27 unchanged sentences
- molecules on certain immune cells that need to be activated (or inactivated) to start an immune response.
−Removed: Cancer cells can find
−Removed: ways to use these checkpoints to avoid being attacked by the immune system.
+Added: Cancer cells can find ways
+Added: to use these checkpoints to avoid being attacked by the immune system.
are developing small molecules that we believe can specifically target these central checkpoints.
28 unchanged sentences
have sought to develop a broad portfolio of novel and transformative drug therapies to treat cancer.
−Removed: Our current portfolio
−Removed: consists of seven drug therapies consisting of peptide and small molecule cancer immunotherapeutics KROS 101, 102, 201, 301,
−Removed: and 401 and therapeutic agents ENV 105 and 205.
+Added: Our current portfolio consists of
+Added: seven drug therapies consisting of peptide and small molecule cancer immunotherapeutics KROS 101, 102, 201, 301 and 401 and therapeutic
+Added: agents ENV 105 and 205.
We started three clinical trials in the fall of 2023 for KROS 201 and ENV 105.
130 unchanged sentences
are currently working towards completing IND-enabling pharmacokinetic, toxicity and safety studies in 2024 .
−Removed: KROS 101 stabilizes the GITR
−Removed: ligand to signal GITR to impact cancer therapy.
+Added: KROS 101 stabilizes
+Added: the GITR ligand to signal GITR to impact cancer therapy.
GITR is a powerful checkpoint that suppresses the immune response against cancer.
−Removed: checkpoint is a central switch that promotes “killer” effector T cell functions and hampers inhibitory regulatory T cell
−Removed: (Treg) functions.
−Removed: Due to its central role in regulating Treg, GITR receptor complex is considered an optimal therapeutic target for treating
−Removed: This may be the optimal complement to add to current checkpoint inhibitors as it shows a dose dependent effective response in
−Removed: increasing the immune response.
−Removed: As a competitive antagonist, KROS 101 could be dosed to avoid the typical common side effects of checkpoint
+Added: This checkpoint is a central switch that promotes “killer” effector T cell functions and hampers inhibitory regulatory T
+Added: cell (Treg) functions.
+Added: Due to its central role in regulating Treg, GITR receptor complex is considered an optimal therapeutic target
+Added: for treating cancer.
+Added: This may be the optimal complement to add to current checkpoint inhibitors as it shows a dose dependent effective
+Added: response in increasing the immune response.
+Added: As a competitive antagonist, KROS 101 could be dosed to avoid the typical common side effects
+Added: of checkpoint inhibitors.
believe our GITR targeting small molecule has the potential to be a significant improvement over existing antibody treatments that have
75 unchanged sentences
accruing patients for the trial in September 2023.
−Removed: This multicenter randomized Phase 2 trial involving Cedars-Sinai Medical Center and
−Removed: City of Hope in Los Angeles California and Huntsman Cancer Center in Utah is testing the combination of a third-generation androgen targeted
−Removed: therapy, apalutamide (Janssen), with or without ENV 105 for prostate cancer patients that have developed resistance to at least one other
−Removed: androgen targeted inhibitor (NCT05534646).
+Added: This multicenter randomized Phase 2 trial involving Cedars-Sinai Medical Center
+Added: and City of Hope in Los Angeles California and Huntsman Cancer Center in Utah is testing the combination of a third-generation androgen
+Added: targeted therapy, apalutamide (Janssen), with or without ENV 105 for prostate cancer patients that have developed resistance to at least
+Added: one other androgen targeted inhibitor (NCT05534646).
Edwin Posadas is the principal investigator of this multi-institutional trial.
−Removed: is Director of the Experimental Therapeutics Program and the Medical Director of the Urologic Oncology Program at the Samuel Oschin Comprehensive
−Removed: Cancer Institute at Cedars-Sinai Medical Center.
−Removed: Companion biomarkers for efficient selection of patients to potentially respond to the
−Removed: drug will be evaluated in this trial.
−Removed: The genetic biomarker potentially identifies responsive patients to ENV 105 prior to therapy for
−Removed: a future Phase 3 trial.
+Added: Posadas is Director of the Experimental Therapeutics Program and the Medical Director of the Urologic Oncology Program at the Samuel
+Added: Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center.
+Added: Companion biomarkers for efficient selection of patients to potentially
+Added: respond to the drug will be evaluated in this trial.
+Added: The genetic biomarker potentially identifies responsive patients to ENV 105 prior
+Added: to therapy for a future Phase 3 trial.
The companion biomarker would require a separate approval by the FDA.
−Removed: Prostate cancer is the most common, non-cutaneous
−Removed: cancer affecting men in the United States and 1.2 million new cases registered worldwide.
−Removed: It is also the second leading cause of cancer
−Removed: death in American males.
+Added: Prostate cancer is the most
+Added: common, non-cutaneous cancer affecting men in the United States and 1.2 million new cases registered worldwide.
+Added: It is also the second
+Added: leading cause of cancer death in American males.
Androgen targeted therapy accounts for USD 15 billion in sales in 8 primary markets.
−Removed: Since nearly all patients
−Removed: eventually develop resistance to androgen targeted therapy, addressing this population with a drug targeting endoglin (ENV 105) is of
−Removed: high value for this single indication.
−Removed: In clinical trials, ENV 105 has been shown to be reasonably well-tolerated in patients as an adjunct
−Removed: to contemporary androgen targeted inhibitors (NCT03418324).
−Removed: Grade 3 hyponatremia, urinary retention, and cellulitis were noted on the
−Removed: abiraterone arm.
+Added: Since nearly all patients eventually develop resistance to androgen targeted therapy, addressing this population with a drug targeting
+Added: endoglin (ENV 105) is of high value for this single indication.
+Added: In clinical trials, ENV 105 has been shown to be reasonably well-tolerated
+Added: in patients as an adjunct to contemporary androgen targeted inhibitors (NCT03418324).
+Added: Grade 3 hyponatremia, urinary retention, and cellulitis
+Added: were noted on the abiraterone arm.
None of these were attributed to the use of ENV105.
−Removed: No grade 3 events were noted on the enzalutamide arm.
−Removed: The most frequent
−Removed: grade 1-2 events occurring in at least two patients (listed as abiraterone, enzalutamide) included anemia, nausea, and gingival bleeding.
−Removed: Careful mechanism-of-action studies have revealed that ENV 105 impacts a more ubiquitous means of cancer drug resistance, cancer dormancy,
−Removed: the growth potential for this drug alone can be large.
−Removed: A Phase 1 EGFR antagonist resistant non-small cell lung cancer targeted therapy
−Removed: combination of Tagrisso (osimertinib, AstraZeneca) and ENV 105 is at Cedars-Sinai Medical Center.
−Removed: The principal investigator of this
−Removed: clinical trial is Dr.
−Removed: Reckamp, Professor in Medicine, Director of the Division of Medical Oncology at Cedars-Sinai Medical Center.
−Removed: We also expect targeted therapies to contribute to the growth of the prostate and EGFR-dependent non-small cell lung cancer market, as
−Removed: immune therapies have not shown efficacy for these two cancer types.
−Removed: 205, an antibody fragment targeting mitochondrial DNA was shown to limit chemotherapy resistant prostate cancer in preclinical
−Removed: Mitochondrial DNA depletion limit inflammation-induced pro-tumorigenic activity and sensitizes prostate cancer to
−Removed: This biologic is a first of its kind strategy of chemotherapy sensitization.
