Full Press Release Details
Therapeutics Reports First Quarter 2023 Financial Results and Provides Corporate Update
Continues for Phase 1 Clinical Trial of Decoy20 for Treatment of Solid Tumors with First Patient Dosed In March 2023
YORK (May 11, 2023) - Indaptus Therapeutics, Inc. (Nasdaq: INDP) ("Indaptus" or the "Company"), today announced
financial results for the first quarter ended March 31, 2023 and provided a corporate update.
the dosing and completion of our first patient in the first cohort of our INDP-D101 trial of Decoy20 for the treatment of solid tumors,
we continue the screening and enrollment process to complete our first cohort," said Jeffrey Meckler, chief executive officer of
Indaptus. "In the interim, we have presented significant data at the American Association for Cancer Research scientific conference,
and received additional recognition within the scientific community. We have also received important additions to our intellectual property
portfolio, now having patent protections for our Decoy immunotherapy platform in all 32 countries for which we applied. As we continue
to screen and enroll patients for our trial, we will continue to prudently manage our cash position."
highlights from Q1 2023 to date:
Highlights for the First Quarter Ended March 31, 2023
and development expenses, for the three-month period ended March 31, 2023, were approximately $1.9 million, an increase of approximately
$600,000 compared with approximately $1.3 million in the three-month period ended March 31, 2022. The increase was primarily for payroll
and related expenses and for our phase 1 clinical trial that was initiated in December 2022.
and administrative expenses, for the three-month period ended March 31, 2023, were approximately $2.6 million, an increase of approximately
$500,000 compared with approximately $2.1 million in the three-month period ended March 31, 2022. The increase was primarily for legal
fees, recruitment costs and other professional fees and was primarily offset by a decrease in directors' and officers' insurance
expenses and in payroll and related expenses.
per share for the three-month period ended March 31, 2023 was approximately $0.51 compared with approximately $0.41 for the three-month
period ended March 31, 2022.
of March 31, 2023, the Company had cash and cash equivalents and marketable securities of approximately $21.7 million. As of December
31, 2022, the Company had cash and cash equivalents and marketable securities of approximately $26.4 million. The Company expects that
its current cash, cash equivalents and marketable securities will support its ongoing operating activities into the second quarter of
2024. This cash runway guidance is based on the Company's current operational plans and excludes any additional funding and any
business development activities that may be undertaken. Indaptus continues to assess all financing options that would support its corporate
cash used in operating activities was approximately $5.0 million for the three-month period ended March 31, 2023, compared with net cash
used in operating activities of approximately $3.1 million for the three-month period ended March 31, 2022. The increase of approximately
$1.9 million in net cash used was primarily attributable to expenses related to research and development activities in connection with
the Phase 1 clinical trial and an increase in general and administrative expenses.
cash provided by investing activities was approximately $2.1 million for the three months ended March 31, 2023 which was related to the
maturity of $9.0 million in marketable securities, offset by net investment of approximately $6.9 million in marketable securities. Net
cash used in investing activities was approximately $2.8 million for the three months ended March 31, 2022 which was primarily related
to net investment in marketable securities in the amount of approximately $3.0 million, offset by approximately $0.2 million from the
proceeds received for assets held for sale.
was no net cash provided by or used in financing activities in the three months ended March 31, 2023 and in the three months ended March
Indaptus Therapeutics
Therapeutics has evolved from more than a century of immunotherapy advances. The Company's novel approach is based on the hypothesis
that efficient activation of both innate and adaptive immune cells and pathways and associated anti-tumor and anti-viral immune responses
will require a multi-targeted package of immune system-activating signals that can be administered safely intravenously (i.v.). Indaptus'
patented technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria producing a multiple
Toll-like receptor (TLR) agonist Decoy platform. The products are designed to have reduced i.v. toxicity, but largely uncompromised ability
to prime or activate many of the cells and pathways of innate and adaptive immunity. Decoy products represent an antigen-agnostic technology
that have produced single-agent activity against metastatic pancreatic and orthotopic colorectal carcinomas, single agent eradication
of established antigen-expressing breast carcinoma, as well as combination-mediated eradication of established hepatocellular carcinomas
and non-Hodgkin's lymphomas in standard pre-clinical models, including syngeneic mouse tumors and human tumor xenografts. In pre-clinical
studies tumor eradication was observed with Decoy products in combination with anti-PD-1 checkpoint therapy, low-dose chemotherapy, a
non-steroidal anti-inflammatory drug, or an approved, targeted antibody. Combination-based tumor eradication in pre-clinical models produced
innate and adaptive immunological memory, involved activation of both innate and adaptive immune cells, and was associated with induction
of innate and adaptive immune pathways in tumors after only one i.v. dose of Decoy product, with associated "cold" to "hot"
tumor inflammation signature transition. IND-enabling, nonclinical toxicology studies demonstrated safe i.v. administration without sustained
induction of hallmark biomarkers of cytokine release syndromes, possibly due to passive targeting to liver, spleen, and tumor, followed
by rapid elimination of the product. Indaptus' Decoy products have also produced significant single agent activity against chronic
hepatitis B virus (HBV) and chronic human immunodeficiency virus (HIV) infections in pre-clinical models.
press release contains forward-looking statements with the meaning of the Private Securities Litigation Reform Act. These include statements
regarding management's expectations, beliefs and intentions regarding, among other things: our expectations and plans regarding
the Phase 1 clinical trial of Decoy20, including the timing and design thereof; the plans and objectives of management for future operations;
our research and development activities and costs; the sufficiency of our cash, cash equivalents and marketable securities to fund our
ongoing activities and our cash management strategy; and our assessment of financing options to support our corporate strategy. Forward-looking
statements can be identified by the use of forward-looking words such as "believe", "expect", "intend",
"plan", "may", "should", "could", "might", "seek", "target",
"will", "project", "forecast", "continue" or "anticipate" or their negatives
or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters.
Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and
uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking
statements. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in
forward-looking statements, including, but not limited to the following: our limited operating history; the need for, and our ability
to raise, additional capital given our lack of current cash flow; our clinical and preclinical development, which involves a lengthy
and expensive process with an uncertain outcome; our incurrence of significant research and development expenses and other operating
expenses, which may make it difficult for us to attain profitability; our pursuit of a limited number of research programs, product candidates
and specific indications and failure to capitalize on product candidates or indications that may be more profitable or have a greater
likelihood of success; our ability to obtain and maintain regulatory approval of any product candidate; the market acceptance of our
product candidates; our reliance on third parties to conduct our preclinical studies and clinical trials and perform other tasks; our
reliance on third parties for the manufacture of our product candidates during clinical development; our ability to successfully commercialize
Decoy20 or any future product candidates; our ability to obtain or maintain coverage and adequate reimbursement for our products; the
impact of legislation and healthcare reform measures on our ability to obtain marketing approval for and commercialize Decoy20 and any
future product candidates; product candidates of our competitors that may be approved faster, marketed more effectively, and better tolerated
than our product candidates; our ability to adequately protect our proprietary or licensed technology in the marketplace; the impact
of, and costs of complying with healthcare laws and regulations, and our failure to comply with such laws and regulations; information
technology system failures, cyberattacks or deficiencies in our cybersecurity; and unfavorable global economic conditions. These and
other important factors discussed under the caption "Risk Factors" included in our Quarterly Report on Form 10-Q for the
quarter ended March 31, 2023 to be filed with the SEC, our most recent Annual Report on Form 10-K filed with the SEC on March 17, 2023,
and our other filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements
made in this press release. All forward-looking statements speak only as of the date of this press release and are expressly qualified
in their entirety by the cautionary statements included in this press release. We undertake no obligation to update or revise forward-looking
statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events, except
as required by applicable law.
