Tg Therapeutics, Inc 10-Q for FY2024 Q1

Tg Therapeutics, Inc. (TGTX)

10-Q 2024-05-06 For: 2024-03-31

Added on April 09, 2026

About this 10-Q

Tg Therapeutics, Inc filed this 10-Q on May 6, 2024, covering the quarter ended March 31, 2024 (FY2024 Q1).

Headline figures

Quarter ended March 31, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $63.47M; up 713.5% from $7.8M a year earlier
Net loss: $10.71M; compared with a net loss of $39.23M a year earlier

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Delaware	36-3898269
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)

Title of Class	Trading Symbol(s)	Exchange Name
Common Stock, par value $0.001	TGTX	Nasdaq Capital Market

Large accelerated filer ☒	Accelerated filer ☐

Non-accelerated filer ☐	Smaller reporting company ☐

	Emerging growth company ☐

SPECIAL CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS		3

SUMMARY RISK FACTORS		4

PART I	FINANCIAL INFORMATION	6

Item 1	Financial Statements:	6

	Condensed Consolidated Balance Sheets	6

	Condensed Consolidated Statements of Operations (unaudited)	7

	Condensed Consolidated Statements of Changes in Stockholders’ Equity (unaudited)	8

	Condensed Consolidated Statements of Cash Flows (unaudited)	9

	Notes to Condensed Consolidated Financial Statements (unaudited)	10

Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	28

Item 3	Quantitative and Qualitative Disclosures About Market Risk	35

Item 4	Controls and Procedures	35

PART II	OTHER INFORMATION	35

Item 1	Legal Proceedings	35

Item 1A	Risk Factors	36

Item 2	Unregistered Sales of Equity Securities and Use of Proceeds	81

Item 3	Defaults of Senior Securities	81

Item 4	Mine Safety Disclosures	81

Item 5	Other Information	81

Item 6	Exhibits	82

	●	our ability to advance drug candidates into, and successfully complete, clinical trials;
	●	our ability to develop, formulate, manufacture and commercialize our product candidates;

	●	our financial performance and cash burn management;
	●	our ability to maintain or obtain adequate product liability and other insurance coverage;

	●	developments relating to our competitors and our industry;
	●	the effects on our company of future regulatory developments or legislative actions, including changes in healthcare, environmental and other laws and regulations to which we are subject;
	●	prevailing economic, market and business conditions;
	●	our ability to retain, attract and hire key personnel; and
	●	fluctuations in the trading price of our common stock.

●	If we are unable to maintain current approval of BRIUMVI, our business will be materially harmed.
●	We cannot predict when or if we will obtain regulatory approval to commercialize our product candidates, including TG-1701 and TG-1801 in B-cell disorders or azer-cel in non-oncology indications.
●	We have limited experience operating as a commercial company, and, as a result, the marketing and sale of BRIUMVI for the treatment of RMS may be less successful than anticipated.
●	If BRIUMVI or any of our future product candidates (if approved) do not achieve broad market acceptance among physicians, patients, payors or the medical community, the revenues that we generate from product sales will be limited.
●	If the market opportunities for BRIUMVI and any future products for which we may receive approval, including TG-1701 or TG-1801 in B-cell disorders or azer-cel in non-oncology indications, are smaller than we estimate or if any approval we obtain is based on a narrower patient population or the labeling includes warnings or limitations that are not acceptable to patients or healthcare providers, our revenue will be adversely affected.
●	We face substantial competition for treatments for our target indications, including from companies with greater resources than we have, which may result in others commercializing drugs before or more successfully than we do, which could result in the reduction or elimination of our commercial opportunity.
●	If we are unable to generate sufficient revenue, we may need to raise substantial additional capital to sustain our business.
●	Product liability lawsuits could cause us to incur substantial liabilities and limit product commercialization.

●	Our success depends upon our ability to obtain and protect our intellectual property, and if the scope of our patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our products may be impaired.
●	Our patent protection could be reduced or eliminated for non-compliance with various procedural and other requirements imposed by governmental patent agencies.
●	We may need to license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
●	If we or our partners are sued for infringing intellectual property rights of third parties, it will be costly and time consuming to defend against such lawsuits, and an unfavorable outcome in any such lawsuit would have a material adverse effect on our business.
●	If we are unable to protect the confidentiality of our trade secrets, our business may be significantly harmed.

