Form 1 Application

NCI SBIR Investor Initiatives
Application

OMB No.: 0925-0766
Expiration Date: 04/30/2023
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NCI SBIR INVESTOR INITIATIVES APPLICATION
INSTRUCTIONS
If you would like to provide images or figures, please submit one additional PDF page (optional Appendix) with your email submission. If
you have a link to a current video pitch of less than 5 minutes, please include the link in the appendix. All forms must be submitted by
EOD February 21, 2023. Email your completed application to NCIsbirEvents@mail.nih.gov.
Review "Application Guide for Investor Initiatives" for additional instructions. Incomplete applications will be returned.
Please note that your application will be reviewed by an external panel of industry personnel and investment
professionals. ONLY PROVIDE NON-CONFIDENTIAL DATA THAT CAN BE SHARED WITH INVESTORS
☐By checking this box, I provide permission to share this application with non-federal investors and reviewers.
NCI SBIR Grant or Contract Number for this product/technology:

If you have multiple awards related to this technology/product, list the product you wish to be the focus of this application.

NCI SBIR Program Director: Select from dropdown

C OMPANY INFORMATION
Official Company Name:

Year Originally Founded:

Company Website:
Company Mailing Address:
Total Number Full-Time Employees:

Total Number Part-Time Employees:

Company CEO:
Email:

Phone:

Contact Person for this Application:
Title/Role:
Email:
Do you plan to apply for a Bridge Award in the next 12 months?
EXECUTIVE SUMMARY

Phone:
Yes

Please provide a short summary of your company & technology. Limit 2400 characters at 9.5 font.

No

NCI SBIR INVESTOR INITIATIVES APPLICATION
1. TECHNOLOGY/PRODUCT OVERVIEW
Type of product/Technology (Select one most relevant option):
Small molecule
Biologics/Vaccine
Cell/Gene therapy

Surgical or Ablative device
Hospital device
Drug delivery device
Imaging device

Imaging agent
In vitro diagnostic
Bioinformatics/Health IT/Digital health
Research Tool

Technology Description (Please provide a short, 1-3 sentence, description of your technology):

Current R&D Status:
Non-clinical technology in prototype development
Non-clinical technology in full development/testing stage
Pre-clinical development
In clinical trials:
Phase I
Phase II
Early Feasibility
Feasibility/Pilot
Commercially available
Other (Please explain):

Phase III
Pivotal

Technology/Product Overview Narrative – Please describe the technology/product that was funded under the NCI SBIR program, its application, and “how
it works”. Include the current or potential impact of your product or technology on cancer patients, including the likelihood of clinical adoption and fit with
existing practice. Limit your response to 3600 characters at 9.5 font. You may refer to any figures or images attached in your one-page appendix.

NCI SBIR INVESTOR INITIATIVES APPLICATION
2. SCIENTIFIC PROGRESS & STAGE OF DEVELOPMENT
510(k)

IDE

FDA Application:

PMA

BLA

IND

NDA

Current Status:

Not yet submitted

Submitted

Reimbursement Planning:

Not started
Insurance coverage

Identification of CPT codes
CMC Processes

Not applicable (no approval needed)

Approved
Technology Add-ons
Other, (described in write-up below)

Stage of Development Narrative – Please describe the current stage of development, major technical milestones achieved to date, and how they suggest
clinical efficacy. Describe your progress toward the commercialization of the product and comment on how your product/prototype can be scalable and
reproducible in a commercial environment. Also, please give a brief overview of the regulatory and reimbursement strategy for the product under
development, including an update on current and imminent regulatory applications, approvals, and hurdles. Please limit your response to 2700 characters
at 9.5pt font. You may refer to any figures or images that you include in your one-page appendix.

3. MARKET DESCRIPTION & PIPELINE PRODUCTS
Please describe the market for the product under development, providing market size and projected market growth, if available. Explain how your product
fills a market niche and addresses an unmet need. Describe current and potential future commercial applications, including new products in development,
and market segments. Limit 1600 characters at 9.5pt font.

NCI SBIR INVESTOR INITIATIVES APPLICATION
4. COMPETITIVE ADVANTAGE
Please list/describe any unique attributes or competitive advantages (including IP, invention reports, trademarks, copyrights) the product has in the
market over both current products and competing technologies under development. Limit 3200 characters at 9.5pt font.

