Actinium Pharmaceuticals, Inc 10-Q for FY2022 Q1

Actinium Pharmaceuticals, Inc. (ATNM)

10-Q 2022-05-13 For: 2022-03-31

Added on April 10, 2026

About this 10-Q

Actinium Pharmaceuticals, Inc filed this 10-Q on May 13, 2022, covering the quarter ended March 31, 2022 (FY2022 Q1).

Headline figures

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

Revenue: $940K; up 51.1% from $622K a year earlier
Net loss: $5.13M; compared with a net loss of $5.32M a year earlier

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Delaware		74-2963609
(State or Other Jurisdiction of Incorporation or Organization)		(I.R.S. Employer Identification No.)

275 Madison Ave, 7^th Floor New York, NY		10016
(Address of Principal Executive Offices)		(Zip Code)

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	☐

PART I – FINANCIAL INFORMATION
Item 1.	Financial Statements	1
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	14
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	26
Item 4.	Controls and Procedures	26

PART II – OTHER INFORMATION
Item 1.	Legal Proceedings	27
Item 1A.	Risk Factors	27
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	55
Item 3.	Defaults Upon Senior Securities	55
Item 4.	Mine Safety Disclosures	55
Item 5.	Other Information	55
Item 6.	Exhibits	56
SIGNATURES		57

	March 31, 2022			December 31, 2021
	(Unaudited)
Assets
Current Assets:
Cash and cash equivalents	$	72,019		$	77,829
Restricted cash - current		392			392
Security deposit		50			50
Prepaid expenses and other current assets		1,592			1,478
Total Current Assets		74,053			79,749

Property and equipment, net of accumulated depreciation of $363 and $335		319			340
Operating leases right-of-use assets		152			241
Finance leases right-of-use assets		38			58
Total Assets	$	74,562		$	80,388

Liabilities and Stockholders’ Equity

Current Liabilities:
Accounts payable and accrued expenses	$	5,261		$	5,535
Other liability		267			998
Operating leases current liability		154			245
Finance leases current liability		41			62
Total Current Liabilities		5,723			6,840

Long-term finance leases obligations		2			3
Total Liabilities		5,725			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; 22,143,974 and 22,143,974 shares issued and outstanding, respectively		22			22
Additional paid-in capital		329,692			329,271
Accumulated deficit		(260,877	)		(255,748	)
Total Stockholders’ Equity		68,837			73,545

Total Liabilities and Stockholders’ Equity	$	74,562		$	80,388

	For the Three Months Ended March 31
	2022			2021

Revenue:
Revenue	$	-		$	-
Other revenue		940			622
Total revenue		940			622

Operating expenses:
Research and development, net of reimbursements		4,369			4,276
General and administrative		1,735			1,718
Total operating expenses		6,104			5,994

Loss from operations		(5,164	)		(5,372	)

Other income:
Interest income - net		35			52
Total other income		35			52

Net loss	$	(5,129	)	$	(5,320	)

Net loss per share of common stock – basic and diluted	$	(0.23	)	$	(0.29	)
Weighted average shares of common stock outstanding – basic and diluted		22,143,974			18,375,442

	Common Stock				Additional Paid-In		Accumulated			Stockholders’
	Shares		Amount		Capital		Deficit			Equity
Balance, January 1, 2022		22,143,974	$	22	$	329,271	$	(255,748	)	$	73,545

Stock-based compensation		-		-		421		-			421
Net loss		-		-		-		(5,129	)		(5,129	)
Balance, March 31, 2022		22,143,974	$	22	$	329,692	$	(260,877	)	$	68,837

(in thousands)	March 31, 2022		December 31, 2021
Cash and cash equivalents	$	72,019	$	77,829
Restricted cash – current		392		392
Cash, cash equivalents and restricted cash	$	72,411	$	78,221

(in thousands)	March 31, 2022		March 31, 2021
Options		1,333		843
Warrants		2,052		2,114
Total		3,385		2,957

	Three months ended
(in thousands)	March 31, 2022		March 31, 2021
Operating lease expense	$	93	$	93

Finance lease cost
Amortization of right-to-use assets	$	20	$	20
Interest on lease liabilities	$	1	$	3
Total finance lease cost	$	21	$	23

Cash flow information:	Three months ended
(in thousands)	March 31, 2022		March 31, 2021

Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flow use from operating leases	$	94	$	94
Operating cash flow use from finance leases	$	1	$	3
Financing cash flow use from finance leases	$	22	$	21

Non-cash activity:

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

Weighted average remaining lease term:
Operating leases		0.4 year
Finance Leases		0.6 year

