MUSTANG BIO INC
For the period ended Sep 30, 2024. Filed Nov 8, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 8, 2024
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-13.
0001558370-24-012051
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-08.
0001558370-24-015048
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 136 previous paragraphs and 144 current paragraphs.
86 unchanged; 35 reworded; 18 added; 8 removed; 7 previous and 5 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (18)
Current report
On November 7, 2024, we announced that the FDA granted Orphan Drug Designation to Mustang for MB-108, a herpes simplex virus type 1 (“HSV-1”) oncolytic virus, for the treatment of malignant glioma. The Orphan Drug Designation provides certain incentives, such as tax credits toward the cost of clinical trials upon approval and prescription drug user fee waivers. If a product receives Orphan Drug Status from the FDA, that product is entitled to seven years of market exclusivity for the disease in which it has Orphan Drug designation, which is independent from intellectual property protection. Due to limited resources, we do not currently expect to initiate this study until such time, if any, that additional resources become available to us.
Current report
On September 10, 2024, the Staff formally notified us that it had determined to delist our securities from Nasdaq based upon our continued non-compliance with the Equity Rule unless we timely request a hearing before the Nasdaq Hearings Panel (the “Panel”). On September 17, 2024, we requested a hearing before the Panel, which stayed any further action by Nasdaq at least pending completion of the hearing and the expiration of any extension that may be granted by the Panel to us following the hearing. The hearing took place on October 29, 2024, and we are currently awaiting the decision of the Panel.
Current report
May 2024 Equity Offering
Current report
Warrant Inducement
Current report
On October 24, 2024, we entered into an inducement offer letter agreement (the “Inducement Letter”) with a certain investor (the “Holder”) that held certain outstanding Series A-3 warrants (the “Existing Warrants”) to purchase up to an aggregate of 16,877,638 shares of our common stock, originally issued to the Holder on May 2, 2024.
Current report
Pursuant to the Inducement Letter, the Holder agreed to exercise for cash the Series A-3 warrants at the exercise price of $0.237 per share in partial consideration for our agreement to issue in a private placement new Series B Common Stock purchase warrants to purchase up to (i) 16,877,638 shares of common stock (the “New Series B-1 Warrant Shares”) and (ii) 16,877,638 shares of common stock (the “New Series B-2 Warrant Shares”). Each Warrant has an exercise price of $0.27 per share and will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares upon exercise of the Warrants (the “Warrant Stockholder Approval”). The New Series B-1 Warrant will expire on the five-year anniversary of the Warrant Stockholder Approval. The New Series B-2 Warrant will expire on the twelve-month anniversary of the Warrant Stockholder Approval.
Current report
The closing of the transaction contemplated pursuant to the Inducement Letter occurred on October 25, 2024 (the “Closing Date”). We received aggregate gross proceeds of approximately $4.0 million from the exercise of the Existing Warrants by the Holder, before deducting placement agent fees and other expenses payable by us. We intend to use the proceeds for general corporate purposes and working capital requirements.
Current report
We engaged Wainwright to act as our exclusive agent in connection with the transaction summarized above and paid Wainwright a cash fee equal to 7.0% of the aggregate gross proceeds from the exercise of the Existing Warrants. In addition, we (i) reimbursed Wainwright for $50,000 of the fees and expenses of Wainwright’s legal counsel and other of its out-of-pocket expenses, (ii) reimbursed Wainwright for its non-accountable expenses in the amount of $25,000, and (iii) paid a management fee equal to 1.0% of the gross proceeds raised. We also issued to Wainwright or its designees (“PA Warrant Holders”) placement agent warrants (the “Placement Agent Warrants”) to purchase up to 1,012,658 shares of Common Stock (the “Placement Agent Warrant Shares”). The Placement Agent Warrants have the same terms as the New Series B-1 Warrants, except that the Placement Agent Warrants have an exercise price equal to $0.2963 per share
Current report
During the nine months ended September 30, 2024, we issued approximately 2.7 million shares of common stock at an average price of $0.44 for gross proceeds of $1.2 million under the ATM Agreement. In connection with these sales, we paid aggregate fees of approximately $45,000.
Current report
In October 2024, we issued approximately 4.4 million shares of common stock at an average price of $0.34 for gross proceeds of approximately $1.5 million under the ATM Agreement. In connection with these sales, we paid aggregate fees of approximately $58,000.
Current report
For the three months ended September 30, 2024 and 2023, research and development expenses were $57,000 and $9.5 million, respectively. The decrease of approximately $9.5 million is primarily attributed to decreased expenses of $1.6 million for personnel related costs, primarily driven by the reduction in workforce, $3.3 million for R&D other expense, primarily related to higher expenses in the third quarter of 2023 of approximately $1.5 million of expense incurred for uBriGene services and $1.5 million of expense for vector supply, $2.5 million for lab supplies, $1.0 million for program related expenses, which includes approximately $0.3 million savings on payables owed to clinical sites, $0.1 million for facility and deprecation expenses, and $0.9 million for consulting expenses.
Current report
(2) Credit for the three months ended September 30, 2024, primarily reflects the savings on the settlement of payables owed to clinical sites.
Current report
(5) Includes approximately $1.5 million of expense incurred for uBriGene services and $1.5 million of expense for vector supply in the third quarter of 2023.
Current report
Gain on the Sale of Property and Equipment
Current report
During the three months ended September 30, 2023, we recorded a gain on the sale of equipment of approximately $1.4 million in connection with the sale of assets to uBriGene. There were no sales of property and equipment during the three months ended September 30, 2024.
