What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-09-06 compared with 2023-06-14 · 82 added, 95 removed, 159 unchanged (53% of the section changed)

19 unchanged sentences

OF OPERATIONS

months ended April 30, 2023 compared with three months ended April 30, 2022

the three months ended April 30, 2023, we recorded revenue of approximately $210,000 from one license agreement.

The license agreement

provided for a one-time, non-recurring, lump sum payment in exchange for a non-exclusive retroactive and future license, and covenant

Pursuant to the terms of the agreement, we have no further obligations with respect to the granted intellectual property

rights, including no obligation to maintain or upgrade the technology, or provide future support or services.

Accordingly, the performance

obligations from this license agreement were satisfied and 100% of the revenue was recognized upon execution of the license agreement.

We had no revenue during the three months ended April 30, 2022.

discussed in Note 1 to our condensed consolidated financial statements, as part of our legacy operations, the Company remains engaged

in limited patent licensing activities which we do not expect to be a significant part of our ongoing operations or revenue, nor do we

expect these activities to require material financial resources or attention of senior management.

have not generated any revenue to date from our therapeutics or vaccine programs.

In addition, while we pursue our therapeutics and vaccine

programs, we may also make investments in and form new companies to develop additional emerging technologies.

We do not expect to begin

generating revenue with respect to any of our current therapy or vaccine programs in the near term.

We intend to achieve a profitable

outcome by eventually licensing our technologies to large pharmaceutical companies that have the resources and infrastructure in place

to manufacture, market and sell our technologies as therapeutics or vaccines.

The eventual licensing of any of our technologies may take

several years, if it is to occur at all, and may depend on positive results from human clinical trials.

months ended July 31, 2023 compared with three months ended July 31, 2022

had no revenue during the three months ended July 31, 2023 and 2022.

the past several years, our revenue, if any, was derived from technology licensing and the sale of patented technologies, including revenue

from the settlement of litigation.

We have not generated any revenue to date from our therapeutics or vaccine programs.

while we pursue our therapeutics and vaccine programs, we may also make investments in and form new companies to develop additional emerging

technologies.

We do not expect to begin generating revenue with respect to any of our current therapy or vaccine programs in the near

We intend to achieve a profitable outcome by eventually licensing our technologies to large pharmaceutical companies that have

the resources and infrastructure in place to manufacture, market and sell our technologies as therapeutics or vaccines.

licensing of any of our technologies may take several years, if it is to occur at all, and may depend on positive results from human

clinical trials.

Royalties, Contingent Legal Fees, Litigation and Licensing Expenses

royalties, contingent legal fees, litigation and licensing expenses for the three months ended April 30, 2023 were approximately $161,000.

Inventor royalties and contingent legal fees are expensed in the period that the related revenues are recognized.

Litigation and licensing

expenses related to patent assertion, other than contingent legal fees, are expensed in the period incurred.

We had no inventor royalties,

contingent legal fees, litigation and licensing expenses during the three-month period ended April 30, 2022.

had no inventor royalties, contingent legal fees, litigation and licensing expenses during the three-month periods ended July 31, 2023

and Development Expenses

and development expenses incurred in the three months ended April 30, 2023 associated with each of our development programs consisted

of approximately $512,000 for cancer vaccines, approximately $413,000 for CAR-T therapeutics and approximately $73,000 for anti-viral

therapeutics.

As of March 9, 2023, we paused further development of our COVID-19 anti-viral therapeutic program.

While our compounds

have shown promise in head-to-head in vitro analysis against Pfizer’s authorized oral treatment, results of additional animal

studies indicate that there is not sufficient oral bioavailability, and it is unclear whether an orally delivered treatment may be developed.

We do not currently believe that there is a viable market for an injectable treatment given the current oral treatments available.

and development expenses incurred in the three months ended July 31, 2023 associated with each of our development programs consisted

of approximately $616,000 for cancer vaccines, approximately $472,000 for CAR-T therapeutics and $0 for anti-viral therapeutics.

March 9, 2023, we paused further development of our COVID-19 anti-viral therapeutic program.

