What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-08-13 compared with 2024-05-14 · 384 added, 262 removed, 38 unchanged (94% of the section changed)

Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read this discussion together with the unaudited interim condensed consolidated financial statements, related notes, and other financial information included

elsewhere in this Quarterly Report on Form 10-Q together with our audited consolidated financial statements, related notes, and other information contained in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed

with the Securities and Exchange Commission (the “SEC”) on March 14, 2023, as amended by the Form 10-K/A filed with the SEC on March 18, 2024 (as amended, the “2023 10-K”).

following discussion contains or is based on assumptions, estimates and other forward-looking statements that involve a number of risks and uncertainties, including those discussed under “Risk Factors,” in Part I, Item 1A of the 2023 10-K and as

described from time to time in our other filings with the SEC.

should read this discussion together with the unaudited interim condensed consolidated financial statements, related notes, and other

financial information included elsewhere in this Quarterly Report on Form 10-Q together with our audited consolidated financial statements,

related notes, and other information contained in our

Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed with the Securities

and Exchange Commission (the “SEC”) on March 14, 2023, as amended by the Form 10-K/A filed with the SEC on March 18,

2024 (as amended, the “2023 10-K”).

The following discussion contains or is based on

assumptions, estimates and other forward-looking statements that involve a number of risks and uncertainties, including those discussed

under “Risk Factors,” in Part I, Item 1A of the 2023 10-K and as described from time to time in our other filings with the

These risks could cause our actual results to differ materially from those anticipated in these forward-looking statements.

We are a life science company committed to realizing the potential of mRNA cell engineering to provide patients with transformational new medicines.

We have in-licensed a portfolio of over 100

patents covering key mRNA cell engineering technologies, including technologies for mRNA cell reprogramming, mRNA gene editing, the NoveSlice TM and UltraSlice TM gene-editing proteins, and the ToRNAdo TM mRNA delivery system, which we collectively

refer to as our “mRNA technology platform.” We refer to aspects of our mRNA technology platform as “mRNA delivery,” “mRNA gene editing” and “mRNA cell reprogramming.” We license our mRNA technology platform from Factor Bioscience Limited (“Factor

Limited”) under an exclusive license agreement.

We believe that our proprietary technology platform can be used to develop novel pharmaceutical products to treat a broad range of diseases and address unmet medical needs.

In the short term, we are planning to derive revenue by leveraging our core intellectual property (“IP”) portfolio by licensing our IP to third parties in out-licensing or co-development

arrangements.

In addition, we are also planning to enhance our developmental activities through preclinical studies in selected indications.

In the mid-term, we are planning to transform our preclinical stage company into a clinical-stage company through investigational new drug application (“IND”)-enabling studies, IND approval, and

initiation of our first-in-human study.

After achieving the initial milestones, we’ll seek to diversify our pipeline of product candidates and strengthen the mRNA technology platform with the goal of generating IND applications each year.

In the long term, we aspire to become a therapeutics company with multiple approved gene and cellular therapy products across multiple indications in oncology, autoimmune diseases, and rare

We refer to aspects of our mRNA technology platform as “mRNA delivery,” “mRNA gene editing” and “mRNA cell reprogramming.”

mRNA Delivery

Nucleic acids, such as mRNA, can be used to induce cells to express desired proteins, including proteins that are capable of re-writing genetic and epigenetic cellular programs.

However, the plasma

membrane surrounding cells normally protects cells from exogenous nucleic acids, preventing efficient uptake and protein translation.

are a life science company committed to realizing the potential of mRNA cell engineering to provide patients with transformational new

We have in-licensed a portfolio of over 100 patents covering key mRNA cell engineering technologies, including technologies

for mRNA cell reprogramming, mRNA gene editing, the NoveSlice TM and UltraSlice TM gene-editing proteins, and the

ToRNAdo TM mRNA delivery system, which we collectively refer to as our “mRNA technology platform.” We refer to

aspects of our mRNA technology platform as “mRNA delivery,” “mRNA gene editing” and “mRNA cell reprogramming.”

We license our mRNA technology platform from Factor Bioscience Limited (“Factor Limited”) under an exclusive license agreement.

believe that our proprietary technology platform can be used to develop novel pharmaceutical products to treat a broad range of diseases

and address unmet medical needs.

the short term, we are planning to derive revenue by leveraging our core intellectual property (“IP”) portfolio by licensing

our IP to third parties in out-licensing or co-development arrangements.

In addition, we are also planning to enhance our developmental

activities through preclinical studies in selected indications.

the mid-term, we are planning to transform our preclinical stage company into a clinical-stage company through investigational new drug

application (“IND”)-enabling studies, IND approval, and initiation of our first-in-human study.

After achieving the initial

milestones, we’ll seek to diversify our pipeline of product candidates and strengthen the mRNA technology platform with the goal

of generating IND applications each year.

the long term, we aspire to become a therapeutics company with multiple approved gene and cellular therapy products across multiple indications

in oncology, autoimmune diseases, and rare diseases.

refer to aspects of our mRNA technology platform as “mRNA delivery,” “mRNA gene editing” and “mRNA cell

reprogramming.”

acids, such as mRNA, can be used to induce cells to express desired proteins, including proteins that are capable of re-writing genetic

and epigenetic cellular programs.

However, the plasma membrane surrounding cells normally protects cells from exogenous nucleic acids,

preventing efficient uptake and protein translation.

Delivery systems can be used to enhance the uptake of nucleic acids by cells.

Conventional delivery systems, such

as lipid nanoparticle (“LNP”)-based delivery, often suffer from endosomal entrapment and toxicity, which can limit their therapeutic use.

Our mRNA delivery technology is designed to use a novel chemical substance that is designed to deliver nucleic

acids, including mRNA, to cells both ex vivo and in vivo .

