75N98026R00109 SBIR Phase I - Amendment 0003_FINAL signed.pdf

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

7. ADMINISTERED BY (If other than Item 6) CODE

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15C. DATE SIGNED

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16C. DATE SIGNED

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

Mandie White, MBA

The purpose of this amendment is to provide key questions and answers received in writing by email.

Offerors are required to submit a signed copy of the SF30 Amendment (page 1 only) with their Business Proposal submission.

The deadline for receipt of proposals remains unchanged at 5:00pm, September 21,2026.

All other terms and conditions of the solicitation remain unchanged.

National Institutes of Health Office of Acquisitions and Logistics Management (OALM) Research and Development and Professional Services – Division B

To All Potential Offerors to RFP: #75N98026R00109

Title: NATIONAL CANCER INSTITUTE (NCI) SMALL BUSINESS INNOVATION

RESEARCH (SBIR) INNOVATIVE CONCEPT PHASE I AWARD PROGRAM

75N98026R00109

1 17

08/10/2026

07/10/2026

AMENDMENT 0003

Solicitation Number: 75N98026R00109 Date of Solicitation Issuance: 07/10/2026 Date of Amendment No. 0003 Issuance: 08/10/2026 Number of Pages: 17 Point of Contact: Kathleen Sears E-mail: ncioasbir@nih.gov Issuing Office: National Cancer Institute (NCI)

QUESTIONS AND RESPONSES

Question 1: We are preparing a potential submission under Topic 1: Development of therapeutic or preventative technologies for treatment or prevention of Pediatric Cancers and/or Rare Cancers. Our proposed concept is a logic-gated RNA therapeutic platform for pancreatic ductal adenocarcinoma (PDAC), using programmable reconfigurable nucleic acid nanoparticles (recNANP) designed to conditionally activate RNAi payloads in PDAC cells expressing defined disease-associated RNA signatures. The proposed Phase I concept would test disease-triggered RNAi suppression of CDK11-pathway chemoresistance targets in PDAC-related 3D models, with milestones focused on trigger-dependent activation, reduced activation in trigger-negative controls, CDK11-pathway knockdown, and preliminary delivery-compatibility testing.

Could you please confirm whether this concept appears to fall within the intended scope of Topic 1 for the FY2027 Innovative Concept Award solicitation?

Answer 1: The proposed technology appears within scope and you should consider applying for the funding opportunity. A few recommendations are: 1) Make sure that your outcomes and aims are clearly defined and focused on product development with clear quantifiable product focused milestones. 2) If budget allows, in vitro and in vivo characterization of anti-tumor efficacy using a relevant murine tumor model is recommended.

Question 2: Also, the pre-solicitation notice mentions an interim deadline for submission and consideration of white papers. Could you please confirm whether NCI is accepting 2-3 page white papers for this FT2027 opportunity, and if so, what the submission deadline, format, and delivery instructions are?

Answer 2: Please note there will be no white paper submission/review this year.

Question 3: Alkhaleeli BioAI LLC is focused on research-only Al and computational biology tools for cancer research, including structured in silica workflows for disease mechanism review, gene and mutation analysis, target identification, candidate concept development, mailto:ncioasbir@nih.gov and prioritization before laboratory validation. The work is intended to support early-stage informatics and research planning and does not make diagnosis, treatment, cure, or clinical-use claims. I also have related intellectual property work in progress, including provisional patent concepts connected to research tools and platform development. I would appreciate guidance on where this information should be included in the SBIR application and whether any additional documentation is recommended at this stage.

Could you please advise me on the correct next steps for preparing and submitting the application, including any required forms, registrations, or attachments?

Answer 3: Companies can provide information regarding their intellectual property in Section F (Potential Commercial Application) of the fillable Technical Proposal Form. You will be able to refer to the solicitation once it's posted (Section 8.5).

Question 4: Are there any upcoming office hours or opportunities to meet with an NCI program director prior to submission to discuss project scope, milestones, and alignment with the solicitation? If available, we would greatly appreciate the opportunity.

Answer 4: Thank you for your interest in the Concept Award. At this time, there are no office hours or planned opportunities to meet individually with an NCI Program Director prior to submission. NCI encourages you to review the published solicitation, which is available here:

htts://sam.gov/worksRace/contractloRRl8fbf26c5215646f582bf9fe4b4fO0fca/view. The solicitation contains important details regarding project scope, milestones, and submission requirements.

If you have questions after reviewing the solicitation, please feel free to submit them via email (ncioasbir@mail.nih.gov). We will accept questions through August 1, and will do our best to provide clarification as appropriate.

Question 5: We have a brief question regarding Attachment 1 - Technical Proposal Form for Solicitation 75N98026R00109 (NCI SBIR Innovative Concept Phase I Award Program).

