We have counted on the consumer for so long to prop up the Canadian economy and that has been a good thing for so many small business owners. However, the reality is hitting consumers after a forced lockdown due to the pandemic, and even as the economy begins to slowly open up, our buying habits are changing.
We have come to realize we don’t need as much stuff as we once thought we did. We don’t eat out as often. We aren’t travelling nor are we spending time in department stores or malls and if we do decide to splurge it appears to be spending on areas such as self-care. While necessities are a focal point, discretionary spending is on the backburner.
According to a new survey from Simplii Financial, when Canadians were asked what was top of mind, the result? Simplicity. An overwhelming majority of Canadians (81%) want to simplify their lives.
This shouldn’t come as any surprise as the alarm bells have been ringing for some time as the debt levels of Canadians continue to grow and have been bordering on being unsustainable for years. Discretionary spending has come to almost a standstill in many cases crushing small business owners.
Here is a classic example of how our lives are changing;
The Agri-Food Analytics Lab at Dalhousie in partnership with Caddle conducted a highly comprehensive survey with over 10,000 participants to assess how many Canadians are thinking of changing their lifestyle to spend more time working from home, even after the pandemic is over.
Approximately 23.6% intend to work from home more often a year from now and of those who plan to work from home 57% plan to spend less at restaurants. This is potentially devastating for the Canadian hospitality industry, which according to the report, stands to lose $20 billion in revenues next year, of which 30% may be due to telecommuting.
It makes sense. Prior to the pandemic 36.8% of us were going to a restaurant for a meal or break once or twice a week. Working from home in many cases outside urban centres results in that number dropping to 23.3%.
The pandemic has forced us to change and taught us to rely more on digital technology. Our behaviours of the past have changed and possibly a new norm is being instituted into our lives.
Simplii Financial also highlights a third of us want to manage our finances and expenses better. And more specifically spending in areas such as food takeout/delivery (44%), household technology (34%) and entertainment (29%) expenses.
Many organizations are not in a hurry to have employees return to the workplace and the result is while Canadians are starting to spend, the focus has for many shifted to what they need versus what they want.
This change in consumer behaviour may be good for the household budget but for business owners who have relied on the consumer, the landscape appears to be shifting and the verdict is still out on whether the consumer will continue to drive the Canadian economy forward.
RBI Has More Room for Bond Buys as India’s Banks Return Cash
(Bloomberg) — Indian banks are returning money they borrowed from the central bank earlier this year, boosting the monetary authority’s capacity to make more direct purchases of government bonds.The Reserve Bank of India on Thursday said it would buy 100 billion rupees ($1.4 billion) of bonds from the secondary market on Sept. 24 in the first such direct purchase in six months. This marks a departure from its preference so far this year for Federal Reserve-like Operation Twists.
While direct open market operations end up adding cash to the banking system, twist operations are typically liquidity neutral as they involve simultaneous buying and selling.
Sovereign bonds gained on Friday, with the 10-year yield down 2 basis points to 6.01%.Traders said there is more scope for direct OMOs now because banks are taking the option to return about 1.25 trillion rupees they borrowed from the RBI in February and March.
These funds were borrowed when the repurchase rate was at 5.15%, making it more attractive for banks to return it now and look to borrow again at a lower rate. So far, about 989 billion rupees has been repaid in four tranches and the remaining money is expected to be repaid Friday.
This creates more space for OMOs at the same time as a run down in the RBI’s stock of Treasury bills acts as a constraint on twist operations, said Shailendra Jhingan, chief executive officer at ICICI Securities Primary Dealership Ltd. In Mumbai.
The RBI has to keep an eye on how much surplus banking liquidity it wants amid rising inflation. Consumer prices rose 6.7% in August, exceeding RBI’s upper limit of 6% for a fifth month.
The central bank has been largely trying to keep yields anchored around 6% via its Operation Twists, discreet purchases and auction signaling, traders say.“The RBI has kept banking liquidity in a surplus of 6-7 trillion rupees in the past three-four months,” said Pankaj Pathak, a fixed income fund manager at Quantum Asset Management Ltd. in Mumbai. “If it wants to maintain similar levels of liquidity, it will open up space for 1-1.5 trillion rupees of OMO.”
