How to Write a Review for Ceos Letter
Press Release
To Our shareholders:
As the yr is drawing to a close, we once again observe ourselves planning for the futurity, but also reflecting on the events of 2020. I am sure we can all agree that 2020 was filled with unforeseen challenges, and for some of united states, as well unexpected opportunities. Nonetheless, I am pleased to written report that, for Allarity, despite the challenges brought about past the global COVID pandemic, it was a yr of positive transformation. We have avant-garde our pipeline, even though somewhat less rapid than nosotros hoped for at the start of the twelvemonth, we have delivered on improving operational results, and we have taken important steps to position the company for what we wait to be an era of carefully managed clinical and financial progress.
In 2020, our fiscal situation significantly improved. Early on in the twelvemonth, we managed to retool our balance sheet and, as a result, steer the company free of the historic dependency on brusque-term loan funding. This type of historical financing had weighed on the company's outlook past creating a headwind. With the elimination of this financing, this headwind is now behind us.
Every bit the year has progressed, we take repeatedly been able to show that our new focus on merely three high priority programs, and our carefully reduction of costs, accept been paying off. As a result, our operational price has become fifty% lower than the previous year. In addition, in June, we appear that our prior stock buy in Lantern Pharma, Inc., from which we in-licensed our Irofulven program several years ago, were realized in our financials, resulting in over USD 500K to our residuum canvas. We also instituted renewed equity financial instruments to better prepare the visitor for the future and creating a financial tailwind.
Along with positive financial improvements in our balance sheet, nosotros monetized two of our non-prioritized portfolio programs, off our balance canvass, past our understanding with Smerud Medical Inquiry International to keep clinical development of both LiPlaCis® and 2X-111, together with their DRP® companion diagnostics, resulting in potential time to come royalty stream on product sales and milestones if both drugs are approved of over Usa $30M. This has transformed our Q2 financials from a celebrated cash burn down story to positively position the visitor for futurity development success. Besides utilizing our equity-financing agreements throughout the year, and monetizing our own secondary assets to the extent possible, our focus naturally also includes, on a continuing ground, to seek alternative non-dilutive sources of funds from the FDA and NIH, likewise equally other regime funding sources, when such opportunities arise.
PORTFOLIO Development
Development continued throughout the twelvemonth in spite of the COVID pandemic. Nosotros advanced the grooming of our U.Due south. NDA for first approval of dovitinib every bit a handling for renal cell carcinoma (RCC). Today, our most advanced clinical oncology asset is dovitinib, and nosotros accept made substantial progress in 2020 in moving dovitinib towards market blessing, along with its DRP® companion diagnostic. In March, we received feedback from our pre-NDA meeting with the FDA, regarding possible approval for dovitinib used to treat renal cell carcinoma (RCC), and during the year our internal planning and preparations accept been progressing fully every bit planned. It is encouraging that the FDA indicated that they would have the NDA filing when submitted. Nosotros received additional guidance including input on the "non-inferiority" margin confronting sorafenib, which had not been pre-defined in the protocol for the prior dovitinib Phase iii trial in RCC. Nosotros too received feedback that no additional pre-clinical studies were required, no safety issues were raised, no additional pharmacokinetics, pharmacology, and/or homo toxicity studies were required, and no new manufacturing (CMC) requests are necessary. Post-obit this encouraging feedback, nosotros aimed to file our dovitinib application with the FDA in late 2020. Unfortunately, the COVID pandemic impacted our tertiary-party drug manufacturer resulting in a delay to our original timeline. Developing new transformational therapies is always full of unforeseeable uncertainties, and this is a case-in-point of such a situation. Our parallel work with submitting a Pre-Market Blessing (PMA) application with the U.S. FDA to seek approval of the DRP® companion diagnostic for dovitinib is also progressing as planned.
However, nosotros are not stopping at that place. To benefit even more patients, nosotros are continuing to develop our PARP inhibitor, stenoparib, as a potential, new breakthrough medicine for COVID-19, and in 2020 we made significant progress. Post-obit a remarkably successful collaboration with the Pathogen and Microbiome Constitute at Northern Arizona University (NAU), a leading U.S. infectious illness test middle, we earlier this year announced that stenoparib had shown in vitro anti-viral activeness against Coronavirus in pre-clinical studies. We announced that we intended to piece of work with FDA and NIH, as well as other funding sources, to advance the drug into clinical trials for the handling of COVID-xix.
It would be extremely positive, in every aspect, if Allarity could play a role in alleviating the disastrous personal-health consequences the Coronavirus pandemic will undoubtedly continue to take for a lengthy period of time – despite the recent encouraging news of vaccine approvals.
Based on all of this progress, our expectation is that our loftier priority portfolio will yield our offset canonical therapeutic, dovitinib, together with its DRP® companion diagnostic, within a not as well distant future. My assessment is that our loftier priority portfolio is at present stronger than it has ever been, as it also includes two additional, promising targeted cancer agents, IXEMPRA® and stenoparib, both in Phase two clinical development, to treat cancer patients with high unmet needs.
