Delaware |
2836 |
85-3899721 | ||
(State or other jurisdiction of incorporation or organization) |
(Primary Standard Industrial Classification Code Number) |
(I.R.S. Employer Identification No.) |
Brian Lee, Esq. Ilan Katz, Esq. Dentons US LLP 1221 Avenue of the Americas New York, NY 10020 (212) 768-6700 |
Ivan K. Blumenthal, Esq. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. 666 Third Avenue New York, NY 10017 (212) 692-6750 |
Large accelerated filer |
☐ |
Accelerated filer |
☐ | |||
Non- accelerated filer |
☒ |
Smaller reporting company |
||||
Emerging growth company |
Per Share and Warrant |
Total |
|||||||
Public Offering Price |
$ |
$ |
||||||
Underwriting Discounts and Commissions (1) |
$ |
$ |
||||||
Proceeds to Us (Before Expenses) (2) |
$ |
$ |
(1) |
In addition to the underwriting discounts and commissions, we have agreed to pay or reimburse the underwriters to cover certain out-of-pocket Underwriting |
(2) |
The amount of proceeds, before expenses, to us does not give effect to any exercise of the Warrants. |
RAYMOND JAMES |
Page |
||||
1 |
||||
2 |
||||
6 |
||||
8 |
||||
55 |
||||
56 |
||||
57 |
||||
58 |
||||
60 |
||||
62 |
||||
63 |
||||
84 |
||||
137 |
||||
145 |
||||
155 |
||||
158 |
||||
160 |
||||
165 |
||||
167 |
||||
174 |
||||
182 |
||||
182 |
||||
182 |
||||
183 |
||||
F-1 |
• | Established proof-of-concept for our DiversitAb platform. |
• | Fully enrolled Phase 2a challenge study for SAB-176 in adults infected with influenza virus. |
• | Advanced to Phase 3 of NIH-Sponsored ACTIV-2 Trial based upon DSMB at interim analysis for SAB-185 (COVID-19) and reached 50% enrollment. |
• | Announced topline data demonstrating that SAB-176 met its primary endpoint in our Phase 2a challenge study in adults infected with influenza virus. |
• | Announced that recent data demonstrated that SAB-185 retains neutralization activity against the Omicron variant of SARS-CoV-2 in an in vitro pseudovirus model. |
• | Reported positive topline Phase 2 virology data demonstrating SAB-185 met criteria for advancement to Phase 3. |
• | We are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception. We realized net loss in the fiscal year ended December 31, 2021, we may incur losses for the foreseeable future and may not be able to generate sufficient revenue to maintain profitability. |
• | Our limited operating history makes future forecasting difficult. |
• | All of our product candidates are in preclinical or clinical development. Clinical drug development is expensive, time consuming and uncertain, and we may ultimately not be able to obtain regulatory approvals for the commercialization of some or all of our product candidates. |
• | The regulatory approval processes of the U.S. Food and Drug Administration (FDA) and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed. |
• | Regulatory approval for the genetic modification of animals, including those from which antibodies are isolated for injection into human patients, requires the approval of a New Animal Drug Application, and if we are ultimately unable to obtain such approval, our business will be substantially harmed. |
• | We are highly dependent on the success of our product candidates and if we are unable to successfully complete clinical development, obtain regulatory approval for or commercialize one or more of our product candidates, or if we experience delays in doing so, our business will be materially harmed. |
• | If our clinical trials fail to replicate positive results from earlier preclinical studies or clinical trials conducted by us or third parties, we may be unable to successfully develop, obtain regulatory approval for or commercialize our product candidates. |
• | The future commercial success of our product candidates will depend on the degree of market acceptance of our potential products among physicians, patients, healthcare payers, and the medical community. |
• | Failure to successfully identify, develop and commercialize additional products or product candidates could impair our ability to grow. |
• | We depend upon senior management and senior scientific staff, and their loss or unavailability could put us at a competitive disadvantage. |
• | We rely on third parties to perform some of our research and preclinical studies and we plan to rely on third parties to conduct our clinical trials. If these third parties do not satisfactorily carry out their contractual duties or fail to meet expected deadlines, our development programs may be delayed or subject to increased costs, each of which may have an adverse effect on our business and prospects. |
• | We intend to rely on third parties to produce commercial supplies of our product candidates. |
• | We are subject to manufacturing risks that could substantially increase the costs and limit supply of product candidates or prevent us from achieving a commercially viable production process. |
• | If we fail to successfully operate our animal production facility, it may adversely affect our clinical trials and the commercial viability of our product candidates. |
• | Outbreaks of livestock diseases and other events affecting the health of our bovine herd can adversely impact our ability to conduct our operations and production of our product candidates. |
• | Cyber-attacks or other failures in our telecommunications or information technology systems, or those of our collaborators, CROs, third-party logistics providers, distributors or other contractors or consultants, could result in information theft, data corruption and significant disruption of our business operations. |
• | We have historically relied on awards from, and contracts with, the U.S. Government to fund our business and operations, and will need to find new and alternative sources of funding following the discontinuance of certain such arrangements. |
• | If our competitors develop more effective competing product candidates our business will be substantially harmed. |
• | We are subject to stringent environmental regulation and potentially subject to environmental litigation, proceedings, and investigations. |
• | Our success may depend on our ability to maintain the proprietary nature of our technology. |
• | We may become involved in litigation to protect or enforce our patents or the patents of our collaborators or licensors, which could be expensive and time-consuming. |
• | If patent laws or the interpretation of patent laws change, our competitors may be able to develop and commercialize our discoveries. |
• | We incur increased costs and demands upon management as a result of complying with the laws and regulations affecting public companies, which could adversely affect our business, financial condition, and results of operations. |
• | We are an “emerging growth company,” and our election to comply with the reduced disclosure requirements as a public company may make our common stock less attractive to investors. |
• | If we fail to maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable regulations could be impaired. |
• | The market price of our securities may be volatile, which could cause the value of any investment in our securities to decline. |
• | We will have broad discretion in how we use the proceeds of this offering and may not use these proceeds effectively, which could affect our results of operations and cause our stock price to decline. |
• | We might not be able to comply with the continued listing standards of Nasdaq. |
• | Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall. |
• | We may issue additional shares common stock (including upon the exercise of warrants or conversion of preferred stock) which would increase the number of shares eligible for future resale in the public market and result in dilution to our stockholders. |
• | If you purchase our common stock in this offering, you will incur immediate and substantial dilution in the book value of your shares. |
• | Warrants are speculative in nature, the Warrants may not have any value, and holders of the Warrants will not have any rights as a common stockholder. |
• | Changes in tax laws and regulations or exposure to additional tax liabilities could adversely affect our financial results. |
Issuer |
SAB Biotherapeutics, Inc. |
Securities offered |
shares of our common stock and Warrants to purchase up to shares of our common stock (the “Offering”). The shares of common stock and Warrants are immediately separable and will be issued separately in the Offering, but will be purchased together in the Offering. Each Warrant to purchase one share of common stock will have an exercise price of $ per share of common stock, will be exercisable immediately, subject to certain limitations based on the holder’s beneficial ownership of our common stock, and will expire five years from the date of issuance. See “ Description of Securities We Are Offering |
Over-allotment option |
We have granted the underwriters a 30-day option to purchase up to an additional shares of our common stock and/or Warrants at the public offering price, less the underwriting discounts. |
Common stock outstanding before the Offering |
As of , 2022, there were shares of our common stock outstanding. |
Common stock outstanding after the Offering |
shares of common stock will be outstanding after the Offering (assuming none of the Warrants issued in the Offering are exercised). |
Use of proceeds |
We expect to use the proceeds received from the Offering: (i) for research and development activities for Tc Bovine polyclonal antibody programs, including SAB 195, SAB-176 and SAB-142 and our oncology discovery program; (ii) to file Pre-IND for SAB-195; (iii) to purchase of raw material inventory for the manufacture of SAB-195 and SAB-176 clinical material; and (iv) for working capital needs and general corporate purposes. See the section entitled “Use of Proceeds |
Risk factors |
Before investing in our securities, you should carefully read and consider the information set forth in “ Risk Factors |
Nasdaq Global Market symbol |
Our common stock is listed on The Nasdaq Global Market under the symbol “SABS”. There is no established trading market for the Warrants, and we do not expect a trading market to develop. We do not intend to list the Warrants on any securities exchange or other trading market. Without a trading market, the liquidity of the Warrants will be extremely limited. |
• | shares of common stock currently being held in escrow to be released upon achievement of certain earnout targets pursuant to the terms of the Business Combination; |
• | shares of common stock issuable upon the exercise of public warrants to purchase shares of common stock outstanding as , with an exercise price of $11.50 per share; |
• | shares of common stock issuable upon exercise of options outstanding as , with a weighted-average exercise price of $ per share; |
• | shares of common stock issuable upon the vesting of restricted stock units outstanding as of ; |
• | shares of common stock available for future issuance as of under the SAB Biotherapeutics, Inc. 2021 Equity Incentive Plan, or the SAB Sciences, Inc. Plan; and |
• | shares of common stock available for future issuance as of under the SAB Biotherapeutics, Inc. Employee Stock Purchase Plan, or the ESPP. |
• | no exercise of the underwriters’ option to purchase up to additional shares of common stock and/or Warrants to purchase shares of common stock in this offering; and |
• | no exercise of the outstanding warrants and options, no release of the earnout shares or vesting of the outstanding restricted stock units described above, in each case, after . |
• | continue the research and development of our clinical- and preclinical-stage product candidates and discovery stage programs, including the clinical trials of SAB-185 and SAB-176; |
• | advance our preclinical-stage product candidates into clinical development; |
• | invest in our technology and platform; |
• | seek to identify, acquire and develop additional product candidates, including through business development efforts to invest in or in-license other technologies or product candidates; |
• | seek regulatory approvals for any product candidates that successfully complete clinical trials; |
• | market and sell our solutions to existing and new partners; |
• | hire additional clinical, quality control, medical, scientific and other technical personnel to support our operations; |
• | maintain, expand, enforce, protect, and defend our intellectual property portfolio; |
• | create additional infrastructure to support operations; |
• | add operational, financial, and management information systems and personnel to support operations as a public company; |
• | undertake any pre-commercialization activities to establish sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products on our own or jointly with third parties; and |
• | experience any delays or encounter issues with any of the above. |
• | preclinical study results may show the product candidate to be less effective than desired or to have harmful side effects; |
• | clinical trial results may show the product candidate to be less effective than expected (e.g., a clinical trial could fail to meet its primary or key secondary endpoint(s)) or have an unacceptable safety or tolerability profile); |
• | failure to receive the necessary regulatory approvals or a delay in receiving approvals; and |
• | post-marketing approval requirements. |
• | the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials; |
• | the results of clinical trials may not meet the level of statistical or clinical significance required by the FDA or comparable foreign regulatory authorities for approval; |
• | the clinical trial results may not confirm the positive results from earlier preclinical studies or clinical trials; |
• | the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials; |
• | the data collected from clinical trials of our product candidates may not be sufficient to the satisfaction of FDA or comparable foreign regulatory authorities to support the submission of a BLA or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere; |
• | regulatory agencies might not approve or might require changes to our manufacturing processes or facilities; and |
• | regulatory agencies may change their approval policies, clinical development guidelines and recommendations, or adopt new regulations in a manner rendering our clinical data insufficient for approval. |
• | restrictions on our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials; |
• | restrictions on the products’ marketing, promotion, distribution or manufacturing processes; |
• | warning letters or untitled letters alleging violations; |
• | civil and criminal penalties; |
• | injunctions; |
• | suspension or withdrawal of regulatory approvals; |
• | product seizures, detentions or import bans; |
• | voluntary or mandatory product recalls and publicity requirements; |
• | imposition of restrictions on operations, including costly new manufacturing requirements; |
• | suspension of substantive review of pending applications, such as NADAs, biologics license applications (BLAs), investigational new animal drug applications (INADs), or investigational new drug applications (INDs), pending data validation; and |
• | refusal to approve pending NADAs or BLAs or supplements to approved NADAs or BLAs. |
• | the size and nature of the patient population; |
• | the design of the trial, including the patient eligibility criteria defined in the protocol; |
• | the size of the study population required for analysis of the trial’s primary endpoints; |
• | the proximity of patients to trial sites; |
• | our ability to recruit clinical trial investigators with the appropriate competencies and experience; |
• | competing clinical trials for similar therapies or other new therapeutics; |
• | clinicians’ and patients’ perceptions as to the potential advantages and side effects of the drug candidate being studied in relation to other available therapies, including any new drugs or treatments that may be approved for the indications we are investigating; |
• | our ability to obtain and maintain patient consents; |
• | travel restrictions and other potential limitations by federal, state, or local governments affecting the workforce or affecting clinical research site policies implemented in response to the COVID-19 pandemic or similar public health emergencies that may arise in the future; |
• | delays in or temporary suspension of the enrollment of patients in our anticipated clinical trials due to the COVID-19 pandemic or similar public health emergencies that may arise in the future; |
• | proximity and availability of clinical trial sites for prospective patients; |
• | the risk that patients enrolled in clinical trials will not complete a clinical trial; and |
• | the availability of approved therapies that are similar in mechanism to our product candidates. |
• | our inability to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that our product candidates are safe and effective; |
• | insufficiency of our financial and other resources to complete the necessary clinical trials and preclinical studies; |
