PolyPid(PYPD) - 2024 Q1 - Quarterly Report

Interim Condensed Consolidated Balance Sheets The company's balance sheet shows a significant increase in total assets and a shift from shareholders' deficit to equity as of June 30, 2024 Balance Sheet Overview As of June 30, 2024, total assets grew to $19,527 thousand, and the company shifted from a shareholders' deficit to positive equity Balance Sheet Highlights (in thousands of U.S. dollars) | Metric | June 30, 2024 (Unaudited) | December 31, 2023 (Audited) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $3,076 | $5,309 | | Short-term deposits | $6,271 | $- | | Total current assets | $9,778 | $6,067 | | Total long-term assets | $9,749 | $9,305 | | Total Assets | $19,527 | $15,372 | | Liabilities | | | | Total current liabilities | $10,286 | $7,286 | | Total long-term liabilities | $7,640 | $10,182 | | Total Liabilities | $17,926 | $17,468 | | Shareholders' Equity | | | | Total shareholders' equity | $1,601 | $(2,096) | - Total assets increased by $4,155 thousand (27.0%) from December 31, 2023, to June 30, 2024, primarily due to an increase in short-term deposits and operating lease right-of-use assets[3] - The company transitioned from a total shareholders' deficit of $(2,096) thousand at December 31, 2023, to a positive total shareholders' equity of $1,601 thousand at June 30, 2024[4] Interim Condensed Consolidated Statements of Operations The company reported a higher net loss for the six months ended June 30, 2024, driven by increased research and development expenses Operating Results Overview The net loss widened to $12,742 thousand for the first half of 2024 due to higher R&D spending, though loss per share decreased Statements of Operations Highlights (in thousands of U.S. dollars, except per share data) | Metric | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Research and development, net | $9,810 | $7,754 | $4,760 | $3,960 | | Marketing and business development | $501 | $742 | $265 | $357 | | General and administrative | $2,111 | $3,112 | $1,096 | $1,503 | | Operating loss | $12,422 | $11,608 | $6,121 | $5,820 | | Financial expense, net | $311 | $262 | $171 | $7 | | Loss before income tax | $12,733 | $11,870 | $6,292 | $5,827 | | Income tax expenses | $9 | $35 | $2 | $10 | | Net loss | $12,742 | $11,905 | $6,294 | $5,837 | | Basic and diluted loss per ordinary share | $2.62 | $10.85 | $1.25 | $3.95 | | Weighted average number of ordinary shares | 4,858,158 | 1,097,015 | 5,024,871 | 1,479,449 | - Net loss for the six months ended June 30, 2024, increased by $837 thousand (7.0%) compared to the same period in 2023[5] - Research and development expenses increased by $2,056 thousand (26.5%) for the six months ended June 30, 2024, reflecting continued investment in product development[5] Interim Condensed Consolidated Statements of Shareholders' Equity (Deficit) Shareholders' equity turned positive in the first half of 2024, driven by capital raised from share and warrant issuances Shareholders' Equity Changes The company's equity position improved from a deficit to $1,601 thousand due to new capital infusions offsetting the net loss Changes in Shareholders' Equity (in thousands of U.S. dollars, except share data) | Metric | Balances as of Jan 1, 2024 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Number of ordinary shares | 1,653,559 | 4,797,252 | | Additional paid-in capital | $236,213 | $252,652 | | Accumulated deficit | $(238,309) | $(251,051) | | Total shareholders' equity (deficit) | $(2,096) | $1,601 | | Key Changes: | | | | Share-based compensation | - | $1,440 | | Issuance of Ordinary shares, warrants, etc | - | $14,999 | | Net loss | - | $(12,742) | - The number of ordinary shares outstanding increased significantly from 1,653,559 at January 1, 2024, to 4,797,252 at June 30, 2024, largely due to new share issuances[11] - Additional paid-in capital increased by $16,439 thousand, primarily from the issuance of ordinary shares, warrants, and pre-funded warrants, net of issuance costs[11] Interim Condensed Consolidated Statements of Cash Flows Cash decreased in the first half of 2024 as cash used in operations and investing outpaced cash generated from financing activities Cash Flow Activities A net decrease in cash of $2,202 thousand resulted from operating and investing outflows partially offset by financing inflows Cash Flow Summary (in thousands of U.S. dollars) | Cash Flow Activity | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(8,494) | $(8,281) | | Net cash used in investing activities | $(6,210) | $(7,863) | | Net cash provided by financing activities | $12,502 | $10,976 | | Decrease in cash, cash equivalents, and restricted deposits | $(2,202) | $(5,168) | | Cash, cash equivalents, and restricted deposits at end of period | $3,484 | $3,974 | - Net cash used in operating