The price action of ASX biotech shares was nothing short of a mixed bag in 2021.

Several of the majors underperformed the benchmark S&P/ASX 200 Pharmaceuticals & Biotechnology index (AXPBJD), whereas many small-cap names came through the ranks to shine brightly ahead of peers.

The broad index itself was choppy throughout 2021, taking a deep plunge throughout December to finish just 2.1% higher for the year.

Investors watching the ASX biotech space will be keen to see how the sector rolls out of the blocks this year.

Commentary on the broader healthcare sector points to a decade of accelerated growth and heavy capital investment, thrust forward by policies bought on by COVID-19.

With these points in mind, we take a look back and see the year that was for the best performing ASX biotech shares.

Imugene Limited (ASX: IMU)

The Imugene share price was a star performer in 2021 and rallied 300% across that time. The biotech finished the year strongly with a set of positive announcements regarding its clinical trial pipeline.

Imugene first advised it had received US Food and Drug Administration (FDA) Investigational New Drug (IND) approval to initiate a phase I clinical trial of its oncolytic virotherapy candidate called VAXINIA.

It then advised the FDA had awarded IND approval for Imugene to initiate a new phase 2 clinical trial of its immunotherapy drug candidate, HER-Vaxx.

Announcements and updates concerning the HER-Vaxx segment were the major driving force for Imugene's share price in 2021.

For instance, the company announced it formed a strategic partnership with clinical-stage biotechnology company Eureka Therapeutics in November.

The pair will investigate the therapeutic potential of combining their technologies for the treatment of solid tumours.

Just after this, Imugene announced it had signed a clinical supply agreement with pharmaceutical juggernauts Merck KGaA (ETR: MRK) and Pfizer Inc (NYSE: PFE).

Together the group will investigate Imugene's HER-Vaxx therapy in combination with Avelumab – a label developed by Pfizer and Merck – as a combination therapy in a certain type of gastric/gastroesophageal cancer.

Avelumab works by blocking a certain molecule that suppresses the immune system, whereas HER-Vaxx is specifically designed to treat tumours.

Following these announcements, the Imugene share price spiked towards new 52-week highs.

In early trading on Tuesday, the Imugene share price is up 6.75% to 42.7 cents.

CSL Limited (ASX: CSL)

Shares in global biotech juggernaut CSL finished in the green in 2021 – but not before undergoing some downside volatility in December.

Just prior to this, CSL had fallen sharply off its 52-week high of $318 in November, as concerns around blood plasma collections in the US surmounted and the new Omicron COVID-19 variant began its impulse throughout financial markets.

After thrusting past this 1-year high, this ASX biotech share reversed course and bottomed at $272 by the middle of December, a substantial drop of $46 per share in less than a month.

However, news of the company's acquisition of Swiss-based biotech company Vifor Pharma for $17.2 billion in cash sent CSL's share price bouncing off this low.

By the time the company completed its capital raising round for the purchase, investors had already driven CSL shares back to $290 and change to finish the year.

Aside from this momentum to close out 2021, CSL share price action was quite volatile across the year, with a spread of 29% between minimum and maximum closing prices in that time.

Nevertheless, analysts at several investment banks are bullish on the company following its recent acquisition. Citi upgraded its recommendation on CSL shares to a buy and values the company at $340 per share. Morgans is equally as bullish and assigned a price target of $334 per share.

Telix Pharmaceuticals Ltd (ASX: TLX)

Shares in oncology company Telix Pharmaceuticals traded in a relatively narrow ascending channel during most of 2021 after popping in May last year.

The company finished the year up 96% and closed the final session at $7.75 apiece.

News around Telix's novel imaging platform for prostate cancer, Illuccix, was the major catalyst that saw investors screaming to secure a spot in the company's growth engine last year.

Adding to the company's flywheel in 2021 was the FDA approving its Illuccix technology for use as a diagnostic imaging platform for prostate cancer.

The company also now expects European approval for registration status no later than 23 March 2022 for the Illucix platform. This comes after it was awarded marketing authorisation application (MAA) in the bloc.

The team at Bell Potter has Telix as a buy and values the company at $9.65. Meanwhile, Wilsons' recently upgraded its price target on the company to $10.35.

