Į ateitį žvelgiantys pareiškimai
This Quarterly Report contains forward-looking statements about our business, financial condition and prospects that reflect management's assumptions and beliefs based on information currently available. The expectations indicated by such forward-looking statements might not be realized. If any of our management's assumptions should prove incorrect, or if any of the risks and uncertainties underlying such expectations should materialize, our actual results may differ materially from those indicated by the forward-looking statements.
Pagrindiniai veiksniai, kurių mes nekontroliuojame ir kurie gali turėti tiesioginės įtakos veiklos rezultatams, yra, bet tuo neapsiribojant, mūsų paslaugų priėmimas, mūsų gebėjimas kurti ir plėsti savo klientų bazę, vadovų gebėjimas pritraukti kapitalą ateitis, pagrindinių darbuotojų išlaikymas ir mūsų pramonės reguliavimo pokyčiai.
Gali būti kitų pavojų ir aplinkybių, kurių vadovybė gali nesugebėti numatyti. Šioje ketvirčio ataskaitoje vartojami tokie žodžiai kaip „tiki“, „tiki“, „ketina“, „planuoja“, „numato“, „skaičiuoja“ ir panašios išraiškos yra skirtos ateities teiginiams identifikuoti, nors gali būti kai kurie į ateitį nukreipti teiginiai, kurių tokie posakiai nėra lydimi.
Q BioMed Inc.(or "the Company") was incorporated in the State of Nevadaon November 22, 2013and is a commercial stage biomedical acceleration and development company focused on licensing, acquiring and providing strategic resources to life sciences and healthcare companies. We intend to mitigate risk by acquiring multiple assets over time and across a broad spectrum of healthcare related products, companies and sectors. We intend to develop these assets to provide returns via organic growth, revenue production, out-licensing, sale or spin out.Our mission is to solve problems by accelerating the development of important therapies and availability of those therapies to patients. The focus for 2022 is to monetize the current pipeline and build a platform for future growth. There are 4 areas of focus: commercial product revenue growth, partnerships, joint venture equity value and future development platform.
We believe that Strontium89 has great potential in the cancer palliation space. As a result of a world in which opioids were a treatment of choice for those patients unlucky enough to be diagnosed with painful metastatic cancers in the bone, we felt that Strontium89 had become a neglected and forgotten drug. We have stayed committed to our belief that Strontium89 was a valuable treatment and have focused on advancing that asset from concept, a neglected drug, to a fully approved, reimbursed commercial product. Since we acquired Strontium89, we have built an infrastructure to commercialize the product, including manufacturing, branding, pharmacovigilance, reporting, federal supply contract, and entering into distribution agreements in
the United Statesand several other countries. We believe that our last remaining investment is now focused on a sales team to promote the drug both in federal and non-government institutions and clinics. Revenue has started to grow even without a sales force fully deployed. Our recent partnership with a sales organization is in place, and once funded we plan to capitalize on the groundwork in place. We expect revenues to grow steadily and over the next 12-18 months.
Taip pat vertiname papildomus branduolinės medicinos produktus, kurie galėtų papildyti mūsų infrastruktūrą ir suteikti papildomų pajamų galimybių.
UTTROSIDE B – chemoterapinis vaistas nuo kepenų vėžio
Along with our developmental partners, we are advancing an innovative treatment for liver cancer, a disease indication that currently has a high unmet need. This molecule was identified in
India, traditionally used to treat liver ailments. Subsequent research on that isolated molecule showed promising data, indicating that the molecule was more cytotoxic, killing cancer cells more effectively, in liver cancer cells lines than the current first line liver cancer chemotherapeutic. We have advanced this from a naturally occurring 15
unsustainable plant product to a commercially viable and scalable synthetic drug candidate. This provides an opportunity to partner this asset with a larger oncology focused institution. Currently, there are only two approved first-line liver cancer therapies. We have received Orphan Drug Designation, and we are now preparing to advance this toward clinical partnership.