While our compounds have shown promise in

head-to-head in vitro analysis against Pfizer’s authorized oral treatment, results of additional animal studies indicate

that there is not sufficient oral bioavailability, and it is unclear whether an orally delivered treatment may be developed.

currently believe that there is a viable market for an injectable treatment given the current oral treatments available.

we believe the needed additional investment in research for alternative delivery methods would divert resources from more promising projects.

2 unchanged sentences

and development expenses are related to the development of our cancer therapeutics and vaccine programs and our anti-viral drug program,

and decreased by approximately $737,000 to approximately $998,000 in the three months ended April 30, 2023, from approximately $1,735,000

in the three months ended April 30, 2022.

The decrease in research and development expenses was primarily due to a decrease in employee

stock option compensation expense of approximately $413,000, a decrease in outside research and development expense related to our anti-viral

drug program of approximately $84,000, a decrease of approximately $78,000 in outside research and development related to our CAR-T therapeutics

program, a decrease in stock option compensation for consultants of approximately $62,000 and a decrease of approximately $50,000 in

outside research and development related to our ovarian cancer vaccine program.

and decreased by approximately $357,000 to approximately $1,088,000 in the three months ended July 31, 2023, from approximately $1,445,000

in the three months ended July 31, 2022.

The decrease in research and development expenses was primarily due to a decrease in outside

research and development expense related to our anti-viral drug program of approximately $289,000, a decrease in employee stock option

compensation expense of approximately $190,000, and a decrease in stock option compensation for consultants of approximately $62,000,

offset by an increase of approximately $81,000 in outside research and development related to our CAR-T therapeutics program, and an

increase of approximately $80,000 in employee compensation and related costs, other than stock option compensation expense.

and Administrative Expenses

and administrative expenses decreased by approximately $243,000 to approximately $1,611,000 in the three months ended April 30, 2023,

from approximately $1,854,000 in the three months ended April 30, 2022.

The decrease in general and administrative expenses was primarily

due to a decrease in employee compensation and related costs, other than stock option compensation expense, of approximately $151,000,

a decrease in warrant expense of approximately $110,000, a decrease in patent related costs of approximately $73,00 and a decrease in

investor and public relations expense, excluding warrant expense, of approximately $61,000, offset by an increase of approximately $146,000

in employee stock option compensation expense.

income was approximately $253,000 and $1,000 in the three-month periods ended April 30, 2023 and 2022, respectively.

and administrative expenses increased by approximately $404,000 to approximately $1,756,000 in the three months ended July 31, 2023,

from approximately $1,352,000 in the three months ended July 31, 2022.

The increase in general and administrative expenses was

primarily due to an increase in employee compensation and related costs, other than stock option compensation expense of

approximately $138,000, an increase in directors stock option expense of approximately $92,000, an increase in directors

compensation, other than stock option compensation expense of approximately $87,000, an increase in investor and public relations

expense of approximately $84,000, and an increase in consultant expenses of approximately $51,000, offset by a decrease in employee

stock option compensation expense of approximately $76,000.

income was approximately $296,000 and $22,000 in the three-month periods ended July 31, 2023 and 2022, respectively.

The increase in

2 unchanged sentences

net loss attributable to noncontrolling interest, representing Wistar’s 5% ownership interest in Certainty’s net loss, was

approximately $19,000 and $44,000, respectively, in the three months ended April 30, 2023 and 2022.

months ended April 30, 2023 compared with six months ended April 30, 2022

the six months ended April 30, 2023, we recorded revenue of approximately $210,000 from one license agreement.

The license agreement

provided for a one-time, non-recurring, lump sum payment in exchange for a non-exclusive retroactive and future license, and covenant

Pursuant to the terms of the agreement, we have no further obligations with respect to the granted intellectual property

rights, including no obligation to maintain or upgrade the technology, or provide future support or services.

Accordingly, the performance

obligations from this license agreement were satisfied and 100% of the revenue was recognized upon execution of the license agreement.