(Adds Friday’s bond prices, updates money banks returned to RBI)
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Futures flat after tech rout drags down Wall Street
Reflecting the ultimate risk and reward, healthcare stocks are capable of delivering big returns at what feels like the drop of a hat, but investors need to be prepared for big risk, too.Unlike companies in other sectors, the survival of many healthcare players, especially when they are in the early stages, hinges on only clinical trials of their therapies or products in development and regulatory rulings, with updates on either front acting as catalysts that can send shares in either direction.So, any piece of good news can propel shares to sky-high levels. Disappointing outcomes, however, can send investors running for the hills.Given the inherently volatile nature of the space, due diligence is necessary before making investment decisions. That’s where the Wall Street pros can lend a hand, as they know the ins and outs of the industry.Bearing this in mind, we used TipRanks’ database to pinpoint healthcare stocks that have received overwhelmingly bullish support from the Street ahead of potential catalysts. Locking in on three in particular, each ticker boasts a “Strong Buy” consensus rating from the analyst community.Aquestive Therapeutics (AQST)Using its patented PharmFilm technology, Aquestive Therapeutics works to improve the delivery of approved drug active ingredients. Ahead of the fast-approaching PDUFA date for one of its products, some members of the Street think that now is the time to get in on the action.Back in February, AQST announced that the FDA had accepted the NDA for Libervant, its diazepam buccal film designed to manage refractory and repetitive seizures (ARRS; seizure clusters), and the PDUFA date had been set for September 27. The NDA was based on results from a single-dose crossover study, which demonstrated comparable systemic diazepam exposures to Diastat (a diazepam rectal gel that was used as a reference) with significantly less variability.Writing for Wedbush, 5-star analyst Liana Moussatos points out that VALTOCO, a nasal spray product developed for use in cluster seizures, got the FDA’s stamp of approval in January, with seven-year orphan drug U.S. marketing exclusivity also granted. “Of note, VALTOCO orphan drug exclusivity approval may prevent a subsequent product approval (same active moiety as well as an indication) during the exclusivity period unless the new product can demonstrate ‘clinical superiority’ to the approved products,” she explained.To this end, Moussatos remains optimistic and sees Libervant’s approval as a major potential catalyst. “Aquestive is confident that Libervant (oral) is clinically superior to the two currently approved device-driven products (rectal gel and nasal spray) and that it meets one or more attributes required by the FDA to be considered a major contribution to patient care. In our view, Libervant may expand patient choice as the first orally delivered diazepam product available to ARRS patient,” she stated.While the COVID-19 pandemic has led to many delays throughout the industry, management doesn’t expect any delays for the review of Libervant. Additionally, if approved, the company has said it’s ready for a launch, with it estimating U.S. net revenues of about $300 million at its peak.Based on the above, Moussatos keeps an Outperform (i.e. Buy) rating and $33 price target on the stock. Should her thesis play out, a potential twelve-month gain of 326% could be in the cards. (To watch Moussatos’ track record, click here)All in all, other analysts echo Moussatos’ sentiment. 3 Buys and no Holds or Sells add up to a Strong Buy consensus rating. With an average price target of $18.67, the upside potential comes in at 136%. (See AQST stock analysis on TipRanks)Eton Pharmaceuticals (ETON)Primarily focused on developing, acquiring and commercializing hospital injectable and pediatric rare disease products, Eton Pharmaceuticals wants to improve the lives of patients from all over the world. With several product candidates currently under review at the FDA, it’s no wonder Wall Street focus has zeroed in on this name.On September 16, ETON announced that its partner hadn’t received any update from the FDA regarding its decision on the review of EM-100, its eye drop product for allergic conjunctivitis. Although the candidate’s Generic Drug User Fee Act (GDUFA) target action date was September 15, H.C. Wainwright’s Raghuram Selvaraju believes approval is imminent. Should approval ultimately be granted, the 5-star analyst thinks it could drive serious upside.On top of this, Eton is awaiting a decision from the FDA for its taste-neutral sprinkle (granule) formulation of hydrocortisone (Alkindi Sprinkle), as a replacement therapy for pediatric adrenal insufficiency (AI). A PDUFA date is set for September 29, 2020.”We assign a 90% probability of regulatory approval to EM-100 and Alkindi Sprinkle […] Currently, we project total revenue of $9M for 2020—essentially unchanged