Zombies are not only reserved for gruesome and grizzly movies. Investors can find them within the ASX All Ords — inflicting harrowing tales of a different type. These ASX shares won't feast upon your natural form, but on your net worth instead.

The truly ghastly fact about zombie companies is how pernicious their capital destruction can be. Rather than presenting a problem in plain sight, these undead entities can wander along for years without their detrimental deeds being detected.

Half of the mission in investing is to make money, the other half is trying not to lose it. That's why I believe it is critical to understand what a zombie share is and ways to avoid them. Being able to distinguish a horde from a haven could help rule out an especially deadly part of the market.

What is a zombie company?

If there are ASX All Ord shares that meet the conditions of a zombie company, what are those conditions?

Well, the technical requirements differ depending on who you ask. However, the general principle is a company that generates inadequate cash earnings from its operations to cover the interest on its debt — let alone pay it down.

Typically, these businesses will make use of additional capital raises and/or more debt to sustain themselves. It might work for a time, but the reality is unless the company can substantially improve its operational earnings, there's a good chance it will eventually collapse.

Right now, some ASX All Ords shares that are emblematic of zombies are Audio Pixels Holdings Ltd (ASX: AKP), Mesoblast Ltd (ASX: MSB), and Magnis Energy Technologies Ltd (ASX: MNS).

Mesoblast is a prime example of a zombie. The regenerative medicine company has dialled up its debt over the past five years, as pictured above. During that time, more funds have been consumed by research and development (among other expenses) than what has been generated by its operations.

Before you go deleting a bunch of companies from your watchlist, there are a few benefits of the doubt that I believe are worth giving:

• Companies can have a challenging year where they become unprofitable. It may turn out to be a temporary sickness, rather than a full-blown zombie awakening
• Sometimes a zombie can return to the land of the living under a successful strategy
• Certain stages of select industries necessitate a period of zombification e.g. drug development and mineral exploration

Unfortunately, the risk that ASX zombie shares pose to shareholders is more prominent now than at any other time in the past decade. This comes down to the cost of capital ballooning amid the face-melting rise in interest rates.

How to dodge ASX All Ord shares with a nasty bite

If staying far, far away from anything that holds any resemblance to a zombie is more in tune with your investing style, there are several fundamentals I'd zero in on.

Firstly, a good place to start is a high EBITDA margin. The higher the margin, the more cash is available to pay interest and fund growth without additional debt. Keep in mind, though, a company can be profitable on an EBITDA basis and still lose money on the bottom line due to non-cash items.

Secondly, and perhaps a no-brainer (pun intended), is to search for ASX shares with minimal debt from the get-go. If the company never takes on debt, it's open ocean ahead — but if it does, you have ample time before it runs aground.

Lastly, a large swathe of ASX zombie shares can be avoided by steering clear of pre-revenue companies. Whether it is a drug developer, mineral explorer, or chip designer, if they are yet to generate meaningful revenue, there's a fair chance they're a zombie in the making (if not one already).

Some of these companies will go on to succeed and reward their investors handsomely. Many others will consume shareholder wealth before fading into oblivion.

If you don't mind going toe-to-toe with zombies, here's my final word. Rule number 22 of Zombieland: when in doubt, know your way out.

It's easy to start making excuses and loosen your standards when a company in your portfolio starts to turn. I personally think it is important to set the goalposts for selling early and don't be tempted to shift them.

The post There are zombies among ASX All Ord shares. How I'd avoid my wealth being devoured appeared first on The Motley Fool Australia.

Four ASX shares that aren't letting that hold them back today are listed below. Here's why they are charging higher:

Mesoblast Ltd (ASX: MSB)

The Mesoblast share price is up 18% to $1.09. This morning, this biotech company revealed that the US FDA has accepted its Biologics License Application resubmission for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). This isn't approval but does guarantee that the FDA will make a decision on the treatment by 2 August.

Polynovo Ltd (ASX: PNV)

The PolyNovo share price is up 3% to $2.29. This is despite there being no news out of the medical device company today. However, it is worth noting that S&P Dow Jones Indices recently announced that PolyNovo will be added to the ASX 200 index on 20 March.

Pushpay Holdings Ltd (ASX: PPH)

The Pushpay share price is up 3% to $1.16. This morning, the payments company revealed that Pegasus Bidco is looking into making a new takeover offer after shareholders rejected a NZ$1.34 per share proposal at a recent scheme meeting.

