iX Biopharma

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SINGAPORE (Aug 29): iX Biopharma is a small Catalist-listed Singapore company focusing on a big goal: Developing pain management drugs that are an alternative to opioids, and the optimum system to deliver these drugs into the body.

One of its patents is WaferiX, a technology that reduces a drug to a wafer-thin tablet to be placed under the tongue for quick absorption, a sublingual drug delivery system that is believed to be the most effective after intravenous therapy.

iX Biopharma has also developed and produced Wafermine, a sublingual wafer of ketamine.

Wafermine is already in use in some Australian hospitals after physicians discovered its efficacy on the Australian victims of the 2002 Bali bombings who were recreational drug users and had developed a resistance to opioids.

Yet, for all its groundbreaking work and potential for exponential growth, shares of iX Biopharma, which made its debut on the Catalist board a year ago, have not performed well. They are nearly 40% lower than at the start of the year, and more than a third off the price at IPO.

Eddy Lee, chairman and CEO of iX Biopharma, is matter-of-fact about how investors in Singapore pick stocks in the sector, noting that the market has barely taken note of the progress the company has made towards the commercialisation of its key products.

“They are more familiar with property. If it all goes wrong, you can sell the land. Here, you’re talking about intellectual property, [which is] a bit harder to grasp. Once the product is out in the marketplace, the investment community will be more interested,” he says.

Source: The Edge

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IPO Price: 0.46

FY 2016

Revenue: -22%
Profits: 28%
Cash: $30m
VAV: 0.062

The Group is primarily a late-stage specialty pharmaceutical company with initial focus on the development and commercialisation of innovative therapies for pain management and male erectile dysfunction.

WafermineTM

The Group undertook and successfully completed KET-009, a Phase 2 multi-dose, placebocontrolled clinical study of WafermineTM. The study, which was completed as scheduled and within iX Biopharma Ltd. budget, confirmed the safety and good tolerability of the product when administered alone and in combination with opioids through three different dosing regimens, in subjects undergoing bunionectomy.

WafermineTM is currently supplied by our GMP-compliant facility in Australia to hospitals and registered pharmacies in Australia under the Special Access Scheme exemption set out in Schedule 5A of the Therapeutic Goods Regulation 1900 of Australia (“TGR”).

BnoX™/ Wafenorphine™

The Group has completed the formulation for a buprenorphine product utilising its WaferiX™ drug delivery technology in FY2016. Upon completion of a successful PK study, our GMP-compliant facility in Australia will be able to supply BnoXTM, our second pain management product, to hospitals and registered pharmacies in Australia under the Special Access Scheme exemption set out in
Schedule 5A of the TGR

http://infopub.sgx.com/FileOpen/iX_4Q20 ... eID=418912

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About iX Biopharma Ltd

iX Biopharma Ltd is a Singapore public-listed specialty pharmaceutical company, with manufacturing and laboratory testing facilities in Australia.

The Group is focused on the development and commercialisation of innovative therapies for improving the quality of life of
those suffering from pain and other health issues.

The Company leverages its patented sublingual drug delivery technology, WaferiX, to develop proprietary products that incorporate
pharmacologically active compounds that have been approved by the United States Food and Drug Administration.

Its portfolio of products under development includes Wafermine and BnoX for pain management, PheoniX for erectile dysfunction, and WafeRest for improved sleep quality

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August 25, 2016

iX BIOPHARMA MAKES SIGNIFICANT STRIDES IN DRUG DEVELOPMENT IN FY16
Expands number of products under development
Ends FY16 in stronger financial position

Singapore, 25 August 2016 – Homegrown specialty pharmaceutical company iX Biopharma Ltd. (“iX Biopharma” or, together with its subsidiaries, “the Group”) made significant strides in the development of the products in its product pipeline during the year ended 30 June 2016 (“FY16”).

In FY16, the Group completed a Phase 2 multi-dose clinical study for its lead product, Wafermine, an oral-sublingual analgesic using ketamine. The study confirmed its safety and tolerability when administered alone and in combination with opioids in three different dosing regimens in subjects undergoing bunionectomy. The next step in development for Wafermine is to conduct a Phase 2 efficacy study with a larger population to determine the optimal dose and dosing interval.

The Group has previously completed pilot bioavailability studies for PheoniX, a drug for erectile dysfunction. In FY16, it had completed a pivotal bioequivalence study of the same drug, and is awaiting the results of the study. Following which, the Group will file PheoniX with the relevant country’s regulatory authority for commercialisation.

The Group also introduced two new products from its research & development (“R&D”) efforts during the year: BnoX, a pain management drug incorporating buprenorphine as the active ingredient, and WafeRest, a melatonin wafer supplement for the alleviation of jet lag.

BnoX will help meet a global need for a viable alternative to opioids, while WafeRest will offer an effective solution for those suffering from flight dysrhythmia.

WafeRest will be the first health supplement in the Group’s pipeline of products. As a health supplement, the drug is not subject to in-human clinical studies, and the time-to-market for this product is expected to be relatively shorter.

The Group has commenced stability testing for WafeRest and, upon successful completion, intends to file the product for export listing with the Australian Therapeutic Goods Administration for sale.

Since its initial public offering, iX Biopharma further boosted its cash balance through the addition of an aggregate of S$9.8 million in net proceeds from a private share placement in April 2016 and a rights issue in July 2016.

http://infopub.sgx.com/FileOpen/iX_Pres ... eID=418913

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iX Biopharma’s male erectile dysfunction drug stands up to the test

By Jude Chan

SINGAPORE (Sept 13): Specialty pharmaceutical company iX Biopharma on Tuesday announced positive results in a pivotal bioequivalence study of its male erectile dysfunction drug.

