Latest news with #biotechs
Wall Street Journal
18 hours ago
- Business
- Wall Street Journal
Venture Interest Slackens in Once-Hot Biotech
Relentless market uncertainty and narrowing opportunities to take startups public are leading venture capitalists to take a step back from biotechnology. U.S. and European biotechs raised $11.2 billion in venture capital in the first half, according to Silicon Valley Bank. That is off last year's pace, when these startups collected $28.6 billion for the full year.
News.com.au
a day ago
- Business
- News.com.au
Health Check: Today's flood of last-minute quarterly ‘homework' scores a solid pass
Plenty of biotechs are lodging late in the piece, but without too many 'dog ate my homework' excuses Telehealth group looks to post-pandemic recovery Botanix, Amplia and Vitrafy pass muster with the brokers Some students hand in their homework with days to spare, while others lob their hastily scrawled efforts at the eleventh hour. Plenty of biotechs also prefer the latter 'just in time' approach, judging from today's clump of quarterly reports lobbing in just ahead of today's end-of-month deadline. But in most cases, we won't mark down their quality. In the drug development domain, the 'students' are look well cashed up and well prepared. They've remembered to bring their excursion money and their sports uniforms. For instance, popular student Amplia (ASX:ATX) ended the quarter with cash of almost $6.7 million. This since has been bolstered by last week's $27.5 million capital raising. The company reported operating cash outflows of $3.8 million. This reflects spending on its 55-patient phase II pancreatic cancer trial, dubbed Accent. The study attracted wide interest by reporting 17 partial responses and two 'complete responses' – a.k.a. a cure. Given pancreatic cancer is such a deadly disease, this was most unexpected. Recovering from its failed Duchenne muscular dystrophy trial, Percheron Therapeutics (ASX:PER) spent just under $2.75 million, ending with cash of $10.16 million. This dosh is a lifeline for the company, which has acquired an immune-oncology drug asset. The developer of an ovarian cancer diagnostic and breast and lung cancer therapies, Inoviq (ASX:IIQ) expended a modest $1.44 million and ended up with cash of $6.5 million. Inoviq's chairman, the ubiquitous David Williams, attributes the company's sagging share price to a fund selling out. 'We anticipate share price recovery as the selling ends and we continue to advance our diagnostic programs,' he says. Medadvisor tempers expectations Following a weak June quarter related partly to cancelled US programs, medication compliance and drug education provider MedAdvisor (ASX:MDR) has tweaked its full-year guidance. Medadvisor now expects revenue for the year to June 2026 of $88 million, compared with the previously envisaged $93-99 million. Management expects an underlying loss of $6.5 to $7.3 million, compared with the previously guided $2.6 to $5.5 million. Medadvisor's June quarter revenue declined 16% to $18.6 million, with full year turnover declining 28%. The company cites several delayed US drug launch programs, which has deferred revenue into the current quarter. Medadvisor is aligned to the drug companies' rollout of new vaccines. But these have been stymied by sluggish demand amid the ongoing political controversy over these prophylactics. Meanwhile, the company has sold its non-core Australian ops to Jonas Software, for $35 million plus $7.5 million of earnouts. After extinguishing all its debt, Medadvisor has a healthy cash balance of $16.5 million. What's up DOC? A profit turnaround Doctor Care Anywhere Group PLC (ASX:DOC) slips under the radar because the telehealth provider operates solely in the UK. But we'll rectify this dearth of coverage by reporting that the company managed cash inflow of £2.17 million ($4.4 million) in the June (second) quarter. This is a turnaround from the March quarter deficit of £1.46 million and an 'historic milestone' for the company Receipts surged 32% to £10.93 million, despite consultations declining 7% year on year to 176,000. DOC ended the stanza with cash of £4.8 million ($10) million, 'enough to see the company through to long term profitability and continued net cash generation.' DOC works with insurers, healthcare providers and corporate customers to connect patients to digitally enabled telehealth services on its proprietary platform. The company listed here in December 2020, amid the pandemic-inspired telehealth craze, raising a chunky $101 million at 80c cents apiece. The shares have been in the sick ward ever since but achieving profitability would be the right prescription. Trio goes to the well Shares in Imagion Biosystems (ASX:IBX), Nyrada (ASX:NYR) and HeraMED (ASX:HMD) are on trading halt pending capital raising, with announcements expected on Monday. With $883,000 in the bank as of June-end, Imagion eyes more funds to further its innovative Magsense imaging system. The company is preparing a submission to the US Food & Drug Administration, for a trial enrolling HER-2 breast cancer patients. With cash of $2.93 million, Nyrada is seeking a top-up to support development of its drug candidate, Xolatryp, for traumatic brain injury and strokes. The company is undertaking a phase I TBI safety and efficacy trial. The developer of a foetal monitoring device, Heramed hasn't yet lodged its June quarterly. At the end of March, the company had cash of $1.88 million. Meanwhile oncology drug developer Prescient Therapeutics (ASX:PTX) said it had raised $3 million from a placement. This follows a share purchase plan that bought in $6.9 million. These readies should be enough to fund the company's phase II trial of its T cell lymphoma dug candidate towards 'potential regulatory approval'. What the brokers say Canaccord has initiated coverage on Botanix Pharmaceuticals (ASX:BOT) with a 'buy' call. This is despite taking a sterner stance on drug pricing, yields and script refill rates than the company's assumptions. Botanix in January launched the US rollout of its drug Sofdra, to treat the excessive underarm sweating condition primary auxiliary hyperhidrosis. Canaccord scribes a 'price target' of 27 cents per share, compared with Thursday' close of 17 cents. The firm assumes current year revenue of $67.8 million and a $41.8 million loss. Next year, turnover rises to $145 million, with a $14.3 million profit. Bell Potter reckons the aforementioned Amplia Therapeutics is worth almost twice as much as its current valuation, despite the drug developer's stellar run. The firm values Amplia shares at 42 cents, compared with 24 cents currently. Bel Potter also has a 'speculative buy' call on cryopreservation play Vitrafy Life Sciences (ASX:VFY). Vitrafy is developing its yet-to-be approved novel deep-freezing device, iiitally for the for research market. Vitrafy listed last November at $1.84 apiece, having raised $35 million. The firm values Vitrafy shares at $2, implying 22% of upside.
News.com.au
4 days ago
- Business
- News.com.au
Health Check: Clarity shares surge after ‘fast and sizeable' $203m raise
• Clarity Pharmaceuticals rocket up to 12% after its blitzkrieg placement • Artrya, Botanix and Imricor are among today's quarterly updates • Lumos outlines US market potential Radiopharmaceutical group Clarity Pharmaceuticals (ASX:CU6) has surprised investors with a monstrous $203 million institutional placement, struck at a 15% premium to the company's 15-day average price. None will be more surprised than the short sellers, who account for close to 10% of the company's register. Executive chairman Dr Alan Taylor says the 'fast, well executed and sizeable' placement was to a small group of local instos 'close to the company'. Unusually, no-one blabbed and the shares did not enter trading halt. 'I have never done a deal that fast,' Taylor told Stockhead. 'A week ago, I would have said we were not doing a capital raising, but there was a lot of interest from a very concentrated group . "The raising was struck at $4.20 a share, a 2.2% premium to Friday's close and a hefty 18% more than the 15-day weighted average price. The raising comes amid what Taylor dubs 'an incredibly tumultuous' period driven by US politics, as well as some 'unfortunate news' from local biotechs (read: Opthea's (ASX:OPT) phase III trial failure). In December Clarity shares were promoted to the ASX200, which was good for enhancing Clarity's profile. But it also contributed to shorting activity. Given the share gains, these investors are likely to be buying up stock to cover their positions. Well funded for trials Clarity emerges from the raising with $288 million of cash, which will fund the company's packed slate of trials. These include two phase III prostate cancer imaging trial aimed at US Food & Drug Administration registration, dubbed Amplify and Clarify. Amplify is for patients with biochemical recurrence post treatment; Clarify is for those intended to undertake prostate removal. Both are open label and single-arm (with no placebo and comparison cohort). Another trial on the sidelines, Co-PSMA compares Clarity's tool with the standard-of-care diagnosis methods. The company expects an initial data readout on this one before the end of the year, with Amplify and Clarify readouts next year. Clarity listed in August 2021, raising a record $92 million at $1.40 apiece. The company then went one better in April last year, raising $121 million in a right issue and placement (at $2.55 a share). The raising is one of the biggest in biotech history and the chunkiest since Mesoblast gathered $260 million in a placement in January. Imricor confident of US approval Imricor Medical Systems (ASX:IMR) is confident of US approval of its world-first ablation catheter this year. We say 'world's first' because the device is the only one capable of being guided by magnetic resonance imaging (MRI), as opposed to x-ray fluoroscopy. Imricor's submission is by way of a staggered, modular process. The company reports the second module is under review and the company expects to submit the third module in the December quarter. 