In early trade, the ASX micro-cap was up over 80% to 4.8 cents.

The clinical stage cell therapy company's shares have eased back a touch since then but remain up 69% to 4.4 cents currently.

Why is this ASX micro-cap rocketing?

The catalyst for this strong gain has been news that the cell therapy company has received clearance from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) application of CHM 2101.

CHM 2101 is Chimeric's first in class CDH17 CAR T cell therapy for gastrointestinal cancers. With receipt of this clearance, the company can now begin initiating a multi-centre, open label Phase 1A/B clinical trial for patients with advanced colorectal cancer, gastric cancer, and neuroendocrine tumours.

The release notes that the clinical program for CHM 2101 builds upon the preclinical studies published in the preeminent scientific journal, Nature Cancer, in March 2022. These experiments demonstrated that CHM 2101 was able to eradicate established tumours in seven cancer models with no toxicity to normal tissues.

Commenting on the trial plan, Michael R. Bishop, MD, Professor of Medicine and Director, The David and Etta Jonas Center for Cellular Therapy, University of Chicago, said:

I am really excited about the planned Phase 1 clinical trial of CHM 2101 and the opportunity to bring a potentially transformative new investigational agent to cancer patients who need them most.

Following today's gain, this ASX micro-cap now has a market capitalisation of approximately $23 million.

The post Guess which ASX micro-cap stock is rocketing 80% on FDA clearance appeared first on The Motley Fool Australia.

Here's what we mean.

Over the past 6 months, the All Ordinaries Index (ASX: XAO) is down 2.2%. Not what you'd like to see. But not close to gut wrenching either.

Now let's looks at some large-cap and small-cap ASX biotech shares.

First up, industry heavy weight CSL Limited (ASX: CSL), with a market cap of $129 billion, is down 13% over 6 months.

Meanwhile the Imugene Limited (ASX: IMU) share price has lost 41%, while fellow ASX biotech share Immutep Ltd (ASX: IMM) is down 33% over that same time.

Moving to the smaller, and more speculative end of the spectrum, Avecho Biotechnology Ltd (ASX: AVE) shares are down 40% in 6 months; the Volpara Health Technologies Ltd (ASX: VHT) share price has lost 43%; and Chimeric Therapeutics Ltd (ASX: CHM) shares are down 55%.

Then there's EBR Systems Inc (ASX: EBR). EBR Systems only listed on the ASX on 24 November last year. While it's up 163% since listing, most all of those gains came on the first days of trading. Since 25 November, shares in EBR system are down 32%.

And it's not just ASX biotech shares under pressure.

Over in the United States the Nasdaq Biotechnology Index is down 25% in 6 months.

What's next for ASX biotech shares?

Chimeric CEO Jennifer Chow said she's hopeful that a few things could turn the cycle around.

According to Chow (quoted by The Australian Financial Review):

Obviously, the world settling a bit. But, for biotech, a lot of development was slowed because of COVID-19 … it had an impact on clinical trial registrations … but patients are getting back to centres and hospitals are focused on clinical trials again. There was also a slowing down in M&A at the end of last year … and that's starting to pick up again.

Matt McNamara is the chief investment officer at Horizon 3. With a 3-to-5-year investment horizon, the recent sell-off isn't keeping him awake:

I look at the positions we hold and none have changed in terms of their investment thesis. I don't see a problem with any of the companies … We're patient investors and ride out the bumps. I think there's good buying at the moment.

Horizon holds ASX biotech shares EBR Systems, Volpara Health and Avecho Biotechnology. McNamara said investors should look at "the prospects of the market they're breaking into, the experience of the management team, and if they have the skills around the board."

Why the small-cap space may be in for more pain yet

Rory Hunter, portfolio manager at SG Hiscock draws a sharp distinction between well-established ASX biotech shares and microcap newcomers.

