mnpr20230630

mnpr20230630_10q.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒	Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the Quarterly Period Ended June 30, 2023

☐	Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the transition period from to

Commission File Number: 001-39070

MONOPAR THERAPEUTICS INC.

(Exact name of registrant as specified in its charter)

Delaware

32-0463781

(State or other jurisdiction of

incorporation or organization)

(I.R.S. employer

identification number)

1000 Skokie Blvd., Suite 350, Wilmette, IL		60091
(Address of principal executive offices)		(zip code)

(847) 388-0349

(Registrant’s telephone number, including area code)

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

Title of each class

Trading

Symbol(s)

Name of each exchange

on which registered

Common Stock, $0.001 par value

MNPR

The Nasdaq Stock Market LLC

(Nasdaq Capital Market)

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated Filer	☒	Smaller reporting company	☒
		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. ☒

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

The number of shares outstanding with respect to each of the classes of our common stock, as of July 28, 2023, is set forth below:

Class		Number of shares outstanding
Common Stock, par value $0.001 per share		14,157,941

		Page
Part I	FINANCIAL INFORMATION

Item 1.	Financial Statements (Unaudited)	7
	Condensed Consolidated Balance Sheets as of June 30, 2023 and December 31, 2022	7
	Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30, 2023 and 2022	8
	Condensed Consolidated Statements of Stockholders’ Equity for the Three and Six Months Ended June 30, 2023 and 2022	9
	Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2023 and 2022	11
	Notes to Condensed Consolidated Financial Statements	12
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	24
Item 4.	Controls and Procedures	33

Part II	OTHER INFORMATION
Item 1A.	Risk Factors	34
Item 6.	Exhibits	34

Signatures		35

●	our ability to raise sufficient funds within the next 12 months in order for us to (1) continue the clinical development of camsirubicin through and beyond our ongoing Phase 1b dose escalation clinical trial, (2) support further preclinical and clinical development of MNPR-101 for radiopharmaceutical use in advanced cancers, and (3) support further development of MNPR-202 and related compounds; as well as our ability to further raise additional funds in the future to support any future product candidate programs through completion of clinical trials, and our current and future product candidate programs through the approval processes and, if applicable, commercialization;

●	our ability to remain in compliance with the Nasdaq listing standards requiring our stock closing bid price to be $1.00 and above, any potential stock price decrease resulting from the Company receiving a non-compliance notification from Nasdaq in the future, and our ability to regain compliance within Nasdaq's time limit should we become non-compliant;

●	our ability to raise funds at acceptable terms;

●	our ability to find a suitable pharmaceutical partner or partners to further our development efforts, under acceptable financial terms;

●	risks and uncertainties associated with our research and development activities, including our clinical trials, regulatory submissions, and manufacturing and quality expenses;

●	estimated timeframes for our clinical trials and regulatory reviews for approval to market products are uncertain;

●	the rate of market acceptance and competitiveness in terms of pricing, efficacy and safety, of any products for which we receive marketing approval, and our ability to competitively market any such products as compared to larger pharmaceutical firms;

●	the difficulties of commercialization, marketing and product manufacturing and overall strategy;

●	uncertainties of intellectual property position and strategy including new discoveries and patent filings;

●	our ability to attract and retain experienced and qualified key personnel and/or to find and utilize external sources of experience, expertise and scientific, medical and commercialization knowledge to complete product development and commercialization of new products;

●	the risks inherent in our estimates regarding the level of needed expenses, capital requirements and the availability of required additional financing at acceptable terms;

●	the impact of government laws and regulations including increased governmental control of healthcare and pharmaceuticals, resulting in direct price controls driving lower prices, other governmental regulations affecting cost requirements and structures for selling therapeutic or imaging products, and recent governmental legislation affecting other industries which may indirectly increase our costs of obtaining goods and services;

●	the uncertain continuing impact of COVID-19 on our ability to advance our clinical programs and raise additional financing;

●	the cumulative impact of domestic and global inflation, volatility in financial markets and the banking industry and/or the potential for an economic recession increasing our costs of obtaining goods and services or making financing more difficult to obtain on acceptable terms or at all;

●	the uncertain impact of the Russia-Ukraine war on our clinical material manufacturing expenses and timelines, as well as on general economic, trade and financial market conditions; and

●	uncertainty of our financial projections and operational timelines and the development of new competitive products and technologies.