●	Public health issues including an epidemic or global pandemic, including the pandemic caused by COVID-19, could have an adverse impact on our financial condition and results of operations and other aspects of our business.
●	Patients and healthcare providers have raised concerns that immunosuppressive products, like anti-CD20 antibodies and other B-cell targeted agents, may increase the risk of acquiring COVID-19 or lead to more severe complications upon infection. These concerns may impact the commercial potential for BRIUMVI and other immunosuppressive products that we have in development.
●	We will need to develop and expand our business, and we may encounter difficulties in managing this development and expansion.
●	Our ability to continue our clinical development and commercialization activities will depend on our ability to attract and maintain key management and other personnel.
●	Certain of our executive officers, directors and other stockholders own more than 5% of our outstanding common stock and may be able to influence our management and the outcome of matters submitted to shareholders for approval.
●	Certain anti-takeover provisions in our charter documents and Delaware law could make a third-party acquisition more difficult, which could limit the price investors might be willing to pay for our common stock.
●	Our stock price is, and we expect it to remain, volatile, which could limit investors’ ability to sell stock at a profit and could subject us to securities and shareholder derivative litigation.
●	Significant disruptions of information technology systems, breaches of data security or unauthorized disclosures of sensitive data could harm our business and subject us to liability or reputational damage.

	*March 31,*			*December 31,*
	*2024*			*2023*
	*(Unaudited)*			*(Note 1)*
Assets
Current assets:
Cash and cash equivalents	$	75,477		$	92,933
Short-term investment securities		134,308			124,575
Accounts receivable, net		64,982			51,093
Inventories		77,719			39,823
Prepaid research and development and other current assets		8,095			9,519
Total current assets		360,581			317,943
Restricted cash		1,289			1,285
Long-term investment securities		1,320			—
Right of use assets		7,906			8,050
Leasehold interest, net		1,362			1,415
Equipment, net		66			95
Goodwill		799			799
Total assets	$	373,323		$	329,587

Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued expenses	$	87,266		$	38,471
Other current liabilities		4,064			1,479
Lease liability – current portion		1,383			1,446
Deferred revenue - current portion		3,373			152
Accrued compensation		3,598			12,172
Total current liabilities		99,684			53,720
Deferred revenue, non-current portion		3,244			6,016
Loan payable – non-current		101,326			100,118
Lease liability – non-current		8,960			9,231
Total liabilities		213,214			169,085
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.001 par value per share (175,000,000 shares authorized, 154,607,052 and 151,465,598 shares issued, 154,565,743 and 151,424,289 shares outstanding at March 31, 2024 and December 31, 2023, respectively)		155			151
Additional paid-in capital		1,685,256			1,674,946
Treasury stock, at cost, 41,309 shares at March 31, 2024 and December 31, 2023		(234	)		(234	)
Accumulated deficit		(1,525,068	)		(1,514,361	)
Total stockholders’ equity		160,109			160,502
Total liabilities and stockholders’ equity	$	373,323		$	329,587

	*Three months ended*
	*March 31,*
	*2024*			*2023*
Revenue:
Product revenue, net	$	50,488		$	7,765
License, milestone, royalty and other revenue		12,986			38
Total revenue	$	63,474		$	7,803

Costs and expenses:
Cost of revenue		5,441			857
Research and development:
Noncash compensation		2,452			1,584
Other research and development		30,270			14,286
Total research and development		32,722			15,870

Selling, general and administrative:
Noncash compensation		6,887			5,240
Other selling, general and administrative		27,694			22,828
Total selling, general and administrative		34,581			28,068

Total costs and expenses		72,744			44,795

Operating loss		(9,270	)		(36,992	)

Other expense (income):
Interest expense		2,288			2,844
Other income		(880	)		(604	)
Total other expense (income), net		1,408			2,240

Net loss before taxes	$	(10,678	)	$	(39,232	)
Income taxes	$	29			—
Net loss	$	(10,707	)	$	(39,232	)

Basic and diluted net loss per common share	$	(0.07	)	$	(0.28	)

Weighted-average shares used in computing basic and diluted net loss per common share		146,209,213			140,312,269