activities increased slightly to $(8,494) thousand in 2024 from $(8,281) thousand in 2023, primarily due to the increased net loss[16] - Net cash provided by financing activities increased to $12,502 thousand in 2024 from $10,976 thousand in 2023, largely driven by proceeds from the issuance of Ordinary shares, warrants, and pre-funded warrants[16] Notes to Interim Condensed Consolidated Financial Statements These notes detail the company's operations, accounting policies, liabilities, equity changes, and subsequent events NOTE 1: General Company Information and Operations The company is a Phase 3 biopharma firm facing going concern risks due to recurring losses and the need for future financing - PolyPid Ltd is a Phase 3 biopharmaceutical company developing targeted, locally administered, and prolonged-release therapeutics using its proprietary PLEX technology[20] - The lead product candidate, D-PLEX100, is designed for the prevention of surgical site infections (SSIs) in bone and soft tissue[20] - The SHIELD I Phase 3 trial did not achieve its primary endpoint, but a pre-specified subgroup analysis showed a 54% reduction in the primary endpoint for subjects with large incisions, leading the FDA to recommend an additional study (SHIELD II) to support a potential NDA submission[23] - The company incurred a loss of $12,742 thousand and had negative cash flows from operating activities of $8,494 thousand for the six months ended June 30, 2024, with an accumulated deficit of $251,051 thousand, raising substantial doubt about its ability to continue as a going concern[26][27] 1.a. Company Overview PolyPid is an Israeli biopharmaceutical company developing prolonged-release therapeutics with its lead product in Phase 3 trials - PolyPid Ltd was incorporated in Israel on February 28, 2008, and focuses on developing prolonged-release therapeutics using its PLEX technology[20] - The company's lead product candidate, D-PLEX100, is in Phase 3 development for the prevention of surgical site infections (SSIs)[20] - The company has wholly-owned subsidiaries in the United States (focused on marketing and business development) and Romania[21] 1.b. Reverse Share Split A 1-for-30 reverse share split was executed in September 2023, with all share data retroactively adjusted - On September 18, 2023, the Company's board of directors approved a 1-for-30 reverse share split[21] - All share and per share amounts in the financial statements have been retroactively adjusted to reflect this reverse share split[21] 1.c. Research and Development and Funding The company's primary focus is R&D, with its SHIELD II trial for D-PLEX100 ongoing after mixed results from SHIELD I - The Company's activities since inception have primarily consisted of research and development[22] - The SHIELD I Phase 3 trial for D-PLEX100 did not meet its primary endpoint, but a pre-specified subgroup analysis for large incisions showed a significant 54% reduction in SSIs[23] - The FDA acknowledged SHIELD I results as supportive evidence and recommended an additional study, with the ongoing SHIELD II trial potentially serving this purpose; recruitment for SHIELD II resumed in June 2023[23] 1.d. Going Concern Substantial doubt exists about the company's ability to continue as a going concern due to significant losses and insufficient funding - The Company expects to incur substantial losses over the next several years during its clinical development phase[25] - As of June 30, 2024, the Company had cash, cash equivalents, and short-term deposits of $9,347 thousand, a net loss of $12,742 thousand, negative operating cash flows of $8,494 thousand, and an accumulated deficit of $251,051 thousand[26] - These factors raise substantial doubt about the Company's ability to continue as a going concern, as it has not yet secured necessary funding for at least one year of activity[27] NOTE 2: Significant Accounting Policies The company's accounting policies conform to U.S. GAAP and are consistent with its 2023 annual report - The interim condensed consolidated financial statements are prepared in conformity with U.S. GAAP and are consistent with the Company's Annual Report on Form 20-F for the year ended December 31, 2023[28] - Management makes estimates and judgments affecting reported amounts, including fair value of financial instruments, useful lives of property and equipment, and share-based compensation[29] - As an 'Emerging Growth Company,' PolyPid has elected to use the extended transition period for new or revised accounting pronouncements[32] 2.a. Basis of presentation and summary of significant accounting policies The unaudited interim financial statements include all normal recurring adjustments and follow policies from the 2023 annual report - The interim financial information is unaudited but reflects all normal