Our nucleic-acid delivery technology is also designed for ex vivo

delivery of mRNA encoding gene-editing proteins and reprogramming factors, including to primary cells, insertion of exogenous sequences into genomic safe-harbor loci, and in vivo delivery of mRNA to the

brain, eye, skin, and lung, which may be useful for the development of mRNA-based therapeutic.

mRNA Gene Editing

Our mRNA gene-editing technology is designed to delete, insert, and repair DNA sequences in living cells, which may be useful for correcting disease-causing mutations, making cells resistant to

infection and degenerative disease, modulating the expression of immunoregulatory proteins to enable the generation of durable allogeneic cell therapies, and engineering immune cells to more effectively fight cancer.

Conventional gene-editing technologies typically employ plasmids or viruses to express gene-editing proteins, which can result in low-efficiency editing and unwanted mutagenesis when an exogenous

nucleic acid fragment is inserted at random locations in the genome.

Our mRNA gene-editing technology instead is designed to employ mRNA to express gene-editing proteins, which can potentially enable gene editing without unwanted insertional

mutagenesis, because, unlike conventional gene-editing technologies that employ viruses or DNA-based vectors, mRNA does not typically cause unwanted insertional mutagenesis.

We believe the efficiency of our mRNA gene-editing technology has the

potential to support development of product candidates that could create new therapeutic approaches.

For example, we anticipate that our mRNA gene-editing technology can be used to generate allogeneic chimeric antigen receptor T-cell (“CAR-T”)

therapies for the treatment of cancer.

In such allogeneic CAR-T therapies, mRNA encoding gene-editing proteins would be used to inactivate the endogenous T-cell receptor to prevent therapeutic T-cells from causing graft-versus-host disease (“GvHD”).

GvHD occurs when transplanted cells view the patient’s (i.e.

the host’s) cells as a threat and attack the host’s cells.

We expect that this same mechanism of action can generate allogeneic stem cell-derived therapies in which mRNA encoding

gene-editing proteins could be used to inactivate one or more components of the human leukocyte antigen (“HLA”) complex to render the cells immuno-nonreactive or “stealth,” which may be useful for the development of allogeneic cell-based therapies.

mRNA Cell Reprogramming

Our mRNA cell-reprogramming technology is capable of generating clonal lines of pluripotent stem cells that can be expanded and differentiated into many desired cell types that may be useful for the

development of regenerative cell therapies.

Conventional cell-reprogramming technologies (e.g., using Sendai virus or episomal vectors) can result in low efficiency reprogramming, can select for cells with abnormal growth characteristics, and

can leave traces of the vector in reprogrammed cells.

Our mRNA cell-reprogramming technology instead is designed to employ mRNA to express reprogramming factors, which can enable cell reprogramming without

leaving traces of the vector in reprogrammed cells, because, unlike conventional cell-reprogramming technologies that employ viruses or DNA-based vectors, mRNA does not typically leave traces of the vector in reprogrammed cells.

Recent Developments

Private Placement of Convertible Notes and Warrants

On December 14, 2023, we entered into a purchase agreement with certain purchasers for the private placement of $9.2 million of convertible notes (the “December 2023 convertible notes” and together

with the July 2023 convertible notes, the “convertible notes”) and warrants to purchase an aggregate of approximately 9.6 million shares of our common stock (the “December 2023 warrants” and together with the July 2023 warrants, the “note

There were two closings under this purchase agreement:

on December 15, 2023, we received $7.8 million and issued $7.8 million in December 2023 convertible notes and December 2023 warrants to purchase approximately 8.1 million shares of

our common stock, and on January 11, 2024, we received the remaining $1.4 million and issued an aggregate of $1.4 million in December 2023 convertible notes and December 2023 warrants to purchase approximately 1.5 million shares of our common

See Notes 4 and 12 to the accompanying condensed consolidated financial statements for additional information.

Notice of Default under Sublease

We have not paid our rent obligations under our Somerville, Massachusetts sublease for February, March, April or May 2024, and, as of the date of filing of this report, we owe approximately $2.3

million in past due rent.

On May 3, 2024, we received a notice of default from the sublessor related to the foregoing and have had subsequent discussions with the Sublessor about remedying the event of default.

See “Liquidity and Capital

Resources—Material Cash Requirements—Somerville Sublease,” below.

Basis of Presentation

Our near-term focus is on deploying our mRNA technology platform through strategic partnerships.

We are not currently developing any product candidates.

Our future revenue, if any, is primarily

expected to come from out-licensing our mRNA technology platform and/or aspects thereof.

In February 2023, we entered into an exclusive option and license agreement with a third party, under which we granted such third party an option to obtain an exclusive sublicense to certain of our

technology for preclinical, clinical and commercial purposes in exchange for a non-refundable up-front payment to us of $0.3 million.

In August 2023, that third party requested that we begin developing certain induced pluripotent stem cell lines in

exchange for a cell line customization fee.

The third party paid us $0.4 million towards the customization fee, which we are recognizing ratably over the customization period, which is expected to be approximately 20 to 25 months.

delivery systems, such as lipid nanoparticle (“LNP”)-based delivery, often suffer from endosomal entrapment and toxicity,

which can limit their therapeutic use.

Our mRNA delivery technology is designed to use a novel chemical substance that is designed to

deliver nucleic acids, including mRNA, to cells both ex vivo and in vivo .

Our nucleic-acid delivery technology is also

designed for ex vivo delivery of mRNA encoding gene-editing proteins and reprogramming factors, including to primary cells, insertion

of exogenous sequences into genomic safe-harbor loci, and in vivo delivery of mRNA to the brain, eye, skin, and lung, which may

be useful for the development of mRNA-based therapeutic.

mRNA gene-editing technology is designed to delete, insert, and repair DNA sequences in living cells, which may be useful for correcting

disease-causing mutations, making cells resistant to infection and degenerative disease, modulating the expression of immunoregulatory

proteins to enable the generation of durable allogeneic cell therapies, and engineering immune cells to more effectively fight cancer.

gene-editing technologies typically employ plasmids or viruses to express gene-editing proteins, which can result in low-efficiency editing

and unwanted mutagenesis when an exogenous nucleic acid fragment is inserted at random locations in the genome.

Our mRNA gene-editing

technology instead is designed to employ mRNA to express gene-editing proteins, which can potentially enable gene editing without unwanted

insertional mutagenesis, because, unlike conventional gene-editing technologies that employ viruses or DNA-based vectors, mRNA does not

typically cause unwanted insertional mutagenesis.