Current report
Comparison of the Nine Months Ended September 30, 2024 and 2023
Current report
Gain on the Sale of Property and Equipment
Current report
During the nine months ended September 30, 2023, we recorded a gain on the sale of equipment of approximately $1.4 million in connection with the sale of assets to uBriGene. No gain on the sale of property and equipment was recorded in the nine months ended September 30, 2024.
Removed paragraphs (8)
Previous report
If we do not regain compliance with the bid price requirement by November 12, 2024, we may be eligible for an additional 180-calendar day compliance period so long as we satisfy the criteria for initial listing on Nasdaq and the continued listing requirement for market value of publicly held shares and we provide written notice to Nasdaq of our intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. In the event we are not eligible for the second grace period, Nasdaq staff will provide written notice that our common stock is subject to delisting; however, we may request a hearing before the Nasdaq Hearings Panel (the “Panel”), which request, if timely made, would stay any further suspension or delisting action by the Staff pending the conclusion of the hearing process and expiration of any extension that may be granted by the Panel. There can be no assurance that we would be successful in our efforts to maintain the listing of our common stock on the Nasdaq Capital Market.
Previous report
May 2024 Public Offering
Previous report
During the six months ended June 30, 2024, no shares of common stock were issued under the ATM Agreement.
Previous report
Pursuant to the terms of the 2018 Sales Agreement, we were previously able to issue and sell, from time to time through or to the Agents, shares of our common stock, having an aggregate offering price of up to $100,000,000, subject to the limitations of Instruction I.B.6 of Form S-3. As a result of the termination of the 2018 Sales Agreement, we will not issue or sell any additional shares of our common stock under the 2018 Sales Agreement.
Previous report
For the three months ended June 30, 2024 and 2023, research and development expenses were $4.4 million and $10.8 million, respectively. The decrease of approximately $6.4 million is primarily attributed to decreased expenses of $5.1
Previous report
(4) Credit for the three months ended June 30, 2024, reflects the reversal of stock-based compensation expense due to the forfeitures of restricted stock units related to the reduction in the workforce in April 2024.
Previous report
Comparison of the Six Months Ended June 30, 2024 and 2023
Previous report
Asset Impairment
Reworded paragraphs (35)
Previous wording
In October 2023, we received a safe-to-proceed “approval” from the FDA for our MB-109 IND application allowing us to initiate a Phase 1, open-label, non-randomized, multicenter study of MB-109 in patients with IL13Rα2+ recurrent GBM and high-grade astrocytoma. In this Phase 1 clinical study, we intend to evaluate the combination of CAR-T cells (MB-101) and the herpes simplex virus type 1 oncolytic virus (MB-108) in patients with IL13Rα2+ high-grade gliomas. The design of this study involves first a lead-in cohort, wherein patients are treated with MB-101 alone without prior MB-108 administration. After successful confirmation of the safety profile of MB-101 alone, the study will then investigate increasing doses of intratumorally administered MB-108 followed by dual intratumoral (ICT) and intraventricular (ICV) administration of MB-101. Due to limited resources, we do not currently expect to initiate this study until such time, if any, that additional resources become available to us.
Current wording
In October 2023, we received a safe-to-proceed “approval” from the FDA for our MB-109 IND application allowing us to initiate a Phase 1, open-label, non-randomized, multicenter study of MB-109 in patients with IL13Rα2+ recurrent GBM and high-grade astrocytoma. In this Phase 1 clinical study, we intend to evaluate the combination of CAR-T cells (MB-101) and the herpes simplex virus type 1 oncolytic virus (MB-108) in patients with IL13Rα2+ high-grade gliomas. The design of this study involves first a lead-in cohort, wherein patients are treated with MB-101 alone without prior MB-108 administration. After successful confirmation of the safety profile of MB-101 alone, the study will then investigate increasing doses of intratumorally administered MB-108 followed by dual intratumoral (ICT) and intraventricular (ICV) administration of MB-101.
Previous wording
On April 10, 2024, our board of directors approved a reduction of our workforce by approximately 81% of our employee base in order to reduce costs and preserve capital due to the fundraising environment and continued uncertainty regarding the CFIUS review of the sale of the Facility and the Transaction with uBriGene (Boston) Biosciences, Inc., a Delaware corporation (“uBriGene”). The workforce reduction took place primarily in April 2024 and was completed in the second
Current wording
On April 10, 2024, our board of directors approved a reduction of our workforce by approximately 81% of our employee base in order to reduce costs and preserve capital due to the fundraising environment and continued uncertainty regarding the CFIUS review of the sale of the Facility and the Transaction with uBriGene (Boston) Biosciences, Inc., a Delaware corporation (“uBriGene”). The workforce reduction took place primarily in April 2024 and was completed in the second quarter of 2024. As a result of these actions, we incurred personnel-related restructuring charges of approximately $0.2 million in connection with one-time employee termination cash expenditures, which were incurred in the second quarter of 2024.
Previous wording
Following the 45-day review period and subsequent 45-day investigation period described above, on February 12, 2024, we and uBriGene requested permission to withdraw and re-file our joint voluntary notice to allow more time for review and discussion regarding the nature and extent of national security risk posed by the Transaction. Upon our joint request to withdraw and re-file their joint voluntary notice to CFIUS, on February 12, 2024, CFIUS granted this request, accepted the joint voluntary notice and commenced a new 45-day review period on February 13, 2024. CFIUS’s new 45-day review ended on March 28, 2024. Because CFIUS had not yet concluded its action, the proceeding transitioned to a second 45-day phase as CFIUS further investigated the Transaction. On March 28, 2024, CFIUS advised us that its investigation would be completed no later than May 13, 2024.
Current wording
to withdraw and re-file their joint voluntary notice to CFIUS, on February 12, 2024, CFIUS granted this request, accepted the joint voluntary notice and commenced a new 45-day review period on February 13, 2024. CFIUS’s new 45-day review ended on March 28, 2024. Because CFIUS had not yet concluded its action, the proceeding transitioned to a second 45-day phase as CFIUS further investigated the Transaction. On March 28, 2024, CFIUS advised us that its investigation would be completed no later than May 13, 2024.
Previous wording
Purchase Agreement and the agreements entered into in connection therewith. The execution of the NSA was the result of CFIUS’ determination that such transactions posed a risk to the national security of the United States. We disagree with this position but did not feel a meaningful likelihood existed that the Transaction would be consummated in light of CFIUS’ objections. The NSA imposes certain conditions on us and uBriGene and its affiliates. Most significantly, we agreed (i) not to effect the Transaction with uBriGene or any of its affiliates; and (ii) to appoint a point of contact representative with whom CFIUS and uBriGene’s designated contact person may interact as needed. The NSA also obligates uBriGene to sell, or otherwise dispose of, the equipment assets purchased within 180 days after the execution of the NSA, with uBriGene able to eliminate some of its obligations under the NSA if it is able to sell the equipment assets purchased back to us within 45 days after the execution of the NSA (an “Expedited Divestment”).
Current wording
On May 13, 2024, together with uBriGene and CFIUS, we executed a National Security Agreement (the “NSA”), pursuant to which we and uBriGene agreed to abandon the Transaction and all other transactions contemplated by the Asset Purchase Agreement and the agreements entered into in connection therewith. The execution of the NSA was the result of CFIUS’ determination that such transactions posed a risk to the national security of the United States. We disagree with this position but did not feel a meaningful likelihood existed that the Transaction would be consummated in light of CFIUS’ objections. The NSA imposes certain conditions on us and uBriGene and its affiliates. Most significantly, we agreed (i) not to effect the Transaction with uBriGene or any of its affiliates; and (ii) to appoint a point of contact representative with whom CFIUS and uBriGene’s designated contact person may interact as needed. The NSA also obligates uBriGene to sell, or otherwise dispose of, the equipment assets purchased within 180 days after the execution of the NSA, with uBriGene able to eliminate some of its obligations under the NSA if it is able to sell the equipment assets purchased back to us within 45 days after the execution of the NSA (an “Expedited Divestment”).
Previous wording
Pursuant to the terms of the Asset Purchase Agreement, we and uBriGene terminated the following agreements between us that were entered into in connection with the Asset Purchase Agreement: (i) the Manufacturing Services Agreement, dated July 28, 2023, and work orders entered into under such agreement, (ii) the Quality Services Agreement, dated July 28, 2023, (iii) the Subcontracting CDMO Agreement, dated July 28, 2023, and work orders entered into under such agreement, (iv) the Quality Services Agreement, dated July 28, 2023, and (v) the Transition Services Agreement.
Current wording
Pursuant to the terms of the Asset Purchase Agreement, we and uBriGene terminated the following agreements between us that were entered into in connection with the Asset Purchase Agreement: (i) the Manufacturing Services Agreement, dated July 28, 2023, and work orders entered into under such agreement, (ii) the Quality Services Agreement, dated July 28, 2023, (iii) the Subcontracting CDMO Agreement, dated July 28, 2023, and work orders entered into under such
Previous wording
On March 13, 2024, we received a deficiency letter (the “Letter”) from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) notifying us that we were not in compliance with the minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(1). Nasdaq Listing Rule 5550(b)(1) requires companies listed on the Nasdaq Capital Market to maintain stockholders’ equity of at least $2,500,000 (the “Stockholders’ Equity Requirement”). As of December 31, 2023, we reported stockholders’ equity
Current wording
On March 13, 2024, we received a deficiency letter (the “Letter”) from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) notifying us that we were not in compliance with the minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(1) (the “Equity Rule”). The Equity Rule requires companies listed on The Nasdaq Capital Market to maintain stockholders’ equity of at least $2.5 million (or, in the alternative, a market value of listed securities of $35 million or net income from continued operations of $500,000 in the most recently completed fiscal year or in two of the last three most recently completed fiscal years). (the “Stockholders’ Equity Requirement”). As of December 31, 2023, we reported stockholders’ equity of $123,000, and as of September 30, 2024, we reported stockholders’ deficit of approximately $8.7 million.
Previous wording
The Letter had no immediate effect on our continued listing on the Nasdaq Capital Market, subject to our compliance with the other continued listing requirements. In accordance with Nasdaq rules, we were provided 45 calendar days, or until April 29, 2024, to submit a plan to regain compliance (the “Compliance Plan”). We submitted our Compliance Plan on April 29, 2024, and the Staff granted our request for an extension of 180 calendar days through September 9, 2024, to regain compliance with the Stockholders’ Equity Requirement.
Current wording
The Letter had no immediate effect on our continued listing on Nasdaq, subject to our compliance with the other continued listing requirements. In accordance with the Nasdaq Listing Rules, we were provided 45 calendar days, or until April 29, 2024, to submit a plan to regain compliance with the Equity Rule (the “Compliance Plan”). We submitted our Compliance Plan on April 29, 2024, and the Staff granted our request for an extension of 180 calendar days through September 9, 2024, to regain compliance with the Equity Rule. We were unable to demonstrate compliance with the Equity Rule by September 9, 2024.