recurring adjustments necessary for fair presentation[30] - No material changes have occurred in the Company's significant accounting policies compared to the 2023 Annual Report on Form 20-F[31] 2.b. Basic and diluted loss per share Basic and diluted loss per share are calculated based on the weighted-average number of ordinary shares outstanding - Basic loss per share is calculated by dividing loss attributable to ordinary shareholders by the weighted-average number of ordinary shares outstanding[31] - Diluted loss per share is the same as basic loss per share when potentially dilutive securities are anti-dilutive[31] 2.c. Fair value of financial instruments The company uses a three-level hierarchy to measure the fair value of its financial instruments - Fair value is defined as the amount received for selling an asset or paid to transfer a liability in an orderly transaction[31] - Assets and liabilities carried at fair value are classified into Level 1 (quoted prices in active markets), Level 2 (observable inputs), or Level 3 (unobservable inputs)[31] - The carrying amounts of most current financial instruments approximate their fair value due to short-term maturity[32] 2.d. Recently adopted accounting pronouncements As an Emerging Growth Company, PolyPid utilizes an extended transition period for new accounting standards - As an 'Emerging Growth Company,' PolyPid has elected to use the extended transition period under the JOBS Act for new accounting pronouncements[32] - The Company has reviewed recent pronouncements and expects no material effect on its condensed consolidated financial statements from their future adoption[32] 2.e. Recently issued accounting pronouncements, not yet adopted The company is evaluating the impact of new accounting standards related to segment reporting and income taxes - ASU 2023-07 (Segment Reporting) requires disclosure of significant expenses and other segment items on an interim and annual basis, effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024[33] - ASU 2023-09 (Income Taxes) requires annual disclosure of specific categories in rate reconciliation and income taxes paid disaggregated by jurisdiction, effective for fiscal years beginning after December 15, 2025[34] - The Company is currently evaluating the impact of adopting ASU 2023-07 and ASU 2023-09[33][34] NOTE 3: Leases The company holds operating leases for office space and vehicles with terms extending to 2027 - The Company leases substantially all of its office space and vehicles under operating leases, with original lease periods expiring between 2024 and 2027[35] - On January 14, 2024, a new lease agreement for premises was entered into, extending the lease term through July 2027[35] Lease Information (as of June 30, 2024) | Metric | Value | | :--- | :--- | | Weighted average remaining lease term | 2.97 years| | Weighted average discount rates | 10.40% | | Total operating lease cost (6 months ended June 30, 2024) | $526 | | Cash payments for operating leases (6 months ended June 30, 2024) | $419 | | Present value of lease liabilities (as of June 30, 2024) | $2,467 | NOTE 4: Line of Credit Arrangement The company maintains a secured line of credit with Kreos Capital, which was recently amended and partially repaid - The Company has a secured line of credit agreement with Kreos Capital VI (Expert Fund) LP, which was amended on March 29, 2023[37] - On January 9, 2024, the Company repaid $1,494 thousand due to a clawback mechanism included in the Credit Line[37] - Interest expenses related to the Credit Line were $756 thousand for the six months ended June 30, 2024, compared to $813 thousand for the same period in 2023[37] NOTE 5: Commitments and Contingent Liabilities The company has royalty payment commitments to the Israel Innovation Authority contingent on future product sales - Through June 30, 2024, the Company received aggregate participation payments of $4,888 thousand from the Israel Innovation Authority (IIA)[38] - The Company is committed to paying royalties at a rate of 3% of sales of developed products, up to 100% of the grants received plus interest[38] - No new participation payments were received, and no royalties have been paid or accrued for the six-month period ended June 30, 2024[38] NOTE 6: Shareholders' Equity (Deficit) Shareholders' equity was significantly impacted by financing rounds, share issuances, and an expanded share option plan - Authorized ordinary shares remained at 107,800,000, while issued and outstanding shares increased from 1,653,559 at December 31, 2023, to 4,797,252 at June 30, 2024[39] - In January 2024, the Company completed a private placement, issuing 3,143,693 Ordinary shares, pre-funded warrants for 227,619 shares, and warrants for 3,371,312 shares, generating $14,999 thousand in net proceeds[43] - The