• | negative or inconclusive results from our clinical trials, preclinical studies or the clinical trials of others for product candidates similar to ours, leading to a decision or requirement to conduct additional clinical trials or preclinical studies or abandon a program; |
• | product-related adverse events experienced by subjects in our clinical trials, including unexpected toxicity results, or by individuals using drugs or therapeutic biologics similar to our product candidates; |
• | delays in submitting an INAD or IND or comparable foreign applications or delays or failure in obtaining the necessary approvals from regulators to commence a clinical trial or a suspension or termination, or hold, of a clinical trial once commenced; |
• | conditions imposed by the FDA or comparable foreign regulatory authorities regarding the scope or design of our clinical trials; |
• | poor effectiveness of our product candidates during clinical trials; |
• | delays in enrolling subjects in our clinical trials; |
• | higher than anticipated clinical trial or manufacturing costs; |
• | failure of our third-party contractors or investigators to comply with regulatory requirements or the clinical trial protocol or otherwise meet their contractual obligations in a timely manner, or at all; and |
• | delays and changes in regulatory requirements, policy and guidelines, including the imposition of additional regulatory oversight around clinical testing generally or with respect to our therapies in particular. |
• | the FDA or comparable foreign regulatory authorities may not file or accept our NADA, BLA or other marketing applications for substantive review; |
• | the FDA or comparable foreign regulatory authorities may disagree with the dosing regimen, design or implementation of our clinical trials; |
• | we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that our product candidates are safe and effective for any of their proposed indications; |
• | the results of our clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval; |
• | we may be unable to demonstrate that our product candidates’ clinical and other benefits outweigh their safety risks; |
• | the data collected from clinical trials of our product candidates may not be sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a NADA, BLA or other comparable submissions in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere; |
• | the FDA or comparable foreign regulatory authorities may find deficiencies with or fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and |
• | the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval. |
• | regulators, institutional review boards (IRBs), or other reviewing bodies may not authorize us or our investigators to commence a clinical trial, or to conduct or continue a clinical trial at a prospective or specific trial site; |
• | we may not reach agreement on acceptable terms with prospective contract research organizations (CROs), and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; |
• | we may experience challenges or delays in recruiting principal investigators or study sites to lead our clinical trials; |
• | the number of subjects or patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be insufficient or slower than we anticipate, and the number of clinical trials being conducted at any given time may be high and result in fewer available patients for any given clinical trial, or patients may drop out of these clinical trials at a higher rate than we anticipate; |
• | our third-party contractors, including those manufacturing our product candidates or conducting clinical trials on our behalf, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; |
• | we may have to amend clinical trial protocols submitted to regulatory authorities or conduct additional studies to reflect changes in regulatory requirements or guidance; |
• | regulators or other reviewing bodies may find deficiencies with, fail to approve or subsequently find fault with the manufacturing processes or facilities of third-party manufacturers with which we enter into agreements for clinical and commercial supplies, or the supply or quality of any product candidate or other materials necessary to conduct clinical trials of our product candidates may be insufficient, inadequate or not available at an acceptable cost, or we may experience interruptions in supply; and |
• | the potential for approval policies or regulations of the FDA or the applicable foreign regulatory agencies to significantly change in a manner rendering our clinical data insufficient for approval. |
• | our available capital resources or capital constraints we experience; |
• | the rate of progress, costs and results of our clinical trials and research and development activities, including the extent of scheduling conflicts with participating clinicians and collaborators; |
• | our ability to identify and enroll patients who meet clinical trial eligibility criteria; |
• | our receipt of approvals by the FDA and other regulatory authorities and the timing thereof; |
• | other actions, decisions or rules issued by regulators; |
• | our ability to access sufficient, reliable and affordable supplies of materials used to manufacture of our product candidates; |
• | the efforts of our collaborators with respect to the commercialization of our product candidates; and |
• | the securing of, costs related to, and timing issues associated with, product manufacturing as well as sales and marketing activities. |
• | we may be forced to suspend marketing of that product, or decide to recall the product or remove it from the marketplace; |
• | regulatory authorities may withdraw or limit their approvals of that product; |
• | regulatory authorities may require additional statements, specific warnings or contraindications on the label or limit access of that product to selective specialized centers with additional safety reporting and with requirements that patients be geographically close to these centers for all or part of their treatment; |
• | we may be required to conduct additional clinical trials or costly post-marketing testing and surveillance to monitor the safety and efficacy of the product; |
• | we may be required to change the way the product is distributed or administered; |
• | we may be subject to regulatory investigations and government enforcement actions; |
• | we could be subject to fines, injunctions, or the imposition of criminal or civil penalties, or to sued and held liable for harm caused to subjects or patients; and |
• | the product may become less competitive, and our reputation may suffer. |
• | our inability to recruit and retain adequate numbers of effective sales and marketing personnel; |
• | our inability of sales personnel to obtain access to or persuade adequate numbers of physicians to prescribe any future products; |
• | the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and |
• | unforeseen costs and expenses associated with creating an independent sales and marketing organization. |
• | decreased demand for any of our future approved products; |
• | injury to our reputation; |
• | withdrawal of clinical trial participants; |
• | termination of clinical trial sites or entire trial programs; |
• | significant litigation costs; |
• | substantial monetary awards to, or costly settlements with, patients or other claimants; |
• | product recalls or a change in the indications for which they may be used; |
• | loss of revenue; |
• | diversion of management and scientific resources from our business operations; and |
• | the inability to commercialize our product candidates. |
• | the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal and state healthcare programs, such as Medicare and Medicaid; |
• | federal civil and criminal false claims laws and civil monetary penalty laws, including the federal False Claims Act, which impose criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent, making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government, or the knowing retention of an overpayment from government health care programs; the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; |
• | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations, which impose obligations on covered healthcare providers, health plans, and healthcare clearinghouses, as well as their business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; |
• | the federal Physician Payments Sunshine Act, which requires manufacturers of certain drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services, or CMS, information related to “payments or other transfers of value” made to physicians, which is defined to include doctors, dentists, optometrists, podiatrists and chiropractors, and certain teaching hospitals and applicable manufacturers to report annually to CMS ownership and investment interests held by the physicians and their immediate family members. Beginning in 2022, applicable manufacturers also will be required to report such information regarding payments and transfers of value provided during the previous year to physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified nurse anesthetists and certified nurse-midwives; and |
• | analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third party payors, including private insurers; state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. |
• | issue a warning letter asserting that we are in violation of the law; |
• | seek an injunction or impose civil or criminal penalties or monetary fines; |
• | suspend or withdraw regulatory approval; |
• | suspend any ongoing clinical trials; |
• | refuse to approve a pending BLA or comparable foreign marketing application (any supplements thereto) submitted by us or our strategic partners; |
• | restrict the marketing or labeling of the product; |
• | restrict manufacturing of the product, the approved manufacturers or the manufacturing process; |
• | restrict product distribution or use; |
• | demand a recall; |
• | seize or detain product or otherwise require the withdrawal of product from the market; |
• | impose fines, restitution or disgorgement of profits or revenues; |
• | impose consent decrees, injunctions or the imposition of civil or criminal penalties; |
• | refuse to permit the import or export of products; or |
• | refuse to allow us to enter into supply contracts, including government contracts. |
• | inability to meet our product specifications and quality requirements consistently; |
• | delay or inability to procure or expand sufficient manufacturing capacity; |
• | issues related to scale-up of manufacturing; |
• | costs and validation of new equipment and facilities required for scale-up; |
• | our third-party manufacturers may not be able to execute our manufacturing procedures and other logistical support requirements appropriately; |
• | our third-party manufacturers may fail to comply with cGMP requirements and other inspections by the FDA or other comparable regulatory authorities; |
• | our inability to negotiate manufacturing agreements with third parties under commercially reasonable terms, if at all; |
• | breach, termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us; |
• | reliance on single sources for drug components; |
• | lack of qualified backup suppliers for those components that are currently purchased from a sole or single-source supplier; |
• | our third-party manufacturers may not devote sufficient resources to our product candidates; |
• | we may not own, or may have to share, the intellectual property rights to any improvements made by our third-party manufacturers in the manufacturing process for our product candidates; |
• | operations of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier; and |
• | carrier disruptions or increased costs that are beyond our control. |
• | we do not have experience in manufacturing our product candidates at commercial scale. |
• | we plan to develop a larger scale manufacturing process for our product candidates. |
• | we may not succeed in scaling up the process. |
• | we may need a larger scale manufacturing process for certain product candidates than what has been planned. |
• | collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations; |
• | collaborators may not perform their obligations as expected; |
• | collaborators may not pursue development and commercialization of any product candidates that achieve regulatory approval or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities; |
• | collaborators may decide not to continue the development of collaboration products and could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours; |
• | a collaborator with marketing, distribution and commercialization rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of any such product candidate; |
• | disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development of any product candidates, might cause delays or termination of the research, development or commercialization of such product candidates, might lead to additional responsibilities for us with respect to such product candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive; |
• | collaborations may be terminated at the convenience of the collaborator or for a material breach by either party, and, if a collaboration is terminated, we could be required to make payments to the collaborator or have our potential payments under the collaboration reduced; and |
• | in the event of the termination of a collaboration, we could be required to raise additional capital to pursue further development or commercialization of the product candidates returned to us by our former collaborator. |
• | the right of our board of directors to issue shares of preferred stock and to fix the terms of such shares; |
• | no cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates; |
• | a classified board of directors with three-year staggered terms, which could delay the ability of stockholders to change the membership of a majority of our board of directors; |
• | the right of our board of directors to elect a director to fill a vacancy created by the expansion of our board of directors or the resignation, death or removal of a director in certain circumstances, which prevents stockholders from being able to fill vacancies on our board of directors; |
• | a prohibition on stockholder action by written consent, which forces stockholder action to be taken at an annual or special meeting of our stockholders; and |
• | requirement that a meeting of stockholders may only be called by members of our board of directors and the ability of our stockholders to call a special meeting is specifically denied, which may delay the ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors. These provisions, alone or together, could delay hostile takeovers and changes in control or changes in our board of directors and management. |
• | Limited availability of market quotations for our securities; |
• | A determination that our common stock is a “penny stock” which will require brokers trading in our securities to adhere to more stringent rules; |
• | Possibly resulting in a reduced level of trading activity in the secondary trading market for shares of our common stock; |
• | A limited amount of analyst coverage; and |
• | A decreased ability to issue additional securities or obtain additional financing in the future. |
• | the success, cost and timing of our product development activities and clinical trials, including statements regarding our plans for clinical development of our product candidates, the initiation and completion of clinical trials and related preparatory work and the expected timing of the availability of results of clinical trials; |
• | our ability to recruit and enroll suitable patients in our clinical trials; |
• | the potential indications, attributes and benefits of our product candidates; |
• | our ability to obtain and maintain regulatory approval for our product candidates, and any related restrictions, limitations or warnings in the label of an approved product candidate; |
• | our ability to obtain funding for our operations, including funding necessary to complete further development, approval and, if approved, commercialization of our product candidates; |
• | the period over which we anticipate our existing cash and cash equivalents will be sufficient to fund our operating expense and capital expenditure requirements; |
• | the potential for our business development efforts to maximize the potential value of our portfolio; |
• | our ability to identify, in-license or acquire additional product candidates; |
• | our ability to compete with other companies currently marketing or engaged in the development of treatments for the indications that we are pursuing for our product candidates; |
• | our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates and the duration of such protection; |
• | our ability to contract with and rely on third parties to assist in conducting our clinical trials and manufacturing our product candidates; |
• | our manufacturing capabilities, third-party contractor capabilities and strategy; |
• | our plans related to manufacturing, supply and other collaborative agreements; |
• | the size and growth potential of the markets for our product candidates, and our ability to serve those markets, either alone or in partnership with others; |
