What changed in this filing

/stocks — the workspaceLOADING

Item 7. Management’s Discussion and Analysis

2025-03-31 compared with 2024-04-16 · 255 added, 153 removed, 258 unchanged (61% of the section changed)

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who work together to ensure that the most promising innovations make it into the hands of people who need them most.

were incorporated in the State of Delaware on September 28, 2017, and our headquarters are in Richmond, Virginia.

The company was founded

with a mission of bringing stakeholders together, to transform promising innovations into products and services that could address some

of the most challenging needs.

were incorporated in the State of Delaware on September 28, 2017, and our headquarters are in Mountain View, California.

The company was

founded with a mission of bringing stakeholders together, to transform promising innovations into products and services that could address

some of the most challenging needs.

The socialization of innovation through engaging stakeholders in every aspect of it, is key to transforming

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(“Adimune”) is focused on leading our immune modulation therapeutic programs.

proprietary immune modulation product candidate, ADI-100™, based on the Apoptotic DNA Immunotherapy™ platform technology,

utilizes a novel approach that mimics the way our bodies naturally induce tolerance to our own tissues.

It includes two DNA molecules

designed to deliver signals to induce tolerance.

ADI-100 has been successfully tested in several preclinical models (e.g., skin grafting,

psoriasis, type 1 diabetes, multiple sclerosis).

May 2023, Adimune entered into a clinical trial agreement with Mayo Clinic to advance clinical studies targeting autoimmune diseases of

the central nervous system (“CNS”) with the initial focus on the rare, but debilitating, autoimmune disease Stiff Person Syndrome

According to the National Organization of Rare Diseases, the exact incidence and prevalence of SPS is unknown;

one estimate places the incidence at approximately one in one million individuals in the general population.

approval by the International Review Board and U.S.

Food and Drug Administration, a human trial for SPS is expected get underway in the first half of 2024 with

enrollment of up to 20 patients, some of whom may also have type 1 diabetes.

ADI-100 will initially be tested for safety and

ADI-100 is designed to tolerize against an antigen known as glutamic acid decarboxylase (“GAD”), which is

implicated in type-1 diabetes, psoriasis, stiff person syndrome, and in many autoimmune diseases of the CNS.

IND-enabling work is also near completion in support of a Clinical Trial Application submission to the Paul Ehrlich

Institute, the regulatory agency in Germany, to initiate clinical trials in psoriasis and type 1 diabetes.

proprietary immune modulation product Apoptotic DNA Immunotherapy™ (ADI™) utilizes a novel approach that mimics the way our

bodies naturally induce tolerance to our own tissues.

It includes two DNA molecules designed to deliver signals to induce tolerance.

the first product candidate based on the ADI platform, is designed to tolerize against an antigen known as glutamic acid decarboxylase

(“GAD”), which is implicated in type-1 diabetes, psoriasis, and in many autoimmune diseases of the CNS and has been successfully

tested in several preclinical models (e.g., skin grafting, psoriasis, type 1 diabetes, multiple sclerosis).

preclinical studies ADI-100 have been completed providing several data points supporting the potential effectiveness of ADI-100 in restoring

durable tolerance over the 10-month duration of the T1D studies both in prevention and treatment study designs.

Preclinical safety and

toxicology studies have shown absence of drug toxicity, no antibody formation to the drug product, and a lack of persistence in all organs

Furthermore, Adimune has demonstrated in three separate preclinical studies that ADI-100 does not impair the responsiveness

of the immune system to combat infection, cancer, or the tumor fighting capabilities of checkpoint inhibitors.

Manufacturing Process (GMP) clinical-grade drug substances have been successfully manufactured by a qualified contract manufacturer.

clinical grade drug substances are now being prepared for shipment to another contract manufacturer to be formulated into the final drug

product in preparation for stability testing and use in the clinical trials pending required regulatory submissions.