Vystymosi platforma – dėmesys retoms ligoms
During 2022 we will focus our future development platform on the Rare Disease Space. This focusses our resources on an area in which we already have a presence. Our liver cancer drug candidate, Uttroside B, has already received Orphan Drug Designation. We expect to partner this asset in mid-2022 and will grow our development platform through in-licensing or acquisition. This rare disease platform will also complement our early-stage treatment for young minimally verbal children on the Autism Spectrum. While our immediate focus is on the above-mentioned assets, we are also developing a new drug candidate to treat young children with pediatric minimally verbal autism. The advancement of this program will depend on the availability of funds and resources as we prioritize our clinical development milestones. There is no effective treatment available to help an estimated 250,000 children born with the condition worldwide each year, 20,000 of them in
the United States. We are working on a discovery and development program to address this highly unmet need.
Įmonės strateginiai tikslai
Our mission is to solve problems by accelerating the development of important therapies and the availability of those therapies to patients. We have been busy building a portfolio that we believe has significant value ranging from blockbuster potential drugs to revenue-producing opportunities.
Deeper Pipeline apžvalga
Stroncis-89 – išleistas FDA patvirtintas vaistas
January 2021, we announced that treatment with Strontium-89 in the hospital out-patient setting is fully reimbursed by Medicare. In March 2021, we were approved as a federal supplier which allows us to sell into federal hospital systems, notably the U.S. Department of Veteran Affairsand the U.S. Department of Defense. We have deployed a VAsales force, and we are preparing to launch an institutional contract sales force to increase our presence and uptake in non-government hospitals Revenue for our fiscal 2021, while still fairly low, is up by over 600% over our fiscal 2020. In January 2021, we received full reimbursement from Medicare and Medicaid, were approved as a federal supplier in March 2021, and engaged a federal sales team working mostly with the U.SDepartments of Veterans' Affairs, the Department of Defenseand Indian Health Services. We have recently retained Eversana to partner on the institutional sales efforts and expect to deploy in field sales reps in 2022. In mid-2020, we began the regulatory registration process for full commercial access in the European Union. These efforts have seen some delay due to Brexit related regulatory requirements. In parallel, we are midway through the registration process in many other countries. Due to some legacy data from previous owners not being available in current reporting standards to complete the filings, we have begun the process of creating our own source documents to complete the filings in non-US jurisdictions. We expect this to be complete in the first half of our fiscal 2022. We have already identified and contracted with a few international distribution partners in anticipation of approval in those countries. Our sales for March, the start of our Q2, have already exceeded those of our Q2 revenue number and we recently received a $500,000order from our distribution partner to supply the Chinese market, which we will begin fulfilling once all the required licenses and logistics are in place. We are encouraged by this growth in the absence of a field sales force, which we expect to deploy post funding.
Mes vertiname kelias galimas klinikinių tyrimų programas, kurios gali išplėsti indikaciją ne tik palengvinti, bet ir terapiniu naudojimu, kuris gali padidinti panaudojimą ateinančiais metais.
Manin Platform vaistai nuo ARDS, glaukomos, inkstų ligų ir kt
March 2021, our technology partner Mannin Research Inc.(Mannin) was granted an additional CAD$1.7 millionfrom the Canadian governments COVID response budget, adding to the approximate $7.7 milliongranted in Europe, which together will fund 65-75 percent 16 Table of Contents
kiekvieno dolerio, patirto siekiant patobulinti COVID pacientų ūminio kvėpavimo distreso sindromo gydymą, taip pat šiuo metu Manin kuriamų kraujagyslių ligų gydymo priemonių portfelį, įskaitant: glaukomą, širdies ir kraujagyslių ligas, ūmią inkstų ligą ir kitas infekcines ligas.