• | the rate and degree of market acceptance of our product candidates, if approved; |
• | the pricing and reimbursement of our product candidates, if approved; |
• | regulatory developments in the United States and foreign countries; |
• | the impact of laws, regulations, accounting standards, regulatory requirements, judicial decisions and guidance issued by authoritative bodies; |
• | our ability to attract and retain key scientific, medical, commercial or management personnel; |
• | our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; |
• | our financial performance; |
• | our ability to maintain our listing on The Nasdaq Global Market; |
• | the effect of COVID-19 on the foregoing; and |
• | our use of the proceeds from this Offering. |
• | for research and development activities for Tc Bovine polyclonal antibody programs, including SAB 195, SAB-176 and SAB-142 and our oncology discovery program; |
• | to file Pre-IND for SAB-195; |
• | to purchase of raw material inventory for the manufacture of SAB-195 and SAB-176 clinical material; and |
• | for working capital needs and general corporate purposes. |
• | on an actual basis; and |
• | on an as adjusted basis to give effect to the sale and issuance by us of shares of our common stock and accompanying Warrants to purchase up to shares of common stock in this Offering in this Offering at the assumed public offering price of $ per share, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us, and assuming no exercise of the Warrants being issued in this Offering and no exercise of the underwriters’ over-allotment option. |
As of June 30, 2022 |
||||||||
(In thousands, except share and per share data) |
Actual |
As adjusted(1) |
||||||
Cash and cash equivalents |
$ | |||||||
|
|
|||||||
Stockholders’ equity: |
||||||||
Preferred stock, $0.0001 par value: 10,000,000 shares designated; shares issued and outstanding |
||||||||
Common stock, $0.0001 par value: 490,000,000 shares designated; shares issued and outstanding; shares issued and outstanding, as adjusted |
||||||||
Additional paid-in capital |
||||||||
Accumulated deficit |
||||||||
|
|
|||||||
Total stockholders’ equity |
||||||||
|
|
|||||||
Total capitalization |
(1) | Each $1.00 increase (decrease) in the assumed public offering price of $ per share and accompanying Warrant would increase (decrease) the as adjusted amount of each of cash and cash equivalents, additional paid-in capital, total stockholders’ equity and total capitalization by approximately $ million, assuming the number of shares and accompanying Warrants offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase (decrease) of 1.0 million shares and accompanying Warrants offered by us would increase (decrease) the as adjusted amount of each of cash and cash equivalents, additional paid-in capital, total stockholders’ equity and total capitalization by approximately $ million, assuming the public offering price per share and accompanying Warrant, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. |
• | shares of common stock issuable upon the exercise of warrants to purchase shares of common stock outstanding as , with an exercise price of $11.50 per share; |
• | shares of common stock issuable upon exercise of options outstanding as , with a weighted-average exercise price of $ per share; |
• | shares of common stock issuable upon the vesting of restricted stock units outstanding as of ; |
• | shares of common stock available for future issuance as of under the SAB Biotherapeutics, Inc. 2021 Equity Incentive Plan, or the SAB Sciences, Inc. Plan; and |
• | shares of common stock available for future issuance as of under the SAB Biotherapeutics, Inc. Employee Stock Purchase Plan, or the ESPP. |
• | shares of our common stock issuable upon the exercise of Warrants offered in this Offering. |
• | any shares of common stock and/or Warrants to be issued upon any exercise of the underwriters’ over-allotment option in this Offering. |
Public offering price per share |
||
Historical net tangible book value per share as of June 30, 2022 |
||
Increase in as adjusted net tangible book value per share attributable to this Offering |
||
As adjusted net tangible book value per share after giving effect to this Offering |
||
Dilution in as adjusted net tangible book value per share to new investors in this Offering |
• | shares of common stock issuable upon the exercise of warrants to purchase shares of common stock outstanding as , with an exercise price of $11.50 per share; |
• | shares of common stock issuable upon exercise of options outstanding as , with a weighted-average exercise price of $ per share; |
• | shares of common stock issuable upon the vesting of restricted stock units outstanding as of June 30, 2022; |
• | shares of common stock available for future issuance as of under the SAB Biotherapeutics, Inc. 2021 Equity Incentive Plan, or the SAB Sciences, Inc. Plan; and |
• | shares of common stock available for future issuance as of under the SAB Biotherapeutics, Inc. Employee Stock Purchase Plan, or the ESPP. |
• | shares of our common stock issuable upon the exercise of Warrants offered in this Offering. |
• | invest in research and development activities to optimize and expand our DiversitAb platform; |
• | develop new and advance preclinical and clinical progress of pipeline programs; |
• | market to and secure partners to commercialize our products; |
• | expand and enhance operations to deliver products, including investments in manufacturing; |
• | acquire businesses or technologies to support the growth of our business; |
• | continue to establish, protect and defend our intellectual property and patent portfolio; and |
• | operate as a public company. |
Three Months Ended June 30, |
||||||||
2022 |
2021 |
|||||||
Salaries & benefits |
$ | 3,577,501 | $ | 2,433,001 | ||||
Laboratory supplies |
1,859,280 | 3,784,605 | ||||||
Animal care |
392,778 | 937,520 | ||||||
Contract manufacturing |
354,530 | 5,966,248 | ||||||
Clinical trial expense |
213,562 | 3,105,066 | ||||||
Outside laboratory services |
704,578 | 1,290,483 | ||||||
Project consulting |
118,395 | 424,592 | ||||||
Facility expense |
1,323,200 | 727,514 | ||||||
Other expenses |
40,603 | 14,373 | ||||||
|
|
|
|
|||||
Total research and development expenses |
$ | 8,584,427 | $ | 18,683,402 | ||||
|
|
|
|
Six Months Ended June 30, |
||||||||
2022 |
2021 |
|||||||
Salaries & benefits |
$ | 6,924,434 | $ | 4,448,632 | ||||
Laboratory supplies |
3,798,613 | 7,589,679 | ||||||
Animal care |
1,073,559 | 1,993,823 | ||||||
Contract manufacturing |
4,783,733 | 9,601,881 | ||||||
Clinical trial expense |
270,880 | 3,233,757 | ||||||
Outside laboratory services |
1,887,392 | 2,235,115 | ||||||
Project consulting |
553,178 | 846,333 | ||||||
Facility expense |
2,559,991 | 1,397,591 | ||||||
Other expenses |
95,912 | 118,595 | ||||||
|
|
|
|
|||||
Total research and development expenses |
$ | 21,947,692 | $ | 31,465,406 | ||||
|
|
|
|
Year Ended December 31, |
||||||||
2021 |
2020 |
|||||||
Salaries & benefits |
$ | 9,944,717 | $ | 4,823,808 | ||||
Laboratory supplies |
14,471,878 | 11,561,462 | ||||||
Animal care |
4,636,515 | 1,626,791 | ||||||
Contract manufacturing |
12,665,794 | 4,216,868 | ||||||
Clinical trial expense |
5,299,817 | 871,607 | ||||||
Outside laboratory services |
4,735,373 | 2,220,277 | ||||||
Project consulting |
1,812,292 | 693,093 | ||||||
Facility expense |
3,415,518 | 1,730,926 | ||||||
Other expenses |
201,685 | 163,827 | ||||||
|
|
|
|
|||||
Total research and development expenses |
$ | 57,183,589 | $ | 27,908,659 | ||||
|
|
|
|
Three Months Ended June 30, |
||||||||
2022 |
2021 |
|||||||
Revenue |
||||||||
Grant revenue |
$ | 6,350,525 | $ | 18,209,502 | ||||
|
|
|
|
|||||
Total revenue |
6,350,525 | 18,209,502 | ||||||
|
|
|
|
|||||
Operating expenses |
||||||||
Research and development |
8,584,427 | 18,683,402 | ||||||
General and administrative |
4,309,042 | 2,398,641 | ||||||
|
|
|
|
|||||
Total operating expenses |
12,893,469 | 21,082,043 | ||||||
|
|
|
|
|||||
Loss from operations |
(6,542,944 | ) | (2,872,541 | ) | ||||
Changes in fair value of warrant liabilities |
1,730,080 | — | ||||||
Interest expense |
(71,237 | ) | (74,434 | ) | ||||
Interest income |
15,824 | 5,296 | ||||||
|
|
|
|
|||||
Total other income (expense) |
1,674,667 | (69,138 | ) | |||||
|
|
|
|
|||||
Loss before income taxes |
(4,868,277 | ) | (2,941,679 | ) | ||||
Income tax benefit |
(92,281 | ) | — | |||||
|
|
|
|
|||||
Net loss |
$ | (4,775,996 | ) | $ | (2,941,679 | ) | ||
|
|
|
|
Six Months Ended June 30, |
||||||||
2022 |
2021 |
|||||||
Revenue |
||||||||
Grant revenue |
$ | 18,153,601 | $ | 35,137,236 | ||||
|
|
|
|
|||||
Total revenue |
18,153,601 | 35,137,236 | ||||||
|
|
|
|
|||||
Operating expenses |
||||||||
Research and development |
21,947,692 | 31,465,406 | ||||||
General and administrative |
9,456,191 | 5,730,447 | ||||||
|
|
|
|
|||||
Total operating expenses |
31,403,883 | 37,195,853 | ||||||
|
|
|
|
|||||
Loss from operations |
(13,250,282 | ) | (2,058,617 | ) | ||||
Changes in fair value of warrant liabilities |
9,579,652 | — | ||||||
Gain on debt extinguishment of Paycheck Protection Program SBA Loan |
— | 665,596 | ||||||
Interest expense |
(143,259 | ) | (149,626 | ) | ||||
Interest income |
23,757 | 10,802 | ||||||
|
|
|
|
|||||
Total other income |
9,460,150 | 526,772 | ||||||
|
|
|
|
|||||
Loss before income taxes |
(3,790,132 | ) | (1,531,845 | ) | ||||
Income tax expense |
— | — | ||||||
|
|
|
|
|||||
Net loss |
$ | (3,790,132 | ) | $ | (1,531,845 | ) | ||
|
|
|
|
Year Ended December 31, |
||||||||
2021 |
2020 |
|||||||
Revenue |
||||||||
Grant revenue |
$ | 60,876,078 | $ | 55,237,759 | ||||
|
|
|
|
|||||
Total revenue |
60,876,078 | 55,237,759 | ||||||
|
|
|
|
|||||
Operating expenses |
||||||||
Research and development |
57,183,589 | 27,908,659 | ||||||
General and administrative |
17,085,692 | 6,772,303 | ||||||
|
|
|
|
|||||
Total operating expenses |
74,269,281 | 34,680,962 | ||||||
|
|
|
|
|||||
(Loss) income from operations |
(13,393,203 | ) | 20,556,797 | |||||
Changes in fair value of warrant liabilities |
(4,151,068 | ) | — | |||||
Gain on debt extinguishment of Paycheck Protection Program SBA Loan |
665,596 | — | ||||||
Other income |
5,488 | 3,996 | ||||||
Interest expense |
(294,459 | ) | (469,151 | ) | ||||
Interest income |
23,115 | 26,131 | ||||||
|
|
|
|
|||||
Net (loss) income |
$ | (17,144,531 | ) | $ | 20,117,773 | |||
|
|
|
|
Three Months Ended June 30, |
||||||||||||||||
2022 |
2021 |
Change |
% Change |
|||||||||||||
Revenue |
$ | 6,350,525 | $ | 18,209,502 | $ | (11,858,977 | ) | (65.1 | )% | |||||||
|
|
|
|
|||||||||||||
Total revenue |
$ | 6,350,525 | $ | 18,209,502 | ||||||||||||
|
|
|
|
Six Months Ended June 30, |
||||||||||||||||
2022 |
2021 |
Change |
% Change |
|||||||||||||
Revenue |
$ | 18,153,601 | $ | 35,137,236 | $ | (16,983,635 | ) | (48.3 | )% | |||||||
|
|
|
|
|||||||||||||
Total revenue |
$ | 18,153,601 | $ | 35,137,236 | ||||||||||||
|
|
|
|
Three Months Ended June 30, |
||||||||||||||||
2022 |
2021 |
Change |
% Change |
|||||||||||||
Research and development |
$ | 8,584,427 | $ | 18,683,402 | $ | (10,098,975 | ) | (54.1 | )% | |||||||
|
|
|
|
|||||||||||||
Total research and development expenses |
$ | 8,584,427 | $ | 18,683,402 | ||||||||||||
|
|
|
|
Six Months Ended June 30, |
||||||||||||||||
2022 |
2021 |
Change |
% Change |
|||||||||||||
Research and development |
$ | 21,947,692 | $ | 31,465,406 | $ | (9,517,714 | ) | (30.2 | )% | |||||||
|
|
|
|
|||||||||||||
Total research and development expenses |
$ | 21,947,692 | $ | 31,465,406 | ||||||||||||
|
|
|
|
Three Months Ended June 30, |
||||||||||||||||
2022 |
2021 |
Change |
% Change |
|||||||||||||
General and administrative |
$ | 4,309,042 | $ | 2,398,641 | $ | 1,910,401 | 79.6 | % | ||||||||
|
|
|
|
|||||||||||||
Total general and administrative expenses |
$ | 4,309,042 | $ | 2,398,641 | ||||||||||||
|
|
|
|
Six Months Ended June 30, |
||||||||||||||||
2022 |
2021 |
Change |
% Change |
|||||||||||||
General and administrative |
$ | 9,456,191 | $ | 5,730,447 | $ | 3,725,744 | 65.0 | % | ||||||||
|
|
|
|
|||||||||||||
Total general and administrative expenses |
$ | 9,456,191 | $ | 5,730,447 | ||||||||||||
|
|
|
|
Three Months Ended June 30, |
||||||||||||||||
2022 |
2021 |
Change |
% Change |
|||||||||||||
Changes in fair value of warrant liabilities |
$ | 1,730,080 | $ | — | $ | 1,730,080 | N/M | |||||||||
|
|
|
|
|||||||||||||
Total non-operating income |
$ | 1,730,080 | $ | — | ||||||||||||
|
|
|
|
Six Months Ended June 30, |
||||||||||||||||
2022 |
2021 |
Change |
% Change |
|||||||||||||
Changes in fair value of warrant liabilities |
$ | 9,579,652 | $ | — | $ | 9,579,652 | N/M | |||||||||
Gain on debt extinguishment of Paycheck Protection Program SBA Loan |
— | 665,596 | (665,596 | ) | N/M | |||||||||||
|
|
|
|
|||||||||||||
Total non-operating income |
$ | 9,579,652 | $ | 665,596 | ||||||||||||
|
|
|
|
Three Months Ended June 30, |
||||||||||||||||
2022 |
2021 |
Change |
% Change |
|||||||||||||
Interest expense |
$ | 71,237 | $ | 74,434 | $ | (3,197 | ) | (4.3 | )% | |||||||
|
|
|
|
|||||||||||||
Total interest expense |
$ | 71,237 | $ | 74,434 | ||||||||||||
|
|
|
|
Six Months Ended June 30, |
||||||||||||||||
2022 |
2021 |
Change |
% Change |
|||||||||||||
Interest expense |
$ | 143,259 | $ | 149,626 | $ | (6,367 | ) | (4.3 | )% | |||||||
|
|
|
|
|||||||||||||
Total interest expense |
$ | 143,259 | $ | 149,626 | ||||||||||||
|
|
|
|
Three Months Ended June 30, |
||||||||||||||||
2022 |
2021 |
Change |
% Change |
|||||||||||||
Interest income |
$ | 15,824 | $ | 5,296 | $ | 10,528 | 198.8 | % | ||||||||
|
|
|
|
|||||||||||||
Total interest income |
$ | 15,824 | $ | 5,296 | ||||||||||||
|
|
|
|
Six Months Ended June 30, |
||||||||||||||||
2022 |
2021 |
Change |
% Change |
|||||||||||||
Interest income |
$ | 23,757 | $ | 10,802 | $ | 12,955 | 119.9 | % | ||||||||
|
|
|
|
|||||||||||||
Total interest income |
$ | 23,757 | $ | 10,802 | ||||||||||||
|
|
|
|
Three Months Ended June 30, |
||||||||||||||||
2022 |
2021 |
Change |
% Change |
|||||||||||||
Income tax benefit |
$ | (92,281 | ) | $ | — | $ | (92,281 | ) | N/M | |||||||
|
|
|
|
|||||||||||||
Total income tax benefit |
$ | (92,281 | ) | $ | — | |||||||||||
|
|
|
|
Six Months Ended June 30, |
||||||||||||||||
2022 |
2021 |
Change |
% Change |
|||||||||||||
Income tax expense |
$ | — | $ | — | $ | — | N/M | |||||||||
|
|
|
|
|||||||||||||
Total income tax expense |
$ | — | $ | — | ||||||||||||
|
|
|
|
Year Ended December 31, |
||||||||||||||||
2021 |
2020 |
Change |
% Change |
|||||||||||||
Revenue |
$ | 60,876,078 | $ | 55,237,759 | $ | 5,638,319 | 10.2 | % | ||||||||
|
|
|
|
|||||||||||||
Total revenue |
$ | 60,876,078 | $ | 55,237,759 | ||||||||||||
|
|
|
|
Year Ended December 31, |
||||||||||||||||
2021 |
2020 |
Change |
% Change |
|||||||||||||
Research and development |
$ | 57,183,589 | $ | 27,908,659 | $ | 29,274,930 | 104.9 | % | ||||||||
|
|
|
|
|||||||||||||
Total research and development expenses |
$ | 57,183,589 | $ | 27,908,659 | ||||||||||||
|
|
|
|
Year Ended December 31, |
||||||||||||||||
2021 |
2020 |
Change |
% Change |
|||||||||||||
General and administrative |
$ | 17,085,692 | $ | 6,772,303 | $ | 10,313,389 | 152.3 | % | ||||||||
|
|
|
|
|||||||||||||
Total general and administrative expenses |
$ | 17,085,692 | $ | 6,772,303 | ||||||||||||
|
|
|
|
Year Ended December 31, |
||||||||||||||||
2021 |
2020 |
Change |
% Change |
|||||||||||||
Changes in fair value of warrant liabilities |
$ | (4,151,068 | ) | $ | — | $ | (4,151,068 | ) | N/M | |||||||
Gain on debt extinguishment of Paycheck Protection Program SBA Loan |
665,596 | — | 665,596 | N/M | ||||||||||||
Other income |
5,488 | 3,996 | 1,492 | 37.3 | % | |||||||||||
|
|
|
|
|||||||||||||
Total non-operating (expense) income |
$ | (3,479,984 | ) | $ | 3,996 | |||||||||||
|
|
|
|
Year Ended December 31, |
||||||||||||||||
2021 |
2020 |
Change |
% Change |
|||||||||||||
Interest expense |
$ | 294,459 | $ | 469,151 | $ | (174,692 | ) | (37.2 | )% | |||||||
|
|
|
|
|||||||||||||
Total interest expense |
$ | 294,459 | $ | 469,151 | ||||||||||||
|
|
|
|
Year Ended December 31, |
||||||||||||||||
2021 |
2020 |
Change |
% Change |
|||||||||||||
Interest income |
$ | 23,115 | $ | 26,131 | $ | (3,016 | ) | (11.5 | )% | |||||||
|
|
|
|
|||||||||||||
Total interest income |
$ | 23,115 | $ | 26,131 | ||||||||||||
|
|
|
|
Six Months Ended June 30, |
||||||||
2022 |
2021 |
|||||||
Net cash (used in) provided by operating activities |
$ | (15,502,600 | ) | $ | 3,067,599 | |||
Net cash used in investing activities |
(1,893,766 | ) | (5,353,607 | ) | ||||
Net cash used in financing activities |
(5,532,159 | ) | (91,699 | ) | ||||
|
|
|
|
|||||
Net decrease in cash, cash equivalents, and restricted cash |
$ | (22,928,525 | ) | $ | (2,377,707 | ) | ||
|
|
|
|
2021 |
2020 |
|||||||
Net cash provided by operating activities |
$ | 3,758,584 | $ | 10,004,795 | ||||
Net cash used in investing activities |
(10,943,657 | ) | (12,722,702 | ) | ||||
Net cash provided by financing activities |
34,119,708 | 8,982,321 | ||||||
|
|
|
|
|||||
Net increase in cash, cash equivalents, and restricted cash |
$ | 26,934,635 | $ | 6,264,414 | ||||
|
|
|
|
Payments Due by Period |
||||||||||||||||||||
Total |
Less than 1 year |
1-3 years |
3-5 years |
Over 5 years |
||||||||||||||||
Notes payable (1) |
$ | 25,013 | $ | 25,013 | $ | — | $ | — | $ | — | ||||||||||
Operating lease liabilities (2) |
2,325,090 | 619,587 | 1,705,503 | — | — | |||||||||||||||
Finance lease liabilities (2) |
6,609,111 | 213,790 | 807,835 | 802,992 | 4,784,494 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total |
$ | 8,959,214 | $ | 858,390 | $ | 2,513,338 | $ | 802,992 | $ | 4,784,494 | ||||||||||
|
|
|
|
|
|
|
|
|
|
(1) | One remaining annual payment on the purchase of a tractor. |
(2) | We are party to certain contractual arrangements for equipment, lab space, and an animal facility, which meet the definition of leases under FASB ASC Topic 842, Leases |
• | the prices at which we most-recently sold preferred shares and the superior rights and preferences of the preferred shares relative to our common shares at the time of each grant; |
• | the lack of liquidity of our equity as a private company; |
• | our stage of development and business strategy and the material risks related to our business and industry; |
• | our financial condition and operating results, including our levels of available capital resources and forecasted results; |
• | developments in our business, including the achievement of milestones such as entering into partnering agreements; |
• | the valuation of publicly traded companies in the life sciences, biopharmaceutical and healthcare technology sectors, as well as recently completed mergers and acquisitions of peer companies; |
• | any external market conditions affecting our industry, and trends within our industry; |
• | the likelihood of achieving a liquidity event for the holders of our preferred shares and holders of our common shares, such as an initial public offering, or IPO, or a sale of our company, given prevailing market conditions; and |
• | the analysis of IPOs and the market performance of similar companies in our industry. |
June 30, 2022 |
December 31, 2021 |
(Initial Measurement) October 22, 2021 |
||||||||||
Risk-free interest rate |
3.00 | % | 1.24 | % | 1.22 | % | ||||||
Expected term remaining (years) |
4.31 | 4.81 | 5.00 | |||||||||
Implied volatility |
73.0 | % | 43.0 | % | 25.5 | % | ||||||
Closing common stock price on the measurement date |
$ | 1.45 | $ | 7.81 | $ | 8.44 |
• | being permitted to present only two years of audited financial statements and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations in this prospectus; |
• | not being required to comply with the auditor attestation requirements on the effectiveness of our internal controls over financial reporting; |
• | not being required to comply with any requirement that may be adopted by the PCAOB regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis); |
• | reduced disclosure obligations regarding executive compensation arrangements; and |
• | exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. |
• | Established proof-of-concept |
• | Fully enrolled Phase 2a challenge study for SAB-176 in adults infected with influenza virus. |
• | Advanced to Phase 3 of NIH-Sponsored ACTIV-2 Trial based upon DSMB at interim analysis for SAB-185 (COVID-19) and reached 50% enrollment. |
• | Announced topline data demonstrating that SAB-176 met its primary endpoint in our Phase 2a challenge study in adults infected with influenza virus. |
• | Announced that recent data demonstrated that SAB-185 retains neutralization activity against the Omicron variant of SARS-CoV-2 |
• | Reported positive topline Phase 2 virology data demonstrating SAB-185 met Criteria for advancement to Phase 3. |
• | Develop Immunogen for Disease Target |
• | Hyperimmunize Tc Bovine |
• | Collect Plasma |
• | Isolate Human Antibodies |
• | Proprietary Pipeline Programs |
• | Partner Collaborations |
• | Rapid Product Development for Global Public Health Security |
• | Polyclonal antibodies have natural multivalency that can be effective against highly-mutating viruses and other diseases with epitope mutations or variants, due to the large number of different antibodies and their ability to bind to or block multiple epitopes. |
• | Polyclonal antibodies are the natural way our bodies fight disease as they work organically with the rest of the immune system to activate effector cell function, which are the cells that defend the body in an immune response. |
• | Polyclonal antibodies can be rapidly and consistently produced to target many different diseases, and the regulatory pathway for plasma-derived polyclonal antibodies allows for broad potency to multiple disease targets within a single drug product vial. Our pAbs can be used as both pre- and post-exposure prophylaxis and treatments. |
• | Our discovery and polyclonal antibody production process can occur simultaneously using our DiversitAb platform, which accelerates development of our pAbs by leveraging the natural antibody selection that occurs in our Tc Bovine. |
• | We have a demonstrated regulatory pathway through the Center for Biologics Evaluation and Research (CBER) that understands our science and is familiar with the multivalent and multitarget properties of our single vial drug products. This further streamlines our ability to rapidly and efficiently develop new and novel drug products where mAbs simply can’t replicate or duplicate our drug product attributes. |
1. |
Fully Human Target Specific High Potency Antibodies |
2. |
Natural Multivalent and Effector Function Properties of Polyclonal Antibodies |
3. |
Multitarget Polyclonal Antibody Diversity in a Single Vial Designed to Effectively Treat Complex Disease |
4. |
Rapid Product Development Capability with Proven Regulatory Pathway |
• | Multi-targeting |
• | Multivalency |
• | Metastasis Prevention |
• | Effector Function |
• | Replicability |
• | Granted U.S. patent relating to methods of cloning a non-human mammal using transgenic ungulate embryos of one or more cells that have a human chromosome fragment and transgenic ungulate embryos of one or more cells that have a human chromosome fragment, and methods for making them (expiring in 2023 and 2025). |
• | Granted patents in the U.S., Europe, Japan, and other major markets relating to a human artificial chromosome vector comprising a gene encoding the human antibody heavy chain, a gene encoding the human antibody light chain, and a gene encoding IgM heavy chain constant region derived (at least in part) from a nonhuman animal (expiring in 2033). |
• | Granted patents U.S., Europe, Japan, and other major markets relating to large-scale production of human antibodies by transgenic animals with high production of fully human IgG of at least 1 g/L in sera (expiring in 2030 and in the U.S., 2031). |
• | A granted U.S. patent relating to reprogramming a call to express a T-cell receptor reactive with an antigen of interest (expiring in 2025). |
• | A granted U.S. patent and a pending U.S. application relating to methods for producing human antibodies against a pathogen comprising injecting a non-human animal with a viral pathogen-derived DNA vaccine in at least two locations of the animal (expiring in 2036). |
• | Granted U.S. patents covering cloned transgenic ungulates (e.g., bovines) in which prion protein activity is reduced by one or more genetically engineered mutations (expiring in 2023 and 2025). |
• | Related to anti-thymocyte globulin (ATG) products, pending patent applications in the U.S., Europe, Japan, and other major markets covering ungulate-derived polyclonal immunoglobulin compositions comprising fully human or substantially human immunoglobulins that specifically bind human thymocytes, T cells, B cells, and/or monocytes, and methods of making and using the same in treating or preventing organ transplant rejection or type 1 diabetes (if issued, naturally expiring in 2041). |
• | Pending international and U.S. patent applications covering ungulate-derived human immunoglobulins that specifically bind coronavirus S protein, and methods of making and using the same in treating or preventing coronavirus disease (if issued, naturally expiring in 2041). |
• | Pending U.S. provisional application covering ungulate-derived human immunoglobulins that specifically bind influenza antigen, and methods of making and using the same in treating or preventing influenza (if issued, naturally expiring in 2042). |
• | Complex chromosome engineering trade secrets. |
• | Immunogen dose levels used for nucleotides, peptides, proteins, closely autologous proteins, virus particles, whole inactivated viruses, cell membranes, whole cells, bacteria, glycol-proteins, human cell immunogens, tissue preparation. |
• | Our adjuvants formulations for immunogen hyperimmunization. |
• | Bovine plasma fractionation procedures and trade secrets contained within our proprietary Standard Operating Procedures. |
• | Animal husbandry procedures for human antibody-producing ungulates. |
• | Transgenic neo-natal ungulate IVIG administration for failure of passive immunity. |
• | Certain cell culture and cloning practices. |
• | Plasma collection procedures. |
• | completion of nonclinical laboratory tests and animal studies according to Good Laboratory Practices (GLPs), and the Animal Welfare Act administered and enforced by the U.S. Department of Agriculture; |
• | submission to CVM of an application for an INAD, which must become effective before human clinical trials may begin; |
• | preparation of clinical trial material in accordance with Good Manufacturing Practices (GMPs); |
• | submission to the FDA of an application for an Investigational New Drug Application (IND), which must become effective prior to beginning any human clinical trials; |
• | approval of the protocol and related documentation by an institutional review board (IRB) or ethics committee at each clinical site prior to initiation of each clinical trial; |
• | performance of adequate and well-controlled human clinical trials according to Good Clinical Practices (GCPs), and any additional requirements for the protection of human research subjects and their health information to establish the safety, purity, potency, and efficacy of the proposed biologic product for its intended use; |
• | preparation of and submission to CVM of a NADA for marketing approval that includes sufficient evidence of establishing the safety, purity, and potency of the proposed altered genome in animals for its intended indication, including from results of nonclinical testing and clinical trials; |
• | submission to the FDA of a BLA for marketing approval that includes substantive evidence of safety, purity, potency, and efficacy from results of nonclinical testing and clinical trials; |
• | payment of user fees for FDA review of the NADA and BLA, unless a fee waiver applies; |
• | satisfactory completion of an FDA inspection prior to a BLA approval of the manufacturing facility or facilities where the biologic product is produced to assess compliance with GMPs to assure that the facilities, methods, and controls are adequate to preserve the biologic’s identity, strength, quality and purity; |
• | potential FDA audit of the nonclinical and clinical study sites that generated the data in support of the NADA and BLA; |
• | potential FDA Advisory Committee meeting to elicit expert input on critical issues, including a vote by external committee members; |
• | FDA review and approval of the NADA and BLA, which may be performed in parallel, but the NADA must be granted before a final decision can be made on the BLA, resulting in the licensure of the biological product for commercial marketing; and |
• | compliance with any post-approval requirements, including the potential requirement to implement a REMS, and the potential requirement to conduct post-approval studies. |
• | Phase 1 |
• | Phase 2 |
• | Phase 3 |
• | Centralized Procedure so-called Community Marketing Authorization is issued by the European Commission, based on the opinion of the Committee for Medicinal Products for Human Use of the EMA. The Community Marketing Authorization is valid throughout the entire territory of the European Economic Area (EEA) (which includes the 28 Member States of the European Union plus Norway, Liechtenstein, and Iceland). The Centralized Procedure is mandatory for certain types of products, such as biotechnology medicinal products, orphan medicinal products, and medicinal products indicated for the treatment of AIDS, cancer, neurodegenerative disorders, diabetes, auto immune and viral diseases. The Centralized Procedure is optional for products containing a new active substance not yet authorized in the EEA, or for products that constitute a significant therapeutic, scientific, or technical innovation or which are in the interest of public health in the European Union. |
• | For medicines that do not fall within these categories, an applicant has the option of submitting an application for a centralized marketing authorization to the EMA, as long as the medicine concerned is a significant therapeutic, scientific, or technical innovation, or if its authorization would be in the interest of public health. |
• | National Authorization Procedures |
• | Decentralized Procedure. Using the Decentralized Procedure, an applicant may apply for simultaneous authorization in more than one European Union country of medicinal products that have not yet been authorized in any European Union country and that do not fall within the mandatory scope of the centralized procedure. Under the Decentralized Procedure the applicant chooses one country as Reference Member State. The regulatory authority of the Reference Member State will then be in charge of leading the assessment of the marketing authorization application. |
• | Mutual Recognition Procedure. In the Mutual Recognition Procedure, a medicine is first authorized in one European Union Member State, in accordance with the national procedures of that country. Following this, further marketing authorizations can be sought from other European Union countries in a procedure whereby the countries concerned agree to recognize the validity of the original, national marketing authorization. |
• | The federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, paying, receiving or providing any remuneration (including any kickback, bribe, or certain rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid; a person or entity need not have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it in order to have committed a violation. The term “remuneration” has been broadly interpreted to include anything of value; |
• | Federal false claims and false statement laws, including the federal civil False Claims Act, prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment or approval that are false, fictitious or fraudulent; knowingly making, using, or causing to be made or used, a false statement or record material to a false or fraudulent claim or obligation to pay or transmit money or property to the federal government; or knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay money to the federal government. Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. In addition, the government may assert that a claim that includes items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act. The FCA also permits a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery. When an entity is determined to have violated the federal civil False Claims Act, the government may impose civil fines and penalties for each false claim, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs; |
• | The federal civil monetary penalties laws, which impose civil fines for, among other things, the offering or transfer or remuneration to a Medicare or state healthcare program beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state health care program, unless an exception applies; |
• | The Health Insurance Portability and Accountability Act of 1996, or HIPAA, created additional federal criminal statutes that prohibit among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, or falsifying, concealing or covering up a material fact or making any false, fictitious, or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services; |
• | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations, impose, among other things, specified requirements on covered entities and their business associates relating to the privacy and |
security of individually identifiable health information including mandatory contractual terms and required implementation of technical safeguards of such information. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates in some cases, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions; |
• | The federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to CMS information related to payments or other “transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. Beginning in 2022, applicable manufacturers also will be required to report such information regarding payments and transfers of value provided during the previous year to physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified nurse anesthetists and certified nurse-midwives; |
• | Federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; and |