	●	We are a clinical stage biopharmaceutical company with a history of financial losses. We expect to continue to incur significant losses for the foreseeable future and may never achieve or maintain cash self-sufficiency or profitability, which could result in a decline in the market value of our common stock.

	●	Funds raised to date are not sufficient to (1) continue the clinical development of camsirubicin through and beyond our ongoing Phase 1b dose escalation clinical trial; (2) support further development of MNPR-101 for radiopharmaceutical use in advanced cancers; or (3) support continued development of MNPR-202 and related compounds. If we are unable to raise enough funds within the next 12 months from the sale of our common stock or other financing efforts, or conclude a strategic agreement or collaboration such as out-licensing our product candidates, or entering into a clinical or commercial partnership, we will likely have to terminate one or more programs. There can be no assurance that we will be able to secure such financing or find a suitable development partner on satisfactory terms.

	●	The termination of our Validive clinical trial at the end of March 2023 resulted in a decrease in our stock price. If the closing bid price of our stock is below $1.00 for 30 consecutive trading days, we will receive a notice from Nasdaq stating that we are out of compliance with Nasdaq listing standards giving us 180 days to regain compliance. Receipt of such notice could cause a further decrease in our stock price, and there can be no assurance that we would regain compliance within Nasdaq’s time limits and requirements. If our stock price does not increase in the next several months, it may have serious adverse consequences on our ability to raise funds, which may cause us to delay, restructure or otherwise reconsider our operations.

	●	We do not have and may never have any approved products on the market. Our business is highly dependent upon receiving marketing approvals from various U.S. and international governmental agencies and would be severely harmed if we are not granted approvals to manufacture and sell our product candidates.

	●	Our clinical trials may not yield sufficiently conclusive results for regulatory agencies to approve the use of our products, which would adversely affect our financial condition.

	●	If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals will be delayed or prevented, which would materially delay our program schedules and adversely affect our financial condition.

	●	If we or our licensees, development collaborators, or suppliers are unable to manufacture our products in sufficient quantities or at defined quality specifications, or are unable to obtain regulatory approvals for the manufacturing facility, we may be unable to develop and/or meet demand for our products and lose time to market and potential revenues.

	●	We rely on qualified third parties to conduct our active pharmaceutical ingredient manufacturing, our drug product manufacturing, non-clinical studies, and our clinical trials. If these third parties do not or cannot successfully carry out their contractual duties and meet expected deadlines or performance goals, the initiation or conduct of our clinical trials would be delayed and we may be unable to obtain regulatory approval for, or commercialize, our current product candidates or any future products, and our financial condition would be adversely affected.

	●	The Russia-Ukraine war, and resulting sanctions against Russia and Russian entities, and Russian reduction in gas shipments to the EU and other allies, have increased fuel costs, reduced access to critical supplies and may cause shipping delays. The broader economic, trade and financial market consequences are uncertain at this time, which may increase the cost of supplies for our clinical materials, may delay the manufacture of our clinical materials, may increase costs of other goods and services or make it more difficult or costly to raise additional financing, any of which could cause an adverse effect on our clinical programs and on our financial condition.

	●	Market variables, such as inflation of product costs, labor rates and fuel, freight and energy costs, as well as geopolitical events could likely cause us to suffer significant increases in our operating and administrative expenses.

	●	Unstable market and economic conditions, such as the recent volatility in the markets due to concerns about bank stability and economic challenges due to inflation, may have serious adverse consequences on our ability to raise funds, which may cause us to delay, restructure or otherwise reconsider our operations.