The "Technology/Product Overview" section lists the following checkbox categories: Small Milecule, Biologics/Vaccine, Cell/Gene Therapy, Surgical or Ablative Device, Hospital Device, Drug Delivery device, Imaging device, Imaging agent, In vitro diagnostic, Bioinformatic/health IT/digital health and research tool.

Our proposed technology is a synthetic RNA oligonucleotide therapeutic (e.g., antisense oligonucleotide/siRNA), which does not map clearly to any of the listed categories. Could you please advise which checkbox we should select to best represent this technology type?

Answer 5: Thanks for your interest in the Concept Award Program. Based on the description provided, NCI recommends selecting Biologics/Vaccine for the "Technology/Product Overview" section of the application.

Question 6: Following Forta Bio's 2025 submission under Solicitation No. 75N91025R00005, which was subsequently cancelled, we have continued to advance the program and are pleased to submit an updated white paper in response to the new Solicitation No.

75N98026R00109.

Over the past year, the program has evolved from a delivery concept to an Aptamer-6tdGO candidate with direct in vitro evidence of potent activity against human glioblastoma (GBM) cells.

The enclosed white paper summarizes the scientific advances, supporting data, and our productfocused development plan. We would greatly appreciate any feedback or comments before we submit our full proposal, as your guidance would help us further strengthen the application.

Thank you very much for your time and consideration.

Answer 6: Thank you for your submission. Page 1, paragraph 1 of the solicitation states "White Papers will not be requested or accepted in response to this solicitation". Further, no review of any white paper submission will take place.

Question 7: Thank you for your response. We are aware that the recent amendment no longer requires white paper submissions.

Our intention in sharing the white paper was simply to provide an update on the significant progress we've made since our previous submission and to see whether you might have any additional guidance or feedback that could help us strengthen our full proposal.

If not, we completely understand and will proceed according to the amended solicitation.

Answer 7: Thank you for your interest in the Concept Award. At this time, there are no office hours or planned opportunities to meet individually with an offeror about white papers prior to submission.

Reviewing your white paper would be a disadvantage to other offerors since we are not accepting any white papers this year.

NCI encourages you to review the published solicitation, which is available here:

httRs://sam.gov/worksRace/contract!oRRl8fbf26c5215646f582bf9fe4b4fO0fca/view. The solicitation contains important details regarding project scope, milestones, and submission requirements.

If you have questions after reviewing the solicitation, please feel free to submit them via email (ncioasbir@mail.nih.gov). We will accept questions through August 1, and will do our best to provide clarification as appropriate.

Question 8: My name is Rui Tang, cofounder of Purely Grow Inc. We are preparing to submit a proposal under the NCI SBIR Innovative Concept Award (Notice 75N98026R00109). Per the program page, I am attaching a 3-page white paper describing our technology and proposed aims for programmatic feedback ahead of the September 21 proposal deadline. In brief, we have developed an engineered, ECM-preserving 3D tumor tissue platform combined with Al-based histopathology analysis, validated in inflammatory breast cancer (IBC). We propose using this platform to develop a quantitative, antigen-specific assay for CAR-T cell tumor infiltration and potency, using CD44v6-targeted CAR-T cells in an IBC model as an initial validation case, with the platform intended to generalize to additional cell- and biologic-therapy modalities in future work.

We are also preparing a separate proposal under the standard NCI SBIR mechanism (PA-27- 100), applying the same core platform to a related but distinct question: quantifying therapeutic response in IBC tissue rather than CAR-T infiltration. The Specific Aims page for PA-27-100 is attached for your reference. I hope this gives you the full picture given the shared underlying platform. I am happy to answer any questions or provide more details.

Given the August 1 deadline for questions, I wanted to share this white paper in case there is time for your feedback for our final proposal. I would also welcome the opportunity for a brief call if that would be helpful.

Answer 8: Page 1, paragraph 1 of the solicitation states "White Papers will not be requested or accepted in response to this solicitation". Further, no review of any white paper submission will take place.

Question 9 Thank you for the reply, and apologies for the confusion.

I found on the NCI website (https://sbir.cancer.gov/small-business-funding/contracts/innovativeconceP-t-award) that Offerors are strongly encouraged to submit a two- to three-page white paper describing their technology and aims for programmatic feedback before submitting a final proposal.

Program Contact: Kathleen Sears (ncioasbir@mail.nih.gov) That was why I sent the white paper to Kathleen for feedback.

Could you please point me to the correct process for submitting questions ahead of the August 1 deadline? I want to make sure any questions we have are submitted through the appropriate channel.

Answer 9: Please see page 1 of the solicitation where it states: Deadline for Receipt of Questions:

As discussed in Section 7 of this solicitation, all questions should be submitted by August 1, 2026 via e-mail to ncioasbir@mail.nih.gov. After that time, questions will be addressed as time permits, and at the discretion of the NCI Office of Acquisitions. Questions will be shared with the public through a solicitation amendment to ensure fair competition. Do not include sensitive information in questions submitted.

On page 1 of the solicitation it also states: Please note that White Papers will not be requested or accepted in response to this solicitation.

Make sure that you click on the highlighted Notice Number in order to see the actual attachments of the solicitation and amendments: 75N98026R00109.

mailto:ncioasbir@mail.nih.gov

Question 10: On the Technical Proposal template, I see that the lettered sections for the technical content indicate not-toexceed characters counts. However, for the Statement of Work portion of the document, sections are marked with a character limit to include spaces.

Does that mean the character limits for the technical content fields are maximums of only alphanumeric characters, or do the indicated limits include spaces also (like the Statement of Work)?

Answer 10: Thanks for reaching out and for your interest in the Concept Award. The character limits for the lettered sections of the Technical Proposal form include spaces. Once the character limit has been reached, the form will not allow you to enter any additional text.

Question 11: I am writing regarding an SBIR grant submitted in Oct 2025. Agenta has made progress over the course of the last year and I was wondering if it would be prudent to submit a grant a Phase I award under the PA-27-102 announcement, followed by a Phase II award.

The PA-27-102 states it is a $700,000 budget under the STTR umbrella. This additional value in funding will allow us to move more quickly into clinical trials.

Alternatively, we now have data that gives us confident to move two products forward .

What are your thoughts on two awards and/or pivoting to a PA-27-102?

Answer 11: Thank you for reaching out and for your interest in the Concept Award.

If the technology proposed in your October 2025 Concept Award submission has advanced significantly, you are welcome to apply for an Omnibus Phase I SBIR grant instead. If you are interested in submitting an Omnibus application, I encourage you to contact the mailbox ncisbir@nih.gov Program Director William Bozza at william.bozza@nih.gov to be connected with a Program Director to discuss your plans.

You are also welcome to submit applications to both the Concept Award and the Omnibus Phase I solicitation, provided they are for different technologies/different indications. Please keep in mind that NIH policy does not allow highly overlapping applications to be under peer review at the same time.

Question 12: My name is Roman Owens, Founder and CEO of OncoVanta Therapeutics, Inc., a biotechnology company developing T-cell receptor {TCR)-based immunotherapies for solid tumors.

Following discussions with NCI Small Business Program Director Dr. Julianne Twomey, I was advised to direct any questions regarding the NCI Innovative Concept Phase I Award to your office, as all pre-award communications for this contract mechanism are coordinated through the Office of Acquisitions.

We have prepared an executive concept summary describing our proposed project and would appreciate any programmatic guidance you are able to provide regarding alignment with the solicitation. Our proposed project is focused on the development of a CD7-targeted polymeric nanoparticle platform for nonviral delivery of therapeutic T-cell receptor constructs, using our mailto:ncisbir@nih.gov

NIH-licensed TP53 R175H-specific TCR as the initial proof-of-concept payload. Specifically, we would appreciate guidance on the following:

• Whether the proposed project appears aligned with the objectives of the Innovative Concept Phase I Award solicitation.

• Whether the scope is appropriate for a Phase I contract.

• Whether there are any general recommendations regarding the fit of the proposed work with the solicitation objectives or areas we should consider before submission.

Answer 12: This type of project aligns with Concept Phase I.

Question 13: I have one procedural question. Can we resubmit the letters of support from last year, or should we obtain updated letters from the same supporters?

Answer 13: We encourage updated Letters of Support that are dated within a few months of submission.

Question 14: First, the Innovative Concept Award website states that offerors are strongly encouraged to submit a two- to three-page white paper prior to submitting a proposal.

However, the solicitation document states that "White Papers will not be requested or accepted in response to this solicitation." Could you clarify whether white papers are part of the current submission process, or whether the solicitation document supersedes the website guidance?

Answer 14: Page 1, paragraph 1 of the solicitation states "White Papers will not be requested or accepted in response to this solicitation". Further, no review of any white paper submission will take place.

Question 15: My name is Prakrit Jena, and I am the Co-founder and Chief Scientific Officer of Lime Therapeutics, a small biotechnology company developing first-in-class small molecule therapies targeting ferroptosis pathways in cancer.

We are considering submitting a proposal to the NCI SBIR Innovative Concept Phase I Award Program (Solicitation No. 75N98026R00109) for a project focused on developing a novel small molecule inhibitor that sensitizes treatment-resistant hepatocellular carcinoma (HCC) to standard-of-care therapy via the inhibition of FSP1 (ferroptosis suppressor protein 1), a recently emerging ferroptosis regulator in cancer.

Before preparing a full proposal, I was hoping to clarify two questions.

First, the Innovative Concept Award website states that offerors are strongly encouraged to submit a two- to three-page white paper prior to submitting a proposal. However, the solicitation document states that "White Papers will not be requested or accepted in response to this solicitation." Could you clarify whether white papers are part of the current submission process, or whether the solicitation document supersedes the website guidance?

Second, based on the brief description above, does the type of project appear to be within the intended scope of Topic 1 of the Innovative Concept Award? Our proposed indication is HCC, which is listed as a rare cancer (NCATS GARD), and has a low survival rate (21.9%, NCI SEER).

The proposed work would evaluate a first-in-class FSP1 inhibitor in preclinical in vivo models of HCC as both a monotherapy and in combination with the standard-of-care agents sorafenib/lenvatinib, and immune checkpoint inhibitors.

We would greatly appreciate any guidance on whether this type of proposal appears to align with the goals and intended scope of Topic 1.

Answer 15: Page 1, paragraph 1 of the solicitation states "White Papers will not be requested or accepted in response to this solicitation". Further, no review of any white paper submission will take place.

Hepatocellular carcinoma has an incidence <200,000 people in the United States and is considered a rare cancer according to the definition in the solicitation. In vivo animal work in a rare or pediatric tumor model is considered in scope for the solicitation.

Question 16: If my company has indirect rates approved by DCAA (at a rate above 40% of total direct costs), are we allowed to use the DCAA-approved rates on our proposed budget with DCAA documentation?

Answer 16: Please see section 8.9 on page 40 of the solicitation where it states: NIH Policy on Threshold for Negotiation of General and Administrative (G&A)/lndirect Costs (IDC) Rates for SBIR proposals - SBIR offerors who propose a G&A/IDC rate of 40 percent of total direct costs or less will not be required to negotiate Final Indirect Rates with the NIH Division of Financial Advisory Services (DFAS), or other cognizant auditing agency. However, awarding Contracting Officers may require offerors to document how they calculated their IDC rate(s) in order to determine that these costs are fair and reasonable. Furthermore, the Division of Financial Advisory Services (DFAS) will retain the authority to require well documented proposals for G&A/IDC rates on an ad hoc basis. If the SBC has a currently effective negotiated indirect cost rate(s) with a Federal agency, such rate(s) shall be used when calculating proposed G&A/IDC costs for an NIH proposal. (However, the rate(s) must be adjusted for IR&D expenses, which are not allowable under HHS awards.)

Question 17: I am writing regarding the NCI SBIR Innovative Concept Award concept solicitation focused on rare cancers and pediatric cancers. I would like to ask whether the concept below appears generally aligned with the intended scope of the opportunity, especially under Topic 2 for diagnostic technologies, digital health tools, and enabling technologies.

Answer 17: The proposed technology is not responsive to the Concept Award solicitation. Research tools are not within scope of this funding opportunity.

Question 18: Thank you for the reply. Is that different from this site that under eligibility states that a white paper is strongly recommended?

I appreciate the response!

https://sbir.cancer.gov/small-business-funding/contracts/innovative-concept-award

Answer 18: Yes. Please click on the Notice Number: 75N98026R00109 on that website. Scroll down to the attachments to select the FY27 NCI SBIR Concept Solicitation Phase I, Amendment 1, and Attachment 1. Read the solicitation and attachments in its entirety for directions on how to submit a proposal for this contract.

Question 19: The solicitation states that rare cancers with a five-year survival rate below 50% are "encouraged." Is a proposal addressing a rare cancer with a five-year survival rate of 50% or greater still responsive to the solicitation, provided that the cancer otherwise qualifies as a rare cancer and the proposal meets the objectives of Topic 1 or Topic 2?

Answer 19: Yes. This is acceptable. While the solicitation encourages applications focused on rare cancers with a five-year survival rate below 50%, proposals addressing other rare cancers are also responsive. Applicants should clearly describe the existing unmet patient need and how the proposed technology addresses that need.

Question 20: Topic 2 includes development of "devices, diagnostic technologies, or digital health tools for treatment, detection, and diagnosis" of pediatric and/or rare cancers. Would an extracorporeal medical device intended to selectively remove or modulate a disease-associated cell population from a patient's blood, followed by return of the processed blood or cellular components to the patient, fall within the intended scope of a device "for treatment" under Topic 2?

Answer 20: Yes. An extracorporeal medical device intended to selectively remove or modulate disease-associated cell populations from a patient's blood, followed by return of the processed blood or cellular components, would be considered within the scope of Topic 2 if the device is intended for the treatment of pediatric and/or rare cancers. As with all proposals, applicants should clearly describe the unmet clinical need, the innovation of the proposed approach, and how the project aligns with the objectives of the solicitation.

