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
November 14, 2019
Date of report (Date of earliest event reported)
Aprea Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
|
Delaware |
|
001-39069 |
|
84-2246769 |
|
(State or other jurisdiction |
|
(Commission |
|
(IRS Employer |
|
535 Boylston Street |
|
02116 |
Registrant’s telephone number, including area code: (617) 463-9385
(Former name or former address, if changed since last report): Not applicable
Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425).
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12).
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)).
o 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 exchange on which registered: |
|
Common stock, par value $0.001 per share |
|
APRE |
|
NASDAQ Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company 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 x
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. x
Item 2.02 Results of Operations and Financial Condition
On November 14, 2019, the Company issued a press release announcing its financial results for the third quarter ended September 30, 2019 and an update on the Company’s operations for the same period. The Company is furnishing a copy of the press release, which is attached hereto as Exhibit 99.1.
In accordance with General Instruction B.2 of Form 8-K, the information included in this Item 2.02, including Exhibit 99.1 hereto, shall not be deemed “filed” for the 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 into any filing made by the Company under the Exchange Act or Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
|
Exhibit |
|
Description |
|
99.1 |
|
Press release issued by Aprea Therapeutics, Inc. dated November 14, 2019. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
Aprea Therapeutics, Inc. | |
|
|
| |
|
|
|
|
|
Dated: November 14, 2019 |
By: |
/s/ Scott Coiante |
|
|
Name: |
Scott Coiante |
|
|
Title: |
Senior Vice President and Chief Financial Officer |
Aprea Therapeutics Reports Third Quarter 2019 Financial Results
BOSTON, MA., Nov. 14, 2019 (GLOBE NEWSWIRE) — Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today reported financial results for the three and nine months ended September 30, 2019 and provided a corporate update.
Third quarter 2019 Corporate Update:
APR-246 Update
Earlier this month, the Company announced that it will present updated data from two Phase 1b/2 clinical studies at the 61st American Society of Hematology Annual Meeting (ASH) on December 9, 2019. Data from the U.S. Phase 1b/2 trial and interim results from the French Phase 1b/2 trial of the Company’s lead product candidate APR-246 in combination with Azacitidine (AZA) in patients with TP53 mutant Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) were both chosen for oral presentations at ASH. The titles of the oral presentations are:
· “Phase 2 Results of APR-246 and Azacitidine (AZA) in Patients with TP53 mutant Myelodysplastic Syndromes (MDS) and Oligoblastic Acute Myeloid Leukemia (AML)”; and
· “APR-246 combined with Azacitidine (AZA) in TP53 mutated myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). A phase 2 study by Groupe Francophone des Myélodysplasies (GFM)”
The Company will host a Clinical Update Meeting and Webcast on December 9, 2019 at 12:00 PM ET. This Clinical Update meeting will be webcast live and can be accessed from “Events Calendar” in the News and Events section of the Company’s website at https://ir.aprea.com/
Initial Public Offering
On October 7, 2019, Aprea completed its initial public offering (IPO) of 6,516,667 shares of its common stock at a price to the public of $15.00 per share, which included the exercise in full by the underwriters of their option to purchase an additional 850,000 shares of common stock. The Company received gross proceeds, before deducting underwriting discounts and commissions and other offering expenses, of approximately $97.75 million.
Third Quarter Financial Results
· Cash and cash equivalents: As of September 30, 2019, prior to completing its IPO on October 7, 2019, Aprea had $52.3 million of cash and cash equivalents compared to $65.7 million of cash and cash equivalents as of December 31, 2018. In October 2019, the Company completed the sale of 6,516,667 shares of common stock in an initial public offering resulting in gross proceeds of approximately $97.75 million. The Company believes its cash and cash equivalents as of September 30, 2019 along with the proceeds received from its initial public offering will be sufficient to meet its current projected operating requirements into 2023.
· Research and Development (R&D) expenses: R&D expenses were $4.9 million for the quarter ended September 30, 2019, compared to $2.3 million for the comparable period in 2018. The increase in R&D expenses was primarily related to the advancement of the Company’s lead product candidate, APR-246. In Q1 2019 the Company commenced a pivotal Phase 3 clinical trial of APR-246 with azacitidine for frontline treatment of TP53 mutant MDS which is supported by two ongoing Phase 1b/2 investigator initiated trials, one in the U.S. and one in France, testing APR-246 with azacitidine as frontline treatment in TP53 mutant MDS and AML patients.
· General and Administrative (G&A) expenses: G&A expenses were $2.3 million for the quarter ended September 30, 2019, compared to $0.6 million for the comparable period in 2018. The increase in G&A expenses was primarily due to increased professional fees of approximately $1.3 million associated with preparation for the Company’s IPO, which was completed in October 2019, as well as increased personnel costs of $0.3 million.
· Net loss: Net loss was $6.2 million for the quarter ended September 30, 2019, compared to a net loss of $3.1 million for the quarter ended September 30, 2018.
About Aprea Therapeutics, Inc.
Aprea Therapeutics, Inc. is a biopharmaceutical company headquartered in Boston, Massachusetts with research facilities in Stockholm, Sweden, focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53. The Company’s lead product candidate is APR-246, a small molecule in clinical development for hematologic malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). For more information, please visit the company website at www.aprea.com.
The Company may use, and intends to use, its investor relations website at www.ir.aprea.com as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.