	●	The effects of economic and political pressure to lower pharmaceutical prices are a major threat to the economic viability of new research-based pharmaceutical products, and any significant decrease in drug prices could materially and adversely affect the financial appeal of our products and investment prospects.

	●	We face significant competition from other biotechnology and pharmaceutical companies, and from research-based academic medical institutions, in our targeted medical indications, and our operating results would be adversely affected if we fail to compete effectively. Many competitors have greater organizational capabilities in our industry, much higher available capital resources, and established marketing resources and sales in the targeted markets. Competition and technological change may make our product candidates obsolete or non-competitive.

	●	The termination of third-party licenses would adversely affect our rights to important compounds or technologies which are essential to develop and market our products.

	●	If we and our third-party licensors do not obtain and preserve protection for our respective intellectual property rights, our competitors may be able to develop and market competing drugs, which would adversely affect our financial condition.

	●	If we lose key management leadership, and/or the expertise and experience of our scientific personnel, and if we cannot recruit qualified employees or other highly qualified and experienced personnel for future requirements, we would be at risk to experience significant program delays and increased compensation and operational costs, and our business would be materially disrupted.

	●	The long-term effects of COVID-19 are highly uncertain, and their scope and impact could have a substantial negative bearing on our business, financial condition, operating results, stock price and ability to raise additional funds.

	*June 30, 2023*			December 31, 2022*

*Assets*

Current assets:
Cash and cash equivalents	$	7,214,757		$	8,186,194
Investments		2,976,649			4,933,550
Other current assets		109,868			45,982
Total current assets		10,301,274			13,165,726

Operating lease right-of-use asset		37,330			61,228
Total assets	$	10,338,604		$	13,226,954

*Liabilities and Stockholders’ Equity*

Current liabilities:
Accounts payable, accrued expenses and other current liabilities	$	2,501,821		$	3,128,894
Total current liabilities		2,501,821			3,128,894

Non-current operating lease liability		—			8,408
Total liabilities		2,501,821			3,137,302

Commitments and contingencies (Note 8)

Stockholders’ equity:
Common stock, par value of $0.001 per share, 40,000,000 shares authorized, 13,898,081 and 12,946,573 shares issued and outstanding at June 30, 2023, and December 31, 2022, respectively		13,898			12,947
Additional paid-in capital		64,254,231			61,871,784
Accumulated other comprehensive income		7,222			8,942
Accumulated deficit		(56,438,568	)		(51,804,021	)
Total stockholders’ equity		7,836,783			10,089,652
Total liabilities and stockholders’ equity	$	10,338,604		$	13,226,954

	*Three Months Ended June 30,*						*Six Months Ended June 30,*
	*2023*			*2022*			*2023*			*2022*
Operating expenses:
Research and development	$	1,594,713		$	2,078,471		$	3,248,082		$	3,756,403
General and administrative		733,496			684,877			1,605,171			1,464,131
Total operating expenses		2,328,209			2,763,348			4,853,253			5,220,534
Loss from operations		(2,328,209	)		(2,763,348	)		(4,853,253	)		(5,220,534	)
Interest income		128,218			417			218,706			881
Net loss		(2,199,991	)		(2,762,931	)		(4,634,547	)		(5,219,653	)
Other comprehensive income (loss):
Foreign currency translation gain (loss)		(4,385	)		21,210			(15,184	)		20,626
Unrealized gain (loss) on investments		(20,180	)		—			13,464			—
Comprehensive loss	$	(2,224,556	)	$	(2,741,721	)	$	(4,636,267	)	$	(5,199,027	)
Net loss per share:
Basic and diluted	$	(0.16	)	$	(0.22	)	$	(0.35	)	$	(0.41	)
Weighted average shares outstanding:
Basic and diluted		13,420,029			12,632,381			13,263,770			12,618,489

								*Accumulated*
					*Additional*			*Other*						*Total*
	*Common Stock*				*Paid-*			*Comprehensive*			*Accumulated*			*Stockholders’*
	*Shares*		*Amount*		*in Capital*			*Income*			*Deficit*			*Equity*