According to Hunter (quoted by the AFR):

We've gone from this euphoria phase to the opposite end of the spectrum, and that's why there's been so much value destruction. You're going to see a flight to quality. People have lost a lot of money in some of these companies that came to market last year. It'll remain really challenging for quite some time.

We are looking to redeploy capital into companies that are already in the commercialisation phase. When we get a view on the better market conditions, we'll also look at those business that are in phase three trials … and have significant addressable markets.

The post Do ASX biotech shares offer 'good buying' after the sell-off? Experts weigh in appeared first on The Motley Fool Australia.

Chimeric shares are rallying after the company announced a key update regarding its CAR Technology.

Read on for more details.

What did Chimeric Therapeutics announce?

Chimeric advised that the European Patent Office has granted the company a patent covering its chimeric antigen receptor (CAR) technology.

CAR Therapy is being developed for patients with Glioblastoma, where it is currently being studied in a phase 1 trial at City of Hope Medical Centre in the US.

The patent covers "certain applications" of the CAR technology using cholorotoxin (CLTX), and also the company's clinical-stage label CHM 1101.

It was published in the "European Patent Bulletin dated September 22, 2021", according to Chimeric, under patent number EP 3,362,470 B1.

Effectively the patent grants protection for CAR over these "applications" that will use CLTX and CHM 1011 until 2036.

In addition, Chimeric also "holds the exclusive worldwide license" to commercialise the patent, and "related patent applications filed in other global territories" for the compound.

This is an important milestone for clinical-stage biotechnology companies, as they need to secure the rights to sell their compounds if they can successfully develop them.

Investors appear to love the news and are pushing the Chimeric Therapeutics share price towards its previous high of 35 cents on 7 September.

What did management say?

Speaking on the patent milestone, Chimeric's CEO and managing director, Jennifer Chow said:

We are pleased to see the continued advancement of the strong intellectual property portfolio underpinning Chimeric's CLTX CAR T program, on this occasion in a geography that holds significant market potential.

Chimeric share price snapshot

The Chimeric Therapeutics share price has had a very difficult year to date and has posted a return of 14% since listing in January.

However, over the last month, it has stepped a further 1.5% into the green and is also up another 3% this past week.

It is still early days for Chimeric, but it is still trading ahead of the S&P/ASX 200 index (ASX: XJO)'s year to date gain of 12%.

At the time of writing, Chimeric Therapeutics has a market capitalisation of $105 million.

The post The Chimeric (ASX:CHM) share price jumps 6% on patent success appeared first on The Motley Fool Australia.

At market's close, the Chimeric share price was trading at 29 cents, down 3.33%.

Established in 2020, Chimeric is developing a breakthrough cancer cell therapy drug for solid tumours. The company uses chlorotoxin, from scorpion venom, to bind and direct T cells to target glioblastoma, or GBM.

Initial scientific research conducted in Los Angeles has found promising anti-tumour activity from CAR T therapy.

What did Chimeric update the ASX with?

In its announcement, Chimeric advised it has started treatment on the second cohort of its CLTX CAR T phase 1 trials. The study is being conducted at the City of Hope, a world-renowned cancer treatment and research centre near Los Angeles.

Specifically, the first patient in the second dosing group received a higher level of treatment than that administered to the first dosing group. The dose-escalation study seeks to assess Chlorotoxin CAR T's safety and maximum tolerance in participants suffering from recurrent or progressive GBM.

Patients in this group will be administered their treatment via two methods – intracranial intratumoral (ICT) and intracranial intraventricular (ICV) at a total dose of 88 x 106 CAR T cells.

Chimeric hopes to recruit between 18 to 36 people with MMP2+ recurrent or progressive GBM across 4 different dose levels. This is expected to run over the course of a 24-month period. Once the appropriate dosing amount is established, the company will move to phase 2 trials.

Chimeric chief operating officer Jennifer Chow commented:

We are very encouraged by the continued progress of the trial, moving to this important next phase with dose escalation and dual routes of administration.

