35 unchanged sentences
the products may not gain market acceptance among physicians, patients, hospitals and others in the medical community;
−Removed: business is highly dependent on the success of its lead product candidate, high-dose sublingual aspirin, which will require significant additional clinical
−Removed: testing before Aspire can seek regulatory approval and potentially launch commercial sales;
+Added: business is highly dependent on the success of its lead product candidate, high-dose sublingual aspirin, which will require significant
+Added: additional clinical testing before Aspire can seek regulatory approval and potentially launch commercial sales;
development involves a lengthy and expensive process with uncertain outcomes, and results of earlier studies and trials may not be
29 unchanged sentences
Before you invest in us, you should carefully consider the following risks, as well as general
−Removed: economic and business risks, and all of the other information contained in this proxy statement/prospectus.
−Removed: Aspire shareholders should
−Removed: carefully consider the following risk factors, together with all of the other information included in this proxy statement/prospectus,
−Removed: before they decide whether to vote or instruct their vote to be cast to approve the relevant proposals described in this proxy statement/prospectus.
−Removed: When determining whether to invest, you should also refer to the other information contained in this proxy statement/prospectus, including
−Removed: the financial statements of Aspire and the related notes thereto, and the other financial information concerning us included elsewhere
−Removed: in this proxy statement/prospectus.
−Removed: These risk factors are not exhaustive and investors are encouraged to perform their own investigation
−Removed: with respect to our business, financial condition and prospects.
+Added: economic and business risks, and all of the other information contained in this Report.
+Added: Aspire shareholders should carefully consider
+Added: the following risk factors, together with all of the other information included in this Report, before they decide whether to vote or
+Added: instruct their vote to be cast to approve the relevant proposals described in this Report.
+Added: When determining whether to invest, you should
+Added: also refer to the other information contained in this Report, including the financial statements of Aspire and the related notes thereto,
+Added: and the other financial information concerning us included elsewhere in this Report.
+Added: These risk factors are not exhaustive and investors
+Added: are encouraged to perform their own investigation with respect to our business, financial condition and prospects.
related to our Business
249 unchanged sentences
and laws and regulations.
−Removed: Our business, operations, financial position
−Removed: and clinical development plans and timelines, could be materially adversely affected by the continuing military action in Ukraine and
−Removed: the war between Israel and Hamas.
−Removed: As a result of the military action commenced in February
−Removed: 2022 by the Russian Federation and Belarus in Ukraine and the war between Israel and Hamas commenced in October 2023, and related economic
−Removed: sanctions imposed or that may in the future be imposed by certain governments, our financial position and operations may be materially
−Removed: and adversely affected.
−Removed: As our ability to continue to operate will be dependent on raising debt and equity finance, any adverse impact
−Removed: to those markets as a result of these conflicts, including due to increased market volatility, decreased availability in third-party financing
−Removed: and/or a deterioration in the terms on which it is available (if at all), could negatively impact our business, results of operations,
−Removed: cash flows, financial condition, and/or prospects.
−Removed: The extent of any potential impact is not yet determinable, however.
−Removed: International trade disputes, including U.S.
+Added: business, operations, financial position and clinical development plans and timelines, could be materially adversely affected by the
+Added: continuing military action in Ukraine and the war between Israel and Hamas.
+Added: a result of the military action commenced in February 2022 by the Russian Federation and Belarus in Ukraine and the war between Israel
+Added: and Hamas commenced in October 2023, and related economic sanctions imposed or that may in the future be imposed by certain governments,
+Added: our financial position and operations may be materially and adversely affected.
+Added: As our ability to continue to operate will be dependent
+Added: on raising debt and equity finance, any adverse impact to those markets as a result of these conflicts, including due to increased market
+Added: volatility, decreased availability in third-party financing and/or a deterioration in the terms on which it is available (if at all),
+Added: could negatively impact our business, results of operations, cash flows, financial condition, and/or prospects.
+Added: The extent of any potential
+Added: impact is not yet determinable, however.
+Added: International
+Added: trade disputes, including U.S.
trade tariffs and retaliatory tariffs, could adversely impact our business.
−Removed: International trade disputes,
−Removed: including threatened or implemented tariffs by the United States and threatened or implemented tariffs by foreign countries in retaliation,
−Removed: could adversely impact our business.
−Removed: Many of our tenants sell imported goods and tariffs or other trade restrictions could increase costs
−Removed: for these tenants.
−Removed: To the extent our tenants are unable to pass these costs on to their customers, our tenants could be adversely impacted.
