Latest news with #oncology
The Independent
16 hours ago
- Business
- The Independent
Cancer drug demand drives higher sales for AstraZeneca
AstraZeneca has announced a jump in sales in recent months after a surge in demand for cancer drugs, as the pharmaceutical giant prepares to plug 50 billion dollars (£37 billion) into its US expansion. The drug-maker reported total revenues of 28 billion US dollars (£21 billion) for the first half of 2025. This is 11% higher, at constant exchange rates, than the same period a year ago. AstraZeneca said the uplift was largely driven by its oncology medicines, with product sales surging by 16% year on year, thanks to growth in demand for drugs including Tagrisso and Imfinzi. Revenues from oncology products, which refer to the diagnosis and treatment of cancer, made up 43% of the company's total sales. The group's pre-tax profit soared by 27% to 6.5 billion US dollars (£4.9 billion) for the first half, compared with last year. AstraZeneca, which is based in the UK, last week pledged a mammoth investment into the US over the next five years, where it generates the highest proportion of sales. The money will fund a new multibillion dollar manufacturing facility in Virginia, to be the firm's largest single manufacturing investment in the world. The new factory will produce drug substances for its growing weight management and metabolic portfolio, including oral GLP-1 products. GLP-1 is the scientific term for weight-loss medication, which works by reducing food cravings. Oral medicines can be taken in tablet form, while other drugs are taken as injections. 'Our strong momentum in revenue growth continued through the first half of the year and the delivery from our broad and diverse pipeline has been excellent,' Pascal Soriot, AstraZeneca's chief executive, said. 'This landmark investment reflects not only America's importance but also our confidence in our innovative medicines to transform global health and power AstraZeneca's ambition to deliver 80 billion dollars revenue by 2030.'
Associated Press
16 hours ago
- Business
- Associated Press
NeoGenomics Reports Second Quarter 2025 Results
FORT MYERS, Fla.--(BUSINESS WIRE)--Jul 29, 2025-- NeoGenomics, Inc. (NASDAQ: NEO) (the ' Company ' ), a leading provider of oncology diagnostic solutions that enable precision medicine, today announced its second-quarter results for the period ended June 30, 2025. 'In the second quarter clinical revenue increased by 16% driven by sequential improvement in AUP, a record quarter for volumes, and NGS growth of 23%,' said Tony Zook, CEO of NeoGenomics. 'Strength in our Clinical business was largely offset by continuing pressure in pharma revenue that was beyond our initial assumptions, and a delay in our commercial launch of PanTracer™ Liquid Biopsy that impacted our expected NGS revenue.' 'Looking ahead, we believe Neo will continue to perform as a double-digit revenue growth company, poised to capture additional market share,' continued Mr. Zook. 'We are enhancing our R&D efforts to develop new therapy selection and next-gen MRD products. We are also preparing for the commercial launch of PanTracer Liquid Biopsy, continuing to grow our sales team, increasing efficiencies, and pursuing partnerships through business development efforts that will enhance our portfolio and strengthen our community channel. We are confident that Neo will deliver long-term value for our customers, patients, and shareholders.' Second-Quarter Results Consolidated revenue for the second quarter of 2025 was $181 million, an increase of 10% over the same period in 2024 primarily due to higher volume partially offset by lower non-clinical revenue. Average revenue per clinical test ('revenue per test') increased by 2% to $465. This increase reflects higher value tests, including NGS, and strategic reimbursement initiatives. Consolidated gross profit for the second quarter of 2025 was $77 million, an increase of 7% compared to the second quarter of 2024. This increase was primarily due to an increase in revenue partially offset by higher compensation and benefit costs and an increase in supplies expense. Consolidated gross profit margin, including amortization of acquired intangible assets and stock-based compensation expense, was 43%. Adjusted Gross Profit Margin (1), excluding amortization of acquired intangible assets and stock-based compensation expense, was 45%. Operating expenses for the second quarter of 2025 were $125 million, an increase of $30 million, or 32%, compared to the second quarter of 2024. The increase in operating expenses primarily