vs. the previous $9.4M—and $43.9M in revenue for 2021, down somewhat from the previous $50.7M. We have accordingly revised our loss per share estimates for 2020 to $1.04 per share vs. the prior net loss of $1.28 per share, while maintaining our net loss per share projection for 2021 of $0.20. We continue to expect Eton to potentially achieve cash flow breakeven during 2H21. […] Our assumptions yield a roughly $420M firm value,” Selvaraju noted.To this end, Selvaraju maintains a Buy rating on ETON shares, along with an $18 price target. This figure suggests 141% upside potential from current levels. (To watch Selvaraju’s track record, click here)Are other analysts in agreement? They are. Only Buy ratings have been issued in the last three months, 3 to be exact. Therefore, the message is clear: ETON is a Strong Buy. Given the $15 average price target, shares could double in the next year. (See Eton stock analysis on TipRanks)Mesoblast (MESO)Last but not least we have Mesoblast, which develops therapeutics and medical devices based on its mesenchymal precursor stem cell platform. After an Oncologic Drugs Advisory Committee (ODAC) voted in favor of its therapy, several of the Street’s pros have high hopes for this healthcare company ahead of the September 30 PDUFA date.On August 13, the FDA held an AdCom meeting to discuss MESO’s biologics license application (BLA) filing for Ryoncil (remestemcel-L), which was designed as a treatment for children with steroid-refractory acute graft versus host disease (SR-aGVHD). Acute GVHD occurs in roughly half of the 30,000 patients who undergo allogeneic bone marrow transplant (BMT).At the meeting, the committee members voted 9-to-1 in support of the drug’s efficacy in a difficult indication. 5-star analyst Jason McCarthy, of Maxim Group, told clients, “This was in contrast to the briefing documents ahead of the Adcom on August 11, which stated concerns related to efficacy that resulted in MESO shares plummeting 35% at that time. Our view is that it was a premature ‘knee-jerk’ reaction to an Adcom that didn’t even happen yet. As such, Ryoncil is very much still on track and the PDUFA is next.”Looking more closely at the data, two randomized Phase 3 trials in GvHD, study 265 and study 280, were conducted by Osiris Therapeutics, which previously owned the candidate. Both studies missed their primary endpoints compared to the placebo, but study 265 “was conducted in newly-treated GvHD patients (not steroid refractory), and therefore is not entirely relevant to Ryoncil’s BLA,” according to McCarthy. As for study 280, it missed its durable complete response endpoint in the target population, but overall response at day 28 was 64% for Ryoncil and 36% for placebo.“Ultimately, these studies were not in the target population for the current BLA, and in patients that fit the criteria, a positive effect was observed,” McCarthy commented. Additionally, he points out that an aggregated dataset demonstrated a consistent response across three separate trials including study 280.Speaking to the unmet needs in this indication, in patients with severe disease, there is currently a 90% mortality rate and there are no approved therapies for pediatric steroid-refractory patients. Jakafi has been approved for patients aged 12 and older, but McCarthy believes Ryoncil compares favorably. He said, “Considering the positive safety profile of Ryoncil compared to other therapies and the unmet need in the indication, we continue to see a high likelihood of approval.”In line with his optimistic approach, McCarthy reiterated a Buy rating and $22 price target. This target conveys his confidence in MESO’s ability to climb 22% higher in the next year. (To watch McCarthy’s track record, click here)Other analysts don’t beg to differ. 5 Buys and no Holds or Sells add up to a Strong Buy consensus rating. At $21.60, the average price target implies 22% upside potential. (See Mesoblast stock analysis on TipRanks)To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.
Onxeo Reports its Financial Results for the First Half of 2020 and Provides an Update on its Activities | 2020-09-17 | Press Releases
- The cash position of €19.6 million, which was strengthened in the first half of the year by two strategic transactions, provides financial visibility into Q1 2022
- Patient inclusion process has started in the Phase 1b/2 REVOCAN study evaluating the effect of AsiDNA™ on resistance to niraparib and preliminary results are expected in early 2021
- Topline results of the AsiDNA™ DRIIV-1b study in combination with chemotherapy are expected in late 2020/early 2021
- Invus, new reference shareholder, has been coopted as a director of the Company
PARIS, Sept. 17, 2020 (GLOBE NEWSWIRE) — Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), (“Onxeo” or “the Company”), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage response (DDR), in particular against rare or resistant cancers, today reported its consolidated financial results for the six months ended June 30, 2020, and provided an update on its activities.
