Actinium Pharmaceuticals, Inc 10-K for FY2022

Actinium Pharmaceuticals, Inc. (ATNM)

10-K 2023-03-31 For: 2022-12-31

Added on April 10, 2026

About this 10-K

Actinium Pharmaceuticals, Inc filed this 10-K on March 31, 2023, covering the fiscal year ended December 31, 2022 (FY2022).

Headline figures

Fiscal year ended December 31, 2022, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $1.03M; down 10.0% from $1.14M a year earlier
Net loss: $33.02M; compared with a net loss of $24.77M a year earlier
Diluted EPS: -$1.37; compared with -$1.20 a year earlier

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Title of each class		Trading symbol		Name of exchange on which registered
Common stock, par value $0.001		ATNM		NYSE American

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

Item 1.	Business	1
Item 1A.	Risk Factors	24
Item 1B.	Unresolved Staff Comments	55
Item 2.	Properties	55
Item 3.	Legal Proceedings	55
Item 4.	Mine Safety Disclosures	55

Item 5.	Market for Registrant’s Common Equity, Related Stockholders Matters, and Issuer Purchases of Equity Securities	56
Item 6.	Reserved	56
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	57
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	63
Item 8.	Financial Statements and Supplementary Data	F-1
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	64
Item 9A.	Controls and Procedures	64
Item 9B.	Other Information	64
Item 9C	Disclosure Regarding Foreign Jurisdictions That Prevent Inspections	64

Item 10.	Directors, Executive Officers and Corporate Governance	65
Item 11.	Executive Compensation	78
Item 12.	Security Ownership of Certain Beneficial Owners and Management	82
Item 13.	Certain Relationships and Related Transactions, and Director Independence	84
Item 14.	Principal Accountant Fees and Services	84

Item 15.	Exhibits, Financial Statement Schedules	85

Signature Page		88

	●	We are a clinical-stage company and have generated no revenue from commercial sales to date;

	●	We have incurred net losses in every year since our inception and anticipate that we will continue to incur net losses in the future;

	●	If we fail to obtain additional financing, we will be unable to continue or complete our product development or product commercialization and you will likely lose your entire investment;

	●	We are highly dependent on the success of Iomab-B and the SIERRA trial and we may not be able to complete the necessary clinical development or our development efforts may not result in the data necessary to receive regulatory approval;

	●	Our business could be adversely affected by the effects of health epidemics, including the global COVID-19 pandemic;

	●	We have not demonstrated that any of our products are safe and effective for any indication and will continue to expend substantial time and resources on clinical development before any of our current or future product candidates will be eligible for FDA approval, if ever;

	●	Our clinical trials may fail to demonstrate adequately the efficacy and safety of our product candidates, which would prevent or delay regulatory approval and commercialization;

	●	Preliminary, Interim, and “top-line” data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.;

	●	Healthcare legislative reform measures intended to increase pressure to reduce prices of pharmaceutical products paid for by Medicare or, otherwise, affect the federal regulation of the U.S. healthcare system could have a material adverse effect our business, future revenue, if any, and results of operations;

	●	We rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates;

	●	We currently depend on a single third-party manufacturer to produce our pre-clinical and clinical trial drug supplies. Any disruption in the operations of our current third-party manufacturer, or other third-party manufacturers we may engage in the future, could adversely affect our business and results of operations;

	●	Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences;

	●	Our patent position is highly uncertain and involves complex legal and factual questions.

	●	The use of hazardous materials, including radioactive and biological materials, in our research and development efforts imposes certain compliance costs on us and may subject us to liability for claims arising from the use or misuse of these materials;

	●	We are highly dependent on our key personnel, and the demand for talent in the biotechnology industry is highly competitive; if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement or execute our business strategy;

	●	Certain provisions of our Certificate of Incorporation and Bylaws and Delaware law make it more difficult for a third party to acquire us and make a takeover more difficult to complete, even if such a transaction were in our stockholders’ interest; and

	●	Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.

	●	theft or misappropriation of funds;

	●	loss, corruption, or misappropriation of intellectual property, or other proprietary, confidential or personally identifiable information (including supplier, clinical data or employee data);

	●	disruption or impairment of our and our business operations and safety procedures;

	●	damage to our reputation with our potential partners, patients and the market;

	●	exposure to litigation;

	●	increased costs to prevent, respond to or mitigate cybersecurity events.