Question 21: The solicitation states that preliminary data are not required and that Concept Awards are intended to support a few key activities demonstrating proof-of-concept and feasibility. For a therapeutic device at an early stage of development, may Phase I focus on benchtop and in vitro engineering and biological feasibility studies using model systems, rather than requiring an integrated clinical-scale prototype or studies involving patients?

Answer 21: Yes. Benchtop and in vitro engineering and biological feasibility studies are appropriate for early-stage therapeutic device projects. Applicants are encouraged to design studies that generate meaningful proof-of-concept and feasibility data to de-risk the technology for future development. While human subjects research is not supported under this solicitation, applicants should consider whether in vivo animal studies, when appropriate, would strengthen the feasibility package and support future Phase II development.

Question 22: The solicitation states that non-exempt human-subjects research will not be supported. May a Phase I project conduct in vitro feasibility studies using de-identified patient-derived human specimens obtained from a commercial source, biobank, or other repository, provided the proposed work does not constitute non-exempt human-subjects research?

Answer 22: Yes. The use of de-identified human specimens may be appropriate under this solicitation, provided the proposed work does not constitute non-exempt human subject’s research. Applicants are encouraged to use the NIH Human Subjects Research Decision Tool to help determine whether their proposed research involves human subjects:

https://grants.nih.gov/policY.-and-compliance/policy.= topics/human-subjects/hs-decision.

Question 23: On page 15 of the Solicitation (NO. 75N98026R00109), there is a description of "A minimum of two-thirds of the research or analytical effort must be performed by the awardee."

Does this mean that if a subcontractor institute being involved, only a maximum of one-third of the funding can be budgeted in the subcontractor institute. And this subcontract budget ( direct + indirect costs in the subcontractor) will be considered/treated as a part of direct costs for the contract award for calculating induct cost of the contract awards. Right?

Answer 23: Yes. In general, the small business must perform a minimum of two-thirds of the research or analytical effort under the Phase I award. However, as described in the solicitation, services obtained from Contract Research Organizations (CROs), Contract Development and Manufacturing Organizations (CDMOs), and similar entities that provide routine or commercial fee-for-service activities and are not responsible for the scientific or technical direction of the project may be treated as vendor procurements. In those cases, the associated costs may be included as part of the small business concern's performance of work. With respect to budgeting and indirect costs, applicants should prepare their budgets in accordance with the instructions in the solicitation and Appendix C.

Question 24: The downloaded NIH Biosketch template is an old version format. So, this means that the use of SciENcv to generate biosketches is not needed. Right?

Answer 24: The NIH Biosketch template provided with the solicitation should be used when preparing and submitting your proposal. You can use the template provided on page 44 of the solicitation.

Question 25: I was referred to you by Julianne Twomey regarding our upcoming application for the Concept Award. Following our discussion, Julianne suggested I reach out to you for feedback as we prepare our submission.

Please find attached our one-page introduction. We would greatly appreciate your guidance on the overall application, as well as your feedback on the following specific questions: Is our proposed technology appropriate for Award Topic 2?

Answer 25: Based on the information provided, your proposed EV-based liquid biopsy diagnostic technology for early detection of pancreatic cancer appears responsive to Topic 2, which supports the development of innovative diagnostic technologies for pediatric and/or rare cancers. Applicants should clearly describe the unmet clinical need, the innovation of the proposed approach, and how the project aligns with the objectives of the solicitation.

Question 26: Is the Phase I scope suitable for a 12-month, $300,000 Concept Award, or should Aim 2 be narrowed?

Answer 26 The proposed Phase I activities should be appropriately scoped to achieve meaningful proof-ofconcept and feasibility within the 12-month project period. Applicants should ensure that the proposed aims are focused on generating de-risking data that support future product development and potential Phase II activities.

Question 27: Are deidentified retrospective plasma samples acceptable for this solicitation, given that nonexempt human-subjects research is not supported?

Answer 27: Yes. The use of de-identified human specimens may be appropriate under this solicitation, provided the proposed work does not constitute non-exempt human subject’s research. Applicants are encouraged to use the NIH Human Subjects Research Decision Tool to help determine whether their proposed research involves human subjects:

https://grants.nih.gov/P-olicY.-and-comP-liance/P-olicY.-tOP-ics/human-subjects/hs-decision.

Question 28: We had a question about biosketches for the NCI SBIR Innovative Concept Award submission. The link in the solicitation goes to a non-SciENcv format. Must we use this format? Or may we include a SciENcv-generated biosketch?

https://grants.nih.gov/P-olicY.-and-comP-liance/P-olicY.-tOP-ics/human-subjects/hs-decision

Answer 28: Thank you for your interest in the NCI SBIR Innovation Concept Award. I am not clear on what you are seeing exactly. Please use the link on page 44 of the solicitation under "NIH BIOSKETCH." It should be an MS Word document that you can turn into a PDF for your proposal.