Condensed Consolidated Balance Sheets
| March 31, 2023 | December 31, 2022 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 6,805,146 | $ | 9,626,800 | ||||
| Marketable securities | 14,875,693 | 16,806,009 | ||||||
| Prepaid expenses and other current assets | 470,751 | 811,433 | ||||||
| Total current assets | 22,151,590 | 27,244,242 | ||||||
| Non-current assets: | ||||||||
| Property and equipment, net | 1,698 | 2,019 | ||||||
| Right-of-use asset | 236,506 | 79,294 | ||||||
| Other assets | 754,728 | 738,251 | ||||||
| Total non-current assets | 992,932 | 819,564 | ||||||
| Total assets | $ | 23,144,522 | $ | 28,063,806 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and other current liabilities | $ | 1,722,622 | $ | 3,352,847 | ||||
| Operating lease liability, current portion | 99,837 | 80,494 | ||||||
| Total current liabilities | 1,822,459 | 3,433,341 | ||||||
| Non-current liabilities: | ||||||||
| Operating lease liability, net of current portion | 136,669 | - | ||||||
| Total non-current liabilities | 136,669 | - | ||||||
| Total liabilities | 1,959,128 | 3,433,341 | ||||||
| Commitments and contingent liabilities | ||||||||
| Stockholders' equity: | ||||||||
| Common stock: $0.01 par value, 200,000,000 shares authorized as of March 31, 2023 and December 31, 2022; 8,401,047 shares issued and outstanding as of March 31, 2023 and December 31, 2022 | 84,011 | 84,011 | ||||||
| Additional paid in capital | 55,170,849 | 54,443,705 | ||||||
| Accumulated deficit | (34,246,923 | ) | (29,993,685 | ) | ||||
| Accumulated other comprehensive income | 177,457 | 96,434 | ||||||
| Total stockholders' equity | 21,185,394 | 24,630,465 | ||||||
| Total liabilities and stockholders' equity | $ | 23,144,522 | $ | 28,063,806 |
Condensed Consolidated Statements of Operations
| Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 1,879,900 | $ | 1,297,098 | ||||
| General and administrative | 2,575,266 | 2,104,975 | ||||||
| Total operating expenses | 4,455,166 | 3,402,073 | ||||||
| Loss from operations | (4,455,166 | ) | (3,402,073 | ) | ||||
| Other income, net | 201,928 | 36,919 | ||||||
| Net loss | $ | (4,253,238 | ) | $ | (3,365,154 | ) | ||
| Net loss available to common stockholders per share of common stock, basic and diluted | $ | (0.51 | ) | $ | (0.41 | ) | ||
| Weighted average number of shares used in calculating net loss per share, basic and diluted | 8,401,047 | 8,258,597 | ||||||
| Net loss | $ | (4,253,238 | ) | $ | (3,365,154 | ) | ||
| Other comprehensive income (loss): | ||||||||
| Reclassification adjustment for realized gain on marketable securities included in net loss | (129,229 | ) | - | |||||
| Unrealized gain (loss) on marketable securities | 210,252 | (9,221 | ) | |||||
| Comprehensive loss | $ | (4,172,215 | ) | $ | (3,374,375 | ) |
Condensed Consolidated Statements of Cash Flows
| For the three months ended | ||||||||
| March 31, | ||||||||
| 2023 | 2022 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | (4,253,238 | ) | $ | (3,365,154 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 321 | 534 | ||||||
| Stock-based compensation | 727,144 | 831,183 | ||||||
| Realized gain on marketable securities | (129,229 | ) | - | |||||
| Realized gain on assets held for sale | - | (24,155 | ) | |||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and other current assets | 324,205 | 364,708 | ||||||
| Accounts payable and other current liabilities | (1,630,225 | ) | (925,204 | ) | ||||
| Operating lease right-of-use asset and liability, net | (1,200 | ) | 360 | |||||
| Net cash used in operating activities | (4,962,222 | ) | (3,117,728 | ) | ||||
| Cash flows from investing activities: | ||||||||
| Proceeds received for assets held for sale | - | 172,555 | ||||||
| Maturity of marketable securities | 9,000,000 | - | ||||||
| Purchase of marketable securities | (6,859,432 | ) | (2,970,681 | ) | ||||
| Net cash provided by (used in) investing activities | 2,140,568 | (2,798,126 | ) | |||||
| Net decrease in cash and cash equivalents | (2,821,654 | ) | (5,915,854 | ) | ||||
| Cash and cash equivalents at beginning of period | 9,626,800 | 39,132,165 | ||||||
| Cash and cash equivalents at end of period | $ | 6,805,146 | $ | 33,216,311 | ||||
| Noncash investing and financing activities | ||||||||
| Change in unrealized gain/loss on marketable securities | $ | 81,023 | $ | - | ||||
| ASC 842 lease renewal option exercise | $ | 236,506 | $ | - | ||||
| Reclassification of security deposit | $ | 16,477 | $ | - | ||||
| Supplemental Disclosures | ||||||||
| Cash received for interest earned on deposits | $ | 36,123 | $ | 1,318 |