Weighted average discount rates:
Operating leases	8	%
Finance Leases	8	%

(in thousands) Year ending December 31,	Operating Leases			Finance Leases
2022 (excluding three months ended March 31, 2022)	$	157		$	40
2023		-			4
Total lease payments	$	157		$	44
Less imputed interest		(3	)		(1	)
Present value of lease liabilities	$	154		$	43

(in thousands, except for per-share amounts)	Number of Shares			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (in years)	Aggregate Intrinsic Value
Outstanding, January 1, 2022		1,362		$	12.45	8.69	$	-
Granted		5			5.89
Cancelled		(34	)		8.47
Outstanding, March 31, 2022		1333			12.52	8.36		-

Exercisable, March 31, 2022		415			24.23	6.74		-

	For the Three Months Ended March 31,
(in thousands)	2022			2021

Cash used in operating activities	$	(5,781	)	$	(5,642	)
Cash used in investing activities		(7	)		(4	)
Cash used in /provided by financing activities		(22	)		14,340

Net change in cash, cash equivalents and restricted cash	$	(5,810	)	$	8,694

	●	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 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.

	●	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;

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

	●	delays by us or third parties in the collection or analysis of data from our clinical trials; or

	●	delays due to COVID-19 or a similar global health pandemic.

	●	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 Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, which imposes criminal and civil liability for, among other things, executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters and also imposes obligations, including mandatory contractual terms, on covered entities, including certain healthcare providers, health plans, and healthcare clearinghouses, and their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of the covered entity as well as their covered subcontractors, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

	●	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; 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;

Exhibit No.		Description
3.1		Certificate of Incorporation of Actinium Pharmaceuticals, Inc. (incorporated by reference to Exhibit 3.1 of the Company’s Form 8-K filed with the SEC on April 17, 2013).

3.2		Certificate of Amendment to Certificate of Incorporation, as amended, filed January 7, 2014 (incorporated by reference to Exhibit 3.5 to Form S-1 filed on January 31, 2014).

3.3		Certificate of Amendment to Certificate of Incorporation, as amended, filed February 3, 2014. (incorporated by reference to Exhibit 3.1 to Form 8-K filed on February 7, 2014).

3.4		Certificate of Amendment to Certificate of Incorporation, as amended, filed on February 26, 2015 (incorporated by reference to Exhibit 3.1 to Form 8-K filed on March 4, 2015).

3.5		Certificate of Amendment to Certificate of Incorporation, as amended, filed on February 26, 2018 (incorporated by reference to Exhibit 3.1 to Form 8-K filed on February 26, 2018).

3.6		Certificate of Amendment to Certificate of Incorporation, as amended, filed on March 6, 2019 (incorporated by reference to Exhibit 3.7 to Form 10-K filed on March 15, 2019).

3.7		Certificate of Amendment to Certificate of Incorporation, as amended, filed on June 16, 2020 (incorporated by reference to Exhibit 3.1 to Form 8-K filed on June 16, 2020).

3.8		Certificate of Amendment to Certificate of Incorporation, as amended, filed on August 10, 2020 (incorporated by reference to Exhibit 3.1 to Form 8-K filed on August 14, 2020).

3.9		Amended and Restated Bylaws, dated August 8, 2018 (incorporated by reference to Exhibit 3.1 to Form 10-Q filed on August 9, 2018).

3.10		Amendment to Amended and Restated Bylaws, dated May 7, 2020 (incorporated by reference to Exhibit 3.1 to Form 8-K filed on May 5, 2020).

31.1*		Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2*		Certification of the Principal Financial and Accounting Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1**		Certification of the Chief Executive Officer pursuant to U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*

32.2**		Certification of the Principal Financial and Accounting Officer pursuant to U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*

101.INS *		Inline XBRL Instance Document
101.SCH *		Inline XBRL Taxonomy Schema Document
101.CAL *		Inline XBRL Taxonomy Calculation Linkbase Document
101.DEF *		Inline XBRL Taxonomy Definition Linkbase Document
101.LAB *		Inline XBRL Taxonomy Label Linkbase Document
101.PRE *		Inline XBRL Taxonomy Presentation Linkbase Document
104*		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

*	Filed herewith.
**	Furnished herewith.
#	Indicates a management contract or compensatory plan or arrangement.

	ACTINIUM PHARMACEUTICALS, INC.

Date: May 13, 2022	By:	/s/ Sandesh Seth
		Sandesh Seth
		Chairman and Chief Executive Officer (Duly Authorized Officer and Principal Executive Officer)

	By:	/s/ Steve O’Loughlin
		Steve O’Loughlin
		Chief Financial Officer
		(Duly Authorized Officer and Principal Financial and Accounting Officer)