penetrating, CO2 laser-assisted procedure known as CLASS (CO2 Laser-Assisted Sclerotomy Surgery) to reduce elevated intraocular pressure. CLASS is an automated, easy to perform procedure which requires only a short learning curve and provides a safer and more precise alternative to the complex and risky glaucoma surgeries that are currently available.
Bio Light is primarily marketing the IOPtiMate[TM] system to leading physicians and medical centers in Asia and Europe, which has resulted in first sales of the system in Hong Kong, Poland, Hungary, Romania, Peru and Portugal, with distribution agreements under negotiation in additional countries. The Company also recently signed a joint-financing agreement in November 2015 with two Asia-based venture capital firms to further support the global commercialization of the IOPtiMate™ system, as well as to initiate a regulatory approval pathway process for it with the U.S. Food and Drug Administration. With a Canadian license now in place, Bio Light plans to initiate commercial activity in Canada through a local distributer.
"According to CNIB, glaucoma is the second leading cause of vision loss for seniors in Canada, and more than 250,000 Canadians suffer from chronic open-angle glaucoma, the most common form of the disease," explained Biolight's Chief Executive Officer, Suzana Nahum Zilberberg. "The IOPtiMate[TM] system represents a true breakthrough for people who are afflicted by this terrible disease, and we are thrilled to secure the necessary approval to drive the adoption and commercialization of this innovative surgical solution in Canada."
BioLight Announces First IOPtiMate™ System Sale in Portugal
PR Newswire BioLight Life Sciences Investments Ltd.
TEL AVIV, Israel, December 8, 2015 /PRNewswire/ --
BioLight Life Sciences Investments Ltd. (TASE: BOLT, OTCQX: BLGTY) ("BioLight" or the "Company"), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, today announced the first sale of the IOPtiMate™ system to a medical center located in Portugal.
The IOPtiMate™ system is based on CO2 laser technology that enables the performance of a unique filtration surgery to treat glaucoma without penetrating the inner part of the eyeball, thus allowing for substantial reductions in post-operative complications and use of eye drops compared with alternatives.
The IOPtiMate system is currently being marketed primarily to leading physicians and medical centers in Asia and Europe. These marketing efforts have resulted in recent first sales of the IOPtiMate™ system in Hong Kong, Poland, Hungary, Romania and Peru.
Recently, the Company announced that it had entered into a joint financing agreement with two Asia-based venture capital firms (the "New Investors"), pursuant to which BioLight and the New Investors will make a direct equity investment in BioLight's IOPtima Ltd. subsidiary via a private placement. The financing will help IOPtima to continue the global commercialization of its innovative IOPtimate™ system, as well as to initiate a regulatory approval pathway process for the system with the U.S. Food and Drug Administration, commencing 2016.
This press release is being made in accordance with BioLight's policy of announcing a first sale in a new territory.
BioLight Chugging Along Slowly But Steadily
Dec. 4, 2015 3:25 PM ET | About: BioLight Israeli Life Sciences Investments Ltd. ADR (BLGTY)
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. (More...)
Summary
On December 1, 2015 BioLight Israeli Life Sciences Ltd. (OTCQX: BLGTY, TASE: BOLT) reported third quarter financial results.
For the third quarter of 2015 BioLight's revenues were $167k, mostly from the sales of IOPtiMate systems.
The company burned roughly $1.4 million in cash from operational activities and exited the third quarter with a cash balance of $9.4 million.
There are several catalysts in the pipeline that have the potential to drive up shareholder value.
Operational Update
During the second quarter of 2015 BioLight signed a strategic partnership with Rock-One International Holdings Ltd. to help maximize its presence within China. Rock-One has a history of successful international collaborations and vast experience and understanding of China's unique regulatory requirements. As China is the second largest healthcare market in the world after the U.S., and since Rock-One has a reliable domestic distribution and service infrastructure within China, the partnership with Rock-One should help BioLight expand their reach within the country.
In July of this year the company announced the changes in American Depository Receipts (ADR) conversion ratio. A 1-for-10 reverse split of its ordinary shares, where one ADR represents ten shares.
Product development pipeline…
…IOPtiMate…
To-date, BioLight has installed the IOPtiMate system in healthcare centers in Thailand, Italy, Eastern Europe (Poland, Hungary, and Romania), Turkey, Hong Kong, and China as they sported favorable market dynamics and insurance reimbursement. In August 2015, one system was sold in Peru, following which the company entered into additional distribution agreements in Argentina and Portugal. BioLight generates revenues for IOPtiMate systems from two channels; from initial sales of the device as well as from the fees customers pay for each procedure they perform using the system.