Judith Greciet, CEO of Onxeo, said: “The first half of 2020 has truly been extraordinary, with a pandemic that has directly or indirectly impacted the lives of every one of us. I would like to take this opportunity to thank all of our employees who have been able to adapt to this unprecedented context and whose mobilization and team spirit have made it possible to achieve an exceptional first half of the year in terms of preclinical and clinical development as well as financial performance. We are delighted that AsiDNA™’s development is gaining momentum and that we are progressively moving closer to our strategic objectives: to finalize the DRIIV-1b study to confirm AsiDNA™’s interest in combination with DNA breakers and to demonstrate AsiDNA™’s ability to abrogate the acquired resistance of tumors to certain targeted therapies. Indeed, while the efficacy of cancer treatments is increasingly improving, resistance is a real problem in the short and medium term and delaying or even preventing its emergence represents one of the major challenges in oncology today. This is the objective of REVOCAN, a phase 1b/2 study set up with Gustave Roussy, in which AsiDNA™ is being tested in patients with relapsed ovarian cancer showing signs of acquired resistance to niraparib treatment. The patient inclusion process in this study has started and, in accordance with our road map, we expect preliminary results as early as the first quarter of 2021.
“It is also important to note that, despite the highly uncertain environment in the financial markets, we have considerably strengthened Onxeo’s financial position with two major strategic transactions. In April, we received €6 million from our US partner Acrotech in consideration for the grant of additional exclusive rights to belinostat, and in early June, we completed a €7.3 million private placement with Financière de la Montagne, our historical shareholder, and Invus, a strategic international investor. In addition to reinforcing the financial visibility until the first quarter of 2022, well beyond the expected key clinical results, this operation has brought into the capital, with a seat on the Board of Directors, a second reference investor who is able to support the company’s growth strategy over the long term.
“Thus, the impact of Covid-19 on our activities remains limited to date and we remain fully mobilized to deliver tangible results and confirm the value of our assets”.
FINANCIAL RESULTS1 OF THE 1st HALF-YEAR 2020
Revenues for the first half of 2020 amounted to 1.1 million euros and consisted mainly of direct sales of Beleodaq® under the European Controlled Access Program (NPP), transferred to the partner Acrotech Biopharma as part of the agreement signed in early April, and to royalties on sales of Beleodaq® in the United States by Acrotech, used in full to repay the bond loan from SWK Holdings. These revenues have been recognized up to the date of the agreement signed with Acrotech, which explains the decrease compared to the recurring revenues of EUR 1.4 million recorded in H1 2019.
Operating expenses amounted to EUR 5.5 million in H1 2020, a significant decrease compared to the expenses recognized in H1 2019. This change is mainly due to completion in 2019 of industrial activities for clinical trial purposes relating to AsiDNA™.
The agreement concluded with Acrotech Biopharma on April 6, 2020 was analyzed under IFRS as a disposal of belinostat-related assets. This led to the recognition of the following items in other operating income and expenses (non-current):
- A net income of 5,686 thousand euros corresponding to the transaction price of 6,116 thousand euro less the amount of future belinostat development costs to be borne by Onxeo estimated at 430 thousand euros.
- An expense of 2,769 thousand euros corresponding to the net carrying amount of Beleodaq®/belinostat-related R&D assets.
- In the context of the bond loan from SWK, an income of 7,171 thousand euros corresponding to the estimated royalties still to be received from the initial license2 as of the date of signature of the new agreement with Acrotech. These royalties will be entirely allocated to the repayment of the balance of the bond loan. Although this future income is booked upfront in accordance with IFRS, the interest expense relating to the bond loan from SWK will continue to be booked on an annual basis.
After taking into account the financial result and a tax related to the transaction with Acrotech, Onxeo reported a net profit of €5 million for the first half of 2020, compared to a loss of €8.5 million in 2019.
1Limited review procedures have been performed on the interim financial statements. The review report was issued after the completion of the procedures required for the publication of the interim financial report.
2In March 2019, Acrotech acquired from Spectrum Pharmaceuticals (SPPI) the license to belinostat for certain territories, including the United States, Canada, Mexico, and India. The new agreement grants Acrotech a royalty-free license to belinostat in all other territories.
|Consolidated income statement (IFRS)
In thousands of euros
|Other current operating income||34||–|
|Current operating income||(3,951)||(6,934)|
|Other non-current operating income and expenses||10,040||–|
|Share of profit (loss) of companies accounted for by the equity method||–||(28)|
|Operating profit after equity method income (loss)||6,089||(6,962)|
CASH AND CASH EQUIVALENTS AS OF JUNE 30, 2020
At June 30, 2020, the Company had consolidated cash and cash equivalents of 19.6 million euros, compared to 5.7 million euros at December 31, 2019.