Question 29: On the Technical Proposal template, I see that the lettered sections for the technical content indicate not-toexceed characters counts. However, for the Statement of Work portion of the document, sections are marked with a character limit to include spaces.

Does that mean the character limits for the technical content fields are maximums of only alphanumeric characters, or do the indicated limits include spaces also (like the Statement of Work)?

Answer 29: Thanks for reaching out and for your interest in the Concept Award. The character limits for the lettered sections of the Technical Proposal form include spaces. Once the character limit has been reached, the form will not allow you to enter any additional text.

Question 30: Thank you for your assistance regarding the FY2027 NCI SBIR Innovative Concept Award solicitation (Notice No. 75N98026R00109).

Dadto Legacy Holdings, LLC is preparing a potential proposal focused on a highly innovative translational technology for a qualifying rare or pediatric cancer population. Before finalizing our proposal strategy, we would appreciate clarification regarding the scope of eligible technologies addressing cancer treatment-related complications and survivorship.

Our proposed NeuroVine™ technology is centered on a standardized grape-derived polyphenol platform and an integrated metabolomics and biomarker strategy. The scientific hypothesis is that polyphenol-derived metabolites may influence biological pathways associated with treatment-related cognitive dysfunction, potentially including neuroinflammation, oxidative stress, metabolic dysfunction, and gut-brain axis mechanisms. Our proposed research would focus on a qualifying rare or pediatric cancer population and would seek to establish proof-of-concept for a novel intervention and biomarker framework intended to improve care and outcomes associated with treatment-related cognitive impairment. Could you please clarify whether a proposal focused on a treatment-associated complication such as cognitive impairment in a qualifying rare or pediatric cancer population would be considered responsive to the FY2027 Innovative Concept Award, provided that the proposed technology has a direct and well-defined connection to improving prevention, treatment, or care of that cancer population?

We would also appreciate clarification regarding whether the solicitation permits the proposed technology to address a significant treatment-related survivorship complication, rather than directly targeting the underlying cancer, when the technology has the potential to substantially improve the care and quality of life of patients affected by that cancer.

Answer 30: The FY2027 NCI SBIR Innovative Concept Award solicitation is intended to support innovative technologies for the prevention, diagnosis, detection, and treatment of pediatric and/or rare cancers. Technologies primarily focused on supportive care, survivorship, or treatment-related complications are not responsive to this solicitation. Applicants should ensure that the proposed technology directly addresses the prevention, diagnosis, detection, or treatment of a qualifying pediatric and/or rare cancer. Applicants developing technologies outside the scope of this solicitation, including supportive care technologies, may wish to consider other NCI SBIR funding opportunities, such as the NCI SBIR Omnibus Grant Solicitation, which supports a broader range of innovative cancer technologies. httgs://sbir.cancer.gov/small-business-fundingfgrants/omnibus-solicitation.

Question 31: I am writing to inquire about the NCI Small Business Innovation Research (SBIR) Innovative Concept Award.

We have recently established a startup company, Ethope Bio, focused on developing novel therapeutics for recurrent medulloblastoma and diffuse intrinsic pontine glioma (DIPG). I would like to ask whether it would be appropriate to submit a two- to three-page white paper describing our technology and specific aims to obtain programmatic feedback prior to submitting a full application.

In addition, could you please confirm the deadline for submitting the pre-proposal/white paper? I understand it may be August 1, while the full application deadline is September 26, 2026, but I would appreciate your confirmation. I could not find more details about the other requirement of this grant, such as page limit, etc. this is my first time to submit SBIR grant, although I have served as reviewers for SBIR grant previously.

Answer 31: Thank you for your interest with NCI SBIR Innovation Concept Award contract. Please note that on page one of the solicitation it states that white papers will not be accepted, the deadline for receipt of proposals is due on September 21, 2026 before 5 pm (Eastern Time), and questions should be sent to this email address no later than August 1, 2026.

Please click on the Notice Number: 75N98026R00109 in order to retrieve the entire solicitation.

Scroll down to the attachments to select the FY27 NCI SBIR Concept Solicitation Phase I, Amendment 1, and Attachment 1. Read the solicitation and attachments in its entirety for the directions on how to submit a proposal for this contract.

Question 32: I just met with Dr. Swamy Tripurani about applying for a Phase 1 SBIR. He thought that our company and technology might be a good fit for the Innovative Concept Award.

Our Technology: We call it Bicycle PCR. It is the first ever PCR blocking technology that enables modulation of the blocking efficiency. This means we can "turn-off" the blocking.