We had no revenue during the six months ended April 30, 2022.

approximately $37,000 and $29,000, respectively, in the three months ended July 31, 2023 and 2022.

months ended July 31, 2023 compared with nine months ended July 31, 2022

the nine months ended July 31, 2023, we recorded revenue of approximately $210,000 from one license agreement relating to our legacy

The license agreement provided for a one-time, non-recurring, lump sum payment in exchange for a non-exclusive retroactive

and future license, and covenant not to sue.

Pursuant to the terms of the agreement, we have no further obligations with respect to the

granted intellectual property rights, including no obligation to maintain or upgrade the technology, or provide future support or services.

Accordingly, the performance obligations from this license agreement were satisfied and 100% of the revenue was recognized upon execution

of the license agreement.

We had no revenue during the nine months ended July 31, 2022.

discussed in Note 1 to our condensed consolidated financial statements, as part of our legacy operations, the Company remains engaged

12 unchanged sentences

Royalties, Contingent Legal Fees, Litigation and Licensing Expenses

royalties, contingent legal fees, litigation and licensing expenses for the six months ended April 30, 2023 were approximately $161,000.

royalties, contingent legal fees, litigation and licensing expenses for the nine months ended July 31, 2023 were approximately $161,000.

Inventor royalties and contingent legal fees are expensed in the period that the related revenues are recognized.

2 unchanged sentences

We had no inventor royalties,

contingent legal fees, litigation and licensing expenses during the six-month period ended April 30, 2022.

contingent legal fees, litigation and licensing expenses during the nine-month period ended July 31, 2022.

and Development Expenses

and development expenses incurred in the six months ended April 30, 2023 associated with each of our development programs consisted of

approximately $979,000 for cancer vaccines, approximately $849,000 for CAR-T therapeutics and approximately $238,000 for anti-viral therapeutics.

and development expenses incurred in the nine months ended July 31, 2023 associated with each of our development programs consisted of

approximately $1,595,000 for cancer vaccines, approximately $1,321,000 for CAR-T therapeutics and approximately $238,000 for anti-viral

therapeutics.

As of March 9, 2023, we paused further development of our COVID-19 anti-viral therapeutic program.

While our compounds have shown promise

in head-to-head in vitro analysis against Pfizer’s authorized oral treatment, results of additional animal studies indicate that

there is not sufficient oral bioavailability, and it is unclear whether an orally delivered treatment may be developed.

We do not currently

believe that there is a viable market for an injectable treatment given the current oral treatments available.

Furthermore, we believe

the needed additional investment in research for alternative delivery methods would divert resources from more promising projects.

continue to prosecute our U.S.

While our compounds

have shown promise in head-to-head in vitro analysis against Pfizer’s authorized oral treatment, results of additional animal studies

indicate that there is not sufficient oral bioavailability, and it is unclear whether an orally delivered treatment may be developed.

We do not currently believe that there is a viable market for an injectable treatment given the current oral treatments available.

we believe the needed additional investment in research for alternative delivery methods would divert resources from more promising projects.

We continue to prosecute our U.S.

patent applications of this technology and may decide to restart development at some time in the future.

and development expenses are related to the development of our cancer therapeutics and vaccine programs and our anti-viral drug program,

and decreased by approximately $1,507,000 to approximately $2,066,000 in the six months ended April 30, 2023, from approximately $3,573,000

in the six months ended April 30, 2022.

and decreased by approximately $1,864,000 to approximately $3,154,000 in the nine months ended July 31, 2023, from approximately $5,018,000

in the nine months ended July 31, 2022.