Lastly, two remaining

drug product release assays specifically designed for ADI-100 are in the final stages of validation to be used once the final drug product

and manufacturing data, including the clinical-grade drug substance, are essential components of the complete dossier that we intend to

submit to the regulatory agencies, which evaluate the safety and quality of the final drug product to be administered in the clinical

Adimune has had pre-submission meetings with the regulatory agency in Germany and has completed the additional studies requested.

the clinical trials that are planned in Germany, Adimune has engaged with a Contract Research Organization (CRO) to manage the process,

including site selection for clinical studies planned in psoriasis and type 1 diabetes.

In parallel, Adimune is working with the Mayo

Clinic to prepare the IND package for FDA submission and is awaiting a pre-IND meeting expected in the second quarter of this year to

review the package before full submission.

In May 2023, Adimune entered into a clinical trial agreement with Mayo Clinic to advance clinical

studies targeting autoimmune diseases of the central nervous system (“CNS”) with the initial focus on the rare, but debilitating,

autoimmune disease Stiff Person Syndrome (“SPS”).

According to the National Organization of Rare Diseases, the exact incidence

and prevalence of SPS is unknown;

however, one estimate places the incidence at approximately one in one million individuals in the general

Pending approval by the International Review Board and U.S.

Food and Drug Administration, a human trial for SPS is expected

get underway in 2025 with enrollment of 10-20 patients, some of whom may also have type 1 diabetes.

ADI-100 will initially

be tested for safety and efficacy.

discovery of immunosuppressive (anti-rejection and monoclonal) drugs over 40 years ago has made possible life-saving organ transplantation

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PEARSANTA, INC.

in January 2023, our subsidiary Pearsanta™, Inc.

(“Pearsanta”) seeks to take personalized medicine to a whole new level

by delivering “Health by the Numbers.” Since its founding, Pearsanta has been building the platform for enabling our vision

of lab quality testing, anytime, anywhere.

Our plan for Pearsanta’s platform is for it to be the transactional backbone for sample

collection, sample processing (on- and off-site), and reporting.

This will require the development and convergence of multiple components

developed by Pearsanta, or through transactions with third parties, including collection devices, “lab-on-a-chip” technologies,

Lab Developed Test (LDT) assays, a data-driven analysis engine, and telemedicine.

According to a comprehensive research report by Market

Research Future, the clinical and consumer diagnostic market is estimated to hit $429.3 billion by 2030.

We believe that timely and

personalized testing enables far more informed treatment decisions.

Pearsanta’s platform is being developed as a seamless digital

healthcare solution.

This platform will integrate at-location sample collection, Point-of-Care (“POC”) and LDT assays, and

an analytical reporting engine, with telemedicine-enabled visits with licensed physicians to review test results and, if necessary, order

a prescription.

Pearsanta’s goal of extending its platform to enable consumers to monitor their health more proactively as the goal

is to provide a more complete picture about someone’s dynamic health status, factoring in genetic makeup and their response to medication.

The POC component of Pearsanta would enable diagnostic testing at-home, at work, in pharmacies, and more to generate results quickly so

that an individual can access necessary treatment faster.

With certain infections, prescribing the most effective treatment according

to one’s numbers can prevent hospital emergency room admissions and potentially life-threatening consequences.

of indication-focused tests for the Test2Treat platform will include the evaluation for advanced urinary tract infections (“UTIs”),

COVID-19/flu/respiratory syncytial virus, sexually transmitted infections, gut health, pharmacogenomics (i.e., how your genes affect the

way your body responds to certain therapeutics), and sepsis.

We believe that these offerings are novel and needed as the current standard

of care using broad spectrum antibiotic treatment can be ineffective and potentially life-threatening.

For example, improperly prescribed

antibiotics may approach 50% of outpatient cases.

Further, according to an article published in Physician’s Weekly, only 1% of board-certified

critical care medicine physicians are trained in infectious disease.

The best approach may be its

early detection.

Pearsanta is pioneering the development of molecular tests based on the mitochondrial genome to develop tests for early

detection of cancer.