During the second quarter of this year BioLight announced their first commercial sales of the IOPtiMate system in Hungary as well as in Romania. It was the first sale in Romania using the pay-per-procedure model. Physician adoption is a major driver of revenue for new technologies, and thus far, sales have been nominal as the IOPtiMate systems are still largely in an evaluation stage. As physicians share their clinical experience, we expect adoption and utilization to increase gradually. Since the IOPtiMate system already has a CE Mark, the company is continuing its efforts to accelerate sales in the European Union.
In March 2014, the China Food and Drug Administration (CFDA) approved the marketing and sale of the IOPtiMate system in that country. The devices that were installed in a few medical centers across the country the past year are currently undergoing clinical evaluation. BioLight intends to use the Chinese market as an anchor to enter additional developing Asian territories, such as India, which could be an additional long-term revenue catalyst. BioLight is pursuing regulatory approval in Canada and is in search of a partner in the U.S. to market their device. We see these regions as having potential to meaningfully drive up sales of the IOPtiMate systems.
BioLight, along with venture funds in Taiwan and China invested roughly $7.2 million in its subsidiary IOPtima in November 2015. BioLight will hold approximately 71% of IOPtima's issued and outstanding shares when the deal closes in the coming weeks. As per the agreement the investors will have the right to trigger a "drag along mechanism" if IOPtima fails to reach the forecasted revenue ($13.7 million) and regulatory milestones (FDA approval) within three years of deal closing.
Meanwhile, in September 2015 the IOPtiMate system was granted an Israeli patent that will expire on December 30, 2029.
…EyeD…
Clinical trials in the U.S. (Phase 1/2a) involving the EyeD technology are currently underway. While conducting the trials in humans with the prototype (EyeD) device, the R&D team gathered an initial base of clinical experience. Due to a slower than expected enrollment rate and optimizations of the insert's structure and its insertion procedures the results of the clinical trials are expected during the first half of 2016.
…TeaRx…
In February 2015, the company reported clinical study findings that identified positive statistical correlations between the TeaRx test's diagnostic parameters and widely used benchmark tests for dry eye syndrome (NYSEARCA:DES). BioLight has initiated a second clinical trial in order to assess the effectiveness of the tests in tears of healthy subjects as well as patients with severe DES. Management noted in its third quarter report that the enrollment of subjects for the trial was completed at the beginning of Q3 2015 and the results from this second trial are expected by end of Q4 2015. The process of defining the reliable combination of parameters that are required for the DES diagnostic kit is underway after which BioLight will initiate regulatory approval activities.
In mid-June 2015, BioLight announced their collaboration with Ora Inc., a world-leading independent, full-service ophthalmic contract research organization (CRO) and product development firm, to aid in the commercial development of TeaRx. The two companies have agreed to fund the clinical study and other activities required to obtain U.S. 510K regulatory approval for TeaRx as well as to incorporate the test kit in other clinical trials sponsored by third parties and performed by Ora.
Diagnostear received investment from BioLight as well as from the Office of Chief Scientist in the amount of $550k. BioLight's holdings in Diagnostear will be 74%.
…OphRx…
OphRx offers a unique drug delivery technology that is based on the principle of molecular transport across cell membranes using liquid crystals. The technology creates a basis to load different molecules and release them in a controlled mechanism to the target location. BioLight believes that this technology could be utilized for ophthalmic drug delivery for front and/or back of the eye diseases. The company is currently working on developing a novel formulation for the molecule. It is being designed to deliver the correct dose, follow a predictive route, and release the drug either in a controlled or sustained pattern. Once the formulation is completed, management anticipates commencing pre-clinical trials.
In November 2015, XL Vision and Integra invested the aggregate amount of $0.4 million in OphRx.
…CellDetect…
A large unmet need exists in the U.S. and Europe for non-invasive screening of bladder/cervical cancer. Studies have shown the incidence/mortality rates as well as the costs associated with the disease detection to be high.