With the uptake of vaccines for COVID-19 growing, the infection numbers are still soaring around the world due to new variants and communities growing apathy and resistance to mandates and social restrictions. Together with
Mannin Research Inc., our technology partner, we are pursuing a treatment for Acute Respiratory Distress Syndrome, the condition that causes the most severe symptoms in COVID patients usually resulting in hospitalization and death. The treatment is not dependent on targeting any specific viral variant but rather is virus agnostic, which we believe makes it an invaluable treatment for Corona viruses and other viral diseases like influenza, pneumonia and any future viral pandemic outbreaks. The MAN-19 therapeutic is a recombinant fusion protein that treats the patient, instead of targeting the virus. It is not a cure for COVID-19, but it strengthens a patient's blood vessels and protects them against ARDS, breathing problems, sepsis and other infections that may cause the body's organs to begin shutting down. It is designed to keep COVID-19 or other ARDS patients out of the ICU and off a ventilator. Pending upcoming toxicology testing, we believe that clinical trials for the drug will start in 2022. If the drug proves both safe and effective, our goal is to have it available for use by patients by early 2023. The market for this kind of treatment in the current pandemic climate is substantial and global. COVID-19 is not going away any time soon. As a result, there is a need to develop more effective treatments. We believe that this technology will play a role in the broader treatment landscape and not only for COVID-19, but also for other infectious diseases that cause ARDS.
GDF 15 glaukomos diagnostika – klinikinių tyrimų ir produktų kūrimo metu ir FDA patvirtinimas numatomas 2022 m. pradžioje
In early 2019, we licensed a diagnostic biomarker known as GDF-15 for determining the severity of glaucoma from
Washington University in St. Louis. . GDF15 is an attractive biomarker for glaucoma, with distinct advantages over conventional clinical tests and the potential to be a first-in-class diagnostic test. In collaboration with our development partners, we are developing a prototype for point of care In Vitro Diagnostic (IVD) device to detect GDF15 in clinical samples of aqueous humor. Our teams are generating, assessing, and applying DNA aptamers and DNAzymes to detect GDF15 in aqueous humor, to develop a prototype assay and diagnostic test strip for detection of GDF15 in clinical samples. This integrated and printable diagnostic will allow ophthalmologists to detect and monitor glaucoma progression in patients at their office without need for additional external or expensive equipment. In partnership with Mannin Research Inc.and McMaster University, we are nearing the completion of development of an IVD with both point-of-care (detection in a doctor's office) as well as an external laboratory-based detection (i.e. for use in existing CLIA laboratories using existing diagnostic equipment). With appropriate funding, we anticipate completion of the IVD device and submission to the FDA (510K) for in vitro diagnostic approval in 2022.
UTTROSIDE B – chemoterapinis vaistas nuo kepenų vėžio
Along with our developmental partners, we are advancing an innovative treatment for liver cancer, a disease indication that currently has a high unmet need. Currently, there are only two approved first-line therapies. Uttroside-B was discovered in the leaf of the Black Nightshade plant in
India. As it is not feasible to use the plant as the source for a drug, we successfully synthesized the molecule thereby creating an exact replica of the naturally occurring chemical compound. We have received Orphan Drug Designation and we are now preparing to advance this toward IND application with the FDA.
QBM-001 – ankstyvos stadijos gydymas mažiems, minimaliai verbaliems vaikams, turintiems autizmo spektrą
While our immediate focus is on the above-mentioned assets, we are also developing a new drug candidate to treat young children with pediatric minimally verbal autism. The advancement of this program will depend on the availability of funds and resources as we prioritize our clinical development milestones. There is no effective treatment available to help an estimated 250,000 children born with the condition worldwide each year, 20,000 of them in
the United States. We are working on a discovery and development program to address this highly unmet need. 17 Table of Contents Financial Overview
Svarbi apskaitos politika ir įverčiai
Our management's discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in
the United States of America(" U.S.GAAP"). The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities at the date of our condensed consolidated financial statements, as well as the reported revenue generated and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions and any such differences may be material. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management's judgments and estimates. Other than as set out in Note 3 to our accompanying unaudited condensed consolidated financial statements, if anything, we believe there have been no significant changes in our critical accounting policies as described in the Form 10-K. Unaudited Results of Operations for the three months ended February 28, 2022and 2021: For the three months ended February 28, 2022 February 28, 2021 Change Net Sales $ 75,059 $ - $ 75,059Cost of sales 73,945 40,593 33,352 Gross income (loss) 1,114 (40,593) 41,707 Operating expenses:
General and administrative expenses 1,096,300 2,137,332 (1,041,032) Research and development expenses 69,268 173,430 (104,162) Total operating expenses 1,165,568 2,310,762 (1,145,194) Loss from operations (1,164,454) (2,351,355) 1,186,901 Other (income) expenses: Interest expense 414,377 50,125 364,252 Change in fair value of embedded derivatives 235,817 17,401 218,416 Loss on debt extinguishment 232,100 56,122 175,978 Settlement of registration liability 241,875
- 241,875 Total other expenses 1,124,169 123,648 1,000,521 Net loss
$ (2,288,623) $ (2,475,003) $ 186,380Net Sales During the three months ended February 28, 2022, we recognized approximately $75,000of revenue from sales of Strontium89. We didn't have any sales for the same period in the prior year.