	●	completion of preclinical laboratory tests and animal studies in accordance with FDA’s good laboratory practices (“GLPs”) and applicable requirements for the humane use of laboratory animals or other applicable regulations;

	●	submission to the FDA of an Investigational New Drug (“IND”), which must become effective before human clinical trials in the United States may begin;

	●	performance of adequate and well-controlled human clinical trials in accordance with FDA’s IND regulations, GCPs, and any additional requirements for the protection of human research subjects and their health information, to establish the safety and efficacy of the proposed biological product for its intended use;

	●	submission to the FDA of a BLA for marketing approval that meets applicable requirements to ensure the continued safety, purity, and potency of the product that is the subject of the BLA based on results of preclinical testing and clinical trials;

	●	satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the biological product is produced, to assess compliance with cGMPs and assure that the facilities, methods and controls are adequate to preserve the biological product’s identity, strength, quality and purity;

	●	potential FDA audit of the nonclinical study and clinical trial sites that generated the data in support of the BLA; and

	●	FDA review and approval, or denial, of the BLA.

	●	Phase 1. The biological product is initially introduced into healthy human subjects and tested for safety. In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in subjects.

	●	Phase 2. The biological product is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance, optimal dosage and dosing schedule.

	●	Phase 3. Clinical trials are undertaken to further evaluate dosage, clinical efficacy, potency, and safety in an expanded patient population at geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk to benefit ratio of the product and provide an adequate basis for product labeling.

	●	conditions imposed on us by the FDA or comparable foreign authorities regarding the scope or design of our clinical trials;

	●	delays in receiving, or the inability to obtain, required approvals from IRBs or other reviewing entities at clinical sites selected for participation in our clinical trials;

	●	delays in enrolling patients into clinical trials;

	●	a lower than anticipated retention rate of patients in clinical trials;

	●	the need to repeat or discontinue clinical trials as a result of inconclusive or negative results or unforeseen complications in testing or because the results of later trials may not confirm positive results from earlier preclinical studies or clinical trials;

	●	inadequate supply, delays in distribution, deficient quality of, or inability to purchase or manufacture drug product, comparator drugs or other materials necessary to conduct our clinical trials;

	●	unfavorable FDA or other foreign regulatory inspection and review of a clinical trial site or records of any clinical or preclinical investigation;

	●	serious and unexpected drug-related side effects experienced by participants in our clinical trials, which may occur even if they were not observed in earlier trials or only observed in a limited number of participants;

	●	a finding that the trial participants are being exposed to unacceptable health risks;

	●	the placement by the FDA or a foreign regulatory authority of a clinical hold on a trial; or

	●	delays in obtaining regulatory agency authorization for the conduct of our clinical trials.

	●	failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;

	●	inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;

	●	varying interpretation of data by the FDA or similar foreign regulatory authorities;

	●	failure to achieve primary or secondary endpoints or other failure to demonstrate efficacy;

	●	unforeseen safety issues; or

	●	lack of adequate funding to continue the clinical trial.

	●	the size and nature of the patient population;

	●	the patient eligibility criteria defined in the protocol;

	●	the size of the study population required for analysis of the trial’s primary endpoints;

	●	the proximity of patients to trial sites;

	●	the design of the trial;

	●	our ability to recruit clinical trial investigators with the appropriate competencies and expertise;

	●	competing clinical trials for similar or alternate therapeutic treatments;

	●	clinician’s and patients’ perceptions as to the potential advantages and side effects of the product candidate being studied in relation to other available therapies;

	●	our ability to obtain and maintain patient consents; and

	●	the risk that patients enrolled in clinical trials will not complete a clinical trial.

	●	restrictions on the marketing or manufacturing of our product candidates, withdrawal of the product from the market, or voluntary or mandatory product recalls;

	●	fines, warning letters or holds on clinical trials;

	●	refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of license approvals;

	●	product seizure or detention, or refusal to permit the import or export of our product candidates; and

	●	injunctions or the imposition of civil or criminal penalties.

