8-K
Forte Biosciences, Inc. (FBRX)
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): November 10, 2022
FORTE BIOSCIENCES, INC.
(Exact name of Registrant as Specified in Its Charter)
| Delaware | 001-38052 | 26-1243872 |
|---|---|---|
| (State or Other Jurisdiction<br> <br>of Incorporation) | (Commission<br> <br>File Number) | (IRS Employer<br> <br>Identification No.) |
| 3060 Pegasus Park Dr.<br> <br>Building 6<br> <br>Dallas, Texas | 75247 | |
| --- | --- | |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s Telephone Number, Including Area Code: (310) 618-6994
Not Applicable
(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<br> <br>Symbol(s) | Name of each exchange<br> <br>on which registered |
|---|---|---|
| Common Stock, $0.001 par value | FBRX | The NASDAQ Stock Market LLC |
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 ☒
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 November 14, 2022, Forte Biosciences, Inc. (the “Company”) issued a press release reporting its financial results for the quarter ended September 30, 2022. A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.
The information furnished in this Current Report under Item 2.02 and the exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
| Item 5.02. | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
|---|
Appointment of Director
On November 10, 2022, the Board of Directors (the “Board) of the Company, upon recommendation of the Nominating and Governance Committee of the Board, appointed Scott Brun, M.D. to the Board, effective November 10, 2022. Dr. Brun will serve as a Class II director, with a term expiring at the annual meeting of stockholders to be held in 2025. In addition, the Board appointed Dr. Brun as a member of the Compensation Committee of the Board.
Dr. Brun, 54, is currently President at Gold Mast Consulting, LLC, an advisory firm he founded to provide technical advice and strategic guidance related to biopharmaceutical research and development, pipeline portfolio management, commercialization of new therapeutics and strategic communications related to R&D activities. Dr. Brun is also a Senior Advisor to the business development team at Horizon Therapeutics plc (Nasdaq: HZNP), a Venture Partner at Abingworth LLP, and a Senior Medical Advisor at Launch Therapeutics. Prior to his current roles, Dr. Brun had two decades of experience in various leadership roles at AbbVie, Inc., including 15 years at the predecessor company, Abbott Laboratories. He was most recently Vice President of Scientific Affairs and Head of AbbVie Ventures, a corporate venture fund responsible for investment opportunities within AbbVie’s R&D therapeutic areas as well as technology platforms of interest from March 2016 to March 2019. Previously, Dr. Brun served as Vice President and Head of Pharmaceutical Development at AbbVie from November 2012 to March 2016. Prior to joining AbbVie, Dr. Brun spent over 15 years at Abbott Laboratories, where he held positions of increasing leadership responsibility in drug development within the R&D organization. Dr. Brun is a member of the board of directors of Cabaletta Bio, Inc. (Nasdaq: CABA), a biopharmaceutical company. Dr. Brun is also a member of the board of directors of Axial Biotherapeutics, Inc. and Trishula Therapeutics, Inc., both private, clinical-stage biopharmaceutical companies. Dr. Brun received his B.S. in Biochemistry from the University of Illinois at Urbana-Champaign and earned his M.D. from the Johns Hopkins University School of Medicine. He completed his residency in ophthalmology at the Massachusetts Eye and Ear Infirmary, Harvard Medical School.
Dr. Brun will be compensated in accordance with the Company’s amended and restated non-employee director compensation policy (the “Policy”). Pursuant to the Policy, Dr. Brun will be entitled to receive $40,000 per year for service as a member of the Board and $6,000 per year for service as a member of the Compensation Committee, each paid quarterly in arrears on a pro-rata basis.
In connection with his appointment to the Board as a non-employee director and pursuant to the Company’s 2021 Equity Incentive Plan and the Policy, Dr. Brun also automatically received a stock option for 50,000 shares of Common Stock of the Company, which will vest in equal monthly installments over a three year period such that the option is fully vested on the third anniversary of the date of grant, subject to Dr. Brun’s continued service on the Board through each applicable vesting date.
Dr. Brun has entered into the Company’s standard form of indemnification agreement, a copy of which has been filed as Exhibit 10.1 of the Company’s Registration Statement on Form S-1 (File No. 333-216574), as amended, originally filed on March 9, 2017.