'We expect a steady string of 510(k) product submissions and approvals , which in turn helps accelerate the commercial launch across the US," the company says. In the March quarter European regulators approved Vision-MR, the company's updated catheter for type 1 atrial flutter, under the Continent's bolstered Medical Devices Regulation. In the June quarter they also gave the nod to Advantage-MR, which enables a physician to use a recording system and cardiac stimulator while ablating. The European gatekeepers also approved Northstar, 'the world's only MRI-native 3D mapping and guidance system.' With June quarter receipts of US$85,000, Imricor is yet to start European sales in earnest. The company posted June quarter outflows of US$4.43 million, taking cash on hand to a handy US$50.3 million. Sales will flow this quarter, says plaque-buster Artrya Still on matters of the heart, Artrya (ASX:AYA) expects first US subscription revenue from its AI-enabled Salix coronary plaque detection platform in the current quarter. An algorithm-based artificial intelligence tool, Salix detects the plaque deposits on x-ray coronary computed tomography angiograph (CCTA) images. Despite vulnerable plaque being the cause of most heart attacks, plaque currently is not routinely reported in cardiac imaging and diagnostics. It's difficult to detect with the naked eye in traditional images. In March the FDA approved Salix Coronary Anatomy (SCA) and Artrya is now seeking the agency's consent for Salix Coronary Plaque (SCP). SCP expands applicability to detecting and quantifying coronary arterial plaque for those patients who have undergone a coronary CT angiogram. The SCP module will integrate automatically with SCA. SCA already is being trialled and in clinical use, by Artrya's customers and partners, generating a symbolic $8000 in receipts of the quarter. Earlier this month Artrya inked its first commercial deal, a five-year minimum $600,000 contract with Tanner Health. Artrya expended $5.44 million for the quarter, taking cash to $11.3 million. The company expects a $4.5-5 million R&D tax refund by the end of the year. Botanix reports 600% revenue uptick Botanix Pharmaceuticals (ASX:BOT) reports net revenue of $4.3 million from US sales of Sofdra, compared with $700,000 in the March quarter. The company launched the drug – which treat an excessive sweating condition – in the US in March quarter. The 'net' descriptor is relevant, because some folks were taken aback after the company's July 8 update which showed the extent to which other parties clipped the revenue ticket, Doctors wrote 7053 prescriptions during the quarter, 324% higher than 2975 in the March stanza. The number of prescribers rose 11%, to 2316 from 1075 previously. Launching a drug is not cheap and the company burnt $28.4 million, leaving cash of $64.9 million. Let's be CLIA, it's a big market says Lumos Lumos Diagnostics (ASX:LDX) expects its Febridx virus-versus-bacterial diagnostic tool to capture eight million US patients within three years, via its company making distribution deal with Phase Scientific. Announcing the tie up on July 16, Lumos said the deal would deliver US$2 million immediately – cash the company has, indeed, banked – and a total of US$317 million ($487 million) over six years. Detailing the arrangement on Friday, CEO Doug Ward said the company expected a total addressable market of 80 million, assuming the FDA grants a so-called CLIA waiver. The number consists of patients present with acute respiratory infections. 'Our thinking is that in years two to three we will be 2% or 3% of that,' Ward said. 'In year six, that ramps up to 10%.' As in Clinical Laboratories Improvement Act, CLIA requires hospitals and labs to operate under government accreditation Exemption from CLIA enables parties such as GPs and medical assistants to carry out the low-complexity lateral-flow assays. In financial terms, the market increases tenfold, to US$1 billion a year. Lumos is carrying out a trial to support its FDA application and has recruited close to 120 of the bacterial-positive patients required. Coming back to the finances, Phase pays Lumos another US$1.5 million on its CLIA application, expected next month. On FDA approval, Phase pays another US$5 million. That leaves US$308 million over years three to six, which Ward says is based on minimum order volumes. Lumos shares rocketed 133% on the back of the Phase announcement and have held their gains.
