Apexigen Reports Third Quarter 2022 Financial Results and Provides Business Update
-Ongoing Phase 2 trial in collaboration with
-Encouraging mPFS data supports expansion of the LPS cohort to inform a potential Phase 3 registration trial-
-Presented positive Phase 2 esophageal/GEJ data at ESMO 2022 demonstrating that sotigalimab (sotiga) in combination with neoadjuvant chemoradiation led to increased pathologic complete response rates across patient subgroups and demonstrated sotiga’s ability to turn “cold” tumors “hot”-
-Presented positive Phase 1/2 metastatic melanoma data at SITC 2022 demonstrating that intratumoral sotiga in combination with systemic pembrolizumab activated antigen-presenting cells and T-cells in both local and distant (non-injected) lesions and improved clinical response rate relative to the standard of care, pembrolizumab monotherapy-
-Successful completion of business combination to become a Nasdaq-listed public company, raising approximately
“In the third quarter of 2022, we took important steps to build our business as a publicly listed biopharmaceutical company and continued to advance our lead program, sotigalimab (sotiga): a potential first-in-class and best-in-class immune-priming antibody that activates the CD40 receptor,” said
Recent Program Highlights and Anticipated Upcoming Milestones:
Sotiga:
- Sarcoma:
Apexigen is evaluating sotiga in an ongoing Phase 2 clinical trial in advanced soft tissue sarcoma (STS) in combination with doxorubicin, a chemotherapy that is currently considered standard-of-care treatment for STS.- Based on the mPFS of 12.45 months observed in patients with LPS in the Phase 2 trial with the combination of sotiga and doxorubicin, the LPS cohort in the Phase 2 trial will be expanded to enroll an additional 10 patients to inform a potential Phase 3 registration trial of the combination of sotiga and doxorubicin as a treatment of patients with anthracycline-naive, advanced LPS.
- As a result of these findings,
Apexigen plans to prioritize and focus its development efforts and resources through 2023 on the development of sotiga in patients with LPS.
- Esophageal/gastro-esophageal junction cancer: Presented updated data from a Phase 2 trial of sotiga in combination with chemoradiation as a neoadjuvant therapy in esophageal/gastro-esophageal junction (E/GEJ) cancer at the 2022
European Society for Medical Oncologists (ESMO) Congress inSeptember 2022 . Results demonstrated that increased pathologic complete response rates were observed in patients with both adenocarcinoma and squamous cell carcinoma histologic subtypes and a single dose of sotiga turned immunologically “cold” tumors “hot.” - Melanoma: Building on encouraging data from the company’s Phase 2 trial of sotiga in combination with nivolumab to treat patients with PD-1 blockade refractory melanoma, the company received feedback and support from the FDA in connection with a Type C meeting in
July 2022 . The purpose of the meeting was to discuss a potential registration-enabling clinical trial of sotiga in combination with a PD-1 inhibitor to treat patients with PD-1 blockade refractory melanoma.- Presented updated data from the Phase 1/2 trial of sotiga in combination with pembrolizumab in patients with first-line melanoma at the
Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting in November. Results showed the combination therapy activated antigen-presenting cells and T-cells in both local and distant (non-injected) lesions, was well-tolerated in the trial and improved best overall response rate (ORR) relative to the historical controls treated with the standard of care, pembrolizumab monotherapy.
- Presented updated data from the Phase 1/2 trial of sotiga in combination with pembrolizumab in patients with first-line melanoma at the
- With the Company’s current focus on the study of sotiga in the LPS setting, the Company currently does not plan to independently advance the development of sotiga in E/GEJ cancer and melanoma and will instead seek to engage a collaboration partner to advance the development of sotiga in these settings.
APX601: An anti-TNFR2 antagonist antibody designed to reverse immune suppression in the tumor microenvironment and unleash immune-mediated tumor killing activity through a unique mechanism of action. In preclinical models, APX601 depletes and inactivates TNFR2-expressing Tregs, reverses myeloid-mediated T-cell suppression and directly kills TNFR2-expressing tumor cells. APX601 shows potent anti-tumor activity in tumor models.