−Removed: In addition, international trade disputes, including those related to tariffs, could result in inflationary pressures that directly
−Removed: impact our costs, such as costs for steel, lumber and other materials applicable to our redevelopment projects.
−Removed: Trade disputes could also
−Removed: adversely impact global supply chains which could further increase costs for us and our tenants or delay delivery of key inventories and
−Removed: Significant political, trade, regulatory developments,
−Removed: and other circumstances beyond our control, could have a material adverse effect on our financial condition or results of operations.
−Removed: Significant political, trade,
−Removed: or regulatory developments in the jurisdictions in which we sell our products, such as those stemming from the change in U.S.
−Removed: administration, are difficult to predict and may have a material adverse effect on us.
+Added: International
+Added: trade disputes, including threatened or implemented tariffs by the United States and threatened or implemented tariffs by foreign countries
+Added: in retaliation, could adversely impact our business.
+Added: Many of our tenants sell imported goods and tariffs or other trade restrictions
+Added: could increase costs for these tenants.
+Added: To the extent our tenants are unable to pass these costs on to their customers, our tenants could
+Added: be adversely impacted.
+Added: In addition, international trade disputes, including those related to tariffs, could result in inflationary pressures
+Added: that directly impact our costs, such as costs for steel, lumber and other materials applicable to our redevelopment projects.
+Added: Trade disputes
+Added: could also adversely impact global supply chains which could further increase costs for us and our tenants or delay delivery of key inventories
+Added: and supplies.
+Added: political, trade, regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial
+Added: condition or results of operations.
+Added: political, trade, or regulatory developments in the jurisdictions in which we sell our products, such as those stemming from the change
+Added: federal administration, are difficult to predict and may have a material adverse effect on us.
Similarly, changes in U.S.
−Removed: federal policy that
−Removed: affect the geopolitical landscape could give rise to circumstances outside our control that could have negative impacts on our business
−Removed: For example, during the prior Trump administration, increased tariffs were implemented on goods imported into the U.S.,
−Removed: particularly from China, Canada, and Mexico.
+Added: policy that affect the geopolitical landscape could give rise to circumstances outside our control that could have negative impacts on
+Added: our business operations.
+Added: For example, during the prior Trump administration, increased tariffs were implemented on goods imported into
+Added: the U.S., particularly from China, Canada, and Mexico.
On February 1, 2025, the U.S.
−Removed: imposed a 25% tariff on imports from Canada and Mexico, which
−Removed: were subsequently suspended for a period of one month, and a 10% additional tariff on imports from China.
−Removed: Historically, tariffs have led
−Removed: to increased trade and political tensions, between not only the U.S.
+Added: imposed a 25% tariff on imports from Canada and
+Added: Mexico, which were subsequently suspended for a period of one month, and a 10% additional tariff on imports from China.
+Added: Historically,
+Added: tariffs have led to increased trade and political tensions, between not only the U.S.
and China, but also between the U.S.
−Removed: and other countries in the international
+Added: countries in the international community.
In response to tariffs, other countries have implemented retaliatory tariffs on U.S.
−Removed: Political tensions as a result
−Removed: of trade policies could reduce trade volume, investment, technological exchange, and other economic activities between major international
−Removed: economies, resulting in a material adverse effect on global economic conditions and the stability of global financial markets.
−Removed: in political, trade, regulatory, and economic conditions, including, but not limited to, U.S.
−Removed: and China trade policies, could have a material
−Removed: adverse effect on our financial condition or results of operations.
−Removed: We are dependent on a limited number of suppliers
−Removed: and service providers which subjects our business and results of operations to risks of supplier business interruptions.
−Removed: We currently rely on a limited
−Removed: number of suppliers and service providers, and anticipate that we will do so for future products as well.
−Removed: delays in delivery of or shortages in those or other products and components could interrupt and delay manufacturing of our products and
−Removed: result in the cancellation of orders for our products.
−Removed: Any or all of these suppliers and service providers could discontinue the manufacture,
−Removed: supply, or services related to our products and components at any time.
−Removed: Due to certain business considerations, we may not be able to
−Removed: identify and integrate alternative sources of supply and services in a timely fashion or at all.
−Removed: Any transition to alternate suppliers
−Removed: or service providers may result in production delays and increased costs and may limit our ability to deliver products to our customers.
−Removed: Furthermore, if we are unable to identify alternative sources of supply, we would have to modify our products to use substitute components,
−Removed: which may cause delays in shipments, increased design and manufacturing costs and increased prices for our products.
−Removed: If we are unable
−Removed: to obtain additional financing, we may be unable to pay our suppliers and service providers for product and services and therefore
+Added: Political tensions as a result of trade policies could reduce trade volume, investment, technological exchange, and other economic activities
+Added: between major international economies, resulting in a material adverse effect on global economic conditions and the stability of global
+Added: financial markets.
+Added: Any changes in political, trade, regulatory, and economic conditions, including, but not limited to, U.S.
+Added: trade policies, could have a material adverse effect on our financial condition or results of operations.
+Added: are dependent on a limited number of suppliers and service providers which subjects our business and results of operations to risks of
+Added: supplier business interruptions.
+Added: currently rely on a limited number of suppliers and service providers, and anticipate that we will do so for future products as well.
+Added: delays in delivery of or shortages in those or other products and components could interrupt and delay manufacturing of our products
+Added: and result in the cancellation of orders for our products.
+Added: Any or all of these suppliers and service providers could discontinue the
+Added: manufacture, supply, or services related to our products and components at any time.
+Added: Due to certain business considerations, we may not
+Added: be able to identify and integrate alternative sources of supply and services in a timely fashion or at all.
+Added: Any transition to alternate
+Added: suppliers or service providers may result in production delays and increased costs and may limit our ability to deliver products to our
+Added: Furthermore, if we are unable to identify alternative sources of supply, we would have to modify our products to use substitute
+Added: components, which may cause delays in shipments, increased design and manufacturing costs and increased prices for our products.
+Added: are unable to obtain additional financing, we may be unable to pay our suppliers and service providers for product and services and therefore
may be unable to continue to operate our business.
8 unchanged sentences
heart attacks and strokes.
−Removed: The scientific evidence to support the feasibility of developing product candidates based on Aspire’s high-dose sublingual aspirin is preliminary
−Removed: Advancing these novel therapies creates significant challenges for us, including, among others:
+Added: The scientific evidence to support the feasibility of developing product candidates based on Aspire’s
+Added: high-dose sublingual aspirin is preliminary and limited.
+Added: Advancing these novel therapies creates significant challenges for us, including,
+Added: among others:
approval from regulatory authorities to conduct clinical trials with our product candidates;
12 unchanged sentences
and growing an organization of scientists and business people who can develop and commercialize our products and technology.
−Removed: use of Aspire’s high-dose sublingual aspirin product candidates as potential heart and stroke treatments, even if approved, may not become broadly accepted by
−Removed: physicians, patients, hospitals and others in the medical community.
−Removed: Additional factors will influence whether our product candidates
−Removed: are accepted in the market, including:
+Added: use of Aspire’s high-dose sublingual aspirin product candidates as potential heart and stroke treatments, even if approved, may
+Added: not become broadly accepted by physicians, patients, hospitals and others in the medical community.
+Added: Additional factors will influence
+Added: whether our product candidates are accepted in the market, including:
clinical indications for which our product candidates are approved;
14 unchanged sentences
Development Status of Aspirin Product
−Removed: cGMP batch of patent-pending aspirin product has been manufactured by Glatt in its New Jersey facility.
−Removed: Glatt will be using this
−Removed: batch to finalize the packaging and manufacturing process, and to provide the products to be used in the upcoming clinical tests.
−Removed: scientific team will also be conducting the stability testing required by the FDA on this batch to determine product shelf life.
−Removed: is in addition to prior similar initial testing done in 2022 by Glatt which provided important background data on the stability and manufacturing
−Removed: process for Aspire’s low dose aspirin product.
−Removed: consultants have completed (1) a comprehensive review of relevant regulatory issues and regulatory strategy (including regulations,
−Removed: guidance documents, FDA reviews of approved NDAs for other relevant products, Pediatric Research Equity Act requirements, FDA’s
−Removed: trade name approval requirements, opportunities for accelerated regulatory processes, etc.), (2) a comprehensive summary of relevant
−Removed: safety, efficacy and pharmacokinetic data to support IRB approvals, IND, and 505(b)(2) NDA approval, (3) a target product profile (including
−Removed: product description, composition, strength, route of administration, prescription v.
−Removed: OTC, indications, dosing and claims to differentiate
−Removed: from other aspirin products), and (4) an integrated product development plan (including plans to support each module of an NDA submission:
−Removed: CMC, preclinical safety, human PK, clinical safety, clinical efficacy, timelines, critical path, Gantt chart, etc.).
−Removed: These reviews were done in preparation for Aspire’s pre-IND meeting with the FDA, its clinical testing, and its NDA.
−Removed: plans to conduct an in vivo single-dose bioavailability study in healthy human volunteers in approximately April 2025 (“Trial 1”).
−Removed: This clinical trial will evaluate pharmacokinetic endpoints including but not limited to maximum concentrations of aspirin and/or its
−Removed: metabolites in plasma (“Cmax”), time of maximum concentrations (“Tmax”), and area under the time curve concentrations
−Removed: (“AUC”) following sublingual dosing of two different pharmaceutical formulations of Instaprin compared to standard oral aspirin.
−Removed: Pharmacodynamic effect on serum thromboxane B2 (TXB2, a measure of platelet inhibition) will be evaluated as a secondary endpoint.
−Removed: from this bioavailability study will be used to select the optimal pharmaceutical formulation of Instaprin and to design a pivotal Trial
−Removed: 2 to support filing of an NDA.
−Removed: Trial 1 will be exempt from Investigational New Drug (IND) filing requirements under 21 C.F.R.
−Removed: because it is a human bioavailability trial of an FDA-approved active ingredient that is not a new chemical entity, a radioactively labeled
−Removed: drug product, or cytotoxic drug product, using a dose not exceeding the dose specified in the labeling of the approved drug product,
−Removed: conducted in compliance with the requirements for review by an Institutional Review Board (IRB), with reserve test article samples retained
−Removed: by the study sponsor.
−Removed: completion of Trial 1, Aspire plans to request a pre-IND meeting with the FDA in the second quarter of 2025 to discuss plans for continued
−Removed: development of Instaprin leading to submission of a section 505(b)(2) NDA.
−Removed: Aspire plans to propose a second clinical trial (“Trial
−Removed: 2”) in approximately 24 healthy human volunteers to evaluate the pharmacodynamic effect of a single dose of Instaprin on platelet
−Removed: inhibition compared to that of standard oral aspirin.
−Removed: The proposed primary endpoint for Trial 2 would be time to TXB2 inhibition.
−Removed: of TXB2 inhibition and pharmacokinetic parameters (Cmax, Tmax, AUC, etc.) for aspirin and/or its metabolites in plasma will be analyzed
−Removed: as secondary endpoints.
−Removed: Following completion of Trial 2, Aspire intends to submit a section 505(b)(2) NDA for the high-dose sublingnual product to
+Added: cGMP batch of high-dose aspirin was manufactured by Glatt in its New Jersey facility in March 2025.
+Added: Glatt used this batch to finalize
+Added: the packaging and manufacturing process, and to provide the products which were used in the clinical trials which took place in Florida
+Added: and ended in July, 2025, with the final clinical trial study results provided to Aspire on September 5, 2025.
+Added: Glatt’s scientific
+Added: team will also be conducting the stability testing required by the FDA on this batch to determine product shelf life.
+Added: This is in addition
+Added: to prior similar initial testing done in 2022 by Glatt which provided important background data on the stability and manufacturing process
+Added: for our low dose sublingual aspirin product.
+Added: In January 2026, Aspire contracted with Microsize CDMO for the manufacture of product for
+Added: the next clinical trials of the high-dose aspirin product as per the FDA letter of November 11, 2025.
+Added: consultants have completed (1) a comprehensive review of relevant regulatory issues and regulatory strategy (including regulations, guidance
+Added: documents, FDA reviews of approved NDAs for other relevant products, Pediatric Research Equity Act requirements, FDA’s trade name
+Added: approval requirements, opportunities for accelerated regulatory processes, etc.), (2) a comprehensive summary of relevant safety, efficacy
+Added: and pharmacokinetic data to support IRB approvals, IND, and 505(b)(2) NDA approval, (3) a target product profile (including product description,
+Added: composition, strength, route of administration, prescription v.
+Added: OTC, indications, dosing and claims to differentiate from other aspirin
+Added: products), and (4) an integrated product development plan (including plans to support each module of an NDA submission:
+Added: CMC, preclinical
+Added: safety, human PK, clinical safety, clinical efficacy, timelines, critical path, Gantt chart, etc.).
+Added: These reviews were done in preparation
+Added: for Aspire’s communication with the FDA, its clinical testing, and its NDA.
+Added: have recently conducted an in vivo single-dose bioavailability study in healthy human volunteers which ended in July, 2025.
+Added: clinical trial study report was provided to Aspire on September 5, 2025.
+Added: This clinical trial evaluated pharmacokinetic endpoints including
+Added: but not limited to maximum concentrations of aspirin and/or its metabolites in plasma (“Cmax”), time of maximum concentrations
+Added: (“Tmax”), and area under the time curve concentrations (“AUC”) following sublingual dosing of two different pharmaceutical
+Added: formulations of our sublingual aspirin compared to standard oral aspirin.
+Added: Pharmacodynamic effect on serum thromboxane B2 (TXB2, a measure
+Added: of platelet inhibition) was evaluated as a secondary endpoint.
+Added: Data from this bioavailability study will be used to select the optimal
+Added: pharmaceutical formulation of aspirin and to support filing of an NDA.
+Added: This trial was exempt from Investigational New Drug (IND) filing
+Added: requirements under 21 C.F.R.
+Added: 320.31(d) because it is a human bioavailability trial of an FDA-approved active ingredient that is not a
+Added: new chemical entity, a radioactively labeled drug product, or cytotoxic drug product, using a dose not exceeding the dose specified in
+Added: the labeling of the approved drug product, conducted in compliance with the requirements for review by an Institutional Review Board
+Added: (IRB), with reserve test article samples retained by the study sponsor.
+Added: receipt and analysis of the clinical trial results, on October 31, 2025 Aspire requested a pre-IND meeting with the FDA.
+Added: Aspire received
+Added: a written response to the request in a letter from the FDA dated November 13, 2025.
+Added: Based on the FDA response to the pre-IND request,
+Added: Aspire intends to conduct an additional clinical trial using approximately 32 healthy human volunteers to evaluate the pharmacodynamic
+Added: effect of a single dose of our high dose aspirin on platelet inhibition compared to that of standard oral aspirin.
+Added: The proposed primary
+Added: endpoint for an additional trial would be time to TXB2 inhibition.
+Added: Variability of TXB2 inhibition and pharmacokinetic parameters (Cmax,
+Added: Tmax, AUC, etc.) for aspirin and/or its metabolites in plasma will be analyzed as secondary endpoints.
+Added: If needed, the additional trial
+Added: will be designed to demonstrate a shorter time to clinically meaningful pharmacodynamic effect (TXB2 inhibition) following administration
+Added: of our aspirin compared to standard oral aspirin (standard of care for treatment of suspected acute myocardial infarction).
+Added: completion of this additional trial, Aspire will submit a section 505(b)(2) NDA for our aspirin product to the FDA seeking approval to
+Added: market the product for treatment of suspected acute myocardial infarction.
+Added: Additional clinical trials focused on differentiating our
+Added: aspirin from standard oral aspirin based on TXB2 inhibition and gastrointestinal irritation, ulceration and bleeding during longer term
+Added: use may be conducted to support subsequent 505(b)(2) NDAs and/or supplemental NDAs for our aspirin in other therapeutic indications focused
+Added: on the antithrombotic and analgesic effects of aspirin.
Development Status of Other Products
−Removed: Aspire’s scientists have developed a working formulation for a sublingually administered melatonin sleep-aid product in a 3mg,
−Removed: 5mg, and 10 mg dose.
−Removed: In the next two months, Aspire intends to develop and validate the manufacturing process based on this
−Removed: In May 2025, Aspire plans to conduct a limited pharmokinetic study using at least eight volunteers, comparing to
−Removed: orally administered melatonin products on the market, in order to support its claims and labeling.
−Removed: No FDA approval is required for
−Removed: Melatonin, which is sold as a supplement.
−Removed: Melatonin is a wildly popular sleep aid and Aspire has begun exploring licensing
−Removed: possibilities and has also begun discussions with a manufacturing facility in Puerto Rico.
−Removed: Aspire intends to file for patent
−Removed: protection in the near future.
−Removed: Aspire’s scientists have developed a working formulation for sublingually administered vitamins D, E and K.
−Removed: In the first two quarters
−Removed: of 2025, Aspire intends to develop and validate a manufacturing process and conduct a limited pharmokinetic study.
−Removed: Aspire intends to
−Removed: file for patent protection in the near future.
−Removed: Testosterone :
−Removed: Aspire’s scientists have developed a formulation for sublingually administered testosterone.
−Removed: A patent application for the formulation
−Removed: will be filed in due course.
−Removed: In the third and fourth quarters of 2025, Aspire intends to develop and validate the manufacturing
−Removed: process based on this formulation, and produce a cGMP batch for use in clinical testing and a stability study.
−Removed: Aspire intends to conduct
−Removed: a Phase One clinical test in approximately the first quarter of 2026 for pharmokinetical validation of product properties, using approximately
−Removed: eight volunteers, and to establish criteria for an NDA with the FDA.
−Removed: Aspire anticipates, based on these results, to request a pre-IND
−Removed: meeting with the FDA in the second quarter of 2026, followed by Phase Two clinical testing.
−Removed: Aspire anticipates this testing to use approximately
−Removed: 32 volunteers.
−Removed: Aspire intends to submit an NDA for the testosterone product under 505(b)(2) to the FDA in the second quarter of 2026.
−Removed: Testosterone is not a candidate for fast-track approval, therefore the NDA approval process will likely take as much as three years.
−Removed: Semaglutide :
−Removed: Aspire’s scientists are in the final phases of developing a working formulation for a sublingual semaglutide product.
−Removed: to market will be similar to that of testosterone, above, as semaglutide is not likely a candidate for fast-track approval.
−Removed: Aspire’s scientific team has developed a working formula for a single dose sublingual pre-workout supplement as well
−Removed: as a single dose “coffee or soda replacement” with health benefits.
−Removed: Aspire has manufactured trial runs of this supplement
−Removed: and intends to do consumer and safety testing in Q2 2025.
−Removed: Aspire believes this product will be ready for launch in Q2 or Q3 2025.
−Removed: Aspire’s scientists are currently considering formulations for anti-nausea products, anti-psychotic products, ED
−Removed: drugs, seizure medication, and several other classes of drugs, all using our sublingual mode of administration.
−Removed: we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to
−Removed: successfully develop and commercialize our product candidates, which could materially harm our business, financial condition and results
−Removed: of operations.
−Removed: business is highly dependent on the success of its lead product candidate, high-dose sublingual aspirin, which will require significant additional clinical
−Removed: testing before Aspire can seek regulatory approval and potentially launch commercial sales.
+Added: scientists have developed a working formulation for a sublingually administered melatonin sleep-aid product, in 3mg, 5mg, and 10mg doses
+Added: and has created a batch of product and completed limited testing.
+Added: Aspire may, although it is not required to, conduct a limited pharmacokinetic
+Added: study using at least eight volunteers, comparing to orally administered melatonin products on the market, in order to support its claims
+Added: and labeling.
+Added: No FDA approval is required for melatonin, which is sold as a supplement.
+Added: Melatonin is a popular sleep aid and Aspire has
+Added: begun exploring licensing possibilities.
+Added: The Company has filed for patent protection of its melatonin formulation in patent application
+Added: 63/890,248 filed on 9/25/25 (part of the “Omnibus Patent”).
+Added: scientists have developed a working formulation for sublingually administered vitamins D, E and K.
+Added: The Company has filed for patent protection
+Added: of its vitamin products in the Omnibus Patent.
+Added: Aspire’s scientists are also developing a working formulation for a sublingual ED (erectile dysfunction) product.
+Added: The timeline to market will be similar depending on the speed of formulation, availability of resources, market conditions and other
+Added: FDA approval would likely take at least 2-3 years as ED medication is not likely a candidate for fast-track/breakthrough therapy
+Added: The Company has filed for patent protection of its ED formulation in the Omnibus Patent.
+Added: Aspire has developed a working formula for a single serving sublingual pre-workout supplement as well as a single
+Added: dose “coffee or soda replacement” with health benefits, using its patent-pending sublingual absorption technology.
+Added: has manufactured trial runs of this supplement and conducted consumer and safety testing in the second quarter of 2025.
+Added: Aspire entered
+Added: into a manufacturing agreement with Desert Stream, Inc., a nutrition and supplement manufacture with experience in caffeine products,
+Added: through its wholly-owned subsidiary Buzz Bomb Caffeine Company LC.
+Added: Aspire and Desert Stream have developed a half dozen flavors of the
+Added: Aspire has registered several trademarks that it intends to use with these products and obtained domain names as well.
+Added: unveiled its caffeine product at two large fitness conventions in the first week of August 2025 and began selling initial versions of
+Added: its caffeine products in the third quarter of 2025.
+Added: After that product was well-received, Aspire entered into a manufacturing contract
+Added: with Supranaturals (Springville, UT) to manufacture 2,000,000 units of its caffeine supplement which is marketed under the trademark
+Added: “Buzz Bomb” (see buzzbombcaffeine.com).
+Added: The new marketing and labeling of these 2,000,000 units began on January 15, 2026.
+Added: Aspire’s scientists have created formulations for anti-nausea products (Meclizine and Ondansetron), alprazolam,
+Added: clopidogrel, microdose nicotine, and semaglutide, and are considering formulations for anti-psychotic products, seizure medication, and
+Added: several other classes of drugs, all using our sublingual mode of administration.
+Added: We anticipate taking several of these products to market
+Added: as the research and development dictates, as well as market conditions and company funding.
+Added: Aspire has filed patents protecting several
+Added: of these products:
+Added: nicotine (Omnibus Patent), alprazolam (patent application 63/957,370 filed 1/9/26), meclizine (patent application
+Added: 63/971,320 filed 1/29/26), clopidogrel (patent application 63/957,361 filed 1/9/26), and ondansetron (patent application 63/970,377 filed
+Added: Our scientists are currently considering formulations for anti-nausea products, anti-psychotic products, semaglutide, seizure
+Added: medication, microdose nicotine, and several other classes of drugs, all using our sublingual mode of administration.
+Added: We anticipate taking
+Added: several of these products to market as the research and development dictates, as well as market conditions and company funding.
+Added: business is highly dependent on the success of our lead product candidate, high-dose sublingual aspirin, which will require significant
+Added: additional clinical testing before Aspire can seek regulatory approval and potentially launch commercial sales.
do not have any products that have gained regulatory approval.
Our business and future success depends on our ability to obtain regulatory
−Removed: approval of and then successfully commercialize our lead product candidate, high-dose sublingual aspirin, which is in the early stages of Preclinical development.
−Removed: We are currently conducting our preclinical tests to compile and file an NDA (investigational new drug application).
−Removed: Our ability to develop,
−Removed: obtain regulatory acceptance for high-dose sublingual aspirin to enter clinical trials will depend on several factors, including the following:
+Added: approval of and then successfully commercialize our lead product candidate, high-dose sublingual aspirin.
+Added: We recently completed our clinical
+Added: trials and intend to compile and file an NDA (investigational new drug application).
+Added: Our ability to develop, obtain regulatory acceptance
+Added: for high-dose sublingual aspirin to enter clinical trials will depend on several factors, including the following:
demonstrating that the therapy is reasonably safe for human clinical studies;
2 unchanged sentences
overseeing the administration of the study are qualified.
−Removed: drug product candidates, including high-dose sublingual aspirin, will require additional clinical and non-clinical development, regulatory review and
−Removed: approval in multiple jurisdictions, substantial investment, access to sufficient commercial manufacturing capacity and significant
+Added: drug product candidates, including high-dose sublingual aspirin, will require additional clinical and non-clinical development, regulatory
+Added: review and approval in multiple jurisdictions, substantial investment, access to sufficient commercial manufacturing capacity and significant
marketing efforts before we can generate any revenue from product sales.
−Removed: We are not permitted to market or promote any of our
−Removed: product candidates before we receive regulatory approval from the FDA or comparable foreign regulatory authorities, and we may never
−Removed: receive such regulatory approval for any of our product candidates.
−Removed: If we are unable to develop or receive marketing approval for
−Removed: our aspirin or other products we develop in a timely manner or at all, we could experience significant delays or an inability to
−Removed: commercialize our aspirin or other products, which would materially and adversely affect our business, financial condition and results
−Removed: of operations.
+Added: We are not permitted to market or promote any of our product
+Added: candidates before we receive regulatory approval from the FDA or comparable foreign regulatory authorities, and we may never receive
+Added: such regulatory approval for any of our product candidates.
+Added: If we are unable to develop or receive marketing approval for our aspirin
+Added: or other products we develop in a timely manner or at all, we could experience significant delays or an inability to commercialize our
+Added: aspirin or other products, which would materially and adversely affect our business, financial condition and results of operations.
development involves a lengthy and expensive process with uncertain outcomes, and results of earlier studies and trials may not be predictive
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more of its product candidates, which would prevent or delay regulatory approval and commercialization.
−Removed: obtaining regulatory approvals for the commercial sale of our product candidates, including our high-dose sublingnal aspirin, we must demonstrate through lengthy,
−Removed: complex and expensive preclinical testing and clinical trials that our product candidates are both safe and effective for use in each
−Removed: target indication.
−Removed: Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain.
−Removed: can occur at any time during the clinical trial process.
−Removed: The results of preclinical studies and early clinical trials of our product
−Removed: candidates may not be predictive of the results of later-stage clinical trials.
−Removed: There is typically an extremely high rate of attrition
−Removed: from the failure of product candidates proceeding through clinical trials.
−Removed: Product candidates in later stages of clinical trials may
−Removed: fail to show the desired safety and efficacy profile despite having progressed through preclinical studies and initial clinical trials.
−Removed: A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of
−Removed: efficacy or adverse safety profiles, notwithstanding promising results in earlier trials.
−Removed: We cannot be certain that we will not face
−Removed: similar setbacks.
+Added: obtaining regulatory approvals for the commercial sale of our product candidates, including our high-dose sublingual aspirin, we must
+Added: demonstrate through lengthy, complex and expensive preclinical testing and clinical trials that our product candidates are both safe
+Added: and effective for use in each target indication.