Both Jarden and Jefferies also reckon Telix is a buy, valuing the company at $8.50 and $7 respectively.

Neuroscientific Biopharmaceuticals Ltd (ASX: NSB)

Neuroscientific Biopharmaceuticals was a decent performer among ASX biotech shares in 2021, gaining 36%.

Flying largely under the radar, the company traded as high as 51.5 cents in September last year, before levelling off and fetching 33.5 cents apiece to close out the final session of 2021.

This price action came after investors bid up NSB's share price from a low of 21 cents back in February, and then got ahold of it once more in September.

During that time NSB advised that AusIndustry approved an Advance and Overseas Finding under the R&D tax incentive program (TIP) for the development of the company's lead drug candidate, EmtinB.

The studies will investigate EmtinB as a novel therapeutic treatment for ocular conditions that damage the optic nerve.

Meanwhile, the tax program enables the company to receive R&D tax incentive rebates on up to $25 million of R&D expenditure incurred during 2021, 2022, and 2023. Investors drove up NSB shares in a linear fashion following the release.

Then, in December, the ASX biotech share released positive study readouts from a safety assessment of EmtinB following an in vitro screening program.

Specifically, the researchers were examining ways to predict "drug-induced toxicities in humans prior to first-in-human Phase I clinical studies".

Why is this relevant? It boils down to the fact some drug interactions produce unintended adverse side effects in humans.

This interplay has regulators advocating drug makers such as NSB to produce known "anti-targets" – like the screening program in this latest update – as part of risk mitigation in drug development.

Doing so improves the known safety and risk profiles of various drugs to improve patient outcomes.

The market sent the Neuroscientific Biopharmaceuticals share price 11% higher on the day of the announcement.

Memphasys Ltd (ASX: MEM)

Shares in ASX biotech Memphasys finished 2021 marginally in the red. However, considering its performance in the final quarter of 2021, it is a worthy mention.

Memphasys started 2021 trading up around 11.5 cents apiece before taking a massive plunge to land just below 6 cents in March.

It stayed around those levels for the bolus of the year, trading sideways in a narrow channel with a spread of just 1.3 cents.

That was before shares popped in November after Memphasys received validation and verification for its Felix device.

Shares in the medical device and biotechnology company subsequently closed out the month 58% in the green after peaking at 11 cents apiece.

Its share price has since reverted back to its current levels at 9.3 cents. However, it has found support around this level and is trading sideways once more.

Furthermore, the company announced it made its first commercial sale of the Felix System for clinical IVF use in December. The order was made from a women's centre in Coimbatore, India, marking the first steps in cash flow receipts for this segment.

The post Here are the 5 best performing ASX biotech shares of 2021 appeared first on The Motley Fool Australia.

The Neuroscientific Biopharmaceuticals Ltd (ASX: NSB) share price is rising today on the back of a clinical trial update.

Shares in the company are trading at 34 cents at the time of writing, up 11.48%.

Let's take a look at what may be weighing on investors' minds today.

What did the company announce?

The Neuroscientific Biopharmaceuticals share price is on the rise following promising results from a safety assessment of the company's lead drug candidate, EmtinB.

In research conducted in vitro, the EmtinB drug did not cause any adverse reactions or toxicity. The trial involved screening 173 potential biological targets known to stimulate drug-induced reactions in humans.

Neuroscientific is a biotechnology company working on peptide-based drugs to treat neurodegenerative diseases.

EmtinB binds to specific proteins known as receptors to activate signalling pathways between the cells. This can help to protect and regenerate the nervous system.

The in vitro trials were carried out by research company Eurofins at laboratories in France. This screen is recommended to reduce risk before progressing to human trials.

The completion of this safety assessment is seen by the company as a major step towards conducting phase I trials in humans.

Management commentary

Speaking on the results fuelling the Neuroscientific Biopharmaceuticals share price, chief executive officer and managing director Matt Liddelow said:

These positive safety results add further confidence to existing safety data for EmtinB in demonstrating it's low likelihood to cause any major safety issues in humans — and is another major step towards achieving the landmark milestone of starting first-in-human Phase I studies in the first half of 2022.

I look forward to updating the market with further progress in the New Year as we advance towards Phase I clinical studies.

