Thinly traded nano cap vTv Therapeutics (VTVT+121.6%) rockets on a whopping 121x surge in volume.
The company just filed an 8-K disclosing that top investor MacAndrews & Forbes Group, controlled by noted investor Ronald Perelman, just bought another 1,879,699 Class A common shares at $1.33 per share pursuant to a July 30 agreement. Its stake is now over 36M shares.
SeaSpine Holdings Corporation SPNE, +6.86% a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today preliminary financial results for the three-months ended September 30, 2018.
Preliminary and unaudited revenue for third quarter 2018 is expected to be in the range of $35.5 to $36.0 million, reflecting approximately 12% to 13% growth compared to the prior year period. Compared to third quarter 2017, total U.S. revenue is expected to increase between 12% to 13% to approximately $31.5 to $31.8 million, with both U.S. Orthobiologics and U.S. Spinal Implants revenue expected to increase more than 10%. International revenue is expected to increase between 14% and 20% to approximately $4.0 to $4.2 million.
Cash and cash equivalents at September 30, 2018 are expected to be approximately $11.5 million. The Company borrowed $3.0 million of cash under its credit facility during the third quarter of 2018 and had $7.3 million of outstanding borrowings under the credit facility as of September 30, 2018. The Company has not sold any shares of its common stock under its $50 million “at the market” equity offering program.
“We are pleased by our revenue results for the third quarter, which reflect solid revenue growth across all portfolios,” said Keith Valentine, President and Chief Executive Officer. “This momentum is driven by increasing market penetration from our recently launched products, a more engaged and increasingly exclusive distributor network, and from a deeper commitment in our organization to customer experience and medical education and training. We are confident that we are well positioned to sustain this growth as we continue to deliver cost effective procedural solutions to surgeons and hospitals to improve the quality of patient lives.”
2018 Financial Outlook SeaSpine is increasing its full-year 2018 revenue guidance range to $141 to $142 million, up from $136 to $139 million, reflecting growth of approximately 7% to 8% over full-year 2017 revenue.
Upcoming Investor Conferences As previously announced, SeaSpine management is scheduled to present at the Ladenburg Thalmann 2018 Healthcare Conference in New York, NY today, October 2 at 3:00pm ET. SeaSpine management is also scheduled to present at the Cantor Global Healthcare Conference in New York, NY on Wednesday, October 3 at 9:10am ET. A live webcast of both presentations will be available on the Investor Relations page of the Company’s website at www.seaspine.com. A replay of each presentation will be available on the website for 30 days following the event.
Heel compressions to stimulate circulation in the legs, along with regular walking or some other form of exercise, are helpful in healing venous leg ulcers (VLUs), a systemic review and meta-analysis found.
The findings were based on a comparison between exercise groups and control groups. Exercise was linked with increased healing rates of 14 additional cases per 100 patients, while progressive exercise in conjunction with prescribed physical activity was linked with increased healing of 27 additional cases per 100 patients, reported Andrew Jull, RN, PhD, of University of Auckland, and colleagues in JAMA Dermatology.
The evidence base is limited because of the number of randomized participants and the need for more conclusive trials. However, there is enough evidence for clinicians to recommend the appropriate patients implement progressive resistance exercises and 30 minutes of walking at least 3 days per week into their care, noted the study authors.
“Even if this evidence is found to be incorrect in the future, it is unlikely that such an approach will disadvantage patients, given the benefits of physical activity and the impact of prolonged inactivity on function,” the investigators continued.
Robert Kirsner, MD, PhD, of University of Miami Miller School of Medicine in Florida, noted in an accompanying editorial that venous leg ulcers are “among the most prevalent and costly skin diseases,” affecting some 2% of older individuals each year.
Even with quality care a substantial number “of leg ulcers do not fully heal after 6 months, leading to significant impact in quality of life from pain, mobility issues, and embarrassment from foul-smelling and draining wounds. Other targets for intervention, therefore, are critically needed,” Kirsner wrote.
He was generally supportive of the meta-analysis, while noting its inherent limitations. With the current findings, he wrote, “we are now empowered to recommend exercise for patients with VLUs, while we await further studies that better elucidate how to best target this intervention, informing us which patients with VLUs will benefit most and why.”
