Exhibit 99.3
UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL STATEMENTS
On July 26, 2023, Ayala Pharmaceuticals, Inc. (“Ayala” or “Company”), and its wholly owned subsidiary organized under the laws of the State of Israel, Advaxis Israel Ltd. (“Biosight Merger Sub”), entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”) with Biosight Ltd. (“Biosight”), a privately-held Israeli pharmaceutical company developing innovative therapeutics for hematological malignancies and disorders. Under the terms of the Merger Agreement on October 18, 2023, the Merger Sub merged with and into Biosight, which is now a wholly owned subsidiary of the Company (the “Merger”). Upon completion of the Merger, Ayala’s then-current equity holders own approximately 45% and the former Biosight equity holders own approximately 55% of Ayala’s common stock.
The following unaudited pro forma condensed combined financial information is presented to illustrate the effect of the Merger based on the historical financial position and historical results of operations of Ayala and Biosight. All dollar amounts, except per share, are in thousands. It is presented as follows:
| ● | The unaudited pro forma condensed combined balance sheet as of September 30, 2023 was prepared based on (i) the historical unaudited condensed consolidated balance sheet of Ayala as of September 30, 2023 and (ii) the historical unaudited condensed consolidated balance sheet of Biosight as of September 30, 2023. |
| ● | The unaudited pro forma condensed combined statement of operations for the year ended December 31, 2022 was prepared based on (i) the unaudited pro forma combined statement of operations of Ayala for the year ended December 31, 2022 as presented in exhibit 99.2 to Form 8-K/A filed with the SEC on April 6, 2023 (such statement of operations adjusted for the acquisition of Old Ayala, Inc. (as defined in the April 6, 2023 Form 8-K/A) and (ii) the historical audited consolidated statement of operations of Biosight for the year ended December 31, 2022. |
| ● | The unaudited pro forma condensed combined statement of operations for the nine months ended September 30, 2023 was prepared based on (i) the historical unaudited condensed statement of operations of Ayala for the nine months ended September 30, 2023 and (ii) the historical unaudited consolidated statement of operations of Biosight for the nine months ended September 30, 2023. |
The unaudited pro forma condensed combined financial information set forth below primarily gives effect to the following:
| ● | the consummation of the Merger; |
| ● | the fair value adjustment of Biosight’s assets and liabilities assumed in connection with the merger in accordance with U.S. GAAP; |
| ● | transaction costs incurred in connection with the Merger. |
Assumptions underlying the pro forma adjustments are described in the accompanying notes, which should be read in conjunction with the unaudited pro forma condensed combined financial information. The unaudited pro forma condensed combined balance sheet data gives effect to the Merger as if it had occurred on September 30, 2023. The unaudited pro forma condensed combined statements of operations data gives effect to the Merger as if it had occurred on January 1, 2022.
The unaudited pro forma condensed combined financial information and the accompanying notes are provided for informational and illustrative purposes only, and was derived from and should be read in conjunction with the following historical financial statements, pro forma and the related notes of Ayala and Biosight:
| ● | Separate unaudited pro forma combined financial statements of Ayala adjusted for the acquisition of Old Ayala, Inc.) as of and for the year ended December 31, 2022 as presented in exhibit 99.2 to Form 8-K/A filed with the SEC on April 6, 2023 and unaudited financial statements of Ayala as of and for the nine months ended September 30, 2023 and the related notes include in Ayala’s Form 10-Q file on November 20, 2023. |
| ● | Separate historical audited financial statements of Biosight as of and for the year ended December 31, 2022 and financial statements of Biosight as of and for the nine months ended September 30, 2023 and the related notes included elsewhere in this Form 8-K. |
The unaudited pro forma condensed combined financial information does not purport to project the future financial condition and results of operations of the Company. The actual results of the Company may differ significantly from those reflected in the unaudited pro forma condensed combined financial information.
