UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 25, 2021
ADVAXIS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-36138 | 02-0563870 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
305 College Road East Princeton, New Jersey |
08540 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (609) 452-9813
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| [ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| [ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| [ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| [ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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 per share | ADXS | Nasdaq Global Select Market | ||
| Preferred Stock Purchase Rights | Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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. [ ]
| Item 2.02 | Results of Operations and Financial Condition. |
On January 25, 2021, Advaxis, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal year ended October 31, 2020 and providing a business update. A copy of the press release is furnished herewith as Exhibit 99.1.*
| Item 9.01 | Exhibits. |
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release of the Company, dated January 25, 2021 |
* The information in Item 2.02 of this Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| January 25, 2021 | ADVAXIS, INC. | |
| By: | /s/ Kenneth A. Berlin | |
| Name: | Kenneth A. Berlin | |
| Title: | Chief Executive Officer | |
Exhibit 99.1
Advaxis Reports Fiscal Year 2020 Financial Results and Provides a Business Update
Enrolling strategic expansion of ADXS-503 HOT program in NSCLC to explore potential to enhance and/or restore sensitivity to checkpoint inhibitors
SITC presentation from ongoing ADXS-503 Phase 1/2 clinical trial demonstrated disease control rate of 67% and overall response rate of 17% in first six evaluable patients with immediate prior progression on KEYTRUDA®
Continued durable tumor control with two patients on treatment beyond 12 months
Strengthened balance sheet through $9.2M public offering and utilization of common stock purchase agreement and at-the-market facility
PRINCETON, N.J.– January 25, 2021 – Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announces its financial results for the fiscal year ended October 31, 2020 and provides a business update.
Fiscal Year 2020 and Recent Key Accomplishments:
| ● | Presented updated clinical data from the ongoing Phase 1/2 trial of ADXS-503 as a monotherapy and in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in non-small cell lung cancer (NSCLC) at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting | |||
| ○ | In the Part B combination arm, reported disease control rate of 67% and overall response rate of 17% in first six evaluable patients with immediate prior progression on KEYTRUDA® | |||
| ○ | Reported durable and sustained tumor control, with confirmed stable disease and a partial response lasting out to 10 months | |||
| ○ | Biomarker data across 9 patients across trial arms confirmed on-mechanism activation of innate and adaptive immune responses to ADSX-503 with activation of cytotoxic -and/or memory CD8+ T cells as well as 100% efficient priming by ADXS-503 | |||
| ○ | Across trial arms, ADXS-503 appeared safe and well tolerated as a monotherapy and in combination with KEYTRUDA® with no added toxicities from combination therapy | |||
| ● | Initiated ADXS-503 Part B combination arm efficacy expansion which will enroll up to 15 patients to evaluate the potential of ADXS-503 in combination with KEYTRUDA® to restore and/or enhance responsiveness to checkpoint inhibitors in PD-1/L-1 refractory NSCLC patients | |||
| ● | Initiated ADXS-503 Part C combination arm to evaluate ADXS-503 in combination with KEYTRUDA® as a first line treatment in patients with metastatic NSCLC that would receive KEYTRUDA® alone as per label indication with PD-L1 expression ≥ 1% or who are unfit to receive the standard of care regimen of KEYTRUDA® in combination with platinum based-chemotherapy | |||
| ● | Announced FDA Clearance of new Investigational New Drug (IND) application for ADXS-504 for the treatment of prostate cancer at a leading medical institution | |
| ● | Announced common stock purchase agreement for up to $20 million of common stock with Lincoln Park Capital | |
| ● | Announced an at-the-market offering program for up to $40 million of common stock with A.G.P./Alliance Global Partners, as sales agent | |
| ● | Announced closing of $9.2 million public offering of common stock and warrants, with proceeds being used to fund continued development and expansion of our product pipeline, including investment in our ADXS-HOT program and for general corporate purposes | |
| ● | Cash runway currently anticipated to take the Company into fiscal second quarter of 2022 |
Management Commentary
“Fiscal year 2020 was transformative for Advaxis, with important clinical and biomarker data from the ongoing Phase 1/2 study of ADXS-503 in NSCLC which now consistently show the potential of ADXS-503 to synergistically enhance and/or restore sensitivity to checkpoint inhibitors,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “Based on these encouraging results, we have prioritized this study, beginning enrollment in the expansion of Part B to further evaluate the promising signals of sustained clinical benefit observed in Part B in NSCLC patients with immediate prior progression on KEYTRUDA®, as well as Part C, which will evaluate ADXS-503 in combination with KEYTRUDA® in the first line setting. We remain confident that our clinical strategy will explore the full potential of ADXS-503 to improve responses to checkpoint inhibitors across diverse clinical settings and patient populations, and are highly enthusiastic about the on-mechanism innate and adaptive immune stimulation seen in our broadly accessible, off-the-shelf neoantigen immunotherapy. In addition to these encouraging data, our strengthened balance sheet ensures our continued momentum with the ADXS-HOT program as we advance our Lm-technology to expand the reach of checkpoint inhibitors.”
Balance Sheet Highlights
As of October 31, 2020, Advaxis had cash and cash equivalents of $25.2 million. The Company used $21.9 million in cash to fund operations during fiscal year 2020, mainly attributed to funding research and development and general and administrative activities. Throughout fiscal year 2020, the Company continued to prioritize its strategic pipeline across all programs and reduced its annual operating expenses by approximately $12.2 million, or nearly 31%.