	●	the federal Anti-Kickback Statute, which prohibits persons and entities from, among other things, knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made under federal and state healthcare programs such as Medicare and Medicaid;

	●	the federal false claims laws, including civil whistleblower or qui tam actions under the federal False Claims Act, which impose criminal and civil penalties against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

	●	the federal Civil Monetary Penalties Law, which prohibits, among other things, the offering or transfer of remuneration to a Medicare or state healthcare program beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state healthcare program, unless an exception applies;

	●	the federal Physician Payments Sunshine Act, created under the Affordable Care Act, and its implementing regulations, which requires certain manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually information related to certain payments or other transfers of value provided to physicians and any ownership and investment interests held by physicians or their immediate family members. Beginning in 2022, applicable manufacturers also will be required to report such information regarding payments and other transfers of value to physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists and certified nurse midwives during the previous year; and

	●	analogous state laws and regulations, including (among others) state anti-kickback and false claims laws, which may apply to our business practices, including, but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the United States federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information and that require tracking gifts and other remuneration and items of value provided to healthcare professionals and entities; state and local laws that require the registration of pharmaceutical sales representatives; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal law, thus complicating compliance efforts.

	●	regulatory authorities may withdraw their approval of the product;

	●	regulatory authorities may require the addition of labeling statements, such as warnings or contraindications;

	●	we may be required to change the way the product is administered, conduct additional clinical trials or change the labeling of the product;

	●	we may elect, or we may be required, to recall or withdraw product from the market;

	●	we could be sued and held liable for harm caused to patients; and

	●	our reputation may suffer.

	●	actual or anticipated variations in our operating results;

	●	announcements of developments by us or our competitors;

	●	the timing of IND and/or BLA approval, the completion and/or results of our clinical trials;

	●	regulatory actions regarding our products;

	●	announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments;

	●	adoption of new accounting standards affecting our industry;

	●	additions or departures of key personnel;

	●	introduction of new products by us or our competitors;

	●	sales of our common stock or other securities in the open market;

	●	inaccurate or unfavorable reports from securities or industry analysts; and

	●	other events or factors, many of which are beyond our control.

	●	provide that the authorized number of directors may be changed by resolution of the board of directors;

	●	provide that all vacancies, including newly-created directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum;

	●	divide the board of directors into three classes;

	●	provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide notice in writing in a timely manner, and meet specific requirements as to the form and content of a stockholder’s notice;

Plan category	Number of securities to be issued upon exercise of outstanding options and restricted stock units (1)		Weighted- average exercise price of outstanding options and restricted stock units (2)		Number of securities remaining available for future issuance
Equity compensation plans approved by security holders		3,721,429	$	8.00		6,383,638
Equity compensation plans not approved by security holders		-		-		-
Total		3,721,429	$	8.00		6,383,638

	For the years ended December 31,						Increase
(amounts in thousands)	2022			2021			(Decrease)

Revenue:
Revenue	$	-		$	-		$	-
Other revenue		1,030			1,144			(114	)
Total revenue		1,030			1,144			(114	)

Operating expenses:
Research and development, net of reimbursements		23,135			18,031			5,104
General and administrative		11,999			8,077			3,922
Total operating expenses		35,134			26,108			9,026

Other income
Interest income – net		1,087			190			897
Total other income		1,087			190			897

Net loss	$	(33,017	)	$	(24,774	)	$	(8,243	)

	December 31, 2022			December 31, 2021
Assets
Current Assets:
Cash and cash equivalents	$	108,910		$	77,829
Restricted cash – current		396			392
Security deposit		-			50
Prepaid expenses and other current assets		1,636			1,478
Total Current Assets		110,942			79,749

Property and equipment, net of accumulated depreciation of $487 and $335		604			340
Restricted cash – long term		302			-
Operating lease right-of-use assets		2,341			241
Finance leases right-of-use assets		3			58
Total Assets	$	114,192		$	80,388

Liabilities and Stockholders’ Equity

Current Liabilities:
Accounts payable and accrued expenses	$	10,130		$	5,535
Other revenue deferred – current liability		-			998
Operating leases current liability		494			245
Finance leases current liability		4			62
Total Current Liabilities		10,628			6,840

Long-term license revenue deferred		35,000			-
Long-term operating lease obligations		2,083			-
Long-term finance lease obligations		-			3
Total Liabilities		47,711			6,843

Commitments and contingencies

Stockholders’ Equity:
Preferred stock, $0.001 par value; 50,000,000 shares authorized, 0 shares issued and outstanding		-			-
Common stock, $0.001 par value; 1,000,000,000 shares authorized; 25,674,823 and 22,143,974 shares issued and outstanding		26			22
Additional paid-in capital		355,220			329,271
Accumulated deficit		(288,765	)		(255,748	)
Total Stockholders’ Equity		66,481			73,545

Total Liabilities and Stockholders’ Equity	$	114,192		$	80,388

	For the Year ended December 31,
	2022			2021

Revenue
Revenue	$	-		$	-
Other Revenue		1,030			1,144
Total revenue		1,030			1,144