During the three months ended
February 28, 2022and 2021, we recognized approximately $74,000and $41,000, respectively, in cost of sales. These costs were related to raw materials cost, manufacturing cost, distribution cost and write-offs of expired inventory. The increase in cost of sales was due to more production and sales during the three months ended February 28, 2022compared to the same period in the prior year. Operating expenses We incur various costs and expenses in the execution of our business. The decrease in operating expenses was mainly due to significantly less stock-based compensation recognized in the three months ended February 28, 2022compared to the same period in 18 Table of Contents the prior year. We recognized approximately $0.2 millionand $1.4 millionof stock-based compensation in general and administrative expense during the three months ended February 28, 2022and 2021, respectively.
The following table summarizes interest expense incurred during the three months ended
February 28, 2022and 2021, respectively (amounts are rounded to nearest thousand): For the three months ended February 28, 2022
Palūkanų išlaidos, pagrįstos negrąžintos skolos kupono palūkanų norma
$ 61,000 $ 10,000 Accretion of debt discount 352,000 40,000 Other 1,000 - Total interest expense $ 414,000 $ 50,000
Įterptųjų išvestinių finansinių priemonių tikrosios vertės pokytis
We recognized a loss of approximately
$236,000and $17,000, resulting from the change in fair value of embedded contingent put options in convertible notes during the three months ended February 28, 2022and 2021, respectively. The fluctuation is mainly due to the increased amount of outstanding convertible notes in 2022 and change of our stock price during the reporting periods.
Nuostolis dėl skolos grąžinimo
We recognized a loss of approximately
$232,000and $56,000due to the exchange of outstanding debentures for shares of common stock during the three months ended February 28, 2022and 2021, respectively.
Atsakomybės už registraciją sureguliavimas
Per tris pasibaigusius mėnesius
During the three months ended
February 28, 2022and 2021, we incurred net losses of approximately $2.3 millionand $2.5 million, respectively. Our management expects to continue to incur net losses for the foreseeable future, due to our need to continue to establish a broader pipeline of assets, expenditure on R&D and to implement other aspects of our business plan.
Likvidumas ir kapitalo ištekliai
Kartu pateikiamą sutrumpintą konsoliduotą finansinę atskaitomybę rengėme darydami prielaidą, kad toliau tęsime savo veiklą, kuri numato turto realizavimą ir įsipareigojimų likvidavimą įprastomis verslo sąlygomis.
We have not yet established an ongoing source of significant revenues and must cover our operating costs through debt and equity financings to allow us to continue as a going concern. We had approximately
$137,000in cash as of February 28, 2022. Our ability to continue as a going concern depends on the ability to obtain adequate capital to fund operating losses until we generate adequate cash flows from operations to fund our operating costs and obligations. If we are unable to obtain adequate capital, we could be forced to cease operations.