Weebit Nano Ltd (ASX: WBT)

The Weebit Nano share price is up 6% to $7.88. Investors have been buying this memory technology company's shares this week after it announced the availability of its resistive RAM (ReRAM) IP in SkyWater Technology's 130nm CMOS process. This means that SkyWater customers can now integrate Weebit's non-volatile memory in their system-on-chip designs, if they wanted to.

The post Why Mesoblast, PolyNovo, Pushpay, and Weebit Nano shares are charging higher appeared first on The Motley Fool Australia.

In morning trade, the biotech company's shares rocketed as much as 23% to $1.14.

The Mesoblast share price has pulled back a touch since then but remains up 13% to $1.03.

Why is the Mesoblast share price rocketing higher?

Investors have been buying the company's shares after it was given some good news by the United States Food and Drug Administration (FDA).

According to the release, the FDA's Office of Therapeutic Products has accepted the company's Biologics License Application resubmission for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).

And while this is not an approval, it is a big step in the right direction. Furthermore, the release notes that the FDA considers the resubmission to be a complete response to previous feedback and has set a Prescription Drug User Fee Act (PDUFA) goal date of 2 August.

What is a PDUFA?

My US colleagues cover the PDUFA in detail here. But here's a summary:

The PDUFA's primary goal was to authorize the FDA to collect fees from drugmakers to help pay for the FDA staff needed to review regulatory filings for drugs. But the pharmaceutical industry objected to paying money to the FDA without anything guaranteed in return. The PDUFA helps the FDA by providing the agency with a way to generate money and establishes a set timeline for the agency to make approval decisions.

All in all, this guarantees that Mesoblast will have an answer from the FDA by 2 August for remestemcel-L in the treatment of children with SR-aGVHD.

Mesoblast's Chief Executive, Silviu Itescu, was pleased with the news. He said:

Over the last two years we have worked tirelessly to address the issues previously raised by FDA. We look forward to working closely with the Agency over the review period with the aim to make remestemcel-L available as a therapy for children suffering from SR-aGVHD.

The post Mesoblast share price rockets 23% on FDA news appeared first on The Motley Fool Australia.

Four ASX shares that are climbing more than most today are listed below. Here's why they are rising:

De Grey Mining Limited (ASX: DEG)

The De Grey Mining share price is up 5% to $1.36. This appears to have been driven largely by a broker note out of Macquarie this morning. According to the note, the broker has retained its outperform rating and $1.90 price target on the gold developer's shares.

Kogan.com Ltd (ASX: KGN)

The Kogan share price is up 5.5% to $3.69. Investors have been buying this ecommerce company's shares since the release of its half-year results on Monday. However, one broker that isn't buying is Credit Suisse. It is feeling pessimistic about the company's future given Amazon Australia's significant market share gains and Kogan's inability to compete with the size of its range. The broker expects Kogan to have to focus on a core range to avoid inventory issues, which could limit its growth.

Mayne Pharma Group Ltd (ASX: MYX)

The Mayne Pharma share price almost 7% to $3.36. This is despite the pharmaceutical company reporting a large first-half loss and announcing the cancellation of its proposed capital return. Investors appear to be responding well to news of the sale of its US generics business and management's belief that it is on course to return to profit.

Mesoblast Ltd (ASX: MSB)

The Mesoblast share price is up 4% to 96.7 cents. This morning, this biotech released its half-year results. But as the company is barely generating revenue, it is likely to be a separate announcement that has got investors excited. That announcement reveals that the results from the phase 3 chronic heart failure trial, DREAM-HF, in patients with reduced ejection fraction (HFrEF) highlight the potential for rexlemestrocel-L to make a key difference in patient outcomes, including mortality, heart attack, or stroke.

The post Why De Grey, Kogan, Mayne Pharma, and Mesoblast shares are charging higher appeared first on The Motley Fool Australia.

It's turning out to be a bit of a disappointing day for the ASX share market so far this Thursday. At the time of writing, the All Ordinaries Index (ASX: XAO) has slipped by 0.32% after falling by as much as 0.4% earlier this morning. But that doesn't mean all All Ords shares have had a bad hair day today.

So let's talk about two All Ords shares that have just smashed new 52-week highs this session.

2 ASX All Ords shares that just hit a new 52-week high

Mesoblast Ltd (ASX: MSB)

Mesoblast shares have had a very interesting day. The All Ords healthcare share gave an important update to investors this morning just before market open.

As we covered earlier today, the United States Food and Drug Administration (FDA) has given a Regenerative Medicine Advanced Therapy designation to Mesoblast's rexlemestrocel-L. This treatment targets chronic back pain.

Mesoblast stated that it is now looking forward to marketing its product to US markets.