This strong increase is mainly due to the financing implemented during the six-month period through private placement and equity line, which provided Onxeo with net proceeds of EUR 10.5 million, as well as the agreement with Acrotech Biopharma for a net amount of EUR 5.1 million after payment of the share to SpePharm. These cash inflows added to the receipt of the 2019 research tax credit for an amount of 1.4 million euros and to license revenues and direct sales under the NPP program for 3 million euros have allowed the absorption of operating expenses.
On the basis of its development plan, Onxeo has sufficient financial visibility to carry out its projects beyond the next key milestones until the first quarter of 2022.
HIGHLIGHTS OF THE 1st HALF-YEAR 2020, RECENT DEVELOPMENTS AND OUTLOOK
- In January 2020, Onxeo entered into a clinical research agreement with Gustave Roussy to conduct REVOCAN, a Phase 1b/2 clinical trial of AsiDNA™ in the treatment of relapsing ovarian cancer. This study, which is sponsored by Gustave Roussy, is designed to evaluate the effect of AsiDNA™ on acquired resistance to the PARP inhibitor niraparib (PARPi) in the maintenance treatment of relapsing second-line ovarian cancer.
- In May 2020, the REVOCAN Phase 1b/2 study evaluating the effect of AsiDNA™ on resistance to niraparib, a PARP inhibitor, in relapsed ovarian cancer received approval from the French National Agency for the Safety of Medicines and Health Products (ANSM) and the Committee for the Protection of Persons (CPP).
- At the AACR (American Association for Cancer Research) Annual Meeting held virtually from June 22-24, 2020, Onxeo presented the results of preclinical studies supporting the ability of AsiDNA™ to reverse PARPi resistance by preventing the regrowth of persistent cells. These results are extremely encouraging for the progress of the REVOCAN study and clearly reinforce AsiDNA™’s interest in the fight against resistance.
- On August 25, 2020, the final results of DRIIV, dose-escalation study of AsiDNA™ via intravenous (IV) route, were published in the British Journal of Cancer. This study demonstrated the activity and optimal dose for AsiDNA™ IV in combination. Enrollment of the last two patients in the DRIIV-1b extension study, which is analyzing the combination of AsiDNA™ with chemotherapy in patients with advanced solid tumors, is ongoing and topline results are expected in late 2020/early 2021.
- On September 3, 2020, Onxeo received a Notice of Intent from the U.S. Patent and Trademark Office for a new patent strengthening the protection of AsiDNA™ and its related compounds by systemic administration in the treatment of triple negative breast cancer and chemo-resistant lung cancer, alone or in combination with chemotherapy, radiotherapy or other agents that damage tumor DNA. It will be valid in the United States until 2037.
- In late January 2020, Onxeo presented to the scientific community OX401, a next-generation PARP agonist sourced from its proprietary decoy agonist platform, platON™, at the PARP & DDR Inhibitors Summit 2020 in Boston, USA.
- In February 2020, Onxeo announced the acceptance of a poster presentation of OX401 at the ESMO-TAT 2020 congress, which is dedicated to research on targeted cancer therapies.
- In June 2020, Onxeo preclinically confirmed the profile of OX401. Through its action on PARP and the activation of an anti-tumor immune response via the cGAS-STING pathway, OX401 demonstrated in vivo a higher potency of activity than current PARP inhibitors, as evidenced by complete control of tumor growth.
- The next key preclinical milestone will be the study combining OX401 with immune checkpoint inhibitors. For this phase, Onxeo benefits from the expertise accumulated during the development of AsiDNA™ and has thus obtained in a few months an optimized compound, which is ready to enter the final stages of preclinical validation. These translational studies will allow Onxeo to best prepare the compound for entry into the clinic, which could take place within 18 to 24 months.
FINANCING & CORPORATE
- In February 2020, Onxeo announced that it had reached an out-of-court settlement agreement with SpePharm and SpeBio. As part of this agreement, Onxeo sold its shares in SpeBio to SpePharm at their nominal value, thereby transferring its share of the joint venture’s cash to SpePharm for an amount of approximately 3.5 million euros. In addition, Onxeo is required to pay 15 to 20% of the net amounts to be received under future commercial agreements relating to Onxeo’s R&D assets, for a total cumulative amount of 6 million euros within 4 years.
- On April 6, 2020, Onxeo entered into exclusive agreements with Acrotech Biopharma LLC to extend Acrotech’s rights to belinostat to all countries not covered by the previous agreement between Onxeo and Acrotech. In consideration, Onxeo received a payment of $6.6 million (6 million euros) from Acrotech, of which $0.9 million is allocated to the aforementioned settlement agreement. Onxeo will continue to receive from Acrotech the royalties and milestone payments relating to belinostat in the United States for an amount equivalent to the outstanding loan and interest due to SWK Holding. Beyond that, belinostat will no longer generate additional revenues and is therefore no longer considered a strategic product for the Company.