Weak Literature
But other dermatologists contacted by MedPage Today were more cautious.
“I don’t doubt that patients who did exercise healed better, but the data is not large enough to say how much effect the exercise does, and the exercise used in each study was not universal,” said Sahoko Little, MD, PhD, of University of Michigan in Ann Arbor.
“Many of the patients who have venous stasis ulcers are very sedentary, and/or have physical limitations. The patients who can do prescribed exercises are not [the] majority of the patients with venous stasis ulcers,” continued Little.
William Huang, MD, MPH, of Wake Forest School of Medicine in Winston-Salem, North Carolina, noted politely that Jull and colleagues “did their best to try and systematically review available literature.”
But that literature remains weak, he suggested. “Most of the studies are small, few in number, lack sufficient blinding, and outcomes vary, creating problems with coming up with definitive conclusions,” Huang told MedPage Today. “The evidence to support exercise as a component of venous leg ulceration treatment is still limited. Our ‘best evidence’ does suggest that this is a low-risk, low-cost, and simple intervention that may help some patients but we don’t have strong enough evidence to universally recommend [it] for all.”
Study Details
The researchers analyzed 190 participants using data from five randomized controlled trials (RCTs), in which exercise was compared with no exercise in venous leg ulcer patients, compression was a form of standard therapy, and healing outcomes were measured.
The investigators report using the following exercise interventions were included: exercise alone (two RCTs, 53 participants), progressive resistance exercise and prescribed physical activity (two RCTs, 102 participants), walking (one RCT, 35 participants), and ankle exercise (one RCT, 40 participants).
Two trials had participants with adverse events. In one of the trials, the researchers reported, if only the first event of a type was considered, 38 events were reported by intervention participants and 26 by usual care participants (OR 1.32; 95% CI 0.95-1.85), while the second trial reported two non-serious adverse events related to exercise and no adverse events among the group of patients receiving standard care.
One trial reported medical care costs. For exercise participants, the cost per patient to health services was €1,423 and €2,299 for the usual care group, translating to €875 in cost savings per patient each year. Moreover, the researchers also calculated the cost to the patient, which was €114 for the exercise group and €175 for the usual care group, resulting in a cost saving per patient of €61 each year. (Currently, €1 = $1.15.)
Jull, Kirsner, and Huang did not report any disclosures.
Reviewed by Dori F. Zaleznik, MD Associate Clinical Professor of Medicine (Retired), Harvard Medical School, Boston and Dorothy Caputo, MA, BSN, RN, Nurse Planner
Gilead’s Kite is paying $10 million upfront to tap into a neoantigen screening platform developed by Hong Kong biotech HiFiBiO Therapeutics to discover T-cell receptors (TCRs) for cancer.
The two companies say they will adapt the platform to scale up and accelerate the screening process so that it can be applied to cells taken from patient samples—potentially allowing the development of targeted, personalized cellular immunotherapies.
Neoantigen are driving a new form of personalized immunotherapy in which antigens that are found in diseased tissues but not normally in healthy patients are used to develop targeted therapies. That ties in neatly with Kite’s TCR platform, which involves identifying receptors that bind to tumor antigens, modifying autologous peripheral blood T cells to express them and then administering them to patients.
The biotech has been working in the neoantigen/TCR space for some time through a collaboration with the National Institutes of Health (NIH) to discover mutations in oncogenes such as KRAS that can be targeted with T-cell therapies. Two years ago, the partners published a case study of a patient with metastatic colorectal cancer who was successfully treated with T cells that targeting the KRAS G12D mutation.
Since then, Kite has advanced its lead TCR candidates into clinical trials, including KITE-439 for HPV-associated solid tumors—which has initial phase 1 results and also grew out of the NIH collaboration—and MAGE A3/A6-targeted KITE-718.
“Neoantigen-based cell therapy is a very exciting, yet complex, area of research that has the potential to transform the way we treat many solid tumors,” said Alessandro Riva, M.D., who heads up Gilead’s oncology therapeutics and cell therapy programs.
“We are excited about this collaboration with HiFiBiO, which will build upon our existing capabilities focused on discovering cell therapies which target patient-specific tumor neoantigens.”