Though further technical development and clinical validation is required to determine efficacy in multiple diseases

and disease states, our management believes that the unique structural and functional characteristics of mitochondrial DNA (mtDNA), and

more specifically mutated mtDNA, make mtDNA a biological system for biomarker identification, early disease detection, monitoring, risk

assessment, and therapeutic targeting.

Pearsanta acquired the assets

of MDNA Life Sciences Inc.

on January 4, 2024.

Through the acquisition of these assets, and in particular the Mitomic Technology platform,

patents, and intellectual property, our management believes that the Pearsanta is well positioned for research and discovery of mitochondrial

DNA based biomarkers, and though untested and requiring clinical validation, the development and commercial application of mitochondrial

DNA based biomarkers for a wide spectrum of human diseases.

is continuing to leverage this technology to discover mitochondrial DNA based biomarkers.

Though Pearsanta has no commercially available

FDA or foreign regulator approved products, Pearsanta has two product candidates in develop and hopes to enter the cancer screening market

with these two product candidates, and if proven successful continue to discover mitochondrial DNA based biomarkers and develop a pipeline

of disease screening and diagnostics tests.

The current in-development products include a potential product for prostate cancer diagnosis

and a potential product for the detection of endometriosis.

Pearsanta has also discovered mitochondrial DNA based biomarkers, which it

believes are associated with ovarian cancer and lung cancer;

and Pearsanta intends to pursue the biomarker identification phase of development

for pancreatic, liver, breast, stomach, esophageal, and colorectal cancers.

Licensed Technologies

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monitoring of cell activation and levels of cytokine release (i.e., cytokine storms).

are actively involved in the regulatory approval process for AditxtScore assays for clinical use and securing manufacturing, marketing,

and distribution partnerships for application in the various markets.

To obtain regulatory approval to use AditxtScore as a clinical assay,

we have conducted validation studies to evaluate its performance in detection of antibodies and plan to continue conducting additional

validation studies for new applications in autoimmune diseases.

In collaboration with

its partners, the platforms underlying AditxtScore are being further evaluated for evaluating the immune status of individuals including

those with hypersensitivity to certain antigens (e.g., patients with autoimmunity).

These tests may become tools that can monitor dynamic

changes after administration of immunotherapies designed to tolerize to these target antigens.

sophistication of the AditxtScore technology includes the following:

greater sensitivity/specificity.

20-fold higher dynamic range, greatly reducing signal to noise compared to conventional assays.

ability to customize assays and multiplex a large number of analytes with speed and efficiency.

ability to test for cellular immune responses (i.e., T and B cells and cytokines).

proprietary reporting algorithm.

sensitivity/specificity.

higher dynamic range, greatly reducing signal to noise compared to conventional assays.

to customize assays and multiplex a large number of analytes with speed and efficiency.

to test for cellular immune responses (i.e., T and B cells and cytokines).

● proprietary

reporting algorithm.

License Agreement with Leland Stanford Junior University (“Stanford”)

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in AditxtScore TM and securing worldwide exclusivity in all fields of use of the licensed technology.

Acquired Technologies – Mitomic®

Technology Platform

In January 2024 Pearsanta acquired

the assets comprising our Mitomic® Technology platform from MDNA Life Sciences Inc.

This platform seeks to harness the unique properties

of mitochondrial DNA (“mtDNA”) to detect disease through non-invasive, blood-based liquid biopsies.

Though further technical

development and clinical validation is required to determine efficacy in multiple diseases and disease states, our management believes

that the unique structural and functional characteristics of mtDNA, and more specifically mutated mtDNA, make mtDNA a biological system

for biomarker identification, early disease detection, monitoring, risk assessment, and therapeutic targeting.

Pearsanta plans to license

distribution rights through various agreements with U.S.-based and international business partners to commercialize our Mitomic® Technology,

should Mitomic® tests be successfully developed and successfully approved by the FDA or a foreign regulator.