−Removed: The development of chemotherapy resistance
−Removed: is an unfortunate eventuality for patients with solid tumors.
−Removed: ENV 205 has been shown to particularly sensitize tumors to docetaxel,
−Removed: a taxane class of chemotherapy.
−Removed: Docetaxel is used to treat several cancers such as stomach cancer, breast cancer, non-small-cell
−Removed: lung cancer, prostate, and head and neck cancer.
−Removed: Apart from restoring efficacy of docetaxel in certain resistant tumors, the use of
−Removed: ENV 205 allows for reduced dosing of the chemotherapy required to achieve the same tumor cell killing.
−Removed: This is paradigm shifting in
−Removed: patient quality of life, limiting the significant side-effects of chemotherapy.
−Removed: According to Business Research Insights, docetaxel
−Removed: market size $137 billion globally in 2024, and is expected to reach $329 billion by 2033.
+Added: No grade 3 events were noted on the enzalutamide
+Added: The most frequent grade 1-2 events occurring in at least two patients (listed as abiraterone, enzalutamide) included anemia, nausea,
+Added: and gingival bleeding.
+Added: Careful mechanism-of-action studies have revealed that ENV 105 impacts a more ubiquitous means of cancer drug
+Added: resistance, cancer dormancy, the growth potential for this drug alone can be large.
+Added: A Phase 1 EGFR antagonist resistant non-small cell
+Added: lung cancer targeted therapy combination of Tagrisso (osimertinib, AstraZeneca) and ENV 105 is at Cedars-Sinai Medical Center.
+Added: The principal
+Added: investigator of this clinical trial is Dr.
+Added: Reckamp, Professor in Medicine, Director of the Division of Medical Oncology at Cedars-Sinai
+Added: Medical Center.
+Added: We also expect targeted therapies to contribute to the growth of the prostate and EGFR-dependent non-small cell lung
+Added: cancer market, as immune therapies have not shown efficacy for these two cancer types.
+Added: 205, an antibody fragment targeting mitochondrial DNA was shown to limit chemotherapy resistant prostate cancer in preclinical studies.
+Added: Mitochondrial DNA depletion limit inflammation-induced pro-tumorigenic activity and sensitizes prostate cancer to docetaxel.
+Added: This biologic
+Added: is a first of its kind strategy of chemotherapy sensitization.
+Added: The development of chemotherapy resistance is an unfortunate eventuality
+Added: for patients with solid tumors.
+Added: ENV 205 has been shown to particularly sensitize tumors to docetaxel, a taxane class of chemotherapy.
+Added: Docetaxel is used to treat several cancers such as stomach cancer, breast cancer, non-small-cell lung cancer, prostate, and head and
+Added: Apart from restoring efficacy of docetaxel in certain resistant tumors, the use of ENV 205 allows for reduced dosing of
+Added: the chemotherapy required to achieve the same tumor cell killing.
+Added: This is paradigm shifting in patient quality of life, limiting the
+Added: significant side-effects of chemotherapy.
+Added: According to Business Research Insights, docetaxel market size $137 billion globally in 2024,
+Added: and is expected to reach $329 billion by 2033.
Market Opportunity
−Removed: cancer drug spending was valued at approximately $232 billion in 2024, and is expected to reach some $532 billion by 2031 driven
−Removed: largely by the growth of targeted therapies and immuno-oncology
−Removed: (https://www.biospace.com/oncology-drugs-market-to-reach-usd-532-91-billion-by-2031-coherent-market-insights#:~:text=The%20global%20Oncology%20Drugs%20Market,report%20by%20Coherent%20Market%20Insights.).
−Removed: Global immunotherapy market was valued at $226 billion by 2024 and is projected to grow at a CAGR of 11.9% from 2025 to 2030 (Grand
−Removed: View Research).
+Added: cancer drug spending was valued at approximately $232 billion in 2024, and is expected to reach some $532 billion by 2031 driven largely
+Added: by the growth of targeted therapies and immuno-oncology (https://www.biospace.com/oncology-drugs-market-to-reach-usd-532-91-billion-by-2031-coherent-market-insights#:~:text=The%20global%20Oncology%20Drugs%20Market,report%20by%20Coherent%20Market%20Insights.).
+Added: Global immunotherapy market was valued at $226 billion by 2024 and is projected to grow at a CAGR of 11.9% from 2025 to 2030 (Grand View
Increasing patient pool and higher mortality rates are augmenting the need for cancer immunotherapy globally.
−Removed: uniquely positioned to advance our immunotherapies that may have the potential to transform the way cancer is treated using
−Removed: antibodies that target CD105 to reverse drug resistance to prostate and lung cancer and activated T cells that target cancer stem
−Removed: cells that are the root of glioblastoma.
−Removed: Our pipeline of immunotherapeutic agents that signals growth of effector T cells against
−Removed: cancer, and reverse immunosuppression at the cancer site are being rapidly advanced to address large unmet needs in cancer
−Removed: immunotherapy.
+Added: We are uniquely
+Added: positioned to advance our immunotherapies that may have the potential to transform the way cancer is treated using antibodies that target
+Added: CD105 to reverse drug resistance to prostate and lung cancer and activated T cells that target cancer stem cells that are the root of
+Added: glioblastoma.
+Added: Our pipeline of immunotherapeutic agents that signals growth of effector T cells against cancer, and reverse immunosuppression
+Added: at the cancer site are being rapidly advanced to address large unmet needs in cancer immunotherapy.
broad application of ENV 105 as a complementary drug to support standard of care cancer therapy for many cancer types has revealed numerous
6 unchanged sentences
There are some 300,000 castrate resistant prostate cancer patients in the U.S.
−Removed: eligible to be given combination therapy
−Removed: of ENV 105 + androgen signaling inhibitors for $5,000 per month (based on comparable neutralizing antibodies).
−Removed: This would suggest a
−Removed: potential US$9 billion gross sales for ENV 105 for a six-month dose in the U.S.
+Added: eligible to be given combination therapy of
+Added: ENV 105 + androgen signaling inhibitors for $5,000 per month (based on comparable neutralizing antibodies).
+Added: This would suggest a potential
+Added: US$9 billion gross sales for ENV 105 for a six-month dose in the U.S.
for this single indication.
−Removed: As a point of reference,
−Removed: androgen signaling inhibitors on their own make up $10 billion market inclusive of Sanofi;
+Added: As a point of reference, androgen signaling
+Added: inhibitors on their own make up $10 billion market inclusive of Sanofi;
Johnson and Johnson Services, Inc.;
Pfizer, Inc.;
−Removed: Astellas Pharma, Inc.;
−Removed: and Bayer AG – predicted to grow to $15 billion global market by 2027 of castrate
−Removed: resistant prostate cancer patients.
−Removed: None have been approved to extend efficacy apart from chemotherapy (docetaxel and cabazitaxel)
−Removed: with undesirable toxicity profiles.
+Added: Astellas Pharma,
+Added: and Bayer AG - predicted to grow to $15 billion global market by 2027 of castrate resistant prostate cancer patients.
+Added: been approved to extend efficacy apart from chemotherapy (docetaxel and cabazitaxel) with undesirable toxicity profiles.
There are approximately 30,466 patients with an EGFR driven non-small cell lung cancer annually in the U.S.
The incidence
−Removed: of EGFR driven NSCLC is most prevalent in non-smokers and those of east Asian descent, 35-40% of NSCLC – 341,633 patients annually
−Removed: in Asia (China, India, Japan, S.
+Added: of EGFR driven NSCLC is most prevalent in non-smokers and those of east Asian descent, 35-40% of NSCLC - 341,633 patients annually in
+Added: Asia (China, India, Japan, S.
Korea, Thailand, Philippines).
−Removed: To determine lung cancer market share for ENV 105, the current market
−Removed: share for Tagrisso (US$3 billion annual sales for AstraZeneca) can be used as point of reference.
−Removed: Accordingly, ENV 105 could have a $1
−Removed: billion market share in the U.S.
+Added: To determine lung cancer market share for ENV 105, the current market share
+Added: for Tagrisso (US$3 billion annual sales for AstraZeneca) can be used as point of reference.
+Added: Accordingly, ENV 105 could have a $1 billion
+Added: market share in the U.S.
as a combination therapy with EGFR antagonists to improve or extend its efficacy.
2 unchanged sentences
in many solid tumor types.
−Removed: For head and neck cancer, the World Health Organization estimates more than 550,000 new cases of and
−Removed: around 300,000 deaths per year.
−Removed: The rising consumption of alcohol and tobacco is a major factor behind estimated 7.9% increase in
−Removed: the head and neck cancer by 2030.
+Added: For head and neck cancer, the World Health Organization estimates more than 550,000 new cases of and around
+Added: 300,000 deaths per year.
+Added: The rising consumption of alcohol and tobacco is a major factor behind estimated 7.9% increase in the head and
+Added: neck cancer by 2030.
The global head & neck cancer drug market is estimated to reach $8.1 billion in 2031.
−Removed: https://www.ihealthcareanalyst.com/global-head-neck-squamous-cell-carcinoma-drugs-market/).
−Removed: Chemotherapy is the standard of care
−Removed: alone or in combination with radiation therapy, where toxicity is the greatest limitation.
−Removed: Administration of ENV 105 enables lower
−Removed: radiation dosing to improve quality of life.
+Added: (See https://www.ihealthcareanalyst.com/global-head-neck-squamous-cell-carcinoma-drugs-market/).
+Added: Chemotherapy is the standard of care alone or in combination with radiation therapy, where toxicity is the greatest limitation.
+Added: Administration
+Added: of ENV 105 enables lower radiation dosing to improve quality of life.
101 and KROS 102
−Removed: inhibitors are immunotherapeutic agents that block proteins that suppress a potent immune response of the body against cancers and
−Removed: other “foreign” agents.
−Removed: KROS 101 and 102 are checkpoint inhibitors and agonists that enable T cells to expand and
−Removed: contract respectively.
−Removed: The global immune checkpoint inhibitor market size was $47.4 billion in 2023 and anticipated to be $189.1
−Removed: billion in 2032 with a CAGR of 16,7% from 2024 to 2032 (Global Markets Insights;
+Added: inhibitors are immunotherapeutic agents that block proteins that suppress a potent immune response of the body against cancers and other
+Added: “foreign” agents.
+Added: KROS 101 and 102 are checkpoint inhibitors and agonists that enable T cells to expand and contract respectively.
+Added: The global immune checkpoint inhibitor market size was $47.4 billion in 2023 and anticipated to be $189.1 billion in 2032 with a CAGR
+Added: of 16,7% from 2024 to 2032 (Global Markets Insights;
https://www.gminsights.com/industry-analysis/immune-checkpoint-inhibitors-market).
5 unchanged sentences
2022 to 2030 (Grand View Research).
−Removed: KROS 301 is a small molecule that targets the NF-kB pathway in cancer to prevent cancer growth
−Removed: and block checkpoint inhibitor expression of PD-L1.
−Removed: global peptide therapeutics market size was $117.3 billion in 2024 and
−Removed: is estimated to grow CAGR of 10.77% from 2025 to 2030 (Grand View Research).
−Removed: KROS 401 is a cyclic peptide that blocks IL-4 and IL-13 receptors
−Removed: on tumor associated macrophage to reverse immune suppression at the tumor site.
+Added: KROS 301 is a small molecule that targets the NF-kB pathway in cancer to prevent cancer growth and
+Added: block checkpoint inhibitor expression of PD-L1.
+Added: global peptide therapeutics market size was $117.3 billion in 2024 and is estimated to grow CAGR of 10.77% from 2025 to 2030 (Grand View
+Added: KROS 401 is a cyclic peptide that blocks IL-4 and IL-13 receptors on tumor associated macrophage to reverse immune suppression
+Added: at the tumor site.
is debilitating disease of muscle wasting not treatable by nutrition supplementation associated with the death of 50% of all cancer,
1 unchanged sentence
(2023) Nature Reviews Clinical Oncology 20:250-264].
−Removed: Cachexia is an underrecognized consequence of many chronic diseases.
−Removed: We believe ENV 205 is a molecule found to
−Removed: limit the process of muscle wasting through the capture and excretion of mitochondrial DNA in circulation.
−Removed: Cachexia is considered an
−Removed: orphan disease in the U.S.
−Removed: and Europe, increasing hospitalization costs and length of stay in several disease types.
−Removed: cancer cachexia therapeutics market was over $2 billion in 2022 worldwide, with an estimated growth to to over $4 billion by 2032, according to Market.US.
−Removed: The application of ENV 205 as cachexia therapeutic is further supported by the
−Removed: demonstrated restoration of docetaxel therapy sensitivity in resistant prostate cancer models.
−Removed: Taxane-based therapy, inclusive of
−Removed: docetaxel, paclitaxel, and cabazataxel, is standard of care for majority of solid tumors (inclusive of breast cancer, non-small cell
−Removed: lung cancer, advanced stomach cancer, head and neck cancer and metastatic prostate cancer).
−Removed: Strong preclinical data suggest ENV 205
−Removed: chemotherapy sensitization in a combination therapy setting and limit the development of cachexia as a single agent.
+Added: is an underrecognized consequence of many chronic diseases.
+Added: We believe ENV 205 is a molecule found to limit the process of muscle wasting
+Added: through the capture and excretion of mitochondrial DNA in circulation.
+Added: Cachexia is considered an orphan disease in the U.S.
+Added: increasing hospitalization costs and length of stay in several disease types.
+Added: The specific cancer cachexia therapeutics market was over
+Added: $2 billion in 2022 worldwide, with an estimated growth to to over $4 billion by 2032, according to Market.US.
+Added: The application of ENV
+Added: 205 as cachexia therapeutic is further supported by the demonstrated restoration of docetaxel therapy sensitivity in resistant prostate
+Added: cancer models.
+Added: Taxane-based therapy, inclusive of docetaxel, paclitaxel, and cabazataxel, is standard of care for majority of solid tumors
+Added: (inclusive of breast cancer, non-small cell lung cancer, advanced stomach cancer, head and neck cancer and metastatic prostate cancer).
+Added: Strong preclinical data suggest ENV 205 chemotherapy sensitization in a combination therapy setting and limit the development of cachexia
+Added: as a single agent.
will aggressively pursue ENV 105 and ENV 205 in pre-clinical and clinical trials.
24 unchanged sentences
and maximize our success, consisting of strategic partnerships, commercial development, and portfolio optimization.
−Removed: Partnerships – We will focus on expanding our existing pipeline through establishing strategic partnerships with
−Removed: companies that have interesting products and technologies.
−Removed: We intend to focus on novel, early-stage and preclinical assets in a variety
−Removed: of therapeutic areas.
−Removed: Development – We expect to participate and assist in the commercial development activities of its assets with
−Removed: our strategic partners.
−Removed: Commercial development activities may include, but are not limited to, clinical development, market research,
−Removed: healthcare economics, market access, sales/marketing, and commercial launch strategies.
−Removed: Optimization – We will continue to evaluate, prioritize, optimize, and make appropriate changes in our pipeline
−Removed: portfolio as market development dynamics and/or product opportunities change.
+Added: Partnerships - We will focus on expanding our existing pipeline through establishing strategic partnerships with companies
+Added: that have interesting products and technologies.
+Added: We intend to focus on novel, early-stage and preclinical assets in a variety of
+Added: therapeutic areas.
+Added: Development - We expect to participate and assist in the commercial development activities of its assets with our strategic
+Added: Commercial development activities may include, but are not limited to, clinical development, market research, healthcare
+Added: economics, market access, sales/marketing, and commercial launch strategies.
+Added: Optimization - We will continue to evaluate, prioritize, optimize, and make appropriate changes in our pipeline portfolio
+Added: as market development dynamics and/or product opportunities change.
Company is led by our CEO and Chairman, Dr.
39 unchanged sentences
addition, Kairos is required to make payments to Cedars based on the following milestones:
−Removed: (i) successful completion of Phase 1 clinical trial;
−Removed: the successful completion of Phase 2 clinical trial and receipt of U.S.
−Removed: Food and Drug Administration, or FDA, or equivalent regulatory
−Removed: agency in another jurisdiction approval for a Phase 3 clinical trial;
+Added: (i) successful completion of Phase 1 clinical
+Added: (ii) the successful completion of Phase 2 clinical trial and receipt of U.S.
+Added: Food and Drug Administration, or FDA, or equivalent
+Added: regulatory agency in another jurisdiction approval for a Phase 3 clinical trial;
(iii) receipt of FDA approval;
−Removed: and (iv) cumulative net sales exceeding
+Added: and (iv) cumulative net
+Added: sales exceeding $50,000,000.
If all of these milestones are met, the required milestone payments will total $4,400,000.
−Removed: each of the exclusive license agreement in items 2, 3 and 4 above, Kairos is required to (i) pay an initial license fee of $15,000, (ii) reimburse Cedars for patent protection costs ranging from the high four-figures to the mid-five-figures, (iii) pay an
−Removed: annual maintenance fee in the low five-figures and (iv) pay royalties based on a low single-digit percentage of net sales.
−Removed: royalty obligations as to each product will terminate on a country-by-country basis concurrently with the expiration of the last to
−Removed: expire of a valid claim within the patent rights that covers such product, including any term extensions thereof.
−Removed: non-royalty expiration dates.
−Removed: Patent expiration dates and specific jurisdictions of foreign patents that we in-license from
−Removed: Cedars-Sinai are listed in the Patent Table at page 100 below.
+Added: each of the exclusive license agreement in items 2, 3 and 4 above, Kairos is required to (i) pay an initial license fee of $15,000, (ii)
+Added: reimburse Cedars for patent protection costs ranging from the high four-figures to the mid-five-figures, (iii) pay an annual maintenance
+Added: fee in the low five-figures and (iv) pay royalties based on a low single-digit percentage of net sales.
+Added: The royalty obligations as to
+Added: each product will terminate on a country-by-country basis concurrently with the expiration of the last to expire of a valid claim within
+Added: the patent rights that covers such product, including any term extensions thereof.
+Added: There are no non-royalty expiration dates.
+Added: expiration dates and specific jurisdictions of foreign patents that we in-license from Cedars-Sinai are listed in the Patent Table at
+Added: page 100 below.
Intellectual Property Agreements with Cedars-Sinai Medical Center
March 16, 2020, Enviro entered into two Exclusive Option Agreements with Cedars-Sinai Medical Center that gives Enviro options to enter
−Removed: into an Exclusive Agreement with Cedars which would grant Enviro exclusive licensing rights (including the right to sublicense) to
−Removed: certain patent rights owned by Cedars with respect to (1) compositions and methods for treating diseases and conditions by depletion
−Removed: of mitochondrial DNA from circulation for detection of mitochondrial DNA, and (2) sensitization of tumors to therapies through endoglin
+Added: into an Exclusive Agreement with Cedars which would grant Enviro exclusive licensing rights (including the right to sublicense) to certain
+Added: patent rights owned by Cedars with respect to (1) compositions and methods for treating diseases and conditions by depletion of mitochondrial
+Added: DNA from circulation for detection of mitochondrial DNA, and (2) sensitization of tumors to therapies through endoglin antagonism.
consideration of these agreements, Enviro agreed to pay option fees of $2,000 and $3,000, respectively.
20 unchanged sentences
of the date of this Annual Report, we have completed milestones 1, 2 and 3.
−Removed: Pursuant to the two Enviro-Cedars license
−Removed: agreements, Enviro must meet certain milestones relating commercialization, and, if not met or extended, Cedars may convert the
−Removed: exclusive licenses into non-exclusive licenses or to co-exclusive licenses, or terminate the licenses.
−Removed: In exchange for each of the
−Removed: licenses, Enviro is obligated to pay an upfront license fee, plus an additional fee when Enviro has raised at least $250,000 in
−Removed: capital company-wide for any program or purpose;
−Removed: provided, however, that the Company will only have to pay such fee once between
−Removed: both Enviro-Cedars license agreements.
−Removed: Enviro was also obligated to reimburse Cedars for the costs incurred for the prosecution of
−Removed: the patent rights subject to the Enviro-Cedars license agreements prior to the date of execution of such agreements.
−Removed: The aggregate
−Removed: potential fees that Enviro may have to pay in exchange for the licenses is approximately $690,000 as of December 31, 2024.
−Removed: Kairos and Enviro owed a total of approximately $950,000 to Cedars, of which $750,000 was converted into 312,500 shares of common
−Removed: stock, or 60% of the IPO price, upon closing of the IPO.
−Removed: And on November 13, 2024, an additional $200,000 was converted into
−Removed: 150,830 shares of common stock, using a conversion price equal to 60% of the closing price on November 13,
−Removed: Cedars will also be entitled to receive royalty payments of a mid-single-digit percentage of net sales of products associated
−Removed: with the licensed patent right and less than one percent of net sales of other products derived from Cedars’ technical
−Removed: information, with a minimum royalty year in the low five-digits due beginning on the third anniversary of the effective date of the
−Removed: To the extent Enviro derives non-royalty sublicensing revenues, a high single-digit to low double-digit percentage of such
−Removed: revenues shall be due and payable to Cedars, depending on the stage of FDA authorization at the time the sublicense revenue is
−Removed: Non-royalty sublicense revenue would be between 5% and 35% depending on the phase of FDA testing of the product during
−Removed: which the sublicense agreement is signed.
+Added: to the two Enviro-Cedars license agreements, Enviro must meet certain milestones relating commercialization, and, if not met or extended,
+Added: Cedars may convert the exclusive licenses into non-exclusive licenses or to co-exclusive licenses, or terminate the licenses.
+Added: for each of the licenses, Enviro is obligated to pay an upfront license fee, plus an additional fee when Enviro has raised at least $250,000
+Added: in capital company-wide for any program or purpose;
+Added: provided, however, that the Company will only have to pay such fee once between both
+Added: Enviro-Cedars license agreements.
+Added: Enviro was also obligated to reimburse Cedars for the costs incurred for the prosecution of the patent
+Added: rights subject to the Enviro-Cedars license agreements prior to the date of execution of such agreements.
+Added: The aggregate potential fees
+Added: that Enviro may have to pay in exchange for the licenses is approximately $690,000 as of December 31, 2024.
+Added: Together, Kairos and
+Added: Enviro owed a total of approximately $950,000 to Cedars, of which $750,000 was converted into 312,500 shares of common stock, or 60%
+Added: of the IPO price, upon closing of the IPO.
+Added: And on November 13, 2024, an additional $200,000 was converted into 150,830 shares of common
+Added: stock, using a conversion price equal to 60% of the closing price on November 13, 2024.
+Added: Cedars will also be entitled to receive royalty
+Added: payments of a mid-single-digit percentage of net sales of products associated with the licensed patent right and less than one percent
+Added: of net sales of other products derived from Cedars’ technical information, with a minimum royalty year in the low five-digits due
+Added: beginning on the third anniversary of the effective date of the license.
+Added: To the extent Enviro derives non-royalty sublicensing revenues,
+Added: a high single-digit to low double-digit percentage of such revenues shall be due and payable to Cedars, depending on the stage of FDA
+Added: authorization at the time the sublicense revenue is generated.
+Added: Non-royalty sublicense revenue would be between 5% and 35% depending on
+Added: the phase of FDA testing of the product during which the sublicense agreement is signed.
shall pay Cedars in connection with achieving certain milestones relating to products derived from the patent rights:
23 unchanged sentences
or (f) upon mutual written agreement of the parties.
+Added: Effective April 17, 2025, Enviro, Kairos and Cedars
+Added: entered into a novation agreement pursuant to which the exclusive license was transferred from Enviro to Kairos, after which time Kairos
+Added: accepted and assumed all obligations and liabilities under the exclusive license agreements and Enviro was relived of any further liabilities
+Added: or obligations under the license agreements.
License and Supply Agreement with Tracon Pharmaceuticals, Inc.
−Removed: May 21, 2021, Enviro entered into an Enviro-Tracon license agreement with Tracon.
+Added: May 21, 2021, Enviro, the Company’s formerly wholly-owned subsidiary, entered into an Enviro-Tracon license agreement with Tracon.
Pursuant to the Enviro-Tracon license agreement, Tracon
2 unchanged sentences
rights to its “CD105 technologies.”
−Removed: to the Enviro-Tracon license agreement, Enviro paid Tracon an upfront fee of $100,000, and is obligated to pay Tracon an additional $500,000
−Removed: upon its or its successor’s completion of one or more financings through the sale of equity (or debt convertible to equity) in
−Removed: an amount of $10,000,000, and an additional $500,000 within 10 days of its or its successor’s completion of one or more financings
−Removed: through the sale of equity (or debt convertible to equity) in an amount of $22,000,000.
−Removed: In addition, Enviro is obligated to pay Tracon
−Removed: a royalty of 3% of net sales on a country-by-country basis of the products subject to the agreement, and non-royalty payments of 3% of
−Removed: consideration for sublicensing fees.
−Removed: The royalty payments would terminate upon the completion of use of the TRC105 product.
−Removed: The non-royalty
−Removed: payments would terminate upon payment of $500,000 after the financing of an aggregate amount of $22,000,000 to the Company.
−Removed: issued Tracon equity ownership in Enviro equal to a number of shares of restricted common stock of Enviro equal to 7% on a fully diluted
−Removed: and converted basis of all common and preferred shares of Enviro.
−Removed: In connection with the Enviro-Kairos share exchange, the parties agreed
−Removed: that Tracon would receive, in exchange for its Enviro common stock, 280,000 shares of the restricted common stock of Kairos (which is
−Removed: equal to 1.41229% of the issued and outstanding shares of Kairos on a fully diluted and converted basis).
−Removed: Until such time as Tracon has
−Removed: received all of the cash consideration (as described above), Enviro or its successor in interest, shall issue to Tracon, without further
−Removed: consideration, any additional common stock of Enviro, or such successor in interest, necessary so that Tracon maintains ownership of
−Removed: shares of Enviro, or such successor in interest, equal to the Tracon-Enviro Equity on a fully diluted and converted basis of all stock
−Removed: in Enviro (or its successor).
−Removed: Notwithstanding the foregoing, if Tracon receives the full cash consideration within six months of the
−Removed: effective date of the Enviro-Tracon license agreement, then Tracon shall automatically return to Enviro (or any successor entity, if
−Removed: applicable) a number of shares of the restricted common stock of Enviro (or its successor) such that upon such return of shares Tracon
−Removed: shall possess an amount of shares in Enviro (or its successor) equal to 2% on a fully-diluted and converted basis relative to the other
−Removed: Enviro shareholders who exchanged their shares in the Enviro-Kairos share exchange.
−Removed: The returned portion of the Tracon-Enviro equity
−Removed: shall automatically be terminated, cancelled and of no further force and effect.
−Removed: to the Enviro-Tracon license agreement, we have exclusive licensing rights (which include the right to sublicense) to eight issued U.S.
+Added: to the Enviro-Tracon license agreement, Enviro paid Tracon an upfront fee of $100,000, and was obligated to pay Tracon an additional
+Added: $500,000 upon its or its successor’s completion of one or more financings through the sale of equity (or debt convertible to
+Added: equity) in an amount of $10,000,000, and an additional $500,000 within 10 days of its or its successor’s completion of one or
+Added: more financings through the sale of equity (or debt convertible to equity) in an amount of $22,000,000.
+Added: In addition, Enviro was
+Added: obligated to pay Tracon a royalty of 3% of net sales on a country-by-country basis of the products subject to the agreement, and
+Added: non-royalty payments of 3% of consideration for sublicensing fees.
+Added: The royalty payments would terminate upon the completion of use
+Added: of the TRC105 product.
+Added: The non-royalty payments would terminate upon payment of $500,000 after the financing of an aggregate amount
+Added: of $22,000,000 to the Company.
+Added: to becoming a wholly-owned subsidiary of the Company, Enviro issued Tracon equity ownership in Enviro equal to a number of shares of
+Added: restricted common stock of Enviro equal to 7% on a fully diluted and converted basis of all common and preferred shares of Enviro.
+Added: Thereafter, in connection with the Enviro-Kairos share exchange, the parties agreed that Tracon would receive, in exchange for its Enviro common
+Added: stock, 280,000 shares of the restricted common stock of Kairos (which was then equal to 1.41229% of the issued and outstanding shares of
+Added: Kairos on a fully diluted and converted basis).
+Added: Under the Enviro-Tracon license agreement, until such time as Tracon has received all of the cash consideration (as described
+Added: above), Enviro or its successor in interest, shall issue to Tracon, without further consideration, any additional common stock of
+Added: Enviro, or such successor in interest, necessary so that Tracon maintains ownership of shares of Enviro, or such successor in
+Added: interest, equal to the Tracon-Enviro Equity on a fully diluted and converted basis of all stock in Enviro (or its successor).
+Added: However, as of the date of this Annual Report, all Tracon shares in Kairos have been sold and Tracon no longer has
+Added: an ownership interest in Kairos.
+Added: to the Enviro-Tracon license agreement, which was assumed by Kairos effective April 17, 2025 pursuant to a novation agreement, we
+Added: have exclusive licensing rights (which include the right to sublicense) to eight issued U.S.
patents, four U.S.
−Removed: Utility or provisional patent applications, 24 issued patents and 24 patent applications in foreign jurisdictions.
−Removed: Patent expiration dates, specific jurisdictions of foreign patents are listed in the Patent Table below.
−Removed: Number.Sub Case
+Added: provisional patent applications, 24 issued patents and 24 patent applications in foreign jurisdictions.
+Added: Patent expiration dates,
+Added: specific jurisdictions of foreign patents are listed in the Patent Table below.
of the Patent
−Removed: No./Application No.
+Added: No./Application
(Patent granted or Patent application)
or Technologies to which the Patents or Patent Applications Relate
−Removed: of Patent Protection
017431.501AU0
−Removed: SENSITIZATION
−Removed: OF TUMORS TO THERAPIES THROUGH ENDOGLIN ANTAGONISM
−Removed: a Product and a Method of Treatment Patent
+Added: SENSITIZATION OF TUMORS TO THERAPIES
+Added: THROUGH ENDOGLIN ANTAGONISM
+Added: Both a Product
+Added: and a Method of Treatment Patent
017313.004CA0
−Removed: AND METHODS FOR TREATING CANCER AND AUTOIMMUNE DISEASES
−Removed: 101 and KROS 102
−Removed: a Product and a Method of Treatment Patent
+Added: COMPOSITIONS AND METHODS FOR TREATING CANCER
+Added: AND AUTOIMMUNE DISEASES
+Added: KROS 101 and KROS 102
+Added: Both a Product and a Method
+Added: of Treatment Patent
017313.005CA0
−Removed: OF GENERATING ACTIVATED T CELLS FOR CANCER THERAPY
−Removed: a Product and a Method of Treatment Patent
+Added: METHOD OF GENERATING ACTIVATED T CELLS FOR
+Added: CANCER THERAPY
+Added: Both a Product and a Method
+Added: of Treatment Patent
017431.501CA0
−Removed: SENSITIZATION
−Removed: OF TUMORS TO THERAPIES THROUGH ENDOGLIN ANTAGONISM
−Removed: a Product and a Method of Treatment Patent
+Added: SENSITIZATION OF TUMORS TO THERAPIES THROUGH
+Added: ENDOGLIN ANTAGONISM
+Added: Both a Product and a Method
+Added: of Treatment Patent
017431.502CA0
−Removed: AND METHODS FOR TREATING DISEASES AND CONDITIONS BY DEPLETION OF MITOCHONDRIAL OR GENOMIC DNA FROM CIRCULATION
−Removed: a Product and a Method of Treatment Patent
+Added: COMPOSITIONS AND METHODS FOR TREATING DISEASES
+Added: AND CONDITIONS BY DEPLETION OF MITOCHONDRIAL OR GENOMIC DNA FROM CIRCULATION
+Added: Both a Product and a Method
+Added: of Treatment Patent
Number.Sub Case
5 unchanged sentences
017313.004CN1
−Removed: AND METHODS FOR TREATING CANCER AND AUTOIMMUNE DISEASES
+Added: COMPOSITIONS AND METHODS FOR TREATING
+Added: CANCER AND AUTOIMMUNE DISEASES
2024104360758.0
−Removed: 101 and KROS 102
−Removed: a Product and a Method of Treatment Patent
+Added: Both a Product and a Method of
+Added: Treatment Patent
017431.501CN0
−Removed: SENSITIZATION
−Removed: OF TUMORS TO THERAPIES THROUGH ENDOGLIN ANTAGONISM
+Added: SENSITIZATION OF TUMORS TO THERAPIES THROUGH
+Added: ENDOGLIN ANTAGONISM
201780050000.4
−Removed: a Product and a Method of Treatment Patent
+Added: Both a Product and a Method of Treatment Patent
35882-714.7111
−Removed: FORMULATIONS AND USES THEREOF
+Added: ANTIBODY FORMULATIONS
+Added: AND USES THEREOF
201810659773.9
−Removed: a Product and a Method of Treatment Patent
−Removed: (People’s Republic)
+Added: Both a Product and a Method of Treatment Patent
+Added: China (People’s
017313.004EP0
−Removed: AND METHODS FOR TREATING CANCER AND AUTOIMMUNE DESEASES
−Removed: 101 and KROS 102
−Removed: a Product and a Method of Treatment Patent
+Added: COMPOSITIONS AND METHODS FOR TREATING CANCER
+Added: AND AUTOIMMUNE DESEASES
+Added: KROS 101 and KROS 102
+Added: Both a Product and a Method of Treatment Patent
+Added: European Patent
017313.005EP0
−Removed: OF GENERATING ACTIVATED T CELLS FOR CANCER THERAPY
−Removed: a Product and a Method of Treatment Patent
+Added: METHOD OF GENERATING ACTIVATED T CELLS FOR
+Added: CANCER THERAPY
+Added: Both a Product and a Method of Treatment Patent
+Added: European Patent
017431.501EP0
−Removed: SENSITIZATION
−Removed: OF TUMORS TO THERAPIES THROUGH ENDOGLIN ANTAGONISM
−Removed: a Product and a Method of Treatment Patent
+Added: SENSITIZATION OF TUMORS TO THERAPIES THROUGH
+Added: ENDOGLIN ANTAGONISM
+Added: Both a Product and a Method of Treatment Patent
+Added: European Patent
017431.502EP0
−Removed: AND METHODS FOR TREATING DISEASES AND
−Removed: CONDITIONS BY DEPLETION OF MITOCHONDRIAL OR GENOMIC DNA
−Removed: FROM CIRCULATION
−Removed: a Product and a Method of Treatment Patent
+Added: COMPOSITIONS AND METHODS FOR TREATING DISEASES
+Added: AND CONDITIONS BY DEPLETION OF MITOCHONDRIAL OR GENOMIC DNA FROM CIRCULATION
+Added: Both a Product and a Method
+Added: of Treatment Patent
+Added: European Patent
Number.Sub Case
5 unchanged sentences
017313.002EP0
−Removed: AND USE OF COMPOUNDS THAT BIND TO RELA OF NF-KB
−Removed: a Product and a Method of Treatment Patent
−Removed: Germany, Switzerland & Liechtenstein, United Kingdom.
+Added: USE OF COMPOUNDS THAT BIND TO RELA OF NF-KB
+Added: Both a Product and a Method of
+Added: Treatment Patent
+Added: France, Germany, Switzerland &
+Added: Liechtenstein, United Kingdom.
017313.003EP0
−Removed: AND METHODS FOR TREATING FIBROSIS
−Removed: a Product and a Method of Treatment Patent
−Removed: Germany, Switzerland & Liechtenstein, United Kingdom.
+Added: COMPOSITIONS AND METHODS
+Added: FOR TREATING FIBROSIS
+Added: Both a Product and a Method of Treatment Patent
+Added: France, Germany, Switzerland & Liechtenstein,
+Added: United Kingdom.