						*Additional*
	*Common Stock*					*paid-in*			*Treasury Stock*					*Accumulated*
	*Shares*			*Amount*		*capital*			*Shares*		*Amount*			*Deficit*			*Total*
Balance at January 1, 2023		146,426,697		$	146	$	1,585,708			41,309	$	(234	)	$	(1,527,033	)	$	58,587
Issuance of common stock in connection with exercise of options		66,701			*		363			—		—			—			363
Issuance of restricted stock		3,017,736			3		(3	)		—		—			—			—
Warrants issued with debt financing		—			—		595			—		—			—			595
Forfeiture of restricted stock		(73,787	)		*		—			—		—			—			—
Compensation in respect of restricted stock granted to employees, directors and consultants		—			—		7,120			—		—			—			7,120
Net loss		—			—		—			—		—			(39,232	)		(39,232	)
Balance at March 31, 2023		149,437,347			149		1,593,783			41,309		(234	)		(1,566,265	)		27,433

	*As of*
	*March 31,*
	*2024*		*2023*
Unvested restricted stock		9,898,448		9,000,857
Options		4,694,529		4,876,484
Warrants		312,272		312,272
Shares issuable upon note conversion		21,167		20,136
Total		14,926,416		14,209,749

(in thousands)	Three months ended March 31,
	2024		2023
Total product revenue, net	$	50,488	$	7,765
License Revenue		38		38
Milestone Revenue		12,500		-
Royalty Revenue		33		-
Other Revenue		415		-
Total Revenue	$	63,474	$	7,803

	*March 31, 2024*
	*Amortized*		*Gross*		*Gross*
	*cost, as*		*unrealized*		*unrealized*		*Estimated*
(in thousands)	*adjusted*		*holding gains*		*holding losses*		*fair value*
Short-term investments:
Obligations of domestic governmental agencies (maturing between April 2024 and September 2024) (held-to-maturity)	$	134,308	$	—	$	28	$	134,280
Total short-term investments	$	134,308	$	—	$	28	$	134,280

	*December 31, 2023*
	*Amortized*		*Gross*		*Gross*
	*cost, as*		*unrealized*		*unrealized*		*Estimated*
	*adjusted*		*holding gains*		*holding losses*		*fair value*
Short-term investments:
Obligations of domestic governmental agencies (maturing between January 2024 and June 2024) (held-to-maturity)	$	124,575	$	30	$	53	$	124,552
Total short-term investments	$	124,575	$	30	$	53	$	124,552

	*March 31, 2024*
Raw Materials	$	1,712
Work in Process		74,104
Finished Goods		1,903
Total Inventory	$	77,719

	*Financial assets and liabilities at fair value as of March 31, 2024*
(in thousands)	*Level 1*		*Level 2*		*Level 3*		*Total*

Equity Investments	$	1,320	$	—	$	—	$	1,320
Total Assets	$	1,320	$	—	$	—	$	1,320

Forward Contract Liabilities	$	—	$	2,471	$	—	$	2,471
5% Notes	$	—	$	—	$	322	$	322
Total Liabilities	$	—	$	2,471	$	322	$	2,793


	*Financial assets and liabilities at fair value as of December 31, 2023*
	*Level 1*		*Level 2*		*Level 3*		*Total*

5% Notes	$	—	$	—	$	357	$	357
Total Liabilities	$	—	$	—	$	357	$	357

	*Stock Options*			*Restricted Stock*
Equity awards outstanding, beginning of year		4,697,029			9,639,068
Changes during the year:
Granted		—			3,304,468
Exercised or vested		(2,500	)		(1,379,543	)
Expired or Forfeited		—			(165,514	)
Equity awards outstanding, end of period		4,694,529			11,398,479

	Amended Term Loan
Exercise price	$	14.70
Common share price on date of issuance	$	15.04
Volatility		0.88	%
Risk-free interest rate		3.6	%
Expected dividend yield		—	%
Contractual term (in years)		7.00

	*Operating*
(in thousands)	*leases*
Remainder of 2024	$	1,792
2025		2,100
2026		2,080
2027		1,913
2028		1,827
After 2029		4,715
Total lease payments		14,427
Less: interest		(4,084	)
Present value of lease liabilities(*)	$	10,343

Clinical Drug Candidate: (molecular target)	Initial Target Disease	Stage of Development (trial name)
Ublituximab (anti-CD20 mAb)	Relapsing Forms of Multiple Sclerosis (RMS)	APPROVED
TG-1701 (BTK inhibitor)	B-cell disorders	Phase 1 trial
TG-1801 (anti-CD47/CD19 bispecific mAb)	B-cell disorders	Phase 1 trial

	●	Additional exploratory data sets from the ULTIMATE I & II Phase 3 trials continue to be presented at major medical meetings. BRIUMVI is also being studied in the ENHANCE Phase 3b trial evaluating RMS patients who switch from a IV anti-CD20 therapy to BRIUMVI and data from the ENHANCE trial was most recently presented at the 2024 Americas Committee for Treatment and Research in Multiple Sclerosis Annual Meeting held in February 2024.
	●	On February 27, 2024, we announced the issuance of three additional patents by the United States Patent and Trademark Office (USPTO) for BRIUMVI, which extended patent protection through 2042.

	Three months ended
	March 31,
(in thousands)	2024			2023
Product revenue, net	$	50,488		$	7,765
License, milestone, royalty and other revenue		12,986			38
Total Revenue	$	63,474		$	7,803

Costs and expenses:
Cost of revenue		5,441			857
Research and development:
Noncash compensation		2,452			1,584
Other research and development		30,270			14,286
Total research and development		32,722			15,870

General and administrative:
Noncash compensation		6,887			5,240
Other selling, general and administrative		27,694			22,828
Total general and administrative		34,581			28,068

Total costs and expenses		72,744			44,795

Interest expense		2,288			2,844
Other income		(880	)		(604	)
Total other expense, net		1,408			2,240

Net loss before taxes		(10,678	)		(39,232	)
Income taxes		29			—
Net loss	$	(10,707	)	$	(39,232	)

	●	the timing of our receipt of marketing approvals, the terms of such approvals, and the countries in which such approvals are obtained;
	●	the efficacy, safety and tolerability as demonstrated in clinical trials and as compared to alternative treatments;
	●	the timing of market introduction of BRIUMVI and any of our product candidates, as well as competitive products;
	●	the indications for which our products are approved, and other aspects of the approved labeling for such products;
	●	acceptance by physicians, advanced practitioners, major operators of neurology clinics, and patients of our products as safe, tolerable and effective treatments;
	●	the potential and perceived advantages or disadvantages of our products compared to alternative treatments;
	●	our ability to offer our products for sale at competitive prices;
	●	the availability of adequate reimbursement by third-party payors and government authorities;
	●	the extent of patient cost-sharing obligations, including copays and deductibles;
	●	changes in regulatory requirements by government authorities for our products;
	●	relative convenience and ease of administration;
	●	the prevalence and severity of side effects and adverse events;
	●	the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
	●	the effectiveness of our sales and marketing efforts, as well as those of any current or future partners;
	●	protecting our rights in our intellectual property portfolio;
	●	our ability to maintain a reliable supply of our products that meets market demand; and
	●	favorable or unfavorable publicity relating to our products or relating to the Company.

	●	regulatory authorities may withdraw approval or limit the approved indications for use of such products;
	●	regulatory authorities may require the addition of new or different labeling statements, including warnings or boxed warnings, precautions, or contraindications that could diminish the usage of the product or otherwise limit the commercial success of the affected product;
	●	we may be required to change the way such drug candidates are distributed or administered, or to conduct additional clinical trials;
	●	regulatory authorities may require a Risk Evaluation and Mitigation Strategy (REMS), a plan to mitigate risks, which could include a Medication Guide, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools;
	●	we may be subject to regulatory investigations and government enforcement actions;
	●	we may decide to remove such drug candidates from the marketplace;
	●	we may not be able to enter into collaboration agreements on acceptable terms and execute on our business model;
	●	we could be sued and held liable for injury caused to individuals exposed to or taking our products; and
	●	our reputation may suffer.

	●	research and development resources, including personnel and technology;
	●	regulatory experience;
	●	pharmaceutical development, clinical trial and pharmaceutical commercialization experience;
	●	experience and expertise in exploitation of intellectual property rights; and
	●	capital resources.

