Celcuity Inc. 10-Q

ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed financial statements and the related notes appearing under Item 1 of Part I of this Quarterly Report on Form 10-Q (this “Quarterly Report”). This Quarterly Report, including the following discussion and analysis, contains forward-looking statements that involve risks and uncertainties and speak only as of the date of this report. Forward-looking information is included in our discussion of our plans and strategy for our business and expected financial results. You should review the “Risk Factors” discussed in our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 23, 2023, and the information contained elsewhere in this Quarterly Report, for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by forward-looking statements. Overview Celcuity is a clinical-stage biotechnology company focused on the development of targeted therapies for oncology. The Company’s lead therapeutic candidate is gedatolisib, a pan-PI3K/mTOR inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. The Company initiated VIKTORIA-1, a Phase 3 study evaluating gedatolisib in patients with HR+/HER2- advanced breast cancer in 2022 and is currently enrolling patients. In addition to the Phase 3 study, the Company recently announced that it received U.S. Food and Drug Administration (“FDA”) clearance for its Investigational New Drug (IND) submission for the clinical development of gedatolisib in combination with Nubeqa ® (darolutamide), for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC). The Company expects to initiate a Phase 1b/2 study, CELC-G-201, in the first quarter of 2024. Its CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from already approved targeted therapies. Gedatolisib, is a potent, well-tolerated, small molecule reversible dual inhibitor, administered intravenously, that selectively targets all Class I isoforms of PI3K and mammalian target of rapamycin (mTOR). In April 2021, we obtained exclusive global development and commercialization rights to gedatolisib under a license agreement with Pfizer, Inc. We believe gedatolisib’s unique mechanism of action, differentiated chemical structure, favorable pharmacokinetic properties, and intravenous formulation offer distinct advantages over currently approved and investigational therapies that target PI3K or mTOR alone or together. ● Overcomes limitations of therapies that only inhibit a single Class I PI3K isoform or only one mTOR kinase complex. Gedatolisib is a pan-class I isoform PI3K inhibitor with low nanomolar potency for the p110α, p110β, p110γ, and p110δ isoforms and mTORC1 and mTORC2 complexes. Each PI3K isoform and mTOR complex is known to preferentially affect different signal transduction events that involve tumor cell survival, depending upon the aberrations associated with the linked pathway. When a therapy only inhibits a single Class I isoform (e.g., alpelisib, a PI3K-α inhibitor) or only one mTOR kinase complex (e.g., everolimus, an mTORC1 inhibitor), numerous feedforward and feedback loops between the PI3K isoforms and mTOR complexes cross-activate the uninhibited sub-units. This, in turn, induces compensatory resistance that can reduce the efficacy of isoform specific PI3K or single mTOR kinase complex inhibitors. Inhibiting all four PI3K isoforms and both mTOR complexes, as gedatolisib does, thus prevents the confounding effect of isoform interaction that may occur with isoform-specific PI3K inhibitors and the confounding interaction between PI3K isoforms and mTOR. ● Better tolerated by patients than oral PI3K and mTOR drugs. Gedatolisib is administered intravenously (IV) on a four-week cycle of three weeks-on, one week-off, in contrast to the orally administered pan-PI3K or dual PI3K/mTOR inhibitors that are no longer being clinically developed. Oral pan-PI3K or PI3K/mTOR inhibitors have repeatably been found to induce significant side effects that were not well tolerated by patients. This typically leads to a high proportion of patients requiring dose reductions or treatment discontinuation. The challenging toxicity profile of these drug candidates ultimately played a significant role in the decisions to halt their development, despite showing promising efficacy. By contrast, gedatolisib stabilizes at lower concentration levels in plasma compared to orally administered PI3K inhibitors, resulting in less toxicity, while maintaining concentrations sufficient to inhibit PI3K/mTOR signaling. Isoform-specific PI3K inhibitors administered orally were developed to reduce toxicities in patients. While the range of toxicities associated with isoform-specific inhibitors is narrower than oral pan-PI3K or PI3K/mTOR inhibitors, administering them orally on a continuous basis still leads to challenging toxicities. The experience with an FDA approved oral p110-α specific inhibitor, Piqray, illustrates the challenge. In its Phase 3 pivotal trial Piqray was found to induce a Grade 3 or 4 adverse event (AE) related to hyperglycemia in 39% of patients evaluated. In addition, 26% of patients discontinued alpelisib due to treatment related adverse events. By contrast, in the 103-patient dose expansion portion of the Phase 1b (B2151009) clinical trial with gedatolisib, only 7% of patients experienced Grade 3 or 4 hyperglycemia and less than 10% discontinued treatment. 