The study compared iX Biopharma’s novel sildenafil wafer, PheoniX, with a reference drug – the oral tablet Viagra.

Sildenafil is the active compound in both PheoniX and the reference drug, and is used in the treatment of male erectile dysfunction.

Comparing the pharmacokinetics such as absorption, distribution, metabolism and elimination, iXBiopharma says the study found that the sublingual wafer formulation of PheoniX had a similar rate and extent of drug absorption as the reference drug.

PheoniX was well-tolerated and there were no serious adverse events reported, iXBiopharma said in an SGX filing.

“We are excited to reach this important milestone for PheoniX which brings iX Biopharma closer to delivering our novel WaferiX technology to the market,” says Chief Medical Officer Dr Janakan Krishnarajah.

“On the back of [these] positive results, the Group will proceed to apply for registration of PheoniX with the Therapeutic Goods Administration (TGA) in Australia,” Krishnarajah adds.

Shares of iX Biopharma closed at 26 cents on Tuesday.

Source: The Edge

http://smr.theedgemarkets.com/article/i ... 1-87358173

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Time: 1:02PM
Exchange: SGX
Stock: IX Biopharma(42C)
Signal: Resistance - Breakout with High Volume
Last Done: $0.27

Source: UOBKH

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iX Biopharma’s PheoniX rises to Viagra challenge, but will its share price stay up?

By Michelle Teo

SINGAPORE (Sept 16): News that iX Biopharma’s drug to treat male erectile dysfunction is close to appearing on pharmacy shelves has got the market excited.

Shares in the Catalist company rose nearly 8% in trading on Sept 14, a day after it announced that its sublingual wafer drug, PheoniX, has generated positive results in a bioequivalence study comparing it with the market leader, Viagra.

But even as iX Biopharma’s PheoniX rises to the challenge against the famous little blue pill, it’s hard to say if it can sustain the swell in its share price.

(See iX Biopharma’s male erectile dysfunction drug stands up to the test)

The stock had been limping along for most of the past year; at the current price, the counter is still 40% off its market debut.

To be sure, iX Biopharma’s chairman and CEO Eddy Lee maintains no hard feelings about poor market sentiment for the company’s stock.

What will it take to revive investor sentiment? With the latest development, and more in the pipeline, can iX Biopharma’s share price stay up?

Source: The Edge

http://smr.theedgemarkets.com/article/i ... 8-87358173

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Pain management specialist

Key products for pain management

Growing pain market; out-licensing opportunity to fund R&D and accelerate profitability

DCF fair value of S$0.43; expect slow turnaround in FY18F and FY19F but operations should ramp up from FY20F onwards

Key risks: Delay in clinical trials/approval process, no out-licensing or lower than expected fees; high cash burnout rate

Source: DBS

https://researchwise.dbsvresearch.com/R ... E=ccfick-b

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A case of no pain no gain for iX Biopharma

By Michelle Zhu

SINGAPORE (Oct 13): DBS Group Research has derived a fair value estimate of 43 cents for iX Biopharma in its preliminary assessment of what it deems a high-risk stock, with a view that investors should expect 0-20% potential returns from the stock over the next 12 months.

The specialty pharmaceutical company currently has five drugs under development:
1. WafeRest for jetlag and improved sleep quality;
2. PheoniX for the treatment of male erectile dysfunction; as well as
3. Wafermine,
4. BnoX and
5. Wafernyl for pain management.

All five drugs leverage on an under-the-tongue delivery technology, WaferiX, which enables quicker absorption and increases the bioavailability of the drugs such that a lower dosage is required.

(See also: iX Biopharma’s male erectile dysfunction drug stands up to the test)

(See also: iX Biopharma sees FY16 losses narrow to $7.7 mil)

In an unrated report on Tuesday, analyst Ling Lee Keng says although DBS expects a slow turnaround for iX Biopharma in FY18F and FY19F, operations should ramp up from FY20F onwards given a growing market for global pain management, especially with ageing population trends.

“Combining with the sublingual delivery method to improve drug absorption and bioavailability to achieve a lower dosage, iX Biopharma’s products could potentially be key drugs in their respective market segments,” states Ling, who highlights that pain-relieving drugs are currently the second-largest pharmaceutical class worldwide after cancer medicine.

The analyst expects iX Biopharma to “capture a significant market share” once Wafermine and BnoX are ready for commercialisation and exportation, which is likely to take place in late 2018 or early 2019.

Additionally, Ling believes iX Biopharma is likely to explore out-licensing opportunities in 3Q17, to fund further R&D and clinical operations to accelerate its profitability.

“Out-licensing, which is the granting of licences to other companies, could provide a source for funding the group’s R&D and clinical operations from the upfront payment and milestone fees for completion of clinical studies and regulatory approval.

Out-licensing can also accelerate profitability by two years, as compared to the direct sales model,” Ling explains.

Conversely, if the company is unable to reach an out-licensing deal, iX Biopharma would have to incur more R&D and clinical operations costs, which may lead to a higher-than-expected cash burnout rate, warns the analyst.

Shares of iX Biopharma closed 2 cents lower at 33 cents.

Source: The Edge

http://smr.theedgemarkets.com/article/c ... 1-87358173

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iX Biopharma Ltd. has been granted a patent in Canada for its WaferiX drug delivery technology.

Canada has a potential market size of C$515mn and C$97mn for opioids and sleep aids, according to Patented Medicine Prices Review Board of Canada and Euromonitor respectively.

The Group has been granted a similar patent in South Korea earlier this year.

Source: SGX Masnet, Phillip Securities Research