Previous wording
On May 16, 2024, we received a notice (the “Second Letter”) from the Staff of Nasdaq indicating that the bid price of our common stock had closed below $1.00 per share for 31 consecutive business days and, as a result, we were not in compliance with Nasdaq Listing Rule 5550(a)(2), which sets forth the minimum bid price requirement for continued listing on the Nasdaq Capital Market. The Second Letter from Nasdaq had no immediate effect on the listing of our common stock on Nasdaq. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), we were afforded a 180-calendar day grace period, or until November 12, 2024, to regain compliance with the bid price requirement. Compliance can be achieved by evidencing a closing bid price of at least $1.00 per share for a minimum of ten consecutive business days (but generally not more than 20 consecutive business days) during the 180-calendar day grace period.
Current wording
On May 16, 2024, we received a notice (the “Second Letter”) from the Staff indicating that the bid price of our common stock had closed below $1.00 per share for 30 consecutive business days and, as a result, we were not in compliance with Nasdaq Listing Rule 5550(a)(2), which sets forth the minimum bid price requirement for continued listing on The Nasdaq Capital Market (the “Bid Price Rule”). Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), we were afforded a 180-calendar day grace period, or until November 12, 2024, to evidence compliance with the Bid Price Rule, which necessitates a closing bid price of at least $1.00 per share for a minimum of ten consecutive business days by November 12, 2024. Accordingly, we do not expect to evidence compliance with the Bid Price Rule by November 12, 2024, and the bid price deficiency will thereafter serve as an additional basis for delisting from Nasdaq. We addressed our plan to regain compliance with the Bid Price Rule at our hearing before the Panel on October 29, 2024.
Previous wording
On April 29, 2024, we commenced a best efforts public offering with an institutional investor (the “Investor”) (the “May 2024 Offering”) of an aggregate of (i) 1,160,000 shares of common stock, (ii) pre-funded warrants (the “May 2024 Pre-Funded Warrants”) to purchase up to an aggregate of 15,717,638 shares of common stock (the “May 2024 Pre-Funded Warrant Shares”), (iii) Series A-1 warrants (the “Series A-1 Warrants”) to purchase up to an aggregate of 16,877,638 shares of common stock (the “Series A-1 Warrant Shares”), (iv) Series A-2 warrants (the “Series A-2 Warrants”) to purchase up to an aggregate of 16,877,638 shares of common stock (the “Series A-2 Warrant Shares”), and (v) Series A-3 warrants (the “Series A-3 Warrants,” and together with the Series A-1 Warrants and Series A-2 Warrants, the “Warrants”) to purchase up to an aggregate of 16,877,638 shares of common stock (the “Series A-3 Warrant Shares”). Each share of common stock or May 2024 Pre-Funded Warrant was sold together with one Series A-1 Warrant to purchase one share of common stock, one Series A-2 Warrant to purchase one share of common stock, and one Series A-3 Warrant to purchase one share of common stock. The public offering price for each share of common stock and accompanying Warrants was $0.237, and the public offering price for each May 2024 Pre-Funded Warrant and accompanying Warrants was $0.2369. The May 2024 Pre-Funded Warrants have an exercise price of $0.0001 per share, were exercisable immediately and will expire when exercised in full. Each Warrant has an exercise price of $0.237 per share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares upon exercise of the Warrants (the “Warrant Stockholder Approval”), which was obtained on June 27, 2024. The Series A-1 Warrant will expire on the five-year anniversary of the Warrant Stockholder Approval. The Series A-2 Warrant will expire on the twenty-four-month anniversary of the Warrant Stockholder Approval. The Series A-3 Warrant will expire on the nine-month anniversary of the Warrant Stockholder Approval.
Current wording
On April 29, 2024, we commenced a best efforts equity offering with an institutional investor (the “Investor”) (the “May 2024 Offering”) of an aggregate of (i) 1,160,000 shares of common stock, (ii) pre-funded warrants (the “May 2024 Pre-Funded Warrants”) to purchase up to an aggregate of 15,717,638 shares of common stock (the “May 2024 Pre-Funded Warrant Shares”), (iii) Series A-1 warrants (the “Series A-1 Warrants”) to purchase up to an aggregate of 16,877,638 shares of common stock (the “Series A-1 Warrant Shares”), (iv) Series A-2 warrants (the “Series A-2 Warrants”) to purchase up to an aggregate of 16,877,638 shares of common stock (the “Series A-2 Warrant Shares”), and (v) Series A-3 warrants (the “Series A-3 Warrants,” and together with the Series A-1 Warrants and Series A-2 Warrants, the “Warrants”) to purchase up to an aggregate of 16,877,638 shares of common stock (the “Series A-3 Warrant Shares”). Each share of common stock or May 2024 Pre-Funded Warrant was sold together with one Series A-1 Warrant to purchase one share of common stock, one Series A-2 Warrant to purchase one share of common stock, and one Series A-3 Warrant to purchase one share of common stock. The equity offering price for each share of common stock and accompanying Warrants was $0.237, and the equity offering price for each May 2024 Pre-Funded Warrant and accompanying Warrants was $0.2369.
Previous wording
The net proceeds of the May 2024 Offering, after deducting the fees and expenses of the Placement Agent (as defined below), described in more detail below, and other offering expenses payable by us, but excluding the net proceeds, if any, from the exercise of the Warrants, was approximately $3.2 million. The May 2024 Offering closed on May 2, 2024.
Current wording
The net proceeds of the May 2024 Offering, after deducting the fees and expenses of the Placement Agent (as defined below), described in more detail below, and other offering expenses payable by us, but excluding the net proceeds, if any, from the exercise of the Warrants, were approximately $3.2 million. The May 2024 Offering closed on May 2, 2024.
Previous wording
H.C. Wainwright & Co., LLC (“Wainwright”) acted as the exclusive placement agent in connection with the Offerings under an Engagement Letter, dated as of June 18, 2024, between us and Wainwright (the “Engagement Letter”). Pursuant to the Engagement Letter, we issued to Wainwright (or its designees) warrants to purchase up to 367,800 shares of common stock (the “Wainwright Warrants” and, together with the Private Placement Warrants, the “2024 Warrants”). The Wainwright Warrants have substantially the same terms as the Private Placement Warrants, except that the Wainwright Warrants will expire five years from the commencement of the sales of the Offerings and have an exercise price of $0.5125 per share (subject to customary adjustment as set forth in the Wainwright Warrants), representing 125% of the purchase price per share of common stock in the Registered Direct Offering.
Current wording
stock (the “Wainwright Warrants” and, together with the Private Placement Warrants, the “2024 Warrants”). The Wainwright Warrants have substantially the same terms as the Private Placement Warrants, except that the Wainwright Warrants will expire five years from the commencement of the sales of the Offerings and have an exercise price of $0.5125 per share (subject to customary adjustment as set forth in the Wainwright Warrants), representing 125% of the purchase price per share of common stock in the Registered Direct Offering.
Previous wording
Under the ATM Agreement, the Manager may sell ATM Shares by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act. The Manager will use commercially reasonable efforts to sell the ATM Shares from time to time, based upon instructions from us (including any price, time or size limits or other customary parameters or conditions we may impose). We will pay the Manager a commission of 3.0% of the gross proceeds from the sales of ATM Shares sold through the Manager under the ATM Agreement and have provided the Manager with customary indemnification and contribution rights. We will also reimburse the Manager for certain expenses incurred in connection with the ATM Agreement. The Company and the Manager may each terminate the ATM Agreement at any time upon specified prior written notice.
Current wording
efforts to sell the ATM Shares from time to time, based upon instructions from us (including any price, time or size limits or other customary parameters or conditions we may impose). We will pay the Manager a commission of 3.0% of the gross proceeds from the sales of ATM Shares sold through the Manager under the ATM Agreement and have provided the Manager with customary indemnification and contribution rights. We will also reimburse the Manager for certain expenses incurred in connection with the ATM Agreement. Together with the Manager, we may each terminate the ATM Agreement at any time upon specified prior written notice.
Previous wording
The amount of securities we are able to sell pursuant to the registration statements on Form S-3 is limited. See “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Liquidity and Capital Resources.”
Current wording
The number of securities we are able to sell pursuant to the registration statements on Form S-3 is limited. See “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Liquidity and Capital Resources.”
Previous wording
During the six months ended June 30, 2024, there were no new accounting pronouncements or updates to recently issued accounting pronouncements disclosed in the 2023 Form 10-K that are expected to materially affect the Company’s present or future financial statements.
Current wording
During the nine months ended September 30, 2024, there were no new accounting pronouncements or updates to recently issued accounting pronouncements disclosed in the 2023 Form 10-K that are expected to materially affect the Company’s present or future financial statements.
Previous wording
General and administrative expenses consist primarily of salaries and related expenses, including stock-based compensation, for executives and other administrative personnel, recruitment expenses, professional fees and other corporate expenses, including investor relations, legal activities including patent fees, and facilities-related expenses.
Current wording
General and administrative expenses consist primarily of salaries and related expenses, including stock-based compensation, for executives and other administrative personnel, recruitment expenses, professional fees and other corporate expenses, including investor relations and legal activities including patent fees.
Previous wording
For the three months ended June 30, 2024, and 2023, general and administrative expenses were $1.5 million and $3.1 million, respectively. The decrease of approximately $1.6 million is primarily attributed to a $0.5 million decrease in personnel costs, $0.8 million decrease in legal and patent protection expenses, and $0.2 million decrease in professional
Current wording
For the three months ended September 30, 2024, and 2023, general and administrative expenses were $1.4 million and $2.1 million, respectively. The decrease of approximately $0.7 million is primarily attributed to a $0.4 million decrease in personnel costs, $0.2 million decrease in legal and patent protection expenses, and $0.1 million decrease in consulting.
Previous wording
For the three months ended June 30, 2024, and 2023, other income (expense) was $0.3 million and $(2.3) million, respectively. The increase of approximately $2.7 million in income is primarily attributed to a $2.9 million decrease in interest expense, related to the repayment of the Term Loan, partially offset by a $0.1 million decrease in other income and a $0.1 million decrease in interest income.
Current wording
For the three months ended September 30, 2024, and 2023, other income was $47,000 and $0.2 million, respectively. The decrease of approximately $0.2 million in income is primarily attributed to a $0.1 million decrease in interest income, and $0.1 million decrease in other income.
