What changed in this filing

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Item 2. Management’s Discussion and Analysis

2021-11-15 compared with 2021-08-13 · 39 added, 36 removed, 125 unchanged (38% of the section changed)

31 unchanged sentences

assessment of our management.

are a biopharmaceutical company that is developing GP2, an immunotherapy designed to prevent the recurrence of breast cancer following

GP2 is a 9 amino acid transmembrane peptide of the HER2/ neu protein, a cell surface receptor protein that is expressed

in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor)

In a completed Phase IIb clinical trial led by MD Anderson Cancer Center, no recurrences were observed in the HER2/ neu

3+ adjuvant setting after median 5 years of follow-up, if the patient received the 6 primary intradermal injections over the first 6

We are planning to commence a Phase III clinical trial in 2021.

We are a biopharmaceutical

company that is developing GP2, an immunotherapy designed to prevent the recurrence of breast cancer following surgery.

amino acid transmembrane peptide of the HER2/ neu protein, a cell surface receptor protein that is expressed in a variety of

common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor)

In a completed Phase IIb clinical trial led by MD Anderson Cancer Center, no recurrences were observed in the

HER2/ neu 3+ adjuvant setting after median 5 years of follow-up, if the patient received the 6 primary intradermal injections

over the first 6 months.

We are planning to commence a Phase III clinical trial shortly and are currently completing the last

steps to release GP2 drug product and to open clinical sites.

date, we have not generated any revenue and we have incurred net losses.

Our net losses were approximately $1.9 million and $3.4 million

for the years ended December 31, 2020 and 2019, respectively and $1.3 million and $0.5 million for the six months ended

June 30, 2021 and 2020.

for the years ended December 31, 2020 and 2019, respectively and $2.2 million and $0.7 million for the nine months ended September 30,

2021 and 2020.

net losses have resulted from costs incurred in developing the drug in our pipeline, planning and preparing for clinical trials and general

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We will also experience increased costs associated with operating as a public company.

of Operations for the Three Months Ended June 30, 2021 and 2020

of Operations for the Three Months Ended September 30, 2021 and 2020

and Development Expenses

and development expenses increased by $405,730, or 269%, to $556,534 for the three months ended June 30, 2021 from

$150,804 for the three months ended June 30, 2020.

The increase was primarily the result of an increase in compensation and

manufacturing expenses.

and development expenses increased by $499,065, or 316%, to $657,096 for the three months ended September 30, 2021 from $158,031 for

the three months ended September 30, 2020.

The increase was primarily the result of an increase in compensation and manufacturing and

clinical expenses.

and Administrative Expenses

and administrative expenses increased by $137,285, or 230%, to $196,911 for the three months ended June 30, 2021

from $59,626 for the three months ended June 30, 2020.

The increase was primarily the result of an increase in costs for raising

of Operations for the Six Months Ended June 30, 2021 and 2020

and administrative expenses increased by $110,756, or 112%, to $209,590 for the three months ended September 30, 2021 from $98,834 for

the three months ended September 30, 2020.

The increase was primarily the result of an increase in costs for raising capital.

of Operations for the Nine Months Ended September 30, 2021 and 2020

and Development Expenses

and development expenses increased by $537,816, or 179%, to $838,511 for the six months ended June 30, 2021 from

$300,695 for the six months ended June 30, 2020.

The increase was primarily the result of an increase in compensation and

manufacturing expenses.

and development expenses increased by $1,036,881, or 226%, to $1,495,607 for the nine months ended September 30, 2021 from $458,726 for

the nine months ended September 30, 2020.

The increase was primarily the result of an increase in compensation and manufacturing and

clinical expenses.

and Administrative Expenses

and administrative expenses increased by $361,164, or 234%, to $515,540 for the six months ended June 30, 2021 from

$154,376 for the six months ended June 30, 2020.

and administrative expenses increased by $471,920, or 186%, to $725,130 for the nine months ended September 30, 2021 from $253,210 for

the nine months ended September 30, 2020.

The increase was primarily the result of an increase in costs for raising capital.

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may require us to raise additional capital.

As of June 30, 2021 and December 31, 2020, our principal source of liquidity was our cash,

which totaled $29,800,632 and $28,660,375, respectively, and additional loans and accrued unreimbursed expenses from related

Historically, our principal sources of cash have included proceeds from the sale of common stock and preferred stock and related

As of September 30, 2021 and December 31, 2020, our principal source of liquidity was our

cash, which totaled $28,905,993 and $28,660,375, respectively, and additional loans and accrued unreimbursed expenses from related parties.

Historically, our principal sources of cash have included proceeds from the sale of common stock and preferred stock and related party

Our principal uses of cash have included cash used in operations.

We expect that the principal uses of cash in the future

will be for continuing operations, funding of research and development, including our clinical trials, and general working capital requirements.

Flow Activities for the Six Months Ended June 30, 2021 and 2020

incurred net losses of $1,346,753 and $455,071 during the six month periods ended June 30, 2021 and 2020, respectively.

The increase was primarily the result of an increase in compensation, manufacturing expenses, and costs for raising capital.

cash used in operating activities was $1,132,589 for the six months ended June 30, 2021 and $0 for the six months ended June 30,

did not use or generate cash from investing activities during the six months ended June 30, 2021 and June 30, 2020.

used and generated cash netting a total of $2,272,846 from financing activities during the six months ended June 30, 2021 and did not

use or generate cash from financing activities during the six months ended June 30, 2020.

We expect that the principal uses of cash in the future will

be for continuing operations, funding of research and development, including our clinical trials, and general working capital requirements.

Flow Activities for the Nine Months Ended September 30, 2021 and 2020

incurred net losses of $2,209,871 and $711,936 during the nine month periods ended September 30, 2021 and 2020, respectively.

The increase was primarily the result of an increase in compensation, manufacturing and clinical trial expenses, and costs for raising

cash used in operating activities was $2,027,228 for the nine months ended September 30, 2021 and $0 for the nine months ended September

did not use or generate cash from investing activities during the nine months ended September 30, 2021 and September 30, 2020.

used and generated cash netting a total of $2,272,846 from financing activities during the nine months ended September 30, 2021 and $6,207,502

from financing activities during the nine months ended September 30, 2020.

Sheet Arrangements

of June 30, 2021, we did not have any off-balance sheet arrangements as described by Item 303(a)(4) of Regulation S-K.

of September 30, 2021, we did not have any off-balance sheet arrangements as described by Item 303(a)(4) of Regulation S-K.

Accounting Policies

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis