10-Q
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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 September 30, 2023

OR

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 001-34375

 

PLUS THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

33-0827593

(State or other jurisdiction

of incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

 

 

4200 MARATHON BLVD., SUITE 200, AUSTIN, TX

 

78756

(Address of principal executive offices)

 

(Zip Code)

 

(737) 255-7194

(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, par value $0.001

PSTV

Nasdaq Capital Market

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 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 financing 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 Exchange Act). Yes No

As of October 25, 2023 , there were 4,522,656 shares of the registrant’s common stock outstanding.

 

 

 


 

PLUS THERAPEUTICS, INC.

INDEX

 

 

 

 

Page

PART I

 

FINANCIAL INFORMATION

 

 

 

 

 

 

 

 

 

Item 1.

 

Financial Statements (Unaudited)

 

4

 

 

 

 

 

 

 

 

 

 

 

Condensed Balance Sheets

 

4

 

 

 

 

 

 

 

 

 

 

 

Condensed Statements of Operations

 

5

 

 

 

 

 

 

 

 

 

 

 

Condensed Statements of Stockholders’ Equity

 

6

 

 

 

 

 

 

 

 

 

 

 

Condensed Statements of Cash Flows

 

7

 

 

 

 

 

 

 

 

 

 

 

Notes to Condensed Financial Statements

 

8

 

 

 

 

 

 

 

 

 

Item 2.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

18

 

 

 

 

 

 

 

 

 

Item 3.

 

Quantitative and Qualitative Disclosures about Market Risk

 

27

 

 

 

 

 

 

 

 

 

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

 

31

 

 

 

 

 

 

 

 

 

Item 6.

 

Exhibits

 

32

 

2


 

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This report and the exhibits incorporated herein by reference contain “forward-looking statements” which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Statements other than statements of historical fact constitute “forward-looking statements.” These forward-looking statements do not constitute guarantees of future performance. These forward-looking statements may be identified by terms such as “intend,” “expect,” “project,” “believe,” “anticipate,” “initiate,” “will,” “should,” “would,” “could,” “may,” “designed,” “potential,” “evaluate,” “hypothesize,” “plan,” “progressing,” “proceeding,” “exploring,” “opportunity,” “hopes,” “suggest,” and similar expressions, or the negative of such expressions. Such statements are based upon certain assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.

These statements include, without limitation, statements about our anticipated expenditures, including research and development, and general and administrative expenses; our strategic collaborations and license agreements, intellectual property, FDA and EMA approvals and interactions and government regulation; the potential size of the market for our product candidates; our research and development efforts; results from our pre-clinical and clinical studies and the implications of such results regarding the efficacy or safety of our product candidates; the safety profile, pathways, and efficacy of our product candidates and formulations; anticipated advantages of our product candidates over other products available in the market and being developed; the populations that will most benefit from our product candidates and indications that will be pursued with each product candidate; anticipated progress in our current and future clinical trials; plans and strategies to create novel technologies; our IP strategy; competition; future development and/or expansion of our product candidates and therapies in our markets; sources of competition for any of our product candidates; our pipeline; our ability to generate product or development revenue and the sources of such revenue; our ability to effectively manage our gross profit margins; our ability to obtain and maintain regulatory approvals; expectations as to our future performance; portions of the “Liquidity and Capital Resources” section of this report, including our potential need for additional financing and the availability thereof; our ability to continue as a going concern; our ability to remain listed on the Nasdaq Capital Market; our ability to repay or refinance some or all of our outstanding indebtedness and our ability to raise capital in the future; our ability to transfer the drug product manufacture to a contract drug manufacturing organization; and the potential enhancement of our cash position through development, marketing, and licensing arrangements. The forward-looking statements included in this report are also subject to a number of additional material risks and uncertainties, including but not limited to the risks described under “Part I – Item 1A – Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, and under “Part II – Item 1A – Risk Factors” in this Quarterly Report. These risks and uncertainties could cause actual results to differ materially from expectations or those expressed in these forward-looking statements.

Our actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of our product candidates and therapies, the results of our research and development activities, including uncertainties relating to the clinical trials of our product candidates and therapies; our liquidity and capital resources and our ability to raise additional cash, the outcome of our partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to us, market conditions, product performance, potential litigation, and competition within the radiotherapeutics, and more generally, oncological medicine fields, among others. The forward-looking statements included in this report are also subject to a number of additional material risks and uncertainties, including but not limited to the risks described under “Part I – Item 1A – Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, and under “Part II – Item 1A – Risk Factors” in this Quarterly Report. These risks and uncertainties could cause actual results to differ materially from expectations or those expressed in these forward-looking statements.