On this news, the Meobalast share price rocketed out of the gate this morning, climbing as high as $1.33 a share – the company's new 52-week high. However, investors seem to have gotten cold feet as the day has progressed, with Mesoblast shares now down by 2.93% at $1.16 each.

Elmo Software Ltd (ASX: ELO)

All Ords technology share Elmo is another interesting company to watch this Thursday. It's actually the company's last day of trading on the ASX after the Supreme Court of New South Wales gave the green light for Cookie Monster AcquireCo Pty Ltd, an entity of K1 Investment management, to acquire Elmo in full (there seems to be some Sesame Street fans involved here).

After today's session, Elmo shares will leave the ASX. All Ords investors are to receive $4.85 in cash for every Elmo share held. Otherwise, if investors elected to receive scrip instead of cash, they will be issued with shares in Cookie Monster Holdings.

It appears the markets are sending Elmo shares out with a bang, with the company hitting $4.85 per share just after market open this morning, which is Elmo's new 52-week high. The shares are hovering just below that at $4.84 at the time of writing, up by 0.21% so far today:

The post 2 ASX All Ords shares smashing new 52-week highs on Thursday appeared first on The Motley Fool Australia.

In morning trade, the biotechnology company's shares are up 11% to a 52-week high of $1.33.

This means the Mesoblast share price is now up over 50% since the start of the year, as you can see on the chart below.

Why is the Mesoblast share price charging higher today?

Investors have been buying Mesoblast shares again on Thursday after the company made another positive announcement.

According to the release, the United States Food and Drug Administration's (FDA) Office of Tissues and Advanced Therapies has granted Mesoblast Regenerative Medicine Advanced Therapy (RMAT) designation to rexlemestrocel-L.

This is for the treatment of chronic low back pain (CLBP) associated with disc degeneration, in combination with hyaluronic acid (HA) as the delivery agent for injection into the lumbar disc.

What does this mean?

RMAT designations are good news for Mesoblast as they aim to expedite the development of regenerative medicine therapies that are treating serious or life-threatening disease or conditions where preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs.

The release notes that RMAT designation for rexlemestrocel-L provides all the benefits of breakthrough and fast track designations, including rolling review and eligibility for priority review when filing a Biologics License Application (BLA).

Management highlights that there is a significant need for a safe, effective, and durable opioid-sparing treatment in patients with CLBP associated with degenerative disc disease.

The good news is that a completed 404-patient randomised, blinded placebo-controlled Phase 3 trial of rexlemestrocel-L combined with HA has delivered promising results. It was for this reason that the FDA granted its RMAT designation.

Mesoblast's Chief Executive, Silviu Itescu, commented:

We are pleased to receive RMAT designation for our cellular therapy to treat CLBP due to disc degeneration. We look forward to working closely with FDA to efficiently generate the additional data needed to support marketing approval of rexlemestrocel-L for the treatment of this serious and debilitating condition.

Mesoblast highlights that CLBP is a serious condition with an annual prevalence of low back pain in the general US adult population of 10% to 30% and a lifetime prevalence in US adults as high as 65% to 80%. This makes it a potentially lucrative market for Mesoblast to target.

The post Mesoblast share price soars 11% on FDA update appeared first on The Motley Fool Australia.

Here's why these ASX All Ords shares are on form on Monday:

Incannex Healthcare Ltd (ASX: IHL)

The Incannex share price is up 14% to 20.5 cents. This is despite there being no news out of the cannabis and psychedelics company today.

Though, it is worth noting that the company recently announced that the PsiGAD1 clinical trial has achieved its interim milestone of 29 patients completing primary endpoint assessments, and independent analysis of the interim study data has commenced.

This trial is assessing Incannex's psilocybin-assisted psychotherapy for the treatment of generalised anxiety disorder (GAD). The company notes that the treatment of GAD with currently accepted medications and therapies remains inadequate, with less than half of patients achieving remission. Positively, psilocybin-assisted psychotherapy has shown promise in the treatment of several mental health conditions.

Mesoblast Ltd (ASX: MSB)

The Mesoblast share price has jumped 11% to $1.16. Once again, this is despite there being no news out of the regenerative medicine company this morning.

However, investors have been fighting to get hold of the company's shares in recent sessions thanks to a promising announcement from last week. That announcement revealed that it has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA).

This is for the approval of remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). The resubmission contains substantial new information as required by the FDA. Investors appear optimistic that this might be enough to finally get the thumbs up from the regulator.

The post 2 ASX All Ords shares going gangbusters on Monday appeared first on The Motley Fool Australia.

