Q BIOMED INC. Vadovybės aptarimas ir finansinės būklės bei veiklos rezultatų analizė (forma 10-Q)

Q BIOMED INC.  Vadovybės aptarimas ir finansinės būklės bei veiklos rezultatų analizė (forma 10-Q)

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.

Apžvalga

Q BioMed Inc. (or "the Company") was incorporated in the State of Nevada on
November 22, 2013 and 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.

Komercinis produktas


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 States and 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.

Partnerystės galimybės

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

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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


In 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 Affairs and the U.S. Department
of Defense. We have deployed a VA sales 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.S
Departments of Veterans' Affairs, the Department of Defense and 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 $500,000 order 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


In March 2021, our technology partner Mannin Research Inc. (Mannin) was granted
an additional CAD$1.7 million from the Canadian governments COVID response
budget, adding to the approximate $7.7 million granted in Europe, which together
will fund 65-75 percent

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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.

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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, 2022 and
2021:

                                                                  For the three months ended
                                                   February 28, 2022      February 28, 2021       Change
Net Sales                                         $            75,059    $                 -   $      75,059
Cost 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)   $     186,380


Net Sales

During the three months ended February 28, 2022, we recognized approximately
$75,000 of revenue from sales of Strontium89. We didn't have any sales for the
same period in the prior year.

Pardavimo savikaina


During the three months ended February 28, 2022 and 2021, we recognized
approximately $74,000 and $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, 2022 compared 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, 2022 compared to
the same period in

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the prior year. We recognized approximately $0.2 million and $1.4 million of
stock-based compensation in general and administrative expense during the three
months ended February 28, 2022 and 2021, respectively.

Palūkanų išlaidos


The following table summarizes interest expense incurred during the three months
ended February 28, 2022 and 2021, respectively (amounts are rounded to nearest
thousand):

                                                                  For the three months ended
                                                          February 28, 2022

2021 m. vasario 28 d
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 $236,000 and $17,000, resulting from the
change in fair value of embedded contingent put options in convertible notes
during the three months ended February 28, 2022 and 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 $232,000 and $56,000 due to the exchange
of outstanding debentures for shares of common stock during the three months
ended February 28, 2022 and 2021, respectively.

Atsakomybės už registraciją sureguliavimas

Per tris pasibaigusius mėnesius 2022 m. vasario 28 dsudarėme abipusio išleidimo sutartį su konvertuojamo banknoto turėtoju, pagal kurią savininkas sutiko pridėti 241 875 USD registracijos mokėjimo prievolė iki negrąžintos pagrindinės sumos. Mes atpažinome 241 875 USD dėl registracijos atsakomybės už pasibaigusius tris mėnesius 2022 m. vasario 28 d.

Grynasis nuostolis


During the three months ended February 28, 2022 and 2021, we incurred net losses
of approximately $2.3 million and $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 $137,000 in 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 6,0 milijono dolerių ateinantiems 18 mėnesių laikotarpiui.


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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, 

2021 m

Net cash (used in) provided by:
Operating activities               $         (376,856)     $         

(817 021)

Financing activities                           170,030               

1 075 000

Grynasis (sumažėjimas) grynųjų pinigų padidėjimas (206 826 USD) 257 979 USD

Panaudoti grynieji pinigai operacinėje veikloje

During the three months ended February 28, 2022, operating activities used $0.4
million of cash, resulting from a net loss of $2.3 million, partially offset by
$0.2 million of 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 million and 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
million of cash, resulting from a net loss of $2.5 million, partially offset by
$1.4 million of 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 $40,000
and 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, 2022 and February 29, 2021 was $0.2 million and $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

Teisinė


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 Pleas in
Buck County, Pennsylvania claiming that we had failed to pay approximately
$106,000 in 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.

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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.

Nuomos sutartis


In December 2016, we entered into a lease agreement for office space located in
Cayman Islands for $30,000 per annum. The initial term of the agreement ended in
December 2019 and 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     $           

105 000

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