We believe the efficiency of our mRNA gene-editing technology has the potential to

support development of product candidates that could create new therapeutic approaches.

For example, we anticipate that our mRNA gene-editing

technology can be used to generate allogeneic chimeric antigen receptor T-cell (“CAR-T”) therapies for the treatment of cancer.

In such allogeneic CAR-T therapies, mRNA encoding gene-editing proteins would be used to inactivate the endogenous T-cell receptor to

prevent therapeutic T-cells from causing graft-versus-host disease (“GvHD”).

GvHD occurs when transplanted cells view the

patient’s (i.e., the host’s) cells as a threat and attack the host’s cells.

We expect that this same mechanism of action

can generate allogeneic stem cell-derived therapies in which mRNA encoding gene-editing proteins could be used to inactivate one or more

components of the human leukocyte antigen (“HLA”) complex to render the cells immuno-nonreactive or “stealth,”

which may be useful for the development of allogeneic cell-based therapies.

Cell Reprogramming

mRNA cell-reprogramming technology is capable of generating clonal lines of pluripotent stem cells that can be expanded and differentiated

into many desired cell types that may be useful for the development of regenerative cell therapies.

cell-reprogramming technologies (e.g., using Sendai virus or episomal vectors) can result in low efficiency reprogramming, can select

for cells with abnormal growth characteristics, and can leave traces of the vector in reprogrammed cells.

Our mRNA cell-reprogramming

technology instead is designed to employ mRNA to express reprogramming factors, which can enable cell reprogramming without leaving traces

of the vector in reprogrammed cells, because, unlike conventional cell-reprogramming technologies that employ viruses or DNA-based vectors,

mRNA does not typically leave traces of the vector in reprogrammed cells.

Sublessor Draw on Letter

of Credit and Termination of Sublease

2022, we entered into a sublease for office and laboratory space in Somerville, Massachusetts.

See Note 8 to the accompanying condensed

consolidated financial statements for additional information regarding the sublease.

As previously reported, on May

3, 2024, we received a notice from the sublessor regarding past due rent of approximately $2.3 million that we did not pay for the months

of February, March, April and May 2024.

We also did not pay the rent for June, July or August 2024 and, as of August 1, 2024, we owed

approximately $4.0 million in the aggregate in past due rent.

In connection with entering into

the sublease, we delivered a security deposit in the form of a letter of credit in the amount of $4.1 million.

The letter of credit was

collateralized with $4.1 million of cash deposited in a restricted account.

On August 5, 2024, the sublessor

drew down on the letter of credit for the full $4.1 million to cover the approximately $4.0 million of past due rent payments, plus interest

and penalties.

On August 9, 2024, we and the

sublessor entered into a sublease termination agreement pursuant to which the parties agreed to terminate the sublease effective August

Pursuant to the sublease termination agreement, we agreed to surrender and vacate the premises, all of our right, title and

interest in all furniture, fixtures and laboratory equipment at the premises will become the property of the sublessor, and both parties

will be released of their obligations under the sublease.

As a result of the sublease termination, we expect to save approximately $58.5

million in base rental payments plus parking, operating expenses, taxes and utilities that we would have paid over the remaining lease

We do not expect

that the termination of the sublease will impact our current business needs.

Parte Re-examination Certificates Received

November 16, 2022, three of our in-licensed patents were subject to re-examination by the United States Patent and Trademark Office (“USPTO”),

under Re-examination Request Nos.

US 90/019,127, US 90/019,128, and US 90/019,129.

We have now received Ex Parte Reexamination Certificates

for each of these requests, as of June 5, 2024, June 28, 2024, and June 21, 2024, respectively.

In each case, the challenged patents

survived this challenge to their validity.

The challenged claims were minimally amended, and none were invalidated.

The claims have now

been twice examined by the USPTO and twice allowed.

Non-Compliance

with Nasdaq’s Minimum Stockholders’ Equity Rule

As previously reported, on March 19, 2024, we received a notice from The Nasdaq Stock Market LLC stating that we

are not in compliance with Nasdaq Listing Rule 5550(b)(1) (the “Minimum Stockholders’ Equity Rule”) because we reported

stockholders’ equity of less than $2.5 million as of December 31, 2023.

Our stockholders’ equity was $2.2 million as of December

The notice had no immediate effect on our Nasdaq listing.

In May 2024, we submitted a plan to Nasdaq advising of actions we

have taken or will take to regain compliance with the Minimum Stockholders’ Equity Rule.

Nasdaq accepted our plan and granted us

a 180-day extension, or through September 16, 2024, to regain compliance with the Minimum Stockholders’ Equity Rule.

factor titled “Our failure to meet the continued listing requirements of Nasdaq could result in a delisting of our common stock,”

Risk Factors of Part II of this report.

of Presentation

near-term focus is on deploying our mRNA technology platform through strategic partnerships.

are not currently developing any product candidates.

Our future revenue, if any, is primarily expected to come from out-licensing our

mRNA technology platform and/or aspects thereof.

February 2023, we entered into an exclusive option and license agreement with a third party, under which we granted such third party

an option to obtain an exclusive sublicense to certain of our technology for preclinical, clinical and commercial purposes in exchange

for a non-refundable up-front payment to us of $0.3 million.

In August 2023, that third party requested that we begin developing certain

induced pluripotent stem cell lines in exchange for a cell line customization fee.

The third party paid us $0.4 million towards the customization

fee, which we are recognizing ratably over the customization period, which is expected to be approximately 20 to 25 months.

earn the remaining amount of the customization fee if we make certain progress towards delivery of the customized cell line.

We estimate the amount of consideration we expect to recognize as revenue that is not probable of having a significant

reversal of such recognized revenue, and we place a constraint on the remaining contractual consideration.

As it becomes evident that the constrained amounts are no longer at risk of a significant reversal of revenue, we will remove the constraint

from the related revenue and recognize a cumulative catch-up adjustment to revenue in the period in which the constraint was removed.