reflect $20.0 million of impairment charges from impairment of assets held for sale related to the planned sale of Trapelo and the InVisionFirst®-Lung intangible asset impairments, as well as $4.4 million in higher compensation and benefit costs. These increases were partially offset by a decrease in restructuring activities due to the completion of restructuring activities in the fourth quarter of 2024. Net loss for the quarter increased $26 million, or 142%, to $45 million compared to net loss of $19 million for the second quarter of 2024. Adjusted EBITDA (1) for the second quarter of 2025 remained relatively flat at positive $10.7 million, compared to positive $10.9 million in the second quarter of 2024. Adjusted Net Loss (1) was $3.6 million compared to Adjusted Net Loss (1) of $4 million in the second quarter of 2024. Cash and cash equivalents and marketable securities totaled $164 million at quarter end. Pathline, LLC Acquisition On April 4, 2025, the Company completed the acquisition of a 100% ownership interest in Pathline, LLC ('Pathline'), a CLIA/CAP/NYS-certified laboratory based in New Jersey. The purchase price consisted of (i) initial cash consideration of $8.0 million, subject to working capital and other adjustments, and (ii) contingent consideration of $1.0 million. The Pathline acquisition aligns with the Company's strategic objective of expanding its presence, capabilities, and offerings in the Northeastern United States. 2025 Financial Guidance(2) The Company again revised its full-year 2025 guidance (2), as previously revised on April 29, 2025. Conference Call The Company has scheduled a webcast and conference call to discuss its second quarter 2025 results on Tuesday , July 29, 2025 at 8:30 a.m. Eastern Time. To access the live call via telephone, interested investors should dial (888) 506-0062 (domestic) or (973) 528-0011 (international) at least five minutes prior to the call. The participant access code provided for this call is 859170. The live webcast may be accessed by visiting the Investor Relations section of our website at A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Company's website. About NeoGenomics, Inc. NeoGenomics, Inc. is a premier cancer diagnostics company specializing in cancer genetics testing and information services. We offer one of the most comprehensive oncology-focused testing menus across the cancer continuum, serving oncologists, pathologists, hospital systems, academic centers, and pharmaceutical firms with innovative diagnostic and predictive testing to help them diagnose and treat cancer. Headquartered in Fort Myers, FL, NeoGenomics operates a network of CAP-accredited and CLIA-certified laboratories for full-service sample processing and analysis services throughout the US and a CAP-accredited full-service sample-processing laboratory in Cambridge, United Kingdom. We routinely post information that may be important to investors on our website at Forward Looking Statements This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as 'anticipate,' 'expect,' 'plan,' 'could,' 'would,' 'may,' 'will,' 'believe,' 'estimate,' 'forecast,' 'goal,' 'project,' 'guidance,' 'plan,' 'potential' and other words of similar meaning, although not all forward-looking statements include these words. These forward-looking statements address various matters, including statements regarding 2025 financial guidance, seasonality impacts, and long-range strategic objectives and initiatives set forth in the Company's long-range plans.. Each forward-looking statement contained in this press release is subject to a number of risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the Company's ability to identify and implement appropriate financial and operational initiatives to improve performance, to assemble and maintain an effective executive team, to continue gaining new customers, offer new types of tests, integrate its acquisitions, manage the effects of seasonality, execute on its long-range strategic priorities, and otherwise implement its business plans, and the risks identified under the heading 'Risk Factors' contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, and filed with the SEC on February 18, 2025, as well as subsequently filed Quarterly Reports on Form 10-Q and the Company's other filings with the Securities and Exchange Commission. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at and on our website at for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document (unless another date is indicated), and we undertake no obligation to update or revise any of these statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Use of Non-GAAP Financial Measures In order to provide greater transparency regarding our operating performance, the financial results and financial guidance in this press release refer to certain non-GAAP financial measures that involve adjustments to GAAP results. Non-GAAP financial measures exclude certain income and/or expense items that management believes are not directly attributable to the Company's core operating results and/or certain items that are inconsistent in amounts and frequency, making it difficult to perform a meaningful evaluation of our current or past operating performance. Management believes that the presentation of operating results using non-GAAP financial measures provides useful supplemental information to investors by facilitating the analysis of the Company's core test-level operating results across reporting periods. These non-GAAP financial measures may also assist investors in evaluating future prospects. Management also uses non-GAAP financial measures for financial and operational decision making, planning and forecasting purposes and to manage the business. These non-GAAP financial measures do not replace the presentation of financial information in accordance with U.S. GAAP financial results, should not be considered measures of liquidity, and are unlikely to be comparable to non-GAAP financial measures provided by other companies. Definitions of Non-GAAP Measures Non-GAAP Adjusted EBITDA 'Adjusted EBITDA' is defined by NeoGenomics as net (loss) income from continuing operations before: (i) interest income, (ii) interest expense, (iii) tax (benefit) or expense, (iv) depreciation and amortization expense, (v) stock-based compensation expense, and, if applicable in a reporting period, (vi) CEO transition costs, (vii) restructuring charges, (viii) impairment charges, (ix) intellectual property ('IP') litigation costs, and (x) other significant or non-operating (income) or expenses, net. Non-GAAP Adjusted Cost of Revenue, Adjusted Gross Profit and Adjusted Gross Profit Margin 'Adjusted cost of revenue' is defined by NeoGenomics as cost of revenue before: (i) amortization of acquired intangible assets, and, if applicable in a reporting period, (ii) stock-based compensation expense. 'Adjusted gross profit' is defined by NeoGenomics as total revenue less adjusted cost of revenue. 'Adjusted gross profit margin' is defined by NeoGenomics as adjusted cost of revenue divided by total revenue. Non-GAAP Adjusted Net (Loss) Income 'Adjusted net (loss) income' is defined by NeoGenomics as net (loss) income from continuing operations plus: (i) amortization of intangible assets, (ii) stock-based compensation expense, and, if applicable in a reporting period, (iii) CEO transition costs, (iv) restructuring charges, (v) impairment charges, (vi) IP litigation costs, and (vii) other significant or non-operating (income) or expenses, net. If GAAP net (loss) income is negative and adjusted net (loss) income is positive, adjusted net (loss) income will also be adjusted to reverse any recognized interest expense (including any amortization of discounts) on the convertible notes using the if-converted method unless the effect of this adjustment on both the adjusted net (loss) income and weighted average diluted common shares outstanding would be anti-dilutive. If GAAP net (loss) income is positive and adjusted net (loss) income is negative, adjusted net (loss) income will also be adjusted to reverse any recognized interest expense (including any amortization of discounts) on the convertible notes using the if-converted method. Non-GAAP Adjusted Diluted EPS 'Adjusted diluted EPS' is defined by NeoGenomics as adjusted net (loss) income divided by adjusted diluted shares outstanding. If GAAP net (loss) income is negative and adjusted net (loss) income is positive, adjusted diluted shares outstanding will also include any options or restricted stock that would be outstanding as dilutive instruments using the treasury stock method and the weighted average number of common shares that would be outstanding if the convertible notes were converted into common stock on the original issue date based on the number of days such common shares would have been outstanding in the reporting period, until the effect of these adjustments are anti-dilutive. If GAAP net (loss) income is positive and adjusted net (loss) income is negative, adjusted diluted shares outstanding will exclude any options or restricted stock that would be outstanding as dilutive instruments using the treasury stock method and