Actinium Pharmaceuticals, Inc 10-Q for FY2021 Q2

Actinium Pharmaceuticals, Inc. (ATNM)

10-Q 2021-07-30 For: 2021-06-30

Added on April 10, 2026

About this 10-Q

Actinium Pharmaceuticals, Inc filed this 10-Q on July 30, 2021, covering the quarter ended June 30, 2021 (FY2021 Q2).

Headline figures

Quarter ended June 30, 2021, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $266K
Net loss: $5.02M; compared with a net loss of $4.63M 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	15
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	26
Item 4.	Controls and Procedures	27

PART II – OTHER INFORMATION
Item 1.	Legal Proceedings	28
Item 1A.	Risk Factors	28
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	56
Item 3.	Defaults Upon Senior Securities	56
Item 4.	Mine Safety Disclosures	56
Item 5.	Other Information	56
Item 6.	Exhibits	56

SIGNATURES		57

	June 30, 2021			December 31, 2020
	(Unaudited)
Assets
Current Assets:
Cash and cash equivalents	$	81,912		$	63,560
Restricted cash – current		48			48
Prepaid expenses and other current assets		1,211			1,317
Total Current Assets		83,171			64,925

Property and equipment, net of accumulated depreciation of $339 and $291		329			312
Operating leases right-of-use assets		413			579
Finance leases right-of-use assets		99			140
Security deposit		50			50
Restricted cash		392			391
Total Assets	$	84,454		$	66,397

Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable and accrued expenses	$	3,426		$	4,340
Operating leases current liability		357			342
Finance leases current liability		90			85
Total Current Liabilities		3,873			4,767

Long-term operating leases obligations		62			245
Long-term finance leases obligations		20			66
Total Liabilities		3,955			5,078

Commitments and contingencies (Note 2)

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; 21,090,931 and 17,532,893 shares issued and outstanding, respectively		21			18
Additional paid-in capital		321,793			292,275
Accumulated deficit		(241,315	)		(230,974	)
Total Stockholders’ Equity		80,499			61,319

Total Liabilities and Stockholders’ Equity	$	84,454		$	66,397

	For the Three Months Ended June 30,						For the Six Months Ended June 30,
	2021			2020			2021			2020
Revenue
Revenue	$	-		$	-		$	-		$	-
Other revenue		266			-			888			-
Total revenue		266			-			888			-

Operating expenses:
Research and development, net of reimbursements		3,631			3,508			7,907			7,659
General and administrative		1,710			1,154			3,428			2,686
Total operating expenses		5,341			4,662			11,335			10,345

Loss from operations		(5,075	)		(4,662	)		(10,447	)		(10,345	)

Other income:
Interest income - net		54			37			106			50
Total other income		54			37			106			50

Net loss	$	(5,021	)	$	(4,625	)	$	(10,341	)	$	(10,295	)

Deemed dividend for warrant down-round protection provision		-			(1	)		-			(1	)
Net loss applicable to common stockholders	$	(5,021	)	$	(4,626	)	$	(10,341	)	$	(10,296	)

Net loss per share of common stock – basic and diluted	$	(0.25	)	$	(0.41	)	$	(0.54	)	$	(1.20	)
Weighted average shares of common stock outstanding, including outstanding pre-funded warrants– basic and diluted		20,231,278			11,379,345			19,308,487			8,559,385

	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		-		-		376		-			376
Sale of common stock, net of costs		1,712,745		1		14,360		-			14,361
Net loss		-		-		-		(5,320	)		(5,320	)
Balance, March 31, 2021		19,245,638	$	19	$	307,011	$	(236,294	)	$	70,736

Stock-based compensation		8,705		-		459		-			459
Sale of common stock, net of costs		1,835,688		2		14,317		-			14,319
Issuance of shares from exercise of stock options		900		-		6		-			6
Net loss		-		-		-		(5,021	)		(5,021	)
Balance, June 30, 2021		21,090,931	$	21	$	321,793	$	(241,315	)	$	80,499

(in thousands)	June 30, 2021		December 31, 2020
Cash and cash equivalents	$	81,912	$	63,560
Restricted cash – current		48		48
Restricted cash – long-term		392		391
Cash, cash equivalents and restricted cash	$	82,352	$	63,999

(in thousands)	June 30, 2021		June 30, 2020
Options		859		365
Warrants		2,114		2,871
Total		2,973		3,236

	Three months ended				Six months ended
(in thousands)	June 30, 2021		June 30, 2020		June 30, 2021		June 30, 2020
Operating lease expense	$	93	$	93	$	186	$	186

Finance lease cost
Amortization of right-to-use assets	$	21	$	21	$	41	$	41
Interest on lease liabilities	$	2	$	4	$	5	$	9
Total finance lease cost	$	23	$	25	$	46	$	50

Weighted average remaining lease term:
Operating leases		1.2 years
Finance Leases		1.3 years

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

(in thousands)
Year ending December 31,	Operating Leases			Finance Leases
2021 (excluding six months ended June 30, 2021)	$	188		$	47
2022		252			64
2023		-			4
Total lease payments	$	440		$	115
Less imputed interest		(21	)		(5	)
Present value of lease liabilities	$	419		$	110

(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, 2021		815		$	21.53		8.51	$	120
Granted		95			8.33
Exercised		(1	)		6.69
Cancelled		(50	)		67.99
Outstanding, June 30, 2021		859			17.38		8.23		156
Exercisable, June 30, 2021		308			30.97		6.80		59

	●	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 many not 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;

	●	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;

	●	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;

	●	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; or

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

	●	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 if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement 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.

	●	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.

	●	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.

Exhibit No.	Title of Document	Location
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.	Attached

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

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*	Attached

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*	Attached

101.INS	Inline XBRL Instance Document	Attached

101.SCH	Inline XBRL Taxonomy Extension Schema Document	Attached

101.CAL	Inline XBRL Taxonomy Calculation Linkbase Document	Attached

101.DEF	Inline XBRL Taxonomy Extension Definition Linkbase Document	Attached

101.LAB	Inline XBRL Taxonomy Label Linkbase Document	Attached

101.PRE	Inline XBRL Taxonomy Presentation Linkbase Document	Attached

104	Cover Page Interactive Data file (formatted as Inline XBRL and contained in Exhibit 101)	Attached

	ACTINIUM PHARMACEUTICALS, INC.

Date: July 30, 2021	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)

	Date: July 30, 2021

	By:	/s/ Sandesh Seth
		Sandesh Seth
		Chairman & CEO
		(Duly Authorized Officer and
		Principal Executive Officer)

	Date: July 30, 2021

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