The decrease in research and development expenses was primarily due to a decrease in employee

stock option compensation expense of approximately $1,347,000, a decrease in outside research and development expense related to our

anti-viral drug program of approximately $148,000, a decrease in outside research and development expense related to ovarian cancer CAR-T

program of approximately $98,000 and a decrease of approximately $89,000 of consultant stock option and warrant expense.

anti-viral drug program of approximately $437,000, and a decrease in consultant stock option and warrant expense of approximately $151,000,

offset by an increase in employee compensation and related costs, other than stock option compensation expense, of approximately $145,000.

and Administrative Expenses

and administrative expenses decreased by approximately $797,000 to approximately $3,099,000 in the six months ended April 30, 2023, from

approximately $3,896,000 in the six months ended April 30, 2022.

decrease in general and administrative expenses was primarily due to a decrease in employee stock option compensation expense of approximately

$293,000, a decrease in warrant expense of approximately $220,000, a decrease in investor and public relations expense, excluding warrant

expense of approximately $166,000 and a decrease in patent related costs of approximately $133,000.

income was approximately $455,000 and $2,000 in the six-month periods ended April 30, 2023 and 2022, respectively.

and administrative expenses decreased by approximately $393,000 to approximately $4,855,000 in the nine months ended July 31, 2023, from

approximately $5,248,000 in the nine months ended July 31, 2022.

The decrease in general and administrative expenses was primarily due

to a decrease in employee stock option compensation expense of approximately $369,000, a decrease in consultant warrant expense of approximately

$220,000, and a decrease in patent related costs of approximately $124,000, offset by an increase in employee compensation and related costs, other than stock

option compensation expense of approximately $120,000 and an increase in directors stock option compensation

expense of approximately $88,000.

income was approximately $751,000 and $24,000 in the nine-month periods ended July 31, 2023 and 2022, respectively.

The increase in interest

2 unchanged sentences

net loss attributable to noncontrolling interest, representing Wistar’s 5% ownership interest in Certainty’s net loss, was

approximately $51,000 and $94,000, respectively, in the six months ended April 30, 2023 and 2022.

approximately $88,000 and $123,000, respectively, in the nine months ended July 31, 2023 and 2022.

AND CAPITAL RESOURCES

primary sources of liquidity are cash, cash equivalents and short-term investments.

on currently available information as of June 14, 2023, we believe that our existing cash, cash equivalents, short-term investments

on currently available information as of September 6, 2023, we believe that our existing cash, cash equivalents, short-term investments

and expected cash flows will be sufficient to fund our activities for at least the next twelve months.

7 unchanged sentences

to obtain more working capital.

Under our at-the-market equity program as of April 30, 2023, we may sell up to $100 million of common

We did not sell any shares under our at-the-market equity program during the three and six months ended April 30, 2023.

Under our at-the-market equity program as of July 31, 2023, we may sell up to $100 million of common

We did not sell any shares under our at-the-market equity program during the three and nine months ended July 31, 2023.

seek to obtain working capital during our fiscal year 2023 or thereafter through sales of our equity securities or public or private

11 unchanged sentences

us to reduce operating expenses, which would significantly harm the business and development of operations.

the six months ended April 30, 2023, cash used in operating activities was approximately $2,795,000.

Cash used by investing activities

the nine months ended July 31, 2023, cash used in operating activities was approximately $4,240,000.

Cash used in investing activities

was approximately $5,009,000, resulting from the purchase of short-term investments totaling approximately $27,502,000, which was offset

by proceeds on the maturities of short-term investments of approximately $13,377,000.

by the proceeds on maturities of short-term investments of approximately $22,493,000.

Cash provided by financing activities was approximately

As a result, our cash, cash equivalents, and short-term investments at April 30, 2023 decreased approximately $2,711,000 to

approximately $26,976,000 from approximately $29,687,000 at the end of fiscal year 2022.

$87,000, resulting from proceeds from exercise of stock options of approximately $81,000 and proceeds from the sale of common stock pursuant

to our employee stock purchase plan of approximately $6,000.

Our cash and cash equivalents including short-term investments, at July

31, 2023 decreased approximately $4,153,000 to approximately $25,534,000 from approximately $29,687,000 at the end of fiscal year 2022.

ACCOUNTING POLICIES

12 unchanged sentences

complex judgments:

Revenue Recognition;

Stock-Based Compensation.

Compensation.

revenue has been derived solely from technology licensing and the sale of patented technologies.

57 unchanged sentences

financial statements.

See Note 7 of the accompanying condensed consolidated financial statements.

See Note 7 to the accompanying condensed consolidated financial statements.

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