+Added: Clinical testing is expensive and can take many years to complete, and its outcome is
+Added: inherently uncertain.
+Added: Failure can occur at any time during the clinical trial process.
+Added: The results of preclinical studies and early clinical
+Added: trials of our product candidates may not be predictive of the results of later-stage clinical trials.
+Added: There is typically an extremely
+Added: high rate of attrition from the failure of product candidates proceeding through clinical trials.
+Added: Product candidates in later stages
+Added: of clinical trials may fail to show the desired safety and efficacy profile despite having progressed through preclinical studies and
+Added: initial clinical trials.
+Added: A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical
+Added: trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials.
+Added: We cannot be certain
+Added: that we will not face similar setbacks.
Most product candidates that commence clinical trials are never approved as commercial products.
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Aspire fails to develop additional product candidates, its commercial opportunity will be limited.
−Removed: expect to initially develop our lead product candidate, high-dose sublingual aspirin, a fast-acting form of powdered aspirin that could rapidly stop heart
−Removed: attacks and strokes.
+Added: expect to initially develop our lead product candidate, high-dose sublingual aspirin, a fast-acting form of powdered aspirin that could
+Added: rapidly stop heart attacks and strokes.
However, one of our strategies is to pursue clinical development of additional product candidates.
−Removed: Developing, obtaining
−Removed: regulatory approval for and commercializing additional product candidates will require substantial funding and are prone to the risks
−Removed: of failure inherent in medical product development.
−Removed: We cannot assure you that we will be able to successfully advance any of these additional
−Removed: product candidates through the development process.
+Added: Developing, obtaining regulatory approval for and commercializing additional product candidates will require substantial funding and
+Added: are prone to the risks of failure inherent in medical product development.
+Added: We cannot assure you that we will be able to successfully
+Added: advance any of these additional product candidates through the development process.
if we obtain FDA approval to market additional product candidates for the treatment of heart attacks and strokes, we cannot assure you
260 unchanged sentences
Related to Being a Public Company After a Business Combination
−Removed: price of our Common Stock and warrants may fluctuate significantly following the Business Combination and you could lose all or part
−Removed: of your investment as a result.
−Removed: market price of New Aspire Common Stock and New Aspire warrants may be volatile.
+Added: price of our Common Stock and warrants may fluctuate significantly you could lose all or part of your investment as a result.
+Added: market price of Aspire Common Stock and Aspire warrants may be volatile.
The stock market in general, and the market for biopharmaceutical
3 unchanged sentences
Many factors may have a material
−Removed: adverse effect on the market price of New Aspire’s securities, including, but not limited to:
+Added: adverse effect on the market price of Aspire’s securities, including, but not limited to:
commencement, enrollment, delay, or results of our ongoing or future clinical trials, or changes in the development status of our
25 unchanged sentences
or expectation of additional financing efforts;
−Removed: of New Aspire’s shares by us, New Aspire’s executive officers or directors or New Aspire’s stockholders;
+Added: of Aspire’s shares by us, Aspire’s executive officers or directors or Aspire’s stockholders;
and market conditions in the U.S.
9 unchanged sentences
has often been brought against that company.
−Removed: Because of the potential volatility of our Common Stock and warrant price, New Aspire may
−Removed: become the target of securities litigation in the future.
+Added: Because of the potential volatility of our Common Stock and warrant price, Aspire may become
+Added: the target of securities litigation in the future.
Securities litigation could result in substantial costs and divert management’s
2 unchanged sentences
including those described in this “ Risk Factors ” section, could have a dramatic and material adverse impact on the
−Removed: market price of our common stock following the Business Combination.
−Removed: Your percentage ownership in us may be diluted by future issuances of capital stock, which could reduce your influence over matters on
−Removed: which stockholders vote.
−Removed: Aspire board of directors has the authority, without action or vote of the New Aspire stockholders, to issue all or any part of our authorized
+Added: market price of our common stock following the Reverse Recapitalization.
+Added: percentage ownership in us may be diluted by future issuances of capital stock, which could reduce your influence over matters on which
+Added: stockholders vote.
+Added: Aspire board of directors has the authority, without action or vote of the Aspire stockholders, to issue all or any part of our authorized
but unissued shares of common stock, including shares issuable upon the exercise of options, or shares of our authorized but unissued
4 unchanged sentences
the complete list of risks relating to our operations, see the section titled “Risk Factors” contained in our prospectus
−Removed: dated January 8, 2025, and other reports and filings we have made, and will make with the Securities and Exchange Commission.
+Added: dated February 17, 2026 and other reports and filings we have made, and will make with the Securities and Exchange Commission.
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.