Forward-Looking Statement
Certain information contained in this press release includes “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, related to our clinical trials, regulatory submissions and projected cash position. We may, in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties. Any or all of the forward-looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward looking statements are subject to risks and uncertainties including risks related to the success and timing of our clinical trials or other studies and the other risks set forth in our filings with the U.S. Securities and Exchange Commission, including our Registration Statement on Form S-1 (File No. 333-233662) and our Quarterly Report on Form 10-Q. For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
Source: Aprea Therapeutics
Corporate Contacts:
Scott M. Coiante
Sr. Vice President and Chief Financial Officer
617-463-9385
Gregory A. Korbel
Vice President of Business Development
617-463-9385
Aprea Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
|
|
|
September 30, |
|
December 31, |
| ||
|
Assets |
|
|
|
|
| ||
|
Current assets: |
|
|
|
|
| ||
|
Cash and cash equivalents |
|
$ |
52,334,102 |
|
$ |
65,675,931 |
|
|
Deferred offering costs |
|
4,070,690 |
|
— |
| ||
|
Prepaid expenses and other current assets |
|
339,814 |
|
322,146 |
| ||
|
Total current assets |
|
56,744,606 |
|
65,998,077 |
| ||
|
Property and equipment, net |
|
31,032 |
|
24,450 |
| ||
|
Right of use lease asset |
|
560,318 |
|
— |
| ||
|
Other noncurrent assets |
|
102 |
|
111 |
| ||
|
Total assets |
|
$ |
57,336,058 |
|
$ |
66,022,638 |
|
|
Liabilities, Convertible Preferred Stock and Stockholders’ Deficit |
|
|
|
|
| ||
|
Current liabilities: |
|
|
|
|
| ||
|
Accounts payable |
|
$ |
3,510,105 |
|
$ |
1,739,337 |
|
|
Accrued expenses |
|
5,847,364 |
|
3,128,772 |
| ||
|
Lease liability—current |
|
226,852 |
|
— |
| ||
|
Total current liabilities |
|
9,584,321 |
|
4,868,109 |
| ||
|
Lease liability—noncurrent |
|
358,404 |
|
— |
| ||
|
Total liabilities |
|
9,942,725 |
|
4,868,109 |
| ||
|
Commitments and contingencies |
|
|
|
|
| ||
|
Convertible preferred stock: |
|
|
|
|
| ||
|
Series A convertible preferred stock, $0.001 par value; 612,446 shares issued and outstanding at September 30, 2019 and December 31, 2018 (liquidation preference of $6,483,044 at September 30, 2019) |
|
6,483,044 |
|
6,483,044 |
| ||
|
Series B convertible preferred stock, $0.001 par value; 7,235,969 shares issued and outstanding at September 30, 2019 and December 31, 2018 (liquidation preference of $62,288,856 at September 30, 2019) |
|
49,742,942 |
|
49,742,942 |
| ||
|
Series C convertible preferred stock, $0.001 par value; 5,179,877 and 4,712,698 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively (liquidation preference of $66,451,815 at September 30, 2019) |
|
61,963,007 |
|
56,364,645 |
| ||
|
Total convertible preferred stock |
|
118,188,993 |
|
112,590,631 |
| ||
|
Stockholders’ equity (deficit): |
|
|
|
|
| ||
|
Common stock, par value $0.001 at September 30, 2019 and $0.11 at December 31, 2018; 1,181,733 and 1,155,366, shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively. |
|
1,182 |
|
127,091 |
| ||
|
Additional paid-in capital |
|
20,346,849 |
|
19,666,588 |
| ||
|
Accumulated other comprehensive loss |
|
(13,688,166 |
) |
(8,761,325 |
) | ||
|
Accumulated deficit |
|
(77,455,525 |
) |
(62,468,456 |
) | ||
|
Total stockholders’ deficit |
|
(70,795,660 |
) |
(51,436,102 |
) | ||
|
Total liabilities, convertible preferred stock and stockholders’ deficit |
|
$ |
57,336,058 |
|
$ |
66,022,638 |
|
Aprea Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
|
|
|
Three Months Ended |
|
Nine Months Ended September 30, |
| ||||||||
|
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
| ||||
|
Operating expenses: |
|
|
|
|
|
|
|
|
| ||||
|
Research and development |
|
$ |
4,910,409 |
|
$ |
2,307,022 |
|
$ |
12,908,679 |
|
$ |
9,799,811 |
|
|
General and administrative |
|
2,307,946 |
|
623,702 |
|
4,655,861 |
|
1,790,222 |
| ||||
|
Total operating expenses |
|
7,218,355 |
|
2,930,724 |
|
17,564,540 |
|
11,590,033 |
| ||||
|
Other income (expense): |
|
|
|
|
|
|
|
|
| ||||
|
Interest expense |
|
(6,098 |
) |
4 |
|
(13,537 |
) |
(184 |
) | ||||
|
Foreign currency gain (loss) |
|
975,034 |
|
(207,542 |
) |
2,591,008 |
|
741,616 |
| ||||
|
Total other income (expense) |
|
968,936 |
|
(207,538 |
) |
2,577,471 |
|
741,432 |
| ||||
|
Net loss |
|
$ |
(6,249,419 |
) |
$ |
(3,138,262 |
) |
$ |
(14,987,069 |
) |
$ |
(10,848,601 |
) |
|
Other comprehensive loss: |
|
|
|
|
|
|
|
|
| ||||
|
Foreign currency translation |
|
(2,940,174 |
) |
65,800 |
|
(4,926,841 |
) |
(1,110,408 |
) | ||||
|
Total comprehensive loss |
|
(9,189,593 |
) |
(3,072,462 |
) |
(19,913,910 |
) |
(11,959,009 |
) | ||||
|
Net loss per share attributable to common stockholders, basic and diluted |
|
$ |
(5.29 |
) |
$ |
(2.72 |
) |
$ |
(12.72 |
) |
$ |
(9.40 |
) |
|
Weighted average basic and diluted shares of common stock outstanding |
|
1,181,726 |
|
1,154,573 |
|
1,178,206 |
|
1,154,264 |
| ||||