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Heathcare and Biotech Updates

NantKwest Shares Jump More than 50% Following JP Morgan Healthcare Conference Presentation

By The Life Science Report

Source: Streetwise Reports   01/16/2020

Shares of NantKwest Inc. spiked as much as 85% higher in mid-morning trading setting a new 52-week high price after the company reported a series of positive results at the 38th J.P. Morgan Healthcare Conference in San Francisco. The firm reported that complete responses were noted in as many as six different multiple tumor types when “natural killer” cells and T cells are activated simultaneously.

In a presentation to the 2020 JP Morgan Healthcare Conference in San Francisco, Patrick Soon-Shiong, M.D., chairman and CEO of NantKwest Inc. ((NK:NASDAQ), a clinical-stage immunotherapy company focused on harnessing the power of the innate immune system by using the natural killer cell to treat cancer, infectious diseases and inflammatory diseases, and ImmunityBio Inc. presented an update of the Cancer Breakthrough 2020 Initiative and findings on the preliminary safety and early signals of efficacy in Phase 1 and 2 trials for multiple tumor types.

The firm advised in the presentation that “complete Responses were noted in multiple tumor types including Pancreatic, Triple Negative Breast, Head and Neck, Merkel Cell, and Bladder cancers and Non-Hodgkin’s Lymphoma when Natural Killer cells and T cells are activated simultaneously.”

Dr. Soon-Shiong commented, “We hypothesized that a common treatment protocol that harnesses both the natural-killer cell and T cells could be effective in inducing immunogenic cell death leading to durable responses across multiple tumor types. We are grateful for the support of the FDA and over 200 investigators in 41 states who have been involved in testing this hypothesis in cancer patients with advanced disease…The number of patients who experienced a complete remission in this advanced setting is encouraging and further validates our premise that high-dose chemo is harmful and that a paradigm change of exposing the tumor to a carefully orchestrated ‘triple triangle offense’ of NK cell, Dendritic cell and T-cell activation, is a safe cellular and immunotherapy regimen and can be administered in the outpatient setting with promising activity across multiple tumor types. Testing this hypothesis has been the basis of the QUILT trials since 2017.”

Dr. Soon-Shiong previously announced the initiative at the JP Morgan Healthcare Conference in 2016 and advised that the initiative has made significant progress since then based on research and clinical trials. Some of the specific highlights and achievements included for the initiative are that from 2017 to 2019 it has reportedly obtained 39 Investigational New Drugs authorizations from the FDA to undertake Phase 1 and 2 trials across multiple tumor types to assess safety and efficacy with 10 first-in-human immunotherapy agents as single agents and in novel combinations.

The report explained that “the Cancer Breakthroughs 2020 program is one of the most comprehensive cancer initiatives launched to date which seeks to accelerate the potential of combination immunotherapy as the next generation standard of care in cancer patients by inducing immunogenic cell death and thereby avoiding the adverse effects of high dose chemotherapy.”

NantKwest is headquartered in Culver City, Calif., and stated that “it is an innovative, clinical-stage immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and virally induced infectious diseases,” and further claimed that it is the “leading producer of clinical dose forms of off-the-shelf Natural Killer (NK) cell therapies.” The company indicated that the safety of its optimized, activated NK cells along with their activity against a broad range of cancers, have been tested in Phase I clinical trials in Canada and Europe, and in multiple U.S.-based Phase I and II clinical trials.

The report indicated that ImmunityBio is a privately held immunotherapy company and its “oncological goals are to employ its broad portfolio of biological molecules to activate endogenous NK and CD8+ T cells, and to develop a T cell memory cancer vaccine to combat multiple tumor types without the use of high-dose chemotherapy.” The firm is also registered in Culver City, Calif.

NantKwest has a has a market capitalization of around $521.3 million with approximately 98.37 million shares outstanding and a short interest of about 2.9%. NK shares opened relatively unchanged today at $5.35 (+$0.05, +0.94%) over yesterday’s $5.30 closing price. The share price then took off during mid-morning trading and reached a new 52-week high price of $9.90. The stock has traded today between $5.35 to $9.90 per share and is presently trading at $8.16 (+$2.86, +53.96%).

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: (NK:NASDAQ,
)

Biotech Announces Deal with Bayer on Non-Hormonal Contraception

By The Life Science Report

Source: Streetwise Reports   01/15/2020

Details of the arrangement and an update on the company’s pipeline are provided in a Dawson James report.

In a Jan. 13 research note, Dawson James Securities analyst Jason Kolbert reported that Daré Bioscience Inc. (DARE:NASDAQ) partnered with Bayer, the company behind the Marina intrauterine device, to advance Daré’s Ovaprene, a hormone-free, intravaginal contraceptive ring. “Bayer’s track record with this device makes it an ideal partner to commercialize Ovaprene,” he added.

Kolbert explained the deal, which goes into effect when and if Bayer pays Daré $20 million for clinical expenses. Daré will get access to Bayer’s clinical and market capabilities, including talent working with Daré on next steps. Daré will retain control of the clinical development and regulatory process of Ovaprene. The arrangement also includes milestone payments of up to $310 million and tiered, double-digit royalties on net sales.

As for what’s next regarding Ovaprene, Kolbert pointed out, Daré will file an investigation device exemption, in H1/20 it said. Then in H2/20, assuming acceptance by the U.S. Food and Drug Administration, Daré will commence a pivotal contraceptive effectiveness and safety clinical study of Ovaprene, “the goal being to, based on this trial, pursue U.S., European and other key countries.”

Kolbert indicated the progress of Daré’s other candidates in the pipeline. DARE-BV1, being developed as a gel treatment for bacterial vaginosis, is expected to enter Phase 3 in the clinic this year. “With high cure rates (as high as 86%), the product appears superior to the standard of care treatments that average 50%,” Kolbert highlighted.

Daré’s Sildenafil cream for female sexual arousal disorder (FSAD) is slated to enter a Phase 2b study this year. Sildenafil “has shown efficacy to address a segment of the female population (10 million-plus sexually active women) that is currently living with the disorder,” noted Kolbert. Today, no therapeutics are on the market for FSAD.

Finally, Kolbert outlined the order in which Dawson James expects commercialization of these there Daré products. DARE-BV1 will be first, in 2021 in the U.S., followed by Ovaprene in 2023 in the U.S. Next would be Sildenafil in 2024 in the U.S., Ovaprene in 2025 in the European Union (EU) and, finally, Sildenafil in 2026 in the EU.

Dawson James has a Buy rating and a $4 per share price target on Daré Bioscience, whose stock is currently trading at around $1.39 per share.

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Disclosure:
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Disclosures for Dawson James Securities, Dare Bioscience, January 13, 2020,

The Firm does not make a market in the securities of the subject company(s). The Firm has NOT engaged in investment banking
relationships with Dare in the prior twelve months, as a manager or co-manager of a public offering and has NOT received compensation resulting from those relationships. The Firm may seek compensation for investment banking services in the future from the subject company(s). The Firm has received any other compensation from the subject company(s) in the last 12 months for services unrelated to managing or co-managing of a public offering.

Neither the research analyst(s) whose name appears on this report nor any member of his (their) household is an officer, director or advisory board member of these companies. The Firm and/or its directors and employees may own securities of the company(s) in this report and may increase or decrease holdings in the future. As of December 31, 2019, the Firm as a whole did not beneficially own 1% or more of any class of common equity securities of the subject company(s) of this report. The Firm, its officers, directors, analysts or employees may affect transactions in and have long or short positions in the securities (or options or warrants related to those securities) of the company(s) subject to this report. The Firm may affect transactions as principal or agent in those securities.

