UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): March 15, 2021
THERAPEUTICS ACQUISITION CORP.
(Exact name of registrant as specified in its charter)
| Delaware | 001-39311 | 85-0800493 |
|
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
|
200 Berkeley Street, 18th Floor Boston, MA |
02116 |
| (Address of principal executive offices) | (Zip Code) |
(617) 778.2500
Registrant’s telephone number, including area code
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Registrant under any of the following provisions:
| x | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Class A common stock, par value $0.0001 | RACA | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 7.01 Regulation FD Disclosure.
On March 15, 2021, Therapeutics Acquisition Corp. d/b/a Research Alliance Corp. I (“RACA”) made available an investor webinar (the “Webinar”) with POINT BioPharma Inc. (“POINT”) regarding the proposed business combination (the “Business Combination”) between RACA and POINT.
Attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated into this Item 7.01 by reference is a transcript of the Webinar. A copy of the Business Combination Agreement (as it may be amended, supplemented or otherwise modified from time to time, the “Business Combination Agreement”), dated March 15, 2021, by and among RACA, Bodhi Merger Sub, Inc. and POINT, related to the Business Combination will be attached as an Amendment of Form 8-K/A to RACA’s Current Report on Form 8-K filed with the Securities and Exchange Commission (“SEC”) on March 15, 2021 within four (4) business days of the date thereof as Exhibit 2.1.
The foregoing (including Exhibit 99.1) is being furnished pursuant to Item 7.01 and will not be deemed to be filed for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise be subject to the liabilities of that section, nor will it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act.
Item 8.01 Other Events
The information included under Item 7.01 above is incorporated herein by reference.
Important Information About the Merger and Where to Find It
A full description of the terms of the Business Combination will be provided in the registration statement on Form S-4 (the “S-4 Registration Statement”) to be filed with the SEC by RACA, which will include a prospectus with respect to RACA’s securities to be issued in connection with the Business Combination and a proxy statement with respect to the stockholder meeting of RACA to vote on the Business Combination. RACA urges its investors, stockholders and other interested persons to read, when available, the preliminary proxy statement/prospectus as well as other documents filed with the SEC because these documents will contain important information about RACA, POINT and the Business Combination. After the S-4 Registration Statement is declared effective, the definitive proxy statement/prospectus to be included in the registration statement will be mailed to stockholders of RACA as of a record date to be established for voting on the proposed Business Combination. Once available, stockholders will also be able to obtain a copy of the S-4 Registration Statement, including the proxy statement/prospectus, and other documents filed with the SEC without charge, by directing a request to: Therapeutics Acquisition Corp., 200 Berkeley Street, 18th Floor, Boston, Massachusetts 02116. The preliminary and definitive proxy statement/prospectus to be included in the S-4 Registration Statement, once available, can also be obtained, without charge, at the SEC’s website (www.sec.gov).
Participants in the Solicitation
RACA and POINT and their respective directors and executive officers may be considered participants in the solicitation of proxies with respect to the Business Combination under the rules of the SEC. Information about the directors and executive officers of RACA is set forth in RACA’s final prospectus filed with the SEC pursuant to Rule 424(b) of the Securities Act on July 9, 2020, and is available free of charge at the SEC’s website at www.sec.gov or by directing a request to: Therapeutics Acquisition Corp., 200 Berkeley Street, 18th Floor, Boston, Massachusetts 02116. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of RACA’s stockholders in connection with the proposed Business Combination will be set forth in the registration statement containing the proxy statement/prospectus for the proposed Business Combination when it is filed with the SEC. These documents can be obtained free of charge from the sources indicated above.
Forward Looking Statements
This Current Report contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Current Report, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this Current Report include, but are not limited to, statements regarding the proposed Business Combination, including the timing and structure of the Business Combination, the proceeds of the Business Combination, the initial market capitalization of the combined company following the Closing and the benefits of the Business Combination, as well as statements about the potential attributes and benefits of POINT’s product candidates and the format and timing of POINT’s product development activities and clinical trials. We cannot assure you that the forward-looking statements in this Current Report will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, the ability to complete the Business Combination due to the failure to obtain approval from RACA’s stockholders or satisfy other closing conditions in the Business Combination Agreement, the occurrence of any event that could give rise to the termination of the Business Combination Agreement, the ability to recognize the anticipated benefits of the Business Combination, the outcome of any legal proceedings that may be instituted against RACA or POINT following announcement of the proposed Business Combination and related transactions, the impact of COVID-19 on POINT’s business and/or the ability of the parties to complete the Business Combination, the ability to obtain or maintain the listing of RACA’s Class A Common Stock on Nasdaq following the proposed Business Combination, costs related to the proposed Business Combination, changes in applicable laws or regulations, the possibility that RACA or POINT may be adversely affected by other economic, business, and/or competitive factors. and other risks and uncertainties, including those to be included under the header “Risk Factors” in the S-4 Registration Statement to be filed by RACA with the SEC and those included under the header “Risk Factors” in the final prospectus of RACA related to its initial public offering. Most of these factors are outside RACA’s and POINT’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this Current Report represent our views as of the date of this Current Report. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Current Report.
No Offer or Solicitation
This Current Report is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed Business Combination and shall not constitute an offer to sell or a solicitation of an offer to buy any securities, nor shall there be any sale of securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
|
Exhibit Number |
Description | |
| 99.1 | Transcript of Webinar, dated March 15, 2021. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: March 15, 2021 | THERAPEUTICS ACQUISITION CORP. | |
| By: | /s/ Matthew Hammond | |
| Name: | Matthew Hammond | |
| Title: | Chief Financial Officer | |
Exhibit 99.1
Public Investor Presentation Transcript
Ari Shomair (Point VP Corporate Affairs & Strategy):
Slide 1
Hello and thank you for joining us. The purpose of today’s call is to provide an overview of the proposed merger of POINT Biopharma with Research Alliance Corp. I, a special purpose acquisition company sponsored by RA Capital.
Joining us on the call today are Dr. Joe McCann, CEO and co-founder of POINT Biopharma, and Peter Kolchinsky, CEO of Research Alliance Corp. I, as well as a founder and managing partner at RA Capital.
Please note that today’s presentation is neither an offering of securities nor a solicitation of a proxy vote. The information discussed today is qualified in its entirety by the registration statement on Form S-4, containing a prospectus/proxy statement, that POINT Biopharma and Research Alliance Corp. I will file with the SEC in the near future. The shareholders of Research Alliance Corp. I are urged to read those filings carefully when they become available as they will contain important information about the proposed transaction.
A full press release regarding the proposed combination as well as any materials referenced on today’s call are available for download at POINTBiopharma.com. Additionally, during this call we will make certain forward-looking statements that reflect our current views related to our future financial performance, future events, and industry and market conditions, as well as forward-looking statements related to the business combination, including the timing, proceeds and benefits of the transaction, as well as statements about:
- The timing and success of various clinical programs and drug approvals
- The scale and accessibility of market opportunities; and
- The cash position and plans of the combined company.
Commentary on these topics constitutes forward-looking statements within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act. We refer you to the registration statement on Form S-4 that will be filed in the near future and made available on the SEC’s website. The registration statement on Form S-4 will contain additional information on risks and uncertainties that could influence actual results and cause them to differ materially from our current expectations, particularly those in the section titled “Risk Factors”.
I will now pass the mic to Peter to provide a short introduction on Research Alliance Corp. I’s decision to propose a business combination with POINT.
Peter Kolchinsky (Research Alliance Corp. I CEO):
Good morning. When we decided to form our SPAC last year the intent was to provide a company-friendly path to the public markets for high quality healthcare companies that aim to address major healthcare challenges and require significant capital investment. Today we are excited to announce our merger with Point Biopharma, a Phase 3 radiopharmaceutical company with a deep pipeline of product candidates that we believe have great potential to transform the future standard of care for prostate cancer, neuroendocrine tumors, and beyond. In a space as specialized as radiopharmaceuticals, we believe it is critical for companies to manage their own manufacturing infrastructure in-house.
Today’s merger announcement and PIPE financing will properly capitalize POINT to allow the team to develop its lead programs through late stage clinical trials while simultaneously building out a manufacturing facility that will enable POINT to control its own destiny. We are excited to be along for the ride.
Slide 2
And now I will pass it off to Joe.
Slide 3
Joe McCann (Point CEO):
Thank you Peter, and welcome everyone. I am excited today to introduce you all to POINT.
Radiopharmaceuticals, if you are not familiar with them, have been used for decades in the treatment of late-stage cancer. Substantial clinical data has shown they are a safe and effective way to treat this disease. Yet radiopharmaceuticals are currently only available for a very small number of cancers, and can be difficult for patients to access.
We founded POINT to make radiopharmaceuticals applicable to more cancers, available to more people, thereby improving the lives of cancer patients and their families everywhere. The way we are doing this is by building a platform for the development and commercialization of radiopharmaceuticals, which addresses the major complexities that have held this drug class back.
Slide 4
I have borne witness to these complexities firsthand, having spent the last 11 years working in the radiopharmaceutical industry, most recently as CEO of a world leading radiopharmaceutical contract manufacturer. It was from that experience that it became clear that the only way radiopharmaceuticals will ever reach their full potential is if a company was created focused on them, and we have created that company with POINT.
Joining me as one of the founders of this company is Dr. Neil Fleshner, our chief medical officer. Neil is an internationally recognized uro-oncologist at Princess Margaret Hospital in Toronto, a top cancer research hospital globally, and an early supporter of the potential for radiopharmaceutical treatments for prostate cancer.
We are also fortunate to have two leaders in the radiopharmaceutical space. Jessica Jensen is our Executive Vice President of Clinical Development. Jessica has extensive experience in pharmaceutical development, most recently leading the development of cutting edge radiopharmaceuticals. Todd Hockemeyer is our EVP, US Manufacturing Operations. Todd has had tremendous success leading the buildout of facilities and is leading our Indianapolis operations.
Our Chief Commercial Officer Michael Gottlieb comes from Sanofi Genzyme, where he headed the Rare Disease Franchise for Canada, and our CFO Bill Demers spent the majority of his career at Ernst and Young, where he was an Assurance Partner & the National IPO Leader for Canada.
We also have a very strong Board of Directors with a broad range of expertise, including executives from established pharmaceutical companies and public company management. Our board is chaired by Allan Silber, a recognized leader in pharmaceutical and healthcare organizations, as well as a co-founder of POINT.
POINT has raised a total of $45 million to-date through private equity financings and achieved some very significant milestones including assembling a team of leading experts in the radiopharmaceuticals field, beginning construction of our 80,000 sq ft radiopharmaceutical manufacturing center, securing redundant radioisotope supply, and finally assembling our pipeline with two Phase 3 programs, two early-stage programs, and one very exciting platform technology. I look forward to sharing with you more about each of these significant milestones.
Slide 5
To begin, let’s confirm what we are talking about when we say precision radiopharmaceuticals. Many cancer cells have characteristics that can be used as a target for treatment delivery. What POINT does is design treatments which use those characteristics as targets to guide the precision delivery of radiation to the cancer cells.
The images you see on slide 5 are a real-life example of this, our PNT2002 prostate cancer therapy in action. Prostate cancer cells heavily express an enzyme called PSMA, which is not found in high volumes in healthy tissue. Our PNT2002 program combines a ligand which is an inhibitor of the PSMA enzyme, linked to the radioisotope lutetium-177. When PNT2002 is administered to a patient, the ligand seeks out the prostate cancer cells via their expression of PSMA and delivers the radioactive payload directly to the cancer cells, minimizing the collateral damage to healthy tissue. Our therapies use isotopes that do not require specialized infrastructure for patient treatment such as lead lined rooms that other isotopes such as iodine-131 require.