35882-714.741
−Removed: FORMULATIONS AND USES THEREOF
+Added: ANTIBODY FORMULATIONS
+Added: AND USES THEREOF
1538/DELNP/2015
−Removed: a Product and a Method of Treatment Patent
+Added: Both a Product and a Method of Treatment Patent
35882-714.7611
−Removed: FORMULATIONS AND USES THEREOF
−Removed: a Product and a Method of Treatment Patent
+Added: ANTIBODY FORMULATIONS
+Added: AND USES THEREOF
+Added: Both a Product and a Method of Treatment Patent
35882-714.7612
−Removed: FORMULATIONS AND USES THEREOF
−Removed: a Product and a Method of Treatment Patent
+Added: ANTIBODY FORMULATIONS
+Added: AND USES THEREOF
+Added: Both a Product and a Method of Treatment Patent
017313.003JP0
−Removed: AND METHODS FOR TREATING FIBROSIS
−Removed: a Product and a Method of Treatment Patent
+Added: COMPOSITIONS AND METHODS
+Added: FOR TREATING FIBROSIS
+Added: Both a Product and a Method of Treatment Patent
017313.003JP1
−Removed: AND METHODS FOR TREATING FIBROSIS
−Removed: a Product and a Method of Treatment Patent
+Added: COMPOSITIONS AND METHODS
+Added: FOR TREATING FIBROSIS
+Added: Both a Product and a Method of Treatment Patent
017313.004JP0
−Removed: AND METHODS FOR TREATING CANCER AND AUTOIMMUNE
−Removed: 101 and KROS 102
−Removed: a Product and a Method of Treatment Patent
+Added: COMPOSITIONS AND METHODS
+Added: FOR TREATING CANCER AND AUTOIMMUNE
+Added: KROS 101 and KROS 102
+Added: Both a Product and a Method of Treatment Patent
017313.004JP1
−Removed: AND METHODS FOR TREATING CANCER AND AUTOIMMUNE
−Removed: 101 and KROS 102
−Removed: a Product and a Method of Treatment Patent
+Added: COMPOSITIONS AND METHODS
+Added: FOR TREATING CANCER AND AUTOIMMUNE
+Added: KROS 101 and KROS 102
+Added: Both a Product and a Method of Treatment Patent
017431.501JP0
−Removed: SENSITIZATION
−Removed: OF TUMORS TO THERAPIES THROUGH ENDOGLIN ANTAGONISM
−Removed: a Product and a Method of Treatment Patent
+Added: SENSITIZATION OF TUMORS TO THERAPIES THROUGH
+Added: ENDOGLIN ANTAGONISM
+Added: Both a Product and a Method of Treatment Patent
Number.Sub Case
5 unchanged sentences
017431.502JP0
−Removed: AND METHODS FOR TREATING DISEASES AND CONDITIONS BY DEPLETION OF MITOCHONDRIAL OR GENOMIC DNA FROM CIRCULATION
−Removed: a Product and a Method of Treatment Patent
+Added: COMPOSITIONS AND METHODS FOR TREATING
+Added: DISEASES AND CONDITIONS BY DEPLETION OF MITOCHONDRIAL OR GENOMIC DNA FROM CIRCULATION
+Added: Both a Product
+Added: and a Method of Treatment Patent
017313.004KR0
−Removed: AND METHODS FOR TREATING CANCER AND AUTOIMMUNE DISEASES
+Added: COMPOSITIONS AND METHODS FOR TREATING CANCER
+Added: AND AUTOIMMUNE DISEASES
10-2021-7006602
−Removed: 101 and KROS 102
−Removed: a Product and a Method of Treatment Patent
−Removed: Republic of (KR)
+Added: KROS 101 and KROS 102
+Added: Both a Product and a Method of Treatment Patent
+Added: Korea, Republic of (KR)
017313.004KR1
−Removed: AND METHODS FOR TREATING CANCER AND AUTOIMMUNE DISEASES
+Added: COMPOSITIONS AND METHODS FOR TREATING CANCER
+Added: AND AUTOIMMUNE DISEASES
10-2025-7000546
−Removed: 101 and KROS 102
−Removed: a Product and a Method of Treatment Patent
−Removed: Republic of (KR)
+Added: KROS 101 and KROS 102
+Added: Both a Product and a Method of Treatment Patent
+Added: Korea, Republic of (KR)
35882-714.911
−Removed: FORMULATIONS AND USES THEREOF
−Removed: a Product and a Method of Treatment Patent
+Added: ANTIBODY FORMULATIONS
+Added: AND USES THEREOF
+Added: Both a Product and a Method of Treatment Patent
35882-714.781
−Removed: FORMULATIONS AND USES THEREOF
−Removed: a Product and a Method of Treatment Patent
+Added: ANTIBODY FORMULATIONS
+Added: AND USES THEREOF
+Added: Both a Product and a Method of Treatment Patent
Number.Sub Case
5 unchanged sentences
35882-714.861
−Removed: FORMULATIONS AND USES THEREOF
−Removed: a Product and a Method of Treatment Patent
+Added: ANTIBODY FORMULATIONS AND USES
+Added: Both a Product and a Method of
+Added: Treatment Patent
35882-706.202
−Removed: States of America
+Added: ENDOGLIN ANTIBODIES
+Added: United States of America
35882-706.302
−Removed: States of America
+Added: ENDOGLIN ANTIBODIES
+Added: Method of treatment
+Added: United States of America
35882-706.401
−Removed: States of America
+Added: ENDOGLIN ANTIBODIES
+Added: Composition of matter
+Added: United States of America
35882-714.831
−Removed: FORMULATIONS AND USES THEREOF
−Removed: and Formulation
−Removed: States of America
+Added: ANTIBODY FORMULATIONS AND USES THEREOF
+Added: Product and Formulation
+Added: United States of America
017313.002US0
−Removed: AND USE OF COMPOUNDS THAT BIND TO RELA OF NF-KB
−Removed: States of America
+Added: METHODS AND USE OF COMPOUNDS THAT BIND TO RELA
+Added: Method of treatment
+Added: United States of America
017313.002US1
−Removed: AND USE OF COMPOUNDS THAT BIND TO RELA OF NF-KB
−Removed: States of America
+Added: METHODS AND USE OF COMPOUNDS THAT BIND TO RELA
+Added: Method of treatment
+Added: United States of America
017313.003US0
−Removed: AND METHODS FOR TREATING FIBROSIS
−Removed: Pharmaceutical
−Removed: States of America
+Added: COMPOSITIONS AND METHODS FOR TREATING FIBROSIS
+Added: Pharmaceutical composition
+Added: United States of America
Number.Sub Case
5 unchanged sentences
017313.003US1
−Removed: AND METHODS FOR TREATING FIBROSIS
−Removed: States of America
+Added: COMPOSITIONS AND METHODS FOR TREATING
+Added: United States
017313.003US2
−Removed: AND METHODS FOR TREATING FIBROSIS
−Removed: a Product and a Method of Treatment Patent
−Removed: States of America
+Added: COMPOSITIONS AND METHODS FOR TREATING FIBROSIS
+Added: Both a Product and a Method
+Added: of Treatment Patent
+Added: United States of America
017313.004US0
−Removed: AND METHODS FOR TREATING CANCER AND AUTOIMMUNE DISEASES
−Removed: 101 and KROS 102
−Removed: a Product and a Method of Treatment Patent
−Removed: States of America
+Added: COMPOSITIONS AND METHODS FOR TREATING CANCER
+Added: AND AUTOIMMUNE DISEASES
+Added: KROS 101 and KROS 102
+Added: Both a Product and a Method of Treatment Patent
+Added: United States of America
017313.005US0
−Removed: OF GENERATING ACTIVATED T CELLS FOR CANCER THERAPY
−Removed: a Product and a Method of Treatment Patent
−Removed: States of America
+Added: METHOD OF GENERATING ACTIVATED T CELLS FOR
+Added: CANCER THERAPY
+Added: Both a Product and a Method of Treatment Patent
+Added: United States of America
017431.501US1
−Removed: SENSITIZATION
−Removed: OF TUMORS TO THERAPIES THROUGH ENDOGLIN ANTAGONISM
−Removed: a Product and a Method of Treatment Patent
−Removed: States of America
+Added: SENSITIZATION OF TUMORS
+Added: TO THERAPIES THROUGH ENDOGLIN ANTAGONISM
+Added: Both a Product and a Method of Treatment Patent
+Added: United States of America
017431.502US0
−Removed: AND METHODS FOR TREATING DISEASES AND CONDITIONS BY DEPLETION OF MITOCHONDRIAL OR
−Removed: GENOMIC DNA FROM CIRCULATION
−Removed: a Product and a Method of Treatment Patent
−Removed: States of America
+Added: COMPOSITIONS AND METHODS FOR TREATING DISEASES
+Added: AND CONDITIONS BY DEPLETION OF MITOCHONDRIAL OR GENOMIC DNA FROM CIRCULATION
+Added: Both a Product and a Method
+Added: of Treatment Patent
+Added: United States of America
Reorganization
22 unchanged sentences
assets and liabilities being recognized.
