8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) 

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): March 29, 2022

AMPIO PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-35182	26-0179592
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

373 Inverness Parkway, Suite 200

Englewood, Colorado 80112

(Address of Principal Executive Offices) (Zip Code)

Registrant’s telephone number, including area code: (720) 437-6500

Not Applicable

(Former name, or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol	Name of each exchange on which registered
Common Stock, $0.0001 par value	AMPE	NYSE American

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

	Entry into a Material Definitive Agreement.
Item 2.02.	Results of Operations and Financial Condition.

On March 29, 2022, Ampio Pharmaceuticals, Inc. (the “Company”) issued a press release announcing operating and financial highlights for the quarter and year ended December 31, 2021. A copy of the Company’s press release is furnished as Exhibit 99.1 on this Current Report on Form 8-K.

The information in this Form 8-K is furnished under “Item 2.02 Results of Operations and Financial Condition” and Exhibit 99.1, attached hereto, and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. It may be incorporated by reference in a filing under the Exchange Act or the Securities Act of 1933, as amended, only if such subsequent filing specifically references such disclosure in this Form 8-K.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

99.1	Press release, dated March 29, 2022
104	The cover page from this Current Report on Form 8-K, formatted in Inline XBRL.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	AMPIO PHARMACEUTICALS, INC.
Date:  March 29, 2022	By:	/s/ Daniel G. Stokely
		Name: Daniel G. Stokely
		Title: Chief Financial Officer and Secretary

EX-99.1

Exhibit 99.1

Ampio Pharmaceuticals Reports Fourth-Quarter and Full-Year 2021 Financial Results and Operational Highlights

Cash and Cash Equivalents of $34 Million Expected to Fund Current Operations into 2H 2023

Company to host Conference Call Tuesday, March 29, 2022, at 4:30pm EDT

ENGLEWOOD, CO, March 29, 2022 – Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunomodulatory therapies for the treatment of pain resulting from osteoarthritis in the knee and potentially other articular joints, today reported financial results and operational highlights for the fourth quarter and year ended December 31, 2021.

“We have made significant progress on core objectives, including the release of positive Phase 3 data and the submission of a Type C meeting request to the FDA,” said Mike Martino, Chairman and CEO of Ampio. “Additionally, we have secured incremental liquidity that improves financial strength and is expected to fund current operations into the second half of 2023. This provides strategic options as we continue discussions with the FDA and potential partners. Further, we have strengthened our corporate governance, compliance, and clinical development expertise through the expansion of our Board of Directors and appointments of key leadership positions.”

Ampio is pleased to provide recent operational highlights that are summarized below.

OAK Clinical Development

· Phase 3 Study, AP-013: The AP-013 study, a Phase 3 trial designed to evaluate pain and function in patients with the target condition of severe osteoarthritis of the knee (OAK), was designed to confirm the efficacy observed in the first pivotal study, AP-003-A, and support an Ampion Biologics Licensing Application (BLA). The AP-013 study was found to have been impacted by COVID-19 using a blinded sensitivity analysis. To mitigate this impact, a modified-intent-to-treat (mITT) population is proposed to evaluate efficacy in AP-013.

· Analysis of AP-013 Data: AP-013 analysis of the three efficacy analysis populations demonstrated:

o In the mITT population, Ampion demonstrated a statistically significant reduction in pain (p=0.042) and trended toward improvement in function versus saline control.

o In the Per Protocol population of AP-013, Ampion demonstrated statistically significant reduction in pain (p = 0.020) and a statistically significant improvement in function (p = 0.027) versus saline control.

o The Intent to Treat population was impacted by a large amount of missing data and mandated imputation due to COVID-19 and did not demonstrate statistically significant reduction in pain or statistically significant improvement in function.

· Type C Meeting with FDA: The FDA has agreed to a written response to our Type C Meeting request regarding the AP-013 study. By the end of the first half of this year, the Company expects to have FDA clarity on whether the AP-013 trial together with AP-003-A will support an Ampio BLA for the treatment of pain associated with severe OAK.

COVID-19 Clinical Development

· AP-017 Intravenous (IV) Treatment for Severe COVID: Study AP-017 was designed to evaluate IV Ampion treatment in severe COVID-19 patients in up to 200 patients with an interim analysis at 30 patients for sample size re-estimation. The interim enrollment and analysis for sample size re-estimation is complete. The observed safety profile of IV Ampion treatment has been excellent to date and there will be no sample size adjustment in the study. However, enrollment has been slow, and the COVID-19 treatment and regulatory approval landscape has evolved. Therefore, the Company has stopped further enrollment and will analyze the data completely to determine next steps for the use of IV Ampion.

· AP-018 Inhaled Treatment for Long-COVID: Study AP-018 was designed to evaluate inhaled Ampion treatment in 30 patients with Long-COVID. Enrollment was completed in December 2021, and the Day 60 post-treatment safety and efficacy measures are currently underway. Once complete, the data will be prepared for analysis, and the Company will determine next steps for the program when the analysis has been completed. Ampio is on track to complete the data analysis by the end of the second quarter of 2022.

· AP-019 Inhaled Treatment for Severe COVID: Study AP-019 was designed to evaluate inhaled Ampion treatment in up to 200 severe COVID-19 patients with an interim analysis for sample size re-estimation. The interim enrollment was completed with 129 patients in the first quarter of 2022. Ampio is on track to complete the data analysis by the end of the second quarter of 2022, at which time the Company will determine next steps for the study.

Expansion of Leadership

· Expansion of Board of Directors: Ampio announced the appointment of J. Kevin Buchi, Michael Martino, and Elizabeth Varki Jobes, Esq. to the Ampio Pharmaceuticals Board of Directors. These appointments expand the Company’s Board of Directors to eight members and prepares the Company for its next phase.

· Strengthening of Management: Ampio announced the appointment of Michael Martino as Chairman of the Board of Directors and Chief Executive Officer. Additionally, Howard Levy, M.B.B.Ch., Ph.D., M.M.M., was appointed as Chief Medical Officer, and Holli Cherevka was promoted to the position of President and Chief Operating Officer.

Fourth Quarter and Full-Year 2021 Financial Results

· Net Loss: Net loss was $6.2 million for the fourth quarter compared to net loss of $4.6 million for the fourth quarter of 2020, and $17.1 million for the year compared to a loss of $15.9 million for the year ended December 31, 2020. Further details on these variances are below.

· R&D Expenses: Research and development expenses were $4.7 million for the fourth quarter compared to $2.1 million for the fourth quarter of 2020, and $11.9 million for the year compared to $9.2 million for the year ended December 31, 2020. The primary drivers of the year-over-year increase were incremental costs associated with the COVID-19 Phase 1 and 2 studies which were initiated late in 2020 and during the 2021 period.  These costs were partially offset by (i) reduction in costs associated with the AP-013 study which was paused in the 2020 period.

· G&A Expenses: General and administrative expenses were $4.5 million for the fourth quarter compared to $1.8 million for the fourth quarter of 2020, and $8.7 million for the year compared to $6.7 million for the year ended December 31, 2020. The increase was primarily attributable to (i) increase in share-based compensation and professional fees for legal and other advisory services

· Cash position: Cash and cash equivalents on December 31, 2021, totaled $33.9 million, compared to $17.3 million as of December 31, 2020, driven primarily by (i) net proceeds from the closing of a registered direct offering in December totaling $20.7 million, and (ii) net proceeds of $10.0 million from the sale of common stock with the “at-the-market” equity offering program throughout the year; partially offset by cash used in operating activities totaling $14.1 million. Ampio projects its cash position will fund current operations into 2H 2023.

Further details on Fourth Quarter and Full-Year 2021 Financial and key variances are included below.

AMPIO PHARMACEUTICALS, INC.

Balance Sheets

	December 31,		December 31,
	2021		2020
Assets
Current assets
Cash and cash equivalents	$	33,892,000	$	17,346,000
Prepaid expenses and other		1,740,000		1,147,000
Total current assets		35,632,000		18,493,000
Fixed assets, net		2,564,000		3,561,000
Right-of-use asset, net		629,000		824,000
Total assets	$	38,825,000	$	22,878,000
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable and accrued expenses	$	4,811,000	$	1,550,000
Lease liability-current portion		311,000		284,000
Total current liabilities		5,122,000		1,834,000
Lease liability-long-term		614,000		925,000
Warrant derivative liability		5,805,000		2,607,000
Total liabilities		11,541,000		5,366,000
Commitments and contingencies (Note 7)
Stockholders’ equity
Preferred Stock, par value $0.0001; 10,000,000 shares authorized; none issued		—		—
Common Stock, par value $0.0001; 300,000,000 shares authorized; shares issued and outstanding - 227,325,381 as of December 31, 2021 and 193,378,996 as of December 31, 2020		23,000		19,000
Additional paid-in capital		244,863,000		218,020,000
Accumulated deficit		(217,602,000)		(200,527,000)
Total stockholders’ equity		27,284,000		17,512,000
Total liabilities and stockholders’ equity	$	38,825,000	$	22,878,000

AMPIO PHARMACEUTICALS, INC.