Four ASX shares that are climbing more than most today are listed below. Here's why they are rising:

Argosy Minerals Limited (ASX: AGY)

The Argosy Minerals share price is up 5% to 66.7 cents. This morning, the lithium developer provided an update on its Rincon project in Argentina. Argosy Minerals revealed that it remains on track to start steady-state production by the end of the second quarter of calendar year 2023.

Credit Corp Group Limited (ASX: CCP)

The Credit Corp share price is up 2.5% to $22.20. This follows the release of the debt collection company's half year results. Credit Corp reported an 8% increase in revenue to $220.5 million but a 30% decline in profit to $31.8 million. The market appears to have been expecting even worse for its profits.

Flight Centre Travel Group Ltd (ASX: FLT)

The Flight Centre share price is up 9% to $17.27. Investors have responded positively to the travel agent's plan to acquire United Kingdom-based luxury travel brand Scott Dunn for $211 million. To support the acquisition, Flight Centre has raised $180 million from institutional investors at a 7.8% discount of $14.60 per new share. Flight Centre also released a solid trading update yesterday.

Mesoblast Ltd (ASX: MSB)

The Mesoblast share price is up over 11% to $1.06. This morning, the biotech company revealed that it has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). The resubmission contains substantial new information as required by the FDA.

The post Why Argosy Minerals, Credit Corp, Flight Centre, and Mesoblast shares are racing higher appeared first on The Motley Fool Australia.

At the time of writing, the biotechnology company's shares are up almost 13% to $1.07.

Whys is this ASX All Ords biotech share rocketing higher?

Investors have been scrambling to buy the ASX biotech's shares following the release of a positive regulatory update.

According to the release, the allogeneic cellular medicines developer has resubmitted to the U.S. Food and Drug Administration (FDA) its Biologics License Application (BLA) for approval of remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).

The company notes that the resubmission contains substantial new information as required by the FDA.

This includes new long-term survival data of children enrolled in the Phase 3 trial showing durability of treatment effect through at least four years and new data showing remestemcel-L's treatment benefit in high-risk disease activity and on survival in propensity-matched studies of children in the Phase 3 trial.

It also highlights that new data shows that the validated potency assay has low variability and can adequately demonstrate manufacturing consistency and reproducibility. The lack of consistency was a key issue that the FDA had previously brought up.

All in all, management appears hopeful that this will be enough to get remestemcel-L approved by the FDA this time around.

Mesoblast's chief executive, Dr. Silviu Itescu, commented:

There is an urgent need for a therapy that improves the dismal survival outcome in children with SRaGVHD. Our team has worked tirelessly over the past two years to provide a comprehensive response to the FDA. We are grateful for the agency's active dialogue and constructive feedback that will ensure a high bar is met in terms of product consistency and predictability of clinical outcomes.

Pleasingly, shareholders won't have too long to wait for a result. The resubmission will have a review period up to six months from filing upon acceptance by FDA.

The post Guess which ASX All Ords biotech share is rocketing 13% on FDA news appeared first on The Motley Fool Australia.

Four ASX shares that have failed to follow the market higher today are listed below. Here's why they are falling:

Brainchip Holdings Ltd (ASX: BRN)

The Brainchip share price is down a further 1.5% to 66 cents. This semiconductor company's shares have come under pressure this week after it raised capital again. Investors appear concerned that this could mean the company's latest quarterly sales performance underwhelmed and it needed a cash injection.

Core Lithium Ltd (ASX: CXO)

The Core Lithium share price is down 3% to $1.15. This may have been driven by a bearish broker note out of Goldman Sachs this morning. According to the note, the broker has reiterated its sell rating and 95 cents price target on this lithium developer's shares. Goldman believes Core Lithium's shares are overvalued at the current level.

Deterra Royalties Ltd (ASX: DRR)

The Deterra Royalties share price is down 2.5% to $4.68. This may also have been driven by a broker note out of Goldman Sachs. This morning, the broker downgraded the mining royalties company's shares to a neutral rating with a $4.50 price target. Goldman made the move largely on valuation grounds after a strong gain since October.

Mesoblast Ltd (ASX: MSB)

The Mesoblast share price is down 2.5% to 93.5 cents. This is despite there being no news out of the biotech company. However, with its shares up strongly since the start of the year, some profit taking could be happening. The Mesoblast share price remains up 7% year to date.

The post Why Brainchip, Core Lithium, Deterra Royalties, and Mesoblast shares are falling appeared first on The Motley Fool Australia.

The Mesoblast Ltd (ASX: MSB) share price has been on a top run lately. It's launched 25% higher over the last 30 days.