Bladder Cancer - Management reported successful results from their blinded, multi-center clinical study using the CellDetect technology. The primary endpoint of effectively detecting the recurrence of bladder cancer in subjects with a history of the disease was achieved. BioLight is pursuing an Israeli AMAR approval, pending which the company hopes to launch in Israel by Q1 2016. The company is now focused on building awareness of the product to facilitate broader roll-out in Europe using distribution agreements in CE Mark territories. In November 2015, BioLight entered into a partnership with Axella Research LLC, to help manage clinical trials and obtain regulatory approval for marketing the CellDetect diagnostic test kit in the U.S. Axella has agreed to contribute over $1 million for this purpose and in exchange will be paid royalties from future U.S.-based sales of CellDetect diagnostic test kits.
Cervical Cancer - Proof of concept has been completed for cervical cancer detection and identification using the CellDetect kit. CE Marking was granted for marketing CellDetect in Europe and Israeli Ministry of Health approved the marketing of CellDetect in Israel. The product also received CFDA approval for marketing in China. BioLight is scouting for possible distribution channels in China and India to commercialize the CellDetect technology for the detection of cervical cancer. The company is also actively pursuing strategies to accelerate sales with their existing distributors in other geographical regions.
In July 2015, the U.S. and European patent office issued a patent for the CellDetect technology, intended to identify cervical cancer cells, which will be in effect until 2030.
In September 2015, the company obtained approval for conducting a clinical trial for diagnosing prostate cancer in urine samples using the CellDetect technology. The trial is expected to conclude by end of Q1 2016.
…BRONJ…
BRONJ is a severe side effect from the use of biophosphonate drugs, prescribed to metastatic cancer patients and osteoporosis patients, causing necrosis of the maxillary bone. This side effect has a prevalence rate of up to 18.6% among multiple myeloma patients, 1.2-12% among breast cancer patients, 6.5-7% among prostate cancer patients and up to 0.1% among osteoporosis patients treated orally. Over 15 million prescriptions for biophosphonates, administered orally or by way of infusion, are issued in the U.S. alone.
At Tel Hashomer Medical Center, Israel, a study was conducted to identify the unique genetic profile that enables the assessment of risk among cancer patients to develop BRONJ and results were reported in May 2014. In order to validate the findings from this study, another trial was performed at the Florida University in the U.S., and at the Tel Hashomer Medical Center, Israel, using diverse patient populations from the U.S., Europe, and Israel. The trial involved 125 subjects who were treated with bisphosphonate drugs, of which 108 were multiple myeloma patients, 13 were breast cancer patients, and four were patients suffering from other cancers. Of the total number of subjects, 69 patients developed BRONJ and the remaining 56 did not. In August 2015, the company announced that they are developing a novel SNP assay (licensed technology from the University of Florida) to detect individuals with a unique genetic profile that are 10 times more susceptible to develop BRONJ. Eventually, the company anticipates developing a test kit that will allow categorizing the risk of developing BRONJ in patients who are treated for cancer.
Valuation
BioLight is currently working towards expanding its distribution network in the global regions by increasing the number of distributors and engaging independent sales representatives. The IOPtiMate systems are currently under clinical evaluations at several leading medical centers in Europe and Asia and therefore are yet to be fully launched. Although this process builds awareness and helps in expanding the device's presence in the respective regions, being in the "try-out" phase by physicians alone does not translate into meaningful revenue numbers. Since the commercial roll-out in Q4 2014, quarterly sales revenues have been incrementally increasing from the beginning of 2015 but have been relatively light. While we remain optimistic that IOPtiMate device uptake may gain traction as awareness builds, we think that revenues could be uneven until demand grows for state-of-the-art technologies in glaucoma surgery. As market adoption increases, we anticipate a significant increase in system/procedure sales beginning late 2016 which would help smooth this unevenness. Therefore, we have modeled sales to be light in the initial years since device uptake may be slow but built in double-digit sales growth in most territories in the out years.
We think that BioLight is likely to gain entry into the U.S. market for the IOPtiMate system around 2018 and if the company is successful in obtaining regulatory approval, it has the potential to steepen the revenue curve. We are looking forward to the results from the clinical trials employing the TeaRx and EyeD technology. OphRx's molecule, a nascent-stage product in the pipeline could be a potential source of revenue in the long term.
The slower than anticipated market adoption of the device has prompted us to make some meaningful downward revisions to our forecasted revenues in the near term. Consequently, this has resulted in a downward revision in the target price from $12.00/share to $10.00/share. However, there are several catalysts in the pipeline that have the potential to drive up shareholder value. We remain optimistic as the company continues to execute its growth strategy. We maintain our Buy rating.