14 As of September 30, 2023, 492 patients with solid tumors have received gedatolisib in eight completed clinical trials sponsored by Pfizer. Of the 492 patients, 129 were treated with gedatolisib as a single agent in three clinical trials. The remaining 363 patients received gedatolisib in combination with other anti-cancer agents in five clinical trials. Additional patients received gedatolisib in combination with other anti-cancer agents in nine investigator sponsored clinical trials. A Phase 1b trial (B2151009) evaluating patients with HR+/HER2- metastatic breast cancer was initiated in 2016 and subsequently enrolled 138 patients. Six patients from this study continue to receive study treatment, as of September 30, 2023, each of whom have received study treatment for more than four years. The B2151009 clinical was an open label, multiple arm Phase 1b study that evaluated gedatolisib in combination with palbociclib (CDK4/6 inhibitor) and endocrine therapy (fulvestrant or letrozole) in patients with HR+/HER2- advanced breast cancer. Thirty-five patients were enrolled in two dose escalation arms to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) of gedatolisib when used in combination with the standard doses of palbociclib and endocrine therapy. The MTD was determined to be 180 mg administered intravenously once weekly. A total of 103 patients were subsequently enrolled in one of four expansion arms (A, B, C, D). High objective overall response rates (ORR) were observed in all four expansion arms and were comparable in each arm for PIK3CA WT and PIK3CA MT patients. As of the data cut-off date, March 16, 2023, for treatment- naïve patients in Escalation Arm A and Expansion Arm A (n=41), median progression free survival (mPFS) was 48.6 months, median duration of response (mDOR) was 46.9 months, and ORR was 79%. respectively. This data compares favorably to published data for current first-line standard-of-care treatments for patients with HR+/HER2- advanced breast cancer. In patients who received prior hormonal therapy alone or in combination with a CDK4/6 inhibitor (Arms B, C, and D), ORR (including unconfirmed partial responses) ranged from 36% to 77%. Each arm achieved its primary endpoint target, which was reporting higher ORR in the study arm than ORR from either the PALOMA-2 (ORR=55%) study that evaluated palbociclib plus letrozole for Arm A or the PALOMA-3 study (ORR=25%) that evaluated palbociclib plus fulvestrant for Arms B, C, and D. For all enrolled patients, a clinical benefit rate (CBR) of ≥79% was observed. Median progression-free survival (PFS) was 12.9 months for patients who received a prior CDK4/6 inhibitor and were treated in the study with the Phase 3 dosing schedule (Arm D). Gedatolisib combined with palbociclib and endocrine therapy demonstrated a favorable safety profile with manageable toxicity. The majority of treatment emergent adverse events were Grade 1 and 2. The most frequently observed adverse events included stomatitis/mucosal inflammation, the majority of which were Grade 1 and 2. The most common Grade 4 AEs were neutropenia and neutrophil count decrease, which were assessed as related to treatment with palbociclib. No grade 5 events were reported in this study. We are currently enrolling patients in a Phase 3, open-label, randomized clinical trial (VIKTORIA-1) to evaluate the efficacy and safety of two regimens in adults with HR+/HER2- advanced breast cancer whose disease has progressed after prior CDK4/6 therapy in combination with an aromatase inhibitor: 1) gedatolisib in combination with palbociclib and fulvestrant; and 2) gedatolisib in combination with fulvestrant. Approximately two hundred clinical sites in North America, Europe, South America, Asia, and Australia have been selected to participate in the study. The first clinical site was activated in the third quarter of 2022, and the first patient was dosed in December 2022. The VIKTORIA-1 Phase 3 clinical trial will enable separate evaluation of subjects according to their PIK3CA status. Subjects who meet eligibility criteria and are PIK3CA WT will be randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant (Arm A), gedatolisib and fulvestrant (Arm B), or fulvestrant (Arm C). Subjects who meet eligibility criteria and are PIK3CA MT will be randomly assigned (3:3:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant (Arm D), or alpelisib and fulvestrant (Arm E), or gedatolisib and fulvestrant (Arm F). The CELC-G-201 Phase 1b/2 clinical trial will enroll up to 54 participants with mCRPC who progressed after metastic castration resistant prostate cancer (“mCRPC”) treatment with a next-generation androgen receptor inhibitor and have not received docetaxel for mCRPC. In the Phase 1b portion of the study, we expect 36 participants will be randomly assigned to receive 600 mg darolutamide administered orally twice daily combined with either 120 mg gedatolisib in Arm 1 or 180 mg gedatolisib received intravenously in Arm 2. An additional 12 participants will then be enrolled in the Phase 2 portion of the study at the Recommended Phase 2 Dose (RP2D) level to enable evaluation of 30 participants treated with the RP2D of gedatolisib. The primary objectives of the Phase 1b portion of the trial include assessment of the safety and tolerability of gedatolisib in combination with darolutamide and determination of the RP2D dose of gedatolisib. The primary objective of the Phase 2 portion of the trial is to assess the radiographic progression-free survival (rPFS) at six months of patients who received the RP2D. We expect to initiate the study in the first quarter of 2024. Our proprietary CELsignia diagnostic platform is the only commercially ready technology we are aware of that uses a patient’s living tumor cells to identify the specific abnormal cellular process driving a patient’s cancer