What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-03-12 compared with 2023-09-06 · 74 added, 131 removed, 110 unchanged (65% of the section changed)

19 unchanged sentences

OF OPERATIONS

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

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 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.

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 $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 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

interest income was due primarily to an increase in interest rates on our cash, cash equivalents and short-term investments.

Loss Attributable to Noncontrolling Interest

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

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

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.

months ended January 31, 2024 compared with three months ended January 31, 2023

had no revenue during the three-month periods ended January 31, 2024 and 2023.

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

3 unchanged sentences

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.

Royalties, Contingent Legal Fees, Litigation and Licensing Expenses

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.

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 nine-month period ended July 31, 2022.

We hope 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.

and Development Expenses

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.

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 $1,864,000 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 $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 development expenses are related to the development of our cancer therapeutics and vaccine programs and the expenses incurred in

the three months ended January 31, 2024 consisted of approximately $629,000 and $720,000 for CAR-T therapeutics and cancer vaccines,

respectively.

and development expenses increased by approximately $281,000 to approximately $1,349,000 in the three months ended January 31, 2024,

from approximately $1,068,000 in the three months ended January 31, 2023.

The increase in research and development expenses was primarily

due to an increase in outside research and development expenses related to our breast cancer vaccine program of approximately $164,000,

an increase in outside research and development expenses related to our CAR-T therapeutics program of approximately $141,000, and an

increase in employee compensation and related costs, other than stock option compensation expense, of approximately $84,000, offset by

a decrease in outside research and development expenses related to our ovarian cancer vaccine program of approximately $71,000.

and Administrative Expenses

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

income was due primarily to an increase in interest rates on our cash, cash equivalents and short-term investments.

and administrative expenses increased by approximately $772,000 to approximately $2,260,000 in the three months ended January 31, 2024,

from approximately $1,488,000 in the three months ended January 31, 2023.

The increase in general and administrative expenses was primarily

due to an increase in investor and public relations expense of approximately $389,000, an increase in employee stock option compensation

expense of approximately $95,000, an increase in legal and other professional fees of approximately $78,000, an increase in employee

compensation and related costs, other than stock option compensation expense, of approximately $77,000, and an increase in director compensation,

including stock option compensation, of approximately $72,000.

income increased by approximately $117,000 to approximately $319,000 in the three months ended January 31, 2024, from approximately $202,000

in the three months ended January 31, 2023, due to an increase in interest rates and the increased dollar amount held in short-term investments.

Loss Attributable to Noncontrolling Interest

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

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

net loss attributable to noncontrolling interest, representing Wistar’s ownership interest in Certainty’s net loss, increased

by approximately $3,000 to approximately $35,000 in the three months ended January 31, 2024 from approximately $32,000 in the three months

ended January 31, 2023, as Certainty’s net loss increased.

AND CAPITAL RESOURCES

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

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

on currently available information as of March 12, 2024, 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 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

debt from various financial institutions where possible.

We cannot be certain that additional funding will be available on acceptable

terms, or at all.

If we do identify sources for additional funding, the sale of additional equity securities or convertible debt will

result in dilution to our stockholders.

We can give no assurance that we will generate sufficient cash flows in the future to satisfy

our liquidity requirements or sustain future operations, or that other sources of funding, such as sales of equity or debt, would be

available or would be approved by our security holders, if needed, on favorable terms or at all.

If we fail to obtain additional working

capital as and when needed, such failure could have a material adverse impact on our business, results of operations and financial condition.

Furthermore, such lack of funds may inhibit our ability to respond to competitive pressures or unanticipated capital needs, or may force

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

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

Cash provided by financing activities was approximately

$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.

During the three months ended January 31, 2024, we raised approximately $2,196,000, net of expenses,

through an at-the-market equity offering of 555,820 shares of common stock, under which offering we may issue up to $100 million of common

Under our at-the-market equity program, which is currently effective and may remain available for us to use in the future, as

of January 31, 2024, we may sell an additional approximately $98 million of common stock.

We may seek to obtain working capital during

our fiscal year 2024 or thereafter through sales of our equity securities or through bank credit facilities or public or private debt

from various financial institutions where possible.

We cannot be certain that additional funding will be available on acceptable terms,

If we do identify sources for additional funding, the sale of additional equity securities or convertible debt will result

in dilution to our stockholders.

We can give no assurance that we will generate sufficient cash flows in the future to satisfy our liquidity

requirements or sustain future operations, or that other sources of funding, such as sales of equity or debt, would be available or would

be approved by our security holders, if needed, on favorable terms or at all.

If we fail to obtain additional working capital as and

when needed, such failure could have a material adverse impact on our business, results of operations and financial condition.

such lack of funds may inhibit our ability to respond to competitive pressures or unanticipated capital needs, or may force us to reduce

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

the three months ended January 31, 2024, cash used in operating activities was approximately $2,309,000.

Cash provided by investing activities

was approximately $129,000, resulting from the maturities of short-term investments of approximately $20,149,000, offset by purchases

of short-term investments totaling approximately $20,020,000.

Cash provided by financing activities was approximately $2,263,000, resulting

from the sale of 555,820 shares of common stock in an at-the-market equity offering of approximately $2,196,000, net of expenses, and

the proceeds from stock option exercises of approximately $67,000.

As a result, our cash, cash equivalents, and short-term investments

at January 31, 2024 decreased approximately $46,000 to approximately $23,798,000 from approximately $23,844,000 at the end of fiscal

ACCOUNTING POLICIES

12 unchanged sentences

complex judgments:

Compensation.

Compensation, and

and Development Expenses.

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

54 unchanged sentences

the compensation expense that we record may differ significantly from what we have recorded in the current period.

and Development Expenses

recognize research and development expenses as incurred.

Advance payments for future research and development activities are deferred

and expensed as the services are performed.

We recognize our preclinical studies and clinical trial expenses based on the services performed

pursuant to contracts with research institutions, clinical research organizations (“CROs”), clinical manufacturing organizations

(“CMOs”), and other parties that conduct and manage various stages of research and development activities on our behalf.

Fees for such services are recognized based on management’s estimates after considering the activities and tasks completed by each

service provider in a given period, the time period over which services are expected to be performed, and the level of effort expended

in each reporting period.

each balance sheet date, management estimates prepaid and accrued research and development costs by discussing progress or stage of completion

of activities with internal personnel and external service providers, and comparing this information to payments made, invoices received,

and the agreed-upon contractual fee to be paid for such services in the applicable contract or statements of work.

addition, we allocate certain internal compensation costs to research and development expenses based on management’s estimates

of each employee’s time and effort expended.

OF RECENTLY ISSUED PRONOUNCEMENTS

do not believe that any of the recently issued accounting pronouncements will have a material effect on the Company’s consolidated

financial statements.

See Note 7 to the accompanying condensed consolidated financial statements.

discuss the effect of recently issued pronouncements in Note 7 of 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