• | The Foreign Corrupt Practices Act, or FCPA, prohibits U.S. businesses and their representatives from offering to pay, paying, promising to pay, or authorizing the payment of money or anything of value to a foreign official to influence any act or decision of the foreign official in his or her official capacity or to secure any other improper advantage to obtain or retain business. |
Name | Age | Position(s) | ||||
Samuel J. Reich |
47 | Class III Director and Executive Chairman of the Board | ||||
Christine Hamilton, MBA |
66 | Class III Director | ||||
Eddie J. Sullivan, PhD |
56 | Class III Director, President and Chief Executive Officer | ||||
Jeffrey G. Spragens |
80 | Class II Director | ||||
William Polvino, MD |
61 | Class I Director | ||||
David Link, MBA |
66 | Class II Director | ||||
Scott Giberson |
53 | Class I Director | ||||
Russell P. Beyer, MBA, CMA |
67 | Chief Financial Officer | ||||
Alexandra Kropotova |
49 | Chief Medical Officer | ||||
Cristoph Bausch, PhD |
51 | Chief Science Officer |
• | each Class I director having a term that expires immediately following our annual meeting of stockholders for the calendar year ended December 31, 2025; |
• | each Class II director having a term that expires immediately following our annual meeting of stockholders for the calendar year ended December 31, 2023; and |
• | each Class III director having a term that expires immediately following our annual meeting of stockholders for the calendar year ended December 31, 2024 |
• | the appointment, compensation, retention, replacement, and oversight of the work of the independent registered public accounting firm engaged by us; |
• | pre-approving all audit and permitted non-audit services to be provided by the independent registered public accounting firm engaged by us, and establishing pre-approval policies and procedures; |
• | setting clear hiring policies for employees or former employees of the independent registered public accounting firm, including but not limited to, as required by applicable laws and regulations; |
• | setting clear policies for audit partner rotation in compliance with applicable laws and regulations; |
• | obtaining and reviewing a report, at least annually, from the independent registered public accounting firm describing (i) the independent registered public accounting firm’s internal quality-control procedures, (ii) any material issues raised by the most recent internal quality-control review, or peer review, of the audit firm, or by any inquiry or investigation by governmental or professional authorities within the preceding five years respecting one or more independent audits carried out by the firm and any steps taken to deal with such issues and (iii) all relationships between the independent registered public accounting firm and us to assess the independent registered public accounting firm’s independence; |
• | reviewing and approving any related party transaction required to be disclosed pursuant to Item 404 of Regulation S-K promulgated by the SEC prior to us entering into such transaction; and |
• | reviewing with management, the independent registered public accounting firm, and our legal advisors, as appropriate, any legal, regulatory or compliance matters, including any correspondence with regulators or government agencies and any employee complaints or published reports that raise material issues regarding our financial statements or accounting policies and any significant changes in accounting standards or rules promulgated by the Financial Accounting Standards Board, the SEC or other regulatory authorities. |
• | reviewing and approving on an annual basis the corporate goals and objectives relevant to our Chief Executive Officer’s compensation, if any is paid by us, evaluating our Chief Executive Officer’s performance considering such goals and objectives and determining and approving the remuneration (if any) of our Chief Executive Officer based on such evaluation; |
• | reviewing and approving on an annual basis the compensation, if any is paid by us, of all our other officers; |
• | reviewing on an annual basis our executive compensation policies and plans; |
• | implementing and administering our incentive compensation equity-based remuneration plans; |
• | assisting management in complying with our proxy statement and annual report disclosure requirements; |
• | approving all special perquisites, special cash payments and other special compensation and benefit arrangements for our officers and employees; |
• | if required, producing a report on executive compensation to be included in our annual proxy statement; and |
• | reviewing, evaluating, and recommending changes, if appropriate, to the remuneration for directors. |
• | screening and reviewing individuals qualified to serve as directors, consistent with criteria approved by the board, and recommending to the board of directors’ candidates for nomination for election at the annual meeting of stockholders or to fill vacancies on the board of directors; |
• | developing and recommending to the board of directors and overseeing implementation of our corporate governance guidelines; and |
• | reviewing on a regular basis our overall corporate governance and recommending improvements as and when necessary. |
Name and Principal Position |
Year |
Salary ($) |
Option Awards (1) ($) |
Non-Equity Incentive Plan Compensation ($) |
All Other Compensation ($) |
Total ($) |
||||||||||||||||||
Eddie J. Sullivan, PhD. |
2021 | 376,154 | — | 140,000 | 10,667 | 526,821 | ||||||||||||||||||
President and Chief Executive Officer |
2020 | 344,615 | — | 124,500 | 9,750 | 478,865 | ||||||||||||||||||
Samuel J. Reich (2) (5) |
2021 | 52,731 | 2,741,235 | — | 1,660 | 2,795,626 | ||||||||||||||||||
Executive Chairman of the Board of Directors |
2020 | — | — | — | — | — | ||||||||||||||||||
Melissa Ullerich (3) (5) |
2021 | 256,196 | 870,751 | 266,126 | — | 1,393,073 | ||||||||||||||||||
Former EVP, Chief of Corporate Communications, Investor Relations Officer (4) |
2020 | — | — | — | — | — |
(1) | Represents the aggregate grant date fair value of stock option awards granted in the respective fiscal year as computed in accordance with FASB ASC Topic 718, Compensation — Stock Compensation |
(2) | We granted Samuel J. Reich a stock option to purchase up to 350,000 shares of our common stock at an exercise price of $11.17 per share, the closing price of our common stock on November 17, 2021. The shares subject to this stock option award will vest as to 33.3% of the shares on October 25, 2022, and vest as to the remainder of the shares in 24 equal monthly installments thereafter. |
(3) | We granted Melissa Ullerich a stock option to purchase up to 104,689 shares of our common stock at an exercise price of $4.04 per share, an estimate of the fair value of our common stock determined with the assistance of an independent third-party valuation firm. The shares subject to this stock option award vested as to 33.3% of the shares on March 29, 2021, and vest as to the remainder of the shares in 24 equal monthly installments thereafter. |
(4) | As of May 2022, Melissa Ullerich ceased being an executive officer and is no longer employed by the Company. |
(5) | The employment of each Mr. Reich and Ms. Ullerich commenced in our 2021 fiscal year, and each received no compensation during our 2020 fiscal year. |
Name |
Fees Earned or Paid in Cash ($) |
Option Awards (1) ($) |
Stock Awards (1) ($) |
Total ($) |
||||||||||||
Samuel J. Reich |
— | 2,741,235 | — | 2,741,235 | ||||||||||||
Christine Hamilton, MBA |
25,000 | — | — | 25,000 | ||||||||||||
Eddie J. Sullivan, PhD |
— | — | — | — | ||||||||||||
Mervyn Turner, PhD.(2) |
25,000 | — | — | 25,000 | ||||||||||||
Jeffrey G. Spragens |
— | — | — | — | ||||||||||||
William Polvino, MD |
25,000 | — | — | 25,000 | ||||||||||||
David Link, MBA |
25,000 | — | — | 25,000 | ||||||||||||
Scott Giberson(2) |
— | — | — | — |
(1) | Represents the aggregate grant date fair value of stock option awards granted in the respective fiscal year as computed in accordance with FASB ASC Topic 718, Compensation — Stock Compensation. The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option valuation model. A discussion of the assumptions used in calculating the amounts in this column may be found in the Notes to our audited consolidated financial statements for the year ended December 31, 2021 set forth in our annual report on Form 10-K. These amounts do not represent the actual amounts paid to or realized by the executives during the fiscal years presented. |
(2) | Mr. Giberson was elected as a director on July 6, 2022 at the Company’s 2022 Annual Meeting of Stockholders, and therefore received no compensation during the fiscal year ended December 31, 2022. Mr. Giberson replaced Dr. Turner, who retired in July 2022 and was replaced as a member of the board of directors at the time of Mr. Giberson’s election by the Company’s stockholders. |
Option Awards |
Stock Awards |
|||||||||||||||||||||||||
Name |
Number of Securities Underlying Unexercised Options (#) Exercisable |
Number of Securities Underlying Unexercised Options (#) Unexercisable |
Option Exercise Price ($) |
Option Expiration Date |
Number of Shares or Units of Stock That Have Not Vested (#) Exercisable |
Market Value of Shares or Units of Stock That Have Not Vested ($) |
||||||||||||||||||||
Eddie J. Sullivan, PhD. |
139,585 | — | 0.54 | 8/4/2024 | — | — | ||||||||||||||||||||
162,850 | — | 0.54 | 12/11/2024 | |||||||||||||||||||||||
162,850 | — | 0.54 | 12/11/2024 | |||||||||||||||||||||||
23,264 | — | 2.69 | 4/26/2030 | |||||||||||||||||||||||
Samuel J. Reich |
(1) | — | 350,000 | 11.17 | 11/16/2031 | — | — | |||||||||||||||||||
Melissa Ullerich (3) |
58,161 | — | 2.15 | 10/31/2028 | — | — | ||||||||||||||||||||
6,979 | — | 2.69 | 4/26/2030 | |||||||||||||||||||||||
(2) | 61,068 | 43,621 | 4.04 | 6/16/2031 |
(1) | The shares subject to this stock option award will vest as to 33.3% of the shares on October 25, 2022, and vest as to the remainder of the shares in 24 equal monthly installments thereafter. |
(2) | The shares subject to this stock option award vested as to 33.3% of the shares on March 29, 2021, and vest as to the remainder of the shares in 24 equal monthly installments thereafter. |
(3) | As of May 2022, Melissa Ullerich ceased being an executive officer and is no longer employed by the Company. |
• | stock options, including incentive stock options, or ISOs; |
• | stock appreciation rights, or SARs; |
• | restricted shares; |
• | deferred stock; |
• | restricted stock units; |
• | performance units and performance shares; |
• | dividend equivalents; |
• | bonus shares; and |
• | other stock-based awards. |
• | 149,645 of the Restricted Shares will become fully vested and unrestricted if, within the Vesting Period, the volume weighted share price of the Company’s common stock equals or exceeds $15.00 during at least 20 trading days within a 30-day trading period; |
• | 149,645 of the Restricted Shares will become fully vested and unrestricted if, within the Vesting Period, the volume weighted share price of the Company’s common stock equals or exceeds $20.00 during at least 20 trading days within a 30-day trading period; |
• | 149,645 of the Restricted Shares will become fully vested and unrestricted if, within the Vesting Period, the volume weighted share price of the Company’s common stock equals or exceeds $25.00 during at least 20 trading days within a 30-day trading period; and |
• | 149,645 of the Restricted Shares will become fully vested and unrestricted if, within the Vesting Period, the volume weighted share price of the Company’s common stock equals or exceeds $30.00 during at least 20 trading days within a 30-day trading period; |
• | the related person’s interest in the related person transaction; |
• | the approximate dollar value of the amount involved in the related person transaction; |
• | the approximate dollar value of the amount of the related person’s interest in the transaction without regard to the amount of any profit or loss; |
• | whether the transaction was undertaken in the ordinary course of business of the Company; |
• | whether the transaction with the related person is proposed to be, or was, entered into on terms no less favorable to the Company than terms that could have been reached with an unrelated third party; |
• | the purpose of, and the potential benefits to the Company of, the transaction; and |
• | any other information regarding the related person transaction or the related person in the context of the proposed transaction that would be material to investors in light of the circumstances of the particular transaction. |
• | each person known to be the beneficial owner of more than 5% of our outstanding common stock; |
• | each of our executive officers and directors; and |
• | all of our executive officers and directors as a group. |
Beneficial Owner |
Number of Shares Beneficially Owned |
Percentage of Common Stock Beneficially Owned |
Shares Beneficially Owned After Offering |
Percentage of Shares Beneficially Owned After Offering |
||||||||||||
Five Percent Stockholders |
||||||||||||||||
Christine Hamilton, MBA (1) |
8,607,426 | 20.0 | % | 8,607,426 | 20.0 | % | ||||||||||
Eddie J. Sullivan, PhD (2) |
5,705,113 | 13.3 | % | 5,705,113 | 13.3 | % | ||||||||||
Executive Officers and Directors |
||||||||||||||||
Christine Hamilton, MBA (1) |
8,601,610 | 20.0 | % | 8,601,610 | 20.0 | % | ||||||||||
Eddie J. Sullivan, PhD (2) |
5,705,113 | 13.3 | % | 5,705,113 | 13.3 | % | ||||||||||
Samuel J. Reich (3) |
964,299 | 2.2 | % | 964,299 | 2.2 | % | ||||||||||
Jeffrey G. Spragens (4) |
312,002 | * | % | 312,002 | * | % | ||||||||||
William Polvino, MD (5) |
81,424 | * | % | 81,424 | * | % | ||||||||||
David Link, MBA (6) |
91,893 | * | % | 91,893 | * | % | ||||||||||
Scott Giberson |
— | * | % | — | * | % | ||||||||||
All current executive officers and directors as a group (10 persons) |
16,359,686 |
38.0 | % | 16,359,686 |
38.0 | % |
* |
Less than 1%. |
(1) | Consists of (i) 4,983,090 shares of common stock held by Ms. Hamilton; (ii) 91,261 shares of common stock held as a co-owner by Ms. Hamilton with her spouse, Dr. Edward Hamilton; (iii) 2,909,022 shares of common stock held by Ms. Hamilton’s spouse, Dr. Edward Hamilton; (iv) 25,000 shares held by Christiansen Investments; (v) 133,768 shares of common stock underlying stock options held by Ms. Hamilton exercisable within 60 days of July 29, 2022; and (vi) 465,285 shares of common stock underlying stock options held by her spouse, Dr. Edward Hamilton, exercisable within 60 days of July 29, 2022. Ms. Hamilton is a control person with voting and dispositive power over shares of Christiansen |
Investments and is deemed to have beneficial ownership of the shares held by Christiansen Investments. Ms. Hamilton disclaims beneficial ownership of such securities except to the extent of her pecuniary interest therein, directly or indirectly. |
(2) | Consists of (i) 5,216,564 shares of common stock held by Dr. Sullivan; and (ii) 488,549 shares of common stock underlying stock options held by Dr. Sullivan exercisable within 60 days of July 29, 2022. |
(3) | Consists of (i) 207,001 shares of common stock held by Mr. Reich; (ii) 1,000 shares of common stock held jointly by Mr. Reich and Mr. Reich’s spouse; (iii) 547,698 of shares of common stock held by Big Cypress Holdings, LLC that are subject to vesting during a period of up to five years after October 22, 2021, which is the Business Combination Closing Date; and (iv) 208,600 shares of common stock underlying warrants that are currently exercisable. Mr. Reich is a managing member with voting and dispositive power over shares of Big Cypress Holdings, LLC and is deemed to have beneficial ownership of the shares held by Big Cypress Holdings, LLC. Mr. Reich disclaims beneficial ownership of such securities except to the extent of his pecuniary interest therein, directly or indirectly. |
(4) | Consists of 13,000 shares of common stock acquired by Mr. Spragens in open market transactions and 299,002 shares of common stock distributed to Mr. Spragens as a member of Big Cypress Holdings, LLC. |
(5) | Consists of 81,424 shares of common stock underlying stock options held by Dr. Polvino exercisable within 60 days of July 29, 2022. |
(6) | Consists of (i) 15,820 shares of common stock held by Mr. Link; (ii) 12,097 of shares of common stock held by Iron Horse Investments, LLC; and (iii) 63,976 shares of common stock underlying stock options held by Mr. Link exercisable within 60 days of July 29, 2022. Mr. Link is a control person with voting and dispositive power over shares of Iron Horse Investments, LLC and is deemed to have beneficial ownership of the shares held by Iron Horse Investments, LLC. Mr. Link disclaims beneficial ownership of such securities except to the extent of his pecuniary interest therein, directly or indirectly. |
• | a stockholder who owns 15% or more of our outstanding voting stock (otherwise known as an “interested stockholder”); |
• | an affiliate of an interested stockholder; or |
• | an associate of an interested stockholder, for three years following the date that the stockholder became an interested stockholder. |