and the targeted therapy that best treats it. This enables us to identify patients whose tumors may respond to a targeted therapy, even though they lack a previously associated molecular mutation. By identifying cancer patients whose tumors lack an associated genetic mutation but have abnormal cellular activity a matching targeted therapeutic is designed to inhibit, CELsignia CDx can expand the markets for a number of already approved targeted therapies. We are supporting the advancement of new potential indications for targeted therapies, controlled by other pharmaceutical companies, that would rely on a CELsignia CDx to select patients. Phase 2 trials are underway to evaluate the efficacy and safety of these therapies in CELsignia selected patients. The FACT-1 trial is expected to have interim results available in the first half of 2024 and final results approximately nine months later. The FACT-2 trial, which was evaluating patients with early-stage triple negative breast cancer, was terminated in the third quarter. This decision was made in response to recent FDA approvals of new therapeutic options for patients with early-stage triple negative breast cancer. The availability of these new therapeutic options negatively impacted enrollment, which led us to conclude that the study was no longer feasible. 15 Under our April 2021 license agreement with Pfizer to research, develop, manufacture and commercialize gedatolisib, we paid a $5.0 million upfront fee and granted to Pfizer $5.0 million shares of Company common stock, which fee and grant were effected and expensed to research & development in full for the quarter in which we signed the license agreement. In addition, we are also required to make milestone payments to Pfizer upon achievement of certain development and commercial milestone events, up to an aggregate of $335.0 million. Additionally, the Company will pay Pfizer tiered royalties on sales of gedatolisib at percentages ranging from the low to mid-teens, which may be subject to deductions for expiration of valid claims, amounts due under third-party licenses and generic competition. Unless earlier terminated, the license agreement will expire upon the expiration of all royalty obligations. The royalty period will expire on a country-by-country basis upon the later of (a) 12 years following the date of first commercial sale of such product in such country, (b) the expiration of all regulatory or data exclusivity in such country for such product or (c) the date upon which the manufacture, use, sale, offer for sale or importation of such product in such country would no longer infringe, but for the license granted in the license agreement, on a valid claim of a licensed patent right. The Company has the right to terminate the license agreement for convenience upon 90 days’ prior written notice. Pfizer may not terminate the agreement for convenience. Either the Company or Pfizer may terminate the license agreement if the other party is in material breach and such breach is not cured within the specified cure period. In addition, either the Company or Pfizer may terminate the license agreement in the event of specified insolvency events involving the other party. Recent Developments In October 2023, Celcuity announced that it entered into a securities purchase agreement to sell pre-funded warrants at a price of $8.70 per warrant, to purchase up to 5,747,787 shares of the Company’s common stock in a private placement. The closing of the private placement occurred on October 20, 2023 and resulted in gross proceeds of approximately $50 million. Each Warrant to purchase one share has a purchase price of $8.699 per share, and an exercise price of $0.001 per share for the Common Stock issuable upon exercise of the Warrant (for aggregate consideration equating to $8.70 per share). The Company expects to use the net proceeds to advance clinical development of gedatolisib and for general corporate purposes. The Company has entered into a Registration Rights Agreement in connection with the private placement, pursuant to which it has agreed to register for resale the shares issuable upon exercise or exchange of the Warrants. In August 2023, Celcuity announced it entered into a clinical trial collaboration and supply agreement with Bayer AG for Celcuity’s Phase 1b/2 clinical trial of gedatolisib and Nubeqa® (darolutamide) in patients with metastatic castration resistant prostate cancer (mCRPC). As part of the supply agreement, Bayer will provide Nubeqa to Celcuity at no cost. In August 2023, Celcuity announced it was notified by the FDA that its Investigational New Drug (IND) submission has been reviewed, and Celcuity can proceed with the clinical development of gedatolisib in combination with Nubeqa® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC). Celcuity’s Phase 1b/2 study (CELC-G-201) will enroll up to 54 participants with mCRPC who progressed after treatment with an androgen receptor inhibitor. The Company expects to begin enrolling patients in the Phase 1b/2 clinical trial in the first quarter of 2024. Impact of COVID-19 on our Business Although we have largely returned to normal operations in our facility, the COVID-19 pandemic continues and its effect on our operations and financial condition will depend in large part on future developments which cannot be reasonably estimated at this time. Future developments include the duration, scope and severity of the pandemic, the emergence of new virus variants that are more contagious or harmful than prior variants, actions taken by governmental authorities, suppliers, clinical