Analysts receive no direct compensation in connection with the Firm’s investment banking business. All Firm employees, including the analyst(s) responsible for preparing this report, may be eligible to receive non-product or service specific monetary bonus compensation that is based upon various factors, including total revenues of the Firm and its affiliates as well as a portion of the proceeds from a broad pool of investment vehicles consisting of components of the compensation generated by investment banking activities, including but not limited to shares of stock and/or warrants, which may or may not include the securities referenced in this report.

Analyst Certification: The analyst(s) whose name appears on this research report certifies that 1) all of the views expressed in this report accurately reflect his (their) personal views about any and all of the subject securities or issuers discussed; and 2) no part of the research analyst’s compensation was, is, or will be directly or indirectly related to the specific recommendations or views expressed by the research analyst in this research report; and 3) all Dawson James employees, including the analyst(s) responsible for preparing this research report, may be eligible to receive non-product or service specific monetary bonus compensation that is based upon various factors, including total revenues of Dawson James and its affiliates as well as a portion of the proceeds from a broad pool of investment vehicles consisting of components of the compensation generated by investment banking activities, including but not limited to shares of stock and/or warrants, which may or may not include the securities referenced in this report.

( Companies Mentioned: DARE:NASDAQ,
)

Disruptive Technology Poised to Deliver Significant Advancement in Bladder Cancer Detection

By The Life Science Report

Source: Chris Temple for Streetwise Reports   01/14/2020

Chris Temple, editor and publisher of The National Investor, explains why he recommends this small-cap as a Buy.

  • Imagin Medical’s disruptive technology is poised to deliver the most significant advancement in bladder cancer detection and removal in decades, making the detection and removal of cancer FAR more efficient and effective.
  • Already, Imagin’s i/Blue Imaging™ System is being embraced by urologists; most recently at the American Urological Association’s annual meeting, held in May in Chicago. Imagin held private focus groups, where leading urologists assessed the initial functional product and provided overwhelmingly positive feedback that was used to finalize the i/Blue product user’s needs.
  • So compelling is Imagin’s proprietary technology and potential benefits for both medical professionals and especially patients that leading urologists have even invested in Imagin Medical!

Whether in bull or bear markets, long-term success for individual investors has always primarily come from discovering and buying good companies when they are cheap.

Sometimes it’s a household name or some other large company that for a time is “unloved” for whatever reason on Wall Street. Many a time, we have picked off such companies at a low level and done quite well.

The real fun, though, is when we can find a company that almost nobody knows about.

Advances in science and technology. . .more efficient means of transportation and communication. . .pending CURES for diseases rather than just better treatment. . .and so many more themes are continually sought after. When you find the right combination of management, support, market need and the rest in a young company, the rewards (and not just monetary) can be astounding!

As I teach in a FREE tutorial on stock picking/research (easily accessible on my website), sometimes great investment ideas are right under our noses one way or another as we go about our everyday lives. Who among us, for instance, does NOT remember the decades-long run of the late actor and comedian Jerry Lewis and his annual Labor Day telethons? For many years our hearts broke for “Jerry’s kids” who were beset by one form or another of the scourge muscular dystrophy.

Years ago my “homework” brought me into contact with a tiny biotech start -up whose science on RNA-based therapeutics showed great promise. Sure enough, shares of Sarepta Therapeutics hit the big time back in 2012, when trials in adolescent patients who have Duchenne muscular dystrophy actually showed that Sarepta’s drug was allowing some of them to produce dystrophin and GROW muscle tissue!

Such a breakthrough as this had never before been seen. Sarepta has now gone from the tiny, largely unknown company it was when I first ran across it to, now, a multi-billion dollar biotech leader. Our members who followed my recommendations on Sarepta have made GOBS of money. More so, we have the satisfaction of being part of a great STORY that is changing lives for the better!

Biotechnology and other medical and health-related breakthroughs, from an investment perspective, are not only exciting and potentially VERY rewarding. They are opportunities as well that have little if anything to do with the broader economy and stock market. So arguably more than in any other sector of the market, health care/biotechnology companies are driven chiefly by their success. . .or failure.

As this is written I have other “story stocks” in this sector among my recommendations: companies working on everything from Alzheimer’s disease (a “return trip” in this one as well, after quadruple-digit gains here, too, a few years back!), to a potential reversal of type one diabetes.

And in the medical device/technology area, we have Imagin Medical.

Imagin—a company I have already recommended to my members at The National Investor—is working on one of the most disruptive new technologies for medical devices in many years.

Chiefly, its technology holds the promise of leading to the most efficient detection and removal of bladder cancer of anything the industry has seen in some 30 years. Managed by a team with past success already in bringing transformative new products to market, Imagin has already been embraced by key urologists and opinion leaders in that industry. Some of them have already become shareholders of Imagin Medical to boot!

The need for a better, more efficient, modern standard of care is indisputable. Bladder cancer is the sixth-most prevalent cancer in America. One reason for its recurrence in too many patients is that the medical profession is, quite simply, using dated technology to detect bladder cancer in the first place. Imagin’s i/Blue Imaging System has the potential to be a game-changer in this area!

As I write this, the company has just had its second key meeting with the U.S. Food and Drug Administration.

On the home page of its website, Imagin Medical bills itself as a medical device and—more—so technology company that is, “. . .focused on establishing a new standard of care in visualizing cancerduring minimally invasive surgery. . .”

As I have rolled up my sleeves and come to get to know Imagin better, the company—which intends to initially focus on bladder cancer—seems to have an imaging technology and platform that is at the same time revolutionary . . . yet quite simple and common-sense. The concept has already shown a better ability to detect cancer and allow urologists to be more certain that they have completely removed it in a procedure.

I’ll quickly explain the current technology here, on the way to explaining how Imagin’s i/Blue Imaging System—if commercially successful—would be such a benefit to both doctors and patients.

Surgical practices have advanced tremendously over the years with advances in technology and know-how. For many procedures, it was once common to open up a part of the body—say, an abdomen—and take care of what needed to be done. Among the things this meant was a longer hospital stay and a longer time to recover and heal following such an invasive procedure.

For almost everything, this has been replaced by minimally invasive surgery (MIS). Advances in optical technology especially have effectively allowed small cameras mounted on endoscopes to be inserted in pretty much any area of the body, whether to take out cancerous tissue, repair a hernia or what have you. Once the necessary procedure has been identified via the endoscope (which comes in many shapes and sizes, but all of which pretty much work on the same principles) the procedure—for our purposes, the identification and removal of bladder cancer—can also be accomplished more simply than in the past.

In light of this, I’m sure you won’t be surprised to learn that globally, nearly $50 billion a year is spent on endoscopic procedures. This is not always to treat maladies or to eradicate cancerous tissue, but sometimes to confirm that further medical attention is not needed.

Where bladder cancer is concerned—the single most-expensive cancer in North America to treat—more than $4 billion per year is spent in the U.S. alone just on bladder cancer surveillance using the current generation’s imaging technology.

It is in this area that Imagin is focusing its technology to make this surveillance—and what the patient has to endure—easier, more efficient and more successful.

When I first had the opportunity to visit at some length a while ago with Jim Hutchens—the C.E.O. of Imagin—I was surprised to learn how in one sense the current technology and products in the market can often fall far short in easily and accurately identifying some cancers and tumors. Indeed, Hutchens quipped that “It is shocking to me how dated it is,” meaning the relatively primitive optics and lighting currently used to “see” bladder cancer and tumors.

In typical white light cystoscopy, a fiber bundle or small camera is mounted at the end of an endoscope—or cystoscope in the case of bladder cancer—and enters the body. These scopes are delivered through the urethra and into the bladder to project clear images; essentially, any tumors that protrude above the wall onto a monitor that the surgeon then evaluates for possible removal.