BioLight Announces Partnership With Axella Research For CellDetect® Non-Invasive Test for Monitoring Recurrence of Bladder Cancer
TEL-AVIV, Israel, November 30, 2015 /PRNewswire/ --
BioLight Life Sciences Investments (OTCQX:BLGTY, TASE:BOLT) ("BioLight" or the "Company"), announced today that its cancer diagnostics subsidiary, Micromedic Technologies (MCTC.TA) ("Micromedic"), has entered into a Collaboration Agreement (the "Agreement") with Axella Research LLC ("Axella"), to advance the clinical and regulatory efforts required to commercialize the CellDetect® non-invasive diagnostic test for the monitoring of bladder cancer recurrence in the United States.
Under terms of the Agreement, Axella will contribute over US$1 million in funding and the delivery of key clinical research organization ("CRO") services, including the management and execution of a clinical trial, in order to obtain regulatory approval for the sales and marketing of CellDetect® in the United States. In exchange for financing and CRO services, Axella will be entitled to royalties from future U.S.-based sales of CellDetect®.
"We are thrilled to announce this strategic partnership with Axella, which will yield meaningful progress towards regulatory approval of CellDetect® in the United States, and accelerate the commercialization of this novel technology," commented Suzana Nahum Zilberberg, BioLight's Chief Executive Officer. "With the highest recurrence rate of all cancers worldwide, there is a pressing need for improved diagnostic technologies to combat bladder cancer. CellDetect® bladder cancer fills that void by delivering an accurate and reliable non-invasive test, offering significant commercial potential in the largest cancer diagnostics market in the world."
Micromedic is currently developing the CellDetect® technology, which allows an accurate diagnosis of cancerous cells based on a unique combination of color differentiation and morphology, by utilizing a proprietary kit containing unique extract and dyes.
Earlier this year, BioLight announced that CellDetect® bladder cancer monitoring had obtained CE Mark, enabling the product to be marketed and sold in Europe. This followed the successful completion of a blinded, multi-center clinical study of CellDetect® in February 2015, which achieved the study's primary endpoint for effectively detecting the recurrence of bladder cancer in subjects with a history of the disease. The CellDetect® bladder cancer test successfully identified cancerous cells in urine samples in patients with a history of the disease, with reported sensitivity of 84.4% and specificity of 82.7% for the study's primary endpoint.
Micromedic plans to submit a Pre-IDE for the Product to the U.S. Food and Drug Administration in H1/2016.
About Bladder Cancer
Bladder cancer is the fourth most prevalent cancer among males in the U.S. and the seventh most prevalent among males worldwide, with nearly 430,000 new cases of the disease diagnosed globally in 2012. The rate of recurrence is the highest of all cancers and ranges from 50% to 80%. According to U.S. clinical guidelines, patients with a history of urinary bladder cancer are required to undergo three to four tests per year to monitor disease recurrence in the first two years immediately following treatment, and one test annually in the years that follow. Because of high recurrence rates, the cost of diagnosing and treating bladder cancer is among the highest of all cancers.
About CellDetect®
Micromedic's CellDetect® technology allows an accurate diagnosis of cancerous and precancerous cells, based on unique combination of color and morphology. The technology may be implemented in screening tests and monitoring tests of disease recurrence in cancer patients after being treated. Micromedic has proven the product's efficacy in diagnosing cervical cancer and bladder cancer in the framework of clinical trials, and estimates that the technology underlying the products may be implemented for use in additional cancer indications. The cervical cancer detection screening diagnostic test kit is in the initial commercial stage and Micromedic recently completed a clinical trial to prove its ability to monitor bladder cancer recurrence. Micromedic believes that the underlying technology may be adapted for other types of cancer as well.
BioLight Announces Joint Investment in IOPtima Subsidiary
PR Newswire BioLight Life Sciences Investments Ltd
TEL-AVIV, Israel, November 25, 2015 /PRNewswire/ --
BioLight Life Sciences Investments (OTCQX: BLGTY, TASE: BOLT) ("BioLight" or the "Company"), a company focused primarily on the discovery, development and commercialization of breakthrough ophthalmic diagnostics and therapeutics, announced today that it has entered into a joint financing agreement (the "Agreement") with two Asia-based venture capital firms (the "New Investors"), pursuant to which BioLight and the New Investors will make a direct equity investment in BioLight's IOPtima Ltd. subsidiary ("IOPtima") via a private placement. The financing will help IOPtima to continue the global commercialization of its innovative IOPtimate™ system used in the treatment of glaucoma, as well as to initiate a regulatory approval pathway process for the IOPtimate™ system with the U.S. Food and Drug Administration, commencing 2016.