Indeed, this time last month, shares in the clinical-stage biotechnology company were trading for 92 cents. Today, the Mesoblast share price is $1.16.

For comparison, the All Ordinaries Index (ASX: XAO) has risen 6% over the last month.

So, what's been bolstering the Mesoblast share price lately? Let's take a look.

What's been going right for the Mesoblast share price lately?

Mesoblast has had a good run recently. That's despite the market appearing disappointed by the only price-sensitive news from the company.

The healthcare company released its latest quarterly update and news of a key trial on 24 November. That same day, the Mesoblast share price slipped 1%.

Over the September quarter, Mesoblast burnt through US$14.3 million and brought in US$1.4 million of revenue. Though, there was more positive news released alongside its earnings.

Mesoblast also revealed the long-term survival results for its remestemcel-L phase 3 trial in children with steroid-refractory acute graft-versus-host disease (SR-aGVHD).

Overall survival at two years for children treated with the drug was 51% compared to between 25% and 38% in recent studies of children or adults treated with the best available therapy.

The company's chair Joseph Swedish said the results reaffirmed the potential significance of the drug as " a life-saving treatment for children with SR-aGVHD".

Mesoblast CEO Dr Silviu Itescu also commented:

These substantial and durable long-term survival outcomes seen in our Phase 3 trial with remestemcel-L are a cornerstone to our [Biologics License Application] resubmission.

That same day the company hosted its annual general meeting (AGM). There, Swedish reiterated the company is hoping to see regulators give remestemcel-L their tick of approval in the first half of 2023.

Mesoblast is also working to get its rexlemestrocel-L to market as a treatment for chronic low back pain associated with degenerative disc disease and for heart failure with reduced ejection fraction.

Interestingly, the biggest gain posted by the Mesoblast share price over the period was on a day of seeming silence. The stock soared 11.6% on Wednesday last week despite no word from the company.

The post Why has the Mesoblast share price boomed 25% in a month? appeared first on The Motley Fool Australia.

At the time of writing, the regenerative medicine company's shares are down 2.5% to 97 cents.

Why is the Mesoblast share price falling?

Investors have been selling Mesoblast's shares this morning after the company released an update on its first quarter update and a key trial.

In respect to the former, Mesoblast recorded minimal quarterly revenue and a loss after tax of US$16.9 million. But thanks to a recent equity raising, it finished the period with a sizeable cash balance of US$85.5 million.

Not much to get excited about there.

Trial update

Some potentially exciting news came from Mesoblast's trial update. However, so far, the market has given it a lukewarm response.

Mesoblast released the top-line long-term survival results for remestemcel-L from its pivotal Phase 3 trial (GVHD-001) in children with steroid-refractory acute graft-versus-host disease (SR-aGVHD).

According to the release, the results showed durable survival through 4 years of follow-up.

Management notes that this new long-term survival data is a key component of the company's resubmission to the FDA for remestemcel-L in the treatment of children with SR-aGVHD, which is a life-threatening condition with no approved treatments for children under 12 years.

Overall survival in the remestemcel-L cohort was 63% at 1 year, 51% at 2 years, and 49% at 4 years, with median survival of 2 to 3 years. This compares to survival rates of 40%-49% at 1 year and 25%-38% at 2 years for current treatments.

Importantly, these comparisons include very different patient cohorts, with 88% of children treated with remestemcel-L having with highest mortality risk. Whereas only 22% to 68% in other studies were considered to have severe disease.

Management believes this reaffirms the potential significance of remestemcel-L as a life-saving therapy for children with SR-aGVHD.

Dr. Joanne Kurtzberg from Duke University, was pleased with the results. She commented:

These exciting long-term results provide further evidence of remestemcel-L's potential as a highly effective treatment for SR-aGVHD in children. Responses are durable, reducing mortality of this often lethal complication of hematopoietic stem cell transplantation.

Time will tell if this data helps Mesoblast gain FDA approval. But judging by its share price performance today, investors appear unsure and may be keeping their powder dry until a decision is made.

The post What's going on with the Mesoblast share price today? appeared first on The Motley Fool Australia.

The Mesoblast limited (ASX: MSB) share price took flight on Monday, soaring 9% to an intraday high of $1.02 before losing some ground in afternoon trading.

Shares in the ASX biotech company closed at 99 cents apiece today, up 6.45% from 93 cents at the market open.

The overall healthcare sector kicked off the week well, too, with the S&P/ASX 200 Health Care Index (ASX: XHJ) gaining 0.48%.