The first challenge of using white light is that a surgeon cannot easily differentiate flat or tiny malignant and premalignant tumors from normal tissue or see the borders/margins of the tumor. Consequently, some cancer cells may remain behind undetected after a procedure. Using this dated technology even now is a contributor to the high recurrence rate of over 50% for bladder cancer.

The “remedy” to this point has been the use of a “blue” light in conjunction with fluorescing imaging agents. The agents are absorbed by the cancerous cells in the bladder. When exposed to blue light, they fluoresce, improving the surgeons’ ability to detect flat cancers and visualize the margin for removal.

The challenge and shortcoming here, though, is that a urologist/surgeon has to switch back and forth between the white and blue images to figure out what is going on. The white light image shows the full landscape of the bladder but doesn’t highlight the cancer. The blue light shows the cancer but doesn’t show exactly where it is, so the surgeon loses orientation. In addition, the current technology gives the surgeons only one image at a time on the monitor, so they have to switch back and forth between the two and compare them from memory to remove the cancer.

The i/Blue Imaging System addresses this problem because it shows both images on the monitor at the same time, side-by-side, and in real-time. So now, the surgeon won’t have to switchback and forth and rely on memory to locate and remove the cancer. The procedure has the potential to make bladder cancer detection and removal more efficient and faster, as well as dramatically reduce bladder cancer recurrence rates.

Another ground-breaking aspect of Imagin’s technology is the consolidation of instrumentation. The current blue light method needs a system tower that houses multiple units, including the light source, camera control unit and the video data recorder. The i/Blue Imaging System, on the other hand, using state-of-the -art technology, combines these three modules into one device , taking up a much smaller footprint. The current system is purchased as a “bundle” and, depending on accessories, can cost well over $100,000. The basic bundle includes the system’s three units along with the company’s proprietary hand-held “blue scope” with its built-in camera, the only scope that can be used with this system.

Imagin, however, plans to sell one System Control Unit and package it with a Dual Camera hand piece (see above). Special “blue scopes” are not needed because the i/Blue is “system agnostic,” which means a medical professional can use practically any endoscope that he/she already has together with Imagin’s superior imaging technology/platform. So not only does the addition of Imagin’s breakthrough technology to existing endoscopes provide transformative NEW efficiency, but with a smaller “foot print” and at a lower cost for the industry! (NOTE: Imagin Medical already has three issued patents—with others pending—on this technology/I.P.–Intellectual Property.)

Stressing the relative simplicity of basically adding its own technology—the i/Blue Imaging System—to the current standards of care/usage in endoscopy, Hutchens reiterated, “We are not in the endoscope business. Our product consists of a dual camera hand piece that houses a micro camera with sophisticated sensors and filters that attaches to endoscopes already in the market and our proprietary consolidated imaging unit. This combination allows us to put both images on the monitor, in real time, simultaneously. This was well received in our focus groups.” (Emphasis added.)

Indeed, a very upbeat Hutchens pointed out when he and I spoke recently how important the feedback was that the company received this past spring at the American Urology Association’s Annual Meeting in Chicago. Imagin held private focus groups where leading urologists assessed the company’s first initial functional product and provided feedback that was used to finalize the i/Blue product’s user needs.

COLLABORATION WITH OPTEL; AND JAY EASTMAN

Again, Imagin is not trying here to totally “reinvent the wheel.” It is simply adding cutting-edge imaging technology to make the “wheel” now used in cancer detection and removal more efficient than anything that has come around now for many decades. To that end, it’s hard to overstate the importance of CEO Hutchens and his team joining forces with such an elite company as Optel.

Notably, Optel is headed up by Dr. Jay Eastman. You might recognize that name, especially if you—as I am—are from upstate New York and/or know the histories of the legendary companies that made that state their home, such as Eastman Kodak.

An industry leader, Dr. Eastman—who serves as Imagin’s Director of Development—has a Ph.D. in optical design. Those talents are helping move along the i/Blue Imaging System to ultimately bring this disruptive technology to the endoscopy market. You can learn more about Jay in a
video interview
and here, for some biographical information.

Imagin seems well positioned to use its protected Intellectual Property (specifically where i/Blue is concerned, in its process for simultaneous/parallel acquisition of images and combining them into one monitor) to first exploit the “low-hanging fruit” of the bladder cancer area. Notably, the company obtained much of this technology and patents from California’s prestigious Lawrence Livermore Lab. Indeed, a confident Hutchens recently mentioned to me, “This market is really ready for innovation. . .they know they’re behind.”

OVERALL MANAGEMENT TEAM WITH A PROVEN TRACK RECORD

What’s especially nice to know here—apart from the company’s progress to date in moving toward development and commercialization—is that this is “not the first rodeo” for Imagin’s management. Looking at the success of Hutchens and others in the medical equipment space overtime—and that added heavyweight name/stature of Dr. Eastman in the optical space—makes Imagin a compelling story of a potential breakthrough technology being shepherded forward by experienced hands.

President and CEO Hutchens’ own background with the likes of Boston Scientific (NYSE-BSX), particularly in the medical device arena, demonstrates that he knows the ropes in developing and bringing to market new and better technology and products. Among his other past accomplishments aside from serving as an executive at BSX, he founded two other medical device companies. Further, Hutchens (at left, as he spoke last Fall at our Chicagoland investment conference) has bolstered research staff now at Imagin to strengthen the process and development regimen for the i/Blue Imaging System ahead of its recent meeting with the FDA as well as in anticipation of making the hoped-for approval process stronger.

John Vacha, Imagin’s chief financial officer, does not just add financial and administrative acumen. John has 20 years of experience in the healthcare field as well. Among other accomplishments, he holds two patents in electrosurgical administration and has as well brought a medical device company from start-up phase to acquisition, in that latter instance, serving for seven years as president, CEO and board member of Intact Medical Corporation before it was acquired by Medtronic, plc (NYSE-MDT) in 2017.

Among other key people, Imagin has brought on board Pam Papineau as sirector of regulatory affairs. Ms. Papineau has over 30 years of experience in quality and regulatory affairs with Baxter, Boston Scientific and Cogentix (Vision-Sciences) and has served as a consultant on a wide variety of devices that includes endoscopy, imaging, GI/GU, orthopedic and cardiovascular. She has successfully prepared dozens of FDA premarket submissions and European Union (EU) technical files.

A key medical advisor to Imagin is Dr. Ashish Kamat. He has been named by Expertscape as the world’s the top-rated expert in urinary bladder neoplasms. Dr. Kamat has extensive experience with cystoscopic procedures, has been a principal investigator for multiple oncology and urology clinical studies for both drugs and devices, and has been involved in blue light cystoscopy studies since 2007. Dr. Kamat is an Endowed Professor of Urologic Oncology and Cancer Research at the University of Texas MD Anderson Cancer Center (MDACC); Associate Cancer Center Director, RFHNH in Mumbai; and President of International Bladder Cancer Group (IBCG) and International Bladder Cancer Network (IBCN).

I encourage you to visit here for an even more complete background on all of the company’s management and advisers.

DEVELOPMENT PROGRESS; WHAT COMES NEXT

Like all medical device companies, Imagin’s fate will be determined by ultimate FDA approvals of the i/Blue Imaging System, its eventual design tweaks and then manufacturing of that system. This is why Hutchens early on knew he had to assemble such a top-flight team, one with direct, hands-on medical device experience in moving products from concept through development to commercialization, including managing the FDA process.

On September 26 Imagin announced that it had met with the FDA for its second so-called “Q-Sub” meeting. “We are pleased with the feedback we received from the FDA during our second meeting to discuss i/Blue’s regulatory path,” said Hutchens. “We will continue to collaborate with the Agency as we move closer to our submission package.”

The company had already announced progress back in July—bolstered, in part, by feedback from that May meeting/focus groups—that its i/Blue product has entered the verification stage of the medical device design control process.