Unaudited Pro Forma Condensed Combined Balance Sheet
As of September 30, 2023
(in thousands)
| | Ayala Pharmaceuticals, Inc. | | | Biosight Ltd. | | | Pro Forma Adjustments | | | Pro Forma Combined | |
CURRENT ASSETS: | | | | | | | | | | | | | | | | |
Cash and cash equivalents | | $ | 2,123 | | | $ | 1,948 | | | $ | - | | | $ | 4,071 | |
Short-term bank deposits | | | 102 | | | | - | | | | - | | | | 102 | |
Prepaid Expenses and other current assets | | | 2,327 | | | | 151 | | | | - | | | | 2,478 | |
Total current assets | | | 4,552 | | | | 2,099 | | | | - | | | | 6,651 | |
LONG TERM ASSETS: | | | | | | | | | | | | | | | | |
Operating lease right of use asset | | | 1,276 | | | | - | | | | - | | | | 1,276 | |
Intangible asset, net | | | 107 | | | | - | | | | 3,800 | | 5A | | 3,907 | |
Goodwill | | | - | | | | - | | | | 2,351 | | 5A | | 2,351 | |
Property and equipment, net | | | 845 | | | | 64 | | | | - | | | | 909 | |
Other assets | | | 201 | | | | - | | | | - | | | | 201 | |
Total long-term assets | | | 2,429 | | | | 64 | | | | 6,151 | | | | 8,644 | |
Total assets | | $ | 6,981 | | | $ | 2,163 | | | $ | 6,151 | | | $ | 15,295 | |
LIABILITIES AND SHAREHOLDERS’ EQUITY: | | | | | | | | | | | | | | | | |
CURRENT LIABILITIES: | | | | | | | | | | | | | | | | |
Trade payables | | $ | 5,056 | | | $ | 1,399 | | | $ | - | | | $ | 6,455 | |
Operating lease liabilities | | | 480 | | | | - | | | | - | | | | 480 | |
Accrued expenses | | | 1,556 | | | | 333 | | | | 200 | | 5C | | 2,089 | |
Accrued payroll and employee benefits | | | 1,231 | | | | - | | | | - | | | | 1,231 | |
Other accounts payable | | | 204 | | | | - | | | | - | | | | 204 | |
Warrant liability | | | - | | | | 394 | | | | (394 | ) | 5D | | - | |
Safe | | | - | | | | 693 | | | | 375 | | 5B | | 1,068 | |
Total current liabilities | | | 8,527 | | | | 2,819 | | | | 181 | | | | 11,527 | |
LONG TERM LIABILITIES: | | | | | | | | | | | | | | | | |
Long-term warrant liability | | | 65 | | | | - | | | | - | | | | 65 | |
Convertible note | | | 2,068 | | | | - | | | | - | | | | 2,068 | |
Uncertain tax position | | | 1,630 | | | | - | | | | - | | | | 1,630 | |
Long-term operating lease liabilities | | | 932 | | | | - | | | | - | | | | 932 | |
Total non-current liabilities | | | 4,695 | | | | - | | | | - | | | | 4,695 | |
COMMITMENTS AND CONTINGENCIES: | | | | | | | | | | | | | | | | |
Redeemable convertible preferred shares | | | - | | | | 57,023 | | | | (57,023 | ) | 5E | | - | |
STOCKHOLDERS’ EQUITY (DEFICIENCY): | | | | | | | | | | | | | | | | |
Common stock | | | 5 | | | | 2 | | | | 4 | | 5F | | 11 | |
Additional paid-in capital | | | 166,307 | | | | 9,201 | | | | (3,693 | ) | 5F | | 171,815 | |
Accumulated deficit | | | (172,553 | ) | | | (66,882 | ) | | | 66,682 | | | | (172,753 | ) |
| | | - | | | | - | | | | (200 | ) | 5C | | | |
| | | - | | | | - | | | | 66,882 | | 5F | | | |
Total shareholders’ equity (deficiency) | | | (6,241 | ) | | | (57,679 | ) | | | 62,993 | | | | (927 | ) |
Total liabilities and shareholders’ equity (deficiency) | | $ | 6,981 | | | $ | 2,163 | | | $ | 6,151 | | | $ | 15,295 | |
Unaudited Pro Forma Condensed Combined Statement of Operations
Year ended December 31, 2022
(in thousands except per share and share data)
| | Ayala Pharmaceuticals, Inc. Pro Forma Fincncial Information (adjusted for acquisition of Old Ayala, Inc.) | | | Biosight Ltd. | | | Pro Forma Adjustments | | | Pro Forma Combined | |