- APX601 is IND-ready and
Apexigen plans to advance APX601 into a Phase 1/2 clinical trial for the treatment of multiple tumor indications of unmet medical need when the company secures adequate financing.
APX801: A natural killer (NK) cell engager designed to specifically activate NK cells leading to effective killing of tumor cells.
- APX801 is currently at the pre-clinical stage and
Apexigen plans to advance APX801 into IND-enabling studies when the company secures additional financing.
Corporate Update:
Completed a business combination with
Third Quarter 2022 Financial Results:
Research and development expenses were
General and administrative expenses were
As of
About
Forward-Looking Statements
This press release contains forward-looking statements 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, including statements regarding Apexigen’s ability to provide innovative oncology solutions, meet the needs of patients and provide meaningful clinical benefits; the potential attributes, uses and effectiveness of its lead candidate sotigalimab; Apexigen’s pursuit of strategic partnerships; Apexigen’s plans with respect to its clinical trials; Apexigen’s cash runway. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements contained in this press release are based on certain assumptions and analyses made by Apexigen’s management in light of their respective experience and their perception of historical trends, current conditions and expected future developments and their potential effects on
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
2022 |
2021 |
|||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 12,708 | $ | 23,443 | ||||
Short-term investments | 7,965 | 12,917 | ||||||
Prepaid expenses and other current assets | 2,544 | 1,681 | ||||||
Deferred financing costs, current | 1,776 | - | ||||||
Total current assets | 24,993 | 38,041 | ||||||
Property and equipment, net | 176 | 245 | ||||||
Right-of-use assets | 198 | 483 | ||||||
Deferred financing costs, non-current | 1,480 | - | ||||||
Other assets | 727 | 327 | ||||||
Total assets | $ | 27,574 | $ | 39,096 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 3,340 | $ | 4,487 | ||||
Accrued liabilities | 7,096 | 8,488 | ||||||
Liability for common stock to be issued | 1,350 | - | ||||||
Deferred revenue | 5,137 | 3,610 | ||||||
Lease liabilities, current portion | 210 | 369 | ||||||
Total current liabilities | 17,133 | 16,954 | ||||||
Derivative warrant liabilities | 28 | - | ||||||
Lease liabilities, less current portion | - | 141 | ||||||
Total liabilities | 17,161 | 17,095 | ||||||
Stockholders’ equity: | ||||||||
Common stock, |
2 | 2 | ||||||
Additional paid-in capital | 180,778 | 166,727 | ||||||
Accumulated deficit | (170,362 | ) | (144,724 | ) | ||||
Accumulated other comprehensive loss | (5 | ) | (4 | ) | ||||
Total stockholders’ equity | 10,413 | 22,001 | ||||||
Total liabilities and stockholders’ equity | $ | 27,574 | $ | 39,096 |
(1) The condensed balance sheet as of
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
(Unaudited)
Three Months Ended |
Nine Months Ended |
|||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 5,683 | $ | 5,501 | $ | 18,796 | $ | 15,122 | ||||||||
General and administrative | 3,116 | 1,807 | 7,240 | 5,735 | ||||||||||||
Total operating expenses | 8,799 | 7,308 | 26,036 | 20,857 | ||||||||||||
Loss from operations | (8,799 | ) | (7,308 | ) | (26,036 | ) | (20,857 | ) | ||||||||
Other income, net | 307 | 7 | 398 | 34 | ||||||||||||
Net loss | $ | (8,492 | ) | $ | (7,301 | ) | $ | (25,638 | ) | $ | (20,823 | ) | ||||
Net loss per share | $ | (0.41 | ) | $ | (0.40 | ) | $ | (1.36 | ) | $ | (1.16 | ) | ||||
Weighted-average common shares used to compute net loss per share, basic and diluted | 20,484,136 | 18,040,783 | 18,895,417 | 18,028,234 | ||||||||||||
Investor Contact:
+1-646-889-1200
bmackle@lifesciadvisors.com
Apexigen Contact:
Chief Financial Officer
+1-650-931-6236
ir@apexigen.com
Source: Apexigen