	●	the costs and time associated with the initial and ongoing training of commercialization personnel on the applicable disease states, products, competitors, and legal and regulatory compliance matters;
	●	the inability of commercialization personnel to obtain access to physicians or to effectively promote or provide education about BRIUMVI and any future approved products;
	●	the lack of complementary drugs to be offered by the Company, which may put us at a competitive disadvantage relative to companies with more extensive product lines;
	●	decisions by third-party payors to deny reimbursement of or delay coverage decisions regarding BRIUMVI or following approval of any product candidates;
	●	our inability to maintain a healthcare compliance program including effective mechanisms for compliance monitoring;
	●	our inability to establish and maintain commercial partnerships outside the U.S.;
	●	our inability, or the inability of a third party with whom we have partnered, to maintain the necessary regulatory approvals required to operate in markets outside of the U.S.;
	●	the timing of product availability for commercial sale following approval and continued product supply; and
	●	unforeseen costs and expenses associated with creating a commercialization organization.

	●	decreased demand for any products that we may commercialize;
	●	injury to our reputation and significant negative media attention;
	●	withdrawal of clinical trial participants;
	●	significant costs to defend the related litigation, including the risk that any individuals who may face such related litigation may in turn seek to recover from us;
	●	substantial monetary awards to trial participants or patients;
	●	loss of revenue; and
	●	the inability to commercialize any products or product candidates that we may develop.

	●	successfully complete clinical trials that meet their clinical endpoints;
	●	initiate and successfully complete all safety, pharmacokinetic, biodistribution, and non-clinical studies required to obtain U.S. and foreign marketing approval for our product and product candidates;
	●	obtain approval from the FDA and foreign equivalents to market and sell our product and product candidates, and maintain FDA, MHRA and EMA approvals of BRIUMVI for RMS;
	●	establish and maintain commercial manufacturing capabilities with third parties that are satisfactory to the regulatory authorities, cost effective, and that are capable of providing commercial supply of our product and product candidates;
	●	expand on our commercialization infrastructure to commercialize BRIUMVI, and/or entering into collaborations with third parties; and
	●	achieve market acceptance of BRIUMVI and any other products for which we may receive regulatory approval in the medical community and with third-party payors.

	●	the success of the commercialization of BRIUMVI and any other products for which we receive regulatory approval;
	●	the costs and timing of clinical and commercial manufacturing supply arrangements for each product and product candidate;
	●	the costs of expanding our sales, distribution, and other commercialization capabilities;
	●	the costs and timing of regulatory approvals;
	●	the progress of our clinical trials, including expenses to support the trials and milestone payments that may become payable under our license agreements;
	●	our ability to establish and maintain strategic collaborations, including licensing and other arrangements;
	●	the costs involved in enforcing or defending patent claims or other intellectual property rights; and
	●	the extent to which we in-license or invest in other indications or product candidates.

	●	we will need to repay the indebtedness by making payments of interest and principal, which will reduce the amount of money available to finance our operations, our research and development efforts and other general corporate activities; and
	●	our failure to comply with the restrictive covenants in the Amended Loan Agreement, as amended, could result in an event of default that, if not cured or waived, would accelerate our obligation to repay this indebtedness, and Hercules could seek to enforce its security interest in the assets securing such indebtedness.

	●	dispose of certain assets;
	●	change its lines of business;
	●	engage in mergers, acquisitions or consolidations;
	●	incur additional indebtedness;
	●	create liens on assets;
	●	pay dividends and make contributions or repurchase our capital stock; and
	●	engage in certain transactions with affiliates.

	●	successful completion of our clinical programs with positive results that support a finding of effectiveness and an acceptable safety profile of our product candidates in the intended populations within the timeframes we have projected;
	●	Investigational New Drugs (INDs) and clinical trial applications (CTAs), being cleared/approved such that our product candidates can commence clinical trials;
	●	successful initiation and completion of preclinical studies and successful initiation of, enrollment in, and completion of clinical trials;
	●	sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials;
	●	receipt of regulatory approvals from applicable regulatory authorities for our product candidates;
	●	establishing commercially viable arrangements with third-party manufacturers for clinical supply and commercial manufacturing; and
	●	obtaining and maintaining patent and trade secret protection or regulatory exclusivity for our product candidates.