trial sites, and other business partners to contain or mitigate the pandemic’s impact, and the potential adverse effects on the suppliers, labor market and general economic activity. Results of Operations We have not generated any revenue from sales to date, and we continue to incur significant research and development and other expenses related to our ongoing operations. As a result, we are not and have never been profitable and have incurred losses in each period since our inception in 2012. For the three months ended September 30, 2023 and 2022, we reported a net loss of approximately $18.4 million and $10.9 million, respectively, and for the nine months ended September 30, 2023 and 2022, we reported a net loss of approximately $44.9 million and $28.8 million, respectively. As of September 30, 2023, we had an accumulated deficit of approximately $141.2 million. As of September 30, 2023, we had cash and cash equivalents and short-term investments of approximately $133.9 million. 16 Components of Operating Results Revenue To date, we have not generated any revenue. With the execution of the Pfizer license agreement in April 2021, whereby we acquired exclusive world-wide licensing rights to develop and commercialize gedatolisib, we initiated a Phase 3 clinical trial, VIKTORIA-1, in 2022 to support potential regulatory approval to market gedatolisib for the treatment of breast cancer. In August 2023, Celcuity announced its plans to proceed with the clinical development of gedatolisib in combination with Nubeqa® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC). If we obtain regulatory approvals to market gedatolisib, we expect to generate revenue from sales of the drug for the treatment of patients who present with the forms of breast or prostate cancer for which gedatolisib has been approved.. Additionally, we will seek to generate revenue from partnership agreements with pharmaceutical companies to provide companion diagnostics for such pharmaceutical partners’ existing or investigational targeted therapies. If a new drug indication is received that requires use of our companion diagnostic to identify eligible patients, we expect to generate revenues from sales of tests to treating physicians. Research and Development Since our inception, we have primarily focused on research and development of gedatolisib, a PI3K/mTOR targeted therapy, and our CELsignia platform and corresponding tests. Research and development expenses primarily include: ● employee-related expenses related to our research and development activities, including salaries, benefits, recruiting, travel and stock-based compensation expenses; ● laboratory supplies; ● consulting fees paid to third parties; ● clinical trial costs; ● validation costs for gedatolisib; ● facilities expenses; and ● legal costs associated with patent applications. Internal and external research and development costs are expensed as they are incurred. As we continue to develop gedatolisib and manage studies and clinical trials, including the VIKTORIA-1 Phase 3 trial, the CELC-G-201 trial, and other clinical trials to evaluate the efficacy of targeted therapies in cancer patients selected with one of our CELsignia tests, the proportion of research and development expenses allocated to external spending will grow at a faster rate than expenses allocated to internal expenses. General and Administrative General and administrative expenses consist primarily of salaries, benefits and stock-based compensation related to our executive, finance and support functions. Other general and administrative expenses include professional fees for auditing, tax, and legal services associated with being a public company, director and officer insurance, investor relations and travel expenses for our general and administrative personnel. Sales and Marketing Sales and marketing expenses consist primarily of professional and consulting fees related to these functions. To date, we have incurred immaterial sales and marketing expenses as we continue to focus primarily on developing our first drug, gedatolisib, managing the VIKTORIA-1 Phase 3 trial, initiating the CELC-G-201 study, and developing our CELsignia platform and corresponding CELsignia tests. We would expect to begin to incur increased sales and marketing expenses in anticipation of the commercialization of our first drug, gedatolisib. These increased expenses are expected to include employee-related and consulting costs. Interest Expense Interest expense is primarily due to a Loan Agreement. Interest Income Interest income consists of interest income earned on our cash equivalents and investment balances. 17 Results of Operations Comparison of the Three Months Ended September 30, 2023 and 2022 Three Months Ended September 30, Increase (Decrease) 2023 2022 $ Percent Change Statements of Operations Data: Operating expenses: Research and development $ 17,488,236 $ 9,621,505 $ 7,866,731 82 % General and administrative 1,409,801 1,022,050 387,751 38 Total operating expenses 18,898,037 10,643,555 8,254,482 78 Loss from operations (18,898,037 ) (10,643,555 ) (8,254,482 ) 78 Other income (expense) Interest expense (1,372,132 ) (537,661 ) (834,471 ) 155 Interest income 1,865,629 287,495 1,578,134 549 Other income (expense), net 493,497 (250,166 ) 743,663 (297 ) Net loss before income taxes (18,404,540 ) (10,893,721 ) (7,510,819 ) 69 Income tax benefits - - - - Net loss $ (18,404,540 ) $ (10,893,721 ) $ (7,510,819 ) 69 % Comparison of the Nine Months Ended September 30, 2023 and 2022 Nine Months Ended September 30, Increase (Decrease) 2023 2022 $ Percent Change