We believe our biomarker

portfolio covers many high-clinical need cancers, with potential applications outside oncology.

Pearsanta a state-of-the-art

facility located in Richmond VA, that is a high-complexity, CLIA-certified, and CAP-accredited laboratory equipped to accommodate rapid

development and rollout of innovative laboratory tests for the clinical market.

Our laboratory facility is optimized for contamination

prevention including dedicated workspaces for key functions;

advanced molecular biology capabilities including digital PCR, real-time

PCR, automated electrophoresis with scale-up capacity and redundancy;

and automated and semi-automated (robotic) processes for DNA/RNA

isolation and liquid handling to achieve efficient and standardized workflows.

Our Mitomic® Products and Product Candidates

The Mitomic® Technology

targets mutations in mitochondrial DNA to detect disease.

Every human cell is home to multiple copies of mitochondrial DNA, some of which

become mutated beyond repair when cells are stressed by diseases such as cancer.

Though further technical development and clinical validation

is required to determine efficacy, Mitomic® tests are being designed to detect this mutated DNA, which can accumulate from the very

early stages of a disease.

If the development of Mitomic® tests is successful and if Mitomic® tests can achieve their still unproven

objective of early disease detection, our Mitomic® Technology presents an opportunity to detect disease before it presents clinically.

The Mitomic® Technology

platform is designed to identify biomarker targets, develop robust assays, discover new biomarkers, and develop new products.

The biomarker

identification program is based on the identification of a new class of molecules generated through a process associated with mitochondria.

The Mitomic® Technology platform has already discovered biomarkers which are believed to be associated with cancer and has generated

an “in-silico” database, which is an experiment that generates thousands of potential biomarkers, developed through computer

software and simulation.

To date, the Mitomic® Technology

biomarker discoveries have identified numerous biomarker targets from the in-silico database and we plan to use these biomarker targets

in its various assay development programs.

Mitomic® Prostate Test

(MPT™) is currently in development and is being designed as a blood-based assay that quantifies the level of the 3.4kb mitochondrial

DNA deletion.

Published analytical data for the 3.4kb mitochondrial DNA deletion associated with prostate cancer, suggests the 3.4kb mitochondrial

DNA deletion may be able to identify clinically significant prostate cancer for men in the prostate-specific antigen (PSA) grey zone (PSA

< 10ng/ml) and if proven through ongoing clinical study, the 3.4kb mitochondrial DNA deletion may be able to aid in the decision to

Some of the significant clinical challenges that have not been met for prostate cancer are that up to 50% of men will be ‘over’

diagnosed with cancer that never harms them 1 and the risks associated with treatment of low-grade cancers (≤ Gleason 6)

appear to outweigh the benefits –e.g.

urinary incontinence, erectile dysfunction.

1 NIH National Cancer Institute reports

this number is even higher at ~ 75% based on 5-year survival rates.

Seer database (https://seer.cancer.gov/statfacts/html/prost.html).

Our Mitomic® Prostate Test

is in development and is being designed with the following objectives:

– The test is expected to be completed using a patient’s blood sample and is not expected to require an algorithm.

New Information – If ongoing clinical studies support the published analytical data for the 3.4kb mitochondrial DNA deletion, healthcare

providers will be provided with new information related to clinically significant prostate cancer – independent of PSA, age, and

family history.

Mitomic Endometriosis Test

(MET™) is currently in development and is being designed as a blood-based assay that quantifies the level of one or more mitochondrial

DNA deletions which published analytical data suggest are associated with endometriosis – a condition affecting approximately 1

in 10 women according to Endometriosis World and the World Health Organization.

The Mitomic Endometriosis Test is intended for use in

females of child-bearing age who present symptoms of endometriosis to determine whether medical or surgical intervention is warranted.

Endometriosis occurs when the

tissue of the uterus (endometrium) grows on areas where it does not belong, most often on the ovaries, fallopian tubes, outer surface

of the uterus, and tissues holding the uterus, but can be found almost anywhere in the body.