• | our board of directors approves the transaction that made the stockholder an “interested stockholder,” prior to the date of the transaction; |
• | after the completion of the transaction that resulted in the stockholder becoming an interested stockholder, that stockholder owned at least 85% of our voting stock outstanding at the time the transaction commenced, other than statutorily excluded shares of common stock; or |
• | on or subsequent to the date of the transaction, our initial business combination is approved by our board of directors and authorized at a meeting of our stockholders, and not by written consent, by an affirmative vote of at least two-thirds of the outstanding voting stock not owned by the interested stockholder. |
• | U.S. expatriates and former citizens or long-term residents of the United States; |
• | persons holding the Securities as part of a hedge, straddle or other risk reduction strategy or as part of a conversion transaction or other integrated investment; |
• | banks, insurance companies, and other financial institutions; |
• | brokers, dealers or traders in securities; |
• | “controlled foreign corporations,” “passive foreign investment companies,” and corporations that accumulate earnings to avoid U.S. federal income tax; |
• | partnerships or other entities or arrangements treated as partnerships for U.S. federal income tax purposes (and investors therein); |
• | tax-exempt organizations or governmental organizations; |
• | persons deemed to sell the Securities under the constructive sale provisions of the Code; |
• | persons subject to special tax accounting rules as a result of any item of gross income with respect to the Securities being taken into account in an “applicable financial statement” (as defined in the Code); |
• | persons who hold or receive the Securities pursuant to the exercise of any employee stock option or otherwise as compensation; |
• | tax-qualified retirement plans; and |
• | “qualified foreign pension funds” as defined in Section 897(l)(2) of the Code and entities all of the interests of which are held by qualified foreign pension funds. |
• | an individual who is a citizen or resident of the United States; |
• | a corporation (or other entity treated as a corporation for U.S. federal income tax purposes) created or organized under the laws of the United States, any state thereof, or the District of Columbia; |
• | an estate, the income of which is subject to U.S. federal income tax regardless of its source; or |
• | a trust that (1) is subject to the primary supervision of a U.S. court and one or more “United States persons” (within the meaning of Section 7701(a)(30) of the Code) have the authority to control substantial decisions of the trust, or (2) has made a valid election under applicable Treasury Regulations to continue to be treated as a United States person for U.S. federal income tax purposes. |
• | fails to furnish the holder’s taxpayer identification number, which for an individual is ordinarily his or her social security number; |
• | furnishes an incorrect taxpayer identification number; |
• | is notified by the IRS that the holder previously failed to properly report payments of interest or dividends; or |
• | fails to certify under penalties of perjury that the holder has furnished a correct taxpayer identification number and that the IRS has not notified the holder that the holder is subject to backup withholding. |
• | the gain is effectively connected with the non-U.S. holder’s conduct of a trade or business within the United States (and, if required by an applicable income tax treaty, the non-U.S. holder maintains a permanent establishment in the United States to which such gain is attributable); |
• | the non-U.S. holder is a nonresident alien individual present in the United States for 183 days or more during the taxable year of the disposition and certain other requirements are met; or |
• | our warrants or our common stock constitute a U.S. real property interest, or USRPI, by reason of our status as a U.S. real property holding corporation, or USRPHC, for U.S. federal income tax purposes. |
Name |
Number of Shares and Accompanying Warrants |
|||
Raymond James & Associates, Inc. |
||||
Total: |
||||
|
|
Per Share And Accompanying Warrant |
Total No Exercise |
Total Full Exercise |
||||||||||
Public offering price |
||||||||||||
Underwriting discounts and commissions (1) |
||||||||||||
Proceeds, before expenses |
(1) | We have agreed to pay the underwriters a commission of 6.5% of the gross proceeds of this Offering. |
• | offer, sell, agree to offer or sell, solicit offers to purchase, grant any call option or purchase any put option with respect to, pledge, encumber, assign, borrow or otherwise dispose of or transfer, any shares of our stock or options, warrants or other securities with respect to our stock; or |
• | enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of our common stock. |
• | to any legal entity which is a qualified investor as defined under the Prospectus Regulation; |
• | to fewer than 150 natural or legal persons (other than qualified investors as defined under the Prospectus Regulation), subject to obtaining the prior consent of the underwriters; or |
• | in any other circumstances falling within Article 1(4) of the Prospectus Regulation, |
• | to any legal entity which is a qualified investor as defined under Article 2 of the UK Prospectus Regulation; |
• | to fewer than 150 natural or legal persons (other than qualified investors as defined under Article 2 of the UK Prospectus Regulation), subject to obtaining the prior consent of underwriters for any such offer; or |
• | in any other circumstances falling within Section 86 of the FSMA. |
• | the aggregate consideration payable on acceptance of the offer or invitation by each offeree or invitee is at least A$500,000 (its equivalent in another currency, in either case, disregarding moneys lent by the |
person offering the shares of our common stock or making the invitation or its associates) or the offer or invitation otherwise does not require disclosure to investors in accordance with Part 6D.2 or 7.9 of the Corporations Act; |
• | the offer, invitation or distribution complied with the conditions of the Australian financial services license of the person making the offer, invitation or distribution or an applicable exemption from the requirement to hold such license; |
• | the offer, invitation or distribution complies with all applicable Australian laws, regulations and directives (including, without limitation, the licensing requirements set out in Chapter 7 of the Corporations Act); |
• | the offer or invitation does not constitute an offer or invitation to a person in Australia who is a “retail client” as defined for the purposes of Section 761G of the Corporations Act; and |
• | such action does not require any document to be lodged with ASIC or the ASX. |
• | a fund for joint investments in trust (i.e., mutual fund), as such term is defined in the Law for Joint Investments in Trust, 5754-1994, or a management company of such a fund; |
• | a provident fund as defined in Section 47(a)(2) of the Income Tax Ordinance of the State of Israel, or a management company of such a fund; |
• | an insurer, as defined in the Law for Oversight of Insurance Transactions, 5741-1981, (d) a banking entity or satellite entity, as such terms are defined in the Banking Law (Licensing), 5741-1981, other than a joint services company, acting for their own account or for the account of investors of the type listed in Section 15A(b) of the Securities Law 1968; |
• | a company that is licensed as a portfolio manager, as such term is defined in Section 8(b) of the Law for the Regulation of Investment Advisors and Portfolio Managers, 5755-1995, acting on its own account or for the account of investors of the type listed in Section 15A(b) of the Securities Law 1968; |
• | a company that is licensed as an investment advisor, as such term is defined in Section 7(c) of the Law for the Regulation of Investment Advisors and Portfolio Managers, 5755-1995, acting on its own account; |
• | a company that is a member of the Tel Aviv Stock Exchange, acting on its own account or for the account of investors of the type listed in Section 15A(b) of the Securities Law 1968; |
• | an underwriter fulfilling the conditions of Section 56(c) of the Securities Law, 5728-1968; |
• | a venture capital fund (defined as an entity primarily involved in investments in companies which, at the time of investment, (i) are primarily engaged in research and development or manufacture of new technological products or processes and (ii) involve above-average risk); |
• | an entity primarily engaged in capital markets activities in which all of the equity owners meet one or more of the above criteria; and |
• | an entity, other than an entity formed for the purpose of purchasing shares in this Offering, in which the shareholders equity (including pursuant to foreign accounting rules, international accounting regulations and U.S. generally accepted accounting rules, as defined in the Securities Law Regulations (Preparation of Annual Financial Statements), 1993) is in excess of NIS 50 million. |
• | to an institutional investor (as defined in Section 4A of the Securities and Futures Act (Chapter 289) of Singapore, as modified or amended from time to time, or the SFA) pursuant to Section 274 of the SFA; |
• | to a relevant person (as defined in Section 275(2) of the SFA) pursuant to Section 275(1) of the SFA, or any person pursuant to Section 275(1A) of the SFA, and in accordance with the conditions specified in Section 275 of the SFA; or |
• | otherwise pursuant to, and in accordance with the conditions of, any other applicable provision of the SFA. |
• | a corporation (which is not an accredited investor (as defined in Section 4A of the SFA)) the sole business of which is to hold investments and the entire share capital of which is owned by one or more individuals, each of whom is an accredited investor; or |
• | a trust (where the trustee is not an accredited investor) whose sole purpose is to hold investments and each beneficiary of the trust is an individual who is an accredited investor, |
• | to an institutional investor or to a relevant person, or to any person arising from an offer referred to in Section 275(1A) or Section 276(4)(i)(B) of the SFA; |
• | where no consideration is or will be given for the transfer; |
• | where the transfer is by operation of law; |
• | as specified in Section 276(7) of the SFA; or |
• | as specified in Regulation 37A of the Securities and Futures (Offers of Investments) (Securities and Securities-based Derivatives Contracts) Regulations 2018. |
Page |
||||
Unaudited Financial Statements: |
||||
F-2 | ||||
F-3 | ||||
F-4 | ||||
F-5 | ||||
F-6 | ||||
Audited Financial Statements: |
||||
F-28 | ||||
F-29 | ||||
F-30 | ||||
F-31 | ||||
F-32 | ||||
F-33 |
June 30, 2022 |
December 31, 2021 |
|||||||
(Unaudited) |
||||||||
Assets |
||||||||
Current assets |
||||||||
Cash and cash equivalents |
$ | $ | ||||||
Restricted cash |
— | |||||||
Accounts receivable, net |
||||||||
Prepaid expenses |
||||||||
|
|
|
|
|||||
Total current assets |
||||||||
Long-term prepaid insurance |
— | |||||||
Operating lease right-of-use |
||||||||
Financing lease right-of-use |
||||||||
Property, plant and equipment, net |
||||||||
|
|
|
|
|||||
Total assets |
$ |
$ |
||||||
|
|
|
|
|||||
Liabilities and Stockholders’ Equity |
||||||||
Current liabilities |
||||||||
Accounts payable |
$ | $ | ||||||
Forward share purchase liability |
— | |||||||
Notes payable |
||||||||
Operating lease liabilities, current portion |
||||||||
Finance lease liabilities, current portion |
||||||||
Due to related party |
— | |||||||
Deferred grant income |
— | |||||||
Accrued expenses and other current liabilities |
||||||||
|
|
|
|
|||||
Total current liabilities |
||||||||
Operating lease liabilities, noncurrent |
||||||||
Finance lease liabilities, noncurrent |
||||||||
Warrant liabilities |
||||||||
|
|
|
|
|||||
Total liabilities |
||||||||
|
|
|
|
|||||
Commitments and contingencies (Note 17) |
||||||||
Stockholders’ equity |
||||||||
Preferred stock; $ |
||||||||
Common stock; $ June 30, 2022 and December 31, 2021; issued, respectively, and and December 31, 2021, respectively |
||||||||
Treasury stock, at cost; December 31, 2021, respectively |
( |
) | — | |||||
Additional paid-in capital |
||||||||
Accumulated deficit |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Total stockholders’ equity |
||||||||
|
|
|
|
|||||
Total liabilities and stockholders’ equity |
$ |
$ |
||||||
|
|
|
|
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
Revenue |
||||||||||||||||
Grant revenue |
$ | $ | $ | $ | ||||||||||||
Total revenue |
||||||||||||||||
Operating expenses |
||||||||||||||||
Research and development |
||||||||||||||||
General and administrative |
||||||||||||||||
Total operating expenses |
||||||||||||||||
Loss from operations |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Changes in fair value of warrant liabilities |
— | — | ||||||||||||||
Gain on debt extinguishment of Paycheck Protection Program SBA Loan |
— | — | — | |||||||||||||
Interest expense |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Interest income |
||||||||||||||||
Total other income (expense) |
( |
) | ||||||||||||||
Loss before income taxes |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Income tax expense (benefit) |
( |
) | — |
— |
||||||||||||
Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Loss per common share attributable to the Company’s shareholders |
||||||||||||||||
Basic and diluted loss per common share |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Weighted-average common shares outstanding – basic and diluted |
Common stock |
Treasury Stock |
|||||||||||||||||||||||||||
Shares |
Amount |
Additional Paid-In Capital |
Shares |
Amount |
Accumulated Deficit |
Total Stockholders’ Equity |
||||||||||||||||||||||
Balance at December 31, 2021 |
$ |
$ |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Issuance of common stock for exercise of stock options |
— | — | — | |||||||||||||||||||||||||
Forward Share Purchase Agreement, final settlement |
— | — | — | — | — | |||||||||||||||||||||||
Repurchase of common stock pursuant to the Forward Share Purchase Agreement |
— | — | ( |
) | ( |
) | — | — | ||||||||||||||||||||
Stock-based compensation |
— | — | — | — | — | |||||||||||||||||||||||
Net income |
— | — | — | — | — | |||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Balance at March 31, 2022 |
$ |
$ |
( |
$ |
( |
$ |
( |
$ |
||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Issuance of common stock for exercise of stock options |
— |
— |
— | |||||||||||||||||||||||||
Stock-based compensation |
— | — | — | — | — | |||||||||||||||||||||||
Net loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Balance at June 30, 2022 |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) |
$ |
|||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock |
Treasury Stock |
|||||||||||||||||||||||||||
Shares |
Amount |
Additional Paid-In Capital |
Shares |
Amount |
Accumulated Deficit |
Total Stockholders’ Equity |
||||||||||||||||||||||
Balance at December 31, 2020 |
$ |
$ |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Stock-based compensation |
— | — | — | — | — | |||||||||||||||||||||||
Net income |
— | — | — | — | — | |||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Balance at March 31, 2021 |
$ |
$ |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Stock-based compensation |
— | — | — | — | — | |||||||||||||||||||||||
Net loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Balance at June 30, 2021 |
$ |
$ |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
||||||||
2022 |
2021 |
|||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to net cash (used in) provided by operating activities: |
||||||||
Gain on debt extinguishment of Paycheck Protection Program SBA Loan |
— | ( |
) | |||||
Depreciation and amortization |
||||||||
Amortization of right-of-use |
||||||||
Stock-based compensation expense |
||||||||
Gain on sale of equipment |
( |
) | ( |
) | ||||
Changes in fair value of warrant liabilities |
( |
) | — | |||||
Changes in operating assets and liabilities |
||||||||
Accounts receivable |
( |
) | ||||||
Prepaid expenses |
( |
) | ||||||
Operating lease right-of-use |
( |
) | ( |
) | ||||
Accounts payable |
( |
) | ||||||
Due to related party |
( |
) | ( |
) | ||||
Deferred grant income |
( |
) | — | |||||
Accrued expense and other current liabilities |
( |
) | ||||||
|
|
|
|
|||||
Net cash (used in) provided by operating activities |
( |
) |
||||||
|
|
|
|
|||||
Cash flows from investing activities: |
||||||||
Proceeds from the sale of equipment |
— | |||||||
Purchases of equipment |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Net cash used in investing activities |
( |
) |
( |
) | ||||
|
|
|
|
|||||
Cash flows from financing activities: |
||||||||
Payments related to the Forward Share Purchase Agreement |
( |
) | — | |||||
Principal payments on finance leases |
( |
) | ( |
) | ||||
Proceeds from exercise of stock options |
— | |||||||