Along the way, a University of Rochester Medical Center 10-subject investigator-sponsored research study had led to some key redesign work of i/Blue. Imagin, in conjunction with Optel, furthered the refinement of the product, essentially from a “clunky box” to the streamlined unit that received such a positive reception back in May at that American Urological Association conference.

Said Dr. Eastman along the way, “The lessons learned from the URMC Research Study has provided valuable technical data, clinical insight and physician feedback that has significantly influenced the design of the i/Blue System. All of this information increased our confidence that the miniaturization, imaging quality and cost reduction goals for the i/Blue System are important to surgeons performing bladder cancer procedures.”

These design improvements will ultimately allow a surgeon/urologist to be more efficient in their work, and that—of course—is the whole point. And there’s something else: that is, Imagin hopes a successful development and commercialization of a superior and cost-effective system will bring the i/Blue Imaging System into practitioners’ offices as well. Greater efficiencies and a better standard of care still could be effected by urologists having such a state-of-the-art and quick system on hand outside the operating room, whether for initial examinations or post-procedure follow-ups.

Now, Imagin is moving forward to finish final design and manufacture of the initial i/Blue functional products, along with the necessary documentation to support them, over the coming few months (hopefully, in fact, prior to the end of 2019.) If all goes well and there are not any unforeseen delays, the company believes it can have a final product ready for commercialization and approval by late 2020. Thereafter, sales and revenue could commence very soon.

A COMPELLING INVESTMENT THESIS AND “RISK-REWARD” DYNAMICS

For any start-up/research-oriented company, a LOT has to go right. More companies over time fail than those which succeed for one or more reasons: everything from inept management and a lack of money to see things through, to the lack of legitimate expertise in its area, to misreading the need for its product/technology and more.

In the case of any such company—and realizing the general inherent risks of investing in such small companies—I always advocate we approach them and make investing decisions simply as Benjamin Franklin would have done. Franklin famously advocated that in any important decision, one simply write opposing pros and cons on a piece of paper opposite one another—weight them as necessary, as to importance—and make a decision based on the preponderance of either positive or negative factors.

In my view, making a decision in this way as to investing in Imagin Medical’s shares is no contest, as the pros as I see them significantly outweigh the cons. Management knows what it is doing, in part due to its past experience. It has world-leading, cutting edge technical know-how, especially in the persons of Dr. Eastman and Dr. Kamat.

Most important, what Imagin is working toward is final FDA approval and commercialization, not in and of itself insurmountable. Keep in mind that the i/Blue Imaging System is simply adding its superior optical technology and far greater efficiency/utility to blue-light endoscope techniques that the F.D.A. has already approved.

Still, by their nature, companies involved in most any kind of research and development such as this are deemed to be speculative. Until Imagin has an approved product(s) for commercialization and the game plan/means to begin selling it to the industry, the company has no revenue, let alone a profit. Thus—as much as this is a compelling story—even an Imagin Medical is not a company that you put your grocery money into!

That said, there certainly does appear to be a great potential reward here to go with the usual risk. As of this writing, Imagin has a market cap of a tiny C$7 million, or about US$ 5.4 million. Compare that against—first—the US$4 billion market on bladder cancer scoping alone; not to mention that—if successful here—Imagin may well be poised to proceed to disrupt other segments of the endoscopy market.

There are two main risks as I see them:

1. The FDA – There is no guarantee that the company’s expected time frame will be realized. It may end up being a bit longer before commercialization is achieved. But the seeming risk would be one more to do with delay to satisfy the agency, not anything fundamental that calls into question Imagin’s technology.

2. Funding – Still topped up for now following its most recent cash injection late last year (including the exercise of prior warrants, largely by management and “insiders”), it’s likely that by the middle of 2020 Imagin will need to go back to market to raise money. With shares on their back foot due to both some investors becoming impatient and the typical tax-loss selling that hits this time of year, any such financing to come could be dilutive of existing shareholders.

With its team, technology, progress and the rest, though, I think it’s much more a question of that than any worry over Imagin being able to raise money at all. And in any case, some dilution to come or not, Imagin’s market cap and share structure even afterwards will STILL be dwarfed by the potential upside, market penetration, etc.

In making a decision on my part to recommend Imagin Medical—and on your part to invest in it—it’s VERY nice to know that we are joining as shareholders medical professionals including Dr. Stan Swierzewski, chief of surgery and director of urology at Holyoke Medical Center in Massachusetts, and Dr. Roger Buckley, division head of urology at North York General Hospital in Toronto.

To say the least, when the potential customers for Imagin’s iBlue System are so excited about what it will do for them and their patients that they want to invest in the company personally, it’s a vote of confidence the likes of which you don’t always see!

Said Dr. Swierzewski PUBLICLY about his own investment decision (investing in a private placement in Imagin in April, 2018),

“As a practicing urologist, I invested in Imagin because I have a duty and responsibility to advance any improvements in treatment and technology that will benefit my patients and save lives. Current technology is cumbersome and time consuming. . .making it less effective as a screening or follow-up tool. Bladder cancer patients are basically monitored for life with in-office cystoscopies which are not effective in differentiating between inflammation and cancer. To be safe, we perform surgery on many patients which often turns out to be negative. Imagin’s i/Blue technology, given its potential speed and sensitivity, will help us assess the patient’s condition more quickly and accurately and avoid unnecessary surgery. It will also make necessary surgery more successful, ultimately saving lives and reducing medical expenses. I’m confident that using the i/Blue system will become the (new) standard of care. . .I cannot wait to use this technology in treating my bladder cancer patients.”

This is all why Imagin Medical is rated as a speculative “BUY” in The National Investor!

I will, of course, have ongoing updates on the company as warranted, whether in my twice-monthly newsletter or, as appropriate, any of my between-issues shorter alerts. For more information, you can visit me at The National Investor.

And, of course, you should do your own due diligence on Imagin Medical directly, starting at the company’s website.

A Reminder. . .

HOW TO PURCHASE SHARES OF IMAGIN MEDICAL IF YOU ARE A U.S. INVESTOR USING A U.S.-BASED BROKERAGE ACCOUNT

For those of you who are not already used to buying shares of companies such as Imagin Medical that are listed primarily in Canada, I want to give you a quick and easy “tutorial.” It’s MUCH easier than you think, if you have never done so, to buy such companies in any U.S. brokerage account. Indeed, as I have explained in one of my investor tutorials, it’s just as easy and inexpensive to buy shares in an Imagin Medical as it is to buy Apple!

Many larger Canadian and other foreign companies have primary listings on more than one major exchange. For those listed on the New York Stock Exchange or the Nasdaq as well as Toronto, you need only buy/sell using the U.S. market. Generally, there would be no reason to check prices and such on the Toronto Exchange first.

More often than not, smaller companies—for both cost and logistical reasons—do not LIST their shares on a major U.S. exchange. But they are still easily TRADABLE in the U.S. via the NASDAQ’s OTC Market. All you need to know is the company’s symbol; unlike most U.S.-listed companies, it will always be a five-letter symbol ending with an “F.”

In Imagin Medical’s case, its ticker symbol in the U.S. is IMEXF , while on the Canadian Securities Exchange (CSE) it is IME. (NOTE: The CSE in Canada is the functional equivalent of the U.S. OTC market.)

The main consideration in buying shares of Canadian stocks via the U.S. OTC market is that SOMETIMES—if you look at the OTC quote FIRST—you are not getting as fresh and accurate a price as you would if you went to the Canadian Exchange. This is because with most, the majority of their activity is on the Canadian market where it is listed; sometimes hours can go by between trades on the OTC, if the company you’re looking to buy isn’t actively traded at the time. Thus, you simply need to insure, via a simple process, that you are neither overpaying for a stock when you buy it, nor getting less than you should when you sell. That is easy to accomplish.