Endometriosis is challenging to identify,

and on average takes ten years to diagnose, and when patients are finally diagnosed, greater than 90% have moderate to severe symptoms.

Acquired Technologies – Adductomics Technology

On March 21 , 2025, Pearsanta

acquired certain patents related to the detection and analysis of DNA adducts.

DNA adducts are chemically modified nucleotides that result

from exposure to carcinogens and other damaging agents, serving as early indicators of genomic instability and increased cancer risk.

The acquired technology includes proprietary mass-tag enhancements designed to improve the sensitivity and specificity of DNA adduct detection

across a full genomic landscape.

Pearsanta intends to develop this platform to enable a comprehensive,

panoramic assessment of DNA adducts using urine, blood, or solid tissue samples.

This approach aims to provide actionable insights into

DNA damage before mutations occur, offering the potential to identify environmental or biological factors that contribute to cancer risk.

The development roadmap includes further validation of the technology and the creation of commercially available diagnostic kits.

still in the early stages, Pearsanta anticipates that additional development over the next two to three years will advance this platform

toward clinical and commercial applications.

in April of 2023, Adivir™, Inc.

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or prior to the Closing of certain conditions, including but not limited to, the following:

Satisfactory completion of due diligence;

Completion by the Company of financing sufficient to consummate the transactions contemplated by the Asset Purchase Agreement;

Receipt by the Company of all required Consents from Governmental Bodies for the Acquisition, including but not limited to, any consents required to complete the transfer and assignment of Cellvera’s membership interests in GRA;

Receipt of executed payoff letters reflecting the amount required to be fully pay all of each of Seller’s and Seller Owner’s Debt to be paid at Closing;

Receipt by the Company of a release from Agility;

Execution of an agreement acceptable to the Company with respect to the acquisition by the Company of certain intellectual property presently held by a third party;

Execution of an amendment to an asset purchase agreement previously entered into by Cellvera with a third party that effectively grants the Company the rights to acquire the intellectual property from the third party under such agreement;

Receipt of a fairness opinion by the Company with respect to the transactions contemplated by the Asset Purchase Agreement;

Receipt by the Company from the Seller Owner of written consent, whether through its official liquidator or the Board of Directors of Seller Owner, to the sale and purchase of the Acquired Assets and Assumed Liabilities pursuant to the Assert Purchase Agreement.

can be no assurance that the conditions to closing will be satisfied or that the proposed acquisition will be completed as proposed or

(i) Satisfactory

completion of due diligence;

(ii) Completion

by the Company of financing sufficient to consummate the transactions contemplated by the Asset Purchase Agreement;

(iii) Receipt

by the Company of all required Consents from Governmental Bodies for the Acquisition, including but not limited to, any consents required

to complete the transfer and assignment of Cellvera’s membership interests in GRA;

of executed payoff letters reflecting the amount required to be fully pay all of each of Seller’s and Seller Owner’s Debt

to be paid at Closing;

by the Company of a release from Agility;

(vi) Execution

of an agreement acceptable to the Company with respect to the acquisition by the Company of certain intellectual property presently held

by a third party;

(vii) Execution

of an amendment to an asset purchase agreement previously entered into by Cellvera with a third party that effectively grants the Company

the rights to acquire the intellectual property from the third party under such agreement;

(viii) Receipt

of a fairness opinion by the Company with respect to the transactions contemplated by the Asset Purchase Agreement;

by the Company from the Seller Owner of written consent, whether through its official liquidator or the Board of Directors of Seller

Owner, to the sale and purchase of the Acquired Assets and Assumed Liabilities pursuant to the Assert Purchase Agreement.

October 2024, the Company received notice that Cellvera was the subject of a liquidation proceeding and that a liquidator had been appointed

by the order of the Eastern Caribbean Supreme Court.

As a result, the Company does not presently believe that the proposed

acquisition of Cellvera will be completed as proposed or at all.

commitment to building our antiviral portfolio is strategic and timely.