Slide 6
On slide 6 we have our pipeline of very exciting radiopharmaceuticals.
PNT2002 is the PSMA targeting radioligand shown on the previous slide, and is currently enrolling patients into a Phase 3 clinical trial in metastatic castration resistant prostate cancer and our product is being positioned prior to the use of chemotherapy.
PNT2003 is a DOTATATE based compound that is completing a Phase 3 trial for patients with neuroendocrine cancer. We are preparing to present exciting interim data to the FDA in the 3Q of 2021.
We also have two programs in pre-clinical development:
PNT2001 is a next generation PSMA targeting radioligand being optimized for earlier usage in the treatment of Prostate Cancer.
PNT2004 is a tissue-agnostic radioligand which targets Fibroblast Activation Protein-α, a characteristic enzyme found in the majority of tumors but not healthy tissue.
And finally we are also working on a prodrug platform activated in the tumor microenvironment. We are planning to combine this platform with an array of targeting molecules to create an expansive pipeline of next generation radioligands.
Slide 7
One of the key insights which lead to POINT’s creation is that radiopharmaceutical usage has been limited by insufficient investment in supply chains and manufacturing. Radiopharmaceuticals are not like other drugs – they are manufactured just-in-time due to shelf lives that are typically no more than a week. To address these complexities POINT is building a fully integrated radiopharmaceutical platform to increase the potential for success of our programs.
The nucleus of our radiopharmaceutical platform is our manufacturing capabilities. We’re currently constructing one of the world’s largest radioligand manufacturing facilities in Indianapolis, IN – an 80,000 sq ft facility that will be able to accommodate a wide variety of medical isotopes, including alpha and beta emitters. We also plan on producing medical isotopes themselves at this facility for our products, both to further strengthen our supply chain as well as reduce our cost of goods.
The facility is strategically located in Indianapolis, less than 30 minutes from the FedEx hazardous materials shipping hub, enabling this facility to service all of North America as well as many international destinations, well within the shelf-lives of our products.
The facility construction is on schedule – we expect it to be complete and fully licensed shortly, with the first clinical dose of PNT2002 shipping from the facility in Q4 of this year.
Slide 8
As described earlier, PNT2002 is our Prostate Cancer radioligand that targets PSMA. We are currently enrolling patients in our Phase 3 trial.
Slide 9
Metastatic prostate cancer continues to be an area of unmet need as nearly all men at this stage succumb to the disease. New molecules that target novel mechanisms of action, such as PSMA targeting, are needed in order to improve and extend patients’ lives.
Slide 10
We believe that PNT2002 is a potential solution. Moving to Slide 10, Our product candidate is based on the well studied PSMA-I&T ligand which has been shown to be safe and effective in academic settings. There is a wealth of data published on this compound, including a prospective study in 56 men where they experienced PSA declines and disease progression rates were 13.7 months. Side effects were mild and resolved post treatment. We leveraged these outcomes as the basis for safety and efficacy for our Phase 3 trial.
Slide 11
Our trial is comparing the use of PNT2002 versus the existing 2nd line androgen receptor axis-targeted therapy options: enzalutamide and abiraterone. This second line option has been shown to have progression rates between 3 to 4 months, which are significantly less than what was seen with our PNT2002 compound.
We’re excited to have the opportunity to develop this new option for men.
Slide 12
Jumping to slide 13, our second Phase 3 program is PNT2003 which targets somatostatin receptors for the treatment of a group of orphan cancers classified as neuroendocrine tumors or NETs.
Slide 13
The treatment of NETs with radioligands has been validated by Novartis’ Lutathera which generated global revenues of $445M last year and over $1B since approval in 2018.
PNT2003 is based on the same targeting ligand as Lutathera called DOTATATE. We are pursuing a subclass of NETs excluded from the Lutathera label where there is a need for a targeted therapy. We are also using unique intellectual property for the production of our product candidate that includes the use of a purer source of the lutetium-177 radioisotope, which does not have long-lived radiochemical impurities that can complicate handling in the clinic.