Neuroscientific Biopharmaceuticals share price snap shot

The Neuroscientific Biopharmaceuticals share price has gained 36% since the start of the year. For perspective, the S&P/ASX 200 Index (ASX: XJO) has returned more than 12% over the same period.

Despite this, the company's shares have lost 7% in the past month but are up around 8% this week.

The company has a market capitalisation of roughly $43.7 million based on its current share price.

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The broad Australian indices have started the day off in the red as the market resets from a number of stirrups this week.

The S&P/ASX 200 index (ASX: XJO) has clipped 0.37% lower today and sits at 7,343 points, whereas the S&P/ASX 200 Health Care index (XHJ) has dropped around 1% from the open.

Yet, these 3 ASX healthcare shares are soaring well ahead of their benchmarks today. Let's take a closer look.

Neuroscientific Biopharmaceuticals Ltd (ASX: NSB)

Neuroscientific is concerned with the development of diagnostics and therapeutics for neurodegenerative diseases.

In today's trading, Neuroscientific's shares are changing hands at 48.5 cents each, which is a 10% gain from the open.

Two recent advancements made on the company's EmtinB drug label appear to have shot the company's shares to new highs. Neuro' is developing EmtinB as a treatment for all kinds of neurodegenerative conditions, such as Alzheimer's and MS.

On 31 August, Neuro' had positive data readouts from a pre-clinical study that showed EmtinB's potential "as an effective treatment for Multiple Sclerosis (MS)". The results add to a list of data that points to it being a potential MS drug candidate.

Aside from this, on 3 September the company advised it had received approval from AusIndustry under the R&D tax incentive program to develop EmtimB as a "novel therapeutic treatment for ocular conditions" with (up to) $25 million in rebates.

Bionomics Ltd (ASX: BNO)

Bionomics shares are now changing hands at 17.5 cents each, which is a 6% gain in afternoon trade. At one point today, shares in the biopharma company were trading at over 18 cents each, up 10% from the previous close.

A recent announcement concerning the company's lead clinical compound, BNC210, appears to have spurred on recent gains for Bionomics.

Last week it announced a "planned (the) commencement" of a clinical trial for BNC210, further investigating its use in the "acute treatment" of social anxiety disorder.

The compound had previously shown promising signs in a Phase 2a clinical study, where it produced "significant anti-anxiety signals".

It is recruiting 150 patients in the US-based study, and intends to submit an application "by the end of this year".

Investors continue to push this ASX healthcare share into the green as we finish trading this week.

Dimerix Ltd (ASX: DXB)

Shares in clinical biopharma company Dimerix hit an intraday high of 31 cents at one point today, an 11% gain from the previous close.

They have since cooled off slightly in afternoon trade and now trade at 30 cents each. Dimerix shares have been on the move today since the company made a key announcement earlier.

The company advised it had been given the green light in India to start the "feasibility/Phase 3 clinical study" of its lead drug candidate, DMX-200.

DMX-200 will now be investigated in the "treatment of respiratory complications associated with COVID-19 imminently", after the Indian authorities met on 2 September to discuss the study.

This marks the "final regulatory agency approval required" to commence the phase 3 study, known as CLARITY 2.0. The first patient is "expected to be dosed in the next few weeks".

Aside from this, DMX-200 is also being investigated in a Phase 3 clinical study for a rare set of kidney disorders.

These 3 ASX healthcare shares have stepped ahead of the broad indices in afternoon trade on Friday.

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The Neuroscientific Biopharmaceuticals Ltd (ASX: NSB) share price has jumped into the green during afternoon trade on Friday.

Neuroscientific shares are on the move as the company released an announcement on its EmtinB label.

Let's investigate further.

What did Neuroscientific announce?

After recommencing trade after Thursday's trading pause, Neuroscientific provided additional colour on its announcement from 19 August.

Recall that Neuro' announced on Thursday that its EmtinB label indicated "strong therapeutic potential" in "preventing severe immune responses from Covid-19".

It achieved this by reducing "important biomarkers" associated with "severe Covid-19…by more than 50%".

As such, Neuro' advised the "serves as clarification" on these results. Consequently, the aim was to provide further clarity "regarding the specifics of the studies".

The explicit clarification as it were, is in reference to EmtinB's mechanism of action in the trials.