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was $627,474 and $756,836, respectively.

The decrease in sales and cost of sales is due to the Company selling less AditxtScores.

During the year ended December

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31, 2023, we incurred a loss from operations of $26,062,425.

This is due to general and administrative expenses of $15,985,552, which

includes $1,516,805 in stock-based compensation, research and development of $7,268,084, which includes $591,518 in stock-based compensation,

sales and marketing expenses of $1,849,460, which includes $1,023,045 in stock-based compensation and impairment on note receivable of

The $7,268,084 in research and development is mainly comprised of $2,145,382 in consulting expenses, and $3,375,757 in compensation

offset by a one-time adjustment to research and development purchases.

During the year, the Company transitioned from purchasing certain

inventory items to internally manufacturing these items.

This is due primarily to general and administrative expenses of $18,607,142.

This includes approximately $9,641,000 in payroll expenses, $4,484,000 in professional fees, and $1,133,077 in stock-based compensation.

Research and development expenses were $7,074,339 which includes $1,815,068 in consulting expenses and $262,154 in stock-based compensation.

Sales and marketing expenses were $269,284, which includes $6,787 in stock-based compensation.

The decrease in expenses during

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of December 31, 2024.

During the year ended December 31, 2023, we purchased $14,407 in fixed assets, for which we made cash payments of

Of the $14,407, $12,356 of these purchased fixed assets were lab equipment and $2,051 was for computers.

During the year ended December 31, 2024, we purchased $0 in fixed assets.

Our consolidated financial

statements have been prepared assuming that we will continue as a going concern.

have funded our operations from proceeds from the sale of equity and debt securities.

On July 2, 2020, we completed our IPO and raised

approximately $9.5 million in net proceeds.

At the time of the IPO, we believed that these funds would be sufficient to fund our operations

for the foreseeable future.

September 10, 2020, we completed a follow-on public offering.

In connection therewith, we issued 1,200 units, or Follow-On Units, excluding

the underwriters’ option to cover overallotments, at an offering price of $8,000.00 per Follow-On Unit, resulting in gross proceeds

of approximately $9.6 million.

January 25, 2021, the Company entered into a securities purchase agreement with an institutional accredited investor (the “Investor”)

for the sale of a $6,000,000 senior secured convertible note (the “Convertible Note”).

The Convertible Note had a term of

24 months, was originally convertible at a price of $8,000.00 per share and was issued at an original issuance discount of $1,000,000.

On August 30, 2021, the Company entered into a defeasance and waiver agreement with the Investor, pursuant to which the Noteholder has

agreed in exchange for (a) a cash payment by the Company to the Investor of $1.2 million (the Cash Payment”), (b) a waiver, in part

of the conversion price adjustment provision such that the January 2021 Note shall be convertible into 2,401 shares of common stock (without

giving effect to the conversion notice received by the company form the Noteholder prior to the date hereof totaling (503 shares) (the

“Shares”), and (c) a voluntary and permanent reduction by the Company of the exercise price of the warrant to purchase 400

shares of the common stock of the Company (the “January 2021 Warrant”) to $5,060 per share.

As of December 31, 2022, the outstanding

principle of the convertible note had been converted to 2,401 shares of common stock.

August 30, 2021, the Company completed a registered direct offering and raised approximately $10.1 million in net proceeds.

October 20, 2021, the Company completed a public offering for net proceeds of $3.8 million.

As part of this offering, we issued 1,417

shares of the Company’s common stock

December 6, 2021, the Company completed a public offering for net proceeds of $16.0 million.

As part of this offering, we issued 4,123

units consisting of shares of the Company’s common stock and warrant to purchase shares of the Company’s common stock and

4,164 pre-funded warrants.

The warrant issued as part of the units had an exercise price of $2,300.00 and the prefunded warrants had an

exercise price of $0.001.

September 20, 2022, the Company completed a public offering for net proceeds of $18.1 million (the “September 2022 Offering”).