On a broader scale, the S&P/ASX 200 Index (ASX: XJO) petered out after a healthy start this morning to finish an unremarkable 0.17% lower.

Let's take a look at what may have influenced the Mesoblast share price on Monday.

What happened?

There's no news to report from Mesoblast today, and in fact, an absence of noteworthy announcements from the company for some time.

Our Fool writers last wrote about Mesoblast at the start of this month when we covered the company's quarterly activities and cashflow report.

However, there are a couple of reasons that could help explain why Mesoblast's shares have jumped higher. For one, the report noted that the company expected to receive FDA clearance to trial rexlemestrocel-L as a treatment for chronic back pain near the end of this year.

Rexlemestrocel-L and Remestemcel-L are the company's mesenchymal precursor cell (MPC) products that Mesoblast is developing to treat various diseases.

Another possible share price driver today is that its annual general meeting (AGM) is approaching fast. Mesoblast will hold its AGM on Wednesday this week in Melbourne.

Some measures shareholders will vote on include the election and re-election of company directors and ratifying the issue of fully paid ordinary shares to major shareholders.

Mesoblast share price snapshot

The Mesoblast share price is down 29.29% year to date and a hefty 42% over the past 12 months. In comparison, the S&P/ASX 200 Index is down a respective 5.9% and 2.9% across the same time periods.

The company's market capitalisation is around $729.7 million.

The post Why did the Mesoblast share price soar 9% today? appeared first on The Motley Fool Australia.

The Mesoblast Limited (ASX: MSB) share price is up 6.25% since the start of the week.

Shares of the regenerative medicine company opened at 88 cents each on Monday and are currently trading for 93.5 cents.

Gains for the company are outperforming the S&P/ASX 200 Health Care Index (ASX: XHJ), which has seen an increase of 1.23% since the start of the week.

So what could be contributing to Mesoblast's success this week?

Mesoblast share price rises on quarterly update

The ASX healthcare share released its quarterly activities and cashflow report for the quarter ended September 30 on Monday morning.

The Mesoblast share price gained 4.52% the day the report was released, and another 1.62% the following day.

Let's take a look at the highlights of the report.

• Net cash used in operating activities: $14.28 million
• Net cash used in investing activities: $0.20 million
• Net cash from financing activities: $40.29 million
• Cash and cash equivalents at end of period: $85.50 million
• Estimated quarters of funding available: 8.8

There's evidence that Mesoblast could have become more efficient in cutting costs in its operations. The company used US$14.3 million for operating activities, down US$3.9 million (22%) on the same quarter last year. It was also US$8 million (47%) less than what was used two years ago.

Another financial highlight is that Mesoblast had US$85.5 million at the end of the quarter and raised US$45 million in August 2022. They can draw down an additional US$40 million from existing financing facilities if they meet certain milestones.

Product pipeline update

Mesoblast made headway in its submissions to the US Food and Drug Administration (FDA) to use remestemcel-L for the treatment of children with a condition called steroid-refractory graft versus host disease, or SR-aGVHD.

Mesoblast submitted new information on clinical and potency assay items to the Investigational New Drug (IND) file for remestemcel-L in the treatment of children with SR-aGVHD, as guided by FDA. The FDA has given it Fast Track Designation, which means the process of studying and approving the drug will be faster than usual.

It also worked with the FDA to potentially use rexlemestrocel-L for the treatment of chronic back pain caused by degenerative disc disease. This drug has been tested in a small group of people and was shown to reduce pain significantly.

Mesoblast plans to have clearance from the FDA by year-end 2022 for the pivotal trial of this drug.

The company is also continuing to investigate using rexlemestrocel-L for the treatment of chronic heart failure.

Mesoblast share price snapshot

Despite its gains this week, the Mesoblast share price is down 33% year to date. It is also down 44% since this time last year.

Meanwhile, the All Ordinaries Index (ASX: XAO) is down almost 10% in 2022 and 9% over the past 12 months.

The company's market capitalisation is around $692.89 million.

The post Why has the Mesoblast share price gained 6% so far this week? appeared first on The Motley Fool Australia.

Four ASX shares that have failed to follow the market higher today are listed below. Here's why they are dropping into the red:

Cronos Australia Ltd (ASX: CAU)

The Cronos Australia share price is down 5% to 68.5 cents. This is despite there being no news out of the medicinal cannabis company. However, it is worth noting that even after today's decline, the Cronos Australia share price is up 25% since this time last month. This could mean that profit taking is weighing on its shares today.

Mesoblast limited (ASX: MSB)

The Mesoblast share price is down over 1% to 83 cents. This also appears to have been driven by profit taking from investors following a strong showing on Monday. The biotech company's shares jumped yesterday following the release of a promising update.