Previous wording
For the six months ended June 30, 2024 and 2023, research and development expenses were $8.2 million and $24.8 million, respectively. The decrease of approximately $16.6 million is primarily attributed to decreased expenses of $10.9 million for personnel related costs, reflecting decreased headcount and includes approximately $2.9 million of costs reimbursed through the subcontracting agreement with uBriGene and the reversal of $1.3 million of 2023 accrued bonus that will not be paid due to the reduction in the workforce that occurred in April 2024, $4.9 million for lab supplies, which includes approximately $0.1 million of costs reimbursed through the subcontracting agreement with uBriGene, $2.4 million for program related expenses, which includes approximately $0.6 million forgiveness of payables to St. Jude as a result of the mutual termination of the license agreement and $0.3 million forgiveness of payables to the Mayo Clinic as a result of the termination of the license agreement, $1.4 million for facility and deprecation expenses, which includes approximately $0.4 million of costs reimbursed through the subcontracting agreement with uBriGene, and $1.2 million for consulting expenses, offset by approximately $4.0 million increase in other expenses, of which approximately $3.2 million of expenses incurred related to the June 2024 Repurchase of Assets from uBriGene.
Current wording
For the nine months ended September 30, 2024 and 2023, research and development expenses were $8.2 million and $34.4 million, respectively. The decrease of approximately $26.2 million is primarily attributed to decreased expenses of $12.5 million for personnel related costs, reflecting decreased headcount and includes the reversal of $1.3 million of 2023 accrued bonus that will not be paid due to the reduction in the workforce that occurred in April 2024, $7.4 million for lab supplies, $4.2 million for program related expenses, which includes approximately $0.6 million forgiveness of payables to St. Jude as a result of the mutual termination of the license agreement and $0.3 million forgiveness of payables to the Mayo Clinic as a result of the termination of the license agreement, $1.5 million for facility and deprecation expenses, and $2.1 million for consulting expenses, offset by approximately $1.5 million increase in other expenses, primarily related to approximately $3.2 million of expenses incurred related to the June 2024 Repurchase of Assets from uBriGene.
Previous wording
The following table provides a breakout of the components of research and development expenses for the six months ended June 30, 2024 and 2023:
Current wording
The following table provides a breakout of the components of research and development expenses for the nine months ended September 30, 2024 and 2023:
Previous wording
(2) Credit for the six months ended June 30, 2024, reflects the forgiveness of outstanding payables and accrued expenses due to the mutual termination of the license agreement and related data transfer agreement with St. Jude.
Current wording
(2) Credit for the nine months ended September 30, 2024, reflects the forgiveness of outstanding payables and accrued expenses due to the mutual termination of the license agreement and related data transfer agreement with St. Jude. Credit for the nine months ended September 30, 2023, reflects credit memos and reimbursements received from termination of services with vendors.
Previous wording
(4) Credit for the six months ended June 30, 2024, reflects the reversal of 2023 accrued bonus that will not be paid due to the reduction in the workforce in April 2024.
Current wording
(4) Credit for the nine months ended September 30, 2024, primarily reflects the reversal of 2023 accrued bonus that will not be paid due to the reduction in the workforce in April 2024.
Previous wording
For the three months ended June 30, 2024, we incurred impairment charges of $2.6 million attributable to our assessment of the recoverability of the asset group consisting of leasehold improvements and associated right-of-use asset. No impairment was recorded in the three months ended June 30, 2023.
Current wording
For the nine months ended September 30, 2024, we incurred impairment charges of $2.6 million attributable to our assessment of the recoverability of the asset group consisting of leasehold improvements and associated right-of-use asset. No impairment was recorded in the nine months ended September 30, 2023.
Previous wording
For the six months ended June 30, 2024, and 2023, general and administrative expenses were $3.0 million and $5.4 million, respectively. The decrease of approximately $2.4 million is primarily attributed to a $1.0 million decrease in personnel costs, $1.0 million decrease in legal and patent protection expenses, $0.2 million decrease in consulting expenses, $0.1 million decrease in professional services. and a $0.3 million decrease across various other general and administrative expenses, offset by $0.2 million increase in the equity fee to Fortress, in connection with the financings.
Current wording
For the nine months ended September 30, 2024, and 2023, general and administrative expenses were $4.4 million and $7.5 million, respectively. The decrease of approximately $3.1 million is primarily attributed to a $1.3 million decrease in personnel costs, $1.2 million decrease in legal and patent protection expenses, $0.3 million decrease in consulting expenses, $0.1 million decrease in professional services. and a $0.4 million decrease across various other general and
Previous wording
services, $0.2 million decrease in consulting, and a $0.1 million decrease across various other general and administrative expenses, offset by $0.2 million increase in the equity fee to Fortress, in connection with the financings.
Current wording
administrative expenses, offset by $0.2 million increase in the equity fee to Fortress, in connection with the financings and ATM activity.
Previous wording
For the six months ended June 30, 2024, and 2023, other income (expense) was $0.4 million and $(2.7) million, respectively. The increase of approximately $3.1 million in income is primarily attributed to a $4.1 million decrease in interest expense, related to the repayment of the Term Loan, partially offset by a $0.5 million decrease in other income and a $0.5 million decrease in interest income.
Current wording
For the nine months ended September 30, 2024, and 2023, other income (expense) was $0.4 million and $(2.5) million, respectively. The increase of approximately $2.9 million in income is primarily attributed to a $4.1 million decrease in interest expense, related to the repayment of the Term Loan, partially offset by a $0.6 million decrease in other income and a $0.6 million decrease in interest income.
Previous wording
We have incurred substantial operating losses and expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. As of June 30, 2024, we had an accumulated deficit of $394.4 million.