- On May 27, 2020, the investment bank Bryan Garnier & Co initiated Onxeo’s coverage with a “buy” recommendation.
- On June 9, 2020, Onxeo completed a private placement for a total amount of approximately €7.3 million with a new investor, Invus Public Equities LP, and its historical shareholder, Financière de la Montagne.
- On July 29, 2020, the Company announced the transfer of the listing of Onxeo shares from the regulated market Euronext Paris (compartment C) to the multilateral trading facility Euronext Growth Paris. This transfer is intended to enable Onxeo to be listed on a market which is more appropriate to the Company’s size and its market capitalization and will be effective at the earliest on October 31, 2020 .
- At its meeting on September 17, 2020, the Board of Directors of Onxeo co-opted Mr. Julien Miara, representing Invus Public Equities LP, as a director of the Company, to replace Mr. Jean-Pierre Kinet who resigned. The Board warmly thanks Mr. Kinet for his significant contribution to its work since 2016.
This cooptation of Mr. Miara follows his appointment as observer to the Board of Directors on June 2, 2020 and will be submitted to the shareholders for approval at the Company’s next ordinary general meeting. The Board of Directors is currently composed of 7 members, 4 men and 3 women, including 4 independent members.
COVID-19 PANDEMIC CONTEXT
- As of March 12, 2020, the Company has implemented appropriate measures to ensure the safety of its employees and the continuity of its operations within the framework of the rules imposed by French health and government authorities. At the date of publication of this press release, the impact of the pandemic is limited on the Company’s planned or ongoing activities. The situation is being closely monitored by Onxeo’s management and will be reassessed and adjusted as the health situation evolves.
The 2020 half-yearly financial report will be available to the public on the Company’s website.
Onxeo (Euronext Paris, NASDAQ Copenhagen: ONXEO) is a clinical-stage biotechnology company developing innovative oncology drugs targeting tumor DNA-binding functions through unique mechanisms of action in the sought-after field of DNA Damage Response (DDR). The Company is focused on bringing early-stage first-in-class or disruptive compounds from translational research to clinical proof-of-concept, a value-creating inflection point appealing to potential partners.
platON™ is Onxeo’s proprietary chemistry platform of oligonucleotides acting as decoy agonists, which generates new innovative compounds and broaden the Company’s product pipeline.
AsiDNA™, the first compound from platON™, is a first-in-class, highly differentiated DNA Damage Response (DDR) inhibitor based on a decoy and agonist mechanism acting upstream of multiple DDR pathways. Translational research has highlighted the distinctive properties of AsiDNA™, notably its ability to abrogate tumor resistance to PARP inhibitors regardless of the genetic mutation status. AsiDNA™ has also shown a strong synergy with other tumor DNA-damaging agents such as chemotherapy and PARP inhibitors. The DRIIV-1 (DNA Repair Inhibitor-administered IntraVenously) phase I study has evaluated AsiDNA™ by systemic administration (IV) in advanced solid tumors and confirmed the active doses as well as a favorable human safety profile. The ongoing DRIIV-1b extension study is assessing the safety and efficacy of a 600 mg dose of AsiDNA™ in combination with carboplatin and then with carboplatin and paclitaxel, in patients with solid tumors who are eligible for such treatments. Preliminary results from the first cohort with carboplatin alone showed good tolerability, stabilization of the disease and an increase in the duration of treatment compared to previous treatments.
OX401 is a new drug candidate from platON™, optimized to be a next-generation PARP inhibitor acting on both the DNA Damage Response and the activation of immune response, without inducing resistance. OX401 is undergoing preclinical proof-of-concept studies, alone and in combination with immunotherapies.
For further information, please visitwww.onxeo.com.
Forward looking statements
This communication expressly or implicitly contains certain forward-looking statements concerning Onxeo and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Onxeo to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Onxeo is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of Onxeo to differ from those contained in the forward-looking statements, please refer to chapter 3 “Risk Factors” (“Facteurs de Risque“) of the Company’s universal registration document filed with the Autorité des marchés financiers on April 27, 2020 under number D.20-0362, which is available on the websites of the Autorité des marchés financiers (www.amf-france.org) and the Company (www.onxeo.com).
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