The most reliable and current quotes for shares of companies such as Imagin are to be

found first on the Canadian Exchange where they are primarily LISTED. Prices and volume activity are updated all through the trading day on the Toronto Exchange, TSX.V and the CSE (again, the equivalent of the U.S. OTC market), just as they are on the NYSE or NASDAQ, and are generally fresh/instantaneous.

I will use the following example to show the simple process that will normally take you LESS THAN TWO MINUTES to enter a trade to buy Imagin’s stock via the OTC market in the U.S., in a typical U.S.-domiciled brokerage account:

1. First check the Canadian quote for the company, via its ticker symbol on the CSE, IME. You’ll find this at the Exchange’s website. Plug in “IME.” We’ll say for purposes of this lesson that the current asked price for IME’s shares is C$0.06, or 6 cents per share in Canadian currency.

2. Next determine what that price is in U.S. currency. If you don’t follow exchange rates on a daily basis, you can get a fresh picture by going to Kitco’s website, at www.kitco.com (or your own favorite one that lists currency differentials; there are many.) Near the bottom of Kitco’s front page, you will find a table of various currency exchange rates. At this writing the Canadian dollar, rounded off, is worth 76.9 cents in U.S. currency.

3. Do the math as to what IME’s U.S. asked (selling) price on the OTC market should be:

C 6 cents per share X .769 = US 4.61 cents per share.

4. Finally, enter a LIMIT ORDER to buy the number of shares of Imagin you want in your U.S. brokerage account at or very near that price. Personally, I would first start with US 3.9 cents per share; as of this writing, Imagin has a respectable amount of activity/liquidity on the OTC market for a company its size. If the order doesn’t fill right away, bump it up by a tenth of a cent once or twice until it does (these days, most online brokers will allow you to use tenths of a cent in pricing.)You would use the company’s 5-letter symbol, which is IMEXF.

It’s that simple! And, of course, you would do much the same thing when it was time to sell some of your holdings. But in the case of a sale, you would focus on the bid price listed on the CSE’s site for the company in question.

Don’t forget that those of you so inclined can follow my thoughts, focus and all daily.

* On Twitter, at https://twitter.com/NatInvestor

* On Facebook at https://www.facebook.com/TheNationalInvestor

* Via my (usually) daily podcasts/commentaries at http://www.kereport.com/

* On my You Tube channel, at https://www.youtube.com/channel/UCdGx9NPLTogMj4_4Ye_HLLA

Chris Temple is editor and publisher of The National Investor. He has had a more than three-decade career in various areas of the financial services industry. Temple is a sought-after guest on radio stations all across America, as well as a sought-after speaker for organizations. His commentaries and some of his recommendations have appeared in Barron’s, Forbes, the Dick Davis Digest, Investors’ Digest, PrudentBear.com, Kitco.com, the Korelin Economics Report and other media.

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Disclosure:
1) Chris Temple: I, or members of my immediate household or family, do not own shares of the following companies mentioned in this article: None. I personally am, or members of my immediate household or family are, paid by the following companies mentioned in this article: None. My company has a financial relationship with the following companies mentioned in this article: Imagin Medical. The National Investor disclosures are below.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: Imagin Medical. Click here for important disclosures about sponsor fees. As of the date of this article, an affiliate of Streetwise Reports has a consulting relationship with Imagin Medical. Please click here for more information. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
3) Statements and opinions expressed are the opinions of the author and not of Streetwise Reports or its officers. The author is wholly responsible for the validity of the statements. The author was not paid by Streetwise Reports for this article. Streetwise Reports was not paid by the author to publish or syndicate this article. Streetwise Reports requires contributing authors to disclose any shareholdings in, or economic relationships with, companies that they write about. Streetwise Reports relies upon the authors to accurately provide this information and Streetwise Reports has no means of verifying its accuracy.
4) This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Imagin Medical, a company mentioned in this article.

6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

The National Investor is published and is e-mailed to subscribers from [email protected] The Editor/Publisher, Christopher L. Temple may be personally addressed at this address, or at our physical address, which is: National Investor Publishing, P.O. Box 1257, Saint Augustine, FL 32085. The Internet web site can be accessed at https://nationalinvestor.com/. Subscription Rates: $275 for 1 year, $475 for two years for “full service” membership (twice-monthly newsletter, Special Reports and between-issues e-mail alerts and commentaries.) Trial Rate: $75 for a one-time, 3-month full-service trial. Current sample may be obtained upon request (for first-time inquirers ONLY.) The information contained herein is conscientiously compiled and is correct and accurate to the best of the Editor’s knowledge. Commentary, opinion, suggestions and recommendations are of a general nature that are collectively deemed to be of potential interest and value to readers/investors. Opinions that are expressed herein are subject to change without notice, though our best efforts will be made to convey such changed opinions to then-current paid subscribers. We take due care to properly represent and to transcribe accurately any quotes, attributions or comments of others. No opinions or recommendations can be guaranteed. The Editor may have positions in some securities discussed. Subscribers are encouraged to investigate any situation or recommendation further before investing. The Editor receives no undisclosed kickbacks, fees, commissions, gratuities, honoraria or other emoluments from any companies, brokers or vendors discussed herein in exchange for his recommendation of them. All rights reserved. Copying or redistributing this proprietary information by any means without prior written permission is prohibited. No Offers being made to sell securities: within the above context, we, in part, make suggestions to readers/investors regarding markets, sectors, stocks and other financial investments. These are to be deemed informational in purpose. None of the content of this newsletter is to be considered as an offer to sell or a solicitation of an offer to buy any security. Readers/investors should be aware that the securities, investments and/or strategies mentioned herein, if any, contain varying degrees of risk for loss of principal. Investors are advised to seek the counsel of a competent financial adviser or other professional for utilizing these or any other investment strategies or purchasing or selling any securities mentioned. Chris Temple is not registered with the United States Securities and Exchange Commission (the “SEC”): as a “broker-dealer” under the Exchange Act, as an “investment adviser” under the Investment Advisers Act of 1940, or in any other capacity. He is also not registered with any state securities commission or authority as a broker-dealer or investment advisor or in any other capacity.

Notice regarding forward-looking statements: certain statements and commentary in this publication may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 or other applicable laws in the U.S. or Canada. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of a particular company or industry to be materially different from what may be suggested herein. We caution readers/investors that any forward-looking statements made herein are not guarantees of any future performance, and that actual results may differ materially from those in forward-looking statements made herein. Copyright issues or unintentional/inadvertent infringement: In compiling information for this publication the Editor regularly uses, quotes or mentions research, graphics content or other material of others, whether supplied directly or indirectly. Additionally he makes use of the vast amount of such information available on the Internet or in the public domain. Proper care is exercised to not improperly use information protected by copyright, to use information without prior permission, to use information or work intended for a specific audience or to use others’ information or work of a proprietary nature that was not intended to be already publicly disseminated. If you believe that your work has been used or copied in such a manner as to represent a copyright infringement, please notify the Editor at the contact information above so that the situation can be promptly addressed and resolved. Additional disclosure: Imagin Medical has paid to National Investor Publishing the sum of US$2,500 for the preparation of and rights to this stand-alone report on the company. Imagin has not paid for the recommendation of the company by either Chris Temple or National Investor Publishing; said recommendation, as disclosed earlier, was already made to paid Members/subscribers to The National Investor prior to the preparation and publishing of this stand-alone Report. Further, as of January, 2020, Imagin has paid to National Investor Publishing the sum of US$10,000.00 to be used/managed at National Investor Publishing’s discretion to make this report and related information/updates available in a wider fashion through paid placement and other means on various web sites, social media and via other outlets.