Blocking allows for low-frequency cancer DNA to be enriched about the error/noise of the detection method. This allows for accurate detection of low-frequency cancer DNA. The downside of blocking is that normal DNA is never replicated, meaning that blocking PCR cannot distinguish a PCR failure from a negative sample. Bicycle PCR solves this problem, by reducing the blocking efficiency during the PCR reaction and allowing normal DNA to replicate.

The innovation: Accurate single copy detection of cancer using any platform (qPCR, dPCR, Sanger or NGS). I have attached the Specific Aims page that I sent Swamy.

I was wondering if we could meet briefly to discuss if our technology would be a good fit for the Innovative Concept Award.

Answer 32: Thank you for your interest in the NCI SBIR Innovation Concept Award. We are not able to review your specific aims as this would give your company an advantage over other offerors.

Once you have completely read over the entire solicitation, and you have specific questions that you would like us to answer you may submit them to this email address before August 1, 2026.

Question 33: Can you tell me if the Innovative Concept Award allows a subcontract to a university?

Answer 33: Thank you for your interest in the NCI SBIR Innovation Concept Award. In the solicitation section 8.9 it states, "all subcontractor costs and consultant costs must be detailed at the same level as prime contractor costs in regards to labor, travel, equipment, etc. Provide detailed substantiation of subcontractor costs in your cost proposal. Enter this information in the Explanatory Material section of the on-line cost proposal form."

Question 34: My name is Rami M. Alkhaleeli, MSc, Founder and CEO of Alkhaleeli BioAI LLC, an Oklahoma-based small business developing Al, Python-based scientific tools, biosensor concepts, and research-only insilico biomedical workflows.

I am writing regarding the NCI SBIR Innovative Concept Award concept solicitation focused on rare cancers and pediatric cancers. I would like to ask whether the concept below appears generally aligned with the intended scope of the opportunity, especially under Topic 2 for diagnostic technologies, digital health tools, and enabling technologies.

My proposed project is:

RareCancer-AI: An Al-Guided ln-Silico Platform for Rare and Pediatric Cancer Target Prioritization, Biomarker Review, and Early Therapeutic Hypothesis Ranking The platform is designed as a research-support system, not a clinical decision tool. It would help investigators organize and analyze public cancer data, review disease mechanisms, evaluate gene and mutation relevance, identify possible biological targets, and rank early-stage therapeutic, diagnostic, biomarker, or mRNA-related research hypotheses before laboratory validation.

The proposed project would be submitted by:

Company: Alkhaleeli BioAI LLC Founder/CEO: Rami M. Alkhaleeli, MSc Business Type: Small Business / Micro Entity Location: Oklahoma, USA SAM.gov Registration: Active Unique Entity ID / UEI: REWQLKXPYFM1

CAGE/NCAGE: 15GR4

Purpose of Registration: All Awards SAM.gov Expiration Date: September 13, 2026 This concept is connected to my broader intellectual-property and biomedical innovation portfolio, including:

1. U.S. Provisional Patent Application No.: 63/936,055 Title: Al-Guided Personalized mRNA Cancer Vaccines with CRISPR-Based Antigen Validation Application Type: Utility Provisional Application under 35 USC 111 (b) Filing Date: 08/08/2025 Filed By: Rami Alkhaleeli First Named Inventor: Rami Mohaned Mahdi Alkhaleeli

2. U.S. Provisional Patent Application No.: 64/004,904 Title: Artificial Intelligence Designed a Synthetic Binding Protein Colorimetric Biosensor Platform for Rapid Diagnostic Detection and Classification of Gram Negative Bacteria, Gram Positive Bacteria, and Fungal Pathogens Application Type: Utility Provisional Application under 35 USC 111 (b) Receipt Date/Time: 03/13/2026, 3:17:15 PM ET Confirmation No.: 3252 Patent Center No.: 74851056 Filed By: Rami Alkhaleeli First Named Inventor: Rami M. Alkhaleeli

3. U.S. Provisional Patent Application No.: 64/017,342 Title: The Five-Stage Magneto-Mechanical RF Harvester for Battery-Free Phones Application Type: Utility Provisional Application under 35 USC 111 (b) Receipt Date/Time: 03/26/2026, 01 :16:29 AM Z ET Confirmation No.: 2992 Patent Center No.: 75019979 Filed By: Rami Alkhaleeli First Named Inventor: Mr. Rami M. Alkhaleeli

4. U.S. Patent No.: 11,058,521 Granted: July 13, 2021 Inventor: Rami Mohanad Mahdi Alkhaleeli Title: Method and apparatus for improving osseointegration, functional load, and related biomedical application. For this NCI opportunity, the cancer-focused platform would operate through the following workflow:

1. Rare cancer case selection The system focuses on rare pediatric and adult cancers with limited datasets, limited treatment options, or fragmented research evidence.