|
|
|
|
|||||
Net cash used in financing activities |
( |
) |
( |
) | ||||
|
|
|
|
|||||
Net decrease in cash, cash equivalents, and restricted cash |
( |
) | ( |
) | ||||
Cash, cash equivalents, and restricted cash |
||||||||
Beginning of year |
||||||||
|
|
|
|
|||||
End of period |
$ | $ | ||||||
|
|
|
|
|||||
Supplemental disclosures: |
||||||||
Cash paid for interest |
$ | $ |
• | SAB Biotherapeutics’ shareholders have the largest portion of voting rights in the Company; |
• | the Board and Management are primarily composed of individuals associated with SAB Biotherapeutics; |
• | the operations of SAB comprise the ongoing operations of the Company. |
June 30, 2022 |
June 30, 2021 |
|||||||
Cash and cash equivalents |
$ | $ | ||||||
Restricted cash |
||||||||
|
|
|
|
|||||
Total cash, cash equivalents, and restricted cash |
$ | $ | ||||||
|
|
|
|
Animal facility equipment |
||
Laboratory equipment |
||
Leasehold improvements |
||
Office furniture & equipment |
||
Vehicles |
(i) | |
or equal to $ |
(ii) | |
(iii) | |
(iv) | |
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
Calculation of basic and diluted loss per share attributable to the Company’s shareholders |
||||||||||||||||
Net loss attributable to the Company’s shareholders |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Weighted-average common shares outstanding – basic and diluted |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net loss per share, basic and diluted |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) |
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
Stock options |
||||||||||||||||
Common stock warrants |
||||||||||||||||
Earnout Shares (1) |
||||||||||||||||
Contingently issuable Earnout Shares from unexercised Rollover Options |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
||||||||||||||||
|
|
|
|
|
|
|
|
(1) | As the Earnout shares are subject to certain vesting requirements not satisfied as of the three and six months ended June 30, 2022, the Earnout Shares held in escrow are excluded from calculating both basic and diluted earnings per share. |
June 30, 2022 |
December 31, 2021 |
|||||||
Laboratory equipment |
$ | $ | ||||||
Animal facility |
||||||||
Animal facility equipment |
||||||||
Construction-in-progress |
||||||||
Leasehold improvements |
||||||||
Vehicles |
||||||||
Office furniture and equipment |
||||||||
|
|
|
|
|||||
Less: accumulated depreciation and amortization |
||||||||
|
|
|
|
|||||
Property, plant and equipment, net |
$ | $ | ||||||
|
|
|
|
June 30, 2022 |
December 31, 2021 |
|||||||
New office space at Headquarters |
$ | $ | ||||||
Laboratory space at Headquarters |
||||||||
Laboratory equipment at Headquarters |
||||||||
IT equipment at Headquarters |
||||||||
Software |
||||||||
Bioreactors |
||||||||
Other |
||||||||
|
|
|
|
|||||
Total construction-in-progress |
$ | $ | ||||||
|
|
|
|
• | In |
• | In |
• | In |
• | In |
Animal Facility |
||
Equipment |
||
Land |
Operating |
Finance |
|||||||
Weighted-average remaining lease term |
||||||||
Weighted-average discount rate |
% | % |
Operating |
Finance |
|||||||
2022 - remaining |
$ | $ | ||||||
2023 |
||||||||
2024 |
||||||||
2025 |
— | |||||||
2026 |
— | |||||||
Thereafter |
— | |||||||
|
|
|
|
|||||
Undiscounted future minimum lease payments |
||||||||
Less: Amount representing interest payments |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Total lease liabilities |
||||||||
Less current portion |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Noncurrent lease liabilities |
$ | $ | ||||||
|
|
|
|
June 30, 2022 |
December 31, 2021 |
|||||||
Accrued vacation |
$ | $ | ||||||
Accrued payroll |
||||||||
Accrued construction-in-progress |
||||||||
Accrued supplies |
||||||||
Accrued consulting |
||||||||
Accrued clinical trial expense |
||||||||
Accrued outside laboratory services |
||||||||
Accrued bonus & severance |
||||||||
Accrued contract manufacturing |
||||||||
Accrued legal |
||||||||
Accrued financing fees payable |
||||||||
Accrued franchise tax payable |
||||||||
Other accrued expenses |
||||||||
|
|
|
|
|||||
$ | $ | |||||||
|
|
|
|
Options |
Weighted Average Exercise Price |
Weighted Average Remaining Contractual Life (years) |
Aggregate Intrinsic Value |
|||||||||||||
Outstanding options, December 31, 2021 |
$ | $ | ||||||||||||||
Granted |
$ | |||||||||||||||
Forfeited |
( |
) | $ | |||||||||||||
Exercised |
( |
) | $ | |||||||||||||
|
|
|||||||||||||||
Outstanding options, June 30, 2022 |
$ | $ | ||||||||||||||
|
|
|||||||||||||||
Options vested and exercisable, June 30, 2022 |
$ | $ | ||||||||||||||
|
|
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
Expected volatility |
% | % | % | % | ||||||||||||
Weighted-average volatility |
% | % | % | % | ||||||||||||
Expected dividends |
— | % | — | % | — | % | — | % | ||||||||
Expected term (in years) |
||||||||||||||||
Risk-free rate |
% | % | % | % |
Number of shares |
Weighted Average Grant Date Fair Value |
|||||||
Unvested as of December 31, 2021 |
— | $ | — | |||||
Granted |
$ | |||||||
Vested |
— | $ | — | |||||
Forfeited |
— | $ | — | |||||
Unvested as of June 30, 2022 |
$ |
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
Research and development |
$ | $ | $ | $ | ||||||||||||
General and administrative |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | $ | $ | $ | ||||||||||||
|
|
|
|
|
|
|
|
As of June 30, 2022 |
||||||||||||||||
Total |
Quoted Prices In Active Markets (Level 1) |
Significant Other Observable Inputs (Level 2) |
Significant Other Unobservable Inputs (Level 3) |
|||||||||||||
Liabilities: |
||||||||||||||||
Public Warrant liability |
$ | $ | $ | — | $ | — | ||||||||||
Private Placement Warrant liability |
— | — | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | $ | $ | — | $ | |||||||||||
|
|
|
|
|
|
|
|
As of December 31, 2021 |
||||||||||||||||
Total |
Quoted Prices In Active Markets (Level 1) |
Significant Other Observable Inputs (Level 2) |
Significant Other Unobservable Inputs (Level 3) |
|||||||||||||
Liabilities: |
||||||||||||||||
Public Warrant liability |
$ | $ | $ | — | $ | — | ||||||||||
Private Placement Warrant liability |
— | — | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | $ | $ | — | $ | |||||||||||
|
|
|
|
|
|
|
|
• | in whole and not in part; |
• | at a price of $ |
• |
upon not less than 30 days’ prior written notice of redemption (the “30-day redemption period”) to each warrant holder; and |
• | if, and only if, |
• | 30-trading day period ending three business days before the Company send the notice of redemption to the warrant holders. |
June 30, 2022 |
||||
Balance, December 31, 2021 |
$ | |||
Change in fair value of Private Placement Warrant liability |
( |
) | ||
|
|
|||
Balance, March 31, 2022 |
$ | |||
Change in fair value of Private Placement Warrant liability |
( |
) | ||
|
|
|||
Balance, June 30, 2022 |
$ | |||
|
|
June 30, 2022 |
December 31, 2021 |
|||||||
Risk-free interest rate |
% | % | ||||||
Expected term remaining (years) |
||||||||
Implied volatility |
% | % | ||||||
Closing common stock price on the measurement date |
$ | $ |
• | The Company paid consulting fees to a board member, Christine Hamilton, who is also a shareholder, of $ 2021 . |
• | The Company made lease and insurance payments to Dakota Ag Properties of approximately $2021 . Dakota Ag Investments (part of Dakota Ag Properties) is a shareholder of the Company. |
• | The Company made lab supply payments to Sanford Health (which is a shareholder of the Company) totaling approximately $ 2021 . |
/s/ Mayer Hoffman McCann P.C. |
San Diego, California |
March 29, 2022 |
December 31, 2021 |
December 31, 2020 |
|||||||
Assets |
||||||||
Current assets |
||||||||
Cash and cash equivalents |
$ | $ | ||||||
Restricted cash |
— | |||||||
Accounts receivable, net |
||||||||
Prepaid expenses |
||||||||
|
|
|
|
|||||
Total current assets |
||||||||
Operating lease right-of-use |
||||||||
Financing lease right-of-use |
||||||||
Equipment, net |
||||||||
|
|
|
|
|||||
Total assets |
$ |
$ |
||||||
|
|
|
|
|||||
Liabilities and Stockholders’ Equity |
||||||||
Current liabilities |
||||||||
Accounts payable |
$ | $ | ||||||
Forward share purchase liability |
— | |||||||
Notes payable – current portion |
||||||||
Operating lease liabilities, current portion |
||||||||
Finance lease liabilities, current portion |
||||||||
Due to related party |
||||||||
Deferred grant income |
||||||||
Accrued expenses and other current liabilities |
||||||||
|
|
|
|
|||||
Total current liabilities |
||||||||
Operating lease liabilities, noncurrent |
||||||||
Finance lease liabilities, noncurrent |
||||||||
Warrant liabilities |
— | |||||||
Notes payable, noncurrent |
— | |||||||
|
|
|
|
|||||
Total liabilities |
||||||||
|
|
|
|
|||||
Commitments and contingencies (Note 17) |
||||||||
Stockholders’ equity |
||||||||
Preferred stock; $ |
||||||||
Common stock; $ December 31, 2021 and 2020; 2021 and 2020, respectively |
||||||||
Additional paid-in capital |
||||||||
Accumulated deficit |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Total stockholders’ equity |
||||||||
|
|
|
|
|||||
Total liabilities and stockholders’ equity |
$ |
$ |
||||||
|
|
|
|
Year Ended December 31, 2021 |
Year Ended December 31, 2020 |
|||||||
Revenue |
||||||||
Grant revenue |
$ | $ | ||||||
|
|
|
|
|||||
Total revenue |
||||||||
|
|
|
|
|||||
Operating expenses |
||||||||
Research and development |
||||||||
General and administrative |
||||||||
|
|
|
|
|||||
Total operating expenses |
||||||||
|
|
|
|
|||||
(Loss) income from operations |
( |
) | ||||||
Changes in fair value of warrant liabilities |
( |
) | — | |||||
Gain on debt extinguishment of Paycheck Protection Program SBA Loan |
— | |||||||
Other income |
||||||||
Interest expense |
( |
) | ( |
) | ||||
Interest income |
||||||||
|
|
|
|
|||||
Net (loss) income |
$ | ( |
) | $ | ||||
|
|
|
|
|||||
Earnings (loss) per common share attributable to the Company’s shareholders |
||||||||
Basic (loss) earnings per common share |
$ | ( |
) | $ | ||||
Diluted (loss) earnings per common share |
$ | ( |
) | $ | ||||
Weighted-average common shares outstanding – basic |
||||||||
Weighted-average common shares outstanding – diluted |
Redeemable Preferred Stock |
Stockholders’ Equity (Deficit) |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Series A-2A Redeemable Preferred Stock |
Series A Preferred Stock |
Series A-1 Preferred Stock |
Series A-2 Preferred Stock |
Series B Preferred Stock |
Common stock |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
Additional Paid-In Capital |
Accumulated Deficit |
Total Stockholders’ Equity (Deficit) |
||||||||||||||||||||||||||||||||||||||||||||||
Balance at December 31, 2019 (as previously reported) |
$ |
$ |
$ |
$ |
$ |
$ |
$ |
$ |
( |
) |
$ |
( |
) | |||||||||||||||||||||||||||||||||||||||||||||||
Retrospective application of reverse recapitalization |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
— |
|||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||
Balance at December 31, 2019, after effect of Business Combination |
— |
$ |
— |
— |
$ |
— |
— |
$ |
— |
— |
$ |
— |
— |
$ |
— |
$ |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||||||||||||||||||||||
Issuance of stock in private offerings, net of issuance cost of $ |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||||||||||||||||
Net income |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||
Balance at December 31, 2020 |
— |
$ |
— |
— |
$ |
— |
— |
$ |
— |
— |
$ |
— |
— |
$ |
— |
$ |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||
Effect of Business Combination and recapitalization, net of redemptions and issuance costs of $ |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of restricted stock, subject to forfeiture |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||||||||||||||||||
Forward Share Purchase Agreement, partial settlement |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock for exercise of stock options |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||||||||||||||||||||
Net loss |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
— |
( |
) |
( |
) | |||||||||||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||
Balance at December 31, 2021 |
— |
$ |
— |
— |
$ |
— |
— |
$ |
— |
— |
$ |
— |
— |
$ |
— |
$ |
$ |
$ |
( |
) |
$ |
|||||||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, 2021 |
Year ended December 31, 2020 |
|||||||
Cash flows from operating activities: |
||||||||
Net (loss) income |
$ |
( |
) |
$ |
||||
Adjustments to reconcile net (loss) income to net cash provided by operating activities: |
||||||||
Gain on debt extinguishment of Paycheck Protection Program SBA Loan |
( |
) |
— |
|||||
Depreciation and amortization |
||||||||
Amortization of right-of-use |
||||||||
Stock-based compensation expense |
||||||||
Gain on sale of equipment |
( |
) |
( |
) | ||||
Changes in fair value of warrant liabilities |
— |
|||||||
Changes in operating assets and liabilities |
||||||||
Accounts receivable |
( |
) | ||||||
Prepaid expenses |
( |
) | ||||||
Right-of-use |
( |
) |
||||||
Accounts payable |
( |
) |
||||||
Deferred income |
— |
|||||||
Due to related party |
( |
) |
||||||
Accrued expense and other current liabilities |
||||||||
|
|
|
|
|||||
Net cash provided by operating activities |
||||||||
|
|
|
|
|||||
Cash flows from investing activities: |
||||||||
Proceeds from the sale of equipment |
— |
|||||||
Purchases of equipment |
( |
) |
( |
) | ||||
|
|
|
|
|||||
Net cash used in investing activities |
( |
) |
( |
) | ||||
|
|
|
|
|||||
Cash flows from financing activities: |
||||||||
Proceeds from Business Combination, net of transaction costs |
— |
|||||||
Proceeds from the sale of stock, net of issuance costs |
— |
|||||||
Proceeds from Paycheck Protection Program SBA Loan |
— |
|||||||
Payments on related party notes payable |
— |
( |
) | |||||
Payments of notes payable |
( |
) |
( |
) | ||||
Principal payments on finance leases |
( |
) |
( |
) | ||||
Proceeds from exercise of stock options |
— |
|||||||
|
|
|
|
|||||
Net cash provided by financing activities |
||||||||
|
|
|
|
|||||
Net increase in cash, cash equivalents, and restricted cash |
||||||||
Cash, cash equivalents, and restricted cash |
||||||||
Beginning of year |
||||||||
|
|
|
|
|||||
End of year |
$ |
$ |
||||||
|
|
|
|
|||||
Supplemental disclosures: |
||||||||
Cash paid for interest |
$ |
$ |
||||||
Supplemental information on non-cash investing and finance activities: |
||||||||
Right-of-use |
$ |
$ |
||||||
Warrant liabilities assumed related to the Business Combination |
$ |
$ |
— |
|||||
Liabilities assumed related to the Forward Share Purchase Agreement |
$ |
$ |
— |
|||||
Financing fee liabilities assumed related to the Business Combination included in accrued expense and other current liabilities |
$ |
$ |
— |
|||||
Unpaid financing fees included in accrued expense and other current liabilities |
$ |
$ |
— |
• |
SAB Biotherapeutics’ shareholders have the largest portion of voting rights in the Company; |
• |
the Board and Management are primarily composed of individuals associated with SAB Biotherapeutics; |
• |
the operations of SAB comprise the ongoing operations of the Company. |
December 31, 2021 |
December 31, 2020 |
|||||||
Cash and cash equivalents |
$ |
$ |
||||||
Restricted cash |
||||||||
|
|
|
|
|||||
Total cash, cash equivalents, and restricted cash shown in the statement of cash flows |
$ |
$ |
||||||
|
|
|
|
|
|
Animal facility equipment |
||
|
|
Laboratory equipment |
||
|
|
Leasehold improvements |
||
|
|
Office furniture & equipment |
||
|
|
Vehicles |
(i) |
(ii) |
(iii) |
(iv) |
Recapitalization |
||||
Cash - BCYP trust and cash, net of redemptions |
$ | |||
Plus: restricted cash - Forward Share Purchase Agreement |
||||
Less: cash transaction costs allocated to the Company’s equity |
( |
) | ||
|
|
|||
Total |
$ | |||
|
|
Recapitalization |
||||
Cash - BCYP trust and cash, net of redemptions |
$ | |||
Plus: restricted cash - Forward Share Purchase Agreement |
||||
Less: non-cash net working capital assumed from BCYP |
( |
) | ||
Less: forward share purchase liability assumed from BCYP |
( |
) | ||
Less: fair value of redeemable warrants |
( |
) | ||
Less: transaction costs allocated to the Company’s equity |
( |
) | ||
|
|
|||
Total |
$ | |||
|
|
Shares |
||||
Common stock, reedeemable and outstanding prior to Business Combination |
||||
Less: redemption of BCYP shares |
( |
) | ||
|
|
|||
Common stock of BCYP |
||||
BCYP Founder and private shares |
||||
Shares issued for services |
||||
|
|
|||
Total BCYP shares |
||||
SAB Biotherapeutics, Inc and subsidiaries shareholders |
||||
|
|
|||
Total shares of common stock immediately after Business Combination |
||||
|
|
Assets Acquired |
||||
BCYP trust and cash, net of redemptions |
$ | |||
Restricted cash - Forward Share Purchase Agreement |
||||
Other assets |
||||
|
|
|||
Assets acquired |
$ | |||
|
|
|||
Liabilities Assumed |
||||
Forward share purchase liability |
$ | |||
Fair value of redeemable warrants |
||||
Other liabilities and accrued expenses |
||||
|
|
|||
Liabilities assumed |
||||
|
|
|||
Net Assets Acquired |
$ | |||
|
|
Year Ended December 31, 2021 |
||||
Calculation of basic and diluted EPS attributable to the Company’s shareholders |
||||
Net loss attributable to the Company’s shareholders |