Mūsų pagrindiniai likvidumo reikalavimai yra mūsų apyvartinio kapitalo poreikių, kapitalo išlaidų ir bendrųjų įmonių poreikių finansavimas. Mūsų nuolatinės kapitalo išlaidos iš esmės yra susijusios su didėjančiomis pajamomis, generuojančiomis pardavimų pastangas ir nuolatinėmis mokslinių tyrimų ir plėtros išlaidomis. Manome, kad mūsų kapitalo išlaidos bus apytiksliai
19 Table of Contents We depend upon our ability, and will continue to attempt, to secure equity and/or debt financing. We cannot be certain that additional funding will be available on acceptable terms, or at all. Our management determined that there was substantial doubt about our ability to continue as a going concern within one year after the condensed consolidated financial statements were issued, and management's concerns about our ability to continue as a going concern within the year following this report persist. The accompanying condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts and classification of liabilities that might result from
this uncertainty. Cash Flows
Šioje lentelėje pateikiami reikšmingi grynųjų pinigų šaltiniai ir panaudojimas šioje ataskaitoje nurodytais laikotarpiais:
For the three months ended
February 28, 2022 February 28,
Net cash (used in) provided by: Operating activities $ (376,856) $
Financing activities 170,030
1 075 000
Grynasis (sumažėjimas) grynųjų pinigų padidėjimas (206 826 USD) 257 979 USD
During the three months ended
February 28, 2022, operating activities used $0.4 millionof cash, resulting from a net loss of $2.3 million, partially offset by $0.2 millionof share-based compensation, change in fair value of embedded conversion options of $0.2 million, settlement on registration liability of approximately $0.2 million, loss on debt extinguishment of approximately $0.2 million, and non-cash interest expense resulting from accretion of debt discounts of $0.4 millionand changes in our operating assets and liabilities of approximately $0.7 million. During the three months ended February 28, 2021, operating activities used $0.8 millionof cash, resulting from a net loss of $2.5 million, partially offset by $1.4 millionof share-based compensation, change in fair value of embedded conversion options of $17,000, loss on debt extinguishment of $56,000, and non-cash interest expense resulting from accretion of debt discounts of $40,000and changes in our operating assets and liabilities of approximately $0.1 million.
Grynieji pinigai, gauti iš finansinės veiklos
Net cash provided by financing activities for the three months ended
February 28, 2022and February 29, 2021was $0.2 millionand $1.1 million, respectively. The net cash provided in the 2022 period relates to proceeds received from the issuance of common stock and warrant, warrants modification and cash advances. The net cash provided in the 2021 period relates to proceeds received from the issuance of common stock and debentures.
Įsipareigojimai ir nenumatyti atvejai
Periodically, we review the status of significant matters, if any exist, and assesses its potential financial exposure. If the potential loss from any claim or legal claim is considered probable and the amount can be estimated, we accrue a liability for the estimated loss. Legal proceedings are subject to uncertainties, and the outcomes are difficult to predict. Because of such uncertainties, accruals are based on the best information available at the time. As additional information becomes available, we reassess the potential liability related to pending claims and litigation. On
March 31, 2022, we received a complaint filed in the Court of Common Pleasin Buck County, Pennsylvaniaclaiming that we had failed to pay approximately $106,000in fees for services provided under two master services agreements that we entered into with the plaintiff. Under those agreements, the plaintiff was to have provided services in connection with the promotion of our Strontium-89 product. We are analyzing how to respond to this recently received complaint. 20 Table of Contents Advisory Agreements
Su įvairiomis sandorio šalimis sudarėme įprastus konsultavimo susitarimus dėl konsultavimo paslaugų teikimo, verslo plėtros ir ryšių su investuotojais paslaugų, pagal kurias sutarėme išleisti paprastųjų akcijų akcijas gavus paslaugas.
December 2016, we entered into a lease agreement for office space located in Cayman Islandsfor $30,000per annum. The initial term of the agreement ended in December 2019and has been further renewed for another three years. This agreement does not identify a specific asset and does not convey the use of substantially all of the shared office capacity. As such, this agreement does not contain a lease under ASC 842. We recognize monthly license payments as incurred over the term of the arrangement.
Nuomos sąnaudos priskiriamos bendrųjų ir administracinių sąnaudų kategorijai taikant tiesinį metodą.
Susijusių šalių sandoriai
We entered into consulting agreements with certain management personnel and stockholders for consulting and legal services. Consulting and legal expenses resulting from such agreements were included within general and administrative expenses in the accompanying Condensed Consolidated Statements of Operations as follows (amounts are rounded to nearest thousand): For the three months ended February 28, 2022 February 28, 2021 Consulting and legal expenses $ 105,000 $
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