( Companies Mentioned: IME:CSE; IMEXF:OTCQB,
)

Transenterix Shares Trade Up 25% on FDA Filing for First Machine Vision System in Robotic Surgery

By The Life Science Report

Source: Streetwise Reports   01/14/2020

Shares of Transenterix opened 50% higher after the company reported that it has submitted a 510(k) submission to the FDA for the first machine vision system for use in robotic surgery.

This morning, medical device company TransEnterix Inc. (TRXC:NYSE.American), which states that it is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, announced that “it has filed a 510(k) submission with an Intelligent Surgical Unit (ISUTM) that is designed to enable machine vision capabilities on the Senhance Surgical System.”

The company’s President and CEO Anthony Fernando commented, “TransEnterix is the first company to seek FDA clearance for machine vision technology in abdominal robotic surgery. Rather than simply passing a video signal to the surgeon, the Intelligent Surgical Unit for Senhance will initially have the ability to actually visualize the surgical field to guide movement and capture information…This technology advance is an important first step towards enabling augmented intelligence and we believe it will support continued machine vision driven advances in surgery performed with the Senhance Digital Laparoscopy Platform.”

Transenterix stated in the report that the ISU will be compatible with the global installed base of Senhance Surgical Systems and other Senhance supported third-party vision systems. The company explained in the report that “the initial features of the ISU are designed to increase control in visualization beyond what has previously been available in digital laparoscopy or robotic surgery.” The firm also advised that though the Senhance System at present, already features unique eye-tracking camera control, the new technology would additionally provide for enabling machine vision driven control of the camera for a surgeon by responding to commands and recognizing certain objects and locations in the surgical field.

Dr. Amit Trivedi, chair of surgery at Hackensack Meridian Health Pascack Valley Medical Center and a participant in the design and usability studies conducted in support of the 510(k) submission of the ISU, commented, “Many of us that perform and teach surgery firmly believe that the care of patients will be transformed by augmented intelligence and machine vision capabilities in the future…Imagine if a computer could be the best assistant you’ve ever had in surgery by anticipating and moving a camera effortlessly to maximize control of the visual field. I’m very excited about this new addition to the Senhance System.”

TransEnterix is a medical device company headquartered in Morrisville, N.C. The firm stated that “it is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment.” The company claims that its Senhance Surgical System which digitizes laparoscopic minimally invasive surgery, offers improved ergonomics, responsible economics and allows for robotic precision, haptic feedback, surgeon camera control via eye sensing. The firm indicated that the Senhance System is intended for use in adult patients in laparoscopic gynecological surgery, cholecystectomy colorectal surgery and inguinal hernia repair.

Transenterix has a market capitalization of around $28.9 million with approximately 19.67 million shares outstanding. TRXC shares opened greater than 50% higher today at $2.25 (+$0.78, +53.06%) over yesterday’s $1.47 closing price. The stock has traded today between $1.79 and $2.62 per share and is currently trading at $1.83 (+$0.36, +24.49%).

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: TRXC:NYSE.American,
)

Two Analysts See Company as a Buy for ‘Game-Changing’ Potential in Bladder Cancer Detection and Surgery

By The Life Science Report

Source: Streetwise Reports   01/14/2020

The disruptive technology is ‘poised to deliver significant advancement in bladder cancer detection.’

Imagin Medical Inc. (IME:CSE; IMEXF:OTCQB) is developing technology that can greatly improve the ability to visualize cancer during minimally invasive surgeries. Its i/Blue Imaging™ System is in development for use in bladder cancer, the sixth most common cancer in the United States. The company has just hit the significant milestone of completing design verification for the system.

The company and its technology have caught the attention of two industry observers.

Chris Temple, editor and publisher of The National Investor, writes that Imagin Medical’s “disruptive technology is poised to deliver the most significant advancement in bladder cancer detection and removal in decades, making the detection and removal of cancer FAR more efficient and effective.”

“Imagin’s i/Blue Imaging System has the potential to be a game-changer.” – Chris Temple

Concerning the value proposition, Temple writes, “There certainly does appear to be a great potential reward here to go with the usual risk. As of this writing, Imagin has a market cap of a tiny C$7 million, or about US$ 5.4 million. Compare that against—first—the US$4 billion market on bladder cancer scoping alone, not to mention that—if successful here—Imagin may well be poised to proceed to disrupt other segments of the endoscopy market.”

Imagin’s technology has the support of experts in the field. “Already, Imagin’s i/Blue Imaging System is being embraced by urologists; most recently at the American Urological Association’s annual meeting, held in May in Chicago. Imagin held private focus groups, where leading urologists assessed the initial functional product and provided overwhelmingly positive feedback that was used to finalize the i/Blue product user’s needs,” Temple writes.

“So compelling is Imagin’s proprietary technology and potential benefits for both medical professionals and especially patients that leading urologists have even invested in Imagin Medical,” he states.

Imagine Medical’s “technology holds the promise of leading to the most efficient detection and removal of bladder cancer of anything the industry has seen in some 30 years. Managed by a team with past success already in bringing transformative new products to market, Imagin has already been embraced by key urologists and opinion leaders in that industry. Some of them have already become shareholders of Imagin Medical to boot!” writes Temple.

“The need for a better, more efficient, modern standard of care is indisputable. Bladder cancer is the sixth-most prevalent cancer in America. One reason for its recurrence in too many patients is that the medical profession is, quite simply, using dated technology to detect bladder cancer in the first place. Imagin’s i/Blue Imaging System has the potential to be a game-changer in this area,” Temple concludes.

Read Chris Temple’s article here in its entirety.

Technical analyst Clive Maund also follows Imagin Medical closely. Writing in CliveMaund.com on January 7, Maund stated, “We were accumulating Imagin Medical stock last fall, most recently in November, and the good news is that it has just staged a dramatic breakout, almost doubling in the last three trading days, or just since the start of the year.

“We can see this dramatic breakout to advantage on the latest 3-month chart, with it soaring above its 200-day moving average on expanding volume to become quite heavily overbought on a short-term basis, which makes it tempting to take profits or at least scale back positions, but should we?”

The longer-term charts come in most useful with respect to making such a decision. The 4-year chart shows that when this stock decides to go up, it goes up big, as it did most notably in late 2017 and early 2018. The spike moves can continue for a long time until it becomes massively overbought, and given that this company has a great invention, as we have already observed, it might be foolishly premature to sell this here as it could go much higher. So we stay long and it is a buy on any dips that might occur.

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Disclosure:
1) Patrice Fusillo compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: Imagin Medical. Click here for important disclosures about sponsor fees. As of the date of this article, an affiliate of Streetwise Reports has a consulting relationship with Imagin Medical. Please click here for more information. An affiliate of Streetwise Reports is conducting a digital media marketing campaign for this article on behalf of Imagin Medical. Please click here for more information.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this interview, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Imagin Medical, a company mentioned in this article.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Additional disclosures
The National Investor has a financial relationship with the following companies mentioned in this article: Imagin Medical.

Clive Maund does not own shares of Imagin Medical and neither he nor his company has been paid by the company.

( Companies Mentioned: IME:CSE; IMEXF:OTCQB,
)

Adaptimmune Shares Triple as SPEAR T-cell Platform Delivers Initial Responses in Four Solid Tumor Indications

By The Life Science Report

Source: Streetwise Reports   01/13/2020

Shares of Adaptimmune Therapeutics more than tripled in value after the company reported that its SPEAR T-cell platform delivered positive initial responses in four different solid tumor indications.

United Kingdom-based clinical-stage immunotherapy company Adaptimmune Therapeutics Plc (ADAP:NASDAQ) today reported two confirmed Partial Responses (PRs) – one in a patient with liver cancer and one in a patient with melanoma at the 38thJP Morgan Healthcare Conference. The firm reported that there are also two other unconfirmed PRs, one in a patient with gastro‑esophageal junction cancer and the other in a patient with head and neck cancer.