Current wording
We have incurred substantial operating losses and expect to continue to incur significant operating losses for the foreseeable future and may never become profitable. As of September 30, 2024, we had an accumulated deficit of $395.8 million.
Previous wording
As of June 30, 2024, the Company had cash and cash equivalents of $4.3 million. On April 10, 2024, our Board approved a reduction in our workforce of approximately 81%, in order to reduce costs and preserve capital due to the fundraising environment and continued uncertainty regarding the CFIUS review of the sale of the Facility and the Transaction with uBriGene. The reduction occurred primarily in April 2024 and was completed in the second quarter. Additionally in April 2024, we terminated our license agreements with St. Jude and Leiden University Medical Centre. The mutual termination of the St. Jude license and associated Data Transfer Agreement included the forgiveness of outstanding amounts owed by us. In June 2024, we terminated our license agreement with the Mayo Clinic, which included the forgiveness of the outstanding amounts owed by us of approximately $0.3 million. In June 2024, we also terminated the sublease of the Mercantile Center Facility. Based on our current operating plan, reflecting these changes described above, we currently expect that such cash and cash equivalents, together with the approximately $5.3 million net proceeds received in the Offerings described above, will be sufficient to fund our operations into the fourth quarter of 2024. We will continue to seek additional funding through corporate partnerships and capital markets fundraising. See “Risk Factors—Risks Related to Our Finances and Capital Requirements.”
Current wording
As of September 30, 2024, the Company had cash and cash equivalents of $3.5 million. On April 10, 2024, our Board approved a reduction in our workforce of approximately 81%, in order to reduce costs and preserve capital due to the fundraising environment and continued uncertainty regarding the CFIUS review of the sale of the Facility and the Transaction with uBriGene. The reduction occurred primarily in April 2024 and was completed in the second quarter. Additionally in April 2024, we terminated our license agreements with St. Jude and Leiden University Medical Centre. The mutual termination of the St. Jude license and associated Data Transfer Agreement included the forgiveness of outstanding amounts owed by us. In June 2024, we terminated our license agreement with the Mayo Clinic, which included the forgiveness of the outstanding amounts owed by us of approximately $0.3 million. In June 2024, we also terminated the sublease of the Mercantile Center Facility. Based on our current operating plan, reflecting these changes described above, we currently expect that such cash and cash equivalents, together with the approximately $1.4 million net proceeds received from the ATM and $3.6 million net proceeds from the exercise of warrants in October, as described above, will be sufficient to fund our operations through the first half of 2025. We will continue to seek additional funding through corporate partnerships and capital markets fundraising. See “Risk Factors—Risks Related to Our Finances and Capital Requirements.”
Previous wording
We enter into contracts in the normal course of business with licensors, CROs, contract manufacturing organizations (CMOs) and other third parties for the procurement of various products and services, including without limitation biopharmaceutical development, biologic assay development, commercialization, clinical and preclinical development, clinical trials management, pharmacovigilance and manufacturing and supply. These contracts typically do not contain minimum purchase commitments and are generally terminable by us upon written notice. Payments due upon termination or cancelation/delay consist of payments for services provided or expenses incurred, including non-cancelable obligations
Current wording
We enter into contracts in the normal course of business with licensors, CROs, contract manufacturing organizations (CMOs) and other third parties for the procurement of various products and services, including without limitation biopharmaceutical development, biologic assay development, commercialization, clinical and preclinical development, clinical trials management, pharmacovigilance and manufacturing and supply. These contracts typically do not contain minimum purchase commitments and are generally terminable by us upon written notice. Payments due upon termination or cancelation/delay consist of payments for services provided or expenses incurred, including non-cancelable obligations of our service providers, up to the date of cancellation; in certain cases, our contractual arrangements with CROs and CMOs include cancelation and/or delay fees and penalties.
Previous wording
Cash Flows for the Six Months Ended June 30, 2024 and 2023
Current wording
Cash Flows for the Nine Months Ended September 30, 2024 and 2023
Previous wording
Net cash used in operating activities was $7.7 million for the six months ended June 30, 2024, compared to $30.2 million for the six months ended June 30, 2023.
Current wording
Net cash used in operating activities was $9.4 million for the nine months ended September 30, 2024, compared to $42.2 million for the nine months ended September 30, 2023.
Previous wording
Net cash used in operating activities for thesix months ended June 30, 2024, was primarily due to approximately $13.4 million in net loss, partially offset by $5.7 million of non-cash items, primarily related to the $2.6 million asset impairment charge, and a $3.1 million change in operating assets and liabilities.
Current wording
Net cash used in operating activities for thenine months ended September 30, 2024, was primarily due to approximately $14.8 million in net loss, partially offset by $2.8 million of non-cash items, primarily related to the $2.6 million asset impairment charge, and a $2.6 million positive change in operating assets and liabilities.
Previous wording
Net cash used in operating activities for thesix months ended June 30, 2023, was primarily due to approximately $32.9 million in net loss and $1.8 million change in operating assets and liabilities, partially offset by $0.3 million of non-cash stock compensation expenses, $1.3 million of depreciation, $2.8 million due to the loss on extinguishment of debt, and $0.1 million from other operating activities.
Current wording
Net cash used in operating activities for thenine months ended September 30, 2023, was primarily due to approximately$43.0 million in net loss and a $2.9 million negative change in operating assets and liabilities, offset in part by $3.6 million of non-cash items, which is primarily attributable to a $2.8 million loss on extinguishment of debt, $1.6 million of depreciation expense and $0.4 million of non-cash stock compensation expenses, offset in part by the $1.4 million gain on the sale of property and equipment to uBriGene.