Balance at January 1, 2023		12,946,573	$	12,947	$	61,871,784		$	8,942		$	(51,804,021	)	$	10,089,652
Issuance of common stock under a Capital on Demand^TM Sales Agreement with JonesTrading Institutional Services, LLC, net of commissions, fees and offering costs of $37,661		244,392		244		807,094			—			—			807,338
Issuance of common stock to non-employee directors pursuant to vested restricted stock units		10,132		10		(10	)		—			—			—
Issuance of common stock to employees pursuant to vested restricted stock units, net of taxes		20,959		21		(16,848	)		—			—			(16,827	)
Stock-based compensation (non-cash)		—		—		476,209			—			—			476,209
Net loss		—		—		—			—			(2,434,556	)		(2,434,556	)
Other comprehensive income, net		—		—		—			22,845			—			22,845
Balance at March 31, 2023		13,222,056		13,222		63,138,229			31,787			(54,238,577	)		8,944,661
Issuance of common stock under a Capital on DemandTM Sales Agreement with JonesTrading Institutional Services, LLC, net of commissions, fees and offering costs of $26,522		621,227		621		659,374			—			—			659,995
Issuance of common stock to non-employee directors pursuant to vested restricted stock units		10,136		10		(10	)		—			—			—
Issuance of common stock to employees pursuant to vested restricted stock units, net of taxes		44,662		45		(16,658	)		—			—			(16,613	)
Stock-based compensation (non-cash)		—		—		473,296			—			—			473,296
Net loss		—		—		—			—			(2,199,991	)		(2,199,991	)
Other comprehensive loss, net		—		—		—			(24,565	)		—			(24,565	)
Balance at June 30, 2023		13,898,081	$	13,898	$	64,254,231		$	7,222		$	(56,438,568	)	$	7,836,783

								Accumulated
					*Additional*			*Other*						*Total*
	*Common Stock*				*Paid-*			*Comprehensive*			*Accumulated*			*Stockholders*’
	*Shares*		*Amount*		*in Capital*			*Income*			*Deficit*			*Equity*

Balance at January 1, 2022		12,598,125	$	12,598	$	60,220,016		$	(3,160	)	$	(41,288,383	)	$	18,941,071
Issuance of common stock to non-employee directors pursuant to vested restricted stock units		11,436		12		(12	)		—			—			—
Issuance of common stock to employees pursuant to vested restricted stock units, net of taxes		11,031		11		(16,677	)		—			—			(16,666	)
Stock-based compensation (non-cash)		—		—		499,812			—			—			499,812
Net loss		—		—		—			—			(2,456,722	)		(2,456,722	)
Other comprehensive loss		—		—		—			(584	)		—			(584	)
Balance at March 31, 2022		12,620,592		12,621		60,703,139			(3,744	)		(43,745,105	)		16,966,911
Issuance of common stock to non-employee directors pursuant to vested restricted stock units		11,436		11		(11	)		—			—			—
Issuance of common stock to employees pursuant to vested restricted stock units, net of taxes		28,177		28		(29,683	)		—			—			(29,655	)
Issuance of common stock upon exercise of stock options		40,532		41		—			—			—			41
Stock-based compensation (non-cash)		—		—		357,293			—			—			357,293
Offering costs		—		—		(35,846	)		—			—			(35,846	)
Net loss		—		—		—			—			(2,762,931	)		(2,762,931	)
Other comprehensive income		—		—		—			21,210			—			21,210
Balance at June 30, 2022		12,700,737	$	12,701	$	60,994,892		$	17,466		$	(46,508,036	)	$	14,517,023