Operating expenses:
Research and development, net of reimbursements		23,135			18,031
General and administrative		11,999			8,077
Total operating expenses		35,134			26,108

Loss from operations		(34,104	)		(24,964	)

Other income:
Interest income - net		1,087			190
Total other income		1,087			190

Net loss	$	(33,017	)	$	(24,774	)

Net loss per common share - basic and diluted	$	(1.37	)	$	(1.20	)

Weighted average common shares outstanding - basic and diluted		24,141,545			20,568,373

	Common Stock				Additional Paid-In		Accumulated			Stockholders’
	Shares		Amount		Capital		Deficit			Equity
Balance, January 1, 2021		17,532,893	$	18	$	292,275	$	(230,974	)	$	61,319
Stock-based compensation		21,306		-		1,694		-			1,694
Sale of common stock, net of offering costs		4,588,875		4		35,296		-			35,300
Issuance of common stock from exercise of stock options		900		-		6		-			6
Net loss		-		-		-		(24,774	)		(24,774	)
Balance, December 31, 2021		22,143,974	$	22	$	329,271	$	(255,748	)	$	73,545
Stock-based compensation		19,639		-		2,795		-			2,795
Sale of common stock, net of offering costs		3,511,210		4		23,154		-			23,158
Net loss		-		-		-		(33,017	)		(33,017	)
Balance, December 31, 2022		25,674,823	$	26	$	355,220	$	(288,765	)	$	66,481

(in thousands)	December 31, 2022		December 31, 2021
Cash and cash equivalents	$	108,910	$	77,829
Restricted cash – current		396		392
Restricted cash – long-term		302		-
Cash, cash equivalents and restricted cash	$	109,608	$	78,221

	December 31,		December 31,
	2022		2021
Prepaid insurance	$	684	$	874
Prepaid clinical trial expenses		887		543
Other prepaid expenses and other current assets		65		61
Total prepaid expenses and other current assets	$	1,636	$	1,478

(in thousands)	Year ended December 31, 2022		Year ended December 31, 2021
Operating lease expense	$	584	$	372

Finance lease cost
Amortization of right-to-use assets	$	55	$	81
Interest on lease liabilities	$	2	$	9
Total finance lease cost		57	$	90

	Year ended
(in thousands)	December 31, 2022		December 31, 2021
Cash flow information:

Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flow use from operating leases	$	352	$	377
Operating cash flow use from finance leases	$	2	$	9
Financing cash flow use from finance leases	$	49	$	85

Non-cash activity:

Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$	2,605	$	-
Finance Leases	$	-	$	-

Weighted average remaining lease term:
Operating leases		4.6 years
Finance Leases		1.0 years

Weighted average discount rates:
Operating leases	4.8	%
Finance Leases	8.0	%

Year ending December 31,	Operating Leases			Finance Leases
2023		606			4
2024		618			-
2025		630			-
2026		643			-
2027		380			-
Total lease payments	$	2,877		$	4
Less imputed interest		(300	)		-
Present value of lease liabilities	$	2,577		$	4

(in thousands, except for per-share amount)	Number of Options			Weighted Average Exercise Price ($)		Weighted Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value ($)
Outstanding, January 1, 2021		815			21.53		8.51		120
Granted		881			6.43
Exercised		(1	)		6.69
Cancelled		(333	)		18.78
Outstanding, December 31, 2021		1,362			12.45		8.69		-
Granted		2,094			5.25
Exercised		-			-
Cancelled		(60	)		12.90
Outstanding, December 31, 2022		3,396			8.00		8.85		15,204

Exercisable, December 31, 2022		804			15.30		7.58		2,432

(in thousands, except for per-share amount)	RSUs		Weighted Average Grant date Fair Value Per Share ($)
Outstanding, January 1, 2022		-		-
Granted		325		5.96
Vested		-		-
Outstanding, December 31, 2022		325		5.96

(in thousands, except for per-share amounts)	Number of Warrants			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value
Outstanding, January 1, 2021		2,113			20.55		2.76		362
Granted		1			8.30
Exercised		-			-
Cancelled		(2	)		50.17
Outstanding, December 31, 2021		2,112			20.52		1.76		276
Granted		-			-
Exercised		-			-
Cancelled		(669	)		29.01
Outstanding, December 31, 2022		1,443			16.58		1.33		5

Exercisable, December 31, 2022		1,440			15.95		1.33		4