−Removed: Company’s subsidiary Enviro was incorporated on November 15, 2019, under the law of the state of California and is an early-stage
−Removed: company that is focused on the development of therapeutics targeting the tumor microenvironment to complement conventional and targeted
−Removed: therapies designed against the cancer cells.
+Added: was incorporated on November 15, 2019, under the law of the state of California and was an early-stage company that is focused on
+Added: the development of therapeutics targeting the tumor microenvironment to complement conventional and targeted therapies designed
+Added: against the cancer cells.
Kairos’s Chairman, Chief Executive Officer and shareholder, Dr.
−Removed: Yu, was also a founder
−Removed: and shareholder of Enviro.
+Added: Yu, was also a founder and
+Added: shareholder of Enviro.
June 3, 2021, Kairos and Enviro entered into a share exchange agreement whereby Kairos acquired of all of the common stock of Enviro
16 unchanged sentences
(including 18,825,957 outstanding shares of common stock, and 1,000,000 warrants exercisable into 1,000,000 shares of common stock).
+Added: Effective April 17, 2025, the Company entered into novation agreements with Enviro and Enviro’s licensors,
+Added: Tracon and Cedars-Sinai Medical Center, pursuant to which the Company assumed all responsibilities, liabilities and obligations of Enviro
+Added: under such agreements and Enviro was released from all liability.
+Added: At the same time, Enviro was dissolved.
Manufacturing
25 unchanged sentences
and diversity:
−Removed: We are committed to efforts to increase diversity and foster an inclusive work environment that supports
−Removed: our workforce.
+Added: We are committed to efforts to increase diversity and foster an inclusive work environment that supports our
+Added: Public Offering
September 17, 2024, we closed on our initial public offering (“IPO”) of 1,550,000 shares of common stock at $4.00 per share,
4 unchanged sentences
Line of Credit Agreement
−Removed: November 12, 2024, the Company and Helena Global Investment Opportunities I Ltd (“Helena”) entered into an equity line
−Removed: of credit agreement (the “ELOC Agreement”), pursuant to which Helena agreed to purchase from the Company up to $30,000
−Removed: shares of common stock (the “ELOC Shares”).
−Removed: The Company issued 670,641 shares of restricted common stock (the
−Removed: “Commitment Fee Shares”), valued at $900,000 (the “Issuance Value”) on the date of issuance, to Helena as
−Removed: the “Commitment Fee” for entry into the ELOC Agreement.
−Removed: The ELOC Agreement will be available for the Company’s use
−Removed: at such time following the filing, and subsequent effectiveness, of a resale registration statement registering the ELOC Shares for
−Removed: Upon the effectiveness of the resale registration statement (the “Effective Date”), the Commitment Fee
−Removed: shares will be subject to a “true-up” pursuant to which, in the event the shares are valued at less than Issuance Value on the
−Removed: Effective Date, additional shares will be issued to Helena to bring ensure the ELOC Shares equal the Issuance Value on the Effective Date.
+Added: November 12, 2024, the Company and Helena Global Investment Opportunities I Ltd (“Helena”) entered into an equity line of
+Added: credit agreement (the “ELOC Agreement”), pursuant to which Helena agreed to purchase from the Company up to $30,000 shares
+Added: of common stock (the “ELOC Shares”).
+Added: The Company issued 670,641 shares of restricted common stock (the “Commitment
+Added: Fee Shares”), valued at $900,000 (the “Issuance Value”) on the date of issuance, to Helena as the “Commitment
+Added: Fee” for entry into the ELOC Agreement.
+Added: The ELOC Agreement will be available for the Company’s use at such time following
+Added: the filing, and subsequent effectiveness, of a resale registration statement registering the ELOC Shares for resale.
+Added: Upon the effectiveness
+Added: of the resale registration statement (the “Effective Date”), the Commitment Fee shares will be subject to a “true-up”
+Added: pursuant to which, in the event the shares are valued at less than Issuance Value on the Effective Date, additional shares will be issued
+Added: to Helena to bring ensure the ELOC Shares equal the Issuance Value on the Effective Date.
ELOC Agreement will terminate upon the following events:
10 unchanged sentences
stock, exercisable at $1.40 per share (the “January 2025 PIPE Offering”).
−Removed: advance of closing, on January 16, 2025, the Company and the Investor entered into an amended and restated purchase agreement (the “A&R Purchase Agreement”), which amended the
−Removed: terms of the Purchase Agreement to include a requirement that the Company obtain shareholder approval prior to issuing in excess of 19.99%
−Removed: of the Company’s common stock and also amended the Common Warrants to make them immediately exercisable and reduce the exercise
−Removed: period from 5.5 years to five years.
+Added: advance of closing, on January 16, 2025, the Company and the Investor entered into an amended and restated purchase agreement (the “A&R
+Added: Purchase Agreement”), which amended the terms of the Purchase Agreement to include a requirement that the Company obtain shareholder
+Added: approval prior to issuing in excess of 19.99% of the Company’s common stock and also amended the Common Warrants to make them immediately
+Added: exercisable and reduce the exercise period from 5.5 years to five years.
Other terms of the agreements remained the same.
16 unchanged sentences
on March 1, 2025.
+Added: January 2026 At-the-Market Offering
+Added: On January 12, 2026, we entered into an at-the-market (“ATM”)
+Added: offering agreement (the “ATM Agreement”) with H.C.
+Added: Wainwright Co., LLC (the “Placement Agent”) for the sale, from
+Added: time to time, of up to $4,524,949 shares of our common stock.
+Added: We registered the common stock offered under the ATM pursuant to prospectus
+Added: supplement filed in conjunction with our shelf registration statement on Form S-3 (SEC File No.
+Added: 333-292686), which was declared effective
+Added: on January 23, 2026.
+Added: Pursuant to the ATM Agreement, the Placement Agent is entitled to a placement agent fee of 3.0% of the gross sale
+Added: price of shares sold under the ATM.
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.