	*For the Six Months Ended*
	*June 30,*
	*2023*			*2022*

Cash flows from operating activities:
Net loss	$	(4,634,547	)	$	(5,219,653	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense (non-cash)		949,505			857,105
Changes in operating assets and liabilities
Other current assets		(63,891	)		28,552
Accounts payable, accrued expenses and other current liabilities		(623,648	)		559,959
Operating lease right-of-use assets and liabilities, net		—			(4,238	)
Net cash used in operating activities		(4,372,581	)		(3,778,275	)
Cash flows from investing activities:
Purchase of short-term investments		(4,921,873	)		—
Maturities of short-term investments		6,892,238			—
Net cash provided by investing activities		1,970,365			—
Cash flows from financing activities:
Cash proceeds from the sales of common stock under a Capital on Demand^TM Sales Agreement, net of commissions, fees and offering costs		1,479,416			—
Other offering costs		—			(35,846	)
Payroll taxes paid related to net share settlement of vested restricted stock units		(33,440	)		(46,321	)
Cash proceeds from the issuance of stock upon exercise of stock options		—			41
Net cash provided by (used in) financing activities		1,445,976			(82,126	)
Effect of exchange rates		(15,197	)		20,101
Net decrease in cash and cash equivalents		(971,437	)		(3,840,300	)
Cash and cash equivalents at beginning of period		8,186,194			20,303,869
Cash and cash equivalents at end of period	$	7,214,757		$	16,463,569

Supplemental non-cash flow information:
Lease liability arising out of obtaining right-of-use asset	$	—		$	92,359

June 30, 2023	*Level 1*		*Total*
Assets:
Cash equivalents⁽¹⁾	$	6,133,928	$	6,133,928
Investments⁽²⁾		2,976,649		2,976,649
Total	$	9,110,577	$	9,110,577

December 31 2022	Level 1		Total
Assets:
Cash equivalents⁽¹⁾	$	7,248,946	$	7,248,946
Investments⁽²⁾		4,933,550		4,933,550
Total	$	12,182,496	$	12,182,496

As of June 30, 2023	*Cost Basis*		*Unrealized Gains*		*Aggregate Fair Value*

U.S. Treasury Bills	$	4,936,367	$	28,503	$	4,964,870
Money Market Accounts		4,145,707		—		4,145,707
Total	$	9,082,074	$	28,503	$	9,110,577

As of December 31, 2022	Cost Basis		Unrealized Gains		Aggregate Fair Value

U.S. Treasury Bills	$	6,905,171	$	15,039	$	6,920,210
Money Market Accounts		5,262,286		—		5,262,286
Total	$	12,167,457	$	15,039	$	12,182,496

	*Options Outstanding*
	*Number of Shares Subject to Options*			*Weighted-Average Exercise Price*
Balances as of December 31, 2022		1,642,950			4.28
Granted⁽¹⁾		508,902			3.14
Forfeited⁽²⁾		(37,851	)		4.10
Balances as of June 30, 2023		2,114,001			4.01
Unvested options outstanding expected to vest⁽³⁾		768,496			3.44

(1)	Cash equivalents as of June 30, 2023 and December 31, 2022, represent the fair value of the Company’s investment in two money market accounts and U.S. Treasury Bills with maturities at the date of purchase of three months or less.

(2)	Investments represents the fair value of the Company’s investment in U.S. Treasury Bills with maturities at the date of purchase from over three months to one year.

(1)	508,902 options vest as follows: options to purchase 443,182 shares of the Company’s common stock vest 6/48ths on the six-month anniversary of grant date and 1/48th per month thereafter; options to purchase 55,720 shares of the Company’s common stock vest quarterly over one year; and options to purchase 10,000 shares of the Company’s common stock vest monthly over one year.

(2)	Forfeited options represent unvested shares and vested, unexercised and expired shares related to employee terminations.

(3)	Forfeitures only include known forfeitures to-date as the Company accounts for forfeitures as they occur due to a limited history of forfeitures.