There is no arrangement or understanding between Dr. Brun and any other persons pursuant to which Dr. Brun was elected as a director. There are no family relationships between Dr. Brun and any of the Company’s directors or executive officers.
Board Committees
In connection with the appointment of Dr. Brun to the Board, the Board approved reconfiguration of the Board committees such that they are comprised as follows, in each case effective as of November 10, 2022: (i) the Compensation Committee is comprised of Steven Kornfeld (Chair), Stephen K. Doberstein, Lawrence Eichenfield and Dr. Brun, (ii) the Nominating and Corporate Governance Committee is comprised of Mr. Kornfeld (Chair), Barbara K. Finck, and Donald A. Williams, and (iii) the Audit Committee continues to consist of Mr. Williams (Chair), Mr. Kornfeld and Patricia Walker.
| Item 7.01. | Regulation FD Disclosure. |
|---|
On November 14, 2022, the Company issued a press release announcing the appointment of Dr. Brun as a director. A copy of the press release is furnished herewith as Exhibit 99.2.
The information furnished in this Current Report under Item 2.02 and the exhibit attached hereto shall not be deemed “filed” for purposes of the Exchange Act, or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, 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 dated November 14, 2022 announcing the Company’s financial results for the period ended September 30, 2022 |
| 99.2 | Press Release dated November 14, 2022 announcing the appointment of Scott Brun to the board of directors |
| 104 | The cover page of this Current Report on Form 8-K, formatted in inline XBRL |
SIGNATURES
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.
| FORTE BIOSCIENCES, INC. | ||
|---|---|---|
| Date: November 14, 2022 | By: | /s/ Antony Riley |
| Antony Riley | ||
| Chief Financial Officer |
EX-99.1
Exhibit 99.1
FORTE BIOSCIENCES, INC. ANNOUNCES THIRD QUARTER 2022 RESULTS AND PROVIDES BUSINESS UPDATE
-FB-102 Continues to Advance Towards the Clinic and Holds Significant Market Potential Across aVariety of Indications
-Leadership Strengthened with the Appointment of Scott Brun, M.D. to the Board of Directors-
-Ended third quarter 2022 with approximately $44.0 million in cash and cash equivalents-
DALLAS, TX – NOVEMBER 14, 2022 – Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a biopharmaceutical company focused on autoimmune diseases, today announced third quarter 2022 results and provided a business update.
“Forte is making excellent progress with its lead program FB-102, which is a direct result of the team’s hard work and diligent efforts. FB-102 holds significant potential in a variety of indications with market potential in excess of $6 billion.” said Paul Wagner, Ph.D., Chairman and Chief Executive Officer of Forte Biosciences. “FB-102 is expected to be in the clinic late 2023 or early 2024. Beyond FB-102, the Forte team continues to explore additional opportunities for pipeline development to drive long-term value creation.”
Third Quarter 2022 Business Highlights
In November 2022, Forte appointed Scott Brun, M.D. to its board of directors, which further strengthened Forte’s board of directors. Dr. Brun is currently a Venture Partner at Abingworth and in addition to his consulting practice, he is also a Senior Advisor for Horizon Therapeutics, and a Senior Medical Advisor at Launch Therapeutics. Dr. Brun previously served in numerous executive capacities at AbbVie most recently as Head of AbbVie Ventures, and previously as Head of Pharmaceutical Development. Dr Brun received his M.D. at The Johns Hopkins University School of Medicine.
“Given Dr. Brun’s extensive experience in pharmaceutical product development, R&D and scientific affairs, his agreeing to join our board is pivotal for Forte. We are extremely fortunate to have board members of Dr. Brun’s caliber join the team to help guide the pipeline development.” said Paul Wagner, Ph.D., Forte’s Chairman and CEO.
Forte ended the third quarter of 2022 with approximately $44.0 million in cash and cash equivalents. Forte had approximately 21.0 million shares of common stock outstanding as of September 30, 2022.