$ | ( |
) | |
Weighted-average common shares outstanding – basic and diluted |
||||
|
|
|||
Net loss per common share, basic and diluted |
$ | ( |
) |
Year Ended December 31, 2021 |
||||
Stock options |
||||
Common stock warrants |
||||
Earnout shares (1) |
||||
Contingently issuable earnout shares from unexercised Rollover Options |
||||
|
|
|||
Total |
||||
|
|
(1) |
As the Earnout shares are subject to certain vesting requirements not satisfied as of the year ended December 31, 2021, the Earnout Shares held in escrow are excluded from calculating both basic and diluted earnings per share. |
Year Ended December 31, 2020 |
||||
Calculation of basic EPS attributable to the Company’s shareholders |
||||
Net income attributable to the Company’s shareholders |
$ | |||
Weighted-average common shares outstanding – basic |
||||
|
|
|||
Net earnings per share, basic |
$ | |||
Calculation of diluted EPS attributable to the Company’s shareholders |
||||
Net income attributable to the Company’s shareholders |
$ | |||
Weighted-average common shares outstanding – diluted |
||||
|
|
|||
Net earnings per share, diluted |
$ |
Year Ended December 31, 2020 |
||||
Weighted-average common shares outstanding – basic |
||||
Stock options |
||||
|
|
|||
Total |
||||
|
|
2021 |
2020 |
|||||||
Laboratory equipment |
$ | $ | ||||||
Animal facility |
||||||||
Animal facility equipment |
||||||||
Construction-in-progress |
||||||||
Leasehold improvements |
||||||||
Vehicles |
||||||||
Office furniture and equipment |
||||||||
|
|
|
|
|||||
Less: accumulated depreciation and amortization |
||||||||
|
|
|
|
|||||
Property, plant and equipment net |
$ | $ | ||||||
|
|
|
|
2021 |
2020 |
|||||||
200L commercial facility |
$ | — | $ | |||||
200L commercial facility equipment |
— | |||||||
New animal barn (#6) |
— | |||||||
New office space (at Headquarters) |
||||||||
Laboratory space at Headquarters |
— | |||||||
Lab equipment at Headquarters |
— | |||||||
IT equipment for new office space |
— | |||||||
Software |
— | |||||||
Bioreactors |
— | |||||||
Other |
||||||||
|
|
|
|
|||||
Total construction-in-progress |
$ | $ | ||||||
|
|
|
|
• | In |
• | In |
• | In |
• | In |
Animal Facility |
||
Equipment |
||
Land |
Operating |
Finance |
|||||||
Weighted-average remaining lease term |
||||||||
Weighted-average discount rate |
% | % |
Operating |
Finance |
|||||||
2022 |
$ | $ | ||||||
2023 |
||||||||
2024 |
||||||||
2025 |
||||||||
2026 |
— | |||||||
Thereafter |
— | |||||||
|
|
|
|
|||||
Undiscounted future minimum lease payments |
||||||||
Less: Amount representing interest payments |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Total lease liabilities |
||||||||
Less current portion |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Noncurrent lease liabilities |
$ | $ | ||||||
|
|
|
|
2021 |
2020 |
|||||||
Accrued vacation |
$ | $ | ||||||
Accrued payroll |
||||||||
Accrued construction-in-progress |
||||||||
Accrued supplies |
||||||||
Accrued consulting |
||||||||
Accrued clinical trial expense |
— | |||||||
Accrued outside laboratory services |
— | |||||||
Accrued bonus & severance |
— | |||||||
Accrued contract manufacturing |
— | |||||||
Accrued legal |
— | |||||||
Accrued financing fees payable |
— | |||||||
Accrued franchise tax payable |
— | |||||||
Other accrued expenses |
||||||||
|
|
|
|
|||||
$ | $ | |||||||
|
|
|
|
2021 |
2020 |
|||||||
Tractor loan |
$ | $ | ||||||
PPP loan |
— | |||||||
|
|
|
|
|||||
Total notes payable |
||||||||
Less: notes payable - current portion |
||||||||
|
|
|
|
|||||
Notes payable, noncurrent |
$ | — | $ | |||||
|
|
|
|
Options |
Weighted Average Fair Value |
Weighted Average Exercise Price |
||||||||||
Balance, December 31, 2019 |
$ | $ | ||||||||||
Granted |
$ | $ | ||||||||||
|
|
|||||||||||
Balance, December 31, 2020 |
$ | $ | ||||||||||
Granted |
$ | $ | ||||||||||
Forfeited |
$ | $ | ||||||||||
Exercised |
$ | $ | ||||||||||
|
|
|||||||||||
Balance, December 31, 2021 |
$ | $ | ||||||||||
|
|
|||||||||||
Unvested at December 31, 2021 |
$ | $ | ||||||||||
Vested and exercisable at December 31, 2021 |
$ | $ |
2021 |
2020 |
|||||||
Research and development |
$ | $ | ||||||
General and administrative |
||||||||
|
|
|
|
|||||
Total |
$ | $ | ||||||
|
|
|
|
Total |
Quoted Prices In Active Markets (Level 1) |
Significant Other Observable Inputs (Level 2) |
Significant Other Unobservable Inputs (Level 3) |
|||||||||||||
Liabilities: |
||||||||||||||||
Public Warrant liability |
$ | $ | $ | — | $ | — | ||||||||||
Private Placement Warrant liability |
— | — | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | $ | $ | — | $ | |||||||||||
|
|
|
|
|
|
|
|
• | in whole and not in part; |
• | at a price of $ |
• | if, and only if, 30-trading day period ending three business days before the Company send the notice of redemption to the warrant holders. |
2021 |
||||
Balance, December 31, 2020 |
$ | |||
Initial measurement on the Closing Date |
||||
Change in fair value of Private Placement Warrant liability |
||||
|
|
|||
Balance, December 31, 2021 |
$ | |||
|
|
(Initial Measurement) October 22, 2021 |
December 31, 2021 |
|||||||
Risk-free interest rate |
% | % | ||||||
Expected term remaining (years) |
||||||||
Implied volatility |
% | % | ||||||
Closing common stock price on the measurement date |
$ | $ |
2021 |
2020 |
|||||||
Deferred tax assets: |
||||||||
Net operating loss carryforwards |
$ | $ | ||||||
Stock-based compensation |
||||||||
Vacation accrual |
||||||||
Lease liabilities |
||||||||
Other accrued expenses |
— | |||||||
Start-up costs |
— | |||||||
|
|
|
|
|||||
Total deferred tax assets |
||||||||
|
|
|
|
|||||
Less valuation allowance |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Total deferred tax assets after valuation allowance |
$ | $ | ||||||
|
|
|
|
|||||
Deferred tax liabilities: |
||||||||
Operating lease right-of-use |
||||||||
Depreciation and amortization |
||||||||
|
|
|
|
|||||
Total deferred tax liabilities |
||||||||
|
|
|
|
|||||
Net deferred tax asset (liability) |
$ | — | $ | — | ||||
|
|
|
|
2021 |
2020 |
|||||||||||||||
Rate reconciliation: |
||||||||||||||||
Net (loss) income before tax |
$ | ( |
) | $ | ||||||||||||
Federal income tax at statutory rate |
( |
) | % | % | ||||||||||||
State income tax |
( |
) | % | — | % | |||||||||||
Permanent items |
( |
)% | ( |
)% | ||||||||||||
Valuation allowance |
( |
)% | ( |
) | ( |
)% | ||||||||||
Other |
( |
) | % | — | % | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
$ | % | $ | % | |||||||||||||
|
|
|
|
|
|
|
|
SEC Registration Fee |
$ | 4,797 | ||
FINRA Filing Fee |
8,263 | |||
Accounting Fees and Expenses |
22,500 | |||
Legal Fees and Expenses |
200,000 | |||
Transfer Agent and Registrar Fees and Expenses |
4,500 | |||
Printing and Engraving Expenses |
125,000 | |||
Total Expenses |
$ | 365,060 |
• | On November 12, 2020, BCYP issued 2,156,250 shares of BCYP common stock to the Sponsor for $25,000 in cash, or approximately $0.012 per share, in connection with formation. |
• | On December 7, 2020, the Sponsor forfeited 161,719 shares of BCYP common stock to BCYP and Ladenburg and certain of its employees purchased an aggregate of 161,719 shares of BCYP common stock from BCYP at an average purchase price of approximately $0.012 per share, for an aggregate purchase price of $1,875. |
• | On January 4, 2021, the Sponsor forfeited 28,750 shares of BCYP common stock to BCYP and Ladenburg and certain of its employees purchased from an aggregate of 28,750 shares of BCYP common stock at an average purchase price of approximately $0.008 per share, for an aggregate purchase price of $230. Following the 1/3 common stock dividend effected January 3, 2021 (as described herein), Ladenburg and certain of its employees then held an aggregate of 244,375 shares of BCYP common stock. |
• | Simultaneously with the closing of the BCYP IPO, the Sponsor purchased an aggregate of 417,200 BCYP units, at a price of $10.00 per BCYP unit, for an aggregate purchase price of $4,172,000, in a private placement. A portion of the proceeds from the private placement was added to the proceeds from the BCYP IPO held in the Trust. |
• | In accordance with the terms and subject to the conditions of the Business Combination Agreement, at the Effective Time, (i) each share of common stock and preferred stock of SAB outstanding as of immediately prior to the Effective Time was exchanged for shares of common stock based on Equity Value and a conversion rate of $10.10; (ii) each outstanding vested and unvested option to purchase shares of SAB common stock was exchanged for a comparable option to purchase common stock, based on the Equity Value and a conversion rate of $10.10; and (iii) holders of vested options to purchase shares of SAB common stock received, in the aggregate, 1,507,124 Earnout RSUs related to shares of common stock. Additionally, holders of SAB common stock and preferred stock are entitled to receive their pro rata share of an aggregate of 12,000,000 Earnout Shares, which will be released if certain conditions are met within Earnout Period. |
• | On the Closing Date, BCYP issued 247,525 shares of common stock to Chardan, as fees for their service as Merger and Acquisition Advisor and Capital Markets Advisor. |
Incorporated by Reference |
||||||||||
Exhibit Number |
Description |
Schedule/ Form |
File No. |
Exhibit |
Filing Date | |||||
10.4¥ | Employment Agreement, dated September 15, 2021, by and between SAB Biotherapeutics, Inc. and Russell Beyer. | 8-K |
001-39871 |
10.5*¥ | October 28, 2021 | |||||
10.5 | Form of Indemnification Agreement. | 8-K |
001-39871 |
10.6 | October 28, 2021 | |||||
10.6¥ | SAB Biotherapeutics, Inc. 2021 Omnibus Equity Incentive Plan. | 8-K |
001-39871 |
10.7¥ | October 28, 2021 | |||||
10.7¥ | SAB Biotherapeutics, Inc. 2021 Employee Stock Purchase Plan. | 8-K |
001-39871 |
10.8¥ | October 28, 2021 | |||||
10.8 | Form of Securities Subscription Agreement, dated November 12, 2020, between the BCYP and Big Cypress Holdings LLC. | S-4/A |
333-258869 |
10.3 | September 22, 2021 | |||||
10.9 | Securities Purchase Agreement, dated December 7, 2020, between BCYP and Ladenburg Thalmann & Co. Inc. and certain of its employees. | S-4/A |
333-258869 |
10.4 | September 22, 2021 | |||||
10.10 | Placement Unit Subscription Agreement dated January 11, 2021 between the Company and Big Cypress Holdings LLC. | S-4/A |
333-258869 |
10.5 | September 22, 2021 | |||||
10.11 | BCYP Stockholders Support Agreement. | S-4/A |
333-258869 |
10.7 | September 22, 2021 | |||||
10.12 | SAB Stockholders Support Agreement. | S-4/A |
333-258869 |
10.8 | September 22, 2021 | |||||
10.13 | Third Amendment to Amended and Restated Lease Agreement | 10-K |
001-39871 |
10.13 | March 29, 2022 | |||||
16.1 | Letter to SEC from Marcum LLP | 8-K |
001-39871 |
16.1 | October 28, 2021 | |||||
21.1 | List of Subsidiaries | 8-K |
001-39871 |
21.1 | October 28, 2021 | |||||
23.1 | Consent of Mayer Hoffman McCann P.C. | |||||||||
23.2* | Consent of Dentons US LLP (included in Exhibit 5.1). | |||||||||
24.1 | Power of Attorney (included on a signature page of the initial filing of this Registration Statement) | |||||||||
101.INS | Inline XBRL Instance Document. | |||||||||
101.SCH | Inline XBRL Taxonomy Extension Schema Document. | |||||||||
101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document. | |||||||||
101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document. | |||||||||
101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document. |
Incorporated by Reference |
||||||||||
Exhibit Number |
Description |
Schedule/ Form |
File No. |
Exhibit |
Filing Date | |||||
101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document. | |||||||||
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). | |||||||||
107.1 | Filing Fee Table |
* | To be filed by amendment. |
+ | Schedules and exhibits have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The Company agrees to furnish supplementally a copy of any omitted schedule or exhibit to the SEC upon request. |
¥ | Indicates a management contract or compensatory plan, contract or arrangement. |
(a) | The undersigned registrant hereby undertakes as follows: |
(1) | To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement: |
(i) | To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933; |
(ii) | To reflect in the prospectus any facts or events arising after the effective date of the registration statement (the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; |
(iii) | To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement. |
(2) | That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
(3) | To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering. |
(4) | That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser, each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. Provided, however, that no statement made in a registration statement or |
prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of first use. |
(5) | That, for the purpose of determining any liability under the Securities Act of 1933 to any purchaser in the initial distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser: |
(i) | Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424; |
(ii) | Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant; |
(iii) | The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or our securities provided by or on behalf of the undersigned registrant; and |
(iv) | Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser. |
(b) | Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the undersigned pursuant to the foregoing provisions, or otherwise, the undersigned has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the undersigned of expenses incurred or paid by a director, officer or controlling person of the undersigned in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the undersigned will, unless in the opinion of our counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue. |
SAB BIOTHERAPEUTICS, INC. | ||
By: | /s/ Eddie Sullivan | |
Eddie Sullivan | ||
President and Chief Executive Officer |
Signature |
Title |
Date |
||||
/s/ Eddie J. Sullivan, Ph.D. |
President and Chief Executive Officer and Director (Principal Executive Officer) |
August 22, 2022 | ||||
Eddie J. Sullivan, Ph.D. | ||||||
/s/ Russell P. Beyer, MBA, CMA |
Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |
August 22, 2022 | ||||
Russell P. Beyer, MBA, CMA | ||||||
/s/ Samuel J. Reich |
Director and Executive Chairman | August 22, 2022 | ||||
Samuel J. Reich | ||||||
/s/ David Link, MBA |
Director | August 22, 2022 | ||||
David Link, MBA | ||||||
/s/ Christine Hamilton, MBA |
Director | August 22, 2022 | ||||
Christine Hamilton, MBA |
||||||
/s/ William Polvino, MD |
Director | August 22, 2022 | ||||
William Polvino, MD |
||||||
/s/ Jeffrey G. Spragens |
Director | August 22, 2022 | ||||
Jeffrey G. Spragens | ||||||
/s/ Scott Giberson |
Director | August 22, 2022 | ||||
Scott Giberson |
Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the inclusion in this Registration Statement on Form S-1 and related prospectus of our report dated March 29, 2022, with respect to the consolidated financial statements of SAB Biotherapeutics, Inc. and Subsidiaries as of December 31, 2021 and 2020 and for each of the two years in the period ended December 31, 2021, and to the reference to us under the heading Experts in the prospectus, which is part of this Registration Statement.
/s/ Mayer Hoffman McCann P.C.
San Diego, California
August 22, 2022
Exhibit 107.1
Calculation of Filing Fee Tables
FORM S-1
(Form Type)
SAB BIOTHERAPEUTICS, INC.
(Exact Name of Registrant as Specified in its Charter)
Table 1: Newly Registered and Carry Forward Securities
Security Type |
Security Class Title | Fee Calculation Rule |
Amount Registered |
Proposed Maximum Offering Price Per Unit |
Maximum Aggregate Offering Price |
Fee Rate | Amount of Registration Fee | |||||||||
Newly Registered Securities | ||||||||||||||||
Fees to Be Paid | Equity | Common Stock, par value $0.0001 per share (1)(2) |
457(o) | | | $23,000,000(3) | $0.0000927 | $2,132.10 | ||||||||
Fees to Be Paid | Equity | Warrants to purchase Common Stock (2)(4)(5) |
457(g) | | | | | | ||||||||
Fees to Be Paid | Equity | Common Stock issuable upon exercise of Warrants(1)(2)(5) |
457(o) | | | $28,750,000(3) | $0.0000927 | $2,665.13 | ||||||||
Total Offering Amounts | $51,750,000 | $4,797.23 | ||||||||||||||
Total Fees Previously Paid | | |||||||||||||||
Total Fee Offsets | | |||||||||||||||
Net Fee Due | $4,797.23 |
(1) | In addition to the shares of Common Stock set forth in this table, pursuant to Rule 416 under the Securities Act of 1933, as amended (the Securities Act), this registration statement also registers such indeterminate number of shares of Common Stock as may become issuable after the date hereof as a result of stock splits, stock dividends, or pursuant to the anti-dilution adjustment provisions of the Warrants registered hereby. |
(2) | Includes securities the underwriters have the option to purchase to cover over-allotments, if any. |
(3) | Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(o) under the Securities Act. |
(4) | No separate registration fee required pursuant to Rule 457(g) of the Securities Act. |