Statements of Operations Data: Operating expenses: Research and development $ 42,512,811 $ 24,685,505 $ 17,827,306 72 % General and administrative 3,988,248 3,066,382 921,866 30 Total operating expenses 46,501,059 27,751,887 18,749,172 68 Loss from operations (46,501,059 ) (27,751,887 ) (18,749,172 ) 68 Other income (expense) Interest expense (3,929,140 ) (1,428,108 ) (2,501,032 ) 175 Interest income 5,499,555 391,301 5,108,254 1,305 Other income (expense), net 1,570,415 (1,036,807 ) 2,607,222 (251 ) Net loss before income taxes (44,930,644 ) (28,788,694 ) (16,141,950 ) 56 Income tax benefits - - - - Net loss $ (44,930,644 ) $ (28,788,694 ) $ (16,141,950 ) 56 % 18 Research and Development Our research and development expenses for the three months ended September 30, 2023 were approximately $17.5 million, representing an increase of approximately $7.9 million, or 82%, compared to the same period in 2022. Of the $7.9 million increase in research and development expense, $0.4 million was related to increased employee-related expenses. The remaining $7.5 million increase of research and development costs is primarily related to costs supporting activities for the VIKTORIA-1 pivotal trial. Our research and development expenses for the nine months ended September 30, 2023 were approximately $42.5 million, representing an increase of approximately $17.8 million, or 72%, compared to the same period in 2022. Of the $17.8 million increase in research and development expenses, $1.8 million was related to increased employee and consulting expenses. The remaining $16.0 million increase of research and development expenses is primarily related to costs supporting activities for the VIKTORIA-1 pivotal trial. Conducting a significant amount of research and development is central to our business model. We plan to increase our research and development expenses for the foreseeable future as we seek to develop gedatolisib, manage the VIKTORIA-1 Phase 3 trial and the CELC-G-201 Phase 1b/2 trial, discover new cancer sub-types, and develop and validate additional CELsignia tests to diagnose such sub-types. We also expect to incur increased expenses to support companion diagnostic business development activities with pharmaceutical companies as we develop additional CELsignia tests and manage the clinical trials for gedatolisib. General and Administrative Our general and administrative expenses for the three months ended September 30, 2023 were approximately $1.4 million, representing an increase of approximately $0.4 million, or 38%, compared to the same period in 2022. Employee related expenses accounted for $0.3 million of the increase. The remaining $0.1 million increase resulted from professional fees and other expenses associated with being a public company. Our general and administrative expenses for the nine months ended September 30, 2023 were approximately $4.0 million, representing an increase of approximately $0.9 million, or 30%, compared to the same period in 2022. Employee related expenses accounted for $0.7 million of the $0.9 million increase, including approximately $0.2 million in non-cash stock-based compensation. The remaining $0.2 million of the increase resulted from professional fees and other expenses associated with being a public company. We anticipate that our general and administrative expenses will increase in future periods, reflecting both increased costs in connection with the potential future commercialization of gedatolisib and CELsignia tests, an expanding infrastructure, and increased professional fees associated with public company regulatory developments and other compliance matters. Interest Expense Interest expense for the three months ended September 30, 2023 was $1.4 million and represents an increase of $0.8 million, or 155%, compared to the same period in 2022. Interest expense is primarily the result of a Loan Agreement that was executed in April 2021 and amended in August 2022. The increase is primarily due to the incremental $20 million funding of Term Loan B in December 2022. The $1.4 million of interest expense includes $0.5 million of non-cash interest expense. Interest expense for the nine months ended September 30, 2023 was $3.9 million and represents an increase of $2.5 million, or 175%, compared to the same period in 2022. The increase is primarily due to the incremental $20 million funding of Term Loan B in December 2022. The $3.9 million of interest expense includes $1.5 million of non-cash interest expense. Interest Income Interest income for the three months ended September 30, 2023 was $1.9 million and represents an increase of $1.6 million compared to the same period in 2022. The increase was primarily the result of the closing of financing activities, leading to higher cash, cash equivalents and short-term investment balances. The $1.9 million of interest income includes $0.5 million of non-cash interest income. Interest income for the nine months ended September 30, 2023 was $5.5 million and represents an increase of $5.1 million compared to the same period in 2022. The increase was primarily due to the closing of financing activities, leading to higher cash, cash equivalents and short-term investment balances. The $5.5 million of interest income includes $0.4 million of non-cash interest income. Liquidity and Capital Resources Since our inception, we have incurred losses and cumulative negative cash flows from operations. Through September 30, 2023, we have funded our operations primarily through private placements and registered offerings of our equity securities and unsecured convertible notes, and borrowings under loan agreements. From inception through September 30, 2023, we raised an aggregate of approximately $223.7 million of net proceeds through sales of our securities, and as of September 30, 2023 had $35.0 million of borrowings under loan agreements. As of September 30, 2023, our cash and cash equivalents and short-term investments were approximately $25.8 million and $108.2 million, respectively, and we had an accumulated deficit of approximately $141.2 million. 