BUSINESS Development
Our business development efforts as well began to bear fruit as we secured full buying of our stenoparib and dovitnib programs, to maximize company and shareholder value resulting from the future success of these priority assets. Only recently, we announced that we have successfully secured expanded commercial rights, from EISAI Co., Ltd., to develop stenoparib in the anti-viral space, including as a COVID-xix treatment, something I am very excited nearly.
In addition, we have resolved our historical, overly-complicated shareholder construction from past Special Purposes Vehicle Structures (SPV), which were established to permit investment into certain of our programs, by converting those investor/shareholder positions to common shares of Allarity. This ensures that we at present accept one investor base representing Allarity Therapeutics and that this shareholder base benefits from the future success of all of our clinical programs. As a consequence, we at present have a much simpler uppercase structure to concenter potential strategic partners and new investors.
Also, to unlock value for our shareholders, and to allow Allairty to sharpen its focus on our loftier priority clinical programs, we signed an out-licensing understanding with Smerud Medical Research International AS to continue the clinical evolution of our secondary LiPlaCis® and 2X-111 programs towards cardinal value inflection points. The touch on this deal had on our Q2 report numbers, mentioned earlier, are negligible compared to the full potential upside this dual deal brings. If our partner meets all the outlined milestones, Allarity expects milestone fees of near USD 30 million plus royalties on future drug sales. Smerud is a leading European-based clinical contract research organization (CRO) with expertise in the evolution of precision cancer drugs, and Smerud has previously worked with Allarity on the LiPlaCis® program too as several other pipeline programs.
At Allarity, nosotros accept dandy pride in our operational operation because we know that it underpins our strategic efforts, our ability to bear witness the market our applied science, and our ability to have a demonstrably positive impact on the patient. Our electric current company contour, with no debt and a focused pipeline, is the outcome we planned for in the stop of 2019, when we started the procedure to completely revamp the company with a renewed strategy and renewed program focus, positioning Allarity as ane of the key hereafter contributors to realizing the promise of personalized cancer care.
ORGANIZATION Construction
In 2020, we took several actions to further meliorate Allarity's ability to seize these opportunities, as we in September we appear that nosotros reorganized the visitor with a new board, and in Nov a new CFO to better capitalize on the evolving and unique dynamics of the concern and to achieve a better footprint in the U.S.
Our new CFO Jens Knudsen is a unique fit with our company at its current stage. Not only does he accept feel from several U.S. listed biotech companies, but he is also a certified Public Accountant and a member of the American Institute of Certified Public Accountants and the Pennsylvania Plant of Certified Public Accountants. Furthermore, he is born and raised in Denmark, the same country equally Allarity was founded, and Jens is now a dual citizen of both the U.South. and Kingdom of denmark. The addition of Jens to the leadership team undoubtedly strengthens the Company'due south ability to access both European and U.S. financial markets.
Just this strengthening of our system with a new CFO was non the just major role change this year. Merely one month before we welcomed two new very seasoned Board Members. One is Soren Gade, a member of the European Parliament, and former Minister of Defense in Denmark. He is also currently serving equally patron for the Danish Bowel Cancer Association. The 2nd new board member, Gail Maderis, is currently CEO of Antiva Biosciences, Inc., and former CEO of V Prime Therapeutics, Inc. Gail brings to our board strong CEO and drug development feel in oncology therapeutics. Nosotros are delighted to have the potent caliber of these individuals as a part of our new lath. Together with our new CFO, these new board members bring all-encompassing experience in and deep knowledge of oncology therapeutics development coupled with diagnostics that volition greatly do good Allarity.
While I am very pleased about these people joining us, information technology is important to stress that nosotros remain very circumspect to keeping our inhouse employee team equally lean as possible. Since I joined the company in tardily 2019, nosotros take seen an ongoing reduction of headcount, which has continued in 2020. Overall, it is a process which has impacted our financials positively in 2020, and in the long term, we expect our focus on cost efficiency will create a base for shareholder value cosmos.
PREPARING FOR SUSTAINED PROGRESS
During the prolonged flow of value refuse, due to market impact of our financing vehicles and the COVID-xix pandemic, and now followed by some stability, we have of grade begun to focus on the grooming for the launch of new products, which is the cease goal of our organization. We believe v important factors volition create meaning opportunities for Allarity to gain foothold as a more prominent biotech company, benefitting from increased awareness from both investors and potential partners in the year ahead.
- We see the potential to gain approval of, and launch, up to iii products over the side by side 5 years, made probable by a recent history of a well-executed corporate strategy.
- Nosotros wait to enjoy dramatic benefits of filing NDA applications for dovitinib and its DRP® companion diagnostic in 2021.