the weighted average number of common shares that would be outstanding if the convertible notes were converted into common stock on the original issue date based on the number of days such common shares would have been outstanding in the reporting period. GAAP net loss in 2025 will be impacted by certain charges, including: (i) expense related to the amortization of intangible assets, (ii) stock-based compensation, and (iii) other one-time expenses. These charges have been included in GAAP net loss available to stockholders and GAAP net loss per share; however, they have been removed from adjusted net loss and adjusted diluted net loss per share The following table reconciles the Company's 2025 outlook for net loss and EPS to the corresponding non-GAAP measures of adjusted net loss, adjusted EBITDA, and adjusted diluted EPS: View source version on CONTACT: Investor Contact Kendra Webster [email protected] Contact Andrea Sampson [email protected] KEYWORD: UNITED STATES NORTH AMERICA FLORIDA INDUSTRY KEYWORD: RESEARCH HOSPITALS GENETICS BIOTECHNOLOGY HEALTH PHARMACEUTICAL GENERAL HEALTH SCIENCE ONCOLOGY SOURCE: NeoGenomics, Inc. Copyright Business Wire 2025. PUB: 07/29/2025 07:05 AM/DISC: 07/29/2025 07:05 AM
Wall Street Journal
21 hours ago
- Business
- Wall Street Journal
AstraZeneca Books Record Quarterly Revenue as Oncology Boosts Growth
AstraZeneca's AZN -0.11%decrease; red down pointing triangle earnings rose and the drugmaker delivered its largest quarterly revenue, boosted by the oncology segment. The Anglo-Swedish pharmaceutical giant said Tuesday that for the second quarter core earnings per share rose to $2.17 from $1.98 in the same period a year prior. Revenue increased to $14.46 billion from $12.94 billion.
Associated Press
a day ago
- Business
- Associated Press
GeoVax Reports Second Quarter 2025 Financial Results and Provides Business Update
GEO-MVA received favorable European regulatory guidance supporting streamlined development pathway GEO-CM04S1 demonstrates superior robust immune responses in CLL patients; data presented at EHA 2025 Gedeptin(R) highlighted strong safety and efficacy for the treatment of solid tumors; data presented at AACR 2025 Company to host conference call today at 4:30 p.m. ET ATLANTA, GA - July 28, 2025 ( NEWMEDIAWIRE ) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigenic vaccines and immunotherapies for infectious diseases and cancer, today announced financial results for the second quarter ended June 30, 2025, and provided a business update. 'The second quarter marked a pivotal period for GeoVax, with compelling clinical data and regulatory milestones reinforcing the strength of our pipeline and our focus on accelerating to commercial status,' said David Dodd, GeoVax's Chairman and CEO. 'The favorable European regulatory guidance for GEO-MVA, robust immune responses demonstrated by GEO-CM04S1 in immunocompromised patients, particularly those with Chronic Lymphocytic Leukemia (CLL), and the continued progress towards initiation of the Gedeptin(R) Phase 2 trial highlight our expanding footprint in oncology and global infectious disease preparedness. These achievements reflect our commitment to advancing innovative, vaccines and immunotherapies that address urgent and underserved medical needs.' Clinical Trial Progress and Operational Developments GEO-MVA GEO-CM04S1 Gedeptin(R) Other Corporate Updates Second Quarter 2025 Financial Results Net Loss: Net loss for the three-month period ended June 30, 2025, was $5,369,783, or $0.35 per share, as compared to $5,064,042, or $1.99 per share, for the comparable period in 2024. For the six-month period ended June 30, 2025, the Company's net loss was $10,727,434, or $0.79 per share, as compared to $10,914,174, or $4.68 per share, in 2024. Revenue: During the three-month and six-month periods ending June 30, 2025, the Company reported $852,282 and $2,489,145 of government contract revenues associated with the BARDA/RRPV Project NextGen award, compared to $300,677 and $300,677 for the comparable periods in 2024. During the second quarter of 2025 GeoVax received notification that BARDA determined to terminate the contract for convenience to the government. R&D Expenses: Research and development expenses were $4,728,998 and $10,083,586 for the three-month and six-month periods ended June 30, 2025, compared with $4,276,868 and $8,702,596 for the comparable period in 2024, with the overall increase primarily due to program-specific costs associated with the BARDA/RRPV contract and GEO-MVA, partially offset by lower costs for the GEO-CM04S1 clinical trials and