For additional information, see Note 3 to the accompanying condensed consolidated financial statements.

Cost of Revenues

We recognize direct labor and supplies associated with generating our revenue as cost of revenues.

As provided for in the amended and restated exclusive license agreement we entered into with

Factor Limited (the “A&R Factor License Agreement”) discussed in Note 9 to the accompanying condensed consolidated financial statements, we are obligated to pay Factor Limited 20% of any amounts we receive from a customer that is related to the

licensed technology under the A&R Factor License Agreement, which we also recognize as a cost of revenue.

Research and Development Expenses

We expense our research and development costs as incurred.

Our research and development expenses consist of costs incurred for company-sponsored research and development activities, as well as

support for selected investigator-sponsored research.

Upfront payments and milestone payments we make for the in-licensing of technology are expensed as research and development in the period in which they are incurred if the technology is not

expected to have any alternative future uses other than the specific research and development project for which it was intended.

The major components of research and development costs include salaries and employee benefits, stock-based compensation expense, supplies and materials, preclinical study costs, expensed licensed

technology, consulting, scientific advisors and other third-party costs, and allocations of various overhead costs related to our research and development efforts.

We have contracted with third parties to perform various studies.

The financial terms of these agreements vary from contract to contract and may result in uneven payment flows.

We accrue for third

party expenses based on estimates of the services received and efforts expended during the reporting period.

If the actual timing of the performance of the services or the level of effort varies from the estimate, the accrual is adjusted

The expenses for some third-party services may be recognized on a straight-line basis if the expected costs are expected to be incurred ratably during the period.

Payments under the contracts depend on factors such as the achievement

of certain events or milestones, the successful enrollment of patients, the allocation of responsibilities among the parties to the agreement, and the completion of portions of the clinical study or trial or similar conditions.

General and Administrative Expenses

Our general and administrative expenses consist primarily of salaries, benefits and other costs, including equity-based compensation, for our executive and administrative personnel, legal and other

professional fees, travel, insurance, and other corporate costs.

Results of Operations

Comparison of the Three Months Ended March 31, 2024 and 2023

Three months ended March 31,

(In thousands)

the amount of consideration we expect to recognize as revenue that is not probable of having a significant reversal of such recognized

revenue, and we place a constraint on the remaining contractual consideration.

As it becomes evident that the constrained amounts are

no longer at risk of a significant reversal of revenue, we will remove the constraint from the related revenue and recognize a cumulative

catch-up adjustment to revenue in the period in which the constraint was removed.

For additional information, see Note 3 to the accompanying

condensed consolidated financial statements.

recognize direct labor and supplies associated with generating our revenue as cost of revenues.

As provided for in the amended and restated

exclusive license agreement we entered into with Factor Limited (the “A&R Factor License Agreement”) discussed in Note

9 to the accompanying condensed consolidated financial statements, we are obligated to pay Factor Limited 20% of any amounts we receive

from a customer that is related to the licensed technology under the A&R Factor License Agreement, which we also recognize as a cost

and Development Expenses

expense our research and development costs as incurred.

Our research and development expenses consist of costs incurred for company-sponsored

research and development activities, as well as support for selected investigator-sponsored research.

Upfront payments and milestone

payments we make for the in-licensing of technology are expensed as research and development in the period in which they are incurred

if the technology is not expected to have any alternative future uses other than the specific research and development project for which

it was intended.

major components of research and development costs include salaries and employee benefits, stock-based compensation expense, supplies

and materials, preclinical study costs, expensed licensed technology, consulting, scientific advisors and other third-party costs, and

allocations of various overhead costs related to our research and development efforts.

have contracted with third parties to perform various studies.

The financial terms of these agreements vary from contract to contract

and may result in uneven payment flows.

We accrue for third party expenses based on estimates of the services received and efforts expended

during the reporting period.

If the actual timing of the performance of the services or the level of effort varies from the estimate,

the accrual is adjusted accordingly.

The expenses for some third-party services may be recognized on a straight-line basis if the expected

costs are expected to be incurred ratably during the period.

Payments under the contracts depend on factors such as the achievement of

certain events or milestones, the successful enrollment of patients, the allocation of responsibilities among the parties to the agreement,

and the completion of portions of the clinical study or trial or similar conditions.

and Administrative Expenses

general and administrative expenses consist primarily of salaries, benefits and other costs, including equity-based compensation, for

our executive and administrative personnel, legal and other professional fees, travel, insurance, and other corporate costs.

of Operations

of the Three and Six Months Ended June 30, 2024 and 2023

Three months ended

Six months ended

Cost of revenues

2 unchanged sentences

General and administrative

Acquisition of Exacis in-process research and development

Total operating expenses

Loss from operations

Other expense, net:

Other (expense) income, net:

Change in fair value of warrant liabilities

Change in fair value of contingent consideration

Loss on non-controlling investment

Interest (expense) income, net

Total other expense, net

Other expense, net

Total other (expense) income, net

Loss before income taxes

Provision for income taxes

During the three March 31, 2024, we recognized revenue related to the cell line customization activities that we are performing for a third party.

We did not perform any such activities, or

otherwise recognize any revenue, during the three months ended March 31, 2023.

Cost of Revenue

During the three months ended March 31, 2024, our cost of revenues included direct labor and materials to perform the customization cell line activities for a third party.

During the three months

ended March 31 2023, we received a $0.3 upfront payment pursuant to a customer contract with this third party.

Although the $0.3 million was recorded as deferred revenue as of March 31, 2023, the obligation to pay Factor Limited the 20% license fee

was incurred upon receipt of the payment from the third party, and was therefore recognized as a cost of revenue during the three months ended March 31, 2023.

As of March 31, 2024, the $0.3 upfront payment continues to be recognized in long-term

deferred revenue in the accompanying condensed consolidated balance sheet.

Research and Development Expenses

Three months ended March 31,

the three and six months ended June 30, 2024, we recognized revenue related to the cell line customization activities that we are performing

for a third party.