19 Private Placement. On December 9, 2022, we issued 6,182,574 shares of common stock, 1,120,873 shares of Series A Preferred Stock and warrants exercisable for 6,956,450 shares of common stock to certain institutional and other accredited investors pursuant to a securities purchase agreement entered into on May 15, 2022. Pursuant to the securities purchase agreement, the closing (funding) of the private placement occurred following dosage of the first patient in the Company’s Phase 3 study, VIKTORIA-1. Investors purchased shares of common stock and Series A Preferred Stock at a price of $5.75 per share (on an as converted to common stock basis), with forty percent (40%) warrant coverage (on an as converted to common stock basis) and customary resale registration rights. The warrants have an exercise price of $8.05 per share. The private placement generated gross proceeds of approximately $100 million before deducting placement agent fees and other offering expenses of $4.3 million. Open Market Sale Agreement SM . On February 4, 2022, we entered into an Open Market Sale Agreement SM with Jefferies LLC, as agent, pursuant to which we may offer and sell, from time to time, through Jefferies, shares of our common stock having an aggregate offering price of up to $50,000,000. On October 12, 2022, pursuant to this agreement, the Company sold 500,000 shares of common stock in a single transaction at a price of $10.35 per share, generating gross proceeds of $5.2 million ($4.8 million net of commissions and offering expenses). At September 30, 2023, $44.8 million of common stock remains available for sale under the Jefferies agreement. Innovatus Loan Agreement. On April 8, 2021, we entered into a Loan Agreement with Innovatus Life Sciences Lending Fund I, LP (“Innovatus”), under which Innovatus agreed to loan up to $25 million in three tranches consisting of (i) a $15.0 million non-contingent Term A loan that was funded on April 8, 2021, (ii) a $5 million Term B loan with a deadline of March 31, 2022, and (iii) a $5 million Term C loan to be funded upon our request, subject to our ability to achieve certain milestones, no later than March 31, 2023. On August 9, 2022, the Company amended the Loan Agreement with Innovatus to provide for up to $75 million in term loans. As of September 30, 2023, term loans totaling $35 million are outstanding under the Loan Agreement, including the initial Term A loan of $15 million which was funded on April 8, 2021, and a $20 million Term B loan which was funded on December 22, 2022 following the closing of the $100 million private placement described above. Additionally, the Company will be able to draw on two additional tranches of $10 million and one additional tranche of $20 million upon achievement of certain clinical trial milestones and satisfaction of certain financial covenants determined on a pro forma as-funded basis. Funding of these additional tranches is also subject to other customary conditions and limits on when the Company can request funding for such tranches. Pre-Funded Warrants . On October 20, 2023, we issued pre-funded warrants (the “Warrants”) to purchase 5,747,787 shares of common stock in a private placement to certain institutional investors, pursuant to a securities purchase agreement entered into on October 18, 2023. Each Warrant to purchase one share was sold at a purchase price of $8.699 per share and has an exercise price of $0.001 per share for the common stock issuable upon exercise of the Warrants (for aggregate consideration equating to $8.70 per share of common stock). The sale of the Warrants pursuant to the securities purchase agreement generated gross proceeds of approximately $50 million before deducting offering expenses payable by the Company. Please see “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Recent Developments” above for additional details. We expect that our research and development and general and administrative expenses will increase as we continue to develop gedatolisib, manage the VIKTORIA-1 Phase 3 trial, initiate the CELC-G-201 trial, conduct research related to the discovery of new cancer sub-types, conduct other studies and clinical trials, and pursue other business development activities. We would also expect to incur sales and marketing expenses as we commercialize gedatolisib and our CELsignia tests. We expect to use cash on hand, which includes funds received under the debt and equity financings described above, to fund our research and development expenses, clinical trial costs, capital expenditures, working capital, sales and marketing expenses, and general corporate expenses. Based on our current business plan, we believe that our current cash, cash equivalents and short-term investments, together with available borrowings under the Innovatus Loan Agreement, will provide sufficient cash to finance our operations and pay obligations when due for at least the next twelve months. Our expectations as to how long our current capital resources will be sufficient to fund our operations are based on assumptions that may not be accurate, and we could use