To illustrate, on Thursday the company gave a high-level overview of this, whereas, on Friday, Neuro' went into greater depths over just how EmtinB "does what it says on the tin" in this instance.

For instance, the company explained that EmtinB can "dramatically reduce" these biomarkers, which have been identified in "Covid-19 clinical studies as indicators of severe disease and poor prognosis".

Consequently, Neuroscientific reasons that by decreasing these "immune biomarkers", this indicates that EmtinB "may decrease" an inflammatory response that is significantly elevated due to Covid-19.

What did management say?

Speaking on the announcement, Neuroscientific managing director Matt Liddelow said:

These results demonstrate the significant therapeutic utility of EmtinBTM and its potential modulation of
inflammatory processes outside of the central nervous system. For the first time, our team
have demonstrated an EmtinBTM -mediated effect on adaptive immune responses as
evidenced by regulation of these inflammatory biomarkers.

Neuroscientific share price snapshot

The Neuroscientific Biopharmaceuticals share price has posted a year to date return of 34%, extending the previous 12 month's gain of 42.5%.

These results have outpaced the S&P/ASX 200 Index (ASX: XJO)'s return of around 25% over the past year.

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The Neuroscientific Biopharmaceuticals Ltd (ASX: NSB) share price jumped higher this morning before becoming subject to a trading halt at lunchtime.

Before the pause in trading, the Australian biotech company's shares were exchanging hands at 31.5 cents apiece, an 8.6% leap from the open. The share price gain came after an update was released to the market prior to the opening bell.

What did Neuroscientific announce today?

Neuroscientific shares jumped on Thursday as the company provided an update on its EmtinB label.

According to Neuroscientific, "EmtinB is currently being developed as a treatment for neurodegenerative dementia and Alzheimer's disease, and degenerative conditions of the optic nerve".

The announcement said EmtinB was shown to be effective in reducing "important biomarkers" associated with severe COVID-19. The study demonstrated Neuroscientific's label was effective in reducing these biomarkers by "more than 50%", versus controls.

As such, this indicates a "strong therapeutic potential" for EmtinB, "in preventing severe immune responses" from COVID-19.

Neuroscientific's hypothesis in examining EmtinB in COVID-19 was to address the "cytokine storm" that occurs with an aggressive inflammatory response in COVID-19 infection.

For example, this "storm" results in a cascade of uncontrolled inflammation in the body, which decreases a person's lung function. A rise in the incidence of these events has been purported with COVID-19, thereby leading Neuroscientific to conduct its trial.

The results obtained suggest EmtinB "is safe to administer in future work", and are an important milestone for the company.

Why are Neuroscientific shares in a trading halt?

Shares paused trading just after midday on Thursday, with the company stating it was working to "finalise an announcement detailing further information in regard to the results from pulmonary studies as announced today".

The halt will remain in place until Monday 23 August, or until the announcement is released to the market.

Neuroscientific share price snapshot

The Neuroscientific Biopharmaceuticals share price has posted a year-to-date return of 26%, extending the previous 12 months' climb of 31%.

These returns have both outpaced the S&P/ASX 200 Index (ASX: XJO)'s gain of around 25% over the last year.

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NeuroScientific Biopharmaceuticals Ltd (ASX: NSB) shares jumped more than 7% in early trade after the company released the readouts for the successful completion of its pivotal ocular safety study. Since then, however, the NeuroScientific share price has reversed and is currently trading 1.49% in the red at 33 cents.

Let's take a look at what unfolded this morning for the Australian biotech company.

What was the study?

The NeuroScientific share price received a temporary boost this morning after the company provided the ASX with a pre-market update. NeuroScientific's 4-week safety and tolerance study investigated low to high dose regimes of its lead drug candidate emtinB, administered via intravitreal injection. EmtinB is being developed as a potential treatment for Alzheimer's disease and dementia.

Prospective drug candidates in Australia must first pass rigorous safety and tolerance testing prior to advancing towards efficacy and dosing trials.

NeuroScientific advised that emtinB produced no serious adverse outcomes related to treatment in the study cohort across a duration of 28 days.

So, according to the company, today's outcome enables NeuroScientific to advance towards starting Phase 1 clinical study protocols for emtinB, which are set for the second half of this year. There are 3 clinical study phases to complete before successful registration onto the market.