We did not perform any such activities, or otherwise recognize any revenue, during the three or six months ended

June 30, 2023.

the three and six months ended June 30, 2024, our cost of revenues included direct labor and materials to perform the customization cell

line activities for a third party.

During the six months ended June 30, 2023, we received a $0.3 upfront payment pursuant to a customer

contract with this third party.

Although the $0.3 million was recorded as deferred revenue as of June 30, 2023, the obligation to pay

Factor Limited the 20% license fee was incurred upon receipt of the payment from the third party, and was therefore recognized as a cost

of revenue during the six months ended June 30, 2023.

There were no such costs recognized during the three months ended June 30, 2023.

As of June 30, 2024, the $0.3 upfront payment continues to be recognized in long-term deferred revenue in the accompanying condensed

consolidated balance sheet.

and Development Expenses

Three months ended June 30,

(in thousands)

Payroll-related

Stock-based compensation

Other expenses, net

Total research and development expenses

Six months ended June 30,

(in thousands)

Professional fees

3 unchanged sentences

Total research and development expenses

Total research and development expenses decreased by approximately $0.2 million for the three months ended March 31, 2024 when compared to the three months ended March 31, 2023 primarily due to a

decrease in professional fees related to closing down a clinical trial we ended in 2022 and other miscellaneous expenses, partially offset by increased payroll expense due to severance recognized during the three months ended March 31, 2024.

General and Administrative Expenses

Three months ended March 31,

research and development expenses decreased by approximately $0.5 million for the three months ended June 30, 2024 when compared to the

three months ended June 30, 2023 primarily due to a decrease in payroll-related expenses from a reduction in headcount as well as a reduction

in other expenses related to closing down a clinical trial we ended in 2022.

research and development expenses decreased $0.7 million for the six months ended June 30, 2024 when compared to the six months ended

June 30, 2023 primarily related to a decrease in expenses related to closing down the clinical trial from 2022 as well as a reduction

in ongoing research expenses.

and Administrative Expenses

Three months ended June 30,

(in thousands)

Occupancy expense

Stock-based compensation

Payroll-related

Professional fees

Other expenses, net

Total general and administrative expenses

Six months ended June 30,

(in thousands)

Occupancy expense

Stock-based compensation

Payroll-related

Professional fees

Other expenses, net

Total general and administrative expenses

Our general and administrative expenses increased by approximately $0.7 million for the three months ended March 31, 2024 when compared to the three months ended March 31, 2023 primarily due to

increased occupancy expense related to the Somerville sublease that we began to incur in July 2023, as well as increased payroll related to increased general and administrative headcount.

These increases were partially offset by decreases in

professional fees related to legal services, insurance expense due to lower premiums and stock-based compensation expense resulting from a decrease in the fair value of stock options expensed during the three months ended March 31, 2024 compared to

the fair value of the stock options expensed during the three months ended March 31, 2023.

Change in Fair Value of Warrant Liabilities

For the three months ended March 31, 2024 and 2023, we recognized expense related to the change in the fair value of warrant liabilities due to an increase in the market price of our common stock.

Loss on Non-Controlling Investment

We account for our 25% non-controlling investment in NoveCite, Inc.

general and administrative expenses increased by approximately $1.3 and $2.0 million for the three and six months ended June 30, 2024,

respectively, when compared to the three and six months ended June 30, 2023 primarily due to increased occupancy expense related to the

Somerville sublease that we began to incur in July 2023.

The increase in occupancy expense was partially offset by decreases in professional fees related

to legal services and consultants, insurance expense due to lower premiums and payroll-related expenses resulting from a decrease severance

expense during the three and six months ended June 20, 2024 compared to the three and six months ended June 30, 2023.

of Exacis In-Process Research and Development

April 2023, we acquired from Exacis Biotherapeutics Inc.

(“Exacis”) substantially all of its intellectual property

assets, including all of its right, title and interest in and to an exclusive license agreement by and between Exacis and Factor

Limited (the “Purchased License”).

The Purchased License was determined to be an in-process research and development

(“IPR&D”) asset that has no alternative future use and no separate economic value from its original intended

purpose, which is expensed in the period the cost is incurred.

As a result, we expensed the fair value of the Purchased License of

approximately $0.5 million during the three and six month ended June 30, 2023.

For additional information, see Note 3 to the

accompanying consolidated financial statements included in this report.

There was no similar transaction during the three or six

months ended June 30, 2024.

in Fair Value of Warrant Liabilities

recognized credits of approximately $0.1 million in each of the three and six months ended June 30, 2024 for the change in the fair value

of warrant liabilities due to a decrease in the market price of our common stock as of June 30, 2024.

For the three and six months ended

June 30, 2023, we recognized credits of $0.2 million and $0.1 million, respectively, for the change in the fair value of warrant liabilities

due to a decrease in the market price of our common stock as of June 30, 2023.

in Fair Value of Contingent Consideration

the closing date of the acquisition of assets from Exacis in April 2023, we recognized a contingent consideration

liability of $0.2 million for future payments that may be payable to Exacis, which was included as part of the $0.5 million fair

value of the Purchased License asset and expensed as IPR&D for the three and six months ended June 30, 2023.

This contingent

consideration liability is remeasured at each period end, and any change in the fair value of the contingent liability is recognized

in the statement of operations.

As of June 30, 2023, we remeasured the contingent liability and recognized a credit of $0.1 million

for both the three and six months ended June 30, 2023 due to the decrease in the fair value of the contingent consideration

As of June 30, 2024, we remeasured the contingent liability and recognized a credit of $0.1 million for both the three

and six months ended June 30, 2024 due to the decrease in the fair value of the contingent consideration liability.

on Non-Controlling Investment

account for our 25% non-controlling investment in NoveCite, Inc.

(“NoveCite”) under the equity method.

We have not guaranteed any obligations of NoveCite, nor are we otherwise committed to

providing further financial support for NoveCite.

Therefore, we only record 25% of NoveCite’s losses up to our investment carrying amount..

As a result, we did not recognize additional losses related to NoveCite for the three months ended March 31,

For the three months ended March 31, 2023, we recognized approximately $0.1 million of loss.