Revenue | | $ | 942 | | | $ | - | | | $ | - | | | $ | 942 | |
Cost of services | | | (602 | ) | | | - | | | | - | | | | (602 | ) |
Gross profit | | | 340 | | | | - | | | | - | | | | 340 | |
Operating expenses: | | | | | | | | | | | | | | | | |
Research and development | | | 35,467 | | | | 7,708 | | | | - | | | | 43,175 | |
General and administrative | | | 21,978 | | | | 2,262 | | | | 200 | | 6A | | 24,440 | |
Total operating expenses | | | (57,445 | ) | | | (9,970 | ) | | | (200 | ) | | | (67,615 | ) |
Loss from operations | | | (57,105 | ) | | | (9,970 | ) | | | (200 | ) | | | (67,275 | ) |
Other income (expense): | | | | | | | | | | | | | | | | |
Interest income | | | 231 | | | | 1 | | | | - | | | | 232 | |
Net changes in fair value of derivative liabilities | | | 4,853 | | | | 10,461 | | | | (10,461 | ) | 6B | | 4,853 | |
Finance expenses | | | - | | | | (178 | ) | | | - | | | | (178 | ) |
Other expense | | | (9 | ) | | | - | | | | - | | | | (9 | ) |
Loss before income tax | | | (52,030 | ) | | | 314 | | | | (10,661 | ) | | | (62,377 | ) |
Taxes on income | | | 634 | | | | - | | | | - | | | | 634 | |
Net loss | | $ | (52,664 | ) | | $ | 314 | | | $ | (10,661 | ) | | $ | (63,011 | ) |
Accretion of discount and redemption feature of convertible preferred stock | | | (1,025 | ) | | | - | | | | - | | | | (1,025 | ) |
Income available to common stockholders | | $ | (53,689 | ) | | $ | 314 | | | $ | (10,661 | ) | | $ | (64,036 | ) |
| | | | | | | | | | | | | | | | |
Net income (loss) per share basic & diluted | | $ | (10.83 | ) | | | | | | | | | | $ | (5.89 | ) |
Weighted average number of common shares outstanding basic & diluted | | | 4,957,273 | | | | | | | | | | | | 10,870,753 | |
Unaudited Pro Forma Condensed Combined Statement of Operations
Nine months ended September 30, 2023
(in thousands except per share and share data)
| | Ayala Pharmaceuticals, Inc. | | | Biosight Ltd. | | | Pro Forma Adjustments | | | Pro Forma Combined | |
Revenue | | $ | 13 | | | $ | - | | | $ | - | | | $ | 13 | |
Cost of services | | | (13 | ) | | | - | | | | - | | | | (13 | ) |
Gross profit | | | - | | | | - | | | | - | | | | - | |
Operating expenses: | | | | | | | | | | | | | | | | |
Research and development | | | 18,671 | | | | 5,668 | | | | - | | | | 24,339 | |
General and administrative | | | 8,815 | | | | 1,642 | | | | - | | | | 10,457 | |
Loss from operations | | | (27,486 | ) | | | (7,310 | ) | | | - | | | | (34,796 | ) |
Other income (expense): | | | | | | | | | | | | | | | | |
Gain from change in fair value of warrants | | | - | | | | 1,842 | | | | (1,842 | ) | 6B | | - | |
Financial (loss) income, net | | | 72 | | | | (87 | ) | | | - | | | | (15 | ) |
Loss before income tax | | | (27,414 | ) | | | (5,555 | ) | | | (1,842 | ) | | | (34,811 | ) |
Taxes on income | | | 4,015 | | | | - | | | | - | | | | 4,015 | |
Net loss | | $ | (23,399 | ) | | $ | (5,555 | ) | | $ | (1,842 | ) | | $ | (30,796 | ) |
| | | | | | | | | | | | | | | | |
Net income (loss) per share basic & diluted | | $ | (5.03 | ) | | | | | | | | | | $ | (2.92 | ) |
Weighted average number of common shares outstanding basic & diluted | | | 4,648,599 | | | | | | | | | | | | 10,562,079 | |
Notes to the Unaudited Pro Forma Financial Statements:
(dollars in thousands, except share and per share amounts)
1. Description of the Merger