Fiscal Year 2020 Financial Information
Research and development expenses for fiscal year 2020 were $15.6 million, compared with $26.7 million for fiscal year 2019. The $11.1 million decrease was primarily attributable to decreases in clinical trial costs, laboratory costs, drug manufacturing process validation and drug stability studies.
General and administrative expenses for fiscal year 2020 were $11.1 million, compared to $12.2 million for fiscal year 2019.
The net loss for the fiscal year ended October 31, 2020 was $26.5 million or $0.43 per share based on about 61 million weighted average shares outstanding. This compares with a net loss for fiscal year 2019 of $16.6 million or $1.09 per share based on 15.2 million weighted average shares outstanding.
About Advaxis, Inc.
Advaxis, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of proprietary Lm-based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as they integrate multiple functions into a single immunotherapy and are designed to access and direct antigen presenting cells to stimulate anti-tumor T cell immunity, activate the immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the tumor microenvironment to enable T cells to eliminate tumors.
To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook and YouTube.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are any statements that express the current beliefs and expectations of management, including but not limited to statements related to the expected clinical development of the Company’s drug product candidates, statements about the Company’s balance sheet position, and statements related to the goals, plans and expectations for the Company’s ongoing clinical studies. These and other risks are discussed in the Company’s filings with the SEC, including, without limitation, its Annual Report on Form 10-K, filed on January 22, 2021, and its periodic reports on Form 10-Q and Form 8-K. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. The Company cautions readers not to place undue reliance on any forward-looking statements, which speak only as of the date they were made. The Company undertakes no obligation to update or revise forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.
Contact:
Tim McCarthy, LifeSci Advisors, LLC
212.915.2564
tim@lifesciadvisors.com
ADVAXIS, INC.
BALANCE SHEETS
(In thousands, except share and per share data)
| October 31, | ||||||||
| 2020 | 2019 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 25,178 | $ | 32,363 | ||||
| Deferred expenses | 1,808 | 2,353 | ||||||
| Prepaid expenses and other current assets | 865 | 1,433 | ||||||
| Total current assets | 27,851 | 36,149 | ||||||
| Property and equipment (net of accumulated depreciation) | 2,393 | 4,350 | ||||||
| Intangible assets (net of accumulated amortization) | 3,261 | 4,575 | ||||||
| Operating right-of-use asset (net of accumulated amortization) | 4,839 | - | ||||||
| Other assets | 182 | 183 | ||||||
| Total assets | $ | 38,526 | $ | 45,257 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 410 | $ | 976 | ||||
| Accrued expenses | 1,737 | 3,478 | ||||||
| Current portion of operating lease liability | 962 | - | ||||||
| Deferred revenue | 165 | - | ||||||
| Common stock warrant liability | 17 | 19 | ||||||
| Other current liabilities | - | 48 | ||||||
| Total current liabilities | 3,291 | 4,521 | ||||||
| Operating lease liability, net of current portion | 5,055 | - | ||||||
| Other liabilities | - | 1,205 | ||||||
| Total liabilities | 8,346 | 5,726 | ||||||
| Commitments and contingencies – Note 9 | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $0.001 par value; 5,000,000 shares authorized; Series B Preferred Stock; 0 shares issued and outstanding at October 31, 2020 and 2019. Liquidation preference of $0 at October 31, 2020 and 2019. | - | - | ||||||
| Common stock - $0.001 par value; 170,000,000 shares authorized, 78,074,023 and 50,201,671 shares issued and outstanding at October 31, 2020 and 2019. | 78 | 50 | ||||||
| Additional paid-in capital | 440,840 | 423,750 | ||||||
| Accumulated deficit | (410,738 | ) | (384,269 | ) | ||||
| Total stockholders’ equity | 30,180 | 39,531 | ||||||
| Total liabilities and stockholders’ equity | $ | 38,526 | $ | 45,257 | ||||
ADVAXIS, INC.
STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
| Year Ended October 31, | ||||||||
| 2020 | 2019 | |||||||
| Revenue | $ | 253 | $ | 20,884 | ||||
| Operating expenses: | ||||||||
| Research and development expenses | 15,612 | 26,677 | ||||||
| General and administrative expenses | 11,090 | 12,179 | ||||||
| Total operating expenses | 26,702 | 38,856 | ||||||
| Loss from operations | (26,449 | ) | (17,972 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 110 | 435 | ||||||
| Net changes in fair value of derivative liabilities | - | 2,589 | ||||||
| Loss on shares issued in settlement of warrants | (77 | ) | (1,607 | ) | ||||
| Other expense | (3 | ) | (7 | ) | ||||
| Net loss before income tax benefit | (26,419 | ) | (16,562 | ) | ||||
| Income tax expense | 50 | 50 | ||||||
| Net loss | $ | (26,469 | ) | $ | (16,612 | ) | ||
| Net loss per common share, basic and diluted | $ | (0.43 | ) | $ | (1.09 | ) | ||
| Weighted average number of common shares outstanding, basic, and diluted | 61,003,839 | 15,207,637 | ||||||