In return for its $10 million, Kite is taking an exclusive option to license HiFiBiO’s platform to screen T cells for receptors that can be used in engineered T-cell therapies, while the Hong Kong company is also in line for undisclosed milestone payments.
This is the second platform strengthening deal for Kite’s TCR program in the last few months, coming after it took an option to buy Dutch biotech Gadeta and its gamma delta TCR technology.
Tilray Inc. (NASDAQ:TLRY), a global leader in cannabis research, cultivation, production and distribution, today announced that it intends to offer, subject to market conditions and other factors, $400 million aggregate principal amount of Convertible Senior Notes due 2023 (the “notes”) in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). The notes will be sold to accredited investors in Canada pursuant to an exemption from the prospectus requirements of Canadian securities laws. Tilray also intends to grant the initial purchasers of the notes an option to purchase up to an additional $60 million aggregate principal amount of notes.
Tilray intends to use the net proceeds from this offering for working capital, future acquisitions and general corporate purposes, and to repay the approximately $9.1 million existing mortgage related to its facility in Nanaimo, British Columbia.
The notes will be senior unsecured obligations of Tilray and will accrue interest payable semiannually in arrears. The notes will be convertible into cash, shares of Tilray’s Class 2 common stock or a combination of cash and shares of Tilray’s Class 2 common stock, at Tilray’s election. The interest rate, initial conversion rate, repurchase or redemption rights and other terms of the notes will be determined at the time of pricing of the offering.
Neither the notes, nor any shares of Tilray’s Class 2 common stock issuable upon conversion of the notes, have been registered under the Securities Act or any state securities laws, or qualified for distribution by prospectus in Canada, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws, or sold in Canada absent an exemption from the prospectus requirements of Canadian securities laws.
Yesterday, top-line data fromBionomics Limited (ASX:BNO, OTCQX:BNOEF) revealed details of the biopharmaceutical company’sPhase II clinical trial of BNC210 in regards to patients with post-traumatic stress disorder (PTSD). BNC210 is an innovative negative allosteric modulator of the alpha7 nicotinic acetylcholine receptor.
“This trial comprehensively assessed symptoms in 193 patients with PTSD across 25 sites in the US and Australia,” explained Professor Paul Rolan, Bionomics’ consultant Chief Medical Officer. “We found that BNC210 showed excellent tolerability and safety. This adds to the safety picture for BNC210, administered for the first time over a prolonged 3-month treatment period. Although there was no overall treatment effect assessed by CAPS-5, we saw improvements on select components of the scale that are attributable to the mood and anxiety symptoms of the condition.”
Bionomics (ASX: BNO) is a worldwide clinical stage biopharmaceutical company working to create original drug candidates for cancer and central nervous system (CNS) disorders such as Alzheimer’s disease, anxiety, and depression. “Bionomics has a portfolio of well differentiated drug candidates. Each target the treatment of serious conditions with significant unmet clinical need, and for which large market opportunities exist. We are able to not only sustain but accelerate our pipeline development by virtue of two distinguishing attributes: 1) high quality drug candidates and 2) our strategic partnering strategy which allows multiple and diverse programs to be optimally developed,” quotes their website. At the BioPharma Asia Industry Awards during the BioPharma Asia Convention in 2014, Bionomics was named as the Innovative Asian Biotech of the Year.
Bionomics consultant Dr. Murray Stein, Distinguished Professor of Psychiatry, Family Medicine and Public Health at the University of California San Diego offered that “there is great unmet medical need for safe and effective treatments for the large population of patients suffering with PTSD worldwide. While challenging to find which symptoms may respond to the novel pharmacological properties of BNC210, there was great anticipation that it would show clear beneficial effects on improving PTSD symptoms, supporting further development of the drug as a novel treatment for this condition. Results of this trial do not demonstrate those broad benefits, underscoring the complexity of PTSD and the heterogeneity of PTSD symptoms across patients. Future work with BNC210 – and other novel compounds – may be best focused on a subset of symptoms, or a subset of patients, considered most likely to benefit.”