Interest (Expense) Income, net

We recognized an increase in interest expense for the three months ended March 31, 2024 of approximately $0.8 million primarily due to approximately $0.4 million of interest related to the

convertible notes as well as the amortization of the debt discount and debt issuance costs associated with the convertible note financings of approximately $0.4 million.

There were no convertible notes (or similar debt instruments) outstanding

during the three months ended March 31, 2023.

This increase in expense was partially offset by an increase in interest income from our cash that was deposited into interest-bearing accounts.

Provision for Income Taxes

During 2024, we expect to incur state income tax liabilities related to our operations.

We have established a full valuation allowance for all deferred tax assets, including our net

operating loss carryforwards, since we could not conclude that we were more likely than not able to generate future taxable income to realize these assets.

The effective tax rate differs from the statutory tax rate due primarily to our full valuation

Liquidity and Capital Resources

At March 31, 2024, we had cash and cash equivalents of approximately $9.2 million, of which approximately $4.1 million was restricted cash (see—Material Cash Requirements—Somerville Sublease,

below) and an accumulated deficit of approximately $193.6 million.

We have to date incurred operating losses, and we expect these losses to continue in the future.

For the three months ended March 31, 2024, we incurred a net loss of $6.6 million,

and we used $3.7 million in operating activities.

Currently, our sole source of liquidity is through sales of our common stock under the standby equity purchase agreement (the “SEPA”) we entered into with Lincoln Park Capital Fund, LLC (“Lincoln

Park”) in April 2023, pursuant to which Lincoln Park committed to purchase up to $10.0 million of our common stock.

Such sales of common stock by us, if any, are subject to certain conditions and limitations set forth in the SEPA, including a

condition that we may not direct Lincoln Park to purchase any shares of common stock under the SEPA if such purchase would result in Lincoln Park beneficially owning more than 4.99% of our issued and outstanding shares of common stock.

the SEPA may occur from time to time, at our sole discretion, through April 2025.

To date, we have issued and sold approximately 214,000 shares of our common stock to Lincoln Park, including the 74,000 commitment shares, and have received

approximately $0.3 million in gross proceeds from such sales.

We sold no shares under the SEPA during the three months ended March 31, 2024.

Based on our current financial condition and forecasts of available cash, we will not have sufficient capital to fund our operations for the 12 months following the issuance date of the

accompanying condensed consolidated financial statements.

We can provide no assurance that we will be able to obtain additional capital when needed, on favorable terms, or at all.

If we cannot raise capital when needed, on favorable terms or at

all, we will need to reevaluate our planned operations and may need to reduce expenses, file for bankruptcy, reorganize, merge with another entity, or cease operations.

If we become unable to continue as a going concern, we may have to liquidate

our assets, and might realize significantly less than the values at which they are carried on our financial statements, and stockholders may lose all or part of their investment in our common stock.

See the risk factor in Item 1A of Part II of our

2023 10-K titled, “We will require substantial additional capital to fund our operations, and if we fail to obtain the necessary financing, we may not be able to pursue our business strategy.”

Historically, the cash used to fund our operations has come from a variety of sources and predominantly from sales of shares of our common stock and of convertible notes.

We will continue to

evaluate and plan to raise additional funds to support our working capital needs through public or private equity offerings, debt financings, strategic partnerships, out-licensing our intellectual property or other means.

There can be no assurance

that capital will be available when needed or that, if available, it will be obtained on terms favorable to us and our stockholders.

Our ability to raise capital through sales of our common stock will depend on a variety of factors including, among

others, market conditions, the trading price and volume of our common stock, and investor sentiment.

In addition, macroeconomic factors and volatility in the financial market, which may be exacerbated in the short term by concerns over inflation,

interest rates, impacts of the wars in Ukraine and the Middle East, strained relations between the U.S.

and several other countries, and social and political discord and unrest in the U.S., among other things, may make equity or debt financings

more difficult, more costly or more dilutive to our stockholders.

In addition, equity or debt financings may have a dilutive effect on the holdings of our existing stockholders, and debt financings may subject us to restrictive covenants, operational restrictions

and security interests in our assets.

If we raise capital through collaborative arrangements, we may be required to relinquish some rights to our technologies or grant sublicenses on terms that are not favorable to us.

We prepared the accompanying condensed consolidated financial statements on a going concern basis, which assumes that we will realize our assets and satisfy our liabilities in the normal course of

As discussed above, there is substantial doubt about our ability to continue as a going concern because we do not have sufficient cash to satisfy our working capital needs and other liquidity requirements over at least the next 12 months

from the date of issuance of the accompanying condensed consolidated financial statements.

The accompanying condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and

reclassification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty of our ability to remain a going concern.

In addition, while we are not presently pursuing product development, we may do so in the future.

Developing product candidates, conducting clinical trials and commercializing products requires

substantial capital, and we would need to raise substantial additional funds if we were to pursue the development of one or more product candidates.

Cash flows from operating, investing and financing activities, as reflected in the accompanying condensed consolidated statements of cash flows, are summarized as follows:

For the three months ended

We have not guaranteed

any obligations of NoveCite, nor are we otherwise committed to providing further financial support for NoveCite.

Therefore, we only record

25% of NoveCite’s losses up to our investment carrying amount..

As a result, we did not recognize additional losses related to

NoveCite for the three or six months ended June 30, 2024.

We recognized a de minimus loss related to NoveCite for the three months ended

June 30, 2023 and a loss of approximately $0.1 million for the six months ended June 30, 2023.

(Expense) Income, net

recognized an increase in interest expense for the three and six months ended June 30, 2024 of approximately $0.8 million and $1.6

million, respectively, primarily due to approximately $0.4 million and $0.8 million of interest for the three and six months ended

June 30, 2024, respectively, related to the convertible notes as well as the amortization of the debt discount and debt issuance

costs associated with the convertible note financings of approximately $0.5 million and $0.9 million for the three and six months

ended June 30, 2024, respectively.

This increase in interest expense was partially offset by an increase in interest income of $0.1

million in each of the three and six months ended June 30, 2024 from our cash deposited into interest-bearing accounts.