our current capital resources sooner than we currently expect. In addition, we may seek to raise additional capital to finance capital expenditures and operating expenses over the next several years as we launch our integrated therapeutic and companion diagnostic strategy and expand our infrastructure, commercial operations and research and development activities, and to take advantage of financing or other opportunities that we believe to be in the best interests of the Company and our stockholders. Additional capital may be raised through the sale of common or preferred equity or convertible debt securities, entry into debt facilities or other third-party funding arrangements. The sale of equity and convertible debt securities may result in dilution to our stockholders and those securities may have rights senior to those of our common shares. Agreements entered into in connection with such capital raising activities could contain covenants that would restrict our operations or require us to relinquish certain rights. Additional capital may not be available on reasonable terms, or not at all. 20 Cash Flows The following table sets forth the primary sources and uses of cash for the nine months ended September 30: September 30, 2023 2022 Net cash provided by (used in): Operating activities $ (35,276,332 ) $ (26,528,911 ) Investing activities 36,209,923 (46,724 ) Financing activities 254,739 (226,970 ) Net increase (decrease) in cash and cash equivalents $ 1,188,330 $ (26,802,605 ) Operating Activities Net cash used in operating activities was approximately $35.3 million for the nine months ended September 30, 2023 and consisted primarily of a net loss of approximately $44.9 million offset by non-cash expense items of approximately $4.8 million and working capital changes of $4.8 million. Non-cash expense items of approximately $4.8 million primarily consisted of $3.7 million of stock-based compensation expense, net non-cash interest of $1.0 million, and depreciation expense of $0.1 million. The approximately $4.8 million of working capital changes was primarily due to increases in accounts payable and accrued expenses of $3.0 million and $2.8 million, respectively, offset by an approximately $1.0 million increase in other current assets. Net cash used in operating activities was approximately $26.5 million for the nine months ended September 30, 2022 and consisted primarily of a net loss of approximately $28.8 million and working capital changes of approximately $2.0 million, offset by non-cash expense items of approximately $4.3 million. The approximately $2.0 million of working capital changes was primarily due to an increase of approximately $5.9 million in other current assets, partially offset by increases in accounts payable and accrued expenses of approximately $1.6 million and $2.3 million, respectively. Non-cash expense items of approximately $4.3 million primarily consisted of approximately $3.5 million of stock-based compensation expense, non-cash interest expense of approximately $0.6 million and depreciation expense of approximately $0.2 million. Investing Activities Net cash provided by investing activities for the nine months ended September 30, 2023 was approximately $36.2 million and consisted primarily of net proceeds from maturities of short-term investments in government securities (U.S. Treasury Bills and U.S. government securities) partially offset by minimal purchase of property and equipment. Net cash used in investing for the nine months ended September 30, 2022 were minimal and consisted of purchases of property and equipment. Financing Activities Net cash provided by financing activities for the nine months ended September 30, 2023 was approximately $0.3 million and primarily consisted of proceeds from the exercise of employee stock options and proceeds from employee stock purchases, partially offset by payments for secondary registration and debt issuance costs. Net cash used in financing activities was $0.2 million for the nine months ended September 30, 2022 and consisted of payments for secondary registration costs, offset partially by proceeds from the exercise of employee stock options and proceeds from employee stock purchases. Recent Accounting Pronouncements From time-to-time new accounting pronouncements are issued by the Financial Accounting Standards Board or other standard setting bodies and adopted by us as of the specified effective date. Unless otherwise discussed in Note 2 to our unaudited condensed financial statements included in Item 1 of Part I of this Quarterly Report, we believe that the impact of recently issued standards that are not yet effective will not have a material impact on our financial position or results of operations upon adoption. 21 Critical Accounting Policies and Use of Estimates Our management’s discussion and analysis of financial condition and results of operations is based on our unaudited condensed financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported expenses during the reporting periods. These items are monitored and analyzed by us for changes in facts and circumstances, and material changes in these estimates could occur in the future. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances; the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Changes in estimates are reflected in reported results for the period in which they become known. Actual results may differ materially from these estimates. Our significant accounting policies are more fully described in Note 2 to our unaudited condensed financial statements included in Item 1 of Part I of this Quarterly Report. Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Such forward-looking information is included in this Quarterly Report and in other materials filed or to be filed by us with the SEC (as well as information included in oral statements or other written statements made or to be made by us). Forward-looking statements include all statements based on future expectations. This Quarterly Report contains forward-looking statements that involve risks and uncertainties including, but not limited to, (i) our clinical trial plans and the estimated costs for such trials, including our ongoing VIKTORIA-1 Phase 3 clinical trial and our expected Phase 1b/2 study and clinical trial for gedatolisib; (ii) our expectations with respect to costs and timelines to develop, validate and launch CELsignia tests and to continue to develop gedatolisib; (iii) our beliefs related to the perceived advantages of our CELsignia tests compared to traditional molecular or other diagnostic tests; (iv) the expected benefits of gedatolisib; (v) our expectations regarding the timeline of patient enrollment and results from clinical trials, including our existing and upcoming clinical trials for gedatolisib; (vi) the future payments that may be owned to Pfizer under the license agreement; (vii) our expectations regarding partnering with pharmaceutical companies and other third parties; (viii) our expectations regarding revenue from sales of CELsignia tests and revenue from milestone or other payment sources; (ix) our plans with respect to research and development and related expenses for the foreseeable future; (x) our expectations regarding business development activities, including companion diagnostic related activities with pharmaceutical companies, expanding our sales and marketing functions and the costs associated with such activities; (xi) our expectations with respect to the CELsignia tests and the analytical capabilities and potential impact of such tests; (xii) our beliefs regarding the ability of our cash on hand to fund our research and development expenses, capital expenditures, working capital, sales and marketing expenses, and general corporate expenses, as well as the increased costs associated with being a public company; (xiii) our plans with respect to potentially raising capital, and (xiv) our expectations regarding the impact that the COVID-19 pandemic and related economic effects will have on our business and results of operations. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “ongoing,” “plan,” “goal,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are only predictions and are not guarantees of performance. These statements are based on our management’s beliefs and assumptions, which in turn are based on their interpretation of currently available information. These statements involve known and unknown risks, uncertainties and other factors that may cause our results or our industry’s actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Certain risks, uncertainties and other factors include, but are not limited to, our limited operating history; the potential impact of the COVID-19 pandemic on our business; our initial success being heavily dependent on the success of our CELsignia HER2 Pathway Activity Test and of gedatolisib; our inability to develop and commercialize gedatolisib; our inability to determine whether our CELsignia tests are currently commercially viable; challenges we may face in developing and maintaining relationships with pharmaceutical company partners; the complexity and timeline for development of CELsignia tests and gedatolisib; the uncertainty and costs associated with clinical trials; the uncertainty regarding market acceptance by physicians, patients, third-party payors and others in the medical community, and regarding the size of market opportunities available to us; the pricing of molecular and other diagnostic products and services that compete with us; uncertainty with insurance coverage and reimbursement for our products; difficulties we may face in managing growth, such as hiring and retaining a qualified sales force and attracting and retaining key personnel; changes in government regulations; tightening credit markets, higher interest rates, and limitations on access to capital; increasingly sophisticated cybersecurity threats, obtaining and maintaining intellectual property protection for our technology and time and expense associated with defending third-party claims of intellectual property infringement, investigations or litigation threatened or initiated against us. These and additional risks, uncertainties and other factors are described more fully in our Annual Report on Form 10-K for the year ended December 31, 2022 and elsewhere in this Quarterly Report. Copies of filings made with the SEC are available through the SEC’s electronic data gathering analysis and retrieval system (EDGAR) at www.sec.gov. You should read the cautionary statements made in this Quarterly Report as being applicable to all related forward-looking statements wherever they appear in this Quarterly Report. We cannot assure you that the forward-looking statements in this Quarterly Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should read this Quarterly Report completely. Other than as required by law, we undertake no obligation to update these forward-looking statements, even though our situation may change in the future. 22 ITEM 3. Quantitative and Qualitative Disclosures about Market Risk As a smaller reporting company, we are not required to provide disclosure pursuant to this item.