Exercise Prices	Number of Shares Subject to Options Outstanding		Weighted-Average Remaining Contractual Term in Years		Number of Shares Subject to Options Fully Vested and Exercisable		Weighted-Average Remaining Contractual Term in Years
$0.001 - $5.00		1,376,895		7.43		698,533		5.68
$5.01 - $10.00		617,942		6.01		530,365		5.71
$10.01 - $15.00		113,039		6.59		110,482		6.59
$15.01 - $20.00		6,125		6.59		6,125		6.59
		2,114,001		6.97		1,345,505		5.77

				*Weighted- Average*
	*Restricted*			*Grant Date*
	*Stock Units*			*Fair Value*
	*(#)*			*per Unit ($)*
Unvested balance as of December 31, 2022		272,650			4.00
Granted		368,345			3.16
Vested		(115,430	)		4.05
Unvested Balance as of June 30, 2023		525,565			3.40

	-	has a similar cytotoxic potency to doxorubicin
	-	generates increased DNA damage in the cancer cells compared to doxorubicin
	-	has a unique immune activation profile versus doxorubicin
	-	demonstrates increased apoptosis (programmed cell death) compared to doxorubicin
	-	causes a distinct set of genes to be upregulated and downregulated versus doxorubicin and
	-	may also be superior to doxorubicin in certain combination treatment regimens.

●	Advance the clinical development of camsirubicin, by pursuing indications where doxorubicin has demonstrated efficacy. ASTS will be the first indication, which is anticipated to allow camsirubicin to go head-to-head against doxorubicin, the current first-line treatment. In this indication, camsirubicin previously demonstrated clinical benefit (stable disease or partial response) in 52.6% of patients evaluable for tumor progression in a single-arm Phase 2 study. Clinical benefit was proportional to dose and was consistently observed at higher cumulative doses of camsirubicin (>1000 mg/m² cumulative dose). Our current ongoing Phase 1b clinical trial continues towards establishing a new, higher recommended dose for the next Phase 2 ASTS clinical trial.

●	Continue the development of MNPR-101 for radiopharmaceutical use as a therapeutic, diagnostic and imaging agent. We have prioritized our development of radiopharmaceuticals based on promising data from our imaging and efficacy animal model studies. Based on promising preclinical imaging and therapeutic results utilizing radiolabeled MNPR-101, we aim to initiate a first-in-human imaging study with MNPR-101-Zr as early as the end of this year.

●	Continue the development of MNPR-202 and related analogs in multiple types of cancers. The 2-pyrrilino camsirubicin analog (MNPR-202) and related analogs represent proprietary compositions of matter designed to retain the non-cardiotoxic backbone of camsirubicin yet exhibit novel features in terms of antitumor activity and mechanism that distinguish these analogs from camsirubicin as well as from doxorubicin, potentially addressing camsirubicin- and doxorubicin-resistant cancers.

●	Expand our drug development pipeline through advancing current assets, in-licensing, and acquisition of oncology product candidates. We plan to continue the expansion of our drug development pipeline through acquiring or in-licensing additional oncology product candidates, particularly those that leverage existing scientific and clinical data that helps reduce the risks of the next steps in clinical development. To be executed, such expansion will require additional funds.

●	Utilize the expertise and prior experience of our team in the areas of asset acquisition, drug development and commercialization to establish ourselves as a leading biopharmaceutical company. Our senior executive team has relevant experience in biopharmaceutical in-licensing and acquisitions as well as developing product candidates through approval and commercialization. In aggregate, our team has co-founded BioMarin Pharmaceutical (Nasdaq: BMRN), Sensant Corp (acquired by Siemens), American BioOptics (assets acquired by Olympus), Raptor Pharmaceuticals ($800 million sale to Horizon Therapeutics), Wilson Therapeutics (acquired by Alexion in June 2018 for $764 million; Alexion was subsequently acquired by AstraZeneca) and Tactic Pharma, LLC (“Tactic Pharma”).