- Nosotros expect to gain attention from the U.S. biotech community, as we continue to pursue all options to bring stenoparib to the table as a possible COVID-xix handling.
- Nosotros anticipate a pickup in patient enrollment in our ongoing Stage 2 clinical trial of stenoparib as a treatment for ovarian cancer, beingness conducted at the Dana-Farber Cancer Institute (Boston, MA) side by side year as Covid begins to be addressed.
- Nosotros conceptualize the showtime of our Phase two clinical trial of IXEMPRA® equally treatment for metastatic breast cancer in Europe.
During 2020, we also improved our business operations, including quality, by simplifying our construction and processes, including a major endeavor to meliorate our operational effectiveness. These efforts are freeing up resource that tin exist reinvested.
Our business evolution initiatives continue to include majuscule raising efforts and exploration of multiple alternative paths, including additional equity investment, consideration of potentially moving to a U.S. listed market, strategic partnerships with Big pharma, and other opportunities to ameliorate capitalize our company in order to adequately support and accelerate our key programs.
Of course, our business isn't without its risks and challenges. Biotech development is capital intensive only with opportunities. Most meaning, we demand to ensure that our innovation, investment, and risking taking are rewarded in the marketplace, while doing all what nosotros demand to support the DRP® platform and value creation. And, we need to attain all of this while managing through the COVID-nineteen pandemic.
DRIVING ALLARITY TOWARD A Quantum….REALIZED
We firmly believe that the companies, such as Allarity, that create meaningful value for patients over the next few years are the ones that will thrive. That'south why we are putting a renewed emphasis on Allarity's purpose: "Personalized Cancer Care… Realized". Our purpose defines who nosotros are as a company and serves as a focus point of our culture, and also serves as the beacon of our business evolution. The true value of the visitor will only emerge when we fully realize making personalized cancer care a reality.
When we talk well-nigh breakthroughs inside the company, we are non talking almost just big scientific breakthroughs, but also breakthroughs in the style we work, and the style nosotros get our technology and drugs to patients. Together we believe our DRP® engineering science breakthrough will create value for patients, colleagues and shareholders. It is our hope that these things accept all been clearly axiomatic in the by year, and that they will continue into the futurity.
Finally, we once again limited our most sincere appreciation to our valued shareholders and associates; wishing you and your families a very Happy Holiday season and a bright commencement to 2021.
Thank you for your continued support of the work we practise every mean solar day.
Sincerely,
Steve Carchedi
Near Allarity Therapeutics
Allarity Therapeutics (Nasdaq Outset Due north Growth Market place Stockholm: ALLR.ST) develops drugs for personalized treatment of cancer guided by its proprietary drug response predictor engineering, the DRP® platform. The company has a mature portfolio of 6 drug candidates, including compounds in the pre-registration stage. The product portfolio includes: stenoparib (2X-121), a PARP inhibitor in Phase 2 for ovarian cancer; dovitinib, a pan-TKI in mail service-Stage 3 for renal cell carcinoma; IXEMPRA® (Ixabepilone), a microtubulin inhibitor approved in the U.S. for the treatment of breast cancer; LiPlaCis®, a liposomal formulation of cisplatin in Phase 2 trials for breast and prostate cancer; 2X-111, a liposomal formulation of doxorubicin nether manufacturing for Phase 2 in breast cancer; and Irofulven, a DNA damaging agent in Phase 2 for prostate cancer.
Most the Drug Response Predictor – DRP® Companion Diagnostic
Allarity uses its drug specific DRP® to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. By screening patients before handling, the response charge per unit tin exist significantly increased. The DRP® method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic data from cell lines combined with clinical tumor biological science and prior clinical trial outcomes. DRP® is based on messenger RNA from the patient's biopsies. DRP® has proven its power to provide a statistically significant prediction of the clinical effect from drug handling in cancer patients in nearly forty clinical studies that were examined, including an ongoing, prospective Phase 2 trial. The DRP® platform can be used in all cancer types and is patented for more than seventy anti-cancer drugs.
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Forrad-looking statements
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of Allarity's control and which could cause actual results to differ materially from the results discussed in the frontwards-looking statements. Forward-looking statements include statements concerning Allarity'southward plans, objectives, goals, future events, performance and/or other information that is non historical data. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forrard-looking statements. Allarity undertakes no obligation to publicly update or revise forrad-looking statements to reflect subsequent events or circumstances after the date made, except every bit required by law.
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Media Contacts:
Thomas Pedersen
Carrotize PR & Communications
+45 6062 9390
tsp@carrotize.com
Certified Adviser:
Svensk Kapitalmarknadsgranskning AB, Email: ca@skmg.se. Tel: +46 11 32 xxx 732
The information was submitted for publication on xviii December 2020.
- 2020 in Review - a letter from Allarity's CEO
Source: https://www.globenewswire.com/news-release/2020/12/18/2147918/0/en/2020-in-Review-A-Letter-from-Allarity-s-CEO.html
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