As part of the September 2022 Offering, we issued 30,608 of shares of the Company’s common stock, pre-funded warrants to purchase

52,725 shares of the Company’s common stock and warrants to purchase 83,333 shares of the Company’s common stock.

warrants have an exercise price of $240.00 and the pre-funded warrants have an exercise price of $0.004.

April 20, 2023, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with an institutional

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to purchase two shares of Common Stock.

The warrants have an exercise price of $34.40 per share and are exercisable for a three-year period.

In addition, the Company issued a warrant to the placement agent to purchase up to 2,378 shares of common stock at an exercise price of

$61.00 per share.

The warrants have an exercise price of $344,000.00 per share and are exercisable for a three-year

In addition, the Company issued a warrant to the placement agent to purchase up to 1 share of common stock at an exercise price

of $600,000.00 per share.

August 31, 2023, the Company entered into a securities purchase agreement (the “August Purchase Agreement”) with an institutional

investor for the issuance and sale in a private placement (the “Private Placement”) of (i) pre-funded warrants (the “Pre-Funded

Warrants”) to purchase up to 1,000,000 shares of the Company’s common stock at an exercise price of $0.001 per share, and

(ii) warrants (the “Common Warrants”) to purchase up to 1,000,000 shares of the Company’s Common Stock at an exercise

price of $10.00 per share.

Warrants”) to purchase up to 100 shares of the Company’s common stock at an exercise price of $400.00 per share, and (ii)

warrants (the “Common Warrants”) to purchase up to 100 shares of the Company’s Common Stock at an exercise price of

$100,000.00 per share.

The Private Placement closed on September 6, 2023.

The net proceeds to the Company from the Private Placement

were approximately $9 million, after deducting placement agent fees and expenses and estimated offering expenses payable by the Company.

The Company utilized net proceeds received from the Private Placement for (i) payment of approximately $3.1 million in outstanding obligations,

The net proceeds to the Company from the Private Placement were

approximately $9 million, after deducting placement agent fees and expenses and estimated offering expenses payable by the Company.

Company utilized net proceeds received from the Private Placement for (i) payment of approximately $3.1 million in outstanding obligations,

(ii) repayment of approximately $0.4 million of outstanding debt, and (iii) continuing operating expenses and working capital.

On December 29, 2023, the

Company entered into a securities purchase agreement (the “Purchase Agreement”) with an institutional investor (“the

“Purchaser”) for the issuance and sale in a private placement (the “Private Placement”) of (i) pre-funded warrants

(the “Pre-Funded Warrants”) to purchase up to 1,237,114 shares of the Company’s common stock, par value $0.001 (the

“Common Stock”) at an exercise price of $0.001 per share, and (ii) warrants (the “Common Warrants”) to purchase

up to 2,474,228 shares of the Company’s Common Stock, at a purchase price of $4.85 per share.

On December 29, 2023, the Company

entered into a securities purchase agreement (the “Purchase Agreement”) with an institutional investor (“the “Purchaser”)

for the issuance and sale in a private placement (the “Private Placement”) of (i) pre-funded warrants (the “Pre-Funded

Warrants”) to purchase up to 124 shares of the Company’s common stock, par value $0.001 (the “Common Stock”) at

an exercise price of $10.00 per share, and (ii) warrants (the “Common Warrants”) to purchase up to 248 shares of the Company’s

Common Stock, at a purchase price of $48,500.00 per share.

The Private Placement closed on January 4, 2024.

The net proceeds to the Company from the Private Placement are expected to be approximately $5.5 million, after deducting placement

agent fees and expenses and estimated offering expenses payable by the Company.

The Company intends to use the net proceeds received from

the Private Placement for continuing operating expenses and working capital.

The net proceeds to the Company

from the Private Placement are expected to be approximately $5.5 million, after deducting placement agent fees and expenses and estimated

offering expenses payable by the Company.

The Company intends to use the net proceeds received from the Private Placement for continuing

operating expenses and working capital.