The company claimed that “these data further confirm the potential of Adaptimmune’s SPEAR T-cell platform for patients with multiple solid tumors adding that data were previously reported showing compelling efficacy with ADP-A2M4 in synovial sarcoma.”

Adaptimmune Therapeutics’ CEO Adrian Rawcliffe commented, “These responses demonstrate that our proprietary SPEAR T-cell platform is clearly active and can overcome the challenges of treating a range of solid tumors with a T-cell therapy product…These are early results and we need more patient data and durability information to determine which therapies to develop. Nonetheless, this is a critical demonstration of the value of our SPEAR T-cell therapies for people with cancer and a validation of the importance of our proprietary affinity engineering…We look forward to presenting data from these trials at future scientific congresses.”

The firm advised that “there continues to be a favorable benefit:risk profile for all products and indications under study and that most adverse events are consistent with those typically experienced by cancer patients undergoing cytotoxic chemotherapy or other cancer immunotherapies.”

In a separate release today, the company announced that effective immediately it has appointed Dr. Elliot Norry as SVP and chief medical officer (CMO) and further reported some additional changes to its R&D organization. The firm claimed that “these organizational changes will strengthen scientific and clinical development from early to late stage, and accelerate application of translational science learnings to therapeutic candidates and trials.”

The company indicated that Dr. Norry has been serving as the acting CMO since August 2019 and prior to joining Adaptimmune served as head of clinical safety and pharmacovigilance and leader of the ADP-A2AFP program since 2015.

CEO Adrian Rawcliffe remarked, “Elliot has done a fantastic job as acting CMO over the past few months. This builds on his impact leading the ADP-A2AFP program in liver cancer as well as leading our safety and pharmacovigilance team over the last four years. I look forward to continuing to work with Elliot to deliver cell therapy treatments to patients with cancer…In addition, we have made changes to our R&D leadership to accelerate how our products move from research to late stage development, including rapid application of translational learnings that are crucial to bringing cell therapies to patients.”

Adaptimmune is headquartered in Oxfordshire, U.K. and states that it is “a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for people with cancer.” The company proclaimed that “its unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T‑cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.”

Adaptimmune Therapeutics began the day with a market capitalization of around $139.9 million with approximately 105.2 million shares outstanding. ADAP shares opened 65% higher today at $2.20 (+$0.87, +65.41%) over Friday’s closing price of $1.33 and then accelerated even much higher. The stock has traded today between $2.10 and $5.84/share and is currently trading at $4.71 (+$3.38, +254.14%).

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: ADAP:NASDAQ,
)

Applied Genetic Tech’s Shares Double on 6-Month X-Linked RP Study Results

By The Life Science Report

Source: Streetwise Reports   01/09/2020

Shares of Applied Genetic Technologies skyrocketed to a new 52-week high price after the company reported positive six-month data from its ongoing Phase 1/2 clinical study for treatment in X-Linked Retinitis Pigmentosa. The firm stated that the trial data suggests durable and meaningful improvements in central visual sensitivity and advised that it plans to initiate a pivotal trial by year-end 2020.

Clinical-stage biotechnology firm Applied Genetic Technologies Corp. (AGTC:NASDAQ), which is engaged in exploring gene therapies for the treatment of rare and inherited diseases, today announced positive interim six-month data from its ongoing Phase 1/2 clinical program in X-linked retinitis pigmentosa (XLRP). The company reported that “the results show that patients treated centrally with its product candidate demonstrated durable improvement in visual function six months after dosing.”

The firm claimed that the additional data reinforces previously reported efficacy and safety results and that the updated data will be used in the design and implementation of the company’s XLRP pivotal trial that is anticipated to commence by the end of 2020. AGTC stated that it plans to review the data from the XLRP and achromatopsia Phase 1/2 clinical programs at an R&D Day in New York City on January 28, 2020.

The company’s President and CEO Sue Washer commented, “These promising results further demonstrate that our XLRP candidate has tremendous potential to provide meaningful benefit to XLRP patients who today have no treatment options…The positive results observed to date give us confidence that the data as a whole will support advancement of our XLRP clinical program to a pivotal trial in 2020.”

Dr. Paul Yang, MD, PhD, assistant professor of ophthalmology at the Casey Eye Institute, Oregon Health & Science University in Portland, stated, “The sustained improvement in visual sensitivity in centrally dosed patients are compelling and, if confirmed in a pivotal trial, would be highly meaningful to patients…This is the first investigational therapy for XLRP to report on encouraging improvements in visual acuity. The combination of improved visual function across two endpoints in centrally treated patients and the previously reported stabilization of visual function in peripherally dosed patients, suggest that this gene-based therapy has the potential to be an important new approach to treating XLRP.”

The company explained that X-linked Retinitis Pigmentosa (XLRP) “is an inherited condition that causes progressive vision loss in boys and young men. Characteristics of the disease include night blindness in early childhood and progressive constriction of the visual field. In general, XLRP patients experience a gradual decline in visual acuity over the disease course, which results in legal blindness around the 4th decade of life.”

Applied Genetic Technologies is a is a clinical-stage biotechnology company headquartered just north of Gainesville in Alachua, Fla., that employs a proprietary gene therapy platform to develop transformational genetic therapies for patients suffering from rare inherited conditions and debilitating diseases. The firm indicates that its initial focus is in the field of ophthalmology and that its most advanced therapy programs are designed to restore visual function and meet the needs of patients with rare blinding conditions. The company has active clinical trials in X-linked retinitis pigmentosa and achromatopsia. AGTC additionally has preclinical programs in optogenetics and other ophthalmology indications and other central nervous system diseases including adrenoleukodystrophy (ALD).

Applied Genetics started off the day with a market capitalization of about $75.8 million with approximately 18.22 million shares outstanding. AGTC shares opened nearly 60% higher today at $6.65 (+$2.49, +59.86%) over yesterday’s $4.16 closing price. The stock set a new 52-week high price of $8.80/share in morning trading and has traded today between $5.90 and $8.80 per share on extremely high relative volume. The firm’s shares are currently trading at $8.77 (+$4.61, +110.73%).

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: AGTC:NASDAQ,
)

Ultragenyx Shares Increase 30% on Results from Phase 1/2 OTC Deficiency Study

By The Life Science Report

Source: Streetwise Reports   01/10/2020

Rare disease biopharmaceutical company Ultragenyx Pharmaceutical’s shares traded 30% higher after the firm reported positive topline results from Cohorts 2 and 3 in its Phase 1/2 study of DTX301 gene therapy in Ornithine Transcarbamylase Deficiency.

After U.S. markets closed yesterday afternoon, Ultragenyx Pharmaceutical Inc. (RARE:NASDAQ), a biopharmaceutical company engaged in the development of novel products for rare and ultra-rare diseases, announced “positive topline safety and efficacy data from Cohort 3 and longer-term data from Cohort 2 of the ongoing Phase 1/2 study of DTX301, an investigational adeno-associated virus (AAV) gene therapy for the treatment of ornithine transcarbamylase (OTC) deficiency.”

The company advised that the objective of the Phase 1/2 study of DTX301 is to “evaluate the change in the rate of ureagenesis, ammonia levels, neurocognitive assessment, biomarkers, and safety of DTX301 in patients with OTC deficiency.” The firm explained that OTC deficiency is the most common urea cycle disorder that affects more than 10,000 individuals worldwide caused by a genetic defect in a liver enzyme responsible for detoxification of ammonia. The company indicated that to date there have been no infusion-related adverse events and no treatment-related serious adverse events reported in the study.