There were no convertible notes (or similar debt instruments) outstanding during the three or six

months ended June 30, 2023.

the three and six months ended June 30, 2023, we recognized $0.3 million of other expense, all of which related to the value of the

commitment shares issued to Lincoln Park Capital Fund, LLC (“Lincoln Park”) under a standby equity purchase agreement

(“SEPA”) we entered into in April 2023 as well as other associated fees.

We did not recognize any such expense during

the three or six months ended June 30, 2024.

for Income Taxes

2024, we expect to incur state income tax liabilities related to our operations.

We have established a full valuation allowance for all

deferred tax assets, including our net operating loss carryforwards, since we could not conclude that we were more likely than not able

to generate future taxable income to realize these assets.

The effective tax rate differs from the statutory tax rate due primarily to

our full valuation allowance.

and Capital Resources

June 30, 2024, we had cash and cash equivalents of approximately $6.7 million, of which approximately $4.1 million was restricted cash and an accumulated deficit of approximately $199.2 million.

have to date incurred operating losses, and we expect these losses to continue in the future.

For the three and six months ended June

30, 2024, we incurred a net loss of $5.5 million and $12.2 million, respectively.

For the six months ended June 30, 2024, we used $6.0

million in operating activities.

our sole source of liquidity is through sales of our common stock under the SEPA, pursuant to which Lincoln Park committed to

purchase up to $10.0 million of our common stock.

Such sales of common stock by us, if any, are subject to certain conditions and

limitations set forth in the SEPA, including a condition that we may not direct Lincoln Park to purchase any shares of common stock

under the SEPA if such purchase would result in Lincoln Park beneficially owning more than 4.99% of our issued and outstanding

shares of common stock.

Sales under the SEPA may occur from time to time, at our sole discretion, through April 2025.

have issued and sold approximately 214,000 shares of our common stock to Lincoln Park, including the approximately 74,000 commitment

shares, and have received approximately $0.3 million in gross proceeds from such sales.

We sold no shares under the SEPA during the

six months ended June 30, 2024.

on our current financial condition and forecasts of available cash, we will not have sufficient capital to fund our operations for the

12 months following the issuance date of the accompanying condensed consolidated financial statements.

We can provide no assurance that

we will be able to obtain additional capital when needed, on favorable terms, or at all.

If we cannot raise capital when needed, on favorable

terms or at all, we will need to reevaluate our planned operations and may need to reduce expenses, file for bankruptcy, reorganize,

merge with another entity, or cease operations.

If we become unable to continue as a going concern, we may have to liquidate our assets,

and might realize significantly less than the values at which they are carried on our financial statements, and stockholders may lose

all or part of their investment in our common stock.

See the risk factor in Item 1A of Part II of our 2023 10-K titled, “We will

require substantial additional capital to fund our operations, and if we fail to obtain the necessary financing, we may not be able to

pursue our business strategy.”

Historically,

the cash used to fund our operations has come from a variety of sources and predominantly from sales of shares of our common stock and

of convertible notes.

We will continue to evaluate and plan to raise additional funds to support our working capital needs through public

or private equity offerings, debt financings, strategic partnerships, out-licensing our intellectual property or other means.

be no assurance that capital will be available when needed or that, if available, it will be obtained on terms favorable to us and our

stockholders.

Our ability to raise capital through sales of our common stock will depend on a variety of factors including, among others,

market conditions, the trading price and volume of our common stock, and investor sentiment.

In addition, macroeconomic factors and volatility

in the financial market, which may be exacerbated in the short term by concerns over inflation, interest rates, impacts of the wars in

Ukraine and the Middle East, strained relations between the U.S.

and several other countries, and social and political discord and unrest

in the U.S., among other things, may make equity or debt financings more difficult, more costly or more dilutive to our stockholders.

addition, equity or debt financings may have a dilutive effect on the holdings of our existing stockholders, and debt financings may

subject us to restrictive covenants, operational restrictions and security interests in our assets.

If we raise capital through collaborative

arrangements, we may be required to relinquish some rights to our technologies or grant sublicenses on terms that are not favorable to

prepared the accompanying condensed consolidated financial statements on a going concern basis, which assumes that we will realize our

assets and satisfy our liabilities in the normal course of business.

As discussed above, there is substantial doubt about our ability

to continue as a going concern because we do not have sufficient cash to satisfy our working capital needs and other liquidity requirements

over at least the next 12 months from the date of issuance of the accompanying condensed consolidated financial statements.

The accompanying

condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability

and reclassification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty

of our ability to remain a going concern.

addition, while we are not presently pursuing product development, we may do so in the future.

Developing product candidates, conducting

clinical trials and commercializing products requires substantial capital, and we would need to raise substantial additional funds if

we were to pursue the development of one or more product candidates.

flows from operating, investing and financing activities, as reflected in the accompanying condensed consolidated statements of cash

flows, are summarized as follows:

For the six months ended

(in thousands)

4 unchanged sentences

Net decrease in cash and cash equivalents

Net Cash Used in Operating Activities

There was a decrease of approximately $2.3 million in cash used in operating activities for the three months ended March 31, 2024 compared to the same period in 2023.

This change was due to a

decrease in cash used in operating assets and liabilities of $2.5 million, primarily related to accounts payable and accrued expenses, partially offset by a $0.2 million increase in net loss, after giving effect to adjustments made for non-cash

transactions, for the three months ended March 31, 2024 compared to the same period in 2023.

Net Cash Used in Investing Activities

We used approximately $0.1 million to pay for the purchases of property and equipment during the three months ended March 31, 2024.

There were no investing activities during the three months ended

March 31, 2023.

Net Cash Provided by Financing Activities

Net cash provided by financing activities for the three months ended March 31, 2024 includes approximately $1.4 million of proceeds received from the second closing of the December 2023 convertible

notes financing that occurred in January 2024.

There were no financing activities during the three months ended March 31, 2023.

Cash Used in Operating Activities

was a decrease of approximately $3.9 million in cash used in operating activities for the six months ended June 30, 2024 compared to

the same period in 2023.