manufacturing costs not covered by the BARDA/RRPV contract. G&A Expenses: General and administrative expenses were $1,542,190 and $3,229,635 for the three-month and six-month periods ended June 30, 2025, compared to $1,086,030 and $2,543,383 for the comparable periods in 2024, with the overall increase primarily due to higher investor relations consulting costs and stock-based compensation expense. Cash Position: GeoVax reported cash balances of $3,093,862 at June 30, 2025, as compared to $5,506,941 at December 31, 2024. During July 2025, the Company completed a public offering of common stock and warrants with net proceeds of approximately $5.6 million. Summarized financial information is attached. Further information is included in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Conference Call Details Management will host a conference call and live audio webcast today, July 28, 2025, at 4:30 p.m. ET to review financial results and provide an update on corporate developments. A question-and-answer session will follow management's formal remarks. To access the live conference call, participants may register here. The live audio webcast of the call will be available under 'Events and Presentations' in the Investor Relations section of the GeoVax website at To participate via telephone, please register in advance here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. While not required, it is recommended that participants join the call ten minutes prior to the scheduled start. An archive of the audio webcast will be available on GeoVax's website approximately two hours after the conference call and will remain available for at least 90 days following the event. About GeoVax GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company's lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin(R), having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: Forward-Looking Statements This release contains forward-looking statements regarding GeoVax's business plans. The words 'believe,' 'look forward to,' 'may,' 'estimate,' 'continue,' 'anticipate,' 'intend,' 'should,' 'plan,' 'could,' 'target,' 'potential,' 'is likely,' 'will,' 'expect' and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax's immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax's viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax's immuno-oncology products and preventative vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax's immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control. Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Company Contact: [email protected] 678-384-7220 Investor Relations Contact: [email protected] 212-698-8696 Media Contact: Jessica Starman [email protected] FINANCIAL TABLES FOLLOW View the original release on
News.com.au
a day ago
- Business
- News.com.au
Dr Boreham's Crucible: Oncology-focused Qbiotics hopes to crawl through IPO ‘window of opportunity'
Like other IPO candidates – and the list is growing – private oncology drug developer Qbiotics has been closely watching the trajectory of Virgin Australia since the airlines June 24 ASX listing. The biggest float since fast food chain Guzman y Gomez spiced up things in June last year, Virgin's initial public offer (IPO) has been seen as a barometer of broader investor appetite for new offerings. With Virgin shares holding nicely at cruising altitude, is it time for the Brisbane-based Qbiotics to debut? Qbiotics chief Stephen Doyle says IPO timing has never been right in the past, but the company now is positioned to crawl through the window of opportunity when it opens. In March the company appointed Jeffries and Bell Potter as joint lead managers for the putative float, and it is getting its financial reporting into shape. 'We have done the due diligence and prospectus drafting … all the things you need to do for an IPO,' Doyle says. 'At the end of the day it's picking the right time with the right catalysts to create value for shareholders.' Tapping nature's pharmacy The company may have found such a catalyst, having last month reported encouraging results from its phase II soft tissue sarcoma (STS) trial. The study road tests Qbiotics tigilanol tiglate (EBC-46), which derived from the depths of the Daintree rainforest. The company says tigilanol tiglate has a 'multi-factorial mode of action', including activating the protein kinase C. This leads to the disruption of the tumour's blood supply, while also stimulating a local inflammatory response. Separate from this, tigilanol tiglate can directly kill cancer cells within the tumour, in a way that promotes