Ultragenyx indicated that DTX301 has been granted Orphan Drug Designation in the U.S. and Europe and is “an investigational AAV type 8 gene therapy designed to deliver stable expression and activity of OTC following a single intravenous infusion, which has been shown in preclinical studies to normalize levels of urinary orotic acid, a marker of ammonia metabolism.”

Eric Crombez, M.D., chief medical officer of the Ultragenyx Gene Therapy development unit, commented, “We are encouraged to see a more uniform response at the higher doses including three female responders. To date, three patients in the study have discontinued alternate pathway medication and liberalized their diets while remaining clinically and metabolically stable…We are moving to prophylactic steroid use in the next cohort as we believe this could further enhance the level and consistency of expression that we have demonstrated so far.”.

Ultragenyx is headquartered in Novato, Calif., and is a biopharmaceutical company specializing in developing novel products for the treatment of serious rare and ultra-rare genetic diseases. The company aims at addressing diseases with high unmet medical need with clear biology for treatment for which there are no presently approved therapies for treating the underlying disease.

Ultragenyx Pharmaceutical started the day with a market capitalization of approximately $2.5 billion with about 57.77 million outstanding shares and a short interest of around 10.6%. RARE shares opened nearly 12% higher today at $48.91 (+$5.18, +11.85%) over yesterday’s $43.73 closing price. The stock has traded today between $44.84 and $58.54 per share and is currently trading at $58.44 (+$14.71, +33.64%).

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: RARE:NASDAQ,
)

Developer of Oncology Therapeutics to Have ‘Catalyst Rich’ 2020

By The Life Science Report

Source: Streetwise Reports   01/08/2020

The near-term events expected to trigger movement of the biotech’s share price are outlined in a ROTH Capital Partners report.

In a Jan. 2 research note, ROTH Capital Partners analyst Jonathan Aschoff reported that he is assuming coverage on VBL Therapeutics (VBLT:NASDAQ) and changing its target price to $5 per share. The stock is now trading at around $1.26 per share.

Also, Aschoff highlighted that 2020 for VBL Therapeutics will be “catalyst rich” with respect to its lead drug candidate, VB-111, which it is developing for three initial oncology indications: recurrent, platinum-resistant ovarian cancer, glioblastoma multiforme and colon cancer.

Specifically, two interim data readouts are expected in Q1/20 and Q4/20 from VBL’s Phase 3 ovarian cancer trial. The analyses of those data “will evaluate efficacy and futility, as well as serve as an indication that the trial is progressing like the successful prior 21-patient Phase 1/2 ovarian cancer trial that was presented at the annual meeting of the American Society of Clinical Oncology in 2019,” Aschoff explained.

In addition, the analyst pointed out, two further studies involving VB-111 are expected to be launched in Q1/20. One is a randomized, controlled investigator-sponsored trial in recurrent glioblastoma multiforme, for which complete results are anticipated in Q1/21.

The other is a National Cancer Institute-sponsored, colon cancer trial in which VB-111 will be evaluated in combination with the checkpoint inhibitor Opdivo. An initial data readout for that study is anticipated in Q4/20. “The NCI trial is of particular interest because it may show synergy between VB-111 and widely used immunotherapy,” Aschoff indicated.

Two further catalysts expected in late 2020 are investigational new drug application filings by VBL Therapeutics for two of its monoclonal antibodies (mAb) in development: its traditional anti-inflammatory mAb VB-601 and its bispecific anticancer mAb VB-611. These mAbs target MOSPD2, a protein the biopharma has characterized comprehensively. “We believe there is genuine potential outside interest in drugs having this mechanism of action,” commented Aschoff.

He concluded that ROTH’s $5 per share, 12-month price target on VBL Therapeutics is wholly based on the company’s commercial success in the U.S. of VB-111 in ovarian cancer, primarily the recurrent, platinum resistant kind, and in recurrent glioblastoma multiforme. ROTH has a Buy rating on the biopharma.

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Disclosure:
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Disclosures from ROTH Capital Partners, VBL Therapeutics, Company Note, January 2, 2020

Regulation Analyst Certification (“Reg AC”): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

ROTH makes a market in shares of VBL Therapeutics and as such, buys and sells from customers on a principal basis.

Shares of VBL Therapeutics may be subject to the Securities and Exchange Commission’s Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.

Within the last twelve months, ROTH has received compensation for non-investment banking securities-related services
from VBL Therapeutics.

ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.

( Companies Mentioned: VBLT:NASDAQ,
)

Applied Therapeutics Investors Like the ACTION in Phase 2 Galactosemia Study

By The Life Science Report

Source: Streetwise Reports   01/08/2020

Applied Therapeutics’ shares traded 25% higher today after the company reported positive topline results from its Pivotal Phase 2 ACTION Study of AT-007 for use in the treatment of galactosemia. The firm expects to file for regulatory approval of AT-007 in H2/20.

This morning, New York City-based clinical-stage biopharmaceutical company Applied Therapeutics Inc. (APLT:NASDAQ) announced “positive topline results from the Pivotal Phase 2 portion of the ACTION-Galactosemia study of AT-007, a central nervous system (CNS) penetrant Aldose Reductase inhibitor, in adult Galactosemia patients.”

The company explained in the report that “Galactosemia is a rare metabolic disease that affects how the body processes a simple sugar called galactose, and for which there is no known cure or approved treatment available.”

The firm stated that the ACTION study is a double-blind trial evaluating the effects of AT-007 in healthy adult Galactosemia patients, and noted that the “key biomarker outcome of the study was reduction in galactitol, an aberrant toxic metabolite of galactose, formed by Aldose Reductase in Galactosemia patients.”

According to the report, the data from the study showed that the AT-007 treatment resulted in a statistically significant and robust reduction in plasma galactitol versus placebo in adult Galactosemia patients and that reductions in galactitol were dose dependent. The company indicated that AT-007 was well tolerated, with no drug-related adverse events reported in the 72 healthy volunteers treated in the first part of the trial or in Galactosemia diagnosed patients. Applied Therapeutics believes that AT-007 represents a potentially compelling new therapeutic option for patients with Galactosemia and stated that it expects to file for regulatory approval for the drug in H2/20.

The company’s Chief Medical Officer Riccardo Perfetti, MD, PhD, commented, “We are thrilled with these results…Galactosemia is a devastating disease with no treatments currently available. We have long known that dietary restriction alone does not prevent chronic complications of disease. These results provide hope for patients and families that action through drug treatment with AT-007 can potentially change the course of the disease, transforming patients’ lives.”

Shoshana Shendelman, PhD, founder, CEO and chair of the Board of Applied Therapeutics, added, “The Galactosemia program is an example of our overall strategy to apply technological breakthroughs to areas of high unmet need…By employing new regulatory pathways and using biomarkers early in development, we are able to bring critical drugs to patients who desperately need them quickly and effectively. The ACTION-Galactosemia data presented today is our first pivotal study readout – but it’s just the beginning. We are continuing to advance our pipeline of novel drug candidates in other disease indications and look forward to sharing additional successful data readouts in the future.”

Applied Therapeutics is headquartered in New York, N.Y., and describes its business as “a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need.” In addition to AT-007, the company is developing another lead drug candidate, AT-001, a novel aldose reductase inhibitor that is being developed for the treatment of Diabetic Cardiomyopathy, a fatal fibrosis of the heart.

Applied Therapeutics has a market cap of approximately $484 million with about 18.52 million outstanding shares. APLT shares opened more than 20% higher today at $31.75 (+$5.59, +21.37%) over yesterday’s closing price of $6.16 and the company’s stock achieved a new 52-week high price this morning of $40.141. The stock has traded today between $31.00 and $40.141 per share and is presently trading at $33.00 (+$6.84, +26.15%).

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: APLT:NASDAQ,
)