Their pipeline divides into the aforementioned two areas of specialty, CNS and oncology. BNC210 is the company’s lead drug candidate, with primary indications in PTSD, agitation, GAD, and panic. Results divulging that the drug has been ineffective may prove to be detrimental to the company’s efforts. Since the announcement yesterday morning, the Bionomics share price has dropped 69%, a 52-week low.
“We are extremely disappointed that the primary endpoint in this trial was not met. As we move forward we will focus on the completion of the ongoing Phase 2 trial of BNC210 in hospitalised, elderly patients suffering from agitation which is anticipated to readout in Q1, 2019. We plan to stop all other work on BNC210 until that time,” disclosed Dr. Deborah Rathjen, CEO & Managing Director of Bionomics. “In FY18 Bionomics reduced costs by closing the US operations and reducing overall headcount. In order to maintain and enhance shareholder value, we are continuing to assess our strategic options for partnering and portfolio prioritisation whilst conserving cash. We will provide an update on our strategic direction at the Annual General Meeting to be held on 14 November.”
“Bionomics has ongoing drug discovery programs which are anticipated to deliver up to two new therapeutic candidates this financial year. We also have a strategic partnership with Merck & Co., (known as MSD outside the United States and Canada), assessing a cognition therapy candidate in an ongoing Phase 1 program, which entered clinical development and triggered a US$10 million milestone payment last year,” added Dr. Rathjen. “This deal has a potential value of up to US$506 million in terms of the upfront payments, R&D payments and milestone payments, plus additional annual royalties on net sales of licensed drugs. Both the MSD partnership and our drug discovery programs reflect the robustness of Bionomics’ pipeline.”
On Tuesday, Renaissance Capital reported the company founded by former Kite Pharmaexecutives Arie Belldegrun, and David Chang, will offer 16 million shares at a price range of $16 to $18 per share. If the high-end pricing is hit, that would secure $288 million for the company and would, according to Renaissance Capital, give Allogene a “fully diluted market value of $2.1 billion and an enterprise value of $1.4 billion.”
South San Francisco-based Allogene announced its intentions to file for an IPO last month. The company intends to list itself on the Nasdaq Stock Exchange under the ticker symbol “ALLO.” Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC, Cowen and Company, LLC and Jefferies LLC are acting as the joint book-running managers for the proposed offering.
Founded in 2017 and coming out of stealth mode in April, Allogene hit the ground running with $300 million in a Series A financing to develop off-the-shelf CAR-T therapy products. The company’s engineered T-cells are allogeneic, which means they are taken from healthy donors for intended use in any patient. Current approved CAR-T therapies, including Yescarta, which Belldegrun and Chang were instrumental in developing when they were at Kite, are autologous, meaning they are extracted from an individual patient for that patient’s use.
Following Allogene’s launch in April, the company completed an agreement for Pfizer’sallogenic CAR-T portfolio. As part of that deal, Allogene secured the rights to 16 preclinical CAR T assets licensed from Cellectis and Servier and one clinical asset licensed from Servier, UCART19, an allogeneic CAR-T therapy that is being developed for treatment of CD19-expressing hematological malignancies.
In its S-1 filing with the U.S. Securities and Exchange Commission, Allogene said UCART19 is being studied in clinical trials in patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The company said it anticipates UCART19 will be advanced to registrational trials in the second half of 2019. Additionally, Allogene said the company plans to file an Investigational New Drug Application with the U.S. Food and Drug Administration in the first half of next year for the company’s second allogeneic anti-CD19 CAR T cell product candidate, ALLO-501. That therapy will be for the treatment of relapsed or refractory non-Hodgkin lymphoma.
Allogene also noted in its filing that it has a “deep pipeline” of allogeneic CAR T cell product candidates targeting multiple promising antigens in a host of hematological malignancies and solid tumors.
When Allogene’s stock goes public, Belldegrun and Chang will have about 10 percent and 4 percent of the company’s shares, respectively. Those shares will be worth millions, but it’s a position the two men are well acquainted with. When Gilead Sciences acquired Kite Pharmaceuticals, Belldegrun snagged a nice payday of $694 million. Chang walked away with about $98 million.
Allogene is the latest in a series of biotechs going public. Earlier this week Israel-based Gamida Cell Ltd.filed for a $69 million initial public offering.