This is another significant milestone in the development of this important therapy for patients with progressive or recurrent glioblastoma.

Chimeric share price review

Since listing on the ASX boards at the start of this year, Chimeric shares have remained relatively flat. The company's shares reached an all-time high of 44 cents in January, before treading lower, hovering around the 30 cent mark.

Based on today's Chimeric share price, the company has a market capitalisation of roughly $56 million, with approximately 196 million shares outstanding.

The post The Chimeric (ASX:CHM) share price drops despite cancer trial news appeared first on The Motley Fool Australia.

At the end of today's market wrap, the biotechnology company's shares finished the day flat at 28.5 cents.

How did Chimeric perform?

Investors led Chimeric shares to close the day unchanged despite the company recapping its achievements and providing a financial update.

In the release, Chimeric reported a number of highlights, signalling why its shares have surged since listing on the ASX.

Chimeric declared $23.6 million in cash at the end of the March quarter. This is a significant increase from the $65,000 achieved at 31 December 2020. The company noted the funds will be used to progress its clinical trials of CLTX CAR T and begin the development of a cell therapy pipeline.

The net cash used in operating activities stood at $5.4 million, predominately due to the one-off fee paid to the City of Hope. This compares to the $1.9 million recorded in the prior quarter. Most of the fees were allocated towards change of control fee, administrative and corporate costs.

Net cash used in investing activities totalled $2.6 million, which was relatively in line with the December quarter. The payment relates to the second instalment to the City of Hope licence agreement.

The company re-touched on its CLTX CAR T clinical trials, with the second patient cohort now commencing a higher dosing level.

In addition, Chimeric reverted back to its significant management appointments in which several distinguished experts joined the board.

Chimeric share price summary

While the company is still relatively new on the ASX boards, the Chimeric share price moved between the 28 cents and 44 cents range. The company's shares hit its all-time in the same week of its listing.

On valuation metrics, Chimeric presides a market capitalisation of roughly $56.3 million, with 196.5 million shares on issue.

The post Chimeric (ASX:CHM) share price finishes flat on quarterly update appeared first on The Motley Fool Australia.

Established in 2020, Chimeric is developing a breakthrough cancer cell therapy drug for solid tumours. The company uses chlorotoxin, which comes from scorpion venom, to bind and direct T cells to target glioblastoma (GBM). Initial scientific research conducted at the City of Hope Cancer Centre in Los Angeles found promising anti-tumour activity from CAR T therapy.

At the time of writing, the biotechnology company's shares are going for 29 cents apiece, down 1.6%.

What did Chimeric announce?

Investors appear unfazed by the company's latest update, sending Chimeric shares lower.

According to its release, Chimeric advised it has passed the first checkpoint in the City of Hope's phase 1 CLTX CAR T cell clinical trial. All patients in the first group that received the Chlorotoxin CAR T dose have exceeded the 28-day follow-up period without experiencing dose-limiting toxicities.

The dose-escalation study is seeking to assess Chlorotoxin CAR T's safety and maximum tolerance in participants suffering from recurrent or progressive GBM.

While the first cohort received the minimum dosage limit, Chimeric will now move onto the second dosing level. Patients in this group will be administered via two methods – intratumoral (ICT) and intracranial intraventricular (ICV) at a total dose of 88 x 106 CAR T cells.

Chimeric hopes to recruit between 18 to 36 people with MMP2+ recurrent or progressive GBM across 4 different dose levels. Once the appropriate dosing amount is established, the company will then move to phase 2 trials.

Chimeric chief operating officer, Jennifer Chow commented on the achievement:

We are very pleased to have reached this significant milestone with our CLTX CAR T cell therapy as it enables us to advance the development of this important therapy for patients with progressive or recurrent Glioblastoma.

We look forward to further progressing the development of CLTX CAR T and to providing updates as we seek to bring the promise of cell therapy to life for more patients with cancer.