We encourage you to read the risks described under “Risk Factor Summary” and “Part II – Item 1A – Risk Factors” in this report carefully. We caution you not to place undue reliance on the forward-looking statements contained in this report. These statements, like all statements in this report, speak only as of the date of this report (unless an earlier date is indicated) and we undertake no obligation to update or revise the statements except as required by law. Such forward-looking statements are not guarantees of future performance.

3


 

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

PLUS THERAPEUTICS, INC.

CONDENSED BALANCE SHEETS

(UNAUDITED)

(in thousands, except share and par value data)

 

 

 

September 30, 2023

 

 

December 31,
2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

11,006

 

 

$

18,120

 

Grant receivable

 

 

91

 

 

 

 

Other current assets

 

 

487

 

 

 

3,697

 

Total current assets

 

 

11,584

 

 

 

21,817

 

 

 

 

 

 

 

Property and equipment, net

 

 

1,009

 

 

 

1,324

 

Operating lease right-of-use assets

 

 

232

 

 

 

248

 

Goodwill

 

 

372

 

 

 

372

 

Intangible assets, net

 

 

49

 

 

 

94

 

Other assets

 

 

32

 

 

 

12

 

Total assets

 

$

13,278

 

 

$

23,867

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable and accrued expenses

 

$

6,073

 

 

$

10,134

 

Operating lease liability

 

 

117

 

 

 

110

 

Term loan obligation

 

 

4,348

 

 

 

1,608

 

Total current liabilities

 

 

10,538

 

 

 

11,852

 

 

 

 

 

 

 

 

Term loan obligation

 

 

 

 

 

3,786

 

Noncurrent operating lease liability

 

 

118

 

 

 

141

 

Deferred grant liability

 

 

 

 

 

1,643

 

Total liabilities

 

 

10,656

 

 

 

17,422

 

 

 

 

 

 

 

Commitments and contingencies (Note 8)

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock, $0.001 par value; 5,000,000 shares authorized; 1,952 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively

 

 

 

 

 

 

Common stock, $0.001 par value; 100,000,000 shares authorized; 4,522,656 and 2,240,092 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively

 

 

5

 

 

 

2

 

Additional paid-in capital

 

 

479,308

 

 

 

473,628

 

Accumulated deficit

 

 

(476,691

)

 

 

(467,185

)

Total stockholders’ equity

 

 

2,622

 

 

 

6,445

 

Total liabilities and stockholders’ equity

 

$

13,278

 

 

$

23,867

 

 

 

See Accompanying Notes to these Condensed Financial Statements

 

 

4


 

PLUS THERAPEUTICS, INC.

CONDENSED STATEMENTS OF OPERATIONS

(UNAUDITED)

(in thousands, except share and per share data)

 

 

 

 

 

For the Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Grant Revenue

 

$

1,240

 

 

$

73

 

 

$

3,600

 

 

$

73

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

2,493

 

 

 

2,945

 

 

 

6,896

 

 

 

7,560

 

General and administrative

 

 

1,998

 

 

 

2,222

 

 

 

6,165

 

 

 

6,653

 

Total operating expenses

 

 

4,491

 

 

 

5,167

 

 

 

13,061

 

 

 

14,213

 

Loss from operations

 

 

(3,251

)

 

 

(5,094

)

 

 

(9,461

)

 

 

(14,140

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

119

 

 

 

48

 

 

 

290

 

 

 

74

 

Interest expense

 

 

(87

)

 

 

(173

)

 

 

(333

)

 

 

(552

)

Loss on disposal of property and equipment

 

 

 

 

 

 

 

 

(2

)

 

 

 

Change in fair value of liability instruments

 

 

 

 

 

 

 

 

 

 

 

1

 

Total other income (expense)

 

 

32

 

 

 

(125

)

 

 

(45

)

 

 

(477

)

Net loss

 

$

(3,219

)

 

$

(5,219

)

 

$

(9,506

)

 

$

(14,617

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(1.00

)

 

$

(2.85

)

 

$

(3.54

)

 

$

(9.22

)

Basic and diluted weighted average shares used in calculating net loss per share attributable to common stockholders

 

 

3,225,351

 

 

 

1,829,444

 

 

 

2,688,232

 

 

 

1,585,946

 

 

 

See Accompanying Notes to these Condensed Financial Statements

 

5


 

PLUS THERAPEUTICS, INC.

CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY

(UNAUDITED)

(In thousands, except share data)

 

 

 

 

 

 

Convertible

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

Total

 

 

 

Preferred stock

 

 

preferred stock

 

 

Common stock

 

 

 

paid-in

 

 

Accumulated

 

 

stockholders’

 

 

 

Shares

 

 

 

Amount

 

 

Shares

 

 

 

Amount

 

 

Shares

 

 

Amount

 

 

 

capital

 

 

deficit

 

 

equity

 

Balance at December 31, 2021

 

 

 

 

$

 

 

 

 

1,952

 

 

$

 

 

 

 

1,034,002

 

$

 

1

 

 

$

 

457,745

 

$

 

(446,910

)

$

 

10,836

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

180

 

 

 

 

 

 

180

 

Sale of common stock, net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

445,840

 

 

 

 

 

 

 

7,742

 

 

 

 

 

 

7,742

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,116

)

 

 

(4,116

)

Balance at March 31, 2022

 

 

 

 

$

 

 

 

 

1,952

 

 

$

 

 

 

 

1,479,842

 

$

 

1

 

 

$

 

465,667

 

$

 

(451,026

)

$

 

14,642

 

Sale of common stock, net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

18,070

 

 

 

 

 

 

 

152

 

 

 

 

 

 

152

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

167

 

 

 

 

 

 

167

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5,282

)

 

 

(5,282

)

Balance at June 30, 2022

 

 

 

 

$

 

 

 

 

1,952

 

 

$

 

 

 

 

1,497,912

 

$

 

1

 

 

$

 

465,986

 

$

 

(456,308

)

$

 

9,679

 

Sale of common stock, net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

673,421

 

 

 

1

 

 

 

 

6,814

 

 

 

 

 

 

6,815

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

129

 

 

 

 

 

 

129

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5,219

)

 

 

(5,219

)

Balance at September 30, 2022

 

 

 

 

$

 

 

 

 

1,952

 

 

$

 

 

 

 

2,171,333

 

$

 

2

 

 

$

 

472,929

 

$

 

(461,527

)

$

 

11,404

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2022

 

 

 

 

$

 

 

 

 

1,952

 

 

$

 

 

 

 

2,240,092

 

$

 

2

 

 

$

 

473,628

 

$

 

(467,185

)

$

 

6,445

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

140

 

 

 

 

 

 

140

 

Sale of common stock, net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

168,164

 

 

 

 

 

 

 

895

 

 

 

 

 

 

895

 

Issuance of Series F preferred stock

 

 

1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

 

 

 

 

 

1

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,805

)

 

 

(4,805

)

Balance at March 31, 2023

 

 

1

 

 

$

 

 

 

 

1,952

 

 

$

 

 

 

 

2,408,256

 

$

 

2

 

 

$

 

474,664

 

$

 

(471,990

)

$

 

2,676

 

Redemption of Series F preferred stock

 

 

(1

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fractional adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,310

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Sale of common stock, net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

472,674

 

 

 

1

 

 

 

 

1,327

 

 

 

 

 

 

1,328

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

140

 

 

 

 

 

 

140

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,482

)

 

 

(1,482

)

Balance at June 30, 2023

 

 

 

 

$

 

 

 

 

1,952

 

 

$

 

 

 

 

2,879,620

 

$

 

3

 

 

$

 

476,131

 

$

 

(473,472

)

$

 

2,662

 

Sale of common stock, net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,589,655

 

 

 

2

 

 

 

 

2,954

 

 

 

 

 

 

2,956

 

Issuance of common stock for in process research and development

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

53,381

 

 

 

 

 

 

 

75

 

 

 

 

 

 

75

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

148

 

 

 

 

 

 

148

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,219

)

 

 

(3,219

)

Balance at September 30, 2023

 

 

 

 

$

 

 

 

 

1,952

 

 

$

 

 

 

 

4,522,656

 

$

 

5

 

 

$

 

479,308

 

$

 

(476,691

)

$

 

2,622