Management commentary

NeuroScientific CEO and managing director Matt Liddelow commented on today's update:

NeuroScientific is pleased to report these positive safety results for EmtinB, which is a major advancement for our ocular R&D program in the lead up to starting a Phase I clinical study.

NeuroScientific share price snapshot

The NeuroScientific share price has gained 32% since the start of this year. It has a 12-month return of more than 53% at the time of writing.

At the current share price of 33 cents, the company has a market capitalisation of around $48 million and has a 52-week range of 18.5 cents to 38 cents. NeuroScientific shares reached their 52-week high just last month on 24 June.

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The Neuroscientific Biopharmaceuticals Ltd (ASX: NSB) share price is up 20% today on the back of an ASX announcement about its lead compound EmtinB. In a preclinical study, the compound demonstrated positive preliminary results in a Multiple Sclerosis (MS) model. In this study, EmtinB was assessed against the leading therapeutic treatment for MS, Copaxone. 

Copaxone generated peak sales of approximately US$4 billion in revenue in a market approximately worth in excess of US$20 billion. 2.3 million patients are suffering from MS globally.

What is Multiple Sclerosis?

According to healthline, "MS is a chronic illness involving your central nervous system. The immune system attacks myelin, which is a protective layer around nerve fibres. This causes inflammation and scar tissue, or lesions. This can make it hard for your brain to send signals to the rest of your body". 

What did the study find?

An extension of the concluded study results announced on 18 March 2020 demonstrated that EmtinB had a highly significant positive effect on the proliferation and differentiation of the myelin-forming cells of the central nervous system.  

Additionally, in the current study, EmtinB significantly increased myelin formation by greater than 30% at 150 ug/ml concentration. In comparison, the leading marketed drug, Copaxone, demonstrated myelin formation greater than 25% at 120 ug/ml.

Neuroscientific Biopharmaceuticals CEO and Managing Director, Matthew Liddelow, commented "These results represent a potential breakthrough in the treatment of MS as there are currently no approved therapeutic drugs available to patients that have demonstrated the ability to regenerate myelin in the central nervous system".

The company's full report of the study is expected to be available before the end of July.

About Neuroscientific

According to its website, the company's vision is to transform how the pharmaceutical industry approaches the understanding and treatment of neurodegenerative disease. It believes no other disease area holds as much need or as much promise for medical breakthroughs as neuroscience. 

Prior to today's announcement, the Neuroscientific share price had fallen roughly 23% in the last year. However, the positive result has sent the price soaring today to as high as 30 cents per share at one point. At the time of writing, the company's share price had edged back to 24 cents, giving the group a market capitalisation of $18.81 million. 

It will be interesting to see the full report of the study that is expected to be released at the end of July. 

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The Neuroscientific Biopharmaceuticals Ltd (ASX: NSB) share price skyrocketed 190% on Tuesday after news that the company's flagship drug EmtinB was part of a successful study into the treatment of Alzheimer's disease as well as a range of other neurological conditions such as spinal injuries, Multiple Sclerosis, Parkinson's Disease, and Amyotrophic Lateral Sclerosis.

NSB shares had been in a trading halt since Monday, but upon release if its results, the NSB share price has risen from 14 cents per share to 42 cents at close of trading yesterday, a rise of around 190%.

Neuroscientific Biopharmaceuticals stated in its release to the ASX that "the company is pleased to report the results of a breakthrough study that paves the way for a new effective way to treat Alzheimer's, our lead indication. The study also points towards ability of EmtinB to be a powerful avenue to help patients by developing drugs for several other neurodegenerative diseases".

On the potential success of EmtinB, the company also stated that "the highest dose of EmtinB significantly stimulated regeneration of nerve cells by more than 300% in comparison to controls incubated with sterile water".

Neuroscientific Biopharmaceuticals also claims that EmtinB is twice as effective as the current market-leading drug for Multiple Sclerosis, of which $4 billion is sold annually.  The company has ongoing pre-clinical efficacy, safety and toxicology studies and has informed the market to expect results from these soon.  Although the study so far had been testing the EmtinB product on rat nerve cells, the first human studies will begin this quarter.

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