About the Chimeric share price

Since coming online to the ASX at the start of this year, the Chimeric share price has remained relatively flat. The company's shares reached an all-time high of 44 cents in late January, before treading lower.

Based on the current share price, Chimeric has a market capitalisation of roughly $57 million.

The post Chimeric (ASX:CHM) share price edges lower despite positive update appeared first on The Motley Fool Australia.

At the time of writing, the biotechnology company's shares are trading at 31 cents, down 6%.

What did Chimeric announce?

The Chimeric share price is in the red today, irrespective of the company's latest developments.

In today's release, Chimeric advised that it has completed the planned dosing of the first group of patients in its phase 1 Chlorotoxin CAR T trial.

The dose-escalation study will assess Chlorotoxin CAR T's safety and maximum tolerance in participants suffering from recurrent or progressive glioblastoma (GBM).

Chimeric hopes to recruit between 18 to 36 people with MMP2+ recurrent or progressive GBM across 4 different dose levels. Once the appropriate dosing amount is established, the company will then move to phase 2 trials.

The first group of patients were given the lowest dose level through a single-site administration. However, as this is the first in human phase 1 cell therapy trial, all four recruits received staggered treatment. This refers to follow-up intervals between administering the peptide from one patient to another, allowing to monitor any adverse effects.

Chimeric will seek to recruit new subjects for its next dose level after the final patient has completed the dose-limiting toxicity period.

A quick take on Chimeric

Established in 2020, Chimeric is developing a breakthrough cancer cell therapy drug for solid tumours. The company uses chlorotoxin, which comes from scorpion venom, to bind and direct T cells to target GBM.

Initial scientific research conducted at the City of Hope Cancer Centre in Los Angeles found promising anti-tumour activity from CAR T therapy.

Chimeric share price snapshot

Since its initial public offering (IPO) listing in January this year, the Chimeric share price has gained around 8%.

Chimeric commands a market capitalisation of close to $63 million on current valuation grounds, with 196.5 million shares on issue.

The post Chimeric (ASX:CHM) share price falls despite positive update appeared first on The Motley Fool Australia.

The drug development company's shares jumped a whopping 88% at one stage to a high of 37.5 cents.

The Chimeric Therapeutics share price eventually closed the day at 29.5 cents, which is 47.5% higher than its Initial Public Offering (IPO) price of 20 cents.

The Chimeric Therapeutics IPO.

Chimeric Therapeutics' shares landed on the ASX boards today following the completion of an IPO that raised $35 million from investors.

The offer comprised of 175 million shares to raise $35 million at an offer price of $0.20 per share, giving the company a market capitalisation of $66.1 million upon listing.

Management advised that the IPO was met with excellent support from both new and existing institutional, professional, and retail investors within Australia and overseas.

The proceeds from the IPO will be used to fund the phase 1 clinical trial of the CLTX-CAR T at the City of Hope Cancer Centre in Los Angeles and to further develop an oncology focused pipeline of novel cell therapies.

In addition, some of the proceeds will be used to invest in personnel, corporate, and working capital, as well as license fees to City of Hope.

What are Chimeric and CLTX-CAR T?

Chimeric is a clinical stage cell therapy company focused on the development of novel cell therapies for oncology. It is developing CLTX-CAR T, which uses a peptide derived from scorpion toxin, to direct T cells to target glioblastoma (brain cancer).

It has noted potent anti-tumour activity against glioblastoma established in preclinical models.

In light of this, a phase 1 trial of CLTX-CAR T therapy is now underway at the City of Hope cancer centre, where the first patient was dosed in late 2020.

Chimeric's Executive Chairman, Paul Hopper, commented: "The team at Chimeric has been overwhelmed with the support for the IPO and what we believe is a highly promising technology in an attractive area of immuno-oncology. The IPO allows us to further develop the CLTX-CAR T therapy and extend it to patients with an unmet need, including those suffering from GBM as well as other solid tumors."

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