Under the terms of the agreement, the New Investors and BioLight will invest an aggregate amount of US$6.0 million and US$1.2 million, respectively. The investments are being made on the basis of a US$13.5 million pre-money valuation for IOPtima. Upon completion of the private placement, BioLight will hold approximately 71% of IOPtima's issued and outstanding shares. The Agreement also stipulates that the New Investors will have the right to trigger a "drag along mechanism" and other protective provisions if IOPtima fails to reach certain pre-stipulated revenue and regulatory milestones. The private placement is expected to close within the next few weeks, subject to standard closing terms.
IOPtima is a developer of minimally invasive surgical ophthalmic devices. The company's flagship product, IOPtiMateTM, is based on CO2 laser technology that enables the performance of a unique filtration surgery to treat glaucoma without penetrating the inner part of the eyeball. The IOPtiMate procedure provides high efficacy and allows for substantial reductions in post-operative complications and use of eye drops compared with alternatives. Recent marketing efforts by IOPtima have resulted in first sales of IOPtiMate™ in Hong Kong, Poland, Hungary, Romania and Peru, with distribution agreements also being negotiated in additional countries.
"We are excited to have signed this IOPtima financing deal, which will allow us to secure the financial resources needed to maximize IOPtima™'s commercial potential," commented BioLight's Chief Executive Officer, Suzana Nahum Zilberberg. "Interest in IOPtiMate™ and its clinical benefits continues to spread amongst clinicians, patients and payers around the world, and this investment will allow us to continue to drive global awareness and commercialization of this innovative surgical system."
This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.
About BioLight Life Sciences Ltd.
BioLight's ophthalmic product offering and pipeline of product candidates include IOPtiMate™, a laser-based non-invasive surgical treatment for glaucoma; TeaRx™, a point-of-care multi-parameter diagnostic test for dry eye syndrome; Eye-D®, a controlled release drug-delivery insert platform and OphRx's LLC, a non-invasive topical drug delivery technology administered through eye drops as an alternative to the current ocular delivery modalities; BioLight has also invested in biomedical innovations in cancer diagnostics, including proprietary tests that are designated for bladder, cervical, multiple myeloma and other cancers.
Leading key investors are Mr. Israel Makov, Chairman of Sun Pharmaceuticals, former CEO and President of Teva Pharmaceuticals and former Chairman of Given Imaging, Mr. Dilip Shanghvi, founder of Sun Pharmaceuticals, India's largest pharmaceutical company, and Mr. Dan Oren, founder and CEO of Dexcel Pharma, the second-largest pharmaceutical manufacturer in Israel and Rock-One, an Hong Kong-based investment company.
For more information please visit the Company's website at http://www.bio-light.co.il.
CONTACTS:
BioLight
Itai Bar-Natan, CFO
Email: itai@bio-light.co.il
Tel: +972-73-2753400
BioLight’s Eye-D Technology to be Featured at the 5th Annual Partnership Opportunities in Drug Delivery Conference in Boston
PR Newswire BioLight Life Sciences Investments
TEL-AVIV, Israel, September 24, 2015 /PRNewswire/ --
BioLight Life Sciences Investments (OTCQX: BLGTY, TASE: BOLT) ("BioLight" or the "Company"), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, announced today that its Eye-D platform insert will be presented at the 5th Annual Partnership Opportunities in Drug Delivery ("PODD") conference on Monday, October 5, 2015 at 2:00 p.m. Eastern Time at the Boston Intercontinental Hotel in Boston, MA.
The Eye-D is BioLight's platform insert for controlled release ophthalmic medications. The Eye-D is designed to address the known poor compliance of eye drops administration. The first Eye-D indication, the VS-101, contains the market leading glaucoma drug, latanoprost (Pfizer Inc.'s Xalatan®). Utilizing a simple in-office procedure, the VS-101 is intended to release prostaglandin analog (PGA) drug in a controlled manner over time, providing 100% patient compliance to drug therapy.
PODD 2015 seeks to foster a meeting place that inspires innovation and advancement of drug development and delivery as well as providing support for the leaders behind the movement. For more information on the conference, please visit http://theconferenceforum.org/conferences/partners-in-drug-delivery/agenda/.