News.com.au
24-07-2025
- Business
- News.com.au
Health Check: Records tumble as biotech's star quarterly reporters pick up the pace
• Several emerging life science plays are taking revenue to new heights – and some have even turned profitable • Little Green Pharma seeks to avoid a second pay 'strike' • Althea founder exits the building It is a truth, universally acknowledged, that biotechs with little or no revenue and cascading cash outflows will leave their quarterly disclosures to the last possible moment. Given dozens of other companies holding off until around July 31 – the deadline for lodging June quarterlies – this crowds out the bad news. The corollary is that those with pleasant surprises prefer to break with the hoi polio and go early. True to trend, today's reporters have broken more sales records than our Glasgow-bound Gout Gout. In fact, the last time your columnist heard so much about records was in a Brashs store in the 1980s … which dates him somewhat. The company (and patient) are doing well The provider of software to make hospitals run more smoothly, Alcidion (ASX:ALC) reports record quarterly cash flow of $7.4 million for the quarter. This takes the year's surplus to $5.8 million (also an all-time high). Full-year receipts came in at $50.9 million, 16% higher. Alcidion provides software to hospitals – such as patient workflow tools – to enable them to run more smoothly and prevent surgeons from amputating the wrong leg. The company has a meaningful local and UK presence across 400 hospitals and 87 healthcare organisations. Management reports new June quarter sales of $6.7 million, 73% of which are recurring. The company also affirms underlying earnings of $4.5 million for the 2024-25 year, upped from $3 million in June. This should be confirmed at August's full year results prezzo. Hear! Hear! A record year for Audeara The maker of hearing augmentation devices, Audeara (ASX:AUA) reports June quarter revenue of $722,000, which takes full-year turnover to a record $3.78 million (up 22%). Audeara own-branded headphones are sold via hearing clinics. But the company has skewed its business to its AUA Technology arm, which has an 'Intel inside' model of providing the technology to big-ticket international customers. These include the 400-year-old US instrument maker, Avedis Zildjian. Audeara founder and CEO Dr James Fielding dubs the quarter as a 'period of consolidation'. He says the company 'executed on several strategic initiatives to ensure it capitalises on the growth established through the AUA Technology division over the previous 12 months". Audeara also had $757,000 of cash outflows for the quarter, reducing June-end cash to $1.42 million. But Fielding says the company should see a 'material uplift' in current quarter revenues, owing to a chunky Avedis Zildjian re-order. Bioxyne eyes European growth A supplier of cannabis and psychedelic meds, Bioxyne (ASX:BXN) more than doubled full-year revenue to $9.55 million, with full-year revenue up 215% to $29.3 million. Did we mention that was a record? The company also managed positive cash flow of $1.5 million for the June stanza. This takes the full-year cash flow to $6.2 million, compared to a $3.6 million deficit in 2023-24. Management attributes the surge to the Australian operating of its subsidiary Breathe Life Sciences. But Bioxyne's greater growth prospects lie with the UK and European markets, notably Germany where it has inked two key manufacturing and supply agreements. Little Green faces big pay votes Still on pot stocks, Little Green Pharma (ASX:LGP) again faces the music on two remuneration-related motions at its August 21 AGM. As a March balance date entity, Little Green beats the usual AGM rush. Last year, 83% of voting shares were cast against Little Green's 'rem' report, well beyond the 25% 'no' vote threshold. If investors again knock back the proposal, they'll vote on a motion to spill the board (this one requires a minimum 50% 'yes' vote). The board has also reprised last year's proposal to accelerate the vesting of management and executive share incentives, in the event of the "person ceasing to hold such office." Investors overwhelmingly opposed this one last time as well. Thorney Investments is Little Green's biggest shareholder on 19.7%. Gina Rinehart's Hancock Prospecting supported a 2021 capital raising and emerged with 10%. But it's not clear how much she holds now. Althea founder bows out We're not obsessed with cannabis – that's a promise – but it behooves us to report that Althea Group (ASX:AGH) founder and CEO Josh Fegan has left the company, with 'immediate effect'. Fegan created Althea in 2016 and the company listed in September 2018. Fegan had been at the helm all that time. As we reported on Wednesday, Althea has given up on the over-competed local medicinal pot sector. The company now is focusing on the North American recreational market via its subsidiary Peak Processing. Specifically, Peak is getting into THC-laced beverages as an alternative to alcoholic ones. Althea share tumbled 10% on the surprise tidings. On Bell Potter's gut feel, Microba's worth much more Bell Potter reckons there's 60% share price upside in Microba Life Sciences (ASX:MAP), which provides microbiome testing. Microba on Wednesday reported a 13% June quarter revenue decline, to $4.2 million. But stripping out the divestment of a legacy research business, revenue grew 4% year-on-year. Microba has two core products: Metaxplore and Metapanel. Metapanel is the 'first line' test to determine whether a doc can treat a pathogen simply with antibiotics. Metaxplore probes anything else that could be wrong with the patient's microbiome. The company has free cash flow burn of $6.3 million for the quarter and $15.3 million for the year. But this rate has been 'relatively steady' over the last two years. Following a $14.5m capital raising – backed by biggest shareholder Sonic Healthcare – Microba has $20.2 million of cash with no debt. "Most legacy sales have now unwound, so we anticipate more meaningful consolidated topline growth for the group in 2025-26," Bell Potter says. The forecasts an adjusted net loss of $14.6 million for 2024-25 and a simialar deficit this year. The company expects to break even in 2027-28. Bell Potter values stock at 16 cents, tempered from its previous 26 cent guesstimate.