This change was due to a decrease in cash used in operating assets and liabilities of $4.2 million,

primarily related to increased accounts payable, accrued expenses and operating lease liabilities, partially offset by a $0.3

million increase in net loss, after giving effect to adjustments made for non-cash transactions, for the six months ended June 30,

2024 compared to the same period in 2023.

Cash Used in Investing Activities

used approximately $0.3 million to pay for the purchases of property and equipment during the six months ended June 30, 2024.

no investing activities during the six months ended June 30, 2023.

Cash Provided by Financing Activities

cash provided by financing activities for the six months ended June 30, 2024 includes approximately $1.4 million of proceeds received

from the second closing of the December 2023 convertible notes financing that occurred in January 2024 .

Net cash provided by financing

activities for the six months ended June 30, 2023 includes approximately $0.3 million of proceeds received from selling approximately

214,000 shares to Lincoln Park under the SEPA.

The Company did not sell any shares under the SEPA during the six months ended June 30,

Material Cash Requirements

Somerville Sublease

In October 2022, we entered into a sublease for approximately 45,500 square feet of office and laboratory space in Somerville, Massachusetts.

The term of the sublease is approximately 10 years,

and our base rent obligations over the term is estimated to be approximately $63.0 million, plus our share of the sublessor’s parking spaces and operating expenses.

Our base rent obligations under the sublease during 2024 are expected to be $0.5

million per month.

As part of the sublease, we delivered a security deposit in the form of a letter of credit in the amount of $4.1 million, which will be reduced on an incremental basis throughout the term of the sublease.

The letter of credit

was issued by our commercial bank, which required that we cash collateralize the letter of credit with $4.1 million of cash deposited in a restricted account maintained by such bank.

The amount of required restricted cash collateral will decline

in parallel with the reduction in the amount of the letter of credit over the term of the sublease.

On May 3, 2024, we received a notice from the sublessor regarding past due rent payments of approximately $2.3 million, including our share of amounts related to property taxes and common area

maintenance costs, that we have not paid for the months of February, March, April and May 2024.

Failure to pay the past due rent payments in full, plus approximately $70,000 in late fees and interest, within five business days from the date of the

notice constitutes an event of default under the sublease.

We had discussions with the Sublessor subsequent to receiving notice about remedying the event of default, and as a result of those discussions, we did not pay any of the past due rent

payments or any of the late fees or interest within such five business day period.

We also have been in, and intend to continue, discussions with the sublessor to renegotiate the terms of the sublease, which may include, among other things,

deferment of rent payments and/or a reduction of the lease term, square footage, and/or base rent.

If an event of default exists under the sublease, beyond applicable notice and cure periods, the sublessor may draw down the letter of credit and use, apply or retain such portion of the proceeds

from the letter of credit as may be necessary (i) for the payment of any rent or any other sum in default, (ii) for the payment of any other amount which the sublessor may, in accordance with the terms of the sublease, spend or become obligated to

spend by reason of our default, or (iii) to compensate the sublessor, in accordance with the terms of the sublease, for any other loss or damage which the sublessor may suffer by reason of our default, including costs and reasonable attorneys’ fees

incurred by the sublessor to recover possession of the premises following a default by us.

As of the date of filing of this report, the sublessor has not drawn down on the letter of credit.

The use or application of the proceeds from the letter of

credit or any portion thereof does not prevent the sublessor from exercising any other right or remedy provided under the sublease or under law.

If any portion of the letter of credit is so used or applied, we must, upon demand therefor, amend the

letter of credit, provide an additional letter of credit or deposit cash with the sublessor, in each such case in an amount sufficient to restore the security deposit within 10 business days to the appropriate amount.

See the risk factor titled,

“Our monthly rent payment obligations under our sublease are significant and we currently owe approximately $2.3 million in past due rent.

An event of default under our sublease could be an event of default under our outstanding convertible notes,”

Risk Factors of Part II of this report.

Convertible Notes

As of the date of this report, the aggregate amount outstanding under our convertible notes, including accrued interest that has been paid in-kind, is $18.5 million, of which $9.0 million and $9.5

million relates to the July 2023 convertible notes and the December 2023 convertible notes, respectively.

Unless earlier called for redemption by the holders thereof, the convertible notes mature on the five-year anniversary of their date of

of the filing date of this report, the aggregate amount outstanding under our convertible notes, including accrued interest that has

been paid in-kind, is $19.0 million, of which $9.2 million and $9.8 million relates to the July 2023 convertible notes and the

December 2023 convertible notes, respectively.

Unless earlier called for redemption by the holders thereof, the convertible notes

mature on the five-year anniversary of their date of issuance.

We may not redeem any of the convertible notes prior to maturity.

See Note 4 to the accompanying condensed consolidated financial statements for additional information.

See also the risk factor titled, “Our monthly rent payment

obligations under our sublease are significant and we currently owe approximately $2.3 million in past due rent.

An event of default under our sublease could be an event of default under our outstanding convertible notes,” in Item 1A.

of Part II of this report.

Critical Accounting Estimates

There were no significant changes in our critical accounting estimates during the three months ended March 31, 2024 from those described in “Management’s Discussion and Analysis of Financial

Condition and Results of Operations” section of the 2023 10-K.

Recent Accounting Pronouncements

No new Accounting Standards Updates have been issued by the Financial Accounting Standards Board since January 1, 2024 that

would apply to us that are not disclosed in the 2023 10-K.

Note 4 to the accompanying condensed consolidated financial statements for additional information.

Accounting Estimates

were no significant changes in our critical accounting estimates during the three months ended June 33, 2024 from those described in

“Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of the 2023 10-K.

Accounting Pronouncements

new Accounting Standards Updates have been issued by the Financial Accounting Standards Board since

January 1, 2024 that would apply to us that are not disclosed in the 2023 10-K.

Quantitative and Qualitative Disclosures About Market Risk.

Under the rules and regulations of the SEC, as a smaller reporting company we are not required to provide the information otherwise required by this item.

the rules and regulations of the SEC, as a smaller reporting company we are not required to provide the information otherwise required

by this item.

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