the development of anti-tumour immunity. This is like how a vaccine works. Qbiotics has phase II programs for both soft tissue sarcoma and head and neck cancers (HNCs). It also has less advanced programs in venous leg ulcers and anti-microbial and anti-inflammatory applications. Dogged effort wins canine approval Qbiotics has an approved product, Stelfonta, to treat canine mast cell tumours. The current standard of care is surgery - but anaesthesia is dangerous for older dogs and brachycephalic breeds (short snouted ones such as bulldogs, boxers, pugs and shih tzus). Stelfonta is administered by injection directly into the tumour mass. The European Medicines Agency approved Stelfonta in January 2020, followed by the US Food and Drug Administration in November 2020 and the Australian Pesticides and Veterinary Medicines Authority in July 2021. Stelfonta is distributed by the French group Virbac, which is responsible for all sales and marketing, while Qbiotics provides the finished product at a suitable margin. Doyle says the veterinary drug showed Qbiotics could take a product all the way from discovery to commercialisation. 'It was also a derisking strategy,' he says. 'The canine is a good surrogate for the human setting and that has been the case. 'We have some good safety and efficacy data in well over 20,000 dogs'. Stelfonta recently won a label expansion in the UK, for use in resectable mast tumours (not just inoperable ones). The story to date Qbiotics was co-founded by research scientist Dr Victoria Gordon and husband and forest ecologist Dr Paul Reddell. Both founders were employed by the Commonwealth Scientific and Industrial Research Organisation, but in 2000 Dr Gordon busted out to form Ecobiotics. The duo then formed Qbiotics in 2010. -Ecobiotics merged with Qbiotics in 2017. The pair stumbled on tigilanol tiglate when fossicking in rainforest in the Atherton Tablelands of Far North Queensland. They observed that animals spat out the seed of the blushwood tree, pointing to a non-toxic deterrent preventing the critters from eating and thus destroying the seed. Qbiotics isolated tigilanol tiglate and tests for anti-cancer activity in animals proved safe and effective. Doyle was appointed in early September 2024 after Dr Gordon stepped down, but she remains on the board. At the time, Mark Fladrich and David Phillips were appointed, while Andrew Denver and Prof Bruce Robinson stepped down. The company's chair, Dr Susan Foden died suddenly in early November and Mr Fladrich assumed the chair role. The board previously included former ASX and Cochlear chair Rick Holliday-Smith, Cochlear chief financial officer Neville Mitchell and erstwhile Macquarie Bank CEO Nicholas Moore. Taking the low road and the high road A Scottish pharmacist, Doyle has a long history with big pharma companies in medical and commercial roles. Since peregrinating to Australia at the end of 1999 on a working holiday visa, Doyle has held roles with Janssen, Novartis, Sanofi and Boehringer Ingelheim. He had lengthy stints in Paris, Singapore and Shanghai, before being poached by the smaller Aslan Pharmaceuticals (based in the Lion City). 'I liked the idea of roll up your sleeves and multi-tasking, whereas with big pharma you tend to get pigeon-holed,' he said. Doyle joined Qbiotics partly because he liked the idea of returning to Australia, notably Brisbane, but also because of the buzz of developing a drug. 'The risk of biotech is quite exciting,' he says. 'It's not for everyone. If you want a nice stable job ... get a job at Pfizer.' Soft tissue sarcoma Soft tissue sarcoma (STS) is a rare cancer that generally forms as a painless tumour in any bodily soft tissue. The company says there were 128,000 new cases of STS globally in 2023, with the incidence growing at about half a per cent per year. The US Food and Drug Administration has granted tigilanol tiglate orphan drug status for this indication. Conducted at New York's Memorial Sloan Kettering Cancer Centre, stage one of the phase IIa trial covered 10 evaluable patients with advanced STS. The study achieved an objective response rate of 80% in injected tumours, with eight patients having a complete ablation or partial ablation (reduction of 30% or more). Of the injected tumours, 22 out of 27 (81%) showed complete or partial ablation (14 complete). 