May 2, 2024, the Company entered into a Securities Purchase Agreement (the “May PIPE Purchase Agreement”) with certain accredited

investors, pursuant to which the Company agreed to issue and sell to such investors in a private placement (the “Private Placement”)

(i) an aggregate of 17 shares of the Company’s Series C-1 Convertible Preferred Stock (the “Series C-1 Convertible Preferred

Stock”), (ii) an aggregate of 17 shares of the Company’s Series D-1 Preferred Stock (the “Series D-1 Preferred Stock”),

and (iii) warrants (the “May PIPE Warrants”) to purchase up to an aggregate of 162 shares of the Company’s common stock.

The Private Placement closed on May 6, 2024.

The gross proceeds from the Private Placement were approximately $4.2 million, prior to deducting

the placement agent’s fees and other offering expenses payable by the Company.

The Company used $1.0 million of the net proceeds

to fund certain obligations under its merger agreement with Evofem Biosciences, Inc.

and the remainder of the net proceeds from the offering

for working capital and other general corporate purposes.

August 8, 2024, the Company entered into a securities purchase agreement (the “Registered Direct Purchase Agreement”) with

certain institutional investors, pursuant to which the Company agreed to sell to such investors 19 shares (the “Registered

Direct Shares”) of common stock of the Company (the “Common Stock”), pre-funded warrants (the “Registered Direct

Pre-Funded Warrants”) to purchase up to 95 shares of Common Stock of the Company (the “Registered Direct Pre-Funded

Warrant Shares”), having an exercise price of $10.00 per share, at a purchase price of $10,600.00 per share of Common

Stock and a purchase price of $10,590.00 per Registered Direct Pre-Funded Warrant (the “Registered Direct Offering”).

The shares of Common Stock and Registered Direct Pre-Funded Warrants (and shares of common stock underlying the Registered Direct Pre-Funded

Warrants) were offered by the Company pursuant to its shelf registration statement on Form S-3 (File No.

333-280757), which was declared

effective by the Securities and Exchange Commission on August 6, 2024.

closing of the sales of these securities under the Registered Direct Purchase Agreement took place on August 9, 2024.

The gross proceeds

from the offering were approximately $1.0 million, prior to deducting placement agent’s fees and other offering expenses payable

by the Company.

The Company used $500,000 of the net proceeds from the offering to fund certain obligations under its Amended and

Restated Merger agreement with Evofem Biosciences, Inc and the remainder for working capital and other general corporate purposes.

will need significant additional capital to continue to fund our operations and the clinical trials for our product candidates.

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Contractual Obligations

The following table shows

our contractual obligations as of December 31, 2023:

The following table shows our

contractual obligations as of December 31, 2024:

Payment Due by Year

Critical Accounting Polices and Estimates

Our consolidated financial

statements are prepared in accordance with generally accepted accounting principles in the United States.

The preparation of our consolidated

financial statements and related disclosures requires us to make estimates, assumptions and judgments that affect the reported amount

of assets, liabilities, revenue, costs and expenses, and related disclosures.

We believe that our critical accounting policies described

under the heading “Management’s Discussion and Analysis of Financial Condition and Plan of Operations—Critical Accounting

Policies” in our Prospectus, dated September 1, 2020, filed with the SEC pursuant to Rule 424(b), are critical to fully understanding

and evaluating our financial condition and results of operations.

The following involve the most judgment and complexity:

Research and development

Stock-based compensation expense

Preferred Stock

The preparation of financial statements in conformity with U.S.

GAAP requires management to make estimates and assumptions that affect

the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements

and the reported amounts of revenue and expense during the reporting period.

Actual results could differ from those estimates.

estimates underlying the financial statements include the value of preferred shares issued and related derivative liability, our investment

in Evofem preferred stock and the fair value of stock options and warrants.

● Fair value of options and warrants

Stock and Derivative Liabilities

● Investments

Accordingly, we believe the

45 unchanged sentences

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-K

Item 7. Management’s Discussion and Analysis