Slide 14
Combined we are aiming to help patients that don’t have access to DOTATATE based therapies and to eliminate obstacles for clinics using these therapies.
PNT2003’s trial is now fully enrolled, and we recently had an interim data review which was highly encouraging.
Slide 15
Based on that interim data, the primary endpoint exceeds the pre-specified success threshold, and appear to be an improvement on currently approved therapies for our target indication. We are planning to meet with the FDA in 3Q2021.
Slide 16
Our next program is PNT2001, starting on slide 17. The goal of the PNT2001 program is to develop a ligand that can move targeted radioligand therapy much earlier in the treatment of prostate cancer.
Slide 17
To do this we need PSMA targeting ligands that significantly reduce the risk of long-term radiotoxicity effects which will manifest at least 5 years after treatment. In the metastatic space this is not a concern because unfortunately patients do not live long enough to experience these effects.
In early-stage prostate cancer, life expectancy is 15 years or more, which is a sufficient time for these radiotoxicities to manifest. With PNT2001, we are modifying the PSMA targeting ligand to increase tumor uptake such that we can use less radioisotope which will reduce off target exposure and the risk of long-term radiotoxicity. Such an approach could even enable powerful alpha emitters like actinium-225 to be used in prostate cancer treatment.
Slide 18
Early data collected on compound leads in animal models demonstrated a significant increase in tumor uptake. POINT is currently developing the lead compound and we expect to initiate IND-enabling studies in 2022.
Slide 19
PNT2004, featured on slide 20, is an incredibly exciting radioligand.
Slide 20
It is unique from our other programs in that it does not target a marker specific to a cancer, but rather targets a marker present in most solid tumors, Fibroblast Activated Protein-α, or FAP. FAP is expressed in >90% of tumors either on the fibroblasts within the tumor microenvironment or on the tumor cells, as can be seen by these images.
Slide 21
PNT2004 is showing some very positive results in preclinical biodistribution, tumor growth and survival studies. The data generated is quite favorable, with low off target accumulation of the radioligand, clear anti-tumor activity and prolonged survival in the mouse model. Based on these promising results we plan to move towards phase 1 trials in 2022.
Slide 22
The last program I want to tell you about is on slide 23 – it is not a single drug but rather a prodrug platform that can be applied to enhance the therapeutic index of existing and novel radiopharmaceuticals.
Slide 23
The way it does this is by applying a substrate to the ligand that blocks its ability to bind to receptors outside of tumors. That substrate is then only cleaved off once it encounters the FAP present in the tumor microenvironment. Our belief is the application of this technology will increase the therapeutic index of existing radioligands, as well as opening up the door to develop a pipeline next-generation products.
Slide 24
In summary, I am tremendously proud of what we at POINT have accomplished to date, and even more excited about what lays ahead.
Slide 25
| - | I strongly believe the team we have assembled is one of the most experienced and qualified radiopharmaceutical teams globally, with demonstrated success that spans clinical development and manufacturing across many different isotopes |
| - | Our team’s relationships and experience in radiopharmaceuticals significantly strengthen our business and we believe it will accelerate our progress |
| - | With our upfront investment in supply chain and manufacturing, we are addressing many of the other challenges associated with commercializing radiopharmaceuticals. |
| - | Our broad pipeline of programs contains late-stage assets in large, established markets which we believe should lead to a straightforward path to revenue |
| - | Our early-stage pipeline has some incredibly exciting compounds that could revolutionize the role of radiopharmaceuticals in cancer care. |
Slide 26
We’re very excited about the proposed merger as it will sufficiently capitalize the company to bring our production facility online and bring our late-stage programs to commercialization, while at the same time pushing forward our early stage pipeline. Fundraising is a very time consuming activity for the management team, and this proposed merger will enable our management team to focus on the work which drives us all, bringing to market new cancer treatments that will improve the lives of patients and their families everywhere.
Thank you everyone for taking the time to listen to our story today, and I look forward to communicating with you as we complete this merger and work towards accelerating precision medicine. Thank you.