2. Cancer data integration The platform organizes open-source literature, gene/mutation information, pathway data, biomarker evidence, immune biology, and tumor biology.

3. Mechanism-of-disease review The system summarizes key disease mechanisms, including oncogenic mutations, pathway disruption, immune escape, resistance mechanisms, tumor microenvironment factors, and potential therapeutic vulnerabilities.

4. Target and biomarker prioritization The platform ranks potential biological targets and biomarkers based on evidence strength, cancer relevance, feasibility, safety concerns, and validation needs.

5. Candidate hypothesis generation The system organizes early-stage research ideas, including diagnostic concepts, biomarker concepts, drug-like approaches, and research-only mRNA-based therapeutic hypotheses.

6. ln-silico ranking before wet-lab validation Candidate concepts are computationally ranked before laboratory work, helping researchers identify which hypotheses may deserve further testing.

7. Structured validation roadmap The platform produces a research plan that includes scientific rationale, evidence summary, limitations, risk considerations, and recommended next validation steps.

The purpose of this platform is not to claim diagnosis, treatment, cure, clinical use, or validated medical decision-making. The goal is to create a reproducible, transparent, research-only tool that helps investigators move from scattered rare cancer information toward stronger, better-prioritized hypotheses for future laboratory, toxicology, regulatory, and clinical validation.

I believe this concept may align with Topic 2 as an enabling Al/digital research-support platform for rare and pediatric cancer research. It may also support early therapeutic hypothesis development relevant to Topic 1, depending on how the final solicitation defines eligible technologies.

Could you please advise whether this concept appears generally responsive to the intended scope of the NCI SBIR Innovative Concept Award?

Also, would it be appropriate to submit a short white paper for programmatic feedback before the full solicitation is released?

Thank you very much for your time and guidance. I would greatly appreciate any direction on whether this concept is worth developing further for this opportunity.

Answer 34: The proposed technology is not responsive to the Concept Award solicitation. Research tools are not within scope of this funding opportunity.

Question 35: I am a Co-Founder of Seaside Bio, a San Diego based biotech company developing CyPhenom ™, a novel microfluidic platform for the enrichment and multiplex phenotypic characterization of tumor cells from cerebrospinal fluid (CSF). Unlike EpCAM-dependant methods currently in clinical use, CyPhenom TM, enables multiplexed cell surface protein phenotyping of tumor cells directly from CSF.

Our goal is to improve the diagnosis and longitudinal monitoring of rare cancers with 5-year survival rates below 50% with an initial focus on leptomeningeal disease (LMD) arising from solid tumors such as breast, lung cancers, as well as glioblastoma indications for which real time CSF tumor cell detection and phenotyping represents a significant and unmet clinical need.

We are very interested in the FY2027 NCI SBIR Innovative Concept Award Program, specifically Topic 2: Development of devices, diagnostic technologies, or digital health tools for the treatment, detection, and diagnosis of pediatric cancers and/or rare cancers. Based on the brief description above, does this concept appear to align with the intent of Topic 2?

Additionally, while reviewing the pre-solicitation, we noticed the reference to the interim white paper process appears to precede the publication date of the notice. Could you please clarify whether white papers will be accepted for the FY2027 solicitation and, if so, whether there is still an opportunity to submit one for programmatic feedback prior to the full proposal?

Answer 35: Thanks for reaching out and for the interest in the Concept Award. The proposed technology appears within scope and you should consider applying for the funding opportunity.

Please note there will be no white paper submission/review this year.

A few recommendation(s):

Make sure that your outcomes and aims are clearly defined and focused on product development with clear quantifiable product focused milestones.

Question 36: We are interested in applying for this award mechanism with a proposal to develop novel GPRSS receptor antagonists to target pediatric brain tumors. Please advise on the necessity of a white paper and how to submit one in advance of the full application. The small business is Kannalife Sciences, I am cc'ing the CEO of the company. Myself and Dr.

Zeng-jie Yang will be participating researchers.

Thank you so much in advance for this interesting funding opportunity, Answer 36: Thank you for your interest in the NCI SBIR Innovation Concept Award. According to the solicitation on page 1 it states that white papers will not be accepted.

Question 37: Thank you for the reply. Is that different from this site that under eligibility states that a white paper is strongly recommended?

I appreciate the response!

httRs://sbir.cancer.gov/small-business-funding/contracts/innovative-conceRt-award.

Answer 37: Yes. Please click on the Notice Number: 75N98026R00109 on that website. Scroll down to the attachments to select the FY27 NCI SBIR Concept Solicitation Phase I, Amendment 1, and Attachment 1. Read the solicitation and attachments in its entirety for the directions on how to submit a proposal for this contract.