On July 26, 2023, Biosight entered into the Merger Agreement with Ayala and Merger Sub, pursuant to which Merger Sub will merge with and into Biosight, with Biosight as the surviving corporation and becoming a wholly-owned subsidiary of Ayala. The Merger closed on October 18, 2023. Upon closing, Ayala issued an aggregate of 5,913,480 shares of its common stock to Biosight shareholders, which resulted in pre-Merger Ayala stockholders owning approximately 45% of the combined company and Biosight stockholders owning approximately 55% of the combined company.
2. Basis of Presentation
The preceding unaudited pro forma condensed combined financial information has been prepared in accordance with Article 8 of Regulation S-X as amended by the final rule, Release No. 33-10786 “Amendments to Financial Disclosures about Acquired and Disposed Businesses.” Release No. 33-10786 replaces the existing pro forma adjustment criteria with simplified requirements to depict the accounting for the transaction (“Transaction Accounting Adjustments”) and the option to present the reasonably estimable synergies and other transaction effects that have occurred or are reasonably expected to occur (“Management’s Adjustments”). Only Transaction Accounting Adjustments are presented in the following unaudited pro forma condensed combined financial information.
The Company considered ASC 805-10-55 to determine the accounting acquirer in the Merger. As the Company holds a majority of the members of the governing body of the combined Company, the Company’s former management dominates the majority of the senior management of the combined Company, and after considering all other factors according to ASC 805-10-55, the Company was identified as the accounting acquirer in the Merger.
The Merger was accounted for as a business combination and the unaudited pro forma condensed combined financial information was prepared using the acquisition method of accounting for the business acquisition in accordance with ASC 805. Under ASC 805, all assets acquired, which requires, among other things, that assets acquired and liabilities assumed in a business combination be recognized at their fair values as of the acquisition date, while transaction costs associated with the business combination are expensed as incurred. The excess of acquisition consideration over the estimated fair value of assets acquired and liabilities assumed, if any, is allocated to goodwill. The acquisition method of accounting uses the fair value concepts defined in ASC Topic 820, “Fair Value Measurement” (“ASC 820”). Fair value is defined in ASC 820 as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Market participants are assumed to be buyers or sellers in the most advantageous market for the asset or liability. Fair value measurement for an asset assumes the highest and best use by these market participants.
Fair value measurements can be highly subjective, and it is possible the application of reasonable judgment could develop different assumptions resulting in a range of alternative estimates using the same facts and circumstances. Fair value estimates were determined based on preliminary discussions between Biosight and Ayala management, and a preliminary valuation of Biosight’s assets and liabilities using October 18, 2023, as the measurement date.
The enterprise value of Biosight is based on the fair value of Ayala’s common stock issued to Biosight’s shareholders. Refer to Note 4 for additional information. This is used for pro forma purposes only.