Statements of Operations

	Year Ended December 31,
	2021		2020
Operating expenses
Research and development	$	11,900,000	$	9,172,000
General and administrative		8,671,000		6,662,000
Total operating expenses		20,571,000		15,834,000
Other income (expense)
Interest income		4,000		12,000
Paycheck Protection Program loan forgiveness		—		544,000
Derivative gain (loss)		3,492,000		(543,000)
Loss on disposal of fixed asset		—		(73,000)
Total other income (expense)		3,496,000		(60,000)
Net loss	$	(17,075,000)	$	(15,894,000)
Net loss per common share:
Basic	$	(0.09)	$	(0.09)
Diluted	$	(0.10)	$	(0.09)
Weighted average number of common shares outstanding:
Basic		199,299,072		172,846,773
Diluted		204,963,019		172,846,773

Conference Call Details

Date/Time: March 29, 2022, at 4:30 pm EDT

Conferencing Link:  https://event.on24.com/wcc/r/3683372/9CD2C8B658E56541C487F44C34E897BB

Access Code:  66744

Canada dial-in number (Toll Free):   1 833 950 0062Canada dial-in number (Local):         1 226 828 7575US dial-in number (Toll Free):           1 844 200 6205US dial-in number (Local):                 1 646 904 5544Access code:                                         931547

*Participants will need to enter the participant access code before being met by an operator

In order to submit questions, participants must have Internet connectivity, as questions will only be addressed via the webcast. The conference call line will be in listen-only mode.

About Ampio Pharmaceuticals

Ampio Pharmaceuticals, Inc. is a biopharmaceutical company focused on the advancement of immunomodulatory therapies for the treatment of pain resulting from osteoarthritis in the knee and potentially other articular joints. Ampio’s lead drug, Ampion™, is backed by an extensive patent portfolio with intellectual property protection extending through 2037 and may be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the Biologics Price Competition and Innovation Act (BPCIA).

Forward Looking Statements

Ampio’s statements in this press release that are not historical fact, and including, but not limited to, statements that relate to future plans or events or are conditional in nature, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as “believe,”” may”, “will”, “should”, “forecast”, “could”, “expect”, “suggest”, “plan,” “believe”, “estimate”, “continue”, “anticipate”,” and “intend”, “ongoing”, “opportunity”, “potential”, “predicts”, “seek”, “plan,”, or similar expressions words. These forward-looking statements include statements regarding Ampio’s expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, clinical trials (and FDA’s decisions regarding such trials), results of safety profiles, and decisions and changes in business conditions and similar events and the likelihood and timing of Ampion’s approval as a novel biologic under the BPCIA, the ability of liquidity to support future operations, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio’s filings with the Securities and Exchange Commission, including without limitation, under Ampio’s Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Such risks include, but are not limited to: our ability to fund our operations, including our ability to access funding through our “at-the-market” equity offering or through other equity or debt offerings; our ability to retain key employees, consultants, and advisors and to attract, retain and motivate qualified personnel; the progress and results of clinical trials for Ampion and additional costs or delays associated therewith; the significant competition in the search for a successful treatment for the novel Coronavirus Disease 2019 (“COVID-19”); our ability to enroll hospitalized patients in our Phase 1 and 2 trials of Ampion for the treatment of COVID-19 given the unplanned variability of the virus, vaccine rates and mutations in the virus in certain geographies; our ability to receive regulatory approval for and sell the products that we are developing for the treatment of COVID-19; our reliance on third parties to conduct our clinical trials resulting in costs or delays that prevent us from successfully commercializing Ampion; competition for patients in conducting clinical trials, delaying product development and straining our limited financial resources; the risk and costs associated with our decision to suspend enrollment in the Phase 3 clinical trial for treatment of severe Osteoarthritis of the Knee due to considerations relating to the COVID-19 pandemic, and the possibility that the data generated by that clinical trial may have been adversely impacted by the COVID-19 pandemic; our ability to navigate the regulatory approval process in the U.S. and other countries, and our success in obtaining required regulatory approvals for Ampion on a timely basis; commercial developments for products that compete with Ampion; the actual and perceived effectiveness of Ampion, and how Ampion compares to competitive products; adverse effects and the unpredictable nature of the ongoing COVID-19 pandemic; adverse developments in our research and development activities; potential liability if any of our product candidates cause illness, injury or death, or adverse publicity from any such events; our ability to operate our business efficiently, manage capital expenditures and costs (including general and administrative expenses) and obtain financing when required; and our expectations with

respect to future licensing, partnering or other strategic activities. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

Investor and Media Contacts:

Russo Partners
Tony Russo or Nic Johnson 
info@ampiopharma.comtony.russo@russopartnersllc.comnic.johnson@russopartnersllc.com

XML

Document and Entity Information	Mar. 29, 2022
Document and Entity Information [Abstract]
Document Type	8-K
Document Period End Date	Mar. 29, 2022
Entity File Number	001-35182
Entity Registrant Name	AMPIO PHARMACEUTICALS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	26-0179592
Entity Address, Address Line One	373 Inverness Parkway, Suite 200
Entity Address, City or Town	Englewood
Entity Address, State or Province	CO
Entity Address, Postal Zip Code	80112
City Area Code	720
Local Phone Number	437-6500
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.0001 par value
Trading Symbol	AMPE
Security Exchange Name	NYSEAMER
Entity Emerging Growth Company	false
Entity Central Index Key	0001411906
Amendment Flag	false