Company's options pool was increased by 2,000,000 options to 2,312,403 on May 6, 2024, with 867,124 options available for future grants as of June 30, 2024[45] 6.a. Ordinary share capital The number of issued and outstanding ordinary shares increased significantly in the first half of 2024 Ordinary Shares (Number of shares) | Metric | June 30, 2024 (Unaudited) | December 31, 2023 (Audited) | | :--- | :--- | :--- | | Authorized Ordinary shares | 107,800,000 | 107,800,000 | | Issued and outstanding Ordinary shares | 4,797,252 | 1,653,559 | 6.b. Financing rounds The company raised capital through private placements and a public offering in 2023 and 2024 - On March 29, 2023, the Company completed a private placement of pre-funded warrants (PFW) for 345,238 Ordinary shares, generating $3,987 thousand net of fees[40] - On March 31, 2023, a public offering of 561,967 Ordinary shares generated $6,415 thousand net of underwriting commissions and expenses[41] - On January 4, 2024, the Company closed a private placement, issuing 3,143,693 Ordinary shares, pre-funded warrants for 227,619 shares, and warrants for 3,371,312 shares, with net proceeds of $14,999 thousand[43] 6.c. Share option plan The company expanded its share option plan in May 2024 and recognized related compensation expenses - The Company's 2012 Share Option Plan grants options to officers, directors, advisors, management, and other key employees, generally with a four-year vesting period and ten-year expiration[44] - On May 6, 2024, the options pool was increased by 2,000,000 options, bringing the total to 2,312,403, with 867,124 available for future grants as of June 30, 2024[45] Share-Based Compensation (in thousands of U.S. dollars, except per share data) | Metric | Six Months Ended June 30, 2024 | | :--- | :--- | | Share-based compensation expenses: | | | Research and development | $849 | | Marketing and business development | $144 | | General and administrative | $447 | | Total Share-based compensation expense | $1,440 | | Unrecognized compensation costs | $6,305 | | Weighted average period for recognition | 3.07 years | 6.d. Warrants and pre-funded warrants As of June 30, 2024, the company had over 3.6 million warrants outstanding, all of which were exercisable Outstanding Warrants (as of June 30, 2024) | Grant Date | Warrants outstanding as of June 30, 2024 | Average Exercise price per share ($) | Warrants exercisable as of June 30, 2024 | Exercisable through | | :--- | :--- | :--- | :--- | :--- | | September 2020 | 597 | $480.00 | 597 | September 2024 | | April 2022 | 5,193 | $12.60 | 5,193 | April 2029 | | July 2022 | 1,298 | $12.60 | 1,298 | April 2029 | | January 2024 | 3,371,312 | $5.50 | 3,371,312 | January 2026 | | January 2024 | 227,619 | $0.0001 | 227,619 | No maturity date | | Total | 3,606,019 | | 3,606,019 | | - All outstanding warrants as of June 30, 2024, are exercisable into Ordinary shares[50] - No warrants were exercised during the six-month period ended June 30, 2024[50] NOTE 7: Basic and Diluted Loss Per Share Loss per share decreased significantly due to a higher number of outstanding shares, with potential shares being anti-dilutive Loss Per Share Calculation (in thousands of U.S. dollars, except per share data) | Metric | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Net loss attributable to ordinary shareholders | $12,742 | $11,905 | $6,294 | $5,837 | | Weighted average Ordinary shares outstanding | 4,858,158 | 1,097,015 | 5,024,871 | 1,479,449 | | Basic and diluted loss per share | $2.62 | $10.85 | $1.25 | $3.95 | - The weighted average number of ordinary shares outstanding for the six months ended June 30, 2024, was 4,858,158, a substantial increase from 1,097,015 in the prior year[52] - Potential Ordinary shares, including 73,501 ordinary share options and 3,606,019 warrants, were excluded from the computation of diluted loss per share for the six months ended June 30, 2024, because their inclusion would have been anti-dilutive[54] NOTE 8: Subsequent Events After the reporting period, the company raised additional capital, granted new options, and amended its credit line - On July 2, 2024, shareholders approved grants of 198,000 options to the CEO and 132,600 milestone-based options, both with an exercise price of $4.64[55] - On August 1, 2024, the Company entered into a private placement financing, closing on August 6, 2024, to purchase 2,235,457 Ordinary shares (or pre-funded warrants) and warrants for 1,676,588 Ordinary shares, generating approximately $7,500 thousand in net proceeds[56] - On August 1, 2024, the Credit Line with Kreos Capital was amended to delay 60% of remaining principal and interest repayments until April 1, 2025, with an amended interest rate of 12.00%, a $125 thousand restructuring fee, and a potential clawback payment up to $4,500 thousand[57]