The assets and liabilities of Biosight and other pro forma adjustments have been measured based on various preliminary estimates using assumptions that Ayala and Biosight believe are reasonable, based on information that is currently available. Accordingly, the pro forma adjustments are preliminary. Differences between these preliminary estimates and the final acquisition accounting could be significant, and these differences could have a material impact on the accompanying unaudited pro forma condensed combined financial information and the combined company’s future results of operation and financial position.
The unaudited pro forma combined balance sheet data gives effect to the Merger as if it had occurred on September 30, 2023. The unaudited pro forma combined statement of operations data gives effect to the Merger as if it had occurred on January 1, 2022.
The unaudited pro forma condensed combined financial information is presented solely for informational purposes and is not necessarily indicative of the combined results of operations or financial position that might have been achieved for the period or date indicated, nor is it necessarily indicative of the future results of the combined company. The unaudited pro forma condensed combined financial information has not been adjusted to give effect to certain expected financial benefits of the Merger, such as cost synergies or the anticipated costs to achieve these benefits, including the cost of integration activities.
The unaudited pro forma condensed combined financial information has been prepared assuming the combined companies will continue as a going concern. Please see disclosures in Ayala’s and Biosight’s footnotes to their historical financial statements for more information regarding their ability to continue as a going concern.
3. Accounting Policies
The unaudited pro forma condensed combined financial information has been compiled in a manner consistent with the accounting policies of Ayala. Ayala’s and Biosight’s historical financial statements were prepared in accordance with U.S. GAAP and are presented in U.S. dollars. Ayala has determined that no significant adjustments are necessary to conform Biosight’s accounting policies to the accounting policies used by Ayala.
4. Acquisition and Fair Value Allocation
Fair Value of Total Consideration Transferred
The fair value of preliminary purchase consideration transferred on the closing date includes the value of the number of shares of the combined company to be owned by Biosight shareholders at closing of the merger. The fair value per share of Ayala’ common stock used for the preliminary purchase price allocation was $0.9325 per share, the closing price of Ayala common stock on October 18, 2023.
Preliminary purchase consideration | | Amounts | |
Number of Biosight common shares issued and outstanding as of October 18, 2023 | | | 3,244,085 | |
Exchange Ratio - Biosight shares to Ayala shares | | | 1.82285 | |
Equivalent Ayala shares | | | 5,913,480 | |
Ayala price per share as of October 18, 2023 | | $ | 0.9325 | |
Fair value of total purchase consideration | | $ | 5,514 | |
Fair Value Allocation
The following is a preliminary estimate of the fair value of acquired identifiable assets and assumed liabilities of Biosight, which includes preliminary adjustments to reflect the fair value of intangible assets and goodwill acquired and the value of the Simple Agreement for Future Equity by and between Biosight and certain investors, pursuant to which such investors agreed to invest in Biosight up to $2,500, and Biosight agreed to issue equity interests in Biosight to such investors in certain circumstances (the “SAFE”).:
| | Amounts | |
Cash and cash equivalents | | $ | 1,948 | |
Prepaid expenses and other current assets | | | 151 | |
Property and equipment, net | | | 64 | |
Intangible assets | | | 3,800 | |
Goodwill | | | 2,351 | |
Total assets | | | 8,314 | |
| | | | |
Trade payables | | | (1,399 | ) |
Safe | | | (1,068 | ) |
Accrued expenses | | | (333 | ) |
Total liabilities | | | (2,800 | ) |
Estimated purchase price | | $ | 5,514 | |
5. Unaudited Pro Forma Combined Balance Sheet Adjustments
The following provides explanations of the various adjustments to the unaudited pro forma combined balance sheet:
| A. | Represents adjustment related to increase historical Biosight’s goodwill and intangible assets of $2,351 and $3,800. Refer to Note 4 on discussion of this Merger and purchase price allocation. Biosight’s intangibles have indefinite lives. Therefore, no adjustment for amortization expense has been included in this pro forma. |
| B. | Represents an adjustment related to increase Biosight’s SAFE to fair value by $375. Refer to Note 4 on discussion of this Merger and purchase price allocation. |
| C. | Represents $200 of transaction costs expected to be incurred by Ayala in connection with the Merger and are recorded as an increase in accrued expenses and an increase to accumulated deficit. . See also Note 6A. |
| D. | Represents the canceling of Biosight warrants to purchase Biosight stock as a result of the Merger. |
| E. | Represents the conversion of Biosight’s preferred shares of $57,023 prior to and in conjunction with the closing of the Merger, resulting in the removal of the preferred shares and addition of common shares. |
| F. | Represents the elimination of Biosight common stock, paid-in capital and accumulated deficits as well as the adjustments to reflect the capital structure of the combined company. See the explanation of the adjustments: |
| i. | Adjustments to common stock: an increase in common stock of $4 represents the adjustment to the aggregate historical par value of Ayala and Biosight, to reflect 10,751,802 shares outstanding at a total par value of $11 ($0.001 par value per share) calculated as follows: |
| | Amounts | |
Shares of Ayala common stock outstanding on September 30, 2023 | | | 4,838,322 | |
Ayala common stock issued to Biosight shareholders as of closing of merger | | | 5,913,480 | |
Total shares of Ayala common stock outstanding as of merger close | | | 10,751,802 | |
Par value per common share | | $ | 0.001 | |
Common stock total par value at merger | | $ | 11 | |
Common stock total par value of Ayala prior to closing of Merger | | | (5 | ) |
Common stock total par value of Biosight prior to closing of Merger | | | (2 | ) |
Total pro forma merger adjustments | | $ | 4 | |
| ii. | Adjustments to paid-in capital as follows: |
| | Amounts | |
Fair value of consideration paid for Biosight | | $ | 5,514 | |
Elimination of Biosight historical additional paid-in capital | | | (9,201 | ) |
Par value of common stock issued as consideration for Biosight | | | (6 | ) |
Total pro forma merger adjustments | | $ | (3,693 | ) |
| iii. | Adjustments to accumulated deficit as follows: |
| | Amounts | |
Pro forma merger adjustments: | | | | |
Transaction costs expected to be inccured | | $ | (200 | ) |
Elimination of historical Biosight accumulated deficit | | | 66,882 | |
Total pro forma merger adjustments | | $ | 66,682 | |
6. Unaudited Pro Forma Statement of Operations Adjustments
The following provides explanations of the various adjustments to the unaudited pro forma combined statement of operations:
| A. | Represents $200 of additional transaction costs incurred subsequent to September 30, 2023, by Ayala in conjunction with this Merger for transaction related fees and expenses. |
| B. | Biosight’s warrants to purchase Biosight’s stock were cancelled as a result of the Merger. This adjustment represents the removal of the change in fair value of those warrants of $10,461 and $1,842 for the year ended December 31, 2022 and nine months ended September 30, 2023, respectively. |
7. Loss per Share
The unaudited pro forma weighted average number of basic and diluted shares outstanding is calculated as follows:
| | For the nine months ended September 30, 2023 | | | For the year ended December 31, 2022 | |
Weighted average Ayala shares outstanding - basic and diluted | | | 4,648,599 | | | | 4,957,273 | |
| | | | | | | | |
Adjusted for: | | | | | | | | |
Shares issued to BioSight shareholders as if the merger occurred on January 1, 2022 | | | 5,913,480 | | | | 5,913,480 | |
Pro forma adjusted weighted average shares outstanding – basic and dilutive | | | 10,562,079 | | | | 10,870,753 | |
| | | | | | | | |
Pro forma net loss attributable to common shareholders – basic and dilutive | | $ | (30,796 | ) | | $ | (64,036 | ) |
| | | | | | | | |
Pro forma net loss per common share – basic and dilutive | | $ | (2.92 | ) | | $ | (5.89 | ) |