Third Quarter 2022 Operating Results
Research and development expenses were $1.4 million and $5.7 million for the three months ended September 30, 2022 and 2021, and $3.1 million and $12.5 million for the nine months ended September 30, 2022 and 2021, respectively. The decreases in 2022 were primarily due to the wind down of our FB- 401 program as the Company began the shift in development activities to autoimmune indications with FB-102. While research and development expenses decreased in 2022 compared to 2021, we anticipate research and development expenses to increase in the future as we continue to develop our current lead product candidate, FB-102.
General and administrative expenses were $2.0 million for the three months ended September 30, 2022 and 2021. General and administrative expenses remained relatively flat as an increase in legal and professional expenses of $0.4 million was mostly offset by a decrease of approximately $0.4 million in payroll and related expenses. General and administrative expenses were $5.9 million and $5.7 million for the nine months ended September 30, 2022 and 2021, respectively. The increase of $0.2 million was primarily due to an increase in stock-based compensation expenses.
Net losses per share were ($0.18) and ($0.54) for the three months ended September 30, 2022 and 2021, and ($0.56) and ($1.34) for the nine months ended September 30, 2022 and 2021, respectively.
Balance Sheets
FORTE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and par value data)
| December 31, 2021 | |||||
|---|---|---|---|---|---|
| Assets | |||||
| Current assets: | |||||
| Cash and cash equivalents | 44,048 | $ | 42,044 | ||
| Prepaid expenses and other current assets | 546 | 476 | |||
| Total current assets | 44,594 | 42,520 | |||
| Other assets | 534 | 786 | |||
| Total assets | 45,128 | **** | $ | 43,306 | **** |
| Liabilities, convertible preferred stock and stockholders’ equity | |||||
| Current liabilities: | |||||
| Accounts payable | 1,191 | $ | 946 | ||
| Accrued liabilities | 1,102 | 812 | |||
| Total current liabilities | 2,293 | 1,758 | |||
| Commitments and contingencies (Note 4) | |||||
| Series A Convertible Preferred Stock, 0.001 par value; 10,000,000<br>shares authorized and 0 shares issued and outstanding as of September 30, 2022 (unaudited) and December 31,<br>2021; aggregate liquidation preference of 0 as of September 30, 2022 (unaudited) and December 31, 2021 | — | — | |||
| Stockholders’ equity | |||||
| Common stock, 0.001 par value: 200,000,000 shares authorized as of September 30, 2022<br>(unaudited) and December 31, 2021; 21,000,069 and 14,754,447 shares issued and outstanding as of September 30, 2022 (unaudited) and December 31, 2021, respectively | 21 | 15 | |||
| Additional paid-in capital | 124,981 | 114,698 | |||
| Accumulated deficit | (82,167 | ) | (73,165 | ) | |
| Total stockholders’ equity | 42,835 | 41,548 | |||
| Total liabilities, convertible preferred stock and stockholders’ equity | 45,128 | **** | $ | 43,306 | **** |
All values are in US Dollars.
Statements of Operations
FORTE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(inthousands, except share and per share amounts)
| For the Three Months EndedSeptember 30, | For the Nine Months EndedSeptember 30, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | 2022 | 2021 | |||||||||
| Operating expenses: | ||||||||||||
| Research and development | $ | 1,379 | $ | 5,656 | $ | 3,106 | $ | 12,501 | ||||
| General and administrative | 2,044 | 2,043 | 5,851 | 5,686 | ||||||||
| Total operating expenses | 3,423 | 7,699 | 8,957 | 18,187 | ||||||||
| Loss from operations | (3,423 | ) | (7,699 | ) | (8,957 | ) | (18,187 | ) | ||||
| Other income (expense), net | 23 | (52 | ) | (45 | ) | (180 | ) | |||||
| Net loss | $ | (3,400 | ) | $ | (7,751 | ) | $ | (9,002 | ) | $ | (18,367 | ) |
| Per share information: | ||||||||||||
| Net loss per share - basic and diluted | $ | (0.18 | ) | $ | (0.54 | ) | $ | (0.56 | ) | $ | (1.34 | ) |
| Weighted average shares outstanding, basic and diluted | 18,927,446 | 14,241,220 | 16,164,770 | 13,702,727 |
Additional detail on our financial results for the third quarter of 2022 can be found in Forte’s Form 10-Q as filed with the SEC on November 14, 2022. You can also find more information in the investor relations section of our website at www.fortebiorx.com.