Previous wording
During thesix months ended June 30, 2024, no cash was used in or provided by investing activities. Net cash used in investing activities was $34,000 for the six months ended June 30, 2023, primarily for the purchases of fixed assets.
Current wording
During thenine months ended September 30, 2024, no cash was used in or provided by investing activities. Net cash provided by investing activities was $5.9 million for the nine months ended September 30, 2023, primarily reflecting proceeds from the sale of property and equipment to uBriGene of $6.0 million.
Previous wording
Net cash provided by financing activities was $5.3 during thesix months ended June 30, 2024, primarily reflecting the proceeds from the May 2024 Offering and the June 2024 Offering.
Current wording
Net cash provided by financing activities was $6.3 million during thenine months ended September 30, 2024, primarily reflecting the proceeds from the May and June 2024 Offerings and the ATM.
Previous wording
Net cash used in financing activities was $30.3 million during the six months ended June 30, 2023, driven by the repayment of the Term Loan, partially offset by $0.1 million raised from the issuance of common shares in connection with the ESPP.
Current wording
Net cash used in financing activities was $30.0 million during the nine months ended September 30, 2023, driven by the repayment of the Term Loan, partially offset by $0.2 million raised from the issuance of the Company’s common shares in connection with the ESPP, and $0.2 million of net proceeds from the Mustang ATM.
Rearranged current paragraphs (5)
Current report — wording carried from elsewhere
Following the 45-day review period and subsequent 45-day investigation period described above, on February 12, 2024, we and uBriGene requested permission to withdraw and re-file our joint voluntary notice to allow more time for review and discussion regarding the nature and extent of national security risk posed by the Transaction. Upon our joint request
Current report — wording carried from elsewhere
agreement, (iv) the Subcontracting Quality Services Agreement, dated July 28, 2023, and (v) the Transition Services Agreement.
Current report — wording carried from elsewhere
The May 2024 Pre-Funded Warrants have an exercise price of $0.0001 per share, were exercisable immediately and will expire when exercised in full. Each Warrant has an exercise price of $0.237 per share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares upon exercise of the Warrants (the “Warrant Stockholder Approval”), which was obtained on June 27, 2024. The Series A-1 Warrant will expire on the five-year anniversary of the Warrant Stockholder Approval. The Series A-2 Warrant will expire on the twenty-four-month anniversary of the Warrant Stockholder Approval. The Series A-3 Warrant will expire on the nine-month anniversary of the Warrant Stockholder Approval.
Current report — wording carried from elsewhere
H.C. Wainwright & Co., LLC (“Wainwright”) acted as the exclusive placement agent in connection with the Offerings under an Engagement Letter, dated as of June 18, 2024, between us and Wainwright (the “Engagement Letter”). Pursuant to the Engagement Letter, we issued to Wainwright (or its designees) warrants to purchase up to 367,800 shares of common
Current report — wording carried from elsewhere
Under the ATM Agreement, the Manager may sell ATM Shares by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act. The Manager will use commercially reasonable
Rearranged previous paragraphs (7)
Previous report — wording carried elsewhere
quarter of 2024. As a result of these actions, we incurred personnel-related restructuring charges of approximately $0.2 million in connection with one-time employee termination cash expenditures, which were incurred in the second quarter of 2024.
Previous report — wording carried elsewhere
On May 13, 2024, together with uBriGene and CFIUS, we executed a National Security Agreement (the “NSA”), pursuant to which we and uBriGene agreed to abandon the Transaction and all other transactions contemplated by the Asset
Previous report — wording carried elsewhere
of $123,000, and as of June 30, 2024, we reported negative stockholders’ equity of $ ($8.3) million. The Letter further noted that as of its date, we did not have a market value of listed securities of $35 million, or net income from continued operations of $500,000 in the most recently completed fiscal year or in two of the last three most recently completed fiscal years, the alternative quantitative standards for continued listing on the Nasdaq Capital Market.
Previous report — wording carried elsewhere
million for personnel related costs, which includes approximately $0.6 million of costs reimbursed through the subcontracting agreement with uBriGene and the reversal of $1.3 million of 2023 accrued bonus that will not be paid due to the reduction in the workforce that occurred in April 2024, $2.9 million for lab supplies, which includes approximately $0.1 million of costs reimbursed through the subcontracting agreement with uBriGene, $0.6 million for program related expenses, which includes approximately $0.3 million forgiveness of payables to the Mayo Clinic as a result of the mutual termination of the license agreement, $0.6 million for facility and deprecation expenses, which includes approximately $0.2 million of costs reimbursed through the subcontracting agreement with uBriGene, and $0.9 million for consulting expenses, offset by $3.7 million higher other expenses, of which approximately $3.2 million of expenses incurred related to the June 2024 Repurchase of Assets from uBriGene.
Previous report — wording carried elsewhere
(5) Includes approximately $3.2 million of expenses incurred related to the June 2024 Repurchase of Assets from uBriGene.
Previous report — wording carried elsewhere
For the six months ended June 30, 2024, we incurred impairment charges of $2.6 million attributable to our assessment of the recoverability of the asset group consisting of leasehold improvements and associated right-of-use asset. No impairment was recorded in the six months ended June 30, 2023.
Previous report — wording carried elsewhere
of our service providers, up to the date of cancellation; in certain cases, our contractual arrangements with CROs and CMOs include cancelation and/or delay fees and penalties.