Sims Ltd (ASX: SGM)

The Sims share price is down over 1% to $13.05. This has been driven by the scrap metal company's shares trading ex-dividend this morning. Eligible shareholders can now look forward to receiving Sims' partially franked 50 cents per share dividend later this month on 19 October.

WAM Research Limited (ASX: WAX)

The WAM Research share price is down 6% to $1.34. This has also been driven largely by the fund manager's shares going ex-dividend this morning. WAM Research will be paying eligible shareholders a fully franked 5 cents per share dividend in a couple of weeks. That payment is scheduled to hit bank accounts on 17 October.

The post Why Cronos Australia, Mesoblast, Sims, and WAM Research are dropping appeared first on The Motley Fool Australia.

The Mesoblast Limited (ASX: MSB) share price is surging today on the back of a product update.

Mesoblast shares are lifting 7.69% today and are currently trading at 84 cents. For perspective, the S&P/ASX 200 Index (ASX: XJO) is down 0.33% today.

Let's take a look at what's impacting the Mesoblast share price today.

Mesoblast share price rises on "major milestone"

Mesoblast is working on allogeneic cellular medicines for inflammatory diseases.

Investors appear to be buying up Mesoblast shares after the company provided an update on a US Food and Drug Administration (FDA) application.

Mesoblast supplied the FDA with "substantial new information" on the use of remestemcel-L to treat children with steroid-refractory acute graft versus host disease (SR-aGVHD).

This new information is in response to a Complete Response Letter (CRL) from the FDA received in September 2020.

Mesoblast said this is a "major milestone" in the company's response to the FDA.

Commenting on the news, chief executive Dr Silviu Itescu said:

The submission summarizes controlled data providing further evidence of remestemcel-L's ability to save lives.

Additionally, the improved process controls we have put in place to assure robust and consistent commercial product, together with a potency assay that predicts consistent survival outcomes, makes remestemcel-L a compelling treatment for these children.

Mesoblast share price snapshot

The Mesoblast share price has fallen 49% in the past year, while it has lost 40% in the year to date. In the last month, Mesoblast shares have shed more than 1%.

In comparison, the ASX 200 has shed 10% in the past year.

Mesoblast has a market capitalisation of more than $619 based on the current share price.

The post Why is the Mesoblast share price surging 8% on Monday? appeared first on The Motley Fool Australia.

Four ASX shares that are not letting that hold them back are listed below. Here's why they are pushing higher:

Mesoblast limited (ASX: MSB)

The Mesoblast share price is up almost 8% to 84 cents. Investors have been buying this biotech company's shares after it confirmed the submission of substantial new information on clinical and potency assay items to the FDA. This is for items identified by the regulator for its remestemcel-L product in the treatment of children with steroid-refractory acute graft versus host disease.

Unibail-Rodamco-Westfield (ASX: URW)

The Unibail-Rodamco-Westfield share price is up over 4% to $3.20. This has been driven by news that the shopping centre operator has completed the sale of the Villeneuve 2 centre in the Lille region of France to Ceetrus. This means that the company has now completed 3.2 billion euros of disposals, representing 80% of its 4 billion euros European disposal programme.

Widgie Nickel Ltd (ASX: WIN)

The Widgie Nickel share price is up 28% to 30 cents. This follows the announcement of a major lithium discovery from the company's Mt Edwards project. Management commented: "This initial reconnaissance work identifying high grade spodumene over a significant strike length couldn't be a better outcome for Widgie."

Yancoal Australia Ltd (ASX: YAL)

The Yancoal share price is up 2% to $5.78. This morning this coal miner announced that it will make a major debt repayment. Yancoal advised that it intends to prepay US$1.0 billion of debt from available cash on 4 October. This consists of payment toward Yancoal's Syndicated Facility and its unsecured related-party loans. This is expected to deliver an approximate US$207 million reduction in total finance cost over the loan periods.

The post Why Mesoblast, Unibail-Rodamco-Westfield, Widgie Nickel, and Yancoal are rising appeared first on The Motley Fool Australia.

The Mesoblast Limited (ASX: MSB) share price is down 2.3% today to 85 cents.

This fall is in line with the S&P/ASX All Ordinaries Index (ASX: XAO), which has dipped 2.26% at the time of writing.

Which director has bought Mesoblast shares?

The only news out of Mesoblast this month relates to two company directors buying more shares.

The latest purchase is by William Burns, who is the non-executive vice chair of the ASX biotech company.