About Forte
Forte Biosciences, Inc. is a biopharmaceutical company and the lead product, FB-102, is a proprietary molecule with potentially broad autoimmune applications.
Forward Looking Statements
Forte cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the Company’s current beliefs and expectations. Forward looking statements include statements regarding Forte’s beliefs, goals, intentions and expectations regarding its product candidates. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: risks related to Forte’s ability to obtain sufficient additional capital to continue to advance Forte’s product candidates and preclinical programs; results from early-preclinical studies may not be predictive of results from later-stage studies or clinical trials; uncertainties associated with the clinical development and regulatory approval of Forte’s product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; the risk that interim results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; the risk that unforeseen
adverse reactions or side effects may occur in the course of developing and testing product candidates; risks associated with the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; and risks related to the impact of the COVID-19 outbreak on Forte’s operations, the biotechnology industry and the economy generally. Information on these and additional risks, uncertainties, and other information affecting Forte’s business and operating results is contained in Forte’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 as filed with the Securities and Exchange Commission on November 14, 2022 and in its other filings with the Securities and Exchange Commission. All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Forte undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contact:
LifeSci Advisors
Mike Moyer, Managing Director
mmoyer@lifesciadvisors.com
EX-99.2
Exhibit 99.2
DR. SCOTT BRUN, M.D. APPOINTEED TO FORTE BIOSCIENCES BOARD OF DIRECTORS
-Forte Leadership is Significantly Strengthened with the Appointment of Dr. Scott Brun, M.D. to the Board of Directors
DALLAS, TX – NOVEMBER 14, 2022 – Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), announced today that Dr. Scott Brun, M.D. has been appointed to the Forte Biosciences Board of Directors.
Dr. Brun is currently a Venture Partner at Abingworth and in addition to his consulting practice, he is also a Senior Advisor for Horizon Therapeutics, and a Senior Medical Advisor at Launch Therapeutics. Dr. Brun previously served in numerous executive capacities at AbbVie, most recently as Head of AbbVie Ventures. In Dr. Brun’s previous role as Head of Product Development at Abbvie, he led the global organization responsible for the development of AbbVie’s portfolio of early and late-stage clinical preregistration pipeline compounds as well as marketed compounds across a range of therapeutic areas. Dr Brun received his M.D. at The Johns Hopkins University School of Medicine.
Dr. Brun commented, “I am excited to join Paul as well as the Board and leadership team of Forte as they continue to drive forward with their development plans for FB-102 for a number of autoimmune disorders which currently have limited options available.”
“We are extremely fortunate to have board members of Dr. Brun’s caliber join the team to help guide the pipeline development. We are all excited to work with Scott to help drive long term value for Forte.” said Forte’s chairman and CEO Paul Wagner, Ph.D.
About Forte
Forte Biosciences, Inc. is a biopharmaceutical company and the lead product, FB-102, is a proprietary molecule with potentially broad autoimmune applications.
Forward Looking Statements
Forte cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the Company’s current beliefs and expectations. Forward looking statements include statements regarding Forte’s beliefs, goals, intentions and expectations regarding its product candidates. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: risks related to Forte’s ability to obtain sufficient additional capital to continue to advance Forte’s product candidates and preclinical programs; results from early-preclinical studies may not be predictive of results from later-stage studies or clinical trials; uncertainties associated with the clinical development and regulatory approval of Forte’s product candidates, including potential delays in the commencement, enrollment and completion of clinical trials;
the risk that interim results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; the risk that unforeseen adverse reactions or side effects may occur in the course of developing and testing product candidates; risks associated with the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; and risks related to the impact of the COVID-19 outbreak on Forte’s operations, the biotechnology industry and the economy generally. Information on these and additional risks, uncertainties, and other information affecting Forte’s business and operating results is contained in Forte’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 as filed with the Securities and Exchange Commission on November 14, 2022 and in its other filings with the Securities and Exchange Commission. All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Forte undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contact:
LifeSci Advisors
Mike Moyer, Managing Director
mmoyer@lifesciadvisors.com