'None of the 14 completely ablated tumours recurred at six months, indicating tigilanol tiglate may provide durable responses,' the company says. The trial moves to an expanded second stage, with another 40 patients targeted. Doyle says there around 80 to 120 STS sub types, but the company intends to narrow its work to the most common varieties. Head and neck cancers (HNC) Qbiotics currently is recruiting in Australia and UK for the HNC phase II trial. As with the STS trial, it is single-arm and open label. An earlier 19-patient phase I/II trial met safety and tolerability goals. Head and neck cancers are a portfolio of cancers afflicting the mouth, nose, throat, voice box, sinuses, and salivary glands. Doyle says HNCs are challenging in at least two ways. For a start, they occur close to vital organs and vessels. Secondly, patients tend to be from lower socio-economic areas. For instance, mouth cancer is quite prevalent in India and may result from chewing betel nut. Smoking and chewing tobacco and alcohol are key risk factors with mouth and voice box cancers. Oro-pharyngeal cancers are linked to the human papillomavirus. The company hopes to release top-line data later his year. Here, there and everywhere … Doyle says tigilanol tiglate is an 'interesting molecule' because it has multiple modes of action. This includes some evidence of an abscopal effect, over and above the drug's direct effect on the tumour. The abscopal effect is when localised cancer therapies lead to the shrinkage or even disappearance of tumours elsewhere in the body. Not surprisingly, the immune system is thought to transmit the tumour kill signals. In an 'off study' observation the abscopal effect was seen in a melanoma patient, in an earlier phase I 'all comers' study. (The company carried out two melanoma studies, one of them a dose-escalation effort in combo with Keytruda and the other a monotherapy). The company is carrying out exploratory work on the abscopal effect in the STS and HNC programs and hopes to present data at an upcoming congress of learned peers. In the background, the company is also undertaking a dose escalation and safety study for venous leg ulcers, which remain stubbornly hard to treat. A semi-synthetic variant, this one would be a drug rather than a device, which would be rare in wound healing. Finances and performance Qbiotics' unlisted status hasn't prevented the company from raising large wads of money: $194 million since inception, plus $60 million of tax incentives and government grants. In early 2021, the company raised a hefty $85 million, with investment firm TDM Growth Partners accounting for $50 million (existing holders took up the rest). At the end of December 2024, the company had cash of $39 million. 'We have enough money to deliver on our outlined programs, including part two of the STS trial and a venous leg ulcer study,' Doyle says. In the December half year, the company generated $1.16 million from Stelfonta sales, which 'continued to be lower than expected'. With its level of disclosure, Qbiotics' annual report looks more like the work of a listed company. With no listed mechanism – or not yet anyway – buyers and sellers can trade separately via Dr Boreham's diagnosis Doyle says Qbiotics' strategy has been to generate data in multiple tumours, including melanoma, to broaden the company's commercial appeal. 'For us it is about creating proof of concept and evidence in multiple solid tumour types, to make us attractive for partnering. 'Our sweet spot is phase II or IIb, but we need to find a big partner … with the necessary infrastructure and resources to run multiple registration studies targeting multiple solid tumour types.' He says Qbiotics is not yet at the point of having to hone its indications of interest. 'We are small nimble and get to wear multiple hats, but ultimately we are limited by resources.' In its 25th year, Qbiotics offers enough goings-on to maintain the interest of the company's circa 2,600 shareholders ahead of the listing. For the record, Grandview Research values the STS market at US$1.26 billion in 2023 and reckons the HNC sector will be worth US$5.2 billion by 2030. The vet market is estimated at US$100 million. That's decent enough, but a morsel compared to the human oncology opportunities. At a glance Qbiotics is a public unlisted company Chief executive officer: Stephen Doyle Shares on issue: 489,026,611 Financials (half year to December 31, 2024): revenue $1.16 million (up 6%), government grants $3.89 million (-4%), loss of $9.3 million (previously an $8.5 million loss), cash on hand $39.2 million (down 15%). Board: Mark Fladrich (chair), Doyle, Dr Victoria Gordon (co-founder), Dr Paul Reddell (co-founder), David Phillips, Sergio Duchini Major shareholders: TDM Growth Partners 11%, founders and staff 13%, remaining top 20 24%, remaining shareholders 52%