Burns picked up 22,000 shares on 13 September. He paid an average price of approximately 91 cents per share for a total consideration of $20,020.

According to the change of director's interest notice, this takes his total holdings to 85,000 shares and 220,000 options.

About a week earlier, Mesoblast's newest director Jane Bell more than doubled her holdings.

As my Foolish colleague James reported, the non-executive director purchased 133,333 shares on market on 7 September.

According to the change of director's interest notice, she paid an average price of approximately 83 cents per Mesoblast share.

That equates to a total consideration of $109,999.73. This increased her holdings to 247,618 shares.

As James points out, ASX investors generally perceive insider buying as a positive sign. After all, no one knows a company better than its directors, and Bell is certainly optimistic about Mesoblast's future.

When appointed in August, Bell said:

I look forward to joining the Mesoblast Board at such an exciting stage in the company's transition to a commercial organization, with its deep cell therapy product pipeline.

The potential FDA approval and launch in the US market of the first allogeneic cell therapy is an incredibly exciting opportunity for me to be involved with and I look forward to using my background and experience to make a strong contribution.

Mesoblast share price snapshot

Mesoblast shares are down 51% over the past 12 months. In 2022, they have fallen 39%.

The ASX biotech share is currently trading close to its 52-week high of 88 cents.

The post This board member pulled the trigger on more Mesoblast shares appeared first on The Motley Fool Australia.

Over the last six sessions, the biotechnology company's shares have risen a sizeable 14% to 93 cents.

That's despite there being no news out of the company during this time.

What is driving the Mesoblast share price higher?

While it remains unclear why the Mesoblast share price has suddenly taken off, it is worth noting that there has been some significant insider buying recently.

Earlier this week, the company revealed that its newest director, Jane Bell, has been picking up shares since her appointment.

According to a change of director's interest notice, Bell more than doubled her holding on 7 September with the purchase of 133,333 shares through an on-market trade.

The director paid an average of approximately 83 cents per share, which equates to a total consideration of $109,999.73. This increased her holding to 247,618 shares.

Insider buying is often interpreted as a bullish signal for investors as nobody knows a company better than its directors. And Bell certainly is positive on Mesoblast's outlook.

When she was appointed as a director in August, Bell revealed that she was excited about what lies ahead for Mesoblast. She commented:

I look forward to joining the Mesoblast Board at such an exciting stage in the company's transition to a commercial organization, with its deep cell therapy product pipeline. The potential FDA approval and launch in the US market of the first allogeneic cell therapy is an incredibly exciting opportunity for me to be involved with and I look forward to using my background and experience to make a strong contribution.

The post Why has the Mesoblast share price marched 14% higher in 6 days? appeared first on The Motley Fool Australia.

With the unwinding of the high-growth/tech trade of the past two years, many biotechnology names suffered equally in nasty selloffs this year.

Shares of Mesoblast Ltd (ASX: MSB) have taken a hit in 2022 having slipped more than 42% into the red this year to date.

Shares of the regenerative medicine player are currently at 84 cents apiece in early trading on Thursday, gaining the 3% they lost in yesterday's session.

What's Mesoblast been up to?

It was a busy period in the last financial year for Mesoblast, especially in its liaison with the US Food and Drug Administration (FDA).

Mesoblast has made, and is set to make, a host of submissions to the FDA regarding its lead drug candidates, Remestemcel-L and Rexlemestrocel-L.

It intends to resubmit a biologics license application (BLA) with the FDA this quarter for the approval of Remestemcel-L in treating children with steroid-resistant acute graft-versus-host-disease (SR-aGVHD). It is aiming for this approval in early 2023.

Meanwhile, Mesoblast also plans to meet with the FDA in the next quarter under its existing regenerative medicine advanced therapy (RMAT) designation to discuss Rexlemestrocel-L.

They will look over data from the company's recent phase 3 trial of 565 patients with heart failure condition HFrEF.

Rexlemestrocel-L also "gained alignment" with the FDA last period on key metrics for a pivotal phase 3 clinical trial in patients with chronic low back pain (CLBP) associated with disc pathology.

This follows on from the first phase 3 trial covering the same condition and Mesoblast hopes to replicate favourable results produced there.

The company also plans to have received clearance from the FDA by the end of 2022 so it can commence the pivotal trial.

As such, it will be a busy few months for Mesoblast as it looks to progress through this next round of trials in both of its leading drug segments.

In the last 12 months, the Mesoblast share price has faltered 54% into the red.

The post Looking to buy Mesoblast shares? Here's the latest on where the ASX biotech is at with the FDA appeared first on The Motley Fool Australia.