	Three Months Ended June 30,									Six Months Ended June 30,
	(Unaudited)									(Unaudited)
(in thousands)	2023			2022			Variance			2023			2022			Variance
Research and development expenses	$	1,595		$	2,078		$	(483	)	$	3,248		$	3,756		$	(508	)
General and administrative expenses		733			685			48			1,605			1,464			141
Total operating expenses		2,328			2,763			(435	)		4,853			5,220			(367	)
Operating loss		(2,328	)		(2,763	)		435			(4,853	)		(5,220	)		367
Interest income		128			—			128			219			1			218
Net loss	$	(2,200	)	$	(2,763	)	$	563		$	(4,634	)	$	(5,219	)	$	585

	●	advance the clinical development and execute the regulatory strategy for camsirubicin;

	●	continue the preclinical activities and potentially enter clinical development of MNPR-101-derived radioimmunotherapeutics and companion diagnostics, to image and treat cancer;

	●	continue the preclinical activities, and potentially later-on enter clinical development, of MNPR-202 (and related analogs) for various cancer indications;

	●	acquire and/or license additional pipeline drug product candidates and pursue the future preclinical and clinical development and regulatory requirements of such drug product candidates;

	●	seek regulatory approvals for any of our current and future drug product candidates that successfully complete registration clinical trials;

	●	establish or purchase the services of a sales, marketing and distribution infrastructure to commercialize any products for which we obtain marketing approval;

	●	develop or contract for manufacturing/quality capabilities or establish a reliable, high quality supply chain sufficient to support our clinical requirements and to provide sufficient capacity to launch and supply the market for any product for which we obtain marketing approval; and

	●	add or contract for required operational, financial, human resources and management information systems and capabilities and other specialized expert personnel to support our drug product candidate development and planned commercialization efforts.

	●	the progress of clinical development and regulatory interactions and potential approvals of camsirubicin;

	●	the costs, timing and outcomes of seeking, obtaining, and maintaining FDA and international regulatory approvals;

	●	the progress of preclinical and potential clinical development of MNPR-101-derived radioimmunotherapeutics and companion diagnostics, to image and treat cancer, including activities through our collaboration with NorthStar;

	●	the progress of preclinical and potential clinical development of MNPR-202 (and related analogs);

	●	the number and characteristics of other drug product candidates that we may license, acquire, invent or otherwise pursue;

	●	the scope, progress, timing, cost and results of research, preclinical development and clinical trials and regulatory requirements for future drug product candidates;

	●	the costs associated with establishing or contracting for manufacturing/quality requirements and establishing or contracting for sales, marketing and distribution capabilities;

	●	our ability and related costs to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make in connection with the licensing, filing, defense and enforcement of any patents or other intellectual property rights;

	●	our need and ability to hire or contract for additional management, administrative, scientific, medical, sales and marketing, and manufacturing/quality and other specialized personnel or external expertise;

	●	the effect and timing of entry of competing products or new therapies that may limit market penetration or prevent the introduction of our drug product candidates or reduce the commercial potential of our product portfolio;

	●	our need to implement additional required internal management, operational, record keeping, and other systems and infrastructure; and

	●	the economic and other terms, timing and success of our existing collaboration and licensing arrangements and any collaboration, licensing or other arrangements into which we may enter into in the future, including the timing of receipt of or payment to or from others of any license, milestone or royalty payments under these arrangements.

	●	process development, manufacturing costs, clinical trial expenses and clinical database management of camsirubicin in connection with the Phase 1b dose escalation clinical trial and other future clinical development;

	●	support of the development of MNPR-101-derived radioimmunotherapeutics and companion diagnostics to image and treat cancer, including activities through our collaboration with NorthStar;

	●	preclinical studies (and if successful, clinical studies) of MNPR-202 (and related analogs);

	●	increased employee compensation and consultant fees to support the increased scope of activities required for the progress of our product candidate programs including camsirubicin, MNPR-101 RIT (uPRIT and related compounds) and companion diagnostics and MNPR-202 (and related analogs); and

	●	increased sales, marketing, distribution, quality, medical, pharmacovigilance, regulatory and compliance employees and/or consultants to support any of our programs if approved for marketing in any major market.

SEC Form 10-Q filed by Monopar Therapeutics Inc.