INTELLECTUAL PROPERTY
List any patent or patent applications. (Please enter numeric values where applicable. Feel free to expand on IP in your additional one page.)
Status

(Filed, Provisional, Approved)

Number

Title

Date of Filing

List any invention reports, trademarks, or copyrights. (Please enter numeric values where applicable.)
# Filed
Invention Reports
Trademarks
Copyrights

# Approved

Subject matter or name of mark

NCI SBIR INVESTOR INITIATIVES APPLICATION
5. PUBLICATIONS, PRESENTATIONS, & AWARDS
Please list the most significant past and pending publications, presentations, and awards based on the company’s technology. Limit 1500 characters at
9.5pt font.

6. MANAGEMENT
Name, Title/Role

Domain expertise

Value Added/Previous Success

Management Narrative – Describe the team or management structure, highlighting years of experience, background, and relevant previous success,
experience, and domain expertise. Limit 2700 characters at 9.5pt font.

NCI SBIR INVESTOR INITIATIVES APPLICATION
7. BUSINESS DEVELOPMENT & PARTNERSHIPS
Please list and specify any current or pending partnerships (e.g., strategic partner, licensing partner, manufacturing, distribution, technical collaboration,
etc.) the company currently has related to the full commercialization of this product. Please also indicate what kind of partnerships you are seeking and the
timing for seeking those partnerships. Please list company spin-offs, if any. Limit 1500 characters at 9.5pt font.

8. FINANCIAL OVERVIEW
Capital Raised to Date -- Please fill out the table below with information about capital that the company has raised since inception (include
pre-incorporation awards, grants, private equity, venture capital, strategic partners, IPO, etc.)
Date
8/2013

Type (grant, angel,
venture, etc)
Series A

Source(s)
Generic Biotech Venture

Amount

Additional Comments

$3.5M

Example

Financial Overview Narrative – Describe funding received to develop your technology. List the revenue per year for the last 3 years. Also list projected
revenue for the SBIR-funded product/service (such as product revenues, consulting, or licensing fees) and expected timeframes. How much funding are
you currently seeking and what is your timeline for seeking funds? What do you plan to accomplish with these funds? Limit 2000 characters at 9.5pt font.

NCI SBIR INVESTOR INITIATIVES APPLICATION
9. COMPANY MILESTONES
Please list major technical and commercial milestones expected over the next 24 months.

Milestone

Date

10. What is your vision for the company’s future? (Check only one)
Stand-alone company mostly based on government R&D grants and contracts
Stand-alone company mostly based on licensing revenue and/or commercial (R&D) contracts
Stand-alone company mostly based on commercial sales of products or services
Merge with, or be acquired by, another company
Initial Public Offering – IPO
Unsure

11. What would you like to get from your participation in this program?
Seeking strategic partner (large business)
Seeking investment
Seeking scientific collaborators
Other: (describe)

Customer discovery
Increasing company visibility and exposure
Gaining insights into competition and/or IP landscape
Validating business model

12. Select the top 3 meetings/forums that you would like to participate in that are best suited for your technology/product/service
We will try our best to match you with one of your selected conferences, but it is not guaranteed.
Angel Capital Association Summit
BIO CEO & Investor Conference
BIO International Convention
BIO Investor Forum
Biocom’s Global Life Science Partnering Conference
BioNetwork
Biotech Showcase
HIMSS Global Conference & Exhibition

Life Sciences Summit
Medical Alley Innovation Summit
MedTech Strategist Innovation Summit
Precision Medicine World Conference
RESI
The MedTech Conference (Powered by Advamed)
WSGR Medical Device Conference
Other (please specify):

Was your company selected for NCI SBIR Investor Initiatives in 2022?

Yes

No

If yes  Use your one-page appendix to explain why you are re-applying and include details about progress since being selected last year.

ALL APPLICANTS

We encourage you to include a one-page appendix to expand on any of the above sections or to include graphs, images, and/or
charts. If you have a link to an existing video pitch of